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Table 5 Study characteristics of the literature review

From: The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

Author Journal Publication type Publication focus Types of PRO impact discussed
Revicki et al. (2000) [38] Quality of Life Research Guidance paper Recommendations on use of HRQL data to support labelling and promotional claims Informing drug approval
Bottomley et al. (2003) [39] American Society of Clinical Oncology Systematic review HRQL in Non-small-cell lung cancer Influencing clinical decision-making
Efficace et al. (2003) [40] Journal of Clinical Oncology Guidance paper A checklist for evaluating HRQL in prostate cancer trials Informing clinical decision-making
Goodwin et al. (2003) [41] Journal of the National Cancer Institute Literature review HRQL in breast cancer trials Informing clinical decision-making
Bjordal (2004) [42] Annals of Oncology Literature review Impact of HRQL assessments within trials on clinical practice Informing clinical decision-making
Arpinelli and Bamfi (2006) [43] Health and Quality of Life Outcomes Commentary PRO trial data in drug development Informing drug approval
Informing reimbursement decisions
Informing pricing decisions
Avery and Blazeby (2006) [44] World Journal Surgery Systematic review HRQL in breast, prostate, lung and colorectal cancer trials Informing clinical decision-making
Blazeby et al. (2006) [45] Journal of Clinical Oncology Literature review HRQL in surgical oncology trials Informing clinical decision-making
Influencing informed consent
Patrick D. et al. (2007) [46] Value in Health Literature review Use of PRO data to support medical product labelling claims (FDA perspective) Informing drug approval
Efficace et al. (2008) [47] European Journal of Cancer Systematic review HRQL in leukaemia trials Informing clinical decision-making
Gujral et al. (2008) [48] Support Care Cancer Systematic review Quality of life after colorectal cancer surgery Informing clinical decision-making
Parameswaran et al. (2008) [49] Annals of Surgical Oncology Systematic review HRQL in surgery for esophageal cancer Influencing clinical decision-making
Influencing informed consent
McNair and Blazeby (2009) [50] Expert Reviews Pharmaeconomics Outcomes Research Literature review HRQL in gastrointestinal cancer trials Informing clinical practice
Informing clinical decision-making
Inform shared decision-making
Au H. et al. (2010) [51] Expert Review of Pharmacoeconomics & Outcomes Research Review HRQL in oncology clinical trials Informing clinical decision-making
Doward L. et al. (2010) [52] Health and Quality of Life Outcomes Commentary Use of PRO trial data to inform pharmaceutical labelling claims and payers Informing drug approval Informing pricing decisions
Informing reimbursement decisions
Snyder and Brundage (2010) [53] Expert Reviews Pharmaeconomics Outcomes Research Commentary PROs in healthcare policy, research and practice Informing clinical decision-making
Brundage et al. (2011) [54] Quality of Life Research Systematic review PROs in Phase III randomised clinical trials Informing clinical practice
Calvert et al. (2011) [7] The Lancet Systematic review Quality of life in clinical trials Informing clinical decision-making
Informing health policy
Informing drug approval
Ganz (2011) [55] Journal of the National Cancer Institute Commentary Quality of life measurement in breast cancer trials Informing clinical decision-making
Lemieux et al. (2011) [56] Journal of the National Cancer Institute Systematic review Quality of life in breast cancer trials Influencing clinical decision-making
DeMuro et al. (2012) [57] Value in Health Literature review Reasons why PRO label claims were rejected and provide feedback from the regulatory perspective regarding the use of PROs in clinical trials Informing drug approval
Calvert et al. (2013) [58] Health and Quality of Life Outcomes Commentary Implications of the CONSORT PRO extension on clinical trials and practice Informing clinical practice
Informing clinical guidelines
Informing health policy
Informing clinical decision-making
Jacobs et al. (2013) [59] Quality of Life Research Systematic review HRQL in oesophageal cancer trials Informing clinical practice
Informing clinical decision-making
Informing shared decision-making
Zagadailov E. et al. (2013) [60] American Health & Drug Benefits Literature review Challenges and opportunities of incorporating oncology PRO trial data into reimbursement decisions Informing reimbursement decisions
Anker et al. (2014) [61] European Heart Journal Literature review Cardiovascular PRO clinical trials Informing drug approval Informing reimbursement decisions
Dirven et al. (2014) [62] European Journal of Cancer Systematic review PROs in brain tumour trials Influencing clinical decision-making
Efficace et al. (2014) [63] European Association of Urology Systematic review PROs in prostate cancer trials Informing clinical decision-making
Efficace et al. (2014b) [63] European Journal of Cancer Systematic review PROs in gynaecological cancer trials Informing clinical decision-making
Basch E. et al. (2015) [64] JAMA Oncology Qualitative study PRO trial data in cancer drugs development Informing drug approval
Nixon et al. (2015) [65] Farmeconomia. Health Economics and Therapeutic Pathway Commentary PRO data to support drug development decision-making Informing drug approval Informing reimbursement decisions
Informing clinical decision-making
Rees et al. (2015) [66] Journal of Cancer Research and Clinical Oncology Systematic review PROs in colorectal cancer trials Informing clinical decision-making
Rouette et al. (2015) [67] Quality of Life Research Literature review Oncologists’ perspectives on HRQL in trials among countries and specialities Informing clinical decision-making
Gnanasakthy et al. (2016) [68] Journal of Clinical Oncology Literature review PRO labelling for products approved by the Office of Haematology and Oncology Products of the FDA Informing drug approval
Mercieca-Bebber et al. (2016) [69] European Journal of Cancer Systematic review PROs in head, neck and thyroid cancer trials Informing health policy
Informing clinical practice
Informing clinical decision-making
Coon C (2016) [70] Clinical Therapeutics Commentary PRO oncology clinical trials Informing drug approval
Hao Yanni et al. (2016) [71] Clinical Therapeutics Commentary PRO oncology clinical trials Informing reimbursement decisions
Informing pricing decisions Informing clinical decision-making
McNair et al. (2016) [72] PLOS One Systematic review PRO and clinical gastro-intestinal cancer data in trials Informing clinical decision-making
Informing clinical practice
Mott (2017) [73] Oncology and Therapy Qualitative study PROs and lung cancer Informing reimbursement decisions Informing clinical decision-making
Sztankay et al. (2017) [74] BMC Cancer Qualitative study HRQL in patients with advanced non-small cell lung cancer Informing shared decision-making