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Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review
  1. Francesco Sparano1,
  2. Neil K Aaronson2,
  3. Mirjam A G Sprangers3,
  4. Peter Fayers4,
  5. Andrea Pusic5,
  6. Jacobien M Kieffer2,
  7. Francesco Cottone1,
  8. Jonathan Rees6,
  9. Mike Pezold7,
  10. Amelie Anota8,9,
  11. Emilie Charton8,
  12. Marco Vignetti1,
  13. Chonghua Wan10,
  14. Jane Blazeby6 and
  15. Fabio Efficace1
  1. 1Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy
  2. 2Department of Psychosocial Research, Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
  3. 3Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
  4. 4Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
  5. 5Department of Surgery, Harvard University, Boston, Massachusetts, USA
  6. 6Bristol Centre for Surgical Research, Population Health Sciences, University of Bristol, Bristol, UK
  7. 7Division of Vascular Surgery, Department of Surgery, New York University Langone Medical Center, New York, New York, USA
  8. 8Methodology and Quality of Life in Oncology Unit (INSERM UMR 1098), University Hospital of Besançon, Besançon, France
  9. 9French National Platform Quality of Life and Cancer, Besançon, France
  10. 10School of Humanities and Management, Research Center for Quality of Life and Applied Psychology, Guangdong Medical University, Dongguan, China
  1. Correspondence to Dr Francesco Sparano, Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy; f.sparano{at}


Objectives Inclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.

Methods All RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.

Quality of PRO reporting was evaluated using the International Society for Quality of Life Research–PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.

Results Of 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.

Conclusions Our review indicates not only that PRO–RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.

  • older patients
  • patient-reported outcomes
  • quality of life
  • survival
  • cancer
  • randomized-controlled trials
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  • Contributors Study concepts: FE and FS. Study design: FE and FS. Data acquisition: FE and FS. Data analysis and interpretation: all authors. Statistical analysis: FC, FE and FS. Manuscript preparation: FE and FS. Manuscript editing: all authors. Manuscript review: all authors.

  • Funding This work was supported by the Gruppo Italiano Malattie Ematologiche dell’Adulto.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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