Abstract
BackgroundOver the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care.MethodsWe performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool.ResultsWe retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding.ConclusionsWhile the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.
Highlights
Over the past decades there has been a significant increase in the number of published clinical trials in palliative care
Studies were published in fifty-seven different journals, with the most reported being: Journal of Pain and Symptom Management (14.9%, n = 16, impact factor [Impact factor (IF)]: 2.47), Palliative Medicine (13.1%, n = 14, IF: 2.85), Journal of Palliative Medicine (9.3%, n = 10, IF: 2.06) and Journal of Clinical Oncology (5.6%, n = 6, IF: 17.9)
By classifying the studies according to the other key points of palliative care practice we found that 70.1% (n = 75) of the studies were based on symptom control evaluation, teamwork and communication both represented 12.1% (n = 13) of studies, and 5.6% (n = 6) studies highlighted family support
Summary
Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. According to a MEDLINE search, the number of PC clinical trials (CT) published has quadrupled, from inception to 2005 [7, 8]. Whilst this may be beneficial, questions exist around the type and quality of the research being undertaken. Visser et al [5] studied the reality of evidence-based practice in palliative care and highlighted additional problems like unpowered studies, recruitment difficulties and high attrition rates, inadequate duration of follow-up and difficulty in defining outcomes and avoiding performance bias [5, 9, 13]
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