LUN2827: Schizophrenia Treatment Landscape - Questionnaire


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

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

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

SCREENER

S0 Language

Please select

1. / Complete survey in English / o
2. / Complete survey in Portuguese / o
3. / Complete survey in French / o
4. / Complete survey in Danish / o
5. / Complete survey in Finnish / o
7. / Complete survey in German / o
8. / Complete survey in Italian / o
9. / Complete survey in Norwegian / o
10. / Complete survey in Polish / o
11. / Complete survey in Spanish / o
12. / Complete survey in Swedish / o

S0 Country

In which country is your practice located?

COUNTRY CODE
1. / Australia / o / AU
2. / Brazil / o / BR
3. / Canada / o / CA
4. / Denmark / o / DK
5. / Finland / o / FI
6. / France / o / FR
7. / Germany / o / DE
8. / Italy / o / IT
9. / Norway / o / NO
10. / Poland / o / PL
11. / Spain / o / ES
12. / Sweden / o / SW
13. / UK / o / UK
99. / Other [CLOSE] / o

[PN: SINGLE CODE]

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 / o CLOSE
2. / Psychiatrist / o CONTINUE TO S2
3. / Nervenärtze [SHOW IN GERMANY ONLY] / o CONTINUE TO S1a
99. / Other / o 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]

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 / o CONTINUE
2. / No / o 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 / o CONTINUE
2. / No / o 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)

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

LUN2827: Schizophrenia Treatment Landscape - Questionnaire

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

Page 9

LUN2827: Schizophrenia Treatment Landscape - Questionnaire

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.

o  [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:

[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%

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] / ___%
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 / ___%

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 / o
2. / Control of negative symptoms / o
3. / Early treatment response / o
4. / Relapse prevention/maintaining treatment response / o
5. / Control of aggressive symptoms (e.g. hostility and agitation) / o
Side effects
6. / Control of metabolic side effects (including weight gain) / o
7. / Control of extrapyramidal side effects (including tardive dyskinesia, but excluding akathisia) / o
8. / Control of akathisia / o
9. / Control of prolactin-related side effects (including sexual dysfunction) / o
10. / Control of sedation / o
General attributes
11. / Mode of administration / o
12. / Availability of atypical depots / o
13. / Frequency of dosing / o
14. / Transition from oral to depot medication / o
15. / Requirement for blood monitoring and/or liver function/liver status / o
16. / Cost/ reimbursement / o
17. / Patient adherence / o
Patient relevant outcomes
18. / Overall quality of life / o
19. / Patient satisfaction with treatment / o
20. / Level of functioning (e.g. in social situations, being able to live independently) / o
Other
98. / Other, please specify______/ o
99. / None of the above [PN: EXCLUSIVE] / o

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