Patient reported outcomes in randomized controlled cancer trials in advanced disease: a structured literature review

References

• Basch E, Abernethy AP, Mullins CD, et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol Off Am Soc Clin Oncol. 4249–4255;30(34):2012.
   Google Scholar
• Brettschneider C, Lühmann D, Raspe H. Informative value of patient reported outcomes (PRO) in health technology assessment (HTA). GMS Health Technol Assess. 2011;7:Doc01.
   Google Scholar
• Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814–822.
   PubMed Web of Science ®Google Scholar
• Brundage M, Bass B, Davidson J, et al. Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2011;20(5):653–664.
   PubMed Web of Science ®Google Scholar
• Gaertner J, Weingärtner V, Lange S, et al. The role of end-of-life issues in the design and reporting of cancer clinical trials: a structured literature review. PloS One. 2015;10(9):e0136640.
   Google Scholar
• Higginson IJ, Gomes B, Calanzani N, et al. Priorities for treatment, care and information if faced with serious illness: a comparative population-based survey in seven European countries. Palliat Med. 2014;28(2):101–110.
   PubMed Web of Science ®Google Scholar
• World Health Organization (WHO). WHO definition of palliative care [Internet]. 2013 [Zugriff: 2013 Aug 22]. Available from: http://www.who.int/cancer/palliative/definition/en/.
   Google Scholar
• Society AC. Goals of the American Cancer Society [Internet]. (2015). [Zugriff: 2013 Aug 21]. Available from: http://relay.acsevents.org/site/DocServer/ACS%20Mission%20Statement-2015%20Goals.pdf
   Google Scholar
• Food and Drug Administration UDoHaHS, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims [Internet]. December 2009 [Zugriff: 2013 Aug 21]. Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
   Google Scholar
• National Institutes of Health - Department of Health and Human Services. Common fund strategic planning report 2009 [Internet]. January 01, 2011 [Zugriff: 2013 Aug 21]. Available from: http://commonfund.nih.gov/about-cfspr2009.aspx.
   Google Scholar
• Evans CJ, Benalia H, Preston NJ, et al. The selection and use of outcome measures in palliative and end-of-life care research: the MORECare international consensus workshop. J Pain Symptom Manage. 2013;46(6):925–937.
   PubMed Web of Science ®Google Scholar
• Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009;151(4):W65–94.
   PubMed Web of Science ®Google Scholar
• Moher D, Liberati A, Tetzlaff J, et al., PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264–269, W64.
   PubMed Web of Science ®Google Scholar
• Johnston K. What are surrogate outcome measures and why do they fail in clinical research?. Neuroepidemiology. 1999;18(4):167–173.
   PubMed Web of Science ®Google Scholar
• Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev. 2012;1:60.
   PubMedGoogle Scholar
• Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials. 1996;17(1):1–12.
   PubMedGoogle Scholar
• Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg Lond Engl. 2012;10(1):28–55.
   PubMed Web of Science ®Google Scholar
• Jeung H-C, Rha SY, Im CK, et al. A randomized phase 2 study of docetaxel and S-1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy. Cancer. 2011;117(10):2050–2057.
   PubMed Web of Science ®Google Scholar
• Schwartzentruber DJ, Lawson DH, Richards JM, et al. gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma. N Engl J Med. 2011;364(22):2119–2127.
   PubMed Web of Science ®Google Scholar
• European Organisation for Research and Treatment of Cancer. Available from: http://groups.eortc.be/qol/eortc-qlq-c30
   Google Scholar
• Functional Assessment of Cancer. Available from: http://www.facit.org/FACITOrg/Questionnaires
   Google Scholar
• EuroQol 5-dimensional scale. Available from: http://www.euroqol.org/about-eq-5d.html.
   Google Scholar
• Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013;346:f167.
   PubMed Web of Science ®Google Scholar
• Bylicki O, Gan HK, Joly F, et al. Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy. Ann Oncol Off J Eur Soc Med Oncol ESMO. 2015;26(1):231–237.
   PubMed Web of Science ®Google Scholar
• Amdal CD, Jacobsen A-B, Guren MG, et al. Patient-reported outcomes evaluating palliative radiotherapy and chemotherapy in patients with oesophageal cancer: a systematic review. Acta Oncol Stockh Swed. 2013;52(4):679–690.
   PubMed Web of Science ®Google Scholar
• Ghimire S, Kyung E, Kim E. Reporting trends of outcome measures in phase II and phase III trials conducted in advanced-stage non-small-cell lung cancer. Lung. 2013;191(4):313–319.
   PubMed Web of Science ®Google Scholar
• Velikova G, Booth L, Smith AB, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol Off J Am Soc Clin Oncol. 2004;22(4):714–724.
   PubMed Web of Science ®Google Scholar
• Gilbert A, Sebag-Montefiore D, Davidson S, et al. Use of patient-reported outcomes to measure symptoms and health related quality of life in the clinic. Gynecol Oncol. 2015;136(3):429–439.
   PubMed Web of Science ®Google Scholar
• Levy MH, Smith T, Alvarez-Perez A, et al. Palliative care, Version 1.2014. Featured updates to the NCCN Guidelines. J Natl Compr Cancer Netw JNCCN. 2014;12(10):1379–1388.
   PubMed Web of Science ®Google Scholar
• Albers G, Echteld MA, de Vet HCW, et al. Evaluation of quality-of-life measures for use in palliative care: a systematic review. Palliat Med. 2010;24(1):17–37.
   PubMed Web of Science ®Google Scholar
• Mystakidou K, Tsilika E, Parpa E, et al. The relationship between quality of life and levels of hopelessness and depression in palliative care. Depress Anxiety. 2008;25(9):730–736.
   PubMed Web of Science ®Google Scholar
• Cleeland CS, Sloan JA, Cella D, et al. Recommendations for including multiple symptoms as endpoints in cancer clinical trials: a report from the ASCPRO (Assessing the symptoms of cancer using patient-reported outcomes) multisymptom task force. Cancer. 2013;119(2):411–420.
   PubMed Web of Science ®Google Scholar
• Ahmed S, Berzon RA, Revicki DA, et al. The use of patient-reported outcomes (PRO) within comparative effectiveness research: implications for clinical practice and health care policy. Med Care. 1060–1070;50(12):2012.
   Google Scholar
• Mapi Research Trust. Mapi research trust PROQOLID patient-reported outcome and quality of life instruments database. Available from: http://www.proqolid.org/
   Google Scholar
• Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ. 2012;344:d8141.
   Google Scholar