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Original research
Quality versus risk of bias assessment of palliative care trials: comparison of two tools
  1. Sarina R Isenberg1,2,
  2. Dio Kavalieratos3,
  3. Ronald Chow4,
  4. Lisa Le5,
  5. Pete Wegier2,6 and
  6. Camilla Zimmermann4,7
  1. 1Bruyère Research Institute, Ottawa, Ontario, Canada
  2. 2Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada
  3. 3Department of Family and Preventive Medicine, Emory University, Atlanta, Georgia, USA
  4. 4Division of Palliative Care and Department of Supportive Care, University Health Network, Toronto, Ontario, Canada
  5. 5Biostatistics, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
  6. 6Humber River Hospital, Toronto, Ontario, Canada
  7. 7Division of Medical Oncology and Division of Palliative Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Sarina R Isenberg, Bruyère Research Institute, Ottawa, ON K1N 5C7, Canada; SIsenberg{at}bruyere.org

Abstract

Background Randomised controlled trials (RCTs) of palliative care interventions are challenging to conduct and evaluate. Tools used to judge the quality of RCTs do not account for the complexities of conducting research in seriously ill populations and may artificially downgrade confidence in palliative care research.

Objective To compare assessments from the Palliative Care Trial Assessment Tool (PCTAT) and Cochrane Risk of Bias (RoB) tool.

Design Reviewers assessed 43 RCTs using PCTAT and RoB. We compared assessments of each trial, assessed overall agreement (weighted kappa (Kw)) and examined (dis)agreement for comparable items. We assessed quality of life at 1–3 months among trials grouped according to RoB or PCTAT score (using meta-analysis) and whether RoB or quality improved over time (Cochran-Armitage trend test).

Results Of 43 trials, those rated low RoB had a mean PCTAT score of 73 (SD 10); those rated high RoB had a mean PCTAT score of 56 (SD 14). Overall Kw was 0.33 (95% CI 0.19 to 0.42). Total agreement between comparable items was observed for 56% of trials (24/43) and total disagreement for 21% (8/43). The standardised mean difference in quality of life was statistically significant among RCTs with low RoB and high PCTAT, but not for those with medium/low PCTAT or high/unclear RoB. Quality of reporting improved over time, whereas RoB did not.

Conclusion Although there was fair agreement between tools, areas of disagreement/non-comparability suggest the tools capture different aspects of bias/quality. A specific tool to evaluate quality of palliative care trials may be warranted.

  • supportive care

http://dx.doi.org/10.1136/bmjspcare-2020-002539

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    Footnotes

    • Twitter @sarina_isenberg

    • Contributors SRI and CZ conceptualised the study, conducted analyses, assisted with interpretation of the data, and drafted and reviewed the final manuscript for submission. DK conceptualised the study, assisted with interpretation of the data, and drafted and reviewed the final manuscript for submission. RC and LL conducted analyses, assisted with interpretation of the data and reviewed the final manuscript for submission. PW conducted analyses, assisted with interpretation of the data, and reviewed the final manuscript for submission.

    • Funding DK receives research funding from the National Heart Lung and Blood Institute (K01HL133466), and the Cystic Fibrosis Foundation (KAVALI18QI0); portions of this study were supported by the Agency for Healthcare Research and Quality (K12HS22989).

    • Competing interests None declared.

    • Patient consent for publication Not required.

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

    • Data availability statement Data are available upon reasonable request. Data on the risk of bias and quality of reporting assessments of trials are available from SRI. Reuse is permitted if this study and the original systematic review by Kavalieratos et al are cited.