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PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Measurement Instrument Database for the Social Science (MIDSS) - Appraisal of Diabetes Scale (ADS)

- 9/13/20 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: DCAI-R (7/88)
Carey, M. P., Jorgensen, R. S., Weinstock, R. S., Sprafkin, R. P., Lantinga, L. J., Carnrike, C. L. M., Jr., Baker, M. T., & Meisler, A. W. (1991). Appraisal of Diabetes Scale (ADS). Measurement Instrument Database for the Social Science. Retrieved 13.09.20, from www.midss.ie Key references: Carey, M. P., Jorgensen, R. S., Weinstock, R. S., Sprafkin, R. P., Lantinga, L. J., Carnrike, C. L. M., Jr., Baker, M. T., & Meisler, A. W. (1991). Reliability and validity of the appraisal of diabetes scale. Journal of Behavioral Medicine, 14, 43-51. Garratt, A.M., L. Schmidt, and R. Fitzpatrick (2002) Patient-assessed health outcome measures for diabetes: a structured review. Diabetic Med., 19, 1-11. Trief, P.M., W. Grant, K. Elbert, and R.S. Weinstock (1998) Family environment, glycemic control, and the psychosocial adaptation of adults with diabetes. Diabetes Care 21, 241-245. Trief, P.M., C. Aquilino, K. Paradies, and R.S. Weinstock (1999) Impact of the work environment on glycemic control and adaptation to diabetes. Diabetes Care 22, 569-574. Primary use / Purpose: The Appraisal of Diabetes Scale (ADS) is a 7-item self-report scale assessing the individual's appraisal of his or her diabetes. Respondents rate each statement on a 5 point Likert scale. The scale's author state that the ADS can be incisive as a relatively quick (5 minute) screening tool to examine a patient’s adjustment to diabetes or risk for noncompliance with a care regimen. The test is easily administered (written or oral form) and is simple to score and interpret. The smaller the total score, the more positive the appraisal strategy. Thus, lower scores are better. Background: The Appraisal of Diabetes Scale (ADS) was developed and tested with 200 male subjects, two thirds of whom were taking insulin treatment with an mean age of 58 years. All subjects provided blood for routine monitoring of HbA1c, half the subjects completed the ADS as well as five other self-report measures, and the other half completed the ADS on three time points over the course of one week. No significant difference was observed between ADS scores for insulin-dependent and non-insulin-dependent subjects. The ADS has been used in studies parsing the effects of family environment (Trief et al. 1998) and work environment (Trief et al. 1999) on glycemic control and psychosocial adaptation in adults with diabetes. Psychometrics: The psychometric properties of the ADS are examined in Carey et al. (1991). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.274 Scoring the ADS is easy: 1. Reverse score items # 2 and 6. ADS2R = 5 - ADS2 ADS6R = 5 - ADS6 2. Then sum all items, using the reversed scored items 2 and 6. Total score = ADS1 + ADSR2 + ADS3 + ADS4 + ADS5 + ADSR6 + ADS7 There is no manual. Interpretation is straightforward: The smaller the total score, the more positive the appraisal strategy. Thus, lower scores are better.

VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/27/17 - 1 form, 2 itemgroups, 39 items, 2 languages
Itemgroups: Patient administration, VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 7/27/17 - 1 form, 2 itemgroups, 39 items, 2 languages
Itemgroups: Patient administration, VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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