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    P A T I E N T E X P E R I E N C E S O F P A T I E N T S A F E T Y I N

    P R I M A R Y C A R E . A S Y S T E M A T I C R E V I E W O F

    Q U A L I T A T I V E S T U D I E S .

    - R E S E A R C H P R O T O C O L -

    Research Team: Valderas JM (JMV), Ricci N (NR), Sarah C.(SC), Campbell S (SC).

    Updated 13thDecember, 2012.

    CONTENTS

    Introduction .......................................................................................................................................................................... 2

    Objective ............................................................................................................................................................................... 2

    Method ................................................................................................................................................................................... 2

    Search method for identification of studies........................................................................................................... 2

    1. Searching in databases. ............................................................................................................................... 2

    2. Searching in the selected articles. .......................................................................................................... 2

    Managing the references. ............................................................................................................................................ 3

    Selection of studies. ...................................................................................................................................................... 3

    Eligibility criteria .................................................................................................................................................... 3

    Screening process ................................................................................................................................................... 3

    Title and abstract screening. .............................................................................................................................. 4

    Full text screening .................................................................................................................................................. 4

    Data extraction and critical appraisal ...................................................................................................................... 6

    1. Data extraction ............................................................................................................................................... 6

    2. Critical appraisal ............................................................................................................................................ 6

    Analysis of findings ...................................................................................................................................................... 9

    Appendix 1. Search Strategy (executed on 09-01-2012) ...................... ...................... ..................... ............. 13

    Appendix 2. Using EndNote to record and manage the information.............................................................. 15

    Appendix 3. Agreement report .................................................................................................................................... 16

    Appendix 4. Critical Appraisal Skills Programme (CASP)............................................................................... 17

    Figure 1 .............................................................................................................................................................................. 21

    Figure 2 ............................................................................................................................................................................... 22

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    INTRODUCTION

    We aim to systematically review patients experiences in relation to Patient Safety in General Practice,

    as part of a project for the construction of a toolkit for the measurement of safety in English Primary

    Care practices (Developing, testing and implementing the NSPCR Patient Safety Toolkit in general

    practices in England , NIHR School for Primary Care research, 2011-2013; 569,740.0). We will

    identify emerging themes / domains elicited from patients in using qualitative methods, specifically

    the key attributes of safe general practice. Moreover, this will inform on going work to develop an

    operational definition of primary care patient safety, as part of a wider objective of the Patient Safety

    Toolkit study. This information will be later used to inform the identification and development of

    tools that have the greatest potential to assess these attributes.

    OBJECTIVE

    To identify domains and themes related to Patient Safety important to, and as experienced by Primary

    Care patients in the United Kingdom.

    METHOD

    SEARCH METHOD FOR IDENTIFICATION OF STUDIES

    The search methodology will involve two steps. First, we will perform a search in different databases

    and will select the relevant articles. Subsequently, we will screen the citing and cited references of the

    relevant articles previously identified.

    1. SEARCHING IN DATABASES.

    We developed the search strategy according to available guidance from the Cochrane

    Collaboration (1), in general, and Cochrane Qualitative Methods Group (2), in particular. The

    databases selected for the systematic review are: Medline (In-Process & Other Non-Indexed

    Citations and Ovid MEDLINE(R), 1948 to Present), Embase (Embase 1974 to 2012 January 31),

    both acceded via Ovid SP (3) and CINAHL (from 1981 to present), acceded via EBSCO (4).

    Three different search strategies were designed according to the specific characteristics of each

    database. They include four main blocks (Primary Care, Patient Safety, United Kingdom, and

    Qualitative Methods). The final search strategy is available inAppendix 1.A complete report of

    the development and results of the search strategies is available in a separate document.

    2. SEARCHING IN THE SELECTED ARTICLES.

    http://ovidsp.tx.ovid.com/sp-3.4.2a/ovidweb.cgi?&S=GPIAFPIAIMDDNAFMNCBLKEFBBMCFAA00&New+Database=Single%7c20http://ovidsp.tx.ovid.com/sp-3.4.2a/ovidweb.cgi?&S=GPIAFPIAIMDDNAFMNCBLKEFBBMCFAA00&New+Database=Single%7c20http://ovidsp.tx.ovid.com/sp-3.4.2a/ovidweb.cgi?&S=GPIAFPIAIMDDNAFMNCBLKEFBBMCFAA00&New+Database=Single%7c20
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    We will review backward & forward citation for Web of Knowledge (5) for the publications

    finally identified as relevant at the end of the screening process (i.e., those that are chosen to be

    included in the review).

    MANAGING THE REFERENCES.

    After conducting the searches, the results of the searches will be exported to an independent database.

    Subsequently, all the references will be merged in a unique database, and duplicates will be

    automatically identified and removed. Each team member will receive a copy of this final database.

    We will use the reference manager software EndNote X5.

    Selection of studies.

    ELIGIBILITY CRITERIA

    We will include:

    Types of studies: The review will include studies which use qualitative methods of data collection

    and analysis, i.e., either a stand-alone study or a discrete part of a larger mixed-method study. We

    also will include studies using attitudinal surveys.

    Types of articles: original articles and review articles including systematic and narrative

    reviews-.

    Types of participant: Primary Care patients that have or have not suffered any adverse event. All

    ages, conditions and types of intervention will be included.

    Type of outcome measures:

    a. Domains or themes that patient think are critical in relation with patient safety in Primary

    Care.

    b. Key attributes of safe General Practices from a patient perspective.

    Geographical area: Studies conducted in United Kingdom

    Date of publication: We will include articles published since and including 1990.

    We will exclude:

    Articles not published in English

    Citations without an abstract

    SCREENING PROCESS

    The screening process will be conducted in three different stages: 1 screening titles; 2 abstracts; and 3

    full texts (figure 1). Each stage will start with a pilot study, aimed at ensuring the homogeneity among

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    reviewers in applying the eligibility criteria. The information regarding the eligibility of a reference -

    relevant or not relevant- will be recorded in the EndNote database X5. This will allow us to

    automatically monitor all the screening process. A detailed explanation of how we could use EndNote

    to record the screening results is provided in theappendix 2.

    TITLE AND ABSTRACT SCREENING.

    1. Pilot study. All the research team members will independently review the same sample of

    references. References will be categorized as relevant or not relevant according to the

    eligibility criteria above described. The results of this stage will be sent back to the rest of the

    team. NR will analyse the agreement and will send an agreement report to the rest of the team. A

    summary of the information that will contain this report is available in the appendix 3. To

    homogenize the criteria among reviewers, all discrepancies will be discussed during ateleconference meeting. However, all discrepant references will be included in the next stage, as

    only references excluded by the four team members will be excluded. At the title stage the pilot

    will involve the screening of 50 randomly selected references, while at the abstract stage we will

    screen a convenience sample of 30 references -selecting previously discrepant references-.

    2. Screening. It will take place after the pilot study. Each of the four team members will read half

    (3/6) of the total references (excluding those previously reviewed in the pilot study), so that all

    references will be independently read by two reviewers. References will be distributed among the

    reviewers trying to maximize the number of interactions between them (see table 1). Theagreement will be calculated, but in the title and abstract stages the discrepancies will not be

    discussed until reach consensus: all the references selected as relevant by at least one reviewer

    will be included in the next stage.

    Table 1. Reference distribution among reviewers (maximizing the number of

    interactions among them)

    Reviewers References divided by sextils

    1 2 3 4 5 6

    JMV

    SCSaCNR

    FULL TEXT SCREENING

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    1. Obtaining the full text. We will obtain the full text of all the references included after the

    abstract screening. All the pdfs files will be incorporated to the bibliographic database, which

    will be delivered to the rest of the team.

    2. Pilot. A convenience sample of 10 full text articles -chosen among those discrepant in the

    previous stage- will be screened by all the reviewers. At this stage we will apply the

    maximum specificity criteria, i.e., disagreements will be discussed with the rest of the team

    until consensus is reached and only references selected as relevant by all the team will be

    included. As previously, the agreement will be analysed and a report will be sent to the rest of

    the team. For all the excluded references, the exclusion reason will be recorded in an Excel

    sheet.

    3. Screening. Each reviewer will read the full text of half of the references previously selected

    articles (except those included in the pilot), so that all the articles will be independently read

    by two reviewers. The team will contact investigators for clarification where eligibility cannot

    be determined from the published study. As previously, articles will be distributed among the

    research team trying to maximize the number of interactions between them. Again,

    disagreements will be discussed in a meeting with the rest of the team until reach consensus

    and only references selected as relevant by all the team will be included.

    Finally, we will review backward & forward citation for Web of Knowledge for the publications

    finally identified as relevant after the screening process (i.e., references which are cited by and cite

    our relevant articles).Moreover, we will include the list of references provided by the Linnaeus

    Group. All these new references will be stored in a second bibliographic database. They will also be

    screened by using the three stages above described (title, abstract and full text), but no further pilot

    studies will be necessary, as we assume criteria will be very homogeneous at this point.

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    DATA EXTRACTION AND CRITICAL APPRAISAL

    Data extraction and critical appraisal will be conducted simultaneously. Both processes will be piloted

    against a random sample of 10 studies.

    1. DATA EXTRACTION

    A data extraction form will be designed based on previous similar systematic reviews and according

    to the specific characteristics of this one. The data extraction form will include the following items:

    Bibliographic information.

    Study characteristics -objective, research method, setting-.

    Participant characteristics - age, ethnicity, type of experience with patient safety-.

    Main findings

    o describing the understandings of the participants (first-order constructs)

    o interpretations or conclusions of the authors (second order constructs)

    Results of the critical appraisal.

    However, it is expected modifications in the data extraction form as a result of the pilot study.

    All the reviewers will participate in the data extraction. The information of 50% of the articles finally

    selected will be extracted by NR and reviewed by SC and vice versa. The other 50% will be extracted

    by JMV and checked be SC and vice versa. Disagreement will be resolved by discussion until

    consensus is reached. The completed extraction form for each study will be sent electronically to its

    first author, with a request to check for accuracy and completeness of extraction. All the information

    will be stored in an Access database.

    2. CRITICAL APPRAISAL

    Currently there is an important controversy in the literature regarding critical appraisal of qualitative

    research. A research has been conducted to identify the most suitable tools to assess the

    methodological quality of the studies which are going to be included in our Systematic Review. As a

    result of this process, we suggest the use of the Critical Appraisal Skills Program (CASP) for

    qualitative studies (6)(appendix 4). The main reasons for proposing CASP are:

    This tool has been widely used in previous similar systematic reviews(7-16).

    It contains only 10 items, allowing a rapid evaluation.

    It is suitable to be applied for different types of qualitative designs.

    Three categories will be established for each item: 1 clearly not met; 2 clearly met and 3 unclear. Eachpaper will be independently appraised by two reviewers and discrepancies will be discussed with all

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    the team members until consensus is reached. We will use the critical appraisal process not to exclude

    papers prior to the synthesis; rather, it will be used to provide a context for the interpretation of the

    synthesized findings.

    Data extraction form

    Extraction item Details

    Citation

    Aims or Research

    question

    Eligibility criteria of

    he participants

    Sample (participant)

    haracteristics

    Recruitment contexte.g. where people

    were recruited from)

    Sampling method

    Theoretical

    background

    Qualitative method

    Data collection

    Data analysis

    Themes

    More information on

    hemes

    Most relevant

    findings

    Recommendations

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    Critical appraisal. CASP tool1 YES NO COMMENTS

    /NOTES

    1 Was there a clear statement of the aims of the research?Consider: what the goal of the research was, why it is important and its relevance (this

    should be explicitly stated in the abstract or introduction).

    2 Is a qualitative methodology appropriate?

    Consider if the research seeks to interpret or illuminate the actions and/or subjectiveexperiences of research participants (because of the nature of the studies we are including, itis very likely that the answer for this question will always YES. Only in case of clear doubts

    we will answer NO)

    3 Was the research design appropriate to address the aims of the research?Consider: if the researcher has justified the research design (e.g. have they discussed how

    they decided which methods to use?). We will answer YES only in the case we can findin

    the text the justification of the research design.

    4 Was the recruitment strategy appropriate to the aims of the research?

    Answer YES only in the case the researchers provide information enough to conclude that

    there is no selection bias. In case you identify a selection bias OR authors dont provideinformation about the recruitment strategy, we will answer NO.

    5 Were the data collected in a way that addressed the research issue?3 aspects need to be reported in order to answer YES:

    if the researcher has discussed saturation of data AND

    if the researcher has made the methods explicit (e.g. for interview method, is therean indication of how interviews were conducted, did they used a topic guide?) AND

    if the form of data is clear (e.g. tape recordings, video material, notes etc).

    6 Has the relationship between researcher and participants been adequately considered?

    Consider whether it is clear: if the researcher critically examined their own role, potential

    bias and influence during: formulation of research questions, data collection, including

    sample recruitment, and choice of location.

    In case information is reported by the authors either in the methodology section (how they

    avoided this bias) or in the limitations (acknowledging the bias)we will answer YES.

    Otherwise we will answer NO.

    7 Have ethical issues been taken into consideration? Consider:if approval has been soughtfrom the ethics committee

    8 Was the data analysis sufficiently rigorous?

    4 criteria need to be addressed:

    Sufficient data are presented to support the findings (i.e., authors include in thepaper the quotes) AND

    Report the type of analysis used (thematic analysis, grounded theory)AND

    There is an agreement between primary data and secondary data (the results of theauthors has to correspond with the information they extracted).

    Report of triangulation (more than one analyst)

    9 Is there a clear statement of findings?Consider:

    2 criteria need to be addressed in order to answer YES:

    Summary of the results presented at the beginning of the discussion. Adequate discussion of the evidence both for and against the researchers arguments

    10 How valuable is the research?

    Answer YES only if they report the possible implications of their paper forresearch OR for practice OR for policy.

    1Critical Appraisal Skills Programme (CASP). Making sense of evidence. 10 questions to help you make senseof qualitative research. England: Public Health Resource Unit, 2006.

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    ANALYSIS OF FINDINGS

    Different approaches have been suggested in order to analyse the results of a Systematic Review of qualitative

    studies (see table 1). According to the Cochrane Collaboration (1), the election of the most appropriate oneshould be based on the purpose of each Systematic Review (see figure 1).

    Keeping in mind that the objective of our Systematic Review is to To identify domains and themes related to

    Patient Safety important to, and as experienced by Primary Care patients in the United Kingdom, it seems

    reasonable to use the Thematic Anlaysis, which have been described as identification of prominent or

    recurrent themes in the literature, and summarising the findings of different studies under thematic headings.

    Figure 1. Decision flow chart (copied from (18)).

    Meta-ethnography

    Thematic analysis with theory

    generation

    Grounded theory

    Decision to conduct a qualitative evidence

    synthesis

    To aggregate / summarise /

    integrate qualitative data to

    address specific questions

    in relation to a Cochrane

    intervention review

    To interpret synthesised qualitative

    evidence and develop explanatory

    theory or models

    Primarily to integrate and interpret

    qualitative and quantitative evidence

    within a single approach or

    integrated model

    Can be used to develop

    explanatory theory

    Purpose of the additional

    qualitative synthesis

    Thematic analysis without

    theory generation

    Meta-aggregation

    Meta-summary

    Realist review

    EPPI approach

    Narrative synthesis

    Bayesian synthesis

    Critical interpretive synthesis

    Product

    Explanatory theory, analytical or

    conceptual frameworkorinterpretative framework/ mechanism

    Product

    Aggregated findings from

    source papers

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    Table 1 Summary of selected approaches to joint synthesis of qualitative and quantitative evidence. Adapted from Dixon-Woods (19) et al., and Cochrane Handbook of (2)

    Method Outline of approach Sub-forms and developments Some problems Some strengths

    Narrative

    summary

    Narrative description and ordering of primary

    evidence (perhaps selected) with commentary

    and interpretation

    May be theory-led . May include

    triangulation of different evidence types Lack of transparency

    Many variants and absence ofprocedures/standards

    May be dependent on skills/prejudicesof reviewer

    Can cope with large evidence base, comprisingdiverse evidence types

    Flexibility

    Could be used for theory-building

    Thematic analysis Identification of major/recurrent themes inliterature; summary of findings of primary

    studies under these thematic headings

    May be theory- or data-driven Lack of transparency regarding processdecisions

    Largely descriptive basis to groupings,not necessarily developing theory,

    accounting for contradictions

    Flexible procedures for reviewers

    Copes well with diverse evidence types

    Could be used for theory-building

    Grounded theory Constant comparative method (CCM)identifies patterns and interrelations in primary

    data. Sampling responds to analysis, until

    theoretical saturation reached.

    Many researchers use only part of

    approach, e.g. just CCM Possible criticism of lack of

    transparency

    Variants are rife

    Seeks generalised explanations/theories

    Suggests means of sampling papers forinclusion in review

    Sampling to theoretical saturation limitsnumber of papers to review

    Can potentially deal with diverse evidencetypes

    Meta-ethnography Reciprocal translational analysis identifies keythemes in each study, then seeks to translate

    these into context of each other study. Themes

    with best overall fit/explanatory power

    adopted. Attempt made to explain

    contradictions. Seeks general interpretative

    (lines of argument) synthesis.

    Sometimes restricted to primary studiesfrom a single paradigm

    Does not guide sampling

    Lack of transparency regardingselection of primary studies

    May be order-of-synthesis effects

    Seeks higher order (generalised) theories

    Can potentially deal with diverse evidencetypes

    Realist synthesis Theory-driven synthesis based on purposivesampling of primary studies. Context data

    retained. Basic theory is refined concerning

    applicability in context

    Subdivisions: meta-data synthesis,

    drawing on meta-ethnographic

    approach; metamethod synthesis,

    comparing impact of methods onfindings; meta-theory synthesis,

    exploring theoretical frameworks

    Lacks transparency regarding choice of

    evidence to synthesise Can deal with very diverse evidence types

    Explicit orientation towards testing of theory

    Meta-study General framework for and guidance ontechnique, including question formulation andselection of primary studies

    Currently proposed only for qualitativeresearch

    Depends on the rigour of theunderlying methods

    Can potentially deal with diverse evidencetypes

    Usefully draws attention to different purposesand outcomes of synthesis

    Explicitly oriented towards production of mid-range theory

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    Miles and

    Huberman

    Evidence from each primary study firstsummarised and coded under broad thematic

    headings. Evidence then aggregated and

    summarised within theme across studies, with

    brief citation of primary evidence.

    Commonalities and differences between

    studies noted.

    No guidance on sampling of primarystudies

    Highly systematic method

    Potentially allows inclusion of diverse evidencetypes

    Could be used for theory-building

    Content analysis Evidence from each primary study coded underbroad thematic headings, using extraction tool

    designed to aid reproducibility. Occurrences of

    each theme counted and tabulated

    More recent forms of content analysis

    encourage amore interpretive approach Emphasis on frequency compared with

    importance, context-specificity, andinterpretation of evidence

    Term is often mis-used

    Software available

    Can incorporate diverse evidence types

    Could be used for theory-building if notconfined to description

    Case survey Each primary study treated as a case. Studyfindings and attributes extracted using closed-

    form questions, for reliability. Survey analysis

    methods used on extracted data.

    Applicable to outcomes, but lessadequate for process

    Lacks sensitivity to interpretive aspectsof evidence

    Can incorporate diverse evidence types

    Can cope with large numbers of primary studies

    Could be used for theory-building

    Qualitative

    comparative

    analysis

    Boolean analysis of necessary and sufficient

    conditions for particular outcomes to be

    observed, based on presence/absence of

    independent variables and outcomes in each

    primary study

    Focused on causality determination, not

    interpretive aspects of qualitative data Transparent

    Systematic

    Can incorporate diverse forms of evidence

    Allows competing explanations to be exploredand retained and permits theories aboutcausality

    Does not require as many cases as case surveymethod

    Bayesian

    metaanalysis

    Quantified beliefs about effects of variables

    from qualitative studies formally combined

    (through Bayes paradigm) with evidence from

    quantitative studies

    Reversal of roles of qualitative andquantitativeevidence possible in principle

    Conceptually simple, but may betechnicallycomplex to implement (and thus losetransparency)

    Impact of analysts prior beliefs can beexplicitly explored

    Can incorporate diverse forms of evidence

    Could be used for theory-building

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    According to Dixon-Woods et al,.(19) thematic analysis involves the identification of prominent or recurrent

    themes in the literature, and summarising the findings of different studies under thematic headings. Summary

    tables, providing descriptions of the key points, can then be produced. Several recent attempts at providing

    structured or systematic overviews of diverse areas of evidence have adopted this kind of approach. Garcia et al,

    for example, report a thematic analysis of womens views of ultrasound in pregnancy, involving tabulation of

    papers and counts of papers contributing data on each theme. (20)

    Thematic analysis allows clear identification of prominent themes, and organised and structured ways of dealing

    with the literature under these themes. It is flexible, allowing considerable latitude to reviewers and a means of

    integrating qualitative and quantitative evidence. However, it suffers from several important problems. Thematic

    analysis can be either data driven driven by the themes identified in the literature itself or theory driven

    oriented to evaluation of particular themes through interrogation of the literature. The failure of much writing on

    thematic analysis to distinguish adequately between these two approaches has resulted in a lack of transparency.

    More generally, there is lack of clarity about exactly what thematic analysis involves and the processes by which

    it can be achieved; for example, there is a lack of explicitness about procedures and aims, including the extent to

    which thematic analyses should be descriptive or interpretive. It is unclear whether the structure of the analysis

    should reflect the frequency with which particular themes are reported, or whether the analysis should be weighted

    towards themes that appear to have a high level of explanatory value. If thematic analysis is limited to

    summarising themes reported in primary studies, it offers little by way of theoretical structure within which to

    develop higher order thematic categories beyond those identified from the literature.

    Thematic analysis has been applied in similar Systematic Reviews. It allows an integration and interpretation of

    the information. Some of the articles that have used this methodology are (12,20-23)

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    APPENDIX 1. SEARCH STRATEGY (EXECUTED ON 09-01-2012)

    Medline Embase CINAHLBlocks N Terms HITS Terms HITS Terms HITS

    RIMARYARE

    1 exp General Practice/ or exp Ambulatory Care/ orexp primary health care/ or ((general or family or

    primary or community or ambulatory) adj2 (care?or health$ or service?)).tw.

    254370exp General Practice/ or exp Ambulatory Care/ or exp

    primary health care/ or ((general or family or primary orcommunity or ambulatory) adj2 (care? or health$ orservice?)).tw.

    274011 (MH "Family Practice") OR (MH "Ambulatory Care") OR (MH"Primary Health Care") OR ( TI ((general or family or primary orcommunity or ambulatory) W2 (care* or health* or service*)) ) OR (AB ((general or family or primary or community or ambulatory) W2(care* or health* or service*)) )

    80573

    2exp general practitioners/ or exp physicians,

    family/ or exp physicians, primary care/ or GP?.tw.or ((general or family or primary or community orambulatory) adj1 (practitioner? or physician? ordoctor? or nurse? or provider?)).tw.

    111135 exp general practitioner/ or GP?.tw. or ((general or family or

    primary or community or ambulatory) adj1 (practitioner? orphysician? or doctor? or nurse? or provider?)).tw.

    150027 (MH "Physicians, Family") OR TI GP* OR TI ( ((general or family

    or primary or community or ambulatory) W1 (practitioner* orphysician* or doctor* or nurse* or provider*)) ) OR AB GP* OR AB( ((general or family or primary or community or ambulatory) W1(practitioner* or physician* or doctor* or nurse* or provider*)) )

    28555

    3 exp community health centers/ or ((general orfamily or primary or community or ambulatory)adj1 (center? or centre? or practice?)).tw.

    48405 exp health center/ or ((general or family or primary orcommunity or ambulatory) adj1 (center? or centre? or

    practice?)).tw.

    65023 (MH "Practitioner's Office") OR (MH "Community Health Centers")OR TI ( ((general or family or primary or community or ambulatory)W1 (center* or centre* or practice*)) ) OR AB ( ((general or familyor primary or community or ambulatory) W1 (center* or centre* or

    practice*)) )

    15737

    4 (AMERICAN FAMILY PHYSICIAN or AM FAMPHYSICIAN or "Am. Fam. Physician" orANNALS OF FAMILY MEDICINE or ANN FAMMED or "Ann. Fam. Med" or Atencion Primaria orATEN PRIM or "Aten. Prim." or BMC FamilyPractice or "BMC Fam. Pract." or BRITISHJOURNAL OF GENERAL PRACTICE or "Br. J.Gen. Pract." or BRIT J GEN PRACT orCANADIAN FAMILY PHYSICIAN or "Can.Fam. Phys." or CAN FAM PHYSICIAN orFAMILY MEDICINE or "Fam. Med" or "FAMMED." or FAMILY PRACTICE or "Fam. Pr." or"FAM PRACT." or Journal of the American Board

    of Family Medicine or "J. Am. Board Fam. Med."or J AM BOARD FAM MED or JOURNAL OFFAMILY PRACTICE or "J. Fam. Pract." or "JFAM PRACTICE." or "PRIMARY CARE." orSCANDINAVIAN JOURNAL OF PRIMARYHEALTH CARE or "Scand. J. Prim. Health Care"or PRIMARY CARE or Australian FamilyPhysician or "Aust. Fam. Physician" or AUSTFAM PHYSICIAN or Australian Journal ofPrimary Health or "Aust. J. Prim. Health" or AUSTJ PRIM HEALTH).jn.

    55981 AMERICAN FAMILY PHYSICIAN.jn. or AM FAMPHYSICIAN.ja. or "Am. Fam. Physician".ja. or (ANNALSOF FAMILY MEDICINE.jn. or ANN FAM MED.ja. or"Ann. Fam. Med.".ja.) or (Atencion Primaria.jn. or ATENPRIM.ja. or "Aten. Prim.".ja.) or (BMC Family Practice.jn.or "BMC Fam. Pract.".ja. or BMC FAM PRACT.ja.) or(BRITISH JOURNAL OF GENERAL PRACTICE.jn. or"Br. J. Gen. Pract.".ja. or BRIT J GEN PRACT.ja.) or(CANADIAN FAMILY PHYSICIAN.jn. or "Can. Fam.Phys.".ja. or CAN FAM PHYSICIAN.ja.) or (FAMILYMEDICINE.jn. or "Fam. Med.".ja. or FAM MED.ja.) or(FAMILY PRACTICE.jn. or "Fam. Pr.".ja. or FAMPRACT.ja.) or (Journal of the American Board of Family

    Medicine.jn. or "J. Am. Board Fam. Med.".ja. or J AMBOARD FAM MED.ja.) or (JOURNAL OF FAMILYPRACTICE.jn. or "J. Fam. Pract.".ja. or J FAMPRACTICE.ja.) or (PRIMARY CARE.jn. or PrimaryCare.ja. or PRIMARY CARE.ja.) or (SCANDINAVIANJOURNAL OF PRIMARY HEALTH CARE.jn. or "Scand.J. Prim. Health Care".ja. or SCAND J PRIM HEALTH.ja.)or (Australian Family Physician.jn. or "Aust. Fam.Physician".ja. or AUST FAM PHYSICIAN.ja.) or(Australian Journal of Primary Health.jn. or "Aust. J. Prim.Health.".ja. or AUST J PRIM HEALTH.ja.)

    65410 (JN AMERICAN FAMILY PHYSICIAN OR JT AM FAMPHYSICIAN OR JT Am. Fam. Physician) OR (JN AtencionPrimaria OR JT ATEN PRIM OR JT Aten. Prim) OR (JN BMCFamily Practice OR JT BMC Fam. Pract. OR JT BMC FAMPRACT) OR (JN BRITISH JOURNAL OF GENERAL PRACTICEOR JT Br. J. Gen. Pract. OR JT BRIT J GEN PRACT) OR (JNCANADIAN FAMILY PHYSICIAN OR JT Can. Fam. Phys. OR JTCAN FAM PHYSICIAN) OR (JN FAMILY MEDICINE OR JTFam. Med. OR JT FAM MED) OR (JN FAMILY PRACTICE OR JTFam. Pr. OR JT FAM PRACT) OR (JN Journal of the AmericanBoard of Family Medicine OR JT J. Am. Board Fam. Med. OR JT JAM BOARD FAM MED) OR (JN JOURNAL OF FAMILYPRACTICE OR JT J. Fam. Pract. OR JT J FAM PRACTICE) OR

    (JN PRIMARY CARE OR JT Primary Care OR JT PRIMARYCARE) OR (JN SCANDINAVIAN JOURNAL OF PRIMARYHEALTH CARE OR JT Scand. J. Prim. Health Care OR JT SCANDJ PRIM HEALTH) OR (JN Australian Family Physician OR JTAust. Fam. Physician OR JT AUST FAM PHYSICIAN) OR (JNAustralian Journal of Primary Health OR JT Aust. J. Prim. Health.OR JT AUST J PRIM HEALTH) OR (JN ANNALS OF FAMILYMEDICINE OR JT ANN FAM MED OR JT Ann. Fam. Med.)

    14666

    5 1 or 2 or 3 or 4 378413 1 or 2 or 3 or 4 443086 (S1 or S2 or S3 or S4) 108615

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    14

    ATIENTAFETY

    6 exp Safety Management/ or exp Patient Safety/ orpatient safety.tw. or safety culture.tw. or (safe$2adj2 (practice? or management?)).tw. or (st.fs. and(safe or safety).tw.)

    44589 exp patient safety/ or patient safety.tw. or safety culture.tw.or (safe$2 adj2 (practice? or management?)).tw. or (st.fs.and (safe or safety).tw.)

    43610 (MH "Patient Safety+") OR (MH "Hand Off (Patient Safety)") OR(MH "Cultural Safety") OR TI (patient safety or safety culture or(safe* W2 (practice* or management*))) OR AB (patient safety orsafety culture or (safe* W2 (practice* or management*)))

    46231

    7 ((adverse? or preventable? or safet$3) adj1 (event?or effect? or reaction? or outcome?)).tw.

    163587 exp adverse outcome/ or exp adverse drug reaction/ or((adverse? or preventable? or safet$3) adj1 (event? oreffect? or reaction? or outcome?)).tw.

    497628 (MH "Adverse Health Care Event+") OR TI ( ((adverse* orpreventable* or safet*) W1 (event* or effect* or reaction* oroutcome*)) ) OR AB ( ((adverse* or preventable* or safet*) W1(event* or effect* or reaction* or outcome*)) )

    51186

    8 harm$2.tw. 23113 harm$2.tw. 28397

    TI harm* OR AB harm* 13872

    9 exp Iatrogenic Disease/ or iatrogenic.tw. 24216 exp Iatrogenic Disease/ or iatrogenic.tw. 473645 (MH "Iatrogenic Disease") OR TI "Iatrogenic" OR AB "Iatrogenic"2219

    10 exp Medical Errors/ or ((medica$ or diagnostic? ortherapeutic$ or administration? or dispensing? or

    prescri$) adj1 (error? or mistake? or fault?)).tw.

    76322 exp medical error/ or ((medica$ or diagnostic? ortherapeutic$ or administration? or dispensing? or prescri$)

    adj1 (error? or mistake? or fault?)).tw.

    72338 (MH "Health Care Errors+") OR TI ( ((medica* or diagnostic* ortherapeutic* or administration* or dispensing* or prescri*) N1

    (error* or mistake* or fault*)) ) OR AB ( ((medica* or diagnostic* ortherapeutic* or administration* or dispensing* or prescri*) N1(error* or mistake* or fault*)) )

    20880

    11 exp Malpractice/ or malpractice?.tw. 29164 exp Malpractice/ or malpractice?.tw. 30241 (MH "Malpractice") OR TI Malpractice* OR AB Malpractice* 6857

    12 (Quality & safety in health care or Qual Saf HealthCare or International Journal for Quality in HealthCare or IJQHC).jn. and safe$2.mp.

    595 ((Quality & safety in health care or International Journal forQuality in Health Care).jn. or (Qual Saf Health Care orIJQHC).ja.) and safe$2.mp.

    651 ((JN Quality & safety in health care OR JT Qual Saf Health Care)OR (JN International Journal for Quality in Health Care OR JTIJQHC) AND safe*)

    948

    13 6 or 7 or 8 or 9 or 10 or 11 or 12 343189 6 or 7 or 8 or 9 or 10 or 11 or 12 786990 (S6 or S7 or S8 or S9 or S10 or S11 or S12) 92303

    NITEDNGDO

    14 exp Great Britain/ 269034 exp United Kingdom/ 279276 (MH "United Kingdom+") 185291

    15 (United Kingdom or UK or England or GreatBritain or British or Hebrides or Northern Irelandor Scotland or Wales).in,tw.

    879445 (United Kingdom or UK or England or Great Britain orBritish or Hebrides or Northern Ireland or Scotland orWales).in,tw.

    1772173 ((AF United Kingdom or UK or England or Great Britain or Britishor Hebrides or Northern Ireland or Scotland or Wales) OR (TI UnitedKingdom or UK or England or Great Britain or British or Hebrides or

    Northern Ireland or Scotland or Wales) OR (AB United Kingdom orUK or England or Great Britain or British or Hebrides or NorthernIreland or Scotland or Wales))

    94012

    16 14 or 15 1045024 14 or 15 1913945 S14 or S15 217038

    UALITAVE

    TUDES

    17 interview:.tw. or px.fs. or exp health servicesadministration/

    2414128 (interview: or qualitative).tw. or exp health careorganization/

    1183338 (MH "Study Design+") OR (MH "Attitude+") OR (MH"Interviews+")

    555615

    18 exp qualitative research/ or exp Interviews asTopic/ or ((qualitative adj2 (research or stud$3 oranalysis or method? or approach$2 or data)) or

    focus group? or meta synthesis or interview? orgrounded theor$3 or ((content or c onversation) adj1analysis) or ethnograph$ or group discussion?).mp.

    208590 exp qualitative research/ or exp content analysis/ or expinterview/ or exp grounded theory/ or exp ethnography/ or((qualitative adj2 (research or stud$3 or analysis or method?

    or approach$2 or data)) or focus group? or meta synthesis orinterview? or grounded theor$3 or ((content orconversation) adj1 analysis) or ethnograph$ or groupdiscussion?).mp.

    262921 (MH "Qualitative Studies+") or (MH "Focus Groups") OR (MH"Content Analysis") OR (MH "Grounded Theory") or (MH"Ethnographic Research") or ((qualitative* N2 (research or stud* or

    analysis or method* or approach* or data)) or focus group* or metasynthesis or interview* or grounded theor* or ((content orconversation) N1 analysis) or ethnograph* or group discussion*)

    156672

    19 17 or 18 2440965 17 or 18 1225391 S17 or S18 578790

    20 5 and 13 and 16 and 19 1432 5 and 13 and 16 and 19 2094 S5 and S13 and S16 and S19 356

    21 exp Animals/ not exp Humans/ 3644792 exp animal/ not exp human/ 1276287 (MH "Animals+") NOT (MH "Human") 21328

    22 20 not 21 1432 20 not 21 2094 S20 NOT S21 356

    23 limit 22 to last 22 years 1386 limit 22 to last 22 years 1963 Limiters- Published Date from: 19900101-20121231 354

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    15

    APPENDIX 2. USING ENDNOTE TO RECORD AND MANAGE

    THE INFORMATION

    During the screening process, the information regarding the eligibility of a reference (relevant

    or not relevant) will be recorded in the EndNote database. Each author will receive a

    personalized database, containing only the reference which is going to screen. The screening

    process will consist in eliminating the not relevant referencesfrom the database.

    At the end of each stage (pilot and screening of titles, abstracts and full texts), the results of

    the screening will be sent to the rest of the authors in a XML extension, reducing thus the size

    of the file. We will export the references in a XML extension by selecting the references to

    export, and subsequently by going to file/export/save as XML. Otherwise, to import the

    references of the rest of reviewers, we will go to File/Import/file/ and select the import option

    EndNote generated XML.

    Finally, all databases will be merged, the agreement will calculated the followings databases

    will be created for the next screening process (figure 2).

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    16

    APPENDIX 3. AGREEMENT REPORT

    RSSC NR

    Aa Nb Ke A N K A N K

    N N Ref ID list N N Ref ID list N N Ref ID list

    JMV

    NR

    SC

    a, Agreement; b, Not agreement; c, number of references; d, list of the references (only identification number); e Kappa statistic

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    17

    APPENDIX 4. CRITICAL APPRAISAL SKILLS PROGRAMME

    (CASP).

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    18

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    19

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    FIGURE 1

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    22

    FIGURE 2

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    Reference List

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    2. Noyes J, Booth A, Hannes K, Harden A, Harris J, Lewin S, et al. Supplementary Guidance

    for Inclusion of Qualitative Research in Cochrane Systematic Reviews of Interventions:Cochrane Collaboration Qualitative Methods Group; 2011.3. Ovid SP. Wolters Kluwer; 2012 [updated 2012/01/03/]; Available from:http://gateway.ovid.com/autologin.html.

    4. CINAHL Databases. EBSCO Publishing. [Bibligraphic database]: EBSCO; 2012; Available

    from:http://www.ebscohost.com/cinahl/.

    5. Journal Citation Reports. ISI Web of Knowledge. Thomson Reuters; 2012 [updated2012/01/03/]; Available from:http://wokinfo.com/.

    6. Critical Appraisal Skills Programme (CASP). Making sense of evidence. 10 questions to

    help you make sense of qualitative research. England: Public Health Resource Unit, 2006.

    7. Banning M. Older people and adherence with medication: A review of the literature.International Journal of Nursing Studies. 2008;45(10):1550-61.

    8. Banning M. Employment and breast cancer: a meta-ethnography. European Journal ofCancer Care. 2011;20(6):708-19.

    9. Campbell R, Pound P, Pope C, Britten N, Pill R, Morgan M, et al. Evaluating meta-ethnography: a synthesis of qualitative research on lay experiences of diabetes and diabetes

    care. Social Science & Medicine. 2003;56(4):671-84.

    10. Dixon-Woods M, Sutton A, Shaw R, Miller T, Smith J, Young B, et al. Appraisingqualitative research for inclusion in systematic reviews: a quantitative and qualitative

    comparison of three methods. Journal of health services research & policy. 2007;12(1):42-7.Epub 2007/01/25.

    11. Espndola C, Blay S. Bulimia e transtorno da compulso alimentar peridica: revisosistemtica e metassntese. Rev Psiquiatr. 2006;28(3):265-75.

    12. Feder GS, Hutson M, Ramsay J, Taket AR. Women exposed to intimate partner violence:expectations and experiences when they encounter health care professionals: a meta-analysis of

    qualitative studies. Archives of internal medicine. 2006;166(1):22-37. Epub 2006/01/13.13. Kane GA, Wood VA, Barlow J. Parenting programmes: a systematic review and synthesis

    of qualitative research. Child: care, health and development. 2007;33(6):784-93. Epub2007/10/20.

    14. Malpass A, Shaw A, Sharp D, Walter F, Feder G, Ridd M, et al. "Medication career" or"moral career"? The two sides of managing antidepressants: a meta-ethnography of patients'

    experience of antidepressants. Social science & medicine (1982). 2009;68(1):154-68. Epub2008/11/18.

    15. Rhodes T, Treloar C. The social production of hepatitis C risk among injecting drug

    users: a qualitative synthesis. Addiction. 2008;103(10):1593-603.

    16. Wright J, Emerson A, Stephens M, Lennan E. Hospital inpatient self-administration ofmedicine programmes: a critical literature review. Pharmacy World & Science. 2006;28(3):140-51.

    17. Munro SA, Lewin SA, Smith HJ, Engel ME, Fretheim A, Volmink J. Patient Adherence toTuberculosis Treatment: A Systematic Review of Qualitative Research. PLoS Med.

    2007;4(7):e238.

    18. Noyes J, S L. Chapter 6: Supplemental Guidance on Selecting a Method of Qualitative

    Evidence Synthesis, and Integrating Qualitative Evidence with Cochrane Intervention Reviews.In: Noyes J BA, Hannes K, Harden A, Harris J, Lewin S, Lockwood C editor. Supplementary

    Guidance for Inclusion of Qualitative Research in Cochrane Systematic Reviews of InterventionsVersion 1 (updated August 2011): Cochrane Collaboration Qualitative Methods Group; 2011.

    19. Dixon-Woods M, Agarwal S, Jones D, Young B, Sutton A. Synthesising qualitative andquantitative evidence: a review of possible methods. Journal of health services research &policy. 2005;10(1):45-53. Epub 2005/01/26.

    http://gateway.ovid.com/autologin.htmlhttp://gateway.ovid.com/autologin.htmlhttp://www.ebscohost.com/cinahl/http://www.ebscohost.com/cinahl/http://www.ebscohost.com/cinahl/http://wokinfo.com/http://wokinfo.com/http://wokinfo.com/http://wokinfo.com/http://www.ebscohost.com/cinahl/http://gateway.ovid.com/autologin.html
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    20. Garcia J, Bricker L, Henderson J, Martin MA, Mugford M, Nielson J, et al. Women's views

    of pregnancy ultrasound: a systematic review. Birth (Berkeley, Calif). 2002;29(4):225-50. Epub

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    attitudes to clinical practice guidelines. The British journal of general practice : the journal of

    the Royal College of General Practitioners. 2007;57(545):971-8. Epub 2008/02/07.22. McInnes E, Askie L. Evidence review on older people's views and experiences of fallsprevention strategies. Worldviews on evidence-based nursing / Sigma Theta Tau International,

    Honor Society of Nursing. 2004;1(1):20-37. Epub 2006/12/07.23. Noyes J, Popay J. Directly observed therapy and tuberculosis: how can a systematic

    review of qualitative research contribute to improving services? A qualitative meta-synthesis. JAdv Nurs. 2007;57(3):227-43. Epub 2007/01/20.


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