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LUN2827: Schizophrenia Treatment Landscape - Questionnaire

LUN2827

Schizophrenia Treatment Landscape Study

Physician Questionnaire, Physician PRF

Version 9

July 2012

Contact:Cassie [email protected]: +44 (0)1625 509287

mailto:[email protected]


Comments:

- Only black font is shown to respondents

- Red is for information

- Blue is programmer notes (PN)

[PN: All questions should be on separate screens, unless indicated otherwise.]

CONTENTS

SCREENER..............................................................................................................................................7

S1 Specialty........................................................................................................................................7

S1a [ASK Nervenärtzes ONLY:]...........................................................................................................7

S2 Number of years since qualifying..................................................................................................8

S3 Caseload........................................................................................................................................8

S4 Initiate treatment.........................................................................................................................8

S5 Initiate depot treatment...............................................................................................................8

S6 Country regions.............................................................................................................................9

S7 Setting.........................................................................................................................................10

SECTION A: PHYSICIAN QUESTIONNAIRE.............................................................................................12

A1 Setting........................................................................................................................................14

A2 Estimated prescribing.................................................................................................................15

A3 Unmet needs..............................................................................................................................17

A4 Level of adherence among physician’s patients.........................................................................19

A5 Establishing a patient’s level of adherence to treatment regimen.............................................19

A6 Reason for non-adherence.........................................................................................................20

A7 Improving adherence.................................................................................................................21

A8 Knowledge of poor insight into disease......................................................................................22

A9 Establishing level of insight in patients with schizophrenia........................................................22

A10 Prevalence of poor insight among physicians’ patients............................................................23

A11 Improvement of insight into disease........................................................................................23

A12 Impact of poor insight on patient’s prognosis..........................................................................24

A13a Impact of level of insight on treatment decision....................................................................25

A13b Specific impact on depot........................................................................................................25

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SECTION B: PATIENT RECORD FORM...................................................................................................27

B0 Date of most recent consultation...............................................................................................28

B1 Date of birth...............................................................................................................................28

B2 Gender........................................................................................................................................28

B3 BMI.............................................................................................................................................29

B4 Employment status....................................................................................................................30

B5 Family status...............................................................................................................................31

B6a Reason for most recent consultation........................................................................................32

B6b Action from consultation..........................................................................................................32

B7a Date of diagnosis.....................................................................................................................33

B7b Number of years in psychiatrists care......................................................................................33

B8a Number of consultations with patient......................................................................................33

B8b Number of relapses..................................................................................................................33

B9 Patient journey...........................................................................................................................34

B10a Settings versus disease stages................................................................................................35

Hospital (chronic/long-term care)...................................................................................................35

B10b Healthcare professionals........................................................................................................36

B11 Disease severity (CGI)...............................................................................................................37

B12a Current status (option 1)........................................................................................................38

B12b Current status (option 2)........................................................................................................38

B13 Status scale preference............................................................................................................39

B14 Quality of life............................................................................................................................40

B15 Patient’s level of insight............................................................................................................40

B16a Patient circumstances.............................................................................................................41

B16b Patient circumstances: drug / alcohol....................................................................................41

B17 Hospitalisation..........................................................................................................................42

B18 Number of times hospitalised...................................................................................................42

B19 Duration of hospital stay..........................................................................................................42

B20 Treatment change at discharge from hospital..........................................................................43

B21a Treatment at discharge from hospital....................................................................................43

B21b Discharged on a depot formulation........................................................................................44

B22 Current treatments...................................................................................................................45

B23 Side effects...............................................................................................................................47

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B24 Current treatment information................................................................................................48

B24b. Dose change..........................................................................................................................49

B25 Previous treatment before depot.............................................................................................50

B26 Reason prescribed a depot treatment......................................................................................50

B27 First prescription of a depot treatment....................................................................................51

B28 Reason not currently on a depot treatment.............................................................................52

B29 Current symptoms....................................................................................................................53

B30 Severity of symptoms...............................................................................................................54

B31 Patient awareness of symptoms...............................................................................................54

B32 Symptom perception in relation to medication........................................................................55

B33 Reasons for prescribing............................................................................................................56

B34 Anticipated future non-adherence...........................................................................................58

B35 Previous treatment...................................................................................................................59

B36 Previous treatment information...............................................................................................61

B36b. Dose change..........................................................................................................................62

B37 Reasons for discontinuing / switching treatment.....................................................................62

B40 Numbers of patients that are anticipated non-compliant........................................................65

Page 4


SCREENER

S0 Language

Please select

1. Complete survey in English

2. Complete survey in Portuguese

3. Complete survey in French

4. Complete survey in Danish

5. Complete survey in Finnish

7. Complete survey in German

8. Complete survey in Italian

9. Complete survey in Norwegian

10. Complete survey in Polish

11. Complete survey in Spanish

12. Complete survey in Swedish

Page 5


S0 Country

In which country is your practice located?

COUNTRY CODE

1. Australia AU

2. Brazil BR

3. Canada CA

4. Denmark DK

5. Finland FI

6. France FR

7. Germany DE

8. Italy IT

9. Norway NO

10. Poland PL

11. Spain ES

12. Sweden SW

13. UK UK

99. Other [CLOSE]

[PN: SINGLE CODE]

Page 6


SCREENER (2 minutes)

Thank you for your interest in our market research survey on the treatment of patients with schizophrenia. As with any survey, there are certain criteria that must be met in order to participate.

If you qualify for the survey you will be asked to provide information from the charts or medical records for 6 adult patients diagnosed with schizophrenia. Nothing that can identify individual patients will be asked.

The following screening questions should take no more than 2-3 minutes.

Please click ‘Forward’ to continue.

S1 Specialty

What is your primary medical specialty?

1. Primary care physician [UK SHOW:] General practitioner

CLOSE

2. Psychiatrist CONTINUE TO S2

3. Nervenärtze [SHOW IN GERMANY ONLY] CONTINUE TO S1a

99. Other CLOSE

[QUOTA FOR DE SET TO 70/30 for Psychiatrist and Nervenartze]

[PN: SAME SCREEN]

S1a [ASK Nervenärtzes ONLY:]

What proportion of your time in practice do you spend working in psychiatry?

___%

[MUST SPEND AT LEAST 30%, OTHERWISE SCREEN OUT]

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S2 Number of years since qualifying

How many years have you been practicing in your clinical specialty, after qualifying?

____ years

[Terminate if < 2 or > 40]

[PN: allow range 0-90]

S3 Caseload

a. Thinking about an average month, approximately how many patients do you see in total? ________ patients

b. Of these, how many patients with schizophrenia do you personally treat or manage in a month? ________ patients

[Terminate if fewer than 10 patients (S3b)]

[PN: Allow range 0 – 999].

S4 Initiate treatment

Do you initiate or change drug treatment for patients with schizophrenia?

1. Yes CONTINUE

2. No CLOSE

PN: in Nordics show “initiate / prescribe” in place of just initiate.

S5 Initiate depot treatment

Do you initiate depot treatment for patients with schizophrenia?

1. Yes CONTINUE

2. No CONTINUE

PN: in Nordics show “initiate / prescribe” in place of just initiate.

SET MAX OF 50% WHO CANNOT ADMINISTER DEPOTS MONITOR DURING FIELDWORK TO ENSURE SAMPLE INCLUDES ENOUGH PSY PRESCRIBING

DEPOTS (NEED AS HIGH A NUMBER AS POSSIBLE PER MARKET – AT LEAST HALF PER MARKET INITIATING DEPOT)

Page 8


ANALYSIS TO BE COMPLETED BY ORAL/DEPOT AND BY PATIENT FLOW MODEL (INDIVIDUAL COUNTRY LEVEL)

S6 Country regions

Which of the following regions [PN: In CA –show ‘provinces’ not ‘regions’, in AU show ‘states’] do you primarily work in?

[SEE REGIONS ON EXCEL SHEET]

MONITOR DURING FIELDWORK AND ENSURE SAMPLE IS REPRESENTATIVE OF MARKET

Page 9


S7 Setting

Approximately what percentage of your time spent in direct patient care is in each of the following health care locations?

Type in % for each

FR DE ES IT UK CA BR AU PL NORDICS

1 Hospital (acute care)

2 Hospital (chronic / long-term care)

3 Day hospital (intermediary care)

4 Out-patient clinic (CMP)

Ambulatory Service

Centro de Salud Mental

Community Mental Health Center

Out-patient clinic

Out-patient clinic Out-patient clinic / community care

5 Private practice n/a n/a n/a n/a Private practice

n/a

6 Private hospital

n/a n/a n/a Private hospital

n/a

7 Judicial/forensic setting (prison)

8 n/a Psychiatric clinic n/a

9 n/a GP/ PCP clinic n/a

99 Other, please specify

Total: MUST SUM TO 100%

[PN: if sum of code 5 and code 6 (private practice and private hospital) are over 50% for UK, screen out]


MONITOR DURING FIELDWORK AND ENSURE SAMPLE IS REPRESENTATIVE OF MARKET

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SECTION A: PHYSICIAN QUESTIONNAIRE (8 minutes)

INTRODUCTION TO MARKET RESEARCH STUDY

- You are invited to take part in this market research study, the purpose of which is to better understand the treatment of schizophrenia by focusing on individual patients.

- This study is being conducted by an independent market research agency for scientific purposes, and has no promotional intent. This research is being sponsored by a global pharmaceutical company.

- Your responses will be kept completely confidential and anonymous in line with market research codes of conduct and data protection laws, and will be analysed along with a large number of other physicians across several countries.

- We would like you to provide information from the medical records of 6 adult patients diagnosed with schizophrenia that you are currently managing (randomly selected based on instructions that will be provided).

- For each patient we would like you to fill in a patient profile that will take approximately 16-18 minutes to complete. You should use patient medical records to ensure that the information you provide is accurate.

- Please note that no personal identifying information about any patient will be asked. In line with the Data Protection Directive 95/46/EC, all relevant data will be kept strictly confidential and anonymous. This study is also compliant with the EphMRA and ABPI Codes of Conduct.

- Important note: In order to achieve a random sample of patients, we need your cooperation in following the selection criteria outlined CAREFULLY without your cooperation, it is unlikely that our resulting sample will be truly representative of the universe of treated patients (if you select patients based on recall alone, it is likely the resulting sample will be skewed toward atypical cases difficult or atypical cases being easier to recall).

- You can log on several times to complete the web survey and save your progress each time so that you don’t have to complete all of the information and patient profiles at once.

[PN: TICK BOX FOR INSTITUTION APPROVAL] In some countries it is necessary to get permission from your hospital/institution to take part in market research. Please confirm that you understand that you may need approval from your hospital/institution, and that if required, it is your responsibility to obtain this.

[PN: NEW SCREEN]

Adverse events

- We are required to pass on to our client details of adverse events that are raised during the course of market research. Although this is an online market research study and how you will respond will, of course, be treated in confidence, should you raise an adverse event in a specific patient we will need to report this, even if it has already been reported by you directly to the company or the regulatory authorities (UK ONLY


“using the MHRA's ‘Yellow Card' system”). In such a situation you will be contacted to ask whether or not you are willing to waive the confidentiality given to you under the market research codes of conduct specifically in relation to that adverse event. Everything else you say during the course of the study will continue to remain confidential.

[PN: TICK BOX HERE FOR CONSENT] I confirm that I have read, understood, and accept the points above and am happy to proceed with the market research study on this basis.

- Help / Pour assistance / Hilfe / Per assistenza / Ayuda / Ajuda: mail to: [email protected]

Page 13

mailto:[email protected]


[PN: NEW SCREEN]

- First of all we would like you to answer some background and profiling questions, which will take about 8 minutes.

[PN: NEW SCREEN]

A1 Setting

What percentage of your time is spent working with in-patients versus out-patients? Type in % for each

1. In-patients %

2. Out-patients %

Total: MUST SUM TO 100%

Page 14


A2 Estimated prescribing

Thinking about the patients with schizophrenia that you see in a typical month, approximately what proportion would be prescribed each of the following treatments?

Type in % for each. Your total may sum to more than 100% due to combination therapy

Atypical orals

1. OLANZAPINE ___%

2. RISPERIDONE ___%

3. CLOZAPINE ___%

4. QUETIAPINE (Seroquel)

[PN: IN FR SHOW “QUETIAPINE (Xeroquel)”]

___%

5. ARIPIPRAZOLE (Abilify) ___%

6. PALIPERIDONE (Invega) [PN: DO NOT SHOW IN FI, FR, NO, PL] ___%

7. AMISULPRIDE [PN: DO NOT SHOW IN CA, FI, SW] ___%

8. ZIPRASIDONE (Zeldox) [PN: DO NOT SHOW IN FR, UK]

[PN: IN BR SHOW “ZIPRASIDONE (Geodon)”

[PN: IN DK SHOW “ZIPRASIDONE (Geodon/Zeldox)”

___%

9. ASENAPINE (Sycrest) [PN: DO NOT SHOW IN FR, PL]

[PN: IN AU,BR,CA SHOW “ASENAPINE (Saphris)”

___%

10. Other ___%

Atypical depot

11. RISPERIDONE (Risperdal Consta)

[PN: IN DK, DE, NO, PL, SW SHOW “RISPERIDONE”]

___%

12. PALIPERIDONE PALMITATE (Xeplion) – SHOW IN DK, FI, DE, NO, ES, SW, UK

PALIPERIDONE PALMITATE (Invega Sustenna)” - SHOW IN AU, BR, CA

[PN: DO NOT SHOW IN FR, IT, PL]

___%

Page 15


13. OLANZAPINE PAMOATE (Zypadhera)

[PN: IN AU SHOW “OLANZAPINE PAMOATE (Zyprexa Relprevv)”]

[PN: DO NOT SHOW IN BR, CA]

___%

14. Other ___%

Typical oral

15 HALOPERIDOL ___%

16 LEVOMEPROMAZINE [PN: DO NOT SHOW IN AU] ___%

17 CHLORPROMAZINE [PN: DO NOT SHOW IN DK, DE, PL, SW] ___%

18 ZUCLOPENTHIXOL ___%

19. Other ___%

Typical depot

20. FLUPHENAZINE [PN: DO NOT SHOW IN DK, FR, NO, PL] ___%

21. HALOPERIDOL [PN: DO NOT SHOW IN ES] ___%

22. ZUCLOPENTHIXOL ___%

23. FLUPENTIXOL [PN: DO NOT SHOW IN BR, FR, IT, ES] ___%

24. Other ___%

Page 16


A3 Unmet needs

Thinking in general about current treatments for schizophrenia, which of these areas do you feel require most improvement?

Please select up to 7 options from the list below

Efficacy

1. Control of positive symptoms

2. Control of negative symptoms

3. Early treatment response

4. Relapse prevention/maintaining treatment response

5. Control of aggressive symptoms (e.g. hostility and agitation)

Side effects

6. Control of metabolic side effects (including weight gain)

7. Control of extrapyramidal side effects (including tardive dyskinesia, but excluding akathisia)

8. Control of akathisia

9. Control of prolactin-related side effects (including sexual dysfunction)

10. Control of sedation

General attributes11. Mode of administration

12. Availability of atypical depots

13. Frequency of dosing

14. Transition from oral to depot medication

15. Requirement for blood monitoring and/or liver function/liver status

16. Cost/ reimbursement

17. Patient adherence

Patient relevant outcomes18. Overall quality of life

19. Patient satisfaction with treatment

20. Level of functioning (e.g. in social situations, being able to live independently)

Other

Page 17


98. Other, please specify_____________

99. None of the above [PN: EXCLUSIVE]

[PN: MULTICODE; ROTATE OPTIONS WITHIN EACH SUB-GROUP]

Page 18


A4 Level of adherence among physician’s patients

What proportion of your patients are adherent, partially adherent or non-adherent to their prescribed treatment regimen?

Type in % for each

1. Fully adherent i.e. take their medication all of the time

%

2. Partially adherent i.e. take their medication most of the time

%

3. Non-adherent i.e. take their medication occasionally/not at all

%

MUST SUM TO 100%

A5 Establishing a patient’s level of adherence to treatment regimen

How do you establish the level of a patient’s adherence (i.e. fully, partially or non-adherent) to treatment?

Please select all that apply

1. Ask patient

2. Ask accompanying caregiver

3. Ask psychiatric nurse

4. Judge based on severity of symptoms (whether exacerbated, stable, or improved)

4. Use an adherence aid e.g. MEMS cap

99. Other, please specify_____________________________________

[PN: MULTICODE]

Page 19


A6 Reason for non-adherence

What do you think are the main reasons for patients not adhering or only partially adhering to their treatment regimen?


1. Not aware of illness (no insight into disease)

2. Aware of illness/symptoms, but does not recognise the need for treatment

3. Aware of illness but unwilling to accept that they have schizophrenia

4. Belief that they are cured (lack of insight)

5. Other disease symptom(s) affecting ability to take medication (e.g. delusions, hallucinations)

6. Presence of side effects

7. Concerns about potential side effects

8. Lack of family support

9. Complicated medication regimens

10.

Forgetting to take their medication

11.

Cognitive impairment (not related to schizophrenia e.g. dementia, learning disability)

12.

Drug / alcohol abuse

13.

Cost of medication

99.

Other, please specify ____________________

[PN: MULTICODE MAXIMUM OF 5, DO NOT ROTATE]

Page 20


A7 Improving adherence

Please indicate which of the following steps you commonly use to improve non-adherence / partial adherence in your practice, and how much impact these have on adherence.

Please select one option per row

Use, with good impact

Use, with limited/no impact

Do not personally use

1. Re-engage caregiver/support network

2. Switch to other oral antipsychotic with fewer side effects

3. Switch to other oral antipsychotic with perceived improved effect

4. Switch to depot injection

5. Initiate / add cognitive behavioural therapy (CBT)

6. Adjust the dose

7. Discuss reasons for non-adherence with patient

8. Simplify medication routine

99.

Other, please specify___________

[PN: SINGLE CODE PER ROW, ROTATE OPTIONS]

Page 21


A8 Knowledge of poor insight into disease

Are you familiar with the term ‘anosognosia’?`1. Yes, to me this means [please specify]______

2. Yes, I have heard of it but not sure what it means

3. No, not at all

[PN: SINGLE CODE]

A9 Establishing level of insight in patients with schizophrenia

Anosognosia means a patient has poor insight into/awareness of their disease.

In your patients with schizophrenia, how do you establish the patient’s level of insight into their disease? Please type in your answer below______________________________________________________________________________________________________________________________________________________ 97. I don’t

[PN: SINGLE CODE]

Page 22


A10 Prevalence of poor insight among physicians’ patients

Approximately what proportion of your patients at the current moment fit into each of the following categories in relation to their awareness of their schizophrenia?

Type in % for each

1. Fully aware %

2. Moderately aware (i.e. aware of symptoms, but no insight into need for treatment)

%

3. Fully unaware %

MUST SUM TO 100%

A11 Improvement of insight into disease

If a patient is moderately aware / fully unaware of their schizophrenia for a year or more, do you believe the patients’ insight into their disease can improve?Please select one option per row

Yes, insight can

improve

Yes, insight can improve, but only

to some extent

No, insight cannot

improve

Don’t know

1. Moderately aware

2. Fully unaware

[PN: SINGLE CODE PER ROW]

Page 23


A12 Impact of poor insight on patient’s prognosis

What do you think are the main consequences of a patient’s poor/low level of insight into their schizophrenia?


1. Non-adherence to treatment

2. Worsening of symptoms

3. Lower quality of life (QoL)

4. Lower health-related quality of life (HRQoL)

5. Lower level of functioning

6. Creates mistrust between doctor-patient, making it more difficult to engage the patient in treatment

7. Increased workload for treatment team (e.g. more need for close monitoring of treatment progress, surveillance of adherence to treatment)

8. Increased need for caregiver support

99. Other, please specify____________________________________________

97. I don’t think that poor insight impacts on a patient’s prognosis [PN: EXCLUSIVE]

[PN: MULTICODE UP TO 3, ROTATE OPTIONS]

Page 24


A13a Impact of level of insight on treatment decision

How much impact does the patient’s level of insight into their schizophrenia have on your treatment decision, if any? 1. No impact at all

2. Some impact

3. Major impact

[PN: SINGLE CODE]

A13b Specific impact on depot

[PN: ONLY ASK IF INSIGHT HAS AN IMPACT ON PRESCRIBING DECISION I.E. CODE 2 OR 3 AT A13A]

Are you more likely to prescribe a depot medication to a patient with…1. …a high level of insight

2. …a low level of insight

3. ... either high or low insight –it does not have a big influence on my decision to prescribe a depot medication

[PN: SINGLE CODE]

Page 25


[PN: NEW SCREEN]

Thank you for completing the first part of the survey.

INSTRUCTIONS FOR SELECTING PATIENTS

- We would like you to randomly select 6 adult schizophrenia patients that you are currently managing. Please go to your patient files and start your search with patients whose last name begins with [PN: ROTATE “A”, “K”, “S”]. (Note: this is an arbitrary starting point to ensure that the records pulled will be random).

- Using [“A”, “K”, “S”] as a starting point, work through the files alphabetically towards the letter “Z” until you find patients who meet the following criteria:

[PN: IF PHYSICIAN IS ABLE TO ADMINISTER DEPOT (I.E. S5 CODE 1) SHOW NEXT TWO BULLET POINTS]

o A patient who is 18 years of age or over of any type who you have seen in a consultation during the last 24 months – please profile 4 patients meeting this criteria

o A patient who is 18 years of age or over who you have seen in a consultation during the last 24 months AND is receiving a depot medication for their schizophrenia – please profile 2 patients meeting this criteria

[PN: IF PHYSICIAN IS NOT ABLE TO ADMINISTER DEPOT (I.E. S5 CODE 2) SHOW NEXT BULLET POINT]

o A patient who is 18 years of age or over of any type who you have seen in a consultation during the last 24 months – please profile 6 patients meeting this criteria

- Once you have selected the patients please complete the following questions based on their background information and information taken from their most recent consultation.

Page 26


SECTION B: PATIENT RECORD FORM (16-18 minutes)

BX Patient record form

Please select which patient record form you are currently completing from the below options:

[PN: IF PHYSICIAN IS ABLE TO ADMINISTER DEPOT (I.E. S5 CODE 1) SHOW NEXT TABLE]

1. Patient 1 of any type




5. Patient 5 (depot treatment)

6. Patient 6 (depot treatment)

NUMBER OF DEPOT PATIENTS TO BE MONITORED TO ENSURE MINIMUM HALF OF SAMPLE INITIATING DEPOT

[PN: IF PHYSICIAN IS NOT ABLE TO ADMINISTER DEPOT (I.E. S5 CODE 2) SHOW NEXT TABLE]

1. Patient 1

2. Patient 2

3. Patient 3

4. Patient 4

5. Patient 5

6. Patient 6

Please complete the following form for this patient as accurately as possible. You should use patient record forms to ensure that the information you provide is accurate. This information will remain completely confidential and anonymous.

You do not need to save each page, your answers will be saved automatically if you are leaving the survey and intend to resume later.

Page 27


[PN: PLEASE SHOW THIS DESCRIPTION AT TOP OF EACH SCREEN FROM THIS POINT ONWARDS] Patient record form for: [PIPE IN PATIENT ID NUMBER ENTERPoED AT BX]

B0 Date of most recent consultation

Please provide the date of the patient’s most recent consultation.

All patients must have been seen within the last 24 months

______/ _______ (MM/YYYY)

[PN: RANGE: 1900-2012]

B1 Date of birth

Please provide the patient’s year of birth (note, the patient must be 18 years of age or over):

_______ (YYYY)

[PN: RANGE: 1900-1994]

B2 Gender

Please indicate the patient’s gender:

1. Male

2. Female

[PN: SINGLE CODE]

Page 28


B3 BMI

Please indicate the BMI of the patient:

1. < 18.5 (underweight)

2. 18.5 – 24.9 (normal weight)

3. 25 – 29.9 (overweight)

4. > 29.9 (obese)

98. Don’t know

[PN: SINGLE CODE]

Page 29


B4 Employment status

What is the patient’s employment status?

1. Paid full-time employment

2. Paid part-time employment

3. Attend school / educational program

4. Voluntary work

6. Community service or sheltered work

7. Attend job training programme

8. Retired

9. Housewife / husband

10. Unemployed / on disability

99. Other

98. Don’t know

[PN: SINGLE CODE]

Page 30


B5 Family status

What are the patient’s living arrangements?

1. Living alone / independently

2. Living alone with support from a caregiver

3. Living with partner and children

4. Living with partner without children

5. Living with parents

6. Homeless

7. Nursing home / residential care home

8. Sheltered accommodation

99. Other (please specify)_______________

98. Don’t know

[PN: SINGLE CODE]

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B6a Reason for most recent consultation

What was the main reason(s) for the patient’s most recent consultation relating to their schizophrenia?


1. Diagnosis

2. Acute episode / relapse

3. Side effects

4. Referral

5. Scheduled or routine follow-up

6. Unscheduled follow-up (e.g. after an acute episode)

99. Other, please specify_______________

98. Don’t know

[PN: MULTICODE]

B6b Action from consultation

What action was taken regarding the patient’s schizophrenia treatment at the most recent consultation?

1. Treatment initiation

2. Treatment change

3. Treatment restart

4. Treatment repeat (no change)

5. Stop treatment

99. Other, please specify ______________

98. Don’t know / not applicable

[PN: SINGLE CODE]

Page 32


[PN: Show B7a & b on the same screen]

B7a Date of diagnosis

Please provide the date of the patient’s diagnosis with schizophrenia:

__ / __ (MM /YYYY)

[PN: OPEN NUMERIC. RANGE 1-31 /1900-2012. NO FUTURE DATE, ENSURE AFTER DATE OF BIRTH AT B1]

B7b Number of years in psychiatrists care

How long has the patient been in your care?

________________ weeks / months / years

[PN: NUMERICAL ANSWER. RANGE 1-99]

[PN: Show B8a & b on the same screen]

B8a Number of consultations with patient

How many times have you seen the patient for their schizophrenia in the last 12 months?

______ times

[PN: NUMERICAL ANSWER. RANGE 0-365]

B8b Number of relapses

How many psychotic relapses has the patient experienced in the past 12 months?

1. None

2. ______ relapses [PN: OPEN TEXT, NUMERICAL ANSWER]

98. Don’t know [PN: MUTUALLY EXCLUSIVE]

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B9 Patient journey

Thinking about the patient’s schizophrenia, what was the time period between…?

If two events take place on the same day for example diagnosis and initiation of treatment, please enter 0 days.

a) … first experiencing symptoms and first consultation (with yourself or another physician)

___ days/ weeks / months / years

[PN: NUMERIC, RANGE 0-100 FOR ALL, USE DROP DOWN BOX]

Don’t know / not applicable [PN: MUTUALLY EXCLUSIVE]

b) … first consultation and receiving diagnosis

___ days / weeks / months / years



c) … diagnosis and initiation of treatment

___ days / weeks / months / years



Page 34


B10a Settings versus disease stages

Please indicate which of the following settings the patient was being managed in for each of the following stages.

[PN: USE COUNTRY SPECIFIC LIST FROM S7, EXAMPLE BELOW IS FOR FRANCE]

a. First consultation

Select one

b. Diagnosis

Select one

c. Treatment initiation

Select one

d. Current management

(PN: red font) Please tick all

that apply

Hospital (acute care)

Hospital (chronic/long-term care)

Day hospital (intermediary)

Out-patient clinic (CMP)

Private practice

Private hospital

Judicial/forensic setting (prison)

Other, please specify

Don’t know / not applicable - - -

PN [SINGLECODE] [SINGLECODE]

[SINGLECODE] [MULTICODE]

Page 35


B10b Healthcare professionals

And which of the following healthcare professional(s) are/were responsible for each of the following?

a. First consultation

Select one

b. Diagnosis

Select one

c. Treatment initiation

Select one

d. Current management

(PN: red font) Please tick all

that applyYourself Primary care practitioner (IN UK SHOW “GP”)

Other psychiatrist, hospital

Other psychiatrist, officeNeurologist Clinical psychologist Geriatrician Nervenärtze [for Germany ONLY]

Psychiatric nurse Paediatrician / adolescent specialist

Other Don’t know / not applicable

PN [SINGLECODE] [SINGLECODE]

[SINGLECODE] [MULTICODE]

Page 36


B11 Disease severity (CGI)

How would you rate the severity of the patient’s schizophrenia? Please answer using the following scale, based on either a clinical assessment or your own clinical judgment.

1, normal, not at all mentally

ill

2, borderline mentally

ill

3, mildly mentally

ill

4, moderately mentally ill

5, markedly mentally

ill

6, severely mentally

ill

7, extremely mentally

ill

Don’t know

a) At your first involvement

b) At the most recent consultation


Page 37


PN: ROTATE ORDER OF PRESENTING THE FOLLOWING TWO QUESTIONS (B12A & B)

B12a Current status (option 1)

Please indicate the current status of the patient’s schizophrenia using the following options:

1. Acute

2. Stable with residual symptoms

3. Stable without residual symptoms

99. Other, please specify

[PN: SINGLE CODE]

B12b Current status (option 2)

Please indicate the current status of the patient’s schizophrenia using the following options:

1. Acute

2. Response

3. Remission

4. Recovery


[PN: SINGLE CODE]

Page 38


B13 Status scale preference

[PN: ONLY ASK THIS QUESTION ONCE – AT PRF 1]

Do you have a preference for any of the below options when asked to describe a patient’s schizophrenia status?

Scale X:

Acute

Stable with residual symptoms

Stable without residual symptoms

Scale Z:

Acute

Response

Remission

Recovery

1. Scale X

2. Scale Z

3. No preference, either of these options are ok

4. Neither of these options

Page 39


B14 Quality of life

How much impact does the patient’s schizophrenia have on the patient’s…?

Please respond on a scale of 1-5, where 1=no impact and 5=profound impact

1 (no impact

)2 3 4

5 (profound impact)

Don’t know

1. Overall quality of life

2. Activities of daily living (e.g. household chores, shopping)

3. Social relationships

4. Ability to work


B15 Patient’s level of insight

Is your patient aware that he/she has schizophrenia?

1. Fully aware

2. Moderately aware (i.e. aware of symptoms, but no insight into need for treatment)

3. Fully unaware

[PN: SINGLE CODE]

Page 40


B16a Patient circumstances

Please rate the patient’s situation in relation to the following attributes:

Please respond on a scale of 1-5, where 1=very low / very poor and 5=very high / very good

1 (Very low / very

poor)

2 3 45 (Very

high / very good)

Don’t know /

not applicabl

e

1. Relationship with physician

2. Support from healthcare professionals (excluding treating physician) and social workers or other professional caregivers

3. Support from family and/or friends

4. Socio-economic factors (e.g. financial situation)

5. Current treatment response

6. Previous treatment response

[PN: SINGLE CODE PER ROW; DO NOT ROTATE RESPONSES, KEEP CODE 1 & 2 TOGETHER]

B16b Patient circumstances: drug / alcohol

To what extent does the patient use/abuse drugs or alcohol?

1.

Does not use at all

2.

Mild use

3.

Moderate use

4.

Severe use / abuse

99.

Don’t know

Page 41


B17 Hospitalisation

Has the patient ever been hospitalised for their schizophrenia?

1. Yes, currently hospitalised

2. Yes, within the last 12 months

3. Yes, more than 12 months ago

4. No

98. Don’t know

[PN: SINGLE CODE]

B18 Number of times hospitalised

[PN: ONLY ASK B18, B19 and B20 IF CODE 1 or 2 AT B17]

How many times has the patient been hospitalised for their schizophrenia in the last 12 months?

________ [PN: OPEN TEXT, NUMERICAL ANSWER]

B19 Duration of hospital stay

[PN: ONLY ASK B18, B19 and B20 IF CODE 2 AT B17]

What was the duration of the most recent schizophrenia-related hospital stay?

___ days / weeks / months [PN: NUMERIC, RANGE 0-100 FOR ALL, USE DROP DOWN BOX]

Don’t know [PN: MUTUALLY EXCLUSIVE]

Page 42


B20 Treatment change at discharge from hospital

[PN: ONLY ASK IF CODE 2 AT B17]

When the patient was discharged from hospital, had the patient’s antipsychotic treatment regimen changed?

1. Yes

2. No

98. Don’t know

B21a Treatment at discharge from hospital

[PN: ONLY ASK IF B20 CODE 1]

How was the patient’s antipsychotic treatment changed during his/her stay in hospital?


Antipsychotic treatment…

1. … prescribed for the first time ever (i.e. as first-line therapy)

2. … switched from one antipsychotic treatment to another antipsychotic

3. .. switch to an antipsychotic (from another therapeutic category)

4. .. switch from an antipsychotic (to another therapeutic category)

5. … add-on of antipsychotic drug to regimen

6. … stopped, with no other therapies initiated

7. … change in dosing (of existing antipsychotic)

8. … change in formulation (of existing antipsychotic)

9. Other, please specify________

99. Don’t know

[PN: SINGLE CODE]

Page 43


[PN: ONLY ASK IF CODE 2 or 3 AT B17]

B21b Discharged on a depot formulation

Was the patient discharged from hospital on a depot formulation?

1. Yes

2. No

99. Don’t know

Page 44


B22 Current treatments

Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia?


95. No treatment currently prescribed

Atypical orals

1. OLANZAPINE

2. RISPERIDONE

3. CLOZAPINE



5. ARIPIPRAZOLE (Abilify)

6. PALIPERIDONE (Invega) [PN: DO NOT SHOW IN FI, FR, NO, PL]

7. AMISULPRIDE [PN: DO NOT SHOW IN CA, FI, SW]





[PN: IN AU,BR, CA SHOW “ASENAPINE (Saphris)”

10. Other, please specify ___________________________________

Atypical depot





Page 45






14. Other, please specify ___________________________________

Typical oral

15 HALOPERIDOL

16 LEVOMEPROMAZINE [PN: DO NOT SHOW IN AU]

17 CHLORPROMAZINE [PN: DO NOT SHOW IN DK, DE, PL, SW]

18 ZUCLOPENTHIXOL

19. Other, please specify __________________________________

Typical depot

20 FLUPHENAZINE [PN: DO NOT SHOW IN DK, FR, NO, PL]

21 HALOPERIDOL [PN: DO NOT SHOW IN ES]

22 ZUCLOPENTHIXOL

23. FLUPENTIXOL [PN: DO NOT SHOW IN BR, FR, IT, ES]

24. Other, please specify __________________________________

[PN: MULTICODE]

[PN: IF THIS IS A DEPOT MEDICATION PATIENT, CHECK THAT A DEPOT IS SELECTED – IF NOT SHOW ERROR MESSAGE: “This patient should be receiving a depot medication. Please check your responses before moving forward”]

Page 46


B23 Side effects

Please indicate which side effects the patient has experienced as a result of taking [PIPE THROUGH DRUGS SELECTED AT B22], if any?

97. No side effects [PN: EXCLUSIVE]

1. Metabolic side effects (excluding weight gain)

2. Weight gain

3. Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia)

4. Akathisia

5. Prolactin-related side effects (including sexual dysfunction)

6. Sedation

7. Injection site reactions


98. Don’t know [PN: EXCLUSIVE]

[PN: ROTATE OPTIONS]

Page 47


B24 Current treatment information

[PN: DO NOT SHOW IF CODE 95 AT B22 (I.E. NO TREATMENT CURRENTLY PRESCRIBED)]

Please complete the following information for the patient’s current treatment(s).

Mode of administration

Frequency of dosing [PN: DROP DOWN LIST,

SINGLE CODE]

Date treatment was

initially prescribed

mm/yyyy

Current dose, per

administration

(mg)

[PN: RANGE 0.1-2000]

Treatment status - start, repeat, switch, re-start?

Patient’s adherence with drug

1=Fully adherent &3 = Non-adherent

[PN: DROP DOWN LIST, SINGLE CODE]

Your overall satisfaction with drug

1=very poor & 5 = very good


IM acute injection

IM depot Injection

Oral solution

Oral tablet

Oral dispersible

Other

[PN: DROP DOWN LIST,

SINGLE CODE]

Monthly

Twice a month

Weekly

Once a day

Twice a day

Three times a day

Four or more times a day

Other

Start? (i.e. newly initiated, not used the drug previously)

Restart (have used the drug within the past 6 months)

Repeat?

Switch?

Other


1. Fully adherent i.e. take their medication all of

the time

2. Partially adherent i.e. take their medication

most of the time

3. Non-adherent i.e. take their medication

occasionally/not at all

1=very poor

2

3

4

5=very good

[PN: PIPE IN CURRENT TREATMENTS FROM B22, ONE DRUG PER ROW]


[PN: IF THIS IS PATIENT 5 OR 6, CHECK THAT DEPOT IS SELECTED – IF NOT SHOW ERROR MESSAGE]

B24b. Dose change

[PN: DO NOT SHOW IF CODE 95 AT B22 (I.E. NO TREATMENT CURRENTLY PRESCRIBED)]

Has a different dose ever been prescribed for any of the patient’s current treatment(s)? If so, please provide details below

Previous dose

Type in previous dose

(mg)

[PN: RANGE 0.1-2000,]

Date dose was changed

Type in date of dose change

Mm/yyyyDrug dosage not changed Don’t’know

[PN: PIPE IN CURRENT TREATMENTS FROM B22, ONE

DRUG PER ROW]

Page 49


Page 50


B25 Previous treatment before depot

[PN: If ‘IM depot Injection’ selected at B24, show B25, B26 & B27, depot related questions and skip B28]

You have indicated that the patient is currently receiving a depot injection medication. What treatment was the patient receiving before their depot medication?

1. Oral formulation of the same drug

2. Oral formulation of a different drug

3. Another depot treatment

4. No previous treatment [PN: EXCLUSIVE]


[PN: SINGLE CODE]

B26 Reason prescribed a depot treatment

[PN: If ‘IM depot Injection’ selected at B24, show B25, B26 & B27, depot related questions and skip B28]

Why was the patient prescribed a depot formulation treatment?


1. Poor adherence with oral therapy

2. Poor treatment response / residual symptoms

3. Patient request

4. Family request

5. Side effects/tolerability of previous treatment

6. Anticipated side effects/tolerability of prescribed treatment

7. More convenient dosing form

99. Other, please specify _______________________


[PN: MULTI CODE, ROTATE OPTIONS]


B27 First prescription of a depot treatment

[PN: ‘IM depot Injection’ selected at B24, show B25, B26 & B27, depot related questions and skip B28]

How many years after the initial diagnosis was the patient prescribed a depot antipsychotic for the first time?

________ years [PN: OPEN NUMERIC]

Don’t know [PN: MUTUALLY EXCLUSIVE]

Page 52


B28 Reason not currently on a depot treatment

[PN: ‘IM depot Injection’ is NOT selected at B24]

Why is the patient not currently on a depot formulation treatment?


1. Satisfactory adherence with oral therapy

2. Satisfactory treatment response to oral therapy

3. The right drug is not available as a depot formulation

4. Cost/reimbursement

5. Patient unwillingness

6. Family unwillingness

7. Practical reason e.g. not being able to attend hospital for injection

8. Low experience / familiarity with depot treatment

9. I never offered a depot formulation to the patient

10. I am unsure how to approach injections with the patient (e.g. because I don’t want to damage the doctor-patient relationship)

11. Patient current condition/symptoms (e.g. delusions, lack of insight into disease or need for treatment)

12. Formulary restrictions



[PN: MULTICODE, ROTATE OPTIONS]

Page 53


B29 Current symptoms

Please indicate which symptoms the patient currently experiences as part of their schizophrenia.


POSITIVE SYMPTOMS

1. Hallucinations

2. Delusions

3. Thought disorder

4. Changes in behaviour

5. Disorganised speech

NEGATIVE SYMPTOMS

6. Lack of interest

7. Social withdrawal

8. Emotional flatness

9. Inability to concentrate

OTHER SYMPTOMS

10. Suicidal thoughts

11. Motor signs

12. Aggression

13. Irritability

14. Sexual dysfunction

15. Cognitive deficits

16. Anosognosia (poor insight into the disease)

99. Other, please specify:_____

98. None [PN: EXCLUSIVE]


[PN: MULTICODE, ROTATE OPTIONS WITHIN CATEGORY]

Page 54


B30 Severity of symptoms

[PN: DO NOT ASK IF B29 CODE 96 – DON’T KNOW]

Please indicate the severity of each of the patient’s current symptoms on a 1-3 scale.

Please respond on a scale of 1-3, where 1=mild and 3= severe

1=mild 2=moderate 3=severe

Don’t know

[PIPE THROUGH RESPONSES SELECTED AT B29 (symptoms)]


B31 Patient awareness of symptoms

[PN: DO NOT ASK IF B29 CODE 96 – DON’T KNOW]

Is your patient aware that he/she experiences these symptoms?

1. Fully aware

2. Moderately aware (i.e. aware of

symptoms, but no insight into need for

treatment)

3. Fully unaware 99. Don’t know

1. [PN: PIPE THROUGH RESPONSES SELECTED AT B29 (symptoms)]


Page 55


B32 Symptom perception in relation to medication

[PN: ASK FOR ALL SYMPTOMS SELECTED AT B29 AND CODED 3 AT B31 (FULLY AWARE]

If your patient is aware that they experience these symptoms, do they believe that the severity of his/her symptoms have diminished due to their current medication?

Yes, consider

ably

Yes, somewh

atNo, not at all Don’t know

Not applicable

1. [PN: PIPE THROUGH RESPONSES SELECTED AT B31 ANDN CODED AS “Aware”]

Page 56


B33 Reasons for prescribing

Why did you prescribe [PIPE THROUGH DRUGS SELECTED AT B22] to the patient?


Symptoms – to treat…

POSITIVE SYMPTOMS

1. Hallucinations

2. Delusions

3. Thought disorder



NEGATIVE SYMPTOMS

6. Lack of interest




OTHER SYMPTOMS


11. Motor signs

12. Aggression

13. Irritability




Side effects

17. Low risk of metabolic side effects (including weight gain)

18. Low risk of extrapyramidal side effects (including tardive dyskinesia) (not including akathisia)

19. Low risk of akathisia

20. Low risk of prolactin-related side effects (including

Page 57


sexual dysfunction)21. Low risk of sedation

General attributes22. Mode of administration

23. Frequency of dosing

24. No requirement for blood monitoring and/or liver function/liver status

25. Cost/ reimbursement

26. Anticipated (improved) patient adherence

Patient relevant outcomes27. Anticipated positive impact on overall quality of life

28. Anticipated positive impact on overall functioning (cognitive and social)

Other99. Other, please specify_____________



Page 58


B34 Anticipated future non-adherence

[PN: ONLY ASK IF CODE 2 OR 3 SELECTED AT B12a]

You described the patient as currently “stable with/without residual symptoms” [insert as chosen in B12a, code 2 or 3]. Despite the patient being stable, do you anticipate him/her to become non-adherent within the near future?

1. No, I don’t have any reason to anticipate non-adherence in the near future

2. Yes, I anticipate the patient to become non-adherent within the next 3 months

3. Yes, I anticipate the patient to become non-adherent within the next 6 months


[PN: SINGLE CODE]

Page 59


B35 Previous treatment

Which antipsychotic treatment(s) were prescribed as part of the patient’s previous treatment regimen? Do not select all treatments the patient has ever taken, only those that were given as part of the most recent previous regimen.

Please only consider a switch in products (or product formulation) or an addition of a product as a change in regimen; dosage changes are not considered a change in regimen for the purposes of this study.


95. No previous treatment received

Atypical orals

1. OLANZAPINE

2. RISPERIDONE

3. CLOZAPINE



5. ARIPIPRAZOLE (Abilify)

6. PALIPERIDONE (Invega) [PN: DO NOT SHOW IN FI, FR, NO, PL]

7. AMISULPRIDE [PN: DO NOT SHOW IN CA, FI, SW]





[PN: IN AU,BR, CA SHOW “ASENAPINE (Saphris)”


Atypical depot



Page 60









Typical oral

15 HALOPERIDOL

16 LEVOMEPROMAZINE [PN: DO NOT SHOW IN AU]

17 CHLORPROMAZINE [PN: DO NOT SHOW IN DK, DE, PL, SW]

18 ZUCLOPENTHIXOL

19. Other, please specify ________________________

Typical depot

20 FLUPHENAZINE [PN: DO NOT SHOW IN DK, FR, NO, PL]

21 HALOPERIDOL [PN: DO NOT SHOW IN ES]

22 ZUCLOPENTHIXOL

23. FLUPENTIXOL [PN: DO NOT SHOW IN BR, FR, IT, ES]

24. Other, please specify __________________________

[PN: MULTI CODE]

Page 61


B36 Previous treatment information

Please complete the following information for the patient’s most recent previous treatment(s).

[PN: DO NOT SHOW IF CODE 95 AT B35 (I.E. NO PREVIOUS TREATMENT)]

Please complete the following information based on the patient’s previous treatment(s):

Mode of administration

Frequency of dosing [PN: DROP DOWN LIST,

SINGLE CODE]

Dose at point of

discontinuation

(mg)

Enter 00 if not known

[PN: RANGE 0.1-2000]

Duration of treatment

Type in number of

weeks

Enter 00 if not known

[PN: OPEN NUMERIC

BOX]

Treatment status - start, repeat, switch, re-start?

Patient’s adherence with drug

1=Fully adherent &3 = Non-adherent


Your overall satisfaction with drug

1=very poor & 5 = very good


IM acute injection

IM depot Injection

Oral solution

Oral tablet

Oral dispersible

Other

[PN: DROP DOWN LIST,

SINGLE CODE]

Monthly

Twice a month

Weekly

Once a day

Twice a day

Three times a day

Four or more times a day

Other

Start? (i.e. newly initiated, not used the drug previously)

Restart ( have used the drug with in the past 6 months

Repeat?

Switch?

Other

Don’t know


4. Fully adherent i.e. take their medication all of

the time

5. Partially adherent i.e. take their medication

most of the time

6. Non-adherent i.e. take their medication

occasionally/not at all

7. Don’t know

1=very poor

2

3

4

5=very good

8. Don’t know

[PN: PIPE IN PREVIOUS TREATMENTS FROM B37, ONE DRUG PER ROW]

9.


Page 63


B36b. Dose change

[PN: DO NOT SHOW IF CODE 95 AT B35 (I.E. NO PREVIOUS TREATMENT)]

Was a different dose ever prescribed for any of the patient’s previous treatment(s)? If so, please provide details below

Previous dose

Type in previous dose

(mg)

[PN: RANGE 0.1-2000,]

Date dose was changed

Type in date of dose change

Mm/yyyy

Drug dosage not changed

Don’t know

[PN: PIPE IN CURRENT

TREATMENTS FROM B22, ONE DRUG PER ROW]


B37 Reasons for discontinuing / switching treatment

[PN: DO NOT SHOW IF CODE 95 SELECTED AT B35 IE. NO PREVIOUS TREATMENT]

Why was [PIPE THROUGH ALL TREATMENTS SELECTED AT B35 WHICH WERE NOT SELECTED AT B22] switched or discontinued from the patient’s previous regimen?


1. Poor efficacy/symptom control, please specify symptom(s)

[PN: SHOW DROP DOWN LIST FROM B3, SINGLE CODE]

2. Poor tolerability/complaints about side effect(s)

3. Cost/reimbursement

4. Patient request

5. Family request

6. Availability of a new treatment option

7. Formulary restrictions

8. Inconvenience / not easy to use

9. Mode of administration (i.e. change to different formulation)



[PN: SINGLE CODE, ROTATE OPTIONS]

Page 65


B37b. Poor symptom control

PN: ONLY ASK IF CODE 1 SELECTED AT B37

Which symptom(s) was [PIPE THROUGH ALL TREATMENTS SELECTED AT B35 WHICH WERE NOT SELECTED AT B22] poor in controlling?Please select all that apply

POSITIVE SYMPTOMS

1. Hallucinations

2. Delusions

3. Thought disorder



NEGATIVE SYMPTOMS

6. Lack of interest




OTHER SYMPTOMS


11. Motor signs

12. Aggression

13. Irritability




99. Other, please specify:_____

97. None [PN: EXCLUSIVE]


Page 66



B38 This is the end of the patient record form for patient [PIPE IN RESPONSE FROM BX] out of 6 – thank you for your responses.

[PN: IF PATIENT HAS NOT YET COMPLETED 6 PRFS SHOW:]

Please click ‘forward’ to complete another patient record. If you intend to resume later, simply exit the browser and your responses will be saved automatically.

[PN: PLEASE SHOW THIS QUESTION AFTER PRF6 ONLY]

B39 Thank you for completing [PIPE IN ‘6’] patient records.

Page 67


I have completed feedback for all of the patients that I am able to and would like to submit my responses for this study

[PN: REDIRECT TO COMPLETE SCREEN]

B40 Numbers of patients that are anticipated non-compliant

[PN: ONLY SHOW IF B39 SELECTED. THIS QUESTION IS ONLY ASKED ONCE]

Of all the patient record forms that you have completed, how many of these patients would you anticipate to be non-adherent to their treatment for schizophrenia?

1. 1 patient

2. 2 patients

3. 3 patients

4. 4 patients

5. 5 patients

6. 6 patients

[PN: SINGLE CODE]

B40 END

This concludes the survey. Thank you very much for your responses.

If you have any final comments please feel free to type these below.

OPEN ENDED QUESTION

Page 68

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