Inclusion of Older Patients with Cancer in Randomized Controlled Trials with Patient-Reported Outcomes: a Systematic Review

Francesco Sparano, Neil K Aaronson, Mirjam Sprangers, Peter Fayers, Andrea Pusic, Jacobien M Kieffer, Francesco Cottone, Jonathan Rees, Mike Pezold, Amelia Anota, Emilie Charton, Marco Vignetti, Chongua Wan, Jane Blazeby, Fabio Efficace

Research output: Contribution to journalArticle (Academic Journal)peer-review

2 Citations (Scopus)
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Abstract

Objectives
Inclusion of patient-reported outcomes (PROs) in cancer randomized 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 to 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 (ISOQOL)-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 (OS) was the most frequently reported clinical outcome in studies with metastatic/advanced cancer patients (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 cancer.

Conclusions
Our review indicates that, not only PRO-RCT based studies in oncology rarely include older patients, but also that completeness of PRO reporting of many of them is often suboptimal.
Original languageEnglish
Pages (from-to)451 - 463
Number of pages13
JournalBMJ Supportive and Palliative Care
Volume9
Early online date12 Nov 2019
DOIs
Publication statusPublished - 3 Dec 2019

Keywords

  • older patients
  • patient-reported outcomes
  • quality of life
  • survival
  • cancer
  • randomized-controlled trials

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