Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12904-016-0181-9) contains supplementary material, which is available to authorized users.

Cancer survivorship and palliative care: Shared progress, challenges, and opportunities

“…63,65 Conversely, palliative care research has been growing, and many of the most recent clinically influential studies in the field have been centered around oncological diseases. 66 Although well developed in survivorship care, pediatric palliative care still is very much a growing field, and opportunities to further emphasize research in this area remain. [67][68][69] International studies have shown various benefits of the earlier integration of palliative care in terms of QOL, health care use, levels of patient and caregiver distress, and even survival.…”

“…Conversely, palliative care research has been growing, and many of the most recent clinically influential studies in the field have been centered around oncological diseases . Although well developed in survivorship care, pediatric palliative care still is very much a growing field, and opportunities to further emphasize research in this area remain .…”

What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study

“…Recruitment to clinical trials in people with advanced disease or in palliative care can be particularly challenging. For example, a recent systematic review found the target sample size was only achieved in 36.8% of trials assessing a therapeutic intervention [2]. Eligibility can be a major limiting factor affecting recruitment in advanced disease.…”

“…As more people approach the end of their lives with chronic and complex conditions, the need for robust research and evidence has never been greater. However, clinical trials in palliative care remain sparse, often limited by poor funding and methodological weaknesses [2,27,28]. It is therefore important to understand what affects retention so that we can minimise attrition and ensure high-quality clinical trials of palliative care interventions in the future.…”

What influenced people with chronic breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study.

“…However, strategies to improve recruitment into trials have had variable success (3). As more people approach the end of their lives with chronic and complex conditions, the need for robust research and evidence has never been greater, however clinical trials in palliative care remain sparse often limited by poor funding and methodological weaknesses (2,21,22). It is therefore important to understand what affects retention so that we can minimise attrition and ensure high quality clinical trials of palliative care interventions in the future.…”