Why are trials in palliative care so difficult?

Grande, Gunn; Todd, Chris

doi:10.1191/026921600677940614

Cited by 198 publications

(188 citation statements)

References 38 publications

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“…Depression is difficult to diagnose in such patients, and depressive symptoms are very similar to the general symptoms of end-stage cancer. While high attrition rates, together with high heterogeneity, would lead to the need for very large sample sizes, recruitment is difficult for practical and ethical reasons (Grande and Todd, 2000;AddingtonHall, 2002). There is also a lack of reporting on syndromal depression and this too requires further work.…”

Section: Methodological Limitationsmentioning

confidence: 99%

The effectiveness of treatment for depression/depressive symptoms in adults with cancer: a systematic review

2006

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Depression is common in cancer patients, and this often remains undetected and untreated. Depression has been associated with poorer quality of life, in addition to increased impairment of immune response and poorer survival in cancer patients. Previous systematic reviews and meta-analyses of the efficacy of interventions for cancer patients with depression have failed to distinguish between caseness for depression and depressive symptoms. The findings from this systematic review show that there is limited trial data on the efficacy of prescribed antidepressants in reducing the incidence of major depression and depressive symptoms in cancer patients. Contrary to previous reviews that failed to distinguish between depressive symptoms and depression, this review found very little data from clinical trials (without the possibility of confounding factors) to demonstrate that psychotherapeutic interventions are effective in reducing depression in cancer patients. A number of small-scale, single-centre trials indicated that psychotherapeutic interventions (especially cognitive behavioural therapy) can have effects on depressive symptoms in cancer patients. However, given the methodological limitations of studies to date, lack of evidence should not be interpreted as implying lack of efficacy. In conclusion, there is a need for adequately powered studies of pharmacological and psychotherapeutic studies, which are targeted at cancer patients with a diagnosis of depression and include monitoring of the use of other pharmacological/psychotherapeutic and complementary and alternative medicine interventions.

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Section: Methodological Limitationsmentioning

confidence: 99%

The effectiveness of treatment for depression/depressive symptoms in adults with cancer: a systematic review

2006

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“…17,18 The IMSCC data from this study were compared with similar data on 67 patients with MSCC. These comparative data were drawn from the screening database of an ongoing, randomised Phase III Spinal Cord Compression Trial (The All-Ireland Co-operative Oncology Research Group 05-03 Trial) 19 comparing two fractionation schemes.…”

Section: Methodsmentioning

confidence: 99%

A prospective study of patients with impending spinal cord compression treated with palliative radiotherapy alone

et al. 2013

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A prospective study of patients with impending spinal cord compression treated with palliative radiotherapy alone Purpose: To record the characteristics, management and functional outcome of a group of patients with IMSCC, who were treated with radiotherapy in our institution, and compare these parameters with similar data on MSCC patients.Materials and methods: Data (gender, age, primary oncological diagnosis, pain, performance status and neurological status) were prospectively collected for 28 patients. Patients were then followed up post treatment to document their response to treatment and treatment-related toxicity.Results: The median survival of our group of IMSCC patients is similar to that of an MSCC patient. In addition, the IMSCC group exhibits significant clinical symptoms including neurological deficit. Conclusion:Although further studies are necessary, we have found that IMSCC patients in this study share similar prognosis and clinical symptoms with MSCC patients. Clinicians should be aware of this when communicating with IMSCC patients and their families, and short-course radiotherapy should be considered.

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“…The heterogeneity of this population presents significant research challenges 12,15 . From a methodological perspective, homogeneous samples are preferred, in an effort to control extraneous variables.…”

Section: Myth 2: Homogeneous Samples Are Preferred Over Heterogeneousmentioning

confidence: 99%

“…Over the past two decades, numerous concerns regarding methodological issues and debates about the role of evidence-based approaches in palliative care research have been raised [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] . The purpose of this narrative review is to further explore the debate about the use of current evidence-based approaches, such as RCTs, for conducting research and evaluating the literature in palliative care, by addressing the following three questions:…”

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confidence: 99%

Improving the Evidence Base in Palliative Care to Inform Practice and Policy: Thinking Outside the Box

Aoun

Nekolaichuk

2014

Journal of Pain and Symptom Management

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The adoption of evidence-based hierarchies and research methods from other disciplines may not completely translate to complex palliative care settings. The heterogeneity of the palliative care population, complexity of clinical presentations and fluctuating health states present significant research challenges.The aim of this narrative review is to explore the debate about the use of current evidence-based approaches for conducting research, such as RCTs and other study designs, in palliative care, and more specifically to (a) describe key myths about palliative care research; (b) highlight substantive challenges of conducting palliative care research, using case illustrations; and (c) propose specific strategies to address some of these challenges.Myths about research in palliative care revolve around evidence hierarchies, sample heterogeneity, random assignment, participant burden and measurement issues.Challenges arise because of the complex physical, psychological, existential and spiritual problems faced by patients, families and service providers. These challenges 2 can be organized according to six general domains: patient, system/organization, context/setting, study design, research team and ethics. A number of approaches for dealing with challenges in conducting research fall into five separate domains: study design, sampling, conceptual, statistical, and measures and outcomes.Although RCTs have their place whenever possible, alternative designs may offer more feasible research protocols that can be successfully implemented in palliative care. Therefore, this article highlights 'outside the box' approaches that would benefit both clinicians and researchers in the palliative care field. Ultimately, the selection of research designs is dependent on a clearly articulated research question, which drives the research process.

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Why are trials in palliative care so difficult?

Cited by 198 publications

References 38 publications

The effectiveness of treatment for depression/depressive symptoms in adults with cancer: a systematic review

The effectiveness of treatment for depression/depressive symptoms in adults with cancer: a systematic review

A prospective study of patients with impending spinal cord compression treated with palliative radiotherapy alone

Improving the Evidence Base in Palliative Care to Inform Practice and Policy: Thinking Outside the Box

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