11136_2015_963_MOESM1_ESM.docx - Springer Static …10.1007/s111… · Web...

Systematic content evaluation and review of measurement properties of

questionnaires for measuring self-reported fatigue among older people

ONLINE RESOURCE 1. Search strategies:

a) Stage 1 search to identify fatigue questionnaires.

PubMed (January 30, 2015)

#1 Fatigue/diagnosis[mh] OR Asthenia/diagnosis[mh]

#2 fatigue[ti] OR astheni* [ti] OR lassitude[ti] OR tired*[ti] OR exhaustion[ti] OR weariness[ti] OR letharg*[ti]

#31

Instrumentation[sh] OR Methods[sh] OR “Validation Studies”[pt] OR “Psychometrics”[mh] OR psychometr*[tiab] OR clinimetr*[tw] OR clinometr*[tw] OR “Observer variation”[mh] OR “observer variation”[tiab] OR “Health Status Indicators”[mh] OR “Reproducibility of results”[mh] OR reproducib*[tiab] OR “Discriminant analysis”[mh] OR reliab*[tiab] OR unreliab*[tiab] OR valid*[tiab] OR coefficient[tiab] OR homogeneity[tiab] OR homogeneous[tiab] OR “internal consistency”[tiab] OR (cronbach*[tiab] AND (alpha[tiab] OR alphas[tiab])) OR (item[tiab] AND (correlation*[tiab] OR selection*[tiab] OR reduction*[tiab])) OR agreement[tiab] OR precision[tiab] OR imprecision[tiab] OR “precise values”[tiab] OR test–retest[tiab] OR (test[tiab] AND retest[tiab]) OR (reliab*[tiab] AND (test[tiab] OR retest[tiab])) OR stability[tiab] OR interrater[tiab] OR inter-rater[tiab] OR intrarater[tiab] OR intra-rater[tiab] OR intertester[tiab] OR inter-tester[tiab] OR intratester[tiab] OR intra-tester[tiab] OR interobserver[tiab] OR inter-observer[tiab] OR intraobserver[tiab] OR intra-observer[tiab] OR intertechnician[tiab] OR inter-technician[tiab] OR intratechnician[tiab] OR intra-technician[tiab] OR interexaminer[tiab] OR inter-examiner[tiab] OR intraexaminer[tiab] OR intra-examiner[tiab] OR interassay[tiab] OR inter-assay[tiab] OR intraassay[tiab] OR intra-assay[tiab] OR interindividual[tiab] OR inter-individual[tiab] OR intraindividual[tiab] OR intra-individual[tiab] OR interparticipant[tiab] OR inter-participant[tiab] OR intraparticipant[tiab] OR intra-participant[tiab] OR kappa[tiab] OR kappa’s[tiab] OR kappas[tiab] OR repeatab*[tiab] OR ((replicab*[tiab] OR repeated[tiab]) AND (measure[tiab] OR measures[tiab] OR findings[tiab] OR result[tiab] OR results[tiab] OR test[tiab] OR tests[tiab])) OR generaliza*[tiab] OR generalisa*[tiab] OR concordance[tiab] OR (intraclass[tiab] AND correlation*[tiab]) OR discriminative[tiab] OR “known group”[tiab] OR ”Factor Analysis, Statistical”[mh] OR “factor analysis”[tiab] OR “factor analyses”[tiab] OR dimension*[tiab] OR (multitrait[tiab] AND scaling[tiab] AND (analysis[tiab] OR analyses[tiab])) OR “item discriminant”[tiab] OR “interscale correlation”[tiab] OR “interscale correlations”[tiab] OR error[tiab] OR errors[tiab] OR “individual variability”[tiab] OR (variability[tiab] AND (analysis[tiab] OR values[tiab])) OR (uncertainty[tiab] AND (measurement[tiab] OR measuring[tiab])) OR “standard error of measurement”[tiab] OR sensitiv*[tiab] OR responsive*[tiab] OR ((minimal[tiab] OR minimally[tiab]) AND (important[tiab] OR significant[tiab] OR detectable[tiab]) AND (change[tiab] OR difference[tiab])) OR (small*[tiab] AND (real[tiab] OR detectable[tiab]) AND (change[tiab] OR difference[tiab])) OR “meaningful change”[tiab] OR “ceiling effect”[tiab] OR “floor effect”[tiab] OR “Item response model”[tiab] OR IRT[tiab] OR Rasch[tiab] OR “Differential item functioning”[tiab] OR DIF[tiab] OR “computer adaptive testing”[tiab] OR “item bank”[tiab] OR “cross-cultural equivalence”[tiab]

#4 “Validation Studies”[pt] OR “Psychometrics”[mh] OR psychometr*[tiab] OR clinimetr*[tw] OR clinometr*[tw] OR “Observer variation”[mh] OR “observer variation”[tiab] OR propert*[ti] OR“Reproducibility of results”[mh] OR ”Reference Values”[mh] OR reproducib*[tiab] OR “Discriminant analysis”[mh] OR reliab*[tiab] OR unreliab*[tiab] OR validity[tiab] OR

1 Based on Terwee CB et al 2009 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744791/

1

validation[tiab] OR “internal consistency”[tiab] OR precision[tiab] OR imprecision[tiab] OR “precise values”[tiab] OR test–retest[tiab] OR (test[tiab] AND retest[tiab]) OR ”Factor Analysis, Statistical”[mh]

#5

Analy*[ti] OR assess[ti] OR assessment*[ti] OR assessing[ti] OR checklist*[ti] OR Diagnostic Self Evaluation[mh] OR evaluat*[ti] OR index[ti] OR instrument[ti] OR instruments[ti] OR interview*[ti] OR measure[ti] OR measurement*[ti] OR measures[ti] OR "Neuropsychological tests"[mh:noexp] OR "patient report"[ti] OR "patient reported"[ti] OR "Psychological tests" [mh:noexp] OR quantifying[ti] OR quantification[ti] OR questionnaire*[ti] OR Questionnaires[mh] OR scale[ti] OR scales[ti] OR score[ti] OR scores[ti] OR screening[ti] OR "Self report"[mh] OR "Self-assessment"[mh] OR self-assess*[ti] OR self-rating[ti] OR "self report"[ti] OR "self reported"[ti] OR subscale*[ti] OR sub-scale*[ti] OR subtest*[ti] OR test[ti] OR tests[ti] OR testing[ti] OR tool[ti] OR tools[ti]

#6Fatigue/therapy[mh] OR Asthenia/therapy[mh] OR "Fibromyalgia/therapy"[mh] OR "Fatigue Syndrome, Chronic/therapy"[mh] OR "Occupational Diseases"[mh] OR Work[mh] OR "Dentistry"[mh] OR Exercise"[mh] OR "Sports"[mh] OR "exercise therapy"[mh] OR "Athletes"[mh] OR dental journals[sb] OR "Automobile driving"[mh]

#7 ((child[mh] OR adolescent[mh]) NOT adult[mh]) OR (animals[mh] NOT humans[mh])

#8“addresses”[pt] OR “biography”[pt] OR “case reports”[pt] OR “comment”[pt] OR “directory”[pt] OR “editorial”[pt] OR “festschrift”[pt] OR “interview”[pt] OR “lectures”[pt] OR “legal cases”[pt] OR “legislation”[pt] OR “letter”[pt] OR “news”[pt] OR “newspaper article”[pt] OR “patient education handout”[pt] OR “popular works”[pt] OR “congresses”[pt] OR “consensus development conference”[pt] OR “consensus development conference, nih”[pt] OR “practice guideline”[pt]

#9 (#1 AND #3) OR (#2 AND #4 AND #5)#10 #9 NOT (#6 OR #7 OR #8)

PsycINFO (OvidSP) 1806 to January 30, 2015

#1 (fatigue or tiredness or inertia or anergia or vitality or energy or weariness or frailty or asthenia or lassitude or lethargy).tm.

#2 (fatigue or tiredness or inertia or anergia or vitality or energy or weariness or frailty or asthenia or lassitude or lethargy).ti.

#3Rating scales/ or Psychometrics/ or Test Validity/ or Test Reliability/ or Test standardization/ or Interrater Reliability/ or "Error of measurement"/ or Test construction/ or exp Test bias/ or "Consistency (measurement)"/

#4 "Tests & Testing ".cc.#5 (1 and 3) or (2 and 4)

b) Stage 2 search to identify studies investigating measurement properties of included

questionnaires.

MEDLINE (OvidSP) 1946 to 2015 January 28

#1

(Brief Fatigue Inventory or Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire or Cancer related fatigue distress scale or "Fatigue Associated with Depression Questionnaire" or Fatigue Impact Scale or Fisk Fatigue Severity Score or Fatigue Pictogram or "Functional Assessment of Chronic Illness Therapy fatigue" or FACT Fatigue or FACIT Fatigue or Modified Fatigue Impact Scale or MFI-21 or MFI21 or Parkinson Fatigue Scale or PFS-16 or PFS16 or (PROMIS and Fatigue) or ((SF36 or SF 36) and (vitality scale or vitality subscale or vitality sub-scale)) or Symptom Fatigue Scale or Perform Questionnaire or Unidimensional Fatigue Impact Scale).mp.

2

#2

(Brief Fatigue Inventory or Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire or Cancer related fatigue distress scale or "Fatigue Associated with Depression Questionnaire" or Fatigue Impact Scale or Fisk Fatigue Severity Score or Fatigue Pictogram or "Functional Assessment of Chronic Illness Therapy fatigue" or FACT Fatigue or FACIT Fatigue or Modified Fatigue Impact Scale or MFI-21 or MFI21 or Parkinson Fatigue Scale or PFS-16 or PFS16 or (PROMIS and Fatigue) or ((SF36 or SF 36) and (vitality scale or vitality subscale or vitality sub-scale)) or Symptom Fatigue Scale or Perform Questionnaire or Unidimensional Fatigue Impact Scale).ti.

#3(Instrumentation or Methods).fs. or Validation Studies.pt. or Psychometrics/ or Observer variation/ or Health Status Indicators/ or Reproducibility of results/ or Discriminant analysis/ or Factor Analysis, Statistical/

#4

(psychometr* or clinimetr* or clinometr* or observer variation or reproducib* or reliab* or unreliab* or valid* or coefficient or homogeneity or homogeneous or internal consistency or agreement or precision or imprecision or precise values or test-retest or stability or interrater or inter-rater or intrarater or intra-rater or intertester or inter-tester or intratester or intra-tester or interobserver or inter-observer or intraobserver or intra-observer or intertechnician or inter-technician or intratechnician or intra-technician or interexaminer or inter-examiner or intraexaminer or intra-examiner or interassay or inter-assay or intraassay or intra-assay or interindividual or inter-individual or intraindividual or intra-individual or interparticipant or inter-participant or intraparticipant or intra-participant or kappa or kappa's or kappas or repeatab* or discriminative or known group or factor analys* or dimension* or item discriminant or interscale correlation* or error or errors or individual variability or "standard error of measurement" or sensitiv* or responsive* or meaningful change or ceiling effect or floor effect or Item response model or IRT or Rasch or differential item functioning or computer adaptive testing or item bank or cross cultural equivalence or generaliza* or generalisa* or concordance).ti,ab.

#5

((cronbach* adj2 (alpha or alphas)) or (item adj2 (correlation* or selection* or reduction*)) or (test adj5 retest) or ((replicab* or repeated) adj2 (measure* or findings or result or results or test or tests)) or intraclass correlation* or multitrait scaling analys* or (variability analysis or variability values) or (uncertainty adj2 (measurement or measuring)) or (minimal* adj2 (important or significant or detectable) adj2 (change or difference)) or (small* adj2 (real or detectable) adj2 (change or difference))).ti,ab.

#6 1 and (3 or 4 or 5)#7 2 or 6

PsycINFO (OvidSP) 1806 to 2015 January 28

#1

(Brief Fatigue Inventory or Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire or Cancer related fatigue distress scale or "Fatigue Associated with Depression Questionnaire" or Fatigue Impact Scale or Fisk Fatigue Severity Score or Fatigue Pictogram or "Functional Assessment of Chronic Illness Therapy fatigue" or FACT Fatigue or FACIT Fatigue or Modified Fatigue Impact Scale or MFI-21 or MFI21 or Parkinson Fatigue Scale or PFS-16 or PFS16 or (PROMIS and Fatigue) or ((SF36 or SF 36) and (Vitality)) or Symptom Fatigue Scale or Perform Questionnaire or Unidimensional Fatigue Impact Scale).mp.

#2

(Brief Fatigue Inventory or Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire or Cancer related fatigue distress scale or "Fatigue Associated with Depression Questionnaire" or Fatigue Impact Scale or Fisk Fatigue Severity Score or Fatigue Pictogram or "Functional Assessment of Chronic Illness Therapy fatigue" or FACT Fatigue or FACIT Fatigue or Modified Fatigue Impact Scale or MFI-21 or MFI21 or Parkinson Fatigue Scale or PFS-16 or PFS16 or (PROMIS and Fatigue) or ((SF36 or SF 36) and (Vitality)) or Symptom Fatigue Scale or Perform Questionnaire or Unidimensional Fatigue Impact Scale).ti.

#3Rating scales/ or Psychometrics/ or Test Validity/ or Test Reliability/ or Test standardization/ or Interrater Reliability/ or "Error of measurement"/ or Test construction/ or exp Test bias/ or "Consistency (measurement)"/

3

#4 "Tests & Testing ".cc.

#5

(psychometr* or clinimetr* or clinometr* or observer variation or reproducib* or reliab* or unreliab* or valid* or coefficient or homogeneity or homogeneous or internal consistency or agreement or precision or imprecision or precise values or test-retest or stability or interrater or inter-rater or intrarater or intra-rater or intertester or inter-tester or intratester or intra-tester or interobserver or inter-observer or intraobserver or intra-observer or intertechnician or inter-technician or intratechnician or intra-technician or interexaminer or inter-examiner or intraexaminer or intra-examiner or interassay or inter-assay or intraassay or intra-assay or interindividual or inter-individual or intraindividual or intra-individual or interparticipant or inter-participant or intraparticipant or intra-participant or kappa or kappa's or kappas or repeatab* or discriminative or known group or factor analys* or dimension* or item discriminant or interscale correlation* or error or errors or individual variability or "standard error of measurement" or sensitiv* or responsive* or meaningful change or ceiling effect or floor effect or Item response model or IRT or Rasch or differential item functioning or computer adaptive testing or item bank or cross cultural equivalence or generaliza* or generalisa* or concordance).ti,ab.

#6

((cronbach* adj2 (alpha or alphas)) or (item adj2 (correlation* or selection* or reduction*)) or (test adj5 retest) or ((replicab* or repeated) adj2 (measure* or findings or result or results or test or tests)) or intraclass correlation* or multitrait scaling analys* or (variability analysis or variability values) or (uncertainty adj2 (measurement or measuring)) or (minimal* adj2 (important or significant or detectable) adj2 (change or difference)) or (small* adj2 (real or detectable) adj2 (change or difference))).ti,ab.

#7 1 and (3 or 4 or 5 or 6)#8 2 or 7

Embase (OvidSP) 1980 to 2015 January 28

#1

(Brief Fatigue Inventory or Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire or Cancer related fatigue distress scale or "Fatigue Associated with Depression Questionnaire" or Fatigue Impact Scale or Fisk Fatigue Severity Score or Fatigue Pictogram or "Functional Assessment of Chronic Illness Therapy fatigue" or FACT Fatigue or FACIT Fatigue or Modified Fatigue Impact Scale or MFI-21 or MFI21 or Parkinson Fatigue Scale or PFS-16 or PFS16 or (PROMIS and Fatigue) or ((SF36 or SF 36) and (vitality scale or vitality subscale or vitality sub-scale)) or Symptom Fatigue Scale or Perform Questionnaire or Unidimensional Fatigue Impact Scale).mp.

#2

(Brief Fatigue Inventory or Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire or Cancer related fatigue distress scale or "Fatigue Associated with Depression Questionnaire" or Fatigue Impact Scale or Fisk Fatigue Severity Score or Fatigue Pictogram or "Functional Assessment of Chronic Illness Therapy fatigue" or FACT Fatigue or FACIT Fatigue or Modified Fatigue Impact Scale or MFI-21 or MFI21 or Parkinson Fatigue Scale or PFS-16 or PFS16 or (PROMIS and Fatigue) or ((SF36 or SF 36) and (vitality scale or vitality subscale or vitality sub-scale)) or Symptom Fatigue Scale or Perform Questionnaire or Unidimensional Fatigue Impact Scale).ti.

#3 Clinical assessment tool/ or scoring system/ or psychometry/ or measurement/ or rating scale/ or exp reliability/ or exp validity/ or validation study/ or valid*.ti.

#4 2 or (1 and 3)

CINAHL (EbscoHost 2015 January 28)

#1 TX ("Brief Fatigue Inventory" or "Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire" or "Cancer related fatigue distress scale" or "Fatigue Associated with Depression Questionnaire" or "Fatigue Impact Scale" or "Fisk Fatigue Severity Score" or "Fatigue Pictogram" or "Functional Assessment of Chronic Illness Therapy fatigue" or "FACT Fatigue" or "FACIT

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Fatigue" or "Modified Fatigue Impact Scale" or MFI-21 or MFI21 or "Parkinson Fatigue Scale" or PFS-16 or PFS16 or "PROMIS Fatigue" or ((SF36 or SF 36) and ("Vitality scale" or "vitality Subscale" or "vitality sub-scale")) or "Symptom Fatigue Scale" or "Perform Questionnaire" or "Unidimensional Fatigue Impact Scale")

#2

TI ("Brief Fatigue Inventory" or "Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire" or "Cancer related fatigue distress scale" or "Fatigue Associated with Depression Questionnaire" or "Fatigue Impact Scale" or "Fisk Fatigue Severity Score" or "Fatigue Pictogram" or "Functional Assessment of Chronic Illness Therapy fatigue" or "FACT Fatigue" or "FACIT Fatigue" or "Modified Fatigue Impact Scale" or MFI-21 or MFI21 or "Parkinson Fatigue Scale" or PFS-16 or PFS16 or "PROMIS Fatigue" or ((SF36 or SF 36) and ("Vitality scale" or "vitality Subscale" or "vitality sub-scale")) or "Symptom Fatigue Scale" or "Perform Questionnaire" or "Unidimensional Fatigue Impact Scale")

#3

MH ("Instrument Validation" OR "Clinical Assessment Tools" OR "Questionnaires" OR "Research Instruments" OR "Reproducibility of Results" OR "Validation Studies" OR "Test-Retest Reliability" OR "Pearson's Correlation Coefficient" OR "Spearman's Rank Correlation Coefficient" OR "Concurrent Validity" OR "Construct Validity" OR "Intraclass Correlation Coefficient" OR "Interrater Reliability" OR "Intrarater Reliability" OR "Kappa Statistic" OR "Instrument Construction")

#4 S2 OR (S1 AND S3)

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ONLINE RESOURCE 2. Content validity rating scale.

CONTENT VALIDITY RATING SCALE for the construct of self-reported FATIGUE

Questionnaire: ______________________________________ Rater: ___________

1. COMPREHENSIVENESSAre there any items in the questionnaire that appear to be in agreement with the main elements of the construct?

Construct element No Yes List of item numbers

1 A subjective feeling of generalized tiredness, weariness or exhaustion 0 22 Unpleasant, pervasive or overwhelming 0 23 Enduring or persistent 0 14 Abnormal, no apparent cause or non-functional (serves no purpose) 0 15a Affects physical functioning 0 ½5b Affects mental functioning 0 ½5c Affects emotional functioning 0 ½5d Affects social functioning 0 ½6 It is not, or only partially, relieved by rest, sleep or distraction 0 17 Creates a desire to rest or sleep and/or leads to rest-seeking behaviour 0 1

Score for agreement with construct definition: _____ /10Rating for comprehensiveness: _________________

Excellent = 9-10 Good = 7-8Fair = 5-6 Poor = < 5

2. RELEVANCE and SPECIFICITYa) Does the questionnaire measure other constructs? Item(s) that could be

measuring other constructs:

Item relates specifically to cognitive ability, low mood, or level of motivation (Asks level of depression or memory ability rather than whether mood or memory are affected by fatigue).Item relates specifically to feelings following physical activity (exertion fatigue) or intense mental activity.Item relates to sleepiness due to poor quality or quantity of sleep.Item relates to a specific disease process or treatment.Item relates to fatigue in the workplace or sporting context (ie. whether work or sport affects fatigue levels rather than how fatigue affects ability to work or play sport).Item relates to a problem not necessarily related to their fatigue (eg. muscle weakness from any cause).

b) Is the item consistent with the construct? Item(s) not consistent:

persistent but can be dynamic in nature unpleasant incorporates total body feeling ranging from tiredness to exhaustion, unrelenting , persistent, enduring generalized tiredness, weariness or exhaustion / overall condition

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interferes with individuals’ ability to function to their normal capacity pervasive, overwhelming abnormal, no apparent cause or non-functional (serves no purpose) affects physical, mental, emotional or social functioning not, or only partially, relieved by rest, sleep or distraction can create a desire to rest and/or leads to rest-seeking behaviour can have whole body feelings of weakness, clumsiness, slowness but must be

caused by the fatigue can have problems with memory, word finding, concentration but must be

caused by the fatigue

% with good relevance and specificity to the fatigue construct: _________Rating for relevance and specificity: ___________________________

Excellent = 100% items in agreement with the construct and no potential overlapGood = > 90% items in agreement with the construct and no potential overlapFair = > 80% items in agreement with the construct and no potential overlapPoor = ≤ 80% items in agreement with the construct and no potential overlap

3. SUITABILITY FOR OLDER PEOPLEa) Are all items relevant for the population and setting?Is the wording and content suitable for older people, either gender and in any setting?Item(s) not suitable:

Rating for item-level validity: ________________________ Excellent = all ‘Yes’Good = most ‘Yes’Fair = more than half are‘Yes’Poor = half or less than half are ‘Yes’

b) How many response options? ____________________[Older people are known to have difficulty with VAS scales and > 5 response options]

Rating for response options: ____________________Good = ≤ 5 Poor = > 5

Rating for suitability for older people: ____________________Excellent = Excellent + GoodGood = (Good or excellent) + GoodFair = (Fair or Good or Excellent) + (Poor or Good)Poor = Poor + any

OVERALL RATING FOR CONTENT:

EXCELLENT GOOD ADEQUATE INADEQUATEExcellent = all excellentGood = all good or excellent Adequate = at least fair for all categoriesInadequate = all others

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ONLINE RESOURCE 3. Exceptions to the COSMIN rating of methodological quality of studies, and

the rating of the measurement properties, which were applied in this review

1. All measurement properties. During our review we found that few papers reported the number of missing

items or how they were handled. Rather than rate all those studies as fair for all measurement properties,

where many studies would otherwise be rated higher, we disregarded this item when determining the

overall quality rating (COSMIN score) for all studies, and in the results tables we have identified the studies

where information on missing items was not reported.

2. Internal consistency. The scores for items relating to checking of uni-dimensionality were not included in

the final rating of methodological quality because a uni-dimensionality check was rarely performed and its

omission leads to a poor rating in an otherwise good study. There is sufficient evidence that fatigue can be

considered a uni-dimensional construct supporting the use of total scores, and dimensionality of each

questionnaire was assessed by at least one study in the review. However, where evidence supporting uni-

dimensionality of a questionnaire was lacking, the rating for methodological quality of the internal

consistency studies may be overestimated and the rating for internal consistency of the total score may be

inaccurate. In the best evidence synthesis table we have identified the internal consistency results that are

in doubt.

3. Hypothesis testing. We did not require studies to present multiple hypotheses or perform multiple

analyses to gain a score of ‘excellent’.

ONLINE RESOURCE 4. Best evidence synthesis.

To synthesize the results from multiple studies on the same performance test, a ‘best evidence synthesis’ was

performed using the criteria proposed by Terwee et al [1] for internal consistency, reproducibility,

measurement error, structural validity, hypothesis testing, and responsiveness as follows (content validity and

interpretability rated as +, -, 0 or ? only):

+++ or --- = strong evidence (consistent findings in multiple studies of good methodological quality or

in one study of excellent quality)

++ or -- = moderate evidence (consistent findings in multiple studies of fair methodological quality or

in one study of good quality)

+ or - = limited evidence (one study of fair methodological quality)

? = unclear or conflicting findings

0 = no information (no studies or only studies of poor quality)

(+ = positive and - = negative rating results)

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ONLINE RESOURCE 5. List of fatigue questionnaires excluded from content review.

Questionnaire Reason for exclusionAnergia scale (7 items) Diagnostic tool (does not generate a total score)Abbreviated Fatigue Questionnaire Same as (Dutch) Short Fatigue Questionnaire (SFQ).Brief Mental Fatigue Questionnaire Focus was on mental fatigue. No reports of measurement properties of the scale.Clinical Global Impressions (CGI) - Severity for fatigue

Not a self-report questionnaire. Rated by a clinician. Designed for assessment rather than measurement.

Fatigue Pictogram Designed as a screening tool, does not generate a total score, minimal data on measurement properties.

Fatigue and Symptom Distress Scale (FSDS)

Only one fatigue item.

Fatigue Symptom Checklist Developed for post-partum women.Fatigue Symptom Control Checklist Developed for use with worker-related fatigue (although used in one cancer study). No

reports of measurement properties.FibroFatigue Scale Single item for fatigue in multidimensional questionnaire.Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

Same as FACIT-Fatigue.

General Quality of Life (QGEN) – Vitality scale (VITY)

No studies reporting measurement properties in peer reviewed journal articles.

Global Fatigue Index Same as Multidimensional Assessment of Fatigue (MAF).Mental and Physical State and Trait Energy and Fatigue Scales

No published studies reporting measurement properties in peer reviewed journal articles.

Modified Fatigue Symptom Checklist Developed for post-partum women.Multi-Dimensional Fatigue Scale Developed for children.Myasthenia Gravis Fatigue Scale Unable to get the scale content. Little information about measurement properties.NRS-Fatigue Single item questionnaire.Patient Care Monitor (2.0) Administered electronically only. Designed for assessment rather than measurement.

Little information about measurement properties.Patient Global Impression - Severity of Fatigue

Single item questionnaire.

Polio Problem List (PPL) fatigue item Single fatigue item in a large multidimensional questionnaire.Quick Fatigue Assessment Survey (QFAS)

Insufficient information on properties. Only feasibility and acceptability assessed. Designed for assessment rather than measurement. Not able to generate a total score.

Real time digital fatigue scores Single item questionnaire.Rhoten Fatigue Scale Single item questionnaire.Sjogren's Systemic Clinical Activity Index (SCAI)

Single fatigue item in a larger questionnaire.

Somatic Symptom Questionnaire Five (SSQ-5G) – Fatigue subscale

No full-text studies reporting measurement properties in peer reviewed journal articles.

Swedish Occupational Fatigue Inventory (SOFI)

Designed for work/occupation-related fatigue.

Symptom Fatigue Scale No studies reporting measurement propertiesTask induced fatigue scale Related to carrying out a specific (driving) task.Trendall Fatigue Tool Observer rated.VAS for exertion fatigue Single item questionnaire.VAS – Fatigue Severity Same as Lee Fatigue Scale.

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ONLINE RESOURCE 6. Summary of results of content evaluation. Yellow = ‘adequate’, green =

‘good’, grey = inadequate but retained in the review. No questionnaires were given an ‘excellent

rating’.

Name of questionnaire Overall rating Rating for comprehensiveness

Rating for relevance

and specificity

Rating for item-level validity

≤5 response options

(Dutch) Short Fatigue Questionnaire (SFQ) Inadequate Poor Excellent Excellent PoorActivation-Deactivation Adjective Checklist (AD-ACL) - energy subscale Inadequate Poor Excellent Excellent Good

Avlund Fatigue Scales Inadequate Poor Poor Excellent GoodBarrow Neurological Institute Fatigue Scale (BNI-FS) Inadequate Fair Poor Good PoorBrief Fatigue Inventory (BFI) Adequate Good Excellent Excellent PoorBristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ) Good Good Good Excellent Good

Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) Inadequate Poor Excellent Excellent Poor

Cancer Fatigue Scale Inadequate Fair Poor Fair GoodCancer Related Fatigue Distress Scale (CRFDS) Adequate Good Good Excellent PoorChalder Fatigue Scale or Chalder Fatigue Questionnaire or Fatigue Questionnaire or Fatigue Scale or Fatigue Rating Scale (11 items)

Inadequate Poor Poor Excellent Good

Checklist Individual Strength (CIS20R) Inadequate Fair Poor Excellent PoorChecklist Individual Strength (CIS8R) Inadequate Poor Fair Excellent PoorDaily Fatigue Impact Scale (D-FIS) Inadequate Poor Excellent Excellent GoodDiabetes Symptom Checklist-Revised (DSC-R) - Fatigue subscale Inadequate Poor Excellent Excellent Good

Dutch Exertion Fatigue Scale Inadequate Poor Poor Excellent GoodDutch Fatigue Scale Inadequate Good Poor Good GoodDutch Multifactor Fatigue Scale Inadequate Excellent Poor Excellent GoodEmpirical Fatigue Scale Inadequate Poor Poor Excellent PoorEORTC QLQ-C30 Fatigue Inadequate Poor Poor Excellent GoodFatigue and Functional Impact Scale (FFIS) Inadequate Poor Good Excellent PoorFatigue Assessment Instrument (FAI) or Fatigue Severity Inventory Inadequate Good Poor Good Poor

Fatigue Assessment Questionnaire (FAQ) Inadequate Good Poor Excellent GoodFatigue Assessment Scale (FAS) Inadequate Fair Poor Excellent GoodFatigue Associated with Depression Questionnaire (FAsD and FAsD-V2) Adequate Fair Good Good Good

Fatigue Descriptive Scale (FDS) Inadequate Poor Good Good GoodFatigue Impact Scale (FIS) or Fisk Fatigue Severity Score Adequate Fair Fair Good GoodFatigue Scale for Motor and Cognitive Functions Inadequate Good Poor Good GoodFatigue scale of the Self-Care Symptom Management for Living with HIV/AIDS Scale SCSMS-F Inadequate Poor Excellent Excellent Poor

Fatigue Severity Scale (FSS) - 9 item (original) Inadequate Fair Good Good PoorFatigue Severity Scale (FSS) - 7 item Inadequate Poor Excellent Excellent PoorFatigue Severity Scale (FSS) - 5 item Inadequate Poor Excellent Excellent PoorFatigue Symptom Inventory (FSI) Inadequate Poor Excellent Excellent PoorFatigue, Anergia, Consciousness, Energised and Sleepiness Adjective Checklist (FACES) Inadequate Poor Good Good Good

Four Item Fatigue Scale (FIFS) Inadequate Poor Fair Excellent GoodFunctional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Inadequatea Good Poor Excellent Good

General Fatigue Scale Inadequate Poor Excellent Excellent PoorGlobal Vigour and Affect Inadequate Poor Fair Excellent PoorHIV-related Fatigue Scale (Barosso Fatigue Scale) Inadequate Excellent Poor Good PoorIdentity-Consequence Fatigue Scale Inadequate Poor Fair Excellent PoorIowa Fatigue Scale (IFS) Inadequate Poor Poor Good Good

10

Karolinska Exhaustion Scale (KES) Inadequate Good Poor Excellent PoorLee Fatigue Scale (LFS) or Lee Fatigue and Energy Scale Inadequate Poor Fair Excellent PoorLee Fatigue Scale (Short version) Inadequate Poor Excellent Excellent PoorManchester COPD Fatigue Scale Inadequate Good Poor Excellent GoodMaastricht Questionnaire Inadequate Fair Poor Good GoodMay and Kline Adjective Checklist Inadequate Poor Poor Excellent PoorME/CFS Fatigue Type Questionnaire (MFTQ) Inadequate Good Poor Excellent PoorMental Vitality Scale Inadequate Poor Poor Excellent GoodModified Fatigue Impact Scale (MFIS) Good Good Good Excellent GoodMS-specific FSS (MFSS) Inadequate Poor Fair Excellent PoorMultidimensional Assessment of Fatigue (MAF) Inadequate Poor Excellent Good PoorMultidimensional Fatigue Index-20 or Multidimensional Fatigue Inventory-20 (MFI-20 or MFI) Inadequate Fair Poor Excellent Good

Multidimensional Fatigue Symptom Inventory (MFSI) Inadequate Fair Poor Good PoorMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) Inadequate Poor Poor Excellent Good

Neurological Fatigue Index or NFI-MND or NFI-MS Inadequate Fair Poor Excellent GoodNottingham Health Profile (NHP) - energy category/subscale Inadequate Poor Excellent Excellent Good

Parkinson Fatigue Scale (PFS-16) Good Good Excellent Excellent GoodPearson & Byars Feeling Tone Checklist - Form A /Short Form 1 / original (3 versions) Inadequate Poor Excellent Excellent Good

Perform Questionnaire (PQ) Good Good Good Good GoodPerformance Scale – Fatigue Subscale Inadequate Poor Excellent Excellent PoorPrimary Sjogren's syndrome (PSS) Fatigue and Discomfort Questionnaire (Somatic Fatigue subscale, 12 items) OR Profile of Fatigue (ProF) (Somatic Fatigue subscale, 12 of the 16 items)

Inadequate Fair Poor Excellent Poor

Profile of Fatigue-Related Symptoms Inadequate Fair Poor Excellent PoorProfile of Mood States - Fatigue subscale (POMS-F) Inadequate Poor Excellent Excellent GoodPROMIS Fatigue SF7a Inadequate Poor Excellent Excellent GoodPROMIS Fatigue SF8a Adequate Fair Excellent Good GoodPsychological General Well Being Index (PGWBI) - Vitality subscale Inadequate Poor Good Excellent Poor

Revised Piper Fatigue Scale Inadequate Fair Poor Good PoorSchedule of Fatigue and Anergia (SOFA) Inadequate Poor Poor Excellent GoodSchwartz Cancer Fatigue Scale Inadequate Fair Poor Excellent GoodSF-36 - Vitality subscale Inadequatea Poor Excellent Excellent PoorSign and Symptom Checklist HIV (SSC-HIVrev) - Fatigue factor Inadequate Poor Poor Excellent Good

Situational Fatigue Scale Inadequate Poor Poor Good GoodSubjective Vitality Scale (Measure) Inadequate Poor Poor Good PoorSymptom Questionnaire (SQ-48) – Vitality subscale Inadequate Poor Poor Excellent GoodUni-dimensional Fatigue Impact Scale (U-FIS) Adequate Fair Fair Excellent GoodVAS scales for Asthenia Inadequate Poor Poor Excellent PoorWu Cancer Fatigue Scale Inadequate Fair Poor Excellent Good

a These scales almost scored adequate on the rating scale and were included because they were considered important due to widespread usage or other potential advantages.

11

ONLINE RESOURCE 7. Details of studies included in the review of measurement properties

Brief Fatigue Inventory (BFI):

Author Language Aim Propertiesa IRT Sample [sample size for test-retest reliability if different]

Setting, Country

Age of sampleMean (SD) unless otherwise stated

Gender mix% female

% missing items How missing items handled

Scores and distributionMean (SD) unless otherwise stated

Aynehchi etal, 2013*[2](+ modified version)

English Yes IC, RR, HT No Group 1: 52 head and neck cancer patients,Group 2: 57 age-matched controls without cancer from a general otolaryngology clinic

Outpatient clinic, USA

59.2 (12.8), range 26-86 51% - - Cancer patients: 3.1 (1.5),Controls: 2.4 (1.1)

Brown etal, 2010*[3]

English No HT No 30 palliative cancer patients with a planned blood transfusion

Inpatients or day therapy patients, UK

68, range 53-91 37% - - Pre-transfusion group: median 7.7 (range 1.9-10.0), Post-transfusion group: median 5.4 (range 0.6-8.9)

Catania etal, 2013*[4]

Italian Yes IC, SV, HT No 277 cancer patients Outpatient clinics, Italy

76 aged 18-50, 115 aged 51-64, 69 aged >65

approx. 60% 11.2% of participants had missing items

- 3.8 (2.4)

Chang etal, 2007*[5]

Korean Yes Int No 150 cancer patients experiencing fatigue

Hospitals, Korea 50.7 (11.3) 40% - - -

Hwang etal, 2003*[6]

English Yes IC, SV, HT No 180 cancer patients Inpatient and outpatient clinics, USA

Median 68 (range 30-89) - - - 2.5 (2.6)

Kramer etal, 2005*[7]

German No HT No Group 1: 120 patients with chronic hepatitis C infection,Group 2: 100 age-matched healthy controls

Liver clinic, Austria

Group 1: 45 (12),Group 2: 44 (13)

36% - - Chronic hepatitis C infection patients: 3.0 (2.2), median 2.9, range 0.8-11, Healthy controls: 1.6 (1.3)

Lin etal, 2006*[8]

Taiwanese

Yes IC, RR, SV, HT

No 439 cancer patients Oncology clinics and hospital inpatients, Taiwan

58.7 (13.7) 57% Very few missing data

- -

Mead etal, 2007[9]

English Yes Other (feasibility)

No 55 stroke patients Hospital and community, UK

Median 73 44% n/a n/a -

Mendoza etal, 1999[10]

English Yes IC, CV, SV, HT

No Group 1: 305 inpatients and outpatients with cancer,Group 2: 290 community-dwelling adult controls

Cancer center inpatients and outpatients, USA

Group 1: median 55 (range 18-88),Group 2: median 57 (range 17–100)

Group 1: 49%, Group 2: 30%

>98% of patients completed at least 5 items

Missing items replaced with mean of other items used provided as at least 5 items answered.

Cancer patients: 4.7 (2.8),Controls: 2.2 (1.8)

Mendoza etal, 2010[11]

Filipino Yes IC, SV, HT No Group 1: 206 patients with cancer,Group 2: 170 age-matched community-dwelling controls

Hospital clinics (inpatients and outpatients), Philippines

Group 1: median 47 (range 18-76),Group 2: median 45 (range 22-80)

Group 1: 68%, Group 2: 62%

Missing data rate of 0.05%.

n/a given low rate of missing values.

-

Mystakidou etal, 2008*[12]

Greek Yes IC, RR, SV, HT

No 102 patients with incurable cancer Palliative care unit, Greece

64.3 (11.6), range 39-84 46% - - -

Okuyama etal, 2003[13]

Japanese Yes IC, SV, HT No 252 cancer patients Outpatient clinics, Japan

62.5 (12.1) 42% 0.6% If there were any missing items, telephone inquiries were made to obtain the missing answers.

3.1 (2.4)

Radbruch etal, 2003*[14]

German Yes IC, RR, CV, SV, HT

No 117 patients with pain (22 with cancer pain, 95 with non-cancer pain) [101 for test-retest]

Pain clinic, Germany

Cancer patients: 59.5 (12.6),Non-cancer patients: 55.1 (14.4)

63% - - Patients with cancer pain: 4.4 (2.1), Patients with non-cancer pain: 4.6 (2.1)

Shuman-Paretsky etal, 2014*[15]

English Yes IC, SV, HT No 302 community-dwelling older adults Participants from a longitudinal cohort study

76.4 (7.0), range 65-95 54% - - Total score: 13.4 (14.0), BFI severity: 8.2 (6.7), BFI interference: 5.3 (9.0)

Wang etal, 2004*[16]

Chinese Yes IC, SV, HT, Int

No 249 cancer patients Hospital patients, China

51 (range 18-77) 54% - - Severity items: 4.4 (2.5), interference items: 3.6 (2.6)

Wolfe, 2004*[17]

English Yes IC, SV, Res No 7760 patients with RA [5155 for responsiveness]

Participants in other research study, USA

61.3 (12.5) 78% - - 3.4 (2.6)

Yun etal, 2005*[18]

Korean Yes IC, SV, HT No Group 1: 178 cancer patients,Group 2: 178 age and gender matched people without cancer

Hospitals, Korea Group 1: 51.1 (11.3),Group 2: 50.3 (11.0)

Group 1: 40%, Group 2: 40%

0.2% in cancer group, 1.0% in control group.

- -

Yun etal, 2008*[19]

Korean No IC, SV No 1000 population sample Population study, Korea

Range 20-79 with 5% >70 years

50% - - 3.4 (2.1)

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory, RA=Rheumatoid arthritis

Bristol Rheumatoid Arthritis Fatigue Questionnaire (BRAF MDQ):

12


Setting, Country


Gender mix% female

% missing items

How missing items handled


Dures etal, 2013[20]

English Yes RR, ME, Res, Int

No 142 patients with RA[Group 1: 50 for first test-retest, Group 2: 50 for second test-retest, Group 3: 42 for responsiveness study]

Outpatient clinic, UK

Group 1: 56.3(12.8), Group 2: 55.8 (13.6), Group 3: 56.7 (12.6)

Group 1: 72%, Group 2: 68%, Group 3: 81%

0.5% Missing data were handled according to the BRAF scoring instructions.

Study 1: 37.2 (16.8), Study 2: 36.0 (17.8), Study 3: 42.4 (14.7)

Nicklin etal, 2010a[21]


No 229 patients with RA Outpatient clinic, UK

<40 years: 10%,40–59 years: 38%, >60 years: 52%

76% assumed 0% If only one item missing, value was replaced by mean score for the other items.

38.4 (13.7)

Nicklin etal, 2010b[22]

English Yes CV No Group 1: 15 patients with RA (for construct descriptors), Group 2: 17 patients with RA (for focus groups), Group 3: 15 patients with RA (for cognitive interviews)

RA clinic, UK 55.6 (14.4) 80% n/a n/a -

Nicolaus etal, 2012[23]

Dutch Yes CV No 15 patients with RA (plus 10 rheumatologists and 20 nurses)

RA clinic, Netherlands

- - n/a n/a -

Oude Voshaar etal, 2015*[24]

Dutch Yes SV, HT, Int Yes 588 + 427 (retested) patients with RA Participants in other clinical trial, USA

60.2 (12.9) 67% - - 33.8 (12.9)

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory, RA=Rheumatoid arthritis

Cancer-related Fatigue Distress Scale (CRFDS):


Setting, Country


Gender mix% female

% missing items How missing items handled


Holley, 2000*[25]

English Yes IC, CV, SV No 221 adults with cancer Inpatients and outpatients, USA

59.6 (12.6) 55% - - -

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory

Fatigue Associated with Depression (FAsD) questionnaire:


Setting, Country


Gender mix% female

% missing items



Matza etal, 2011[26]

English Yes IC, RR, CV, SV, HT

No Group 1: 20 patients with depression (plus 14 psychiatrists and psychologists for content development),Group 2: 18 patients with depression (for cognitive debriefing interview study), Group 3: 317 patients with depression (for structural validity, reliability and hypothesis testing [only those with evidence of stable fatigue were included in test-retest analysis]

Outpatient clinics, USA

Group 1: 46.4,Group 2: 37.1,Group 3: 47.0 (13.0)


42% missing answers for items 12 and 13. 6 participants missing a response to one item. No participants missing more than one response.

Average of all available items used for score.

3.3 (0.9)

Matza etal, 2013*[27]

English Yes Res, Int (responder definition)

No 96 people with depression Private psychiatry clinics, USA

43.4 (11.4) 55% - - Baseline: 3.5 (0.8), Re-test: 2.8 (1.0)

Matza etal, 2015[28]

English Yes CV No Group 1: 31 patients with major depressive disorder(MDD) (focus groups), Group 2: 13 patients with MDD (cognitive interviews), Group 3: 16 patients with MDD (cognitive interviews)

Targeted sample with diverse ethnicity and no comorbidities, clinics and community, USA

Group 1: 44.5 (14.4),Group 2: 43.1 (8.7),Group 3: 44.8 (10.8)


n/a n/a -

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory

Fatigue Impact Scale (FIS):


Setting, Country


Gender mix% female

% missing items



Armutlu etal, 2007*[29]

Turkish Yes IC, RR, HT No Group 1: 71 people with MS,Group 2: 68 healthy subjects of similar ages and gender

Community sample, Turkey

Group 1: 38.6 (9.9), Group 2: 36.4 (9.3)

61% - - MS patients: 39.6 (24.2),Healthy adults: 20.2 (17.8)

Chipchase etal, 2003*[30]

English No HT No Group 1: 40 people with MS,Group 2: 20 healthy controls

Participants in other research study, UK

Group 1: 45 (8.3) Group 1: 58%

12% - MS group: cognitive median 12.0 , physical median 21.5, social median 29.0, Control group: cognitive median 3.0,

13

physical median 2.0, social median 6.0

Debouverie etal, 2007*[31]

French (version called EMIF-SEP)

Yes IC, RR, ME, SV

No 237 patients with MS [212 for test-retest]

Hospital outpatients, France

42.5 (10.9), range 18-73 71% - - Total score: 57.7 (22.1), cognitive: 45.8 (27.0), physical: 68.6(24.1), social functioning: 52.2 (24.7), psychological: 64.4 (26.2)(Note: Scores standardized to 0-100 scales for total and subscales. Subscales from this study’s factor analysis)

Fisk etal, 1994*[32]

English Yes IC, CV, HT No Group 1: 145 patients with chronic fatigue,Group 2: 105 people with MS,Group 3: 34 patients with mild hypertension

Hospital outpatient clinics, Canada



- - -

Flensner etal, 2005*[33]

Swedish Yes IC, HT No Group 1: 161 people with MS, Group 2: 194 general population

Community sample, Sweden

Group 1: 48.7 (10.1) Group 1: 77%

- Missing values replaced with medians.

MS group: median 71,Control group: median 13.5

Hassoun etal, 2002*[34]

French Yes IC, HT No Group 1: 92 hepatitis C patients, Group 2: 116 patients with primary biliary cirrhosis,Group 3: 213 healthy blood donors

Liver clinic, Canada



- - Primary biliary cirrhosis and hepatitis C patients: median 0.79, Healthy controls: median 0.48 (Note: range of possible scores 0-1.00)

Hobart etal, 2013*[35]

English Yes IC, CV, SV, HT, IRT

Yes 333 patients with MS Participants in other research study, UK

52 (11), range 19-84 74% ≤4.5% missing per item.

- Total score: 45.1 (23.2), cognitive dimension 37.1 (27.1), physical dimension: 58.4 (24.5), social dimension: 42.5 (24.0)

Kramer etal, 2005*[7]

German No HT No Group 1: 120 patients with chronic hepatitis C infection,Group 2: 100 age-matched healthy controls

Liver clinic, Austria

Group 1: 45 (12),Group 2: 44 (13)

36% - - Chronic hepatitis C infection patients: 49.0 (35.0), median 41.5, range 0-125, Healthy controls: 26.0 (22.0)

LaChapelle etal, 1998*[36]

English Yes HT No Group 1: 30 patients with brain injury (post-concussional syndrome),Group 2: 30 age and gender matched healthy volunteers

Outpatient clinic, Canada

Group 1: -,Group 2: 31.9 (11.2)

27% - - -

Lind etal, 2013[37]

Norwegian

Yes IC, CV, HT No Group 1: 38 patients with unexplained self-reported food hypersensitivity,Group 2: 43 patients with irritable bowel syndrome,Group 3: 42 healthy controls

Hospital clinics, Norway

Group 1: 36 (15),Group 2: 41 (16),Group 3: 47 (12)


0.1% n/a (negligible missing values).

Irritable bowel syndrome and food hypersensitivity patients: median 88.5,Healthy controls: median 14.0

Losonczi etal, 2011*[38]

Hungarian Yes IC, RR, HT No Group 1: 111 patients with MS [99 for test-retest],Group 2: 85 age and gender matched healthy controls [79 for test-retest]

Outpatient clinic, Hungary

Group 1: 43.8 (11.6 ),Group 2: 41.6 (12.4)

Group 1: 75%, Group 2: 69%

- - MS patients at baseline: 55.8 (41.2), MS patients at re-test: 60.9 (44.6), Healthy controls at baseline: 25.7 (28.1), Healthy controls at re-test: 29.5 (35.8)

Mathiowetz, 2003*[39]

English Yes RR, HT No 54 people with MS (people with low or no fatigue were omitted from the study)

Community sample (advocacy group), USA

50 (range 31-74) 67% - - 68.9 (26.2)

Prince etal, 2000*[40]

English Yes RR, HT No Group 1: 58 people with primary biliary cirrhosis,Group 2: 31 other hospitalized patients

Hospital and community, UK

Median 59 95% - - Primary biliary cirrhosis patients: median 78,Controls: median 34

Rendas-Baum etal, 2010*[41]

English Yes Int No 184 patients with MS MS clinics, Canada

50.9 (10.5) 75% - - 48.7 (34.7), median 45.5

Theander etal, 2007[42]

Swedish Yes IC, RR, SV, HT

No 296 patients with chronic obstructive pulmonary disease [143 for test-retest]

Outpatient clinics, Sweden

64 (8) 56% 0.6-4% values missing per item, except sexual activity 7% missing.

Missing replaced with median value for the item, participants excluded if ≥6 missing items.

-

Vasconcelos etal, 2006*[43]

English Yes HT No 25 patients with post polio syndrome Participants in other research study, USA

58.9 72% - - 65.6 (only 25% scored higher than the half-way point in the scale despite all reporting disabling fatigue)

Wu etal, 2008*[44]

Chinese Yes IC, SV No 214 patients with infarction stroke Rehab department (in- and outpatients), China

35-50 years: 19%, 51-65 years: 33%, 66-80 years: 44%, >80 years: 4%

35% - - -

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory, MS=Multiple sclerosis

Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue:


Setting, Country


Gender mix% female

% missing items



Al-Shair etal, 2012*[45](+ 9-item version)


Yes 2107 patients with chronic obstructive pulmonary disease

Participants in other research study, 12 countries

63.4 (7.0) 35% - - -

14


English No HT No 30 palliative cancer patients with a planned blood transfusion

Inpatients or day therapy patients, UK

68, range 53-91 37% - - Pre-transfusion group: median 12.5 (range 1.0-47.7), Post-transfusion group: median 23.5 (range 0.0-52.0)

Butt etal, 2013*[46]

English Yes IC, HT No 399 patients: 297 with cancer, 51 with stroke, and 51 with HIV/AIDS

Outpatient clinics, rehab center and inpatients, USA

Cancer 58.1 (13.5), Stroke 62.6 (13.9), HIV 40.2 (6.9)

Cancer 64%, Stroke 51%, HIV 12%

- - Cancer: 36.0 (12.1), Stroke: 38.1 (9.6), HIV: 34.0 (12.6)

Cella etal, 2005*[47]

English Yes IC, HT, Res, Int (MCID)

Yes 636 people with RA [271 people with RA for validation of MCID]


Median 56 (range 21–86) 79% - - 29.2 (11.1)


English Yes IC, SV No Group 1: 1878 general population sample,Group 2: 3140 cancer patients

Participants in other research studies, USA

Two general population data sets: 63.3 (12.9) and 51.8 (17.8),Two cancer data sets: 45.9 (16.6) and 58.7 (13.6)

Two general population data sets: 59% and 55%, Two cancer data sets: 52% and 64%

- Participant excluded if >50% items missing.

Cancer patients group 1: 23.9 (12.6), Cancer patients group 2: 36.9 (11.4), General population group 1: 40.1 (10.4), General population group 2: 38.7 (11.1)

Cella etal, 2002a*[49]

English Yes IC, RR, Int (MCID)

No Group 1: 50 cancer patients (for test-retest only),Group 2: 131 cancer patients,Group 3: 2402 cancer patients receiving chemotherapy

Hospital cancer services, USA

Group 1: Median (range) 52.5 (19–83),Group 2: median (range) 56.0 (20–82),Group 3: 65.2 (17–74)

Group 1: 54%, Group 2: 70%, Group 3: 59%.

- - Group 1: 36.8 (10.5), Group 2: 38.7 (10.9), Group 3: 23.9 (12.6)

Cella etal, 2002b*[50]

English No Int No Group 1: 2369 anemic cancer patients,Group 2: 113 non-anemic cancer patients,Group 3: 1010 general USA population sample

Participants in other research study and community, USA



- - Anemic patients: 23.9 (12.6), range 0-52, Non-anemic group: 40.0 (9.8), range 9-52, General population: 43.6 (9.4), range 2-52. Anemic patients’ scores transformed to 0-100 scale: 50.2 (13.7), median 50.

Chandran etal, 2007*[51]

English Yes IC, RR, HT No 135 patients with psoriatic arthritis [73 for test-retest]

Outpatient clinic, Canada

52 (13) 41% - - 35.8 (12.4)

Dapueto etal, 2014*[52]

Spanish Yes IC, HT, Res No 79 cancer patients during chemotherapy treatment [69 for test-retest]

Private day hospital, Uruguay

53.1 (12.6), range 28-81 84% - - Time 0: 43.1 (7.6), Time 1: 42.1 (9.2)

Dures etal, 2013*[20]

English Yes RR, ME, Res No 142 patients with RA [Group 1: 50 for first test-retest, Group 2: 50 for second test-retest, Group 3: 42 for responsiveness study]

Outpatient department, UK

Group 1: 56.3(12.8),Group 2: 55.8 (13.6),Group 3: 56.7 (12.6)


3% - Study 1: 24.1 (11.5), Study 2: 23.0 (11.1), Study 3: 19.3 (9.8)

Goligher etal, 2008*[53]

English Yes Int (MCID) No 80 patients with systemic lupus erythematosus

Community sample (Lupus Foundation) and patient lists, Canada & USA

47.8 (12.5) 96% - - Raw score 25.7 (12.0), normalized score 50.6 (23.0)

Hagell etal, 2006*[54]

Swedish Yes IC, RR, SV, HT, IRT (precision, rating scale functionality, DIF)

Yes 118 patients with PD Community sample, Sweden

63.9 (9.6) 46% 0.9% missing items and 100% computable total scores.

- 34.2 (9.9)

Harel etal, 2012*[55]

English Yes SV, HT Yes 348 patients with systemic sclerosis Systemic sclerosis research registry, Canada

55.6 (11.5) 85% - - 20.0 (12.2) (Note: scores reversed so high score is worst fatigue)

Hwang etal, 2003*[6]

English Yes IC, SV, HT No 180 cancer patients Inpatient and outpatient clinics, USA

Median 68 (range 30-89) - - - 34.7 (13.5)

Ishikawa etal, 2010*[56]

Portugese Yes IC, RR, HT No 270 cancer patients [85 for reproducibility]

Cancer institute, Brazil

50.5 (11.8), range 19-82 74% - Missing items were replaced with the mean of the other items in the scale.

39.9 (9.1)

Kosinski etal, 2013*[57]

English Yes CV No 21 patients with systemic lupus erythematosus

Research register, USA

43.7 (range 28-70) 90% n/a n/a -

Kwakkenbos etal, 2014*[58]

English, French, Dutch

Yes SV Yes 1339 systemic sclerosis patients (871 English-speaking Canadian, 238 French-speaking Canadian and 230 Dutch)

Community sample (patient organizations), Canada & Netherlands

English-speaking Canadian: 56.6 (12.1),French-speaking: 57.8 (10.4),Dutch: 58.3 (11.1)

English-speaking Canadian: 84%, French-speaking Canadian 88%, Dutch: 84%

- - English: 32.5 (12.1), French: 31.5 (12.2), Dutch: 29.1 (10.4)

Lai etal, 2003*[59]

English No IC, IRT Yes Group 1: 1022 people with cancer,Group 2: 1010 general population sample

Population study, USA

Group 1: 63.4 (12.8),Group 2: 45.7 (16.8)

Group 1: 62%, Group 2: 52%

- - Cancer patients: 23.8 (12.5),General population: 43.6 (9.4)

Lai etal, 2011a*[60]

English Yes IC, HT, Res, Int

No 254 patients with systemic lupus erythematosus [231 retested at 12 weeks]


40.3 (11.9), range 17-71 91% - - Baseline: 19.1 (11.5), 12 weeks: 24.8 (13.0)




- - n/a n/a -

Nillson etal, 2013[61]

Swedish Yes IC, HT Yes 150 people with PD Community sample, Sweden

70 (9) 47% 1-8% missing responses per item. 85% no missing items.

Participant excluded if >10% items missing.

20.0 (10.7), median 18, range 0-46 (Note: scores reversed so high score is worst fatigue).

Pouchot etal, English Yes Int (MCID) No 61 people with RA Outpatient 62.1 (14.8) 85% - - 29.4 (10.6), median 28,

15

2008*[62] clinic, Canada range 8 – 52, normalized mean 43.5 (20.3)

Reddy etal, 2007*[63]

English Yes Res, Int (MCIC)

No 194 patients receiving palliative care treatment

Cancer clinic, USA

56 (12) 63% - - -

Revicki etal, 2011*[64]

English Yes IC, HT, Res No 82 patients with ankylosing spondylitis Participants in other research study, USA & Canada

42.0 (11.5) 24% Data missing from 1.2% of participants.

- 24.0 (10.2)

Santana etal, 2009*[65]

English Yes HT, Int (MCID)

No 43 patients with advanced cancer Outpatient clinic, Canada

59 (range 39-78) 45% - - 25.5 (14.2)

Signorovitch etal, 2011[66]

English Yes IC, RR, SV, HT, Res

No 351 people with chronic immune thrombocytopenia (3 groups)


Median (range) for three groups: 52.5 (18–77), 47.0 (18–85) and 50.0 (18–86)

68% Missing values in <2% of the items, no scale had >2 missing items.

Missing items replaced with mean of other items, participant excluded if ≥6 items missing.

Group 1: 36.3 (9.0), Group 2: 36.0 (12.2), Group 3: 36.1 (11.9)

Tinsley etal, 2011*[67]

English Yes IC, RR, HT, Res

No 209 patients with irritable bowel disease [66 for test-retest]


38.6 (12.6) 53% - - 38.9 (11.0)

Wang etal, 2015*[68]

Chinese Yes IC, RR, ME, CV, HT

No 172 patients receiving routine hemodialysis

Outpatients clinic at hospital

52.6 (12.5) 36% - - Median 41, range 16-52

Webster etal, 2003*[69]

English No Int No 1075 population sample Population study, USA

45.9 (16.6) 57% - - 40.1 (10.4)

Weitz etal, 2013[70]

English, French, Spanish

Yes CV No 29 patients with paroxysmal nocturnal haemoglobinuria

Outpatient clinics, UK, USA, France & Spain

41.2 (13.2) 35% n/a n/a -

Yellen etal, 1997*[71]

English Yes IC, CV, HT No 50 cancer patients Cancer clinics, USA

Median 56 (range 19-83) 54% - - 36.8 (10.5) (Note: scores reversed so high score is worst fatigue).

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityDIF=Differential item functioning, IRT=Item response theory, MCID=minimal clinically important difference, PD=Parkinsons Disease, RA=Rheumatoid arthritis,

Modified Fatigue Impact Scale (MFIS):


Setting, Country


Gender mix% female

% missing items



Amtmann etal, 2012*[72]


Yes 1271 people with MS Community (MS Society mailing list), USA

50.7 (11.6) 80% - - 44.2 (18.2)

Castillo-Cejas etal, 2013*[73]

Spanish Yes HT No 99 patients with either Crohns disease or Ulcerative Colitis

Hospital inpatients, Spain

38 57% - - -

Flachenecker etal, 2002*[74]

German No HT No 151 people with MS Outpatient clinic, Germany

39.0 (9.3), range 22 - 62 75% - - -

Ghajarzadeh etal, 2012*[75]

Persian Yes IC, RR, HT No Group 1: 120 patients with MS [20 for test-retest],Group 2: 75 age-matched controls

MS clinic, Iran Group 1: 30.6 (8.1),Group 2: 31.1 (8.6)

Group 1: 84%, Group 2: 69%

- - MS patients: 29.7 (17.0),Healthy controls: 13.8 (14.1)

Imam etal, 2012*[76]

English Yes IC, HT No 42 people with spinal cord injury Former rehab unit patients, Canada

48.0 (19.0) 24% - - 27.1 (18.2)

Kos etal, 2003*[77]

Dutch Yes RR, HT, Res No Group 1: 51 patients with MS,Group 2: 20 healthy controls

Inpatients and outpatients, Netherlands

Group 1: 51.9 (10.5),Group 2: 50.6 (14.0)

Group 1: 50%, Group 2: 65%

- - MS patients: median 45, range 3-74, Healthy controls: median 20, range 0-56

Kos etal, 2005*[78]

English, Belgian, Italian, Slovenian, Spanish

Yes IC, RR, SV, HT

No 181 patients with MS (51 from Belgium, 50 from Italy, 50 from Slovenia, 30 from Spain)

Inpatients and outpatients, Belgium, Italy, Slovenia & Spain

48.6 (11.6) 64% - - Total score: median 39.0 (range 83-79), Belgium: median 45.0 (range 3-74), Italy: median 40.5 (range 3-79), Slovenia: median 37.5 (range 20-71), Spain: 32.5 (range 14-72)

Learmonth etal, 2013*[79]

English Yes RR, ME, HT, Int

No 82 people with MS Participants in other research study, USA

49.2 (9.0) 77% - - 41.6 (19.7)

Mills etal, 2010*[80]

English Yes IRT (rasch analysis)

Yes 415 people with MS MS clinics, UK - 71% - - -

Rietberg etal, 2010*[81]

Dutch Yes RR, ME, HT, Int

No 43 patients with MS Medical center, Netherlands

48.7 (7) 70% - - Median 41 (SD 18), range 1–74.5

Schiehser etal, 2012*[82]

English Yes IC, SV, HT No 100 people with PD Movement disorders clinics, USA

68.1 (7.3) 34% - - 31.7 (16.6)

Senders etal, 2014*[83]

English Yes IC, HT No 133 patients with MS Outpatient clinics, USA

50.5 (12.8) 78% - 40.7 (19.5)

Tellez etal, 2005*[84]

Spanishb Yes HT No Group 1: 231 people with MS,Group 2: 123 healthy controls

Outpatient clinic, Spain

Group 1: 37.1 (10.0),Group 2: 39.3 (12.2)

Group 1: 69%, Group 2: 55%

- - MS patients: median 33.0 (range 0-82), Healthy controls: median 11.0 (range 0-58)

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported

16

a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityb Translated from English but without cross-cultural validationIRT=Item response theory, MS=Multiple sclerosis, PD=Parkinsons disease

Parkinsons Fatigue Scale (PFS-16):


Setting, Country Age of sampleMean (SD) unless otherwise stated

Gender mix% female

% missing items



Brown etal, 2005[85]

English Yes IC, RR, ME, CV, SV, HT

No 495 people with PD [105 for test-retest]

Community sample (members of PD Society), UK

70.4 (9.5) 36% <2% missing for all items, 31% had missing items, 17% excluded.

Missing items replaced with 3 (middle scoring option), unless ≥4 missing items and then excluded.

Group 1: 3.5 (2.9), Group 2: 3.3 (0.8), median 3.4

Grace etal, 2007*[86]

English Yes IC, HT No Group 1: 50 patients with PD,Group 2: 16 age-matched controls

Outpatient movement disorders clinic, USA

Group 1: 71.7 (1.4),Group 2: 69.9 (2.4)

- - - Group 1: 54.3 (34.8), Group 2: 15.0 (15.5)(Note: Scoring ranged from 16-80)

Hagell etal, 2012*[87]

Swedish Yes IC, RR, HT No 30 people with PD Neurology clinic, Sweden

60.0 (6.7), range 43–70 40% - - Time 1: 2.7 (1.0),Time 2: 2.8 (1.0)

Kummer etal, 2011[88]

Brazilian portugese

Yes IC, HT No 87 patients with PD Movement disorders clinic, Brazil

58.4 (10.8) 56% 0% n/a (no missing items). Group with fatigue: 3.7 (0.3), Group without fatigue: 2.4 (0.6)

Nillson etal, 2013[61]

Swedish Yes IC, HT Yes 150 people with PD Community sample, Sweden

70 (9) 47% 0-2% missing responses per item. 90% no missing.

Participant excluded if >10% items missing.

30.2 (15.0), median 32.0(Note: Scoring ranged from 0-64)

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory, PD=Parkinsons disease

Perform Questionnaire:


Setting, Country


Gender mix% female

% missing items



Baro etal, 2009[89]

Spanish Yes IC, CV, SV, HT

No 238 people with experience of cancer-related fatigue. Most had breast cancer.

Oncology departs, Spain

57.2 (11.7) 56% 22.7% had at least one item missing

Dimension not scored if an item missing, total score not calculated if a dimension missing.

37.0 (9.2), range 14-55

Baro etal, 2011*[90]

Spanish Yes IC, RR, HT, Res, Int (MID)

No 437 cancer patients [64 for test-retest] Oncology departs, Spain

59.1 (11.8) 61% 20% least one item missing.

- 34.8 (12.0)

Gascon etal, 2013[91]

Spanish No Res No 667 cancer patients Cancer clinic, Spain

60 (12) 54% - - 33.4 (13.2)

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityIRT=Item response theory, MID=Minimal important difference

PROMIS Fatigue (Short form 8a and Item bank):


Setting, Country


Gender mix% female

% missing items



Broderick etal, 2013[92](7-item SF and CAT)

English Yes RR, HT No Group 1: 98 osteoarthritis patients, Group 2: 98 general population

Community sample, USA

Group 1: 56.9 (10.0), range 29 –81,Group 2: 43.9 (14.8), range 21–77

Group 1: 60%, Group 2: 51%

<0.5% of participants excluded

Missing values replaced with “a plausible value representing the uncertainty about the value”.

Osteoarthritis patients: 56.9 (7.9), General population: 49.2 (9.6)


English Yes IC, HT Yes 9047 (781 for IC reliability) general population and patient groups

Community sample, USA

Median 50 52% - - Scores converted to T-score (mean 50, SD 10)

Christodoulou etal, 2008[94]

English No CV No 22 patients with a wide array of diseases


63.5 (11.6) 55% n/a n/a -

Cook etal, 2012*(SF8a)[95]

English Yes IRT (DIF) Yes 2479 patients: 337 with muscular dystrophy, 1193 with MS, 441 with post-polio syndrome, 478 with spinal cord injury

Community sample (advocacy organizations), USA

55.5 (12.8) 68% - - Muscular dystrophy group:56.1 (8.2), MS: 58.2 (8.4), Post-polio syndrome group: 58.7 (7.2), Spinal cord injury group: 52.4 (7.7)

DeWalt etal, 2007[96]

English Yes CV No 17 participants for focus groups, 22 participants for cognitive interviews

Rehab facility, outpatients clinic and musculoskeletal disease registry, USA

Focus groups: 48 (range 26–65), cognitive interviews: 63 (range 38–83)

Focus groups: 65%, cognitive interviews: 55%

n/a n/a -

Kalkanis etal, 2013[97](10 items)

English Yes IC No 107 sarcoidosis patients Outpatient pulmonary clinic, USA

49.5 (10.8) 52% 0% Questionnaires were checked before the participant left so missing items could be completed.

2.7 (0.3)(Note: Scoring ranged from 0-10)

Lai etal, 2005*(SF8a)[98]

English No IC, SV, IRT (rasch analysis)

Yes 301 cancer patients Oncology clinics, USA

57.0 (14.4) 64% assumed 0% assumed n/a -

Lai etal, 2006*[99]

English Yes SV No 555 cancer patients Oncology clinics, USA

59.7 (13.4) 64% - - -

Lai etal, English Yes SV, HT Yes Group 1: 803 general population Population Group 1: 51.8 (17.8), Group 1: - - -

17

2011b*[100] sample for dimensionality test,Group 2: 14931 general population sample for calibration study

study, USA Group 2: 54.1 (16.4) 55%, Group 2: 52%

Senders etal, 2014[83]

English Yes HT No 133 patients with MS Outpatient clinics, USA

50.5 (12.8) 78% 10% patients, 0% items

Mean of available scores 56.3 (9.5)

Yost etal 2011*[101]

English Yes ME, Int (MID)

Yes 101 cancer patients [88 retested] Cancer clinics, USA

59.6 (12.0) 55% - Missing items replaced with the mean of the other items, participant excluded if ≥50% items missing.

-

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityDIF=Differential item functioning, IRT=Item response theory, MID=Minimal important difference, MS=Multiple sclerosis

Medical Outcome Study SF-36 Vitality subscale:


Setting, Country


Gender mix% female

% missing items



Aaronson etal, 1998*[102]

Dutch Yes IC, HT No Group 1: 4172 adult residents of Amsterdam,Group 2: 1742 Dutch adults,Group 3: 423 migraine sufferers,Group 4: 485 cancer patients

Participants in other research study plus community volunteers, Netherlands

Group 1: 43.1 (18.1),Group 2: 47.6 (18.0),Group 3: 40.4 (12.8),Group 4: 57.3 (12.1)

Group 1: 54%, Group 2: 44%, Group 3: 84%, Group 4: 58%

1-5% items missing

- Adult 1: 68.6 (19.2), Adult 2: 68.6 (19.3), Migraine: 61.1 (18.6), Cancer: 60.1 (22.3)

Andresen etal, 1999*[103]

English Yes HT No 183 veterans with spinal cord injury Inpatients and outpatients, USA

50.5 (12.7), range: 21-81 1% - - 52.9 (25.2)

Apolone etal, 1998*[104]

Italian Yes IC, RR, HT No Over 7000 participants from 7 studies Participants in other research study, Italy

- - - - 61.9 (20.7)

Basnov etal, 2009*[105]

Danish No No 41 women referred for mammography Mammography clinic, Denmark

47.2 (9.0) 100% - - 63.8 (23.0)

Bjorner etal, 2007*[106]

English Yes Int No 3445 clinic patients Participants in other research study, USA

- - - - -

Brazier etal, 1992[107]

English Yes IC, RR, ME, HT

No 1582 patients randomly selected from two general practice lists [187 for test-retest]

Community sample, UK

Range 16-74, (approx. 7% aged between 65 and 74 years)

Approx. 55% 0.5-4% missing for each dimension of the total SF-36 scale.

Very few data were missing and the study sample was large, therefore the missing data were not substituted.

For age group 65-74 years: 57


English Yes IC, HT, Res No 96 cancer patients who reported pain and/or depression [58 had change scores used for assessment of responsiveness]


59 53% - - 34.1 (23.1)

Buchwald etal, 1996*[109]

English Yes IC, HT No Group 1: 185 patients with CFS,Group 2: 246 unexplained chronic fatigue,Group 3: 111 with infectious mononucleosis,Group 4: 25 with major depression,Group 5: 99 healthy controls

Outpatient clinics and community, USA

Group 1: 39,Group 5: 44

Group 1: 88%, Group 5: 62%

- - -

Busija etal, 2008*[110]

Swedish Yes ME, Int No Group 1: 274 THR patients,Group 2: 105 TKR patients,Group 3: 74 arthroscopic partial menisectomy patients,Group 4: 62 anterior cruciate ligament reconstruction patients,Group 5: 110 population-sampled controls matched to THR patients

Participants in other research study, Sweden

Group 1: 70.5 (8.9), range 41–96,Group 2: 71.3 (8.1), range 43–86,Group 3: 44.8 (12.2), range 14–75,Group 4: 25.9 (5.1), range 18–35,Group 5: 70.7 (7.6), range 52–86

Group 1: 53%, Group 2: 63%, Group 3: 32%, Group 4: 19%, Group 5: 55%

- - Age-matched controls: 69.8 (21.7), THR group: 50.9 (20.1), TKR group: 50.3 (26.7), Arthroscopic partial menisectomy group: 60.8 (22.1), Anterior cruciate ligament reconstruction group: 59.5 (19.3)


English Yes IC, HT, Res, Int (MCID)

Yes 636 people with RA [271 people with RA for validation of MCID]


Median 56 (range 21–86) 79% - - 35.1 (20.8)

Chang etal, 2000*[111]

Chinese (Mandarin & Cantonese)

Yes IC No 1501 Chinese Americans Community sample, USA

40.4 52% - - 68.3 (17.2), median 70.0, range: 0-100

Davenport etal, 2011*[112]

English Yes RR, ME, HT No Group 1: 16 people with CFS, Group 2: 14 sedentary age-matched controls

CFS clinic, USA - 100% - - CFS patients baseline: 22.3 (22.1), CFS patients one week after exercise testing: 15.6 (18.6), Controls baseline: 70.2 (17.0), Controls one week after exercise testing: 77.8 (14.1)

Davey etal, 2003*[113]

English Yes RR, ME No 21 patients with hip or knee osteoarthritis


69.5 (7.2) 33% - - -

Dures etal, 2013*[20]

English Yes RR, ME, Res No 142 patients with RA [Group 1: 50 for first test-retest, Group 2: 50 for second test-retest, Group 3: 42 for responsiveness study]

Outpatient department, UK

Group 1: 56.3(12.8),Group 2: 55.8 (13.6),Group 3: 56.7 (12.6)


1% - Study 1: 33.4 (21.2), Study 2: 35.9 (20.1), Study 3: 29.3 (17.9)

Escobar etal, 2007*[114]

Spanish Yes IC, ME, Res, Int

No 516 patients on waitlist for TKR [423 retested 6 months after surgery, 364 retested 2 years after surgery]

Hospitals, Spain 71.6 (6.7) 75% - - 43.3 (25.4)

Fink etal, 2010*[115]

English Yes IC, HT No 116 myocardial infarct patients during hospitalization [49 retested after discharge]

Hospitals, USA 60 (11) 24% - Missing data were replaced with predicted values, participant excluded if

45.9 (11.6)

18

≥10% items in a scale were missing.

Freeman etal, 2000[116]

English Yes IC, HT, Res No 150 adults with MS [44 for responsiveness]

MS clinic, hospital wards and rehab unit, UK

44.6 (10.8) 68% 0% - 43.6 (22.0)

Fukuhara etal, 1998*[117]

Japanese Yes HT No 3395 people: Group 1: 1078 healthy people, Group 2: 179 with a physical condition, Group 3: 470 with a mental condition (self-rating depression scale), Group 4: 172 with both a physical and mental condition

Community sample, Japan

43.4, 24% were >60 years 51% - - Group 1: 76.5 (SE 0.5), Group 2: 63.3 (SE 1.3), Group 3: 56.9 (SE 0.7), Group 4: 42.1(SE 1.3)

Gandek etal, 1998[118]

Danish, French, German, Italian, Japanese, Dutch, Norwegian, Spanish, Swedish, English.

Yes IC No General population samples in 11 countries (4084 from Denmark, 3308 from France, 2914 from Germany, 1483 from Italy, 3395 from Japan, 1771 from Netherlands, 2323 from Norway, 9151 from Spain, 2056 from UK, 2227 from USA, 8930 from Sweden

Population studies, Denmark, France, Germany, Italy, Japan, Netherlands, Norway, Spain UK, USA, & Sweden

Mean ranged from 41.1 years to 47.6 years

- Average of 1.8% missing response per item. 7% participants excluded.

A person-specific average was used to impute values for missing data, participants excluded if ≥50% items in a scale missing.

-

Goligher etal, 2008*[53]

English Yes Int (MCID) No 80 patients with systemic lupus erythematosus

Community sample (Lupus Foundation) and patient lists, Canada & USA

47.8 (12.5) 96% - - Raw score 37.9 (24.6), normalized score 62.1 (24.6)

Harel etal, 2012*[55]

English Yes SV, HT Yes 348 patients with systemic sclerosis Systemic sclerosis research registry, Canada

55.6 (11.5) 85% - - 44.8 (11.2)

Hoopman etal, 2009[119]

Dutch, English, Moroccan-Arabic, Turkish.

Yes IC, HT No Group 1: 409 Turkish immigrants,Group 2: 377 Moroccan immigrants,Group 3: 9628 Dutch people

Community sample, Netherlands



Average of 0.22%,0.22% and 0.13% missing per item for the 3 samples.

Missing items replaced by the mean scores of the available items, participant excluded if ≥50% items missing.

-

Hoopman etal, 2006*[120]

Moroccan-Arabic, Tarifit (Moroccan), Turkish

Yes IC, HT, Res No Group 1: 90 Turkish immigrant cancer patients, Group 2: 79 Moroccan (Moroccan-Arabic 47 and Tarfit 27) immigrant cancer patients (first or second generation)

Outpatient oncology clinics, Netherlands

Group 1: 49.5 (12.0),Group 2: 50.4 (13.3)

Group 1: 52%, Group 2: 39%

2.2-6.8% missing per h item.

- Turkish: 43.1 (23.8), Moroccan: 49.0 (24.2)

Jenkinson etal, 1994*[121]

English Yes IC, HT No 9332 adult population sample Population study, UK

Range 18-64 55% - - -

Koh etal, 2006[122]

Chinese Yes IC, RR, HT, Res

Yes 401 patients with RA [35 for test-retest]

Hospital patients, Singapore

57 (10.9), range 26–88 86% 0% n/a 52.9 (17.7)

Kosinski etal, 1999[123]

English Yes IC, Other (scaling assumptions and scaling success)

No 1016 patients with RA or osteoarthritis affecting hip or knee

Participants in other research studies, USA

60 72% 0.1%, 1.0%, 0.9% and 0%, responses missing per item. 0-1.6% participants excluded.

Participant excluded if ≥50% of the items were missing.

39.2-46.0 (20.8-22.5), median 45.0-50.0

Kosinski etal, 2000*[124]

English Yes Int (MCID) No 693 patients with RA Participants in other research study, USA

- 76% - - -

Lai etal, 2011a*[60]

English Yes HT, No 254 patients with systemic lupus erythematosus [231 retested at 12 weeks]


40.3 (11.9), range 17-71 91% - - -

Lam etal, 1998[125]

Chinese Yes IC No 236 community sample (51 university students and 185 patients from a family health clinic)

Community samples, Hong Kong

43 (18.3), range 15-93 78% 0% - 55.7 (20.9)

Lera etal, 2013*[126]

Spanish Yes IC No 2143 community-dwelling older adults Community sample, Chile

69.0 (7.0) 68% - - Total score for older people: 71.3 (22.0), Women: 65.8 (22.0), Men: 75.5 (20.0)

Li etal, 2003[127]

Chinese Yes IC, HT No 1972 general population sample Community sample, China

46 49% Average of 3.8% responses missing.

Missing items replaced with the mean of the other items, participant excluded if ≥50% items missing.

Older people over 65 years: 48.4 (22.1)

Lim etal, 2008[128]

Thai Yes IC, HT No 1345 university students [744 included in known-groups validity study]

Community sample, Thailand

Median 31 (range 21-78), >85% under 40 years

61% % of missing responses per item was 0.5%, 0.5%, 0.6%, and 0.2%.

Missing items replaced with the mean of the other items, participant excluded if ≥50% items missing.

62.2 (13.3), median 60

Linde etal, 2008[129]

Danish Yes IC, RR, ME, HT, Res

No Group 1: 200 patients with RA (for validity tests),Group 2: 144 patients with RA (for internal consistency test [87 for test-retest][96 for responsiveness]

Outpatient clinics, Denmark

Group 1: median 59 (range 19-87),Group 2: median 60 (range 22-82)

Group 1: 77%, Group 2: 80%

(assumed) <2% missing data

Missing items imputed with the median score from items answered.

Group 1: 58 (25), median 60, Group 2: 48 (25), median 45

Lindeberg etal, 2006*[130]

Swedish Yes HT No 12607 general population sample Population study, Sweden

Age range 46–49: 12%, Age range 50–54: 24%, Age range 55–59: 23%, Age range 60–64: 25%, Age range 65–68: 15%

56% - - Score range 18–24: 6%, Score range 11–17: 39%, Score range 4–10: 55%

Loge etal, 1998[131]

Norwegian

Yes IC, HT No 1030 patients with RA Community sample, Norway

67 79% - Missing items replaced with the mean of the other items, participant excluded if ≥50% items missing.

40.4 (22.5)

19

Lwin etal, 2003*[132]

English Yes IC, SV No Group 1: 33 patients with Primary Sjogren's syndrome, Group 2: 45 patients with RA, Group 3: 16 patients with systemic lupus erythematosus, Group 4: 30 controls

Outpatient clinics, UK

Group 1: 58.2 (28.4);Group 2: 62.3 (28.0),Group 3: 55.6 (28.0),Group 4: 56.6 (28.5)

100% <2% - -

Martin etal, 2011[133]

English Yes CV No 68 people with type 2 diabetes mellitus or non-dialysis chronic kidney disease-related anemia


66.1 (11.6) 66% n/a n/a -

McHorney etal, 1994[134]

English Yes IC No 3445 patients with chronic medical and psychiatric conditions


54 (range 18-98) 62% 4.2%, 3.8%, 3.1%, and 3.9% missing responses per item. 2.8% excluded.

Missing items replaced with the mean of the other items, participant excluded if >50% items missing.

53.5 (22.1), median: 55.0, range 0-100

Mead etal, 2007[9]

English Yes IC, RR, ME, HT

No 55 stroke patients [51 for test-retest] Hospital and community, UK

Median 73 44% 0% - 11.5 (3.5) (Note: Range of possible scores 4-20)

Mishra etal, 2011*[135]

English Yes IC, SV Yes 4002 older people (428 from Aberdeen Birth Cohort 1936, 358 from Hertfordshire Ageing Study, 3216 from Hertfordshire Cohort Study)

Population studies, UK

64.6 (0.9) 48% - - 66.2 (19.2)

Montazeri etal, 2005[136]

Iranian (Persian)

Yes IC, HT No 4163 healthy adults Community sample, Iran

35.1 (16.0), 6% were >65 years 52% 0% n/a (no missing items). General adult population: 65.8 (17.3), Older people over 65 years: 53.0 (20.3)




- - n/a n/a -

Oude Voshaar etal, 2015*[24]

Dutch Yes SV, HT, Int Yes 588 + 427 (retested) patients with RA Participants in other clinical trial, USA

60.2 (12.9) 67% - - 62.7 (18.8)

Persson etal, 1998*[137]

Swedish Yes HT No 1295 people from two population studies divided into 5 groups: Group 1: No medical diagnoses or mental distress (n=165), Group 2: Several medical diagnoses only (n=141), Group 3: High levels of mental distress only (n=42), Group 4: High levels of mental distress and several medical diagnoses (n=105), Group 5: All others (n=813)

Community sample, Sweden

Group 1: 60.5 (SE 1.0),Group 2: 69.7 (SE 0.5),Group 3: 62.1 (SE 1.7),Group 4: 68.3 (SE 0.7),Group 5: 66.9 (SE 0.3)

Group 1: 89%, Group 2: 71%, Group 3: 89%, Group 4: 89%, Group 5: 83%

- - Group 1: 81.9 (SE 1.1), Group 2: 70.9 (SE 1.5), Group 3: 47.9 (SE 3.2), Group 4: 44.1 (SE 1.6), Group 5: 67.9 (0.8)

Pouchot etal, 2008*[62]

English Yes Int (MCID) No 61 people with RA Outpatient clinic, Canada

62.1 (14.8) 85% - - 45.9 (21.0), median 45, range 0 – 100, normalized mean 54.1 (21.0)

Quintana etal, 2005*[138]

Spanish Yes IC, ME, Res, Int

No 469 patients after THR [379 retested after 6 months, 310 retested after 2 years]

Hospital inpatients, Spain

69.4 (8.8). 51% - - Pre-op: 42.7 (23.6), 6 months post-op: 62.4 (24.0)

Ren etal, 1998[139]

Chinese Yes IC No 156 Chinese Americans Community sample (outpatient clinics, university students, and other community), USA

28% aged >71 years 55% 0.60% Participant excluded if >50% items missing.

59.0 (20.3)

Revicki etal, 2011*[64]

English Yes IC, HT, Res No 397 patients with ankylosing spondylitis

Participants in other research study, USA & Canada

42.0 (11.5) 24% Data missing from 1.2% of participants.

- 33.0 (17.6)

Ruta etal, 1998*[140]

English Yes RR, ME, HT, Res

No 233 patients with RA [31 for test-retest]

Outpatients, UK 56 (14), range 21-87 81% Incomplete data from <1% of participants.

- 39 (24)

Sabbah etal, 2003[141]

Arabic Yes IC, HT No 524 community sample Community sample, Lebanon

38.8 (17.7), range 14-86, 14.9% were >60 years

62% 0.23% values missing from the whole of SF-36 (ranged from 0-1% per item).

Missing items managed according to SF-36 health survey manual and interpretation guide.

60.9 (22.5)

Sanson-Fisher etal, 1998*[142]

English (adapted for Australians)

Yes IC, RR, HT No 855 community sample [100 for test-retest]

Community sample, Australia

48 (16.9) 66% - - Healthy adults: 73.5 (18.4), Patients with minor medical problems: 65.7 (17.4), Patients with major medical problems: 54.9 (22.7), Patients with depressive symptoms: 62.4 (20.2), Patients with major medical problems and depression: 41.3 (24.6)

Signorovitch etal, 2011[66]

English Yes IC, RR, HT, Res

No 351 people with chronic immune thrombocytopenia (3 groups)


Median (range) for three groups: 52.5 (18–77), 47.0 (18–85) and 50.0 (18–86)

68% Missing items in 4.5% of participants.

Assessments missing ≥6 responses were excluded. Missing items were imputed using the average of non-missing responses.

Group 1: 56.7 (20.2), Group 2: 55.1 (26.3), Group 3: 54.6 (23.7)

Sullivan etal, 1995[143]

Swedish Yes IC No 8930 population sample Population study, Sweden

42.7 (range15-93), 13% were >65 years

52% Item 1: 3.2%, item 2: 3.5%, item 3: 3.7%, item 4: 3.0%

Missing items replaced with mean of answered items, participant excluded if >50% of items missing.

68.8 (22.8), median 75

Sullivan etal, 1998*[144]

Swedish Yes HT No 8930 population sample [651 for first hypothesis]

Population study, Sweden

42.7 (range15-93), 13% were >65 years

52% - - Older people aged 75 years or older: Males: 60.9 (SE 3.3), Females: 48.8 (SE 2.7)

Tseng etal, 2003*[145]

Taiwanese

Yes IC, HT No 1181 community sample Community sample, Taiwan

28.2 (14.2) 64% 1-1.2% missing values for each item.

- 65.3 (15.2)

Tuttleman etal, 1997*[146]

English Yes IC, HT No 207 patients with RA Participants in other research study, USA

53.7 (13.2) 78% - - -

20

Wolfe, 2004*[17]

English Yes IC, HT, Res No 7760 patients with RA [5155 for responsiveness]


61.3 (12.5) 78% - - 45.0 (25.3), when rescaled to 1-10 with high score worst fatigue: 5.5 (2.5)

Yu etal, 2013[147]

Chinese Yes IC, SV, HT, Res

No 325 patients with Graves' disease [302 for test-retest]

Hospitals, China 46 (13) 68% Missing subscale scores ranged from 0.2-2.8%.

- -

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityCFS= Chronic fatigue syndrome, MCID=minimal clinically important difference, MS=Multiple sclerosis, PSS= Primary Sjogren's syndrome, RA=Rheumatoid arthritis, THR=Total hip replacement, TKR=Total knee replacement

Uni-dimensional Fatigue Impact Scale (U-FIS):


Setting, Country


Gender mix% female

% missing items



Doward etal, 2010[148]

English, French, German, Spanish, Italian, Swedish

Yes IC, RR, CV, SV, HT

Yes 817 people with MS from seven different countries

Community sample (patient organizations) and clinical centers, USA, Italy, Canada, Germany, Spain, France & Sweden

Ranged across countries: 44.5 (9.9), 46.1 (10.5), 48.5 (10.4), 42.1 (12.3), 53.1 (12.1), 43.6 (11.0), 48.7 (12.1), and 45.7 (10.8)

Ranged across countries: 74%, 64%, 57%, 71%, 65%, 64%, 61% and 82%

Item-level missing data was below 5% for each item.

Questionnaires with items missing were excluded.

Meads etal, 2009*[149]

English Yes IC, RR, CV, SV, HT

Yes Group 1: 35 people with MS (for interviews) and 6 researchers (for item selection/reduction),Group 2: 15 people with MS (for face and content validity interviews),Group 3: 135 people with MS (for validity and reliability)


Group 1: 50 (13.2),Group 2: 47.5 (12.8),Group 3: 50 (11.8)


- - -

Twiss etal, 2010*[150]

English Yes IC, HT, Int (MID - responder definition)

No 911 patients with MS Canada (French and English), France, Germany, Italy, Spain, UK, US & Australia

36.2 (8.4) 67% - - 16.8 (13.9)

Language: Language of questionnaire evaluated in the study. Aim: Was the primary aim of the study to evaluate measurement properties? Properties: Measurement properties evaluated in the study. IRT: Was IRT used?* Number of missing items or how missing items were handled not reported a IC=internal consistency, RR=reproducibility, ME=measurement error, CV=content validity, SV=structural validity, HT=hypothesis testing, Res=responsiveness, Int=interpretabilityMID=Minimal important difference, MS=Multiple sclerosis

21

ONLINE RESOURCE 8. Rating for methodological quality of each analysis (Quality rating) and rating

for the measurement property (Property rating) for each measurement property (internal

consistency, reproducibility, measurement error, content validity, structural validity, hypothesis

testing and responsiveness).

Internal consistency:

Questionnaire Study Quality ratinga Property ratingb Test ResultBrief Fatigue Inventory Catania etal, 2013* Excellent + Cronbach's alpha, item-total correlations 0.94, item-total correlations 0.66-0.83

Hwang etal, 2003* Excellent + Cronbach's alpha 0.95 (severity 0.93 and interference 0.93)

Lin etal, 2006* Excellent + Cronbach's alpha 0.97 (severity 0.96 and interference 0.95)

Mendoza etal, 1999 Good + Cronbach's alpha 0.96

Mendoza etal, 2010 Excellent + Cronbach's alpha for total score and with each item deleted

0.95 (ranging from 0.94-0.95 if one item deleted)

Mystakidou etal, 2008* Excellent + Cronbach's alpha, inter-item correlations 0.95, inter-item correlations ranged from 0.57-0.88

Okuyama etal, 2003 Excellent + Cronbach's alpha 0.96

Radbruch etal, 2003* Excellent + Cronbach's alpha for total score and with each item deleted

0.92 (ranging from 0.91-0.92 if one item deleted)

Shuman-Paretsky etal, 2014*

Excellent + Cronbach's alpha, item-total correlations, inter-item correlations

Severity 0.82 and interference 0.87. Item-total correlations ranged from 0.58-0.79, inter-item correlations ranged from 0.30-0.90.

Wang etal, 2004* Excellent + Cronbach's alpha for dimension scores and with each item deleted

Severity 0.92, interference 0.90, and ranging from 0.86 to 0.91 if one item deleted

Wolfe, 2004* Excellent + Cronbach's alpha 0.98

Yun etal, 2005* Excellent + Cronbach's alpha Cancer group 0.96, control group 0.96

Yun etal, 2008* Excellent + Cronbach's alpha for total score and with each item deleted

0.96 (all > 0.95 if one item deleted)

(Modified version) Aynehchi etal, 2013* Good + Cronbach's alpha 0.94

BRAF MDQ Nicklin etal, 2010a Excellent + Cronbach's alpha 0.93 (living 0.91, cognition 0.92, emotion 0.89, and physical 0.71)

Cancer-related Fatigue Distress Scale

Holley, 2000* Excellent + Cronbach's alpha 0.98

Fatigue Associated with Depression Questionnaire

Matza etal, 2011 Excellent + Cronbach's alpha 0.93 (experience 0.90, impact 0.88)

Fatigue Impact Scale Armutlu etal, 2007* Good + Cronbach's alpha MS group 0.96, healthy adults 0.96 (subscales ranged from 0.89-0.93)

Debouverie etal, 2007* Excellent + Cronbach's alpha Cognitive 0.93, physical 0.93, social role 0.91, psychological 0.82

Fisk etal, 1994* Excellent + Cronbach's alpha 0.97 (subscales all >0.87)

Flensner etal, 2005* Poor ? Item-total correlations Item-total correlations 0.42-0.86

Hassoun etal, 2002* Good + Cronbach's alpha Hepatitis C group ≥0.96 for total and subscales, controls ≥0.92

Hobart etal, 2013* Excellent + Cronbach's alpha, person separation index 0.97 (cognitive 0.96, physical 0.92, social 0.94), and person separation index ≥0.92 for all subscales

Lind etal, 2013 Fair + Cronbach's alpha Patient group 0.98 (physical 0.92, cognitive 0.92, and psychosocial function 0.95)), control 0.97 (physcial 0.90, cognitive 0.93, and psychosocial function 0.94)

Losonczi etal, 2011* Good + Cronbach's alpha MS group 0.99, controls 0.98-0.99, item-total correlations mostly >0.8

Theander etal, 2007 Excellent + Cronbach's alpha, inter-item correlations, item-total correlations

0.98 (cognitive 0.95, physical 0.93, and psychosocial 0.96), item-item correlations ranged from 0.32-0.80, item-total correlations ranged from 0.60-0.80.

Wu etal, 2008* Excellent + Cronbach's alpha Cognitive 0.94, physical 0.92 and social 0.94

FACIT-Fatigue Butt etal, 2013* Good + Cronbach's alpha 0.91-0.97

Cella etal, 2002a* Good + Cronbach's alpha 0.93-0.95

Cella etal, 2005* Excellent + Cronbach's alpha 0.86-0.87

Cella etal, 2011* Excellent + Cronbach's alpha 0.93–0.96

Chandran etal, 2007* Excellent + Cronbach's alpha 0.96

Dapueto etal, 2014* Good + Cronbach's alpha 0.88

Hagell etal, 2006* Excellent + Cronbach's alpha for total score and with each item deleted

0.90 (ranging from 0.89-0.91 if one item removed)

Hwang etal, 2003* Excellent + Cronbach's alpha 0.94

Ishikawa etal, 2010* Excellent + Cronbach's alpha 0.91

Lai etal, 2003* Excellent + Cronbach's alpha Cancer group 0.94, general population 0.93

Lai etal, 2011a* Good + Cronbach's alpha Baseline 0.94, 12 weeks 0.95

Lai etal, 2011c* Excellent + Cronbach's alpha Baseline 0.94, follow-up 0.95

Nillson etal, 2013 Excellent + Person separation index 0.9

Revicki etal, 2011* Excellent + Cronbach's alpha, item-total correlations Baseline 0.82, 12 weeks 0.86, item-total correlations 0.56-0.88

Signorovitch etal, 2011 Excellent + Cronbach's alpha, inter-item correlations, item-total correlations

>0.9, item-total correlations 0.50-0.87

Tinsley etal, 2011* Excellent + Cronbach's alpha 0.94

Yellen etal, 1997* Fair + Cronbach's alpha Baseline 0.93, retest 0.95

Al-Shair etal, 2012* Excellent + Cronbach's alpha 0.92 (0.91 for 9-item version)

Wang etal, 2015* Excellent + Cronbach's alpha, item-total correlations 0.92, item-total correlations 0.66-0.849 (except item 8: 0.44 and 12: 0.36)

Modified Fatigue Impact Scale

Amtmann etal, 2012* Excellent + Cronbach's alpha 0.96 (physical 0.94, cognitive 0.96)

Ghajarzadeh etal, 2012* Excellent + Cronbach's alpha Physical 0.84, cognitive 0.94, psychosocial fu5tion 0.80

Imam etal, 2012* Fair + Cronbach's alpha 0.97 (cognitive 0.96, physical 0.92, psychosocial 0.82)

Kos etal, 2005* Excellent + Cronbach's alpha 0.92 (cognitive 0.92, physical 0.88, psychosocial (only two items) 0.65)

22

Schiehser etal, 2012* Excellent + Cronbach's alpha 0.96 (cognitive 0.95, physical/social 0.95)

Senders etal, 2014 Excellent + Cronbach's alpha 0.97

Parkinson Fatigue Scale Brown etal, 2005 Excellent + Cronbach's alpha 0.98

Grace etal, 2007* Fair + Cronbach's alpha, inter-item correlation 0.97, inter-item correlations ranged from 0.44 to 0.87

Hagell etal, 2012* Excellent + Cronbach's alpha, item-total correlations 0.96, item-total ranged from 0.40 - 0.88.

Kummer etal, 2011 Good + Cronbach's alpha, mean inter-item correlation 0.94, mean inter-item correlations 0.49

Nillson etal, 2013 Excellent + Person separation index 0.95

Perform Questionnaire Baro etal, 2011* Excellent + Cronbach's alpha 0.94

Baro etal, 2009 Excellent + Cronbach's alpha 0.92 (0.78-0.92 for each dimension)

PROMIS fatigue item bank(v1.0 95 items)

Cella etal, 2010* Good ? Cronbach's alpha for each SD band > 0.91 for scores ranging from 2 SDs below the mean to 4 SDs above. <0.70 for those with scores 3 SD or more below the mean (ie low fatigue)

(10 items) Kalkanis etal, 2013 Excellent + Cronbach's alpha 0.96

(SF8a & 72-item item bank)

Lai etal, 2005* Excellent + Cronbach's alpha, item-total correlations For 72-item item bank 0.99, item-total correlations ranged from 0.51–0.85

(72-item item bank) Lai etal, 2006* Excellent + Cronbach’s alpha, item-total correlations and inter-item correlations

For 72-item item bank 0.98; corrected item-total correlations ranged from 0.47-0.80, inter-item correlations ranged from 0.26–0.86.

SF-36 vitality Aaronson etal, 1998* Excellent + Cronbach's alpha, item-scale correlations 0.78-0.83, item-total correlations >0.40

Apolone etal, 1998* Excellent ? Cronbach's alpha, item-scale correlations 0.78, item-scale correlations <0.40 for some items

Brazier etal, 1992 Excellent + Cronbach's alpha 0.96

Brown etal, 2011* Good + Cronbach's alpha 0.91

Buchwald etal, 1996* Excellent ? Cronbach's alpha 0.74

Cella etal, 2005* Excellent + Cronbach's alpha 0.84-0.88

Chang etal, 2000* Excellent + Cronbach's alpha 0.7

Escobar etal, 2007* Fair + Cronbach's alpha 0.82

Fink etal, 2010* Excellent + Cronbach's alpha Time 1 0.83, time 2 0.85

Freeman etal, 2000 Excellent + Cronbach's alpha >0.77

Gandek etal, 1998 Excellent + Cronbach's alpha, and item-total correlations 0.72-0.87, mean item-scale correlations 0.64 (all >0.40)

Hoopman etal, 2006* Fair + Cronbach's alpha Turkish group 0.75, Maroccan-Arabic group 0.81, Tarfit group 0.40

Hoopman etal, 2009 Good ? Cronbach's alpha Turkish group 0.76, Turkish language group 0.73, Moroccan group 0.61, Moroccan-Arabic language group 0.54, Dutch group 0.80

Jenkinson etal, 1994* Excellent + Cronbach's alpha 0.85

Koh etal, 2006 Excellent + Cronbach's alpha 0.72

Kosinski etal, 1999 Excellent + Cronbach's alpha, item-total correlations, inter-item correlations

0.81-0.87, item-total correlations ranged from 0.58-0.75, inter-item correlations ranged from 0.66-0.71.

Lam etal, 1998 Excellent + Cronbach's alpha, item-total correlations 0.74, item total correlations ranged from 0.47 to 0.60

Lera etal, 2013* Excellent + Cronbach's alpha 0.86

Li etal, 2003 Excellent - Cronbach's alpha, item-total correlations 0.66, item-total correlations ranged from 0.39-0.49

Lim etal, 2008 Excellent - Cronbach's alpha 0.68

Linde etal, 2008 Excellent + Cronbach's alpha 0.89

Lindeberg etal, 2006* Excellent + Cronbach's alpha 0.81

Loge etal, 1998 Excellent + Cronbach's alpha, inter-item correlations 0.85, inter-item correlations ranged from 0.65-0.73

McHorney etal, 1994 Excellent + Cronbach's alpha, item-total correlations 0.87, item-total correlations ranged from 0.69-0.75

Mead etal, 2007 Good + Cronbach's alpha Test 1 0.76, Test 2 0.78

Mishra etal, 2011* Excellent + Cronbach's alpha 0.80-0.83

Montazeri etal, 2005 Excellent - Cronbach's alpha 0.65

Quintana etal, 2005* Excellent + Cronbach's alpha 0.77

Ren etal, 1998 Excellent + Cronbach's alpha 0.73

Revicki etal, 2011* Excellent + Cronbach's alpha, item-total correlations Baseline 0.78, 12 weeks 0.88, item-total correlations were 0.57-0.64

Sabbah etal, 2003 Excellent + Cronbach's alpha 0.73

Sanson-Fisher etal, 1998* Excellent + Cronbach’s alpha, item-total correlations 0.86, item-total correlations ranged from 0.69–0.73

Signorovitch etal, 2011 Excellent ? Cronbach's alpha, inter-item correlations, item-total correlations

Item-total correlations >0.20

Sullivan etal, 1995 Excellent + Cronbach's alpha 0.85

Tseng etal, 2003* Excellent + Cronbach's alpha 0.75

Tuttleman etal, 1997* Excellent + Cronbach's alpha 0.87

Wolfe, 2004* Excellent + Cronbach's alpha 0.89

Yu etal, 2013 Excellent + Cronbach's alpha 0.85

Uni-dimensional Fatigue Impact Scale

Doward etal, 2010 Good + Cronbach's alpha 0.95-0.98

Meads etal, 2009* Excellent + Cronbach's alpha 0.96

Twiss etal, 2010* Excellent + Cronbach's alpha 0.97

* Studies that failed to adequately report missing data numbers or handing.a Inclusion of a factor analysis, quality of factor analysis, and reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is Cronbach's alpha >0.7, item-to-total correlations all >0.4MS=multiple sclerosis

Reproducibility:

Questionnaire Study Quality ratinga Property ratingb Test ResultBrief Fatigue Inventory Lin etal, 2006* Poor ? Pearson’s correlation Severity 0.89, interference 0.91

Mystakidou etal, 2008* Fair ? Pearson’s correlation 0.90

Radbruch etal, 2003* Fair ? Pearson’s correlation 0.91

(Modified version) Aynehchi etal, 2013* Fair ? Spearman’s rank correlation 0.8

23

BRAF MDQ Dures etal, 2013 Good ? Pearson's correlation total score and subscales 0.93-0.95, subscales ranged from 0.84-0.94


Matza etal, 2011 Good + ICC 0.85 (experience 0.78, impact 0.84)

Fatigue Impact Scale Armutlu etal, 2007* Good + ICC 0.93 [0.86–0.96] (cognitive 0.89 [0.79–0.94], physical 0.95 (0.91–0.97), social 0.91 [0.83–0.95])

Debouverie etal, 2007* Good + ICC 0.84 (cognitive 0.83, physical 0.82, social role 0.82, psychological 0.74).

Losonczi etal, 2011* Good + ICC MS patients 0.86, controls 0.81

Mathiowetz, 2003* Fair -/+ ICC 0.68-0.85 (physical subscale was below the desired 0.7)

Prince etal, 2000* Poor ? Coefficient of reproducibility (% of mean score) One hour 11.2 (13%), 2 weeks 17.7 (23%)

Theander etal, 2007 Fair ? Pearson’s correlation 0.94 (Item-level correlations ranged from 0.70-0.85)

FACIT-Fatigue Cella etal, 2002a* Good + ICC 0.89

Chandran etal, 2007* Fair + ICC 0.95

Dures etal, 2013* Good ? Pearson's correlation Study 1 0.95, Study 2 0.88

Hagell etal, 2006* Fair + ICC 0.85

Ishikawa etal, 2010* Good + ICC 0.90

Signorovitch etal, 2011 Fair + ICC 0.72 (0.79 for clinically stable sub group)

Tinsley etal, 2011* Good + ICC 0.81

Wang etal, 2015* Good + ICC 0.98 (95% CI: 0.98, 0.99)


Ghajarzadeh etal, 2012* Poor + ICC Item-level ranged from 0.80 to 0.95

Kos etal, 2003* Fair ? Kendall's tau_b Correlation 0.73 (physical 0.71, cognitive 0.74, psychosocial 0.60)

Kos etal, 2005* Good + ICC 0.91 (CI 0.86-0.94)

Learmonth etal, 2013* Good + ICC 0.86 (physical 0.86 cognitive 0.84, psychosocial 0.76)

Rietberg etal, 2010* Fair + ICC 0.85 (subscales ranged from 0.73 to 0.88)

Parkinson Fatigue Scale Brown etal, 2005 Fair ? Pearson’s correlation and Cohen’s coefficients kappa 0.83 (item-level correlations ranged from 0.53-0.72, mean 0.63), Cohen's kappa for individual items 0.41-0.70 (mean 0.55).

Hagell etal, 2012* Fair + ICC 0.93

Perform Questionnaire Baro etal, 2011* Fair + ICC 0.83

PROMIS fatigue item bank Broderick etal, 2013 Good + ICC General population group 0.84, osteoarthritis group 0.85

SF-36 vitality Apolone etal, 1998* Fair ? Pearson’s correlation 0.88

Brazier etal, 1992 Good ? Correlation 0.80

Davenport etal, 2011* Poor + ICC 0.78

Davey etal, 2003* Poor ? Pearson’s correlation 0.03

Dures etal, 2013* Good ? Pearson's correlation Study 1 0.61, Study 2 0.76

Koh etal, 2006 Fair + ICC 0.83

Linde etal, 2008 Good + ICC 0.91 (CI 0.86-0.94)

Mead etal, 2007 Fair - ICC and % agreement 0.51 (CI 0.27-0.69), % agreement for each item 43-59%

Ruta etal, 1998* Fair + ICC 0.83

Sanson-Fisher etal, 1998* Fair ? Spearman’s correlation 0.70

Signorovitch etal, 2011 Fair + ICC >0.70 (>0.72 for clinically stable subgroup)


Doward etal, 2010 Fair ? Spearman’s correlations 0.86-0.92

Meads etal, 2009* Fair ? Spearman’s correlations 0.86

* Studies that failed to adequately report missing data numbers or handing.a Reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is ICC or weighted Kappa >0.7.CI=95% confidence interval, ICC=Intra-class correlation coefficient, MS=multiple sclerosis

Measurement error:

Questionnaire Study Quality ratinga Property ratingb Test ResultBRAF MDQ Dures etal, 2013 Good ? Bland-Altman method to determine LOA (2SD of

difference)LOA for study 1 [-11.1, 10.4], study 2 [-12.6, 12.3]

Fatigue Impact Scale Debouverie etal, 2007* Poor ? Bland-Altman method to determine mean difference in values

Mean difference values were close to 0 and distributed homogeneously

FACIT-Fatigue Dures etal, 2013* Good ? Bland-Altman method to determine LOA (2SD of difference)

LOA for study 1 [-7.2, 7.5], study 2 [-12.2, 7.7]

Wang etal, 2015* Good ? SEM (= SD × √[1-ICC]) 1.2


Learmonth etal, 2013* Good - SEM (= SD baseline × √[1-ICC]) and CV (SD difference/mean of difference x 100)

SEM indicated that a change of 7.3 points can be attributed to measurement error. CV indicated that a change of ≤21.4% may be interpreted as no change.

Rietberg etal, 2010* Fair - SDC (distribution-based method to estimate % change which should be exceeded to exclude measurement error). MDC (= SDC expressed as a percentage of maximal feasible score).

SDC 16.2, MDC 19%, Bland-Altman plot showed no systematic differences.

Parkinson Fatigue Scale Brown etal, 2005 Poor ? Mean difference between 2 tests 0.15 (SD 0.47, CI 0.24–0.05)

PROMIS fatigue item bank Yost etal, 2011* Poor ? SEM calculated with IRT-based method. Results not given.

SF-36 vitality Brazier etal, 1992 Poor + Bland-Altman method Mean difference of 0.39 considered clinically insignificant in a 0-100 point scale.

Busija etal, 2008* Poor ? Standard error of the mean is influenced by both the within-subjects variability and the sample size, therefore group level MDC was calculated as (1.96*√2*SEM)/√n.Individual level MDC was calculated as 1.96*√2*SEM

Group level MDC: 4-7, Individual level MDC: 34-50.

Davenport etal, 2011* Poor - MDC95 (= 1.96 x √2 x SEM). SEM (= baseline variance x [1-reliability])

MDC95 28.3

Davey etal, 2003* Poor ? Mean difference and SEM Mean difference -3.1 (11.5), SEM 11.4, LOA calculated 19.5 to -25.7

Dures etal, 2013* Good ? Bland-Altman method and LOA (2SD of difference) LOA for study 1 [-25, 30.7], study 2: [-29, 28.2]

24

Escobar etal, 2007* Poor ? SEM (= SD baseline x √[1-R]) where R is the Cronbach alpha reliability coefficient), MDC95 (= 1.96 x √2 x SEM).

SEM 10.8, MDC95 29.8

Linde etal, 2008 Good ? LOA (1.96 x SD of difference) -28 to 28

Mead etal, 2007 Fair ? Bland-Altman method to determine LOA LOA -6.8 to 6.5 (Note: range of possible scores 4-20)

Quintana etal, 2005* Poor - SEM (= SD baseline x √[1-R]) where R is the test-retest reliability coefficient from a previous analysis. MDC95 (= 1.96 x √2 x SEM), where a change > MDC95 is interpreted as a true change.

SEM 11.3 and MDC 31.4

Ruta etal, 1998* Fair - MDC95 (= 1.96 x √2 x within-subject standard deviation)

25.0 (which equates to a change of at least 25% at individual level)

* Studies that failed to adequately report missing data numbers or handing.a Reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is minimal important change < SDC, minimal important change outside LOA, or convincing argument re magnitude of SDC.CI=Confidence interval, CV=Coefficient of variance, ICC=Intra-class correlation coefficient, LOA=Limits of agreement, MDC95=Minimal detectable change outside a 95% confidence interval, SD=Standard deviation, SDC=Smallest detectable change, SEM =Standard error of mean

Structural validity:

Questionnaire Study Quality ratinga Property ratingb Test ResultBrief Fatigue Inventory Catania etal, 2013* Good + Principal axis factor analysis Single factor solution explained 68% of the variance.

Hwang etal, 2003* Excellent + Factor analysis Single factor (factor loadings ranging from 0.73-0.89.

Lin etal, 2006* Excellent + Principal axis factor analysis with oblimin rotation Single factor with factor loadings from 0.80-0.94.

Mendoza etal, 1999 Excellent + Factor analysis Single construct explained about 75% of the variance.

Mendoza etal, 2010 Excellent + Principal factor analysis with oblimin rotation Single factor explained about 73% of the variance.

Mystakidou etal, 2008* Excellent + Principal axis factor analysis with varimax rotation (exploratory)

Single factor solution with eigenvalue 6.6 explained 74% of variance.

Okuyama etal, 2003 Good + Factor analysis Single factor solution explained 76% of the variance.

Radbruch etal, 2003* Good + Principle axis factor analysis with oblimin rotation Two factors with eigenvalues >1. Two items cross-loaded and solution difficult to interpret. One factor solution was considered acceptable after comparing SD of correlation residuals (0.09) with the standard error of the correlation coefficient (0.09).


Excellent + Principal component analysis with oblique rotation Bi-dimensional solution with eigenvalues >1 explained 66% of variance.

Wang etal, 2004* Excellent - Factor analysis (exploratory) Single factor with eigenvalue >1, but Harman's criteria for a good model fit indicated model misfit (SD of the residuals was larger than the 1/√n: 0.084 > 0.063). Confirmatory factor analysis with a two-factor solution showed interference dimension (loadings from 0.50-0.86) and severity dimension (loadings from 0.78-0.92) and had good model fit with Harman's criteria.

Wolfe, 2004* Fair + Factor analysis with varimax rotation Single factor explained 94% of the variance.

Yun etal, 2005* Good + Factor analysis Single factor solution with eigenvalue >1 explained 73% of variance (cancer group) and 74% (control group).

Yun etal, 2008* Good + Factor analysis Single factor solution with eigenvalue 6.9 explained 77% of variance.

BRAF MDQ Nicklin etal, 2010a Excellent - Factor analysis 4 distinct dimensions (physical fatigue, living with fatigue, cognition fatigue, and emotional fatigue).

Oude Voshaar etal, 2015* Excellent + Factor Analysis (confirmatory) Evidence to support single dimension (no better with 5 dimension model).

Cancer-related Fatigue Distress Scale

Holley, 2000* Excellent + Factor analysis Evidence of a single dimension


Matza etal, 2011 Excellent - Factor analysis (exploratory) with oblique rotation Two factor solution with factors consistent with the hypothesized domains of experience and impact.

Fatigue Impact Scale Debouverie etal, 2007* Good ? Factor analysis (confirmatory) with varimax orthgonal rotation for 3 or 4 factor solutions.

The CALIS procedure confirmed the 4 factor solution (explaining 61% of variance) was superior to 3 factors. The 4 factors proposed were cognitive, physical, social role and psychological.

Hobart etal, 2013* Excellent ? Principal component analysis Two of the sub-dimensions were supported (cognitive and physical). The social sub-dimension was not identified as a cohesive factor distinct from the others. Item to sub-dimension correlations found 63% of items correlated similarly or more strongly with another sub-dimension. The social sub-dimension had unacceptably high correlation with both physical and cognitive subscales suggesting overlap.

Theander etal, 2007 Excellent ? Factor analysis (confirmatory) 4 factor solution identified (after testing of 3 factor solution proved unacceptable). Strong correlations between the factors indicated an underlying commonality.

Wu etal, 2008* Fair ? Principle component analysis and maximal variance rotation

6 factors with Eigenvalue >0.5 explained 74% of variance. After examining the item contents of the factors the authors concluded that the data supported the same three subscales as proposed.

FACIT-Fatigue Cella etal, 2011* Excellent + Bi-factor factor analysis (confirmatory uni-dimensional factor analysis)

Very good fit found for a single dimension (comparative fit index ranged from 0.92–0.97). Using a bi-factor model to compare the loading of each item with the general fatigue factor versus the sub-dimensions (experience or impact), the item-general loadings were found to be higher than the item sub-dimension loadings. Experience and impact scores were highly correlated (0.80–0.88) further supporting uni-dimensionality.

Hagell etal, 2006* Excellent + Principal component factor analysis (exploratory) and Rasch rating scale model where uni-dimensionality was assessed by determining each item’s information-weighted and outlier-sensitive goodness-of-fit.

Factor and Rasch analyses provided general support for uni-dimensionality.

Harel etal, 2012* Excellent + Confirmatory factor analysis Uni-dimensionality supported.

Hwang etal, 2003* Excellent + Factor analysis Single factor, with factor loadings ranging from 0.51-0.88.

Kwakkenbos etal, 2014* Excellent + Factor analysis (confirmatory) Single factor model showed good fit in all samples.

Signorovitch etal, 2011 Excellent + Common factor analysis to determine uni-dimensionality

Single factor with eigenvalue >1. Commonality estimates ranged from 0.28 to 0.81.

Al-Shair etal, 2012* Excellent - Principle component analysis 3 factors with most items loading onto the first. The correlations between total score and each dimension were ≥0.64.


Amtmann etal, 2012* Excellent ? Factor analysis (confirmatory for uni-dimensionality), and bifactor model.

Uni-dimensionality not supported by confirmatory analysis, but bifactor model fit well.

Kos etal, 2005* Excellent - Principal component analysis using varimax rotation 3 factors with eigenvalue ≥1 were extracted which explained 60% of the total variance. Sub-dimensions were cognitive, physical and psychosocial.

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Schiehser etal, 2012* Poor - Principal component analysis with varimax rotation. 2 factors had eigenvalues >1 (physical and psychosocial combined, and cognitive), plus one item was found to not fit the construct.

Mills etal, 2010* - Rasch analysis Evidence of multidimensionality. The physical dimension required removal of 3 items, and the cognitive dimension required removal of 5 items to achieve uni-dimensionality within the subscales.

Parkinson Fatigue Scale Brown etal, 2005 Excellent + Factor analysis (exploratory) used to test uni-dimensionality

Single factor explained 58% of variance with factor loadings ranging from 0.64–0.83.

Perform Questionnaire Baro etal, 2009 Excellent ? Factor analysis (exploratory) Sub-dimensions confirmed as reasonable and 53% of variance explained.

PROMIS fatigue item bank Lai etal, 2006* Excellent + Factor analysis (exploratory and bi-factor confirmatory)

Results showed between 1 and 17 factors dependent on method used. 9 factors had eigenvalues >1, however the first factor explained 41% and the remaining factors explained ≤3%. The bi-factor confirmatory analysis showed all items loaded strongly onto overall fatigue factor (ranging from 0.64-0.89), indicating sufficient uni-dimensionality.

Lai etal, 2011b* Excellent + Bi-factor analysis Uni-dimensionality supported by factor loadings and fit indexes. High correlation (0.95) between impact and experience items confirmed the same underlying construct.

(72 items) Lai etal, 2005* Poor + Factor analysis with orthogonal rotation. All 72 items had significant factor loadings on single factor ranging from 0.60-0.87.

SF-36 vitality Harel etal, 2012* Excellent + Factor analysis (confirmatory) Uni-dimensionality supported

Lindeberg etal, 2006* Excellent + Principal component analysis of SF-36 vitality and GHQ-30 (anxiety and depression) item scores.

Five components with an eigenvalue >1. The fifth factor (exhaustion) accounted for 7.7% of the variance. All four items of the SF-36 vitality scale loaded on this one single factor.

Mishra etal, 2011* Excellent + IRT uni-dimensionality test

Oude Voshaar etal, 2015* Excellent + Factor Analysis (confirmatory) Evidence to support single dimension

Yu etal, 2013 Excellent + Principal component factor analysis with varimax rotation for whole SF-36 questionnaire.

The vitality subscale's eigenvalue was 2.03 with item factor loadings from 0.59-0.72.


Doward etal, 2010 Fair + IRT Rasch analysis Uni-dimensionality supported

Meads etal, 2009* Good + IRT uni-dimensionality test Uni-dimensionality supported

* Studies that failed to adequately report missing data numbers or handing.a Reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is support for uni-dimensionality with or without support for multiple dimensions as well.IRT=Item response theory, SD=Standard deviation

Content validity:

Questionnaire Content evaluation rating

Property ratinga Content development and validation

Brief Fatigue Inventory Adequate ? Answers to a large questionnaire about fatigue were used to develop items [10].

Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire

Good + Content and inductive thematic analysis of in-depth patient interviews was used to develop items and identify appropriate language and experiences, focus groups were used to develop appropriate wording, and cognitive interviews were used to explore understanding of candidate questions [22]. Iterative analyses using internal consistency tests and factor analyses informed item removal or retention [21].

Cancer-related fatigue distress scale

Adequate + 17 cancer patients participated in 23 interview sessions to generate items. The items were then reviewed by 5 patients. Factor analysis was performed which led to removal of 3 items. 23 items retained for the scale [25].


Adequate + Items were generated from literature review, clinician interviews, and focus groups. Potential items were reviewed during cognitive debriefing interviews with patients [26]. Content validity was further evaluated in terms of ease of use, clarity, comprehensibility, comprehensiveness, possible redundancy, and relevance to patients with depression [28]. The US Food & Drug Administration were consulted resulting in modifications to instructions (FAsD-V2) which avoids attribution of fatigue to depression [28].

Fatigue Impact Scale or Fisk Fatigue Severity Score

Adequate ? All 40 items were taken from other fatigue scales following interviews with 30 patients with MS [32]. In the Lind etal [37] study, experts reviewed the content of the questionnaire to check item appropriateness, which was found to be satisfactory. A modified Delphi technique with 30 experts (health professionals and researchers) was used to investigate face and content validity for MS [35]. They also judged item specificity to the construct and concluded that none of the items were adequately specific to fatigue thus did not support face validity.

Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue)

Not adequate ? Item generation from semi-structured interviews with 14 anaemic oncology patients and 5 oncology experts [71]. Item reduction with a second group of medical experts. Content validity for RA patients was assessed using a 2-round Delphi process with expert clinicians and patients [23]. All items considered good. Semi-structured interviews also used to assess content validity for patients with SLE [57]. Problems identified with four items. ‘Listless’ on item ‘I feel listless (‘washed out’)’ was interpreted as physical or mental impairment. Responses to item ‘I am able to do my usual activities’ included influence of other health conditions. Some participants found item ‘I have energy’ irrelevant and most could not relate to item ‘I am too tired to eat’.However, these two items capture the extreme ends of the spectrum. Content validity for PNH patients was established using cognitive interviews and a survey to assess clarity, comprehensiveness and relevance of each item [70]. Results suggested all items were relevant, clear and comprehensively covered PNH-related fatigue. Finally, content validity was examined for haemodialysis patients [68]. Four nurses, 2 doctors and 3 patients rated the relevance of items to generate item- and scale-level Content Validity Indices (CVI) and Kappa coefficients were calculated. Scale-level CVIs were good. Item-level CVIs and Kappas were good for all items apart from item ‘I need to sleep during the day’ (0.67 and 0.61 respectively) and item ‘I am too tired to eat’ (0.78 and 0.76 respectively), suggesting problems with content validity.

Modified Fatigue Impact Scale Good ? Items selected from the FIS using comments by people with MS on how fatigue affects their daily activities and other life areas [72].

Parkinson Fatigue Scale Good + Focus groups with 39 patients with Parkinsons disease contributed to item generation. Data from postal survey with over 500 respondents was analysed to reduce items [85].

Perform Questionnaire Good + Literature review, two focus groups and expert opinions from oncologists and patient-reported outcomes experts, were used to inform item generation. Expert opinion was used to exclude items considered clinically irrelevant, redundant, ambiguous, or lacking face validity. Item reduction procedures were carried out using data from 238 patients [89].

PROMIS-Fatigue Short Form 8a / full item bank

Adequate + Item selection and content validation carried out though (1) identification of items from other scales, (2) item classification, (3) item review of wording and revision by expert panel, (4) focus group input on domain coverage, (5) cognitive interviews regarding each individual item, and (6) final revision before field testing [94,96]. The PROMIS project aimed to design instruments that cross multiple illnesses, ages, cultures, and lifestyles. Efforts were made to ensure items were accessible for a variety of literacy levels and that had little ambiguity or cognitive difficulty. Network translation experts also reviewed items for translatability. Studies on the FACIT fatigue scale showed that the fatigue experience and the impact of fatigue upon function are reported along a single dimensional continuum. Experience is more likely than impact upon function to be endorsed at lower levels of fatigue. These results were used to confirm a uni-dimensional approach to the PROMIS fatigue item bank was appropriate [48].

SF-36 Vitality Subscale Not adequate + (1) Martin etal [133] carried out a qualitative study that considered the content of the vitality subscale to the construct of 'energy': 1. Patient expressions in the interview transcripts were mapped to each item; 2. Degree of relevance to disease experience; and 3. Cognitive interviews to provide evidence of comprehension of concept. Coverage of the concept appeared to be complete and all items were relevant in reflecting the

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symptom of energy and impact of lacking energy.(2) Two-round Delphi process with a group of expert clinicians and RA patients to assess content. All items were considered good and retained [23].


Adequate + Development involved four stages: (1) Rasch analysis of previously collected FIS data; (2) qualitative, participant-led interviews for new item generation; (3) cognitive debriefing for face and content validity of the draft questionnaire items; and (4) a validation survey on the draft version using Rasch analysis. 9 items from the original scale were removed, 9 new items added, a further item removed and some minor rewording of remaining items. Finally 17 items were removed due to either item misfit, DIF by age or gender, or redundancy. The final 22-item questionnaire fit the Rasch model (Chi-squared = 0.57) [149]. Doward etal [148] then conducted cognitive debriefing interviews with MS patients from several countries to test the acceptability, understanding, relevance, and comprehensiveness of the translations. All items were considered to be easy to understand, relevant to their experiences, presented a good coverage of their experiences and no important aspects of their experience had been missed.

a Property rating based on extent of evaluation (item development procedures, cognitive interviews, expert opinion, and item reduction procedures).MS=multiple sclerosis, PNH=Paroxysmal nocturnal haemoglobinuria, PROMIS=Patient Reported Outcomes Measurement Information System, RA=Rheumatoid arthritis, SLE=Systemic lupus erythematosus

Hypothesis testing A - Correlation studies (convergent and divergent validity):

Questionnaire Study Quality ratinga Property ratingb

Correlation with other fatigue questionnaires Correlation with other constructs

Brief Fatigue Inventory Catania etal, 2013* Fair + SF-36 vitality: -0.67 (hypothesized that correlation would be highest with vitality)

SF-36 bodily pain: -0.56, physical functioning: -0.55, social functioning: -0.54, mental health: -0.50, general health: -0.49, role-emotional limitation: -0.22, role-physical limitation: -0.14

Hwang etal, 2003* Poor + FACIT-Fatigue: -0.77Single item (‘lack of energy’) from MSAS-SF: -0.72

Depression: 0.70Disease status and quality of life scales: 0.56-0.72

Kramer etal, 2005* Good + FIS: 0.77SF-36 Vitality: 0.67

SF-36 Mental health: 0.68

Lin etal, 2006* Fair + POMS-fatigue (vs BFI severity and worst fatigue): 0.82 and 0.87POMS-vigor (vs BFI severity and worst fatigue): -0.69 and -0.71

Karnofsky Performance Status (vs BFI interference): -0.57

Mendoza etal, 1999 Fair + FACIT-Fatigue: 0.88POMS-fatigue: 0.84

Mystakidou etal, 2008* Good + EORTC-fatigue: 0.70MDASI-fatigue:0.77

EORTC-emotional: -0.12MDASI-total: 0.53MDASI-total (except fatigue items): 0.47

Okuyama etal, 2003 Good + Cancer Fatigue Scale: 0.76POMS-fatigue: 0.70POMS-vigor: 0.28EORTC QLQ-C30 fatigue: 0.72

POMS-depression: 0.52EORTCQLQ-C30 global: 0.51

Radbruch etal, 2003* Poor - “Feeling tired” from SF-36: -0.67, -0.58“Worn out” from SF-36: -0.52, -0.51“Sedation” from MIDOS: 0.76, 0.61 (Correlations for BFI sub-dimensions)

“Weakness” from MIDOS: 0.46, 0.52(Correlations for BFI sub-dimensions)


Poor ? Geriatric Depression Scale: 0.45, iADL: 0.33, walking speed: 0.22.All other demographic variables, physical performance measures and cognitive measures: <0.20

Wang etal, 2004* Fair ? SF-36 vitality: -0.62 and -0.61(Correlations for BFI-severity and BFI-interference)

SF-36 physical health: -0.58 and -0.71SF-36 mental health: -0.58 and -0.66SF-36 physical subscale: -0.50 and -0.63(Correlations for BFI-severity and BFI-interference)

Wolfe, 2004* Fair + MAF: 0.86SF-36-vitality: 0.75VAS fatigue: 0.76

Clinical measures: 0.55-0.63

Yun etal, 2005* Fair + EORTC QLQ-C30 fatigue: 0.66 EORTC QLQ-C30 quality of life: -0.51Beck Depression Inventory: 0.56Brief Pain Inventory-severity: 0.58Brief Pain Inventory-interference: 0.58

(Modified version) Aynehchi etal, 2013* Fair + Multidimensional Fatigue Symptom Inventory-Short Form: 0.81

BRAF MDQ Nicklin etal, 2010a Poor + FACIT, MAF and POMS: 0.64-0.81SF-36 Vitality: weak

Disability, mood, helplessness and pain: 0.34-0.63 (pain weakest)

Oude Voshaar etal, 2015* Fair + Pain, self-report disease activity and well-being: 0.29-0.51Disease activity (joint tenderness and ESR): 0.10-0.25


Matza etal, 2011 Fair ? BFI: 0.84SF-36 vitality: 0.65

IDS (depression scale): 0.71Epworth sleepiness scale: 0.37

Fatigue Impact Scale Armutlu etal, 2007* Poor + EDSS: 0.29

Chipchase etal, 2003* Poor ? No correlations between FIS and objective measures of physical or cognitive fatigability

Fisk etal, 1994* Fair + Generic health profile measures of quality of life (Sickness Impact Profile minus items related to sleep and alertness): 0.53-0.57

Flensner etal, 2005* Good ? Single item fatigue severity and impact questions: 0.27 to 0.84

Hassoun etal, 2002* Poor + VAS fatigue: 0.76

Hobart etal, 2013* Fair + MSIS-29 physical functioning: 0.76MSWS-12: 0.69MSIS-29 psychological functioning: 0.60GHQ-30: 0.45(FIS physical subscale only. Hypothesis was for higher correlations with physical function measures than psychological function measures)

Hobart etal, 2013* Fair + MSIS-29 physical functioning: 0.34MSWS-12: 0.53MSIS-29 psychological functioning: 0.71GHQ-30: 0.55

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(FIS cognitive subscale only. Hypothesis was for higher correlations with psychological function measures than physical function measures)

Hobart etal, 2013* Fair + MSIS-29 physical functioning, MSWS-12, MSIS-29 psychological functioning, GHQ-30: 0.52-0.73(FIS physical subscale only. Hypothesis was for moderate correlations with all measures)

Kramer etal, 2005* Good + BFI: 0.77SF-36 vitality: 0.73

LaChapelle etal, 1998* Fair ? FSS: 0.75 (physical), 0.70 (cognitive), 0.78 (social functioning)VAS fatigue: 0.43 (physical), 0.45 (cognitive), 0.48 (social functioning)Objective fatigability (thumb pressing): 0.24 (physical), 0.30 (cognitive), 0.25 (social functioning)

Lind etal, 2013 Fair + Short Form of Nepean Dyspepsia Index: 0.5

Losonczi etal, 2011* Fair + Expanded Disability Status Scale (EDSS) (physical disability): 0.31 to 0.50

Mathiowetz, 2003* Good - SF-36 vitality: 0.55 (higher than for other SF-36 subscales)FSS: 0.44

Prince etal, 2000* Poor + VAS fatigue: 0.73

Vasconcelos etal, 2006* Poor - FSS: 0.29VAS fatigue: 0.20

Beck Depression Inventory-II: <0.21Epworth Sleepiness Scale: <0.21

FACIT-Fatigue Butt etal, 2013* Poor ? ECOG performance status: 0.55 (cancer), 0.28 (stroke), 0.80 (HIV)General quality of life: 0.66-0.80Disease status, gender and age: very low correlations

Cella etal, 2005* Fair + SF-36 vitality: 0.73 to 0.84MAF: -0.84 to -0.88

Chandran e?tal, 2007* Poor + Modified FSS: -0.79

Dapueto etal, 2014* Fair + FACT-G + fatigue: 0.85Trial outcome index + FACT fatigue: 0.91

FACT-G: 0.64Trial outcome index: 0.67HADS Anxiety: -0.36HADS Depression: -0.65

Hagell etal, 2006* Poor + NHP - energy subscale: -0.70FSS: -0.62(Hypothesized 0.6-0.7)

Harel etal, 2012* Fair ? SF-36 vitality: 0.65 Physician rating of disease severity: 0.26Patient rated disease severity: 0.51Centre for Epidemiological Studies CES-D (depression): 0.45

Hwang etal, 2003* Poor + BFI: -0.77Single item (‘lack of energy’) from MSAS-SF: -0.82

Depression: 0.68Disease status and quality of life scales: 0.55– 0.77

Ishikawa etal, 2010* Fair + SF-36 vitality: 0.77 SF-36 physical subscale: 0.30SF-36 other subscales: 0.45-0.56

Lai etal, 2011a* Fair ? SF-36 vitality: 0.68-0.87(Several measurements taken over 1 year)

Patient global rating of disease activity: -0.58- -0.76Physician global rating: -0.09- -0.29SF-36 Physical: 0.59-0.74SF-36 Mental: 0.52-0.69Brief Pain Inventory-intensity -0.60--0.72Brief Pain Inventory-interference: 0.72--0.82BILAG (clinical disease activity screening): -0.25--0.29

Lai etal, 2011c* Fair ? SF-36 vitality: 0.68-0.87 SF-36 physical subscale: 0.59-0.74Brief Pain Inventory: -0.60- -0.82Patient global assessment: -0.58- -0.76BILAG (clinical disease activity screening) total score: <0.3Physician global assessment: <0.3

Revicki etal, 2011* Good ? SF-36 vitality: 0.74 and 0.82Bath Ankylosing SpondylitisDisease Activity Index fatigue item: 0.69

Ankylosing Spondylitis QoL scale: -0.70 at baseline and -0.81 at Week 12

Signorovitch etal, 2011 Good + SF-36 vitality: 0.82 and 0.85

Tinsley etal, 2011* Poor ? C-reactive protein: -0.73Erythrocyte sedimentation rate: -0.77Hematocrit: 0.53Harvey Bradshaw Index for Crohns disease: -0.49Simple Clinical Colitis Activity Index for ulcerative colitis: -0.59

Yellen etal, 1997* Fair + POMS fatigue: 0.83POMS vigor: 0.61Piper Fatigue Scale: 0.77

Wang etal, 2015* Good + Revised Piper Fatigue Scale: 0.66 HADS: 0.57Pittsburg Sleep Quality Index: 0.59Clinical variables including haemoglobin levels: 0.11-0.14

FACIT-Fatigue (+ 9-item version)

Al-Shair etal, 2012* Fair ? Correlation of 9-item with original 13-item FACIT fatigue: 0.99

Respiratory function scale: 0.70Dyspnea scale: -0.48


Amtmann etal, 2012* Fair ? FSS: 0.75 (total) 0.77 (physical), 0.55 (cognitive) Brief Pain Inventory-10 (pain): 0.60Pain Impact Questionnaie-6 (pain): 0.57HADS anxiety: 0.38Patient Health Questionnaire-9 (depression): 0.70

Castillo-Cejas etal, 2013* Poor ? FSS: 0.77Daily-FIS: 0.84

IBDQ-36 (IBS disease status and quality of life): 0.76

Flachenecker etal, 2002* Fair - FSS: 0.56VAS fatigue: 0.47MS-specific FSS: 0.18

Ghajarzadeh etal, 2012* Fair - FSS: 0.69 (total), 0.70 (physical), 0.48 (cognitive), 0.55 (psychosocial function)Beck Depression Inventory: 0.68

Imam etal, 2012* Fair ? FSS: 0.69 (total), 0.57 (cognitive), 0.73 (physical), 0.68 (psychosocial)

Centre for Epidemiological Studies CES-D (depression): 0.64

Kos etal, 2003* Fair - FSS: 0.45Guy’s neurological disability scale – fatigue subscale: 0.49

Age, gender, years since diagnosis, Kurtzke’s expanded disability status scale, Functional independence measure scores, the neuro-psychological battery of Rao, Zung self-rating depression scale and the Mental Health Inventory of the MS Quality of Life Inventory: all <0.30

Kos etal, 2005* Fair - FSS: 0.66

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Learmonth etal, 2013* Poor + FSS: 0.75 PDDS (patient report disease score): 0.59HADS-anxiety: 0.45HADS-depression: 0.52McGill pain questionnaire-sensory: 0.51McGill pain questionnaire-affective: 0.63Pittsburgh Sleep Quality Index (sleepiness): 0.586 min walk test: -0.61Cognitive test: -0.42.

Rietberg etal, 2010* Fair - FSS: 0.66CIS20R: 0.54

Schiehser etal, 2012* Fair + Positive and Negative Affect Schedule (PANAS-X)-fatigue subscale: 0.59(Note: the fatigue subscale includes items ‘sleepy’ and ‘drowsy’)

Anxiety: 0.52Depression: 0.50 and 0.60Apathy: 0.56Age, education, disease duration, motor symptoms, disease severity and overall cognition: all no significant correlations

Senders etal, 2014* Good + PROMIS-Fatigue item bank (CAT): 0.86 Depression: 0.66-0.68Anxiety: 0.57-0.61Pain: 0.67-0.74Physical function: 0.52-0.62

Tellez etal, 2005* Poor - FSS: 0.68 Depression: 0.70Disability status: 0.33

Parkinson Fatigue Scale Brown etal, 2005 Fair ? Rhoten Fatigue Scale (single item fatigue scale): 0.68

Grace etal, 2007* Fair + FSS: 0.84Fatigue rating question: 0.78

Hagell etal, 2012* Fair + FACIT-fatigue: 0.88 MADRS-S: 0.64UPDRS part 1: 0.38UPDRS others: 0.02-0.18Age: -0.13PD duration: 0.27Daily levodopa dose: 0.24MMSE score: 0.13

Kummer etal, 2011 Poor + Beck Depression Inventory: 0.60Hamilton Depression Rating: 0.62Hamilton Anxiety Rating: 0.55Age: 0.23Disease duration: 0.04UPDRS: 0.47Hoen-Yahr scale: 0.39Schwab-England activities of daily living scale: -0.48MMSE: -0.26Epworth sleepiness scale: 0.40

Perform Questionnaire Baro etal, 2011* Fair + FACIT-fatigue: 0.80 NHP psychological: 0.56NHP physical: 0.68Karnofsky index: 0.35

PROMIS fatigue item bank Cella etal, 2010* Fair + FACIT-fatigue: 0.95, SF-36 Vitality: 0.89

Lai etal, 2011b* Fair + FACIT-Fatigue: 0.93 (impact), 0.94 (experience)SF-36 Vitality: 0.85 (impact), 0.90 (experience).

Senders etal, 2014 Good + MFIS: 0.86 Depression: 0.58-0.60Anxiety: 0.47-0.52Pain: 0.62-0.66Physical function: 0.42-0.57

SF-36 vitality Andresen etal, 1999* Poor + Behavioral Risk Factor Surveillance System (BRFSS) ‘full of energy’ subscales: 0.79

Apolone etal, 1998* Poor + General health perception scale: 0.66

Brazier etal, 1992 Fair + NHP – energy subscale: -0.68 Other NHP dimensions: -0.33 to -0.55

Brown etal, 2011* Fair + FIS severity: -0.68FIS impact: -0.71FIS duration: -0.71Patient Health Questionnaire-fatigue item: -0.75

Depression scale: -0.50

Cella etal, 2005* Fair + FACIT-fatigue: 0.73 to 0.84MAF: -0.84 to -0.88

Davenport etal, 2011* Poor - Multidimensional Fatigue Inventory-20: 0.35 to 0.47

Fink etal, 2010* Good ? POMS fatigue subscale: 0.50Fatigue Symptom Inventory-interference scale: 0.69

POMs depression: 0.52POMS anxiety: 0.44POMS anger: 0.32SF-36 physical functioning: 0.30SF-36 bodily pain: 0.38

Freeman etal, 2000 Good ? SF-36 emotional wellbeing: 0.61SF-36 physical function: 0.18

Harel etal, 2012* Fair + FACIT-fatigue: 0.65 Physician rating of disease severity: 0.22Patient rating of disease severity: 0.44Centre for Epidemiological Studies CES-D (depression): 0.49

Jenkinson etal, 1994* Poor ? Self-rating of general health: ‘strong’ association

Koh etal, 2006 Poor ? Patient rated global disease activity: -0.31American College of Rheumatology (ACR) functional status, Chinese Health Assessment Questionnaire (C-HAQ) and markers of RA activity and severity: all <0.3.

Lai etal, 2011a* Fair + FACIT-Fatigue: 0.68 to 0.87

Linde etal, 2008 Fair ? VAS fatigue: -0.72 RAQoL: 0.7515D: -0.75Health assessment questionnaire, Euroqol-5D, VAS pain, VAS global RA: 0.57 to 0.65

Loge etal, 1998 Excellent + Other SF-36 subscales: 0.41-0.64

Lwin etal, 2003* Poor - Chalder Fatigue Scale total, physical and mental subscales: 0.22 to 0.24NHP - energy subscale: 0.35

Mead etal, 2007 Fair - POMS: 0.58Fatigue Assessment Scale: 0.41Multidimensional fatigue symptom inventory: 0.47

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Oude Voshaar etal, 2015* Fair + Pain, self-report disease activity and well-being: 0.38-0.47Disease activity (joint tenderness and ESR): 0.12-0.19

Persson etal, 1998* Good ? SF-36 physical component: 0.48 (rotated principal components)SF-36 mental component: 0.70 (rotated principle components)

Revicki etal, 2011* Good ? Bath Ankylosing SpondylitisDisease Activity Index fatigue item: 0.49FACIT-fatigue: 0.74 and 0.82

Ankylosing Spondylitis Quality of Life scores: -0.53 and -0.72Other clinical measures: significant correlations all < 0.49

Ruta etal, 1998* Poor + American College of Rheumatology (ACR) core disease activity measures - Pain: -0.52HADS (depression): -0.67Other American College of Rheumatology (ACR) core disease activity measures: 0.25-0.50.

Signorovitch etal, 2011 Good + FACIT-Fatigue: 0.82 and 0.85

Sullivan etal, 1998* Fair + Moderate correlations (-0.31 to -0.47) with psychological symptoms and complaints.Pain in legs/joints: -0.31/0.33VAS satisfaction scales: 0.68 (health), 0.58 (QoL), 0.48 (leisure time), 0.39 (work), 0.38 (social/family life).

Tseng etal, 2003* Fair + Stress Coping Inventory (SCI) subscales: 0.26 to 0.53

Tuttleman etal, 1997* Poor + Patient global assessment: -0.44Physician global assessment: -0.38.

Wolfe, 2004* Fair + MAF: 0.79BFI: 0.75VAS fatigue: 0.71

Other clinical measures: 0.50 to 0.62

Yu etal, 2013 Good ? Hamilton Depression Rating Scale (depression): negative correlation. No values reported.


Doward etal, 2010 Good + NHP - energy subscale: ‘Strong’ correlation Other NHP subscales: ‘Moderate’ correlations

Meads etal, 2009* Fair + NHP - Energy subscale: 0.64 NHP-Physical mobility: 0.47NHP-Sleep subscale: 0.16HADS-Depression: 0.60

Twiss etal, 2010* Fair ? Clinical measures: 0.18-0.38Generic health outcome assessment: 0.60MS disease specific QoL and activity limitations: 0.66 to 0.75

* Studies that failed to adequately report missing data numbers or handing.a Reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is correlations with other fatigue scales ≥0.70, correlations with other constructs predicted to have association with fatigue 0.40-0.70, and correlations with other measures predicted to have minimal association with fatigue <0.40.CIS20R=Checklist of individual strength, ECOG=Eastern Cooperative Oncology Group performance ratings, EDSS=Expanded Disability Status scale, EORTC=European Organization for Research and Treatment of Cancer, FSS=Fatigue severity scale, GHQ=General Health Questionnaire, HADS=Hospital anxiety & depression scale, MAF=Multidimensional assessment of fatigue, MDASI=MD Anderson Symptom Inventory, MIDOS=Minimal documentation system, MMSE=Mini mental state examination, MS=Multiple sclerosis, MSAS=Memorial symptom assessment scale, MSIS=Multiple Sclerosis impact scale, MSWS=Multiple Sclerosis walking scale, NHP=Nottingham health profile, PD=Parkinsons disease, POMS=Profile of mood states, RA=Rheumatoid arthritis, UPDRS=Unified Parkinsons disease rating scale, VAS=Visual analogue scale

Hypothesis testing B – Discriminant (known groups) validity:

Questionnaire Study Quality ratinga Property ratingb Statistically significant differences between groups expected to differBrief Fatigue Inventory Brown etal, 2010* Fair + 1. Baseline vs 3 days post transfusion.

2. Responders vs non-responders (patient rated).Catania etal, 2013* Fair + Patients with ECOG 0 vs ECOG 3.

Hwang etal, 2003* Poor + Different levels of Karnofsky Performance Status.

Kramer etal, 2005* Good + Difference between patients and healthy controls.

Lin etal, 2006* Fair + 1. Different Karnofsky Performance Status levels (lower function: 0-50, higher function: >50).2. Inpatients vs outpatients

Lin etal, 2006* Poor + Comparison of before, during and after chemotherapy.

Mendoza etal, 1999 Fair + 1. Patients with cancer vs healthy controls2. Comparison of patients with different levels of performance status (ECOG scale).

Mendoza etal, 2010 Fair + 1. Comparison of patients with different levels of performance status (ECOG scale.2. Cancer patients vs community adults.

Okuyama etal, 2003 Good + Patients with poor vs good performance status (ECOG scale)

Wang etal, 2004* Fair + Comparison of patients with different levels of performance status (ECOG scale).

Yun etal, 2005* Fair + 1. Comparison of patients with different levels of performance status (ECOG scale).2. Cancer patients vs control group.

(Modified version) Aynehchi etal, 2013* Fair + Cancer patients vs control group: Difference in means 0.76.


Matza etal, 2011 Fair + Comparison of groups of participants differentiated by clinician ratings of global severity of depression (CGI-S).

Fatigue Impact Scale Armutlu etal, 2007* Poor ? MS vs healthy adults. No difference between groups for cognitive fatigue subscale after controlling for depression.

Chipchase etal, 2003* Poor + MS vs healthy controls.

Fisk etal, 1994* Fair + Comparison of patients with chronic fatigue, MS and mild hypertension.

Flensner etal, 2005* Good + Comparison of groups with different levels of disease status and response to single item fatigue questions.

Hassoun etal, 2002* Poor + Comparison of groups of patients with chronic hepatitis C, primary biliary cirrhosis and controls.

Kramer etal, 2005* Good + Chronic hepatitis C patients vs healthy controls

LaChapelle etal, 1998* Fair + People with post concussional syndrome and healthy controls

Lind etal, 2013 Fair + 1. Comparison of patients with different levels of disease severity.2. Patients with unexplained self-reported food hypersensitivity and patients with irritable bowel syndrome vs controls.

Losonczi etal, 2011* Fair ? MS patients vs healthy controls. No difference between groups for cognitive fatigue subscale after controlling for depression.

Prince etal, 2000* Poor + Patients with primary biliary cirrhosis vs other hospital patients.

Theander etal, 2007 Fair + Comparison of patients reporting > or < 6hrs per day of fatigue.

Vasconcelos etal, 2006* Poor - Comparison of patients reporting disabling fatigue or not. No significant differences were observed between the groups.

FACIT-Fatigue Brown etal, 2010* Fair + 1. Baseline vs 3 days post transfusion.2. Responders vs non-responders (patient rated).

Butt etal, 2013* Poor + Comparison of patients with different levels of ‘need for bed rest’.

Cella etal, 2005* Fair + Comparison of patients with different levels of clinical change.

Chandran etal, 2007* Poor + 1. Patients with vs without ‘overwhelming fatigue’.2. Patients with vs without fibromyalgia.

30

Dapueto etal, 2014* Fair + Comparison of patients with different ECOG-PS (physical) levels (ECOG 1 vs. 2 vs. 3-4).

Hagell etal, 2006* Poor + Fatigued vs not fatigued patients according to NHP-energy subscale.

Hwang etal, 2003* Poor + 1. Participants with vs without sleeping difficulty.2. According to 4 levels of Karnofsky performance status.3. According to 6 levels of ‘lack of energy distress’ levels.

Ishikawa etal, 2010* Fair + Comparison of patients with different levels of ECOG performance status.

Lai etal, 2011a* Fair ? Comparison of groups with different levels of BILAG values (A vs B vs C/D/E) at baseline, 12, 24 and 52 weeks. Not all comparisons were statistically significantly different at all time points.

Lai etal, 2011c* Fair + Comparison of patients with different levels of clinical disease activity according to British Isles Lupus Assessment Group disease activity index general domain ratings.

Nillson etal, 2013 Fair + Fatigued vs not fatigued.

Revicki etal, 2011* Good + Comparison of patients with different levels of disease severity.

Santana etal, 2009* Fair + Comparison of patients with three levels fatigue progression.

Yellen etal, 1997* Fair + Comparison of patients with different haemoglobin levels and patient-rated performance status.


Amtmann etal, 2012* Fair - Comparison of groups with different levels of mobility. No difference between moderate and severe mobility impairment.

Ghajarzadeh etal, 2012* Fair + Significant difference between the patients with MS and the healthy controls.

Kos etal, 2003* Fair + 1. MS patients vs controls2. Participants with FSS fatigue scores > 4 vs < 4.

Parkinson Fatigue Scale Brown etal, 2005 Fair + Comparison of groups according to answers to two questions (‘Do you experience fatigue?’ ‘Is fatigue a problem for you?’).

Grace etal, 2007* Poor + PD patients vs healthy controls.

Nillson etal, 2013 Fair + Comparison of groups classified as fatigued or not fatigued.

Perform Questionnaire Baro etal, 2009 Good + Several comparisons for groups dichotomised by intensity of fatigue, on curative treatment, and need for a caregiver.

Baro etal, 2011* Fair + Several comparisons for groups dichotomised by intensity of fatigue, anaemia prevalence, haemoglobin, and need for a caregiver.

PROMIS fatigue item bank Broderick etal, 2013 Good + OA patients vs general population.

SF-36 vitality Aaronson etal, 1998* Fair + Several comparisons for groups dichotomised by age, gender, number of self-reported chronic conditions, and disease status indicators.

Andresen etal, 1999* Poor + 1. Patients with upper body difficulties vs no upper body difficulties.2. Patients with severe work disabilities vs no severe work disabilities.

Brazier etal, 1992 Fair + Several comparisons for groups dichotomised by gender, age, socioeconomic class and use of health services. No difference according to age.

Buchwald etal, 1996* Poor + 1. CFS vs healthy controls2. CFS vs unexplained chronic fatigue. Not significantly different.3. People with depression vs healthy controls4. People with mononucleosis vs healthy controls.5. Fatigue vs depression

Cella etal, 2005* Fair + Comparison of patients with different levels of clinical change.

Davenport etal, 2011* Poor + People with CFS vs controls.

Fink etal, 2010* Good - 1. Patients with myocardial infarct patients vs published data for healthy adults.2. Before vs after intervention expected to relieve fatigue. Not significantly different.

Fukuhara etal, 1998* Fair ? 1. Healthy controls vs patients with physical problems.2. Healthy controls vs patients with both mental and physical problems.3. Patients with mental vs patients with physical problems.

Hoopman etal, 2006* Good ? Several comparisons for groups dichotomised by performance status (Karnofsky Performance Status), number of comorbid conditions, functioning at follow-up. Some comparisons did not find difference predicted.

Hoopman etal, 2009 Good ? Several comparisons for groups dichotomised by gender, age, marital status, education, and number of comorbid conditions. Some comparisons did not find differences predicted.

Li etal, 2003 Fair + Comparisons for groups dichotomised by age and gender.

Lim etal, 2008 Good ? Comparisons for groups dichotomised by presence of depression/anxiety, arthritis, impaired vision and problems with eating. No difference found between those with or without arthritis.

Linde etal, 2008 Fair + Several comparisons for groups dichotomised by disease activity score, VAS for disease activity, presence of bone erosions and disability pension status.

Lwin etal, 2003* Poor + Comparison of patient groups to healthy controls.

Montazeri etal, 2005 Good + Comparison of groups according to age and gender.

Persson etal, 1998* Good + Several comparisons of groups according to level of physical and mental health status. Most were significantly different.

Revicki etal, 2011* Good + Comparison of groups with different levels of disease severity.

Ruta etal, 1998* Fair ? Comparison of groups according to functional status (classes I – IV). No difference between class III and IV.

Sabbah etal, 2003 Fair + 1. Several comparisons for groups dichotomised by age, gender, marital status, education level, financial status, social security, QoL and recent serious event.2. Several comparisons for groups according to presence of certain diseases. Result for with osteoporosis went against prediction.

Sanson-Fisher etal, 1998* Fair + Several comparison for groups categorized by self-reported physical and mental health conditions.


Doward etal, 2010 Good + Several comparisons for groups categorised by age, gender, employment status, perceived MS severity and general health. No difference according to age or gender as was predicted.

Meads etal, 2009* Fair ? Several comparisons for groups categorised by self-rated MS severity, self-perceived general health, symptoms flare, employment, depression, MS type, gender and age. No difference according to MS type, gender or age but not clear what was expected.

Twiss etal, 2010* Fair + Comparison of groups with different level of Expanded Disability Status Scale (EDSS) score.

* Studies that failed to adequately report missing data numbers or handing.a Reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is hypotheses supported or, if no stated hypothesis, significant difference in fatigue scores found between groups.CFS=Chronic fatigue syndrome, ECOG=Eastern Cooperative Oncology Group performance ratings, FSS=Fatigue severity scale, MS=multiple sclerosis, NHP=Nottingham health profile, OA=osteoarthritis, PD=Parkinsons disease

Responsiveness:

Questionnaire Study Quality rating1

Property rating2

Brief Fatigue Inventory Wolfe, 2004* Poor - Kendall's Tau coefficient for correlations with change scores for clinical measures ranged from 0.12-0.16.

BRAF MDQ Dures etal, 2013 Fair ? Significant change in scores. Mean change: -7.74, ES for change in global score: 0.56.


Matza etal, 2013* Fair + Correlations between change in fatigue scores and change in BFI (0.73) and ESS (0.42).3. Comparison of groups according to patient and clinician perceived changed. Significant differences in change in fatigue scores between levels.

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FACIT-Fatigue Cella etal, 2005* Poor + Mean change score in participants that achieved 20-50% improvement in ACR criteria: 6.6, ES: 0.60, SRM: 0.77.

Dapueto etal, 2014* Fair - No significant change in scores from baseline to 3 months (peak of treatment toxicity).

Dures etal, 2013* Fair ? Significant change in scores. Mean change: 5.57, ES for change: 0.55

Lai etal, 2011a* Poor - Compared change in fatigue score for each group according to change in patient rated change in global assessment change from one BILAG rating to another. Improved group mean change 10.5 and 8.2, ES 0.82 and 0.69. Unchanged group mean change 3.1 and 4.2, ES 0.30 and 0.41. Worsened group mean change -3.6 and 0.0, ES -0.53 and 0.

Lai etal, 2011c* Fair + Compared change in fatigue score for each group according to change in patient global rating (better, worse, or unchanged) and disease activity grade (more active, stable or less active). Significant difference in fatigue score changes according to these categories. ESs ranged from 0.40-0.60.Correlation with change in SF-36 vitality: 0.63, 0.67, 0.70. Correlation with SF-36 physical component: 0.38, 0.28, 0.47. correlation with patient global rating: -0.46, -0.55, -0.56

Reddy etal, 2007* Fair + Correlation between change fatigue score and Global Benefits of Drug Scale: 0.61. ROC analysis with group dichotomised according the GBS score >=4: Area under ROC = 0.82.

Revicki etal, 2011* Fair + The ASAS responder groups had statistically significantly improved fatigue scores compared with the non-responder group. Mean change scores: non-responders -0.24, ASAS20 9.4, ASAS50 14.3, ASAS70 15.2. ES: Non-responders 0.02, ASAS20 0.92, ASAS50 1.40, ASAS70 1.49.

Signorovitch etal, 2011 Poor + Correlations between SF-36 vitality change scores: 0.63 and 0.62. Fatigue score changes were statistically significantly larger for responders. SRM responders 0.34 and 0.40, non-responders 0.20.

Tinsley etal, 2011* Poor + Changes in fatigue scores according to patient global assessment of change: Much better -11.8, slightly better -2.6, same 0.7, slightly worse +2.4, much worse +5.2.


Kos etal, 2003* Poor ? Significant change in fatigue scores after intervention expected to lead to improvement.

Perform Questionnaire Baro etal, 2011* Poor ? ES for patients reporting at least a ‘small improvement’ (0.57) or ‘small deterioration’ (-1.00).

Gascon etal, 2013* Fair + Spearman's correlation between changes in haemoglobin level and changes in fatigue scores (-0.23).

SF-36 vitality Brown etal, 2011* Poor ? ES and SRM for patients in a clinical trial investigating a treatment for depression and pain.

Cella etal, 2005* Poor + Mean change score in group that achieved 20-50% improvement in ACR criteria 14.5, ES 0.71, SRM 0.76.

Dures etal, 2013* Fair ? Significant change in mean score: 7.68, ES 0.34.

Escobar etal, 2007* Poor ? Patients reporting at least ‘somewhat better’: SRM 0.46 and 0.39, GRI 0.21 and 0.12.

Freeman etal, 2000 Fair - Change in scores after rehabilitation: No significant change.

Hoopman etal, 2006* Fair - Few statistically significant differences found in fatigue scores among groups with improved KPS scores.

Koh etal, 2006 Poor ? For patients with worse patient rated disease status SRM -0.49, ES -0.60 and GRI -0.51. Relative efficacy between those with higher post-scores and those with unchanged post-scores was 0.48.

Linde etal, 2008 Fair ? Significant differences in fatigue scores in patients categorised as improved, not changed or deteriorated. SRM: improved 0.94, not changed 0.05, deteriorated -0.37

Quintana etal, 2005* Poor ? ES 0.80, SRM 0.78 and GRI 0.55

Revicki etal, 2011* Fair + Mean change scores for ASAS non-responders 2.5, ASAS20 13.5, ASAS50 18.5, ASAS70 31.6. ES: Non-responders 0.14, ASAS20 0.77, ASAS50 1.05, ASAS70 1.79.

Ruta etal, 1998* Poor ? In patients reporting improvement, mean change in fatigue scores was 10.6, SRM 0.50. In patients reported worsening, mean change was -4.9, SRM 0.27.

Signorovitch etal, 2011 Good + Correlation between change scores for FACIT fatigue: 0.63. SRM 0.62. Statistically significant difference in scores for responders vs non-responders.

Wolfe, 2004* Poor - Correlations with change scores for clinical measures ranged from 0.12-0.17

Yu etal, 2013 Poor ? Scores improved significantly with SRM 0.57

* Studies that failed to adequately report missing data numbers or handing.a Reporting of numbers and handling of missing data were not considered in the rating of methodological quality. b Criteria for a positive (+) score is hypotheses supported or evidence to support the questionnaire can detect clinically important change. ASAS=Assessment of SpondyloArthritis International Society; BFI=Brief fatigue inventory; ESS=Epworth sleepiness scale; ES=Effect size (mean change/baseline SD): 0.2-0.5=small, 0.5-0.8=medium, >0.8=large; GRI=Guyatt responsiveness index (average change scores of improved patients/SD of change scores of stable patients); SRM=Standardised response mean (mean change/SD of change scores): <0.5=small, 0.5–0.8=medium, >0.8=large.

Interpretability:

Questionnaire Study Property ratinga

Floor / ceiling MCID test: MCID result:

Brief Fatigue Inventory

Wang etal, 2004 + 10% reported 0 on the 'fatigue worst' item

Distribution-based methods: (1) 0.5xSD and (2) SEM. 0.5xSD: 1.3-1.5,SEM 0.7-0.8% of scale range = 7-15%

Wolfe, 2004 + 13.2% / 0.8%

BRAF MDQ Dures etal, 2013 + Anchor question: Has your fatigue changed? (Better/Same/Worse)

Same: mean change -2.4 (95%CI -7.4 to 2.6). Thus 7.4 provides an estimate of MCID for improvement, and 2.6 a MCID estimate for worsening.% of scale range = 3-11%

Oude Voshaar etal, 2015*

- 0% / >30% for 3 of the subscales


Matza etal, 2011 + 0.3% / 0.3%

Matza etal, 2013 + Responder definitions were estimated based on patient report of small but important improvement in fatigue, and clinician report of small but important change in fatigue.Distribution-based method: (1) 0.5xSD, and (2) SEM (using Cronbachs alpha for reliability).

Mean change scores for patients who reported a small but important change in fatigue was -0.59. Mean change for patients who clinicians believed had small but important change in fatigue was -0.31. (1) 0.41, (2) 0.24. Responder definition was 0.62.% of scale range = 6-15%

Fatigue Impact Scale Hobart etal, 2013 + 1.0% / 0%

Rendas-Baum etal, 2010

+ Anchor-based method used proportional odds model to estimate score change that corresponded to a 50% increase in the odds of poorer health. Distribution-based methods: (1) 2xSEM, (2) 0.33xSD, and (3) 0.5xSD.

Anchor-based estimates ranged between 9 and 24, with mean of 15.5. Distribution-based methods: (1) 9.6, (2) 11.6, (3) 17.3. Authors suggest MCID of between 10 and 20 points.% of scale range = 6-13%

FACIT-Fatigue Cella etal, 2002a + Anchor was change in haemoglobin levels and change in Performance Status Rating.Distribution-based methods: (1) Effect size of at least 0.2 and (2) SEM.

SEM 2.3-3.1, other measures 2.7.Authors suggested MCID of 3 points.% of scale range = 6%

Cella etal, 2002b + 0%-0.35% / 0.5%-

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14%Cella etal, 2005 + Distribution-based methods: (1) ES of 0.2 and 0.5 and (2)

scores for those with 1 SEM change.(1) 2.2 to 5.5, (2) SEM suggested 4.1. Authors suggested MCID of 3–4 points.% of scale range = 6-8%

Goligher etal, 2008 - Anchor questions were having “a little bit more” or “a little bit less” fatigue and their interview partners, and having “about the same” fatigue. Distribution-based method: linear regression modelling.

A little bit more fatigue: 17.5, about the same fatigue -1.8, and a little bit less fatigue -5.3. From regression analysis: MCID (95% CI) -5.9 (–8.1 to -3.6).% of scale range = 7-34%

Hagell etal, 2006 + 1.7% / 0%

Lai etal, 2011a + Anchor and distribution-based method: (1) 0.33xSDSD, (2) 0.5xSD and (3) SEM.

Authors suggested MCID of 3 to 7 points.% of scale range = 6-13%

Lai etal, 2011c + Distribution-based methods: (1) 0.33xSD, (2) 0.5xSD, and (3) SEM (using Cronbachs alpha for reliability).

Results ranged from 3-6 points. Authors suggested MCID of 3 to 4 points.% of scale range = 6-8%

Nillson etal, 2013 + 1.0% / 0%

Pouchot etal, 2008 - Anchor question was perceived fatigue level relative to others. Distribution-based method: regression analysis.

Difference between 'about the same' and 'a little more' = 10 points, and 'a little less' = 13 points. Note: scores were normalised to 0-100 scale). Regression-based normalised MCID was 15.9 points. % of scale range = 10-16%

Reddy etal, 2007 - ROC analysis with equal weight to specificity and sensitivity for predicting Global Benefit Score (patients perception of drug benefit) ≥4

Change in score of 10 points had a sensitivity of 73% and a specificity of 78% in predicting clinically important improvement.% of scale range = 19%

Santana etal, 2009 + Anchor questions of ‘more’ fatigue, no change and ‘less’ fatigue.

Score change for ‘more’ fatigue was 5.0. Score change for no change was 1.3. Score change for ‘less’ fatigue was -1.5. Authors suggest MCID of 5 units.% of scale range = 10%


Amtmann etal, 2012 + 1.1% / 0.7%

Kos etal, 2003 + 0% / 0%

Kos etal, 2005 + 0% / 0%

Learmonth etal, 2013 - Distribution-based method: 1.96 × √2 × SEM Authors suggest MCID of 20.2 points (49% of the overall mean score).% of scale range = 24%

Senders etal, 2014 + 5% / 0%

Parkinson Fatigue Scale

Hagell etal, 2012 + 0% / 0%

Kummer etal, 2011 + 0% / 0%

Nillson etal, 2013 + 3.0% / 1.0%

Perform Questionnaire

Baro etal, 2009 + 0% / 0%

Baro etal, 2011 + 1.7% / 0.3% Anchor-based method using the difference in the mean change score between the improved and stable groups based on haemoglobin levels.

MCID 3.5% of scale range = 7%

PROMIS fatigue item bank(17-item short form & 7-item short form)

Yost etal, 2011 + Anchor-based methods used 10 clinically relevant self-report measures both cross-sectional and longitudinal. Distribution-based methods: IRT-based SEM

For anchor-based estimates, median MCID for 17-item short form was 4.2 (ES = 0.61) and for 7-item short form was 4.7 (ES = 0.60). Using longitudinal estimates, the median MCID for 17-item short form was 2.6 (ES = 0.38), and for 7-item short form was 2.4 (ES = 0.29). For 17-item short form, SEM ranged from 1.7 to 1.8. For 7-item SF, SEM ranged from 2.6 to 2.7 Note: used normalised values where group mean is 50 and SD is 10. Authors suggest MCID for 17-item short form was 4 to 8, and for 7-item short form was 2 to 3. % of scale range = 6-12% and 7-11%

(SF8a) Lai etal, 2005 + 0.0% / 2.3%

SF-36 vitality Aaronson etal, 1998 + 0.1-0.2% / 1.0-5.2%

Andresen etal, 1999 + 3.3% / 3.8%

Apolone etal, 1998 + 0.5% / 1.8%

Bjorner etal, 2007 + Anchor-based methods: (1) Change in clinical conditions with a well-understood effect on vitality/fatigue, and (2) clinical and functional outcomes predicted by low vitality.

Decrements of 5-10 points were seen for diseases known to cause fatigue. Further, differences of 5-10 points were associated with significant increased risk of negative outcomes. Authors suggested an MCID of 5 points at group level and 10 points for individuals. % of scale range = 5%

Busija etal, 2008 + 0-3% / 1-13% Distribution-based method: ES of 0.50-0.79. MCID estimated to be at least a 5 point change. % of scale range = 5%

Cella etal, 2005 + Distribution-based methods: (1) ES 0.2, (2) ES 0.5, and (3) 1xSEM

Distribution-based MCID values ranged from 4.1 to 10.3. % of scale range = 4-10%

Chang etal, 2000 + 0.1% / 1.9%

Davenport etal, 2011 - 31%

Davey etal, 2003 + 0% / 0%

Escobar etal, 2007 + 1.0-4.8% / 1.3%-5.7%

Anchor responses ‘somewhat better’ and ‘about the same’.

Mean change for those 'somewhat better' = 3.9 (24.8), mean change for those ‘about the same’ = -1.5 (18.1) % of scale range = 4%

Freeman etal, 2000 + 1.0% / 1.0%

Gandek etal, 1998 + 0.1-0.8% / 1.2-7.9%

Goligher etal, 2008 - Anchor-based method using ‘a little bit more fatigue than interview partners’, ‘a little bit less’ and ‘about the same’. Distribution-based method using linear regression modelling.

‘A little bit more fatigue’ 18.3, ‘about the same fatigue’ -1.5, and ‘a little bit less fatigue’ -7.3Regression analysis: MCID 10.7% of scale range = 7-18%

Hoopman etal, 2006 + 1.4%-6.8% / 2.3%-6.9%

Hoopman etal, 2009 + 0-1.5% / 1.0-3.4%

Koh etal, 2006 + 0% / 0.3%

Kosinski etal, 1999 + 0.8-7.0% / 0.0-0.6%

Kosinski etal, 2000 + Anchor-based method using patient and physician rated global change in health status.

Mean change in score for those that improved one level on patient-rated scale: 11.1. Improved one level on physician-rated scale: 10.3. % of scale range = 10-11%

Lam etal, 1998 + 2.2% / 1.1%

Lim etal, 2008 + 0.1% / 0.3%

Linde etal, 2008 + 1.0%-1.4% / 0.7%-4.1%

Loge etal, 1998 + 0.9% / 4.4%

McHorney etal, 1994 + 1.1% / 0.9%

Montazeri etal, 2005 + 0.2% / 1.8%

Oude Voshaar etal, 2015*

+ 4% / 0%

Pouchot etal, 2008 + Anchor-based method used patient perceived level of fatigue relative to others. Distribution-based methods used regression analysis.

Difference between 'about the same' and 'a little more' was 11.9, and between ‘about the same’ and 'a little less' was 11.3.Regression-based MCID 14.8. % of scale range = 11-15%

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Quintana etal, 2005 + 0.6-5.2% / 1.1-8.0%

Anchor question was ‘somewhat better’ in general health status.

MCID 10.1% of scale range = 10%

Ren etal, 1998 + 0.0% / 2.1%

Ruta etal, 1998 + 4.0% / 0%

Sabbah etal, 2003 + 1.0% / 5.0%

Sanson-Fisher etal, 1998

+ 1.1% / 2.9%

Sullivan etal, 1995 + 0.8% / 7.3%

Tseng etal, 2003 + 0% / 0.9%

Wolfe, 2004 + 0.4% / 3.4%


Twiss etal, 2010 + 7.0% / 0% Anchor-based methods used values from EQ-5D. Distribution-based methods: (1) SEM, (2) ES 0.3.

Responder definition ranged from 2.4-7.0.EQ-5D responder definition for improvement -6.5, and EQ-5D responder definition for deterioration 4.7(1) SEM = 2.4, (2) ES 0.30 = 4.2. % of scale range = 3-8%

* Studies that failed to adequately report missing data numbers or handing.a Criteria for a positive (+) score is floor and ceiling effects <15%, and/or MCID ≤15% of total score range. ES=Effect size, EQ-5D=Euroquol, MCID=Minimal clinically important difference, SD=standard deviation, SEM=Standard error of mean

Other tests including IRT:

Questionnaire Study Other test: Other results:BRAF MDQ Oude Voshaar etal, 2015 DIF No DIF for age or re-test. One item (“mistakes”) DIF for gender but misfit considered minor and scale acceptable.FACIT-Fatigue Cella etal, 2005 Distribution of scores Entire range fatigue was covered, with the exception of those with very little fatigue. The coverage was superior to SF-

36 vitality.Hagell etal, 2006 Rasch model for uni-dimensionality and DIF for age and

gender.One item failed uni-dimensionality criteria: ‘‘I need to sleep during the day’’. No DIF.

Harel etal, 2012 Coverage of the full spectrum of fatigue levels, uni-dimensionality and stochastic ordering were investigated.

No major violations of stochastic ordering. Good coverage at all but the lowest levels of fatigue.

Lai etal, 2003 A rating scale model was utilized. 4 items had >30% unexpected variance or 'misfit'. 3 of these items ('I am able to do my usual activities', 'I need to sleep during the day' and 'I am too tired to eat') also demonstrated DIF.

Nillson etal, 2013 Rasch model analysis and DIF. Signs of misfit due to the sleepiness-related item and mixing of positively/negatively worded items.No DIF by disease duration. Evidence of DIF among those classified as non-fatigued (higher responses for ‘need to sleep or rest’ item).Even spread of scores across range apart from gaps at lower levels of fatigue.Ordering as expected except for item 7.

(+ shortened 9-item version)

Al-Shair etal, 2012 Rasch analysis The 9-item version is not a uni-dimensional construct. No evidence of DIF.

Hobart etal, 2013 Rasch Measurement Theory Analysis Three items showed weak fit. No interdependency (scoring bias) was found among items. Item locations in each subscale were reasonably well spread. Correct empirical ordering was found for response categories for all but 2 items.


Mills etal, 2010 Rasch analysis Uni-dimensionality not supported. Required removal of 8 items for 2-dimension model to work.

Parkinson Fatigue Scale

Nillson etal, 2013 Rasch model analysis Overall Rasch model fit. Fit residuals of Items 1 and 14 were larger than expected but items still considered acceptable.No DIF by disease duration. Evidence of DIF among those classified as non-fatigued (higher responses for ‘need to sleep or rest’ item).Item thresholds were relatively evenly spread along a range that covered the sample distribution, except those with lowest and highest fatigue. Ordering was as expected.

PROMIS fatigue item bank (SF8a)

Cook etal, 2012 DIF No DIF for age. 1 item (‘How often were you too tired to take a bath or shower’) showed small DIF for diagnosis. Impact was negligible.

(SF8a and item bank) Lai etal, 2005 Fit statistics calculated to check for misfit with the construct.

18 items had INfit MnSq values >1.4 indicating misfit with construct. After item removal and reanalysis in 5 stages, 72 items were retained in the item bank.

SF-36 vitality Cella etal, 2005 Distribution of scores The 4 items tend to locate on the high end (better) of the fatigue continuum.Chang etal, 2000 Item scaling tests (comparison of correlations between

items and own scale, and items and other scales).Item-scale: 0.27-0.67Item-other scales: 0.16-0.62Scaling success rate: 67.9%.Items 3 and 4 correlated better with mental health subscale than with vitality.

Gandek etal, 1998 Tests of scaling assumptions (comparison of correlations between items and own scale, and items and other scales).

Items measuring energy showed lower (better) means than items measuring fatigue.

Harel etal, 2012 IRT to evaluate coverage of the scale, uni-dimensionality of the construct and stochastic ordering.

No major violations (>0.3) to the assumption of stochastic ordering. Discriminated well only among patients in the low to average range.

Koh etal, 2006 DIF and Rasch model analysis No DIF between patients with and without comorbidities.Kosinski etal, 1999 Item scaling tests (comparison of correlations between

items and own scale, and between items and other scales).100% scaling success

Lam etal, 1998 Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).

Correlations with scale all >0.47, correlations with other SF-36 scales all <0.43.

Li etal, 2003 (1) Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).(2) Correlation between physical and mental subscales.(3) Test of assumption of equal intervals between response options.

(1) Correlations with scale 0.39-0.49 (75% success). Correlations with other scales: 0.11-0.49 (88% success).(2) Physical: 0.16 (lower than hypothesized), Mental: 0.83 (higher than hypothesized).(3) Assumption violated as positions of the two most undesirable responses were switched.

Lim etal, 2008 Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).

Correlations with scale ranged from 0.64-0.75 which were higher than with other scales.

Loge etal, 1998 Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).

100% scaling success

McHorney etal, 1994 Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).

Correlations with scale: 0.69-0.75, correlations between items and other scales: 0.17-0.55 (100% scaling success)

Mishra etal, 2011 Mokken scaling to support uni-dimensionality Strong scalability (0.5<H<1). H values 0.55, 0.59 and 0.60 for the three cohorts.Montazeri etal, 2005 Item scaling tests (comparison of correlations between

items and own scale, and between items and other scales).Correlations with scale: 0.64-0.77, correlations with other scales all lower (100% scaling success)

Oude Voshaar eta, 2015 DIF No DIF for age, gender or re-test.Sabbah etal, 2003 Item scaling tests (comparison of correlations between

items and own scale, and between items and other scales).Correlations with scale: 0.47-0.56, correlations with other scales: 0.33-0.50 (100% scaling success)

Sullivan etal, 1995 Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).

Correlations with scale: all >0.40, correlations with other scales all lower than with scale (100% scaling success). Note: Except for group aged 75+ where the scale performed poorly: 56% scaling success.

Tseng etal, 2003 (1) Item scaling tests (comparison of correlations between items and own scale, and between items and other scales).(2) Correlation between physical and mental subscales.

(1) Correlations with scale: 0.46-0.63, there was overlap with correlations with other scales therefore failed scaling test.(2) Physical: 0.16 (lower than hypothesized), Mental 0.84 (higher than hypothesized)

34


Doward etal, 2010 Rasch analysis for item stability and DIF. Good item stability over time and minimal DIF (one item in Swedish version showed DIF for gender).

Meads etal, 2009 Rasch analysis for uni-dimensionality and DIF. Uni-dimensionality confirmed and no DIF. Minimal redundancy and good coverage.Rasch analysis indicated a four-point response option (with two responses collapsed) gives the optimal response scoring.

DIF=Differential item functioning, ES=Effect size, SD=standard deviation

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