Quality of life reporting in multiple sclerosis clinical trials: enough quality?

Acquadro C Berzon R Dubois D . Incorporating the patient’s perspective into drug development and communication: an Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001. Value Health 2003; 6: 522–531.

Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. European Medicines Agency pre-authorisation evaluation of medicines for human use. EMEA 2005. Doc. Ref. EMEA/CHMP/EWP/139391/2004 [cited 2012 10 April]; available at:www.ispor.org/workpaper/emea-hrql-guidance.pdf.

Solari A . Role of health-related quality of life measures in the routine care of people with multiple sclerosis. Health Qual Life Outcomes 2005; 3: 16; DOI: 10.1186/1477-7525-3-16.

Kuspinar A Rodriguez AM Mayo NE . The effects of clinical interventions on health-related quality of life in multiple sclerosis: a meta-analysis. Mult Scler J 2012; in press.

Brundage M Bass B Davidson J . Patterns of reporting health-related quality of life outcomes in randomised clinical trials: implications for clinicians and quality of life researchers. Qual Life Res 2011; 20: 653–664.

Boutron I Moher D Altman DG Schulz KF Ravaud P ; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008; 148: 295–309.

Calvert M Blazeby J Revicki D Moher D Brundage M . Reporting quality of life in clinical trials: a CONSORT extension. Lancet 2011; 378: 1684–1685.

Efficace F Bottomley A Osoba D . Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials — does HRQOL evaluation in prostate cancer research inform clinical decision making? J Clin Oncol 2003; 21: 3502–3511.

Chang S Davidson PM Newton PJ Krum H Salamonson Y MacDonald P . What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials? Int J Cardiol 2012; DOI: 10.1016/j.icard.2012.01.019.

Heesen C Solari A Giordano A Kasper J Köpke S . Decisions on multiple sclerosis immunotherapy: New treatment complexities urge patient engagement. J Neurol Sci 2011; 306: 192–197.