Quality versus risk of bias assessment of palliative care trials: comparison of two tools.

IF 2 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES BMJ Supportive & Palliative Care Pub Date : 2024-12-19 DOI:10.1136/bmjspcare-2020-002539
Sarina R Isenberg, Dio Kavalieratos, Ronald Chow, Lisa Le, Pete Wegier, Camilla Zimmermann
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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.

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姑息治疗试验的质量与偏倚风险评估:两种工具的比较。
背景:姑息关怀干预措施的随机对照试验(RCT)在实施和评估方面具有挑战性。用于判断随机对照试验质量的工具没有考虑到在重病患者中开展研究的复杂性,可能会人为降低姑息关怀研究的可信度:比较姑息治疗试验评估工具(PCTAT)和科克伦偏倚风险(RoB)工具的评估结果:设计:评审人员使用 PCTAT 和 RoB 对 43 项 RCT 进行了评估。我们比较了每项试验的评估结果,评估了总体一致性(加权卡帕(Kw)),并检查了可比项目的(不)一致性。我们评估了根据RoB或PCTAT评分分组的试验在1-3个月时的生活质量(采用荟萃分析法),以及RoB或质量是否随时间推移而改善(Cochran-Armitage趋势检验):在 43 项试验中,被评为低 RoB 的试验的 PCTAT 平均得分为 73 分(标准差为 10 分);被评为高 RoB 的试验的 PCTAT 平均得分为 56 分(标准差为 14 分)。总体一致性为 0.33(95% CI 0.19 至 0.42)。56%的试验(24/43)的可比项目之间完全一致,21%的试验(8/43)的可比项目之间完全不一致。在RoB较低和PCTAT较高的临床试验中,生活质量的标准化平均差异具有统计学意义,但在PCTAT中等/较低或RoB较高/不明确的临床试验中,生活质量的标准化平均差异不具有统计学意义。随着时间的推移,报告质量有所提高,而 RoB 没有提高:尽管各工具之间存在相当大的一致性,但存在分歧/不可比性的地方表明这些工具捕捉到了偏差/质量的不同方面。可能需要一种专门的工具来评估姑息治疗试验的质量。
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来源期刊
BMJ Supportive & Palliative Care
BMJ Supportive & Palliative Care Medicine-Medicine (miscellaneous)
CiteScore
4.60
自引率
7.40%
发文量
170
期刊介绍: Published quarterly in print and continuously online, BMJ Supportive & Palliative Care aims to connect many disciplines and specialties throughout the world by providing high quality, clinically relevant research, reviews, comment, information and news of international importance. We hold an inclusive view of supportive and palliative care research and we are able to call on expertise to critique the whole range of methodologies within the subject, including those working in transitional research, clinical trials, epidemiology, behavioural sciences, ethics and health service research. Articles with relevance to clinical practice and clinical service development will be considered for publication. In an international context, many different categories of clinician and healthcare workers do clinical work associated with palliative medicine, specialist or generalist palliative care, supportive care, psychosocial-oncology and end of life care. We wish to engage many specialties, not only those traditionally associated with supportive and palliative care. We hope to extend the readership to doctors, nurses, other healthcare workers and researchers in medical and surgical specialties, including but not limited to cardiology, gastroenterology, geriatrics, neurology, oncology, paediatrics, primary care, psychiatry, psychology, renal medicine, respiratory medicine.
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