Electronic Supplementary Material #3:
A one-year cross-sectional analysis of non-interventional post-marketing study protocols submitted to the German Federal Institute for Drugs and Medical Devices (BfArM)
European Journal of Clinical Pharmacology
Beatrice K. J. G. von Jeinsen and Thomas Sudhop
Corresponding author
Thomas Sudhop, MD
Federal Institute for Drugs and Medical Devices (BfArM)
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Email:
Special questionnaires / Number(HCPa) / Percentage (HCPa) / Number (patients) / Percentage (patients)
Stage of disease / 33 / 24.3% / 3 / 2.2%
- CGI (Clinical Global Impression scale to measure the therapy of psychiatric diseases [1]) / 7 / 5.1%
- EDSS (Kurtzke Expanded Disability Status Scale to measure disability status of patients with multiple sclerosis [2]) / 5 / 3.7%
- Tanner Stage (a stage to measure pubertal changes [3,4]) / 2 / 1.5% / 1 / 0.7%
- Others / 19 / 14.0% / 2 / 1.5%
Quality of life/Health status / 38 / 27.9% / 21 / 15.4%
- Karnofsky Index (an index to measure the effect on daily life abilities of patients suffering from cancer [5]) / 11 / 8.1%
- ECOG performance status (Eastern Cooperative Oncology Group, a questionnaire to measure the effect on daily life abilities of patients suffering from cancer [6]) / 14 / 10.3%
- EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to measure the quality of life of patients suffering from cancer [7]) / 5 / 3.7% / 8 / 5.9%
- EQ-5d (EuroQol, a questionnaire to measure health outcome [8]) / 4 / 2.9% / 3 / 2.2%
- SF-12 Health survey/SF-36 Health survey (Scientific Advisory Committee of the Medical Outcomes Trust, SF-36 as the complete and SF-12 as the short version of an instrument to measure the health status of the patient [9]) / 2 / 1.5% / 2 / 1.5%
- DLQI (Dermatology Life Quality Index [10]) / 2 / 1.5%
- PDQ-8 (Parkinson’s Disease Questionnaire to measure quality of life of patients suffering from Parkinson’s disease [11] ) / 1 / 0.7%
- QOLIE-10-P (Patient Weighted Quality Of Life In Epilepsy [12]) / 1 / 0.7%
- Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form [13]) / 1 / 0.7%
- WHOb 5 (WHOb-Five Well-being Index [14]) / 1 / 0.7%
- Others / 2 / 1.5% / 2 / 1.5%
Pain scales / 7 / 5.1% / 1 / 0.7%
- BPI (Brief Pain Inventory [15]) / 3 / 2.2%
- NRS (Numerical Rating Scale) / 3 / 2.2% / 1 / 0.7%
- VAS (Visual Analogue Scale) / 1 / 0.7%
Concentration/Intelligence test / 4 / 2.9%
- WISC-IV (Wechsler Intelligence Scale for Children – Fourth Edition [16]) / 2 / 1.5%
- D2 Test (d2Test of Attention [17]) / 1 / 0.7%
- SPM+ (Raven's Standard Progressive Matrices, an intelligence test independent of schooling [18]) / 1 / 0.7%
Physical/Mental development / 4 / 2.9%
Adverse drug reactions / 3 / 2.2%
Charlson'sComorbidityIndex (classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies [19]) / 2 / 1.5%
Others / 7 / 5.1% / 2 / 1.5%
ESM 3 Used special questionnaires which had to be filled in by healthcare professionals (HCP) or patients
a healthcare professionals (HCP)
b World Health Organization (WHO)
References
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Education and Welfare, Rockville. Last accessed 12 August 2012
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Last accessed 12 August 2012
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[19] Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J ChronDis 40(5):373-383