A literature review of the impact of exclusion criteria on generalizability of clinical trial findings to patients with chronic pain.
A literature review of the impact of exclusion criteria on generalizability of clinical trial findings to patients with chronic pain.
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DOI：
10.1097/pr9.0000000000001050
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发表时间：
2022-11
期刊：
影响因子：
4.8
通讯作者：
中科院分区：
文献类型：
--
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慢性疼痛患者经常因为合并症而被排除在试验之外。考虑到排除和纳入患者之间的差异，更具包容性的研究将具有更好的概括性。如果只有一小部分不具代表性的患者被允许入组，那么临床试验对慢性疼痛护理的指导作用可能会受到限制。我们总结并报告已发表的研究的新见解，这些研究报告了试验排除如何影响其结果的普遍性。我们对以下术语进行了PubMed检索：（“资格标准”和概括性）或（“排除标准”和概括性）或“排除标准”[ti]或“资格标准”[ti])和疼痛。我们只考虑相关的研究，如果他们分析了以下数据：(1)排除标准的普遍性和性质，或(2)排除标准对样本代表性或研究结果的影响。确定的4篇文章报告了在不同临床试验中纳入和排除的患者的差异：被排除的患者年龄较大，不太可能有有偿工作，基线时功能限制较多，并且更频繁地使用强阿片类药物。这些差异的临床意义尚不清楚。疼痛医学文献很少发表关于排除标准的流行和影响的研究，并且很少跟踪被排除患者的结果。由于慢性疼痛通常与精神疾病合并症同时发生，频繁使用社会心理排斥尤其不利于普遍性。在研究样本中纳入更多具有代表性的患者可以减少招募障碍，并扩大慢性疼痛患者研究结果的普遍性。我们还呼吁进行更多的研究来检查慢性疼痛试验中排除标准的使用，以更好地了解其含义。
Patients with chronic pain are frequently excluded from trials because of comorbidities. More inclusive studies will have better generalizability considering differences between excluded and included patients. The ability of clinical trials to inform the care of chronic pain may be limited if only an unrepresentative subset of patients are allowed to enroll. We summarize and report new insights on published studies that report on how trial exclusions affect the generalizability of their results. We conducted a PubMed search on the following terms: ((“eligibility criteria” AND generalizability) OR (“exclusion criteria” AND generalizability) OR “exclusion criteria”[ti] OR “eligibility criteria”[ti]) AND pain. We only considered studies relevant if they analyzed data on (1) the prevalence and nature of exclusion criteria or (2) the impact of exclusion criteria on sample representativeness or study results. The 4 articles that were identified reported differences in patients who were included and excluded in different clinical trials: excluded patients were older, less likely to have a paid job, had more functional limitations at baseline, and used strong opioids more often. The clinical significance of these differences remains unclear. The pain medicine literature has very few published studies on the prevalence and impact of exclusion criteria, and the outcomes of excluded patients are rarely tracked. The frequent use of psychosocial exclusions is especially compromising to generalizability because chronic pain commonly co-occurs with psychiatric comorbidities. Inclusion of more representative patients in research samples can reduce recruitment barriers and broaden the generalizability of findings in patients with chronic pain. We also call for more studies that examine the use of exclusion criteria in chronic pain trials to better understand their implications.