Table 5.
Study characteristics of the literature review
| 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 |