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BMC Palliative Care
Published in: BMC Palliative Care 1/2017

Open Access 01-12-2017 | Research article

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

Authors: Raquel Bouça-Machado, Madalena Rosário, Joana Alarcão, Leonor Correia-Guedes, Daisy Abreu, Joaquim J. Ferreira

Published in: BMC Palliative Care | Issue 1/2017

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Abstract

Background

Over 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.

Methods

We 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.

Results

We 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.

Conclusions

While 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.
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Literature
1.
Sigurdardottir KR, Oldervoll L, Hjermstad MJ, Kaasa S, Knudsen AK, Løhre ET, et al. How are palliative care cancer populations characterized in randomized controlled trials? A literature review. J Pain Symptom Manag. 2014;47:906–14. e17.CrossRef
2.
Pastrana T, Jünger S, Ostgathe C, Elsner F, Radbruch L. A matter of definition--key elements identified in a discourse analysis of definitions of palliative care. Palliat Med. 2008;22:222–32.CrossRefPubMed
3.
Sepúlveda C, Marlin A, Yoshida T, Ullrich A. Palliative care: the world health organization’s global perspective. J Pain Symptom Manage. 2002;24:91–6.CrossRefPubMed
4.
Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. Br Med J. 1996;312:71–2.CrossRef
5.
Visser C, Hadley G, Wee B. Reality of evidence-based practice in palliative care. Cancer Biol. Med. 2015;12:193–200.
6.
McIlfatrick SJ, Murphy T. Palliative care research on the island of Ireland over the last decade: a systematic review and thematic analysis of peer reviewed publications. BMC Palliat Care. 2013;12:33.CrossRefPubMedPubMedCentral
7.
Flemming K, Adamson J, Atkin K. Improving the effectiveness of interventions in palliative care: the potential role of qualitative research in enhancing evidence from randomized controlled trials. Palliat Med. 2008;22:123–31.CrossRefPubMed
8.
Abernethy AP, Aziz NM, Basch E, Bull J, Cleeland CS, Currow DC, et al. A strategy to advance the evidence base in palliative medicine: formation of a palliative care research cooperative group. J Palliat Med. 2010;13:1407–13. Mary Ann Liebert, Inc. 140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA.CrossRefPubMedPubMedCentral
9.
Aoun SM, Nekolaichuk C. Improving the Evidence Base in Palliative Care to Inform Practice and Policy: Thinking Outside the Box. J Pain Symptom Manag. Elsevier; 2014;48:1222–35.
10.
11.
Bakitas MA, Lyons KD, Dixon J, Ahles TA. Palliative care program effectiveness research: developing rigor in sampling design, conduct, and reporting. J Pain Symptom Manag. 2006;31:270–84. Elsevier.CrossRef
12.
Zimmermann C, Riechelmann R, Krzyzanowska M, Rodin G, Tannock I. Effectiveness of specialized palliative care: a systematic review. JAMA. 2008;299:1698–709.CrossRefPubMed
13.
Hui D, Glitza I, Chisholm G, Yennu S, Bruera E. Attrition rates, reasons, and predictive factors in supportive care and palliative oncology clinical trials. Cancer. 2013;119:1098–105.CrossRefPubMed
14.
Currow DC, Wheeler JL, Glare PA, Kaasa S, Abernethy AP. A framework for generalizability in palliative care the problem : why is generalizability different from other clinical. J Pain Symptom Manag. 2009;37:373–86. Elsevier Inc.CrossRef
15.
Armijo-Olivo S, Fuentes CJ, Rogers T, Hartling L, Saltaji H, Cummings G. How should we evaluate the risk of bias of physical therapy trials?: a psychometric and meta-epidemiological approach towards developing guidelines for the design, conduct, and reporting of RCTs in Physical Therapy (PT) area: a study protocol. Syst Rev. 2013;2:88.CrossRefPubMedPubMedCentral
16.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55.CrossRefPubMed
17.
18.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
19.
Campion EW, Kelley AS, Morrison RS. Palliative care for the seriously Ill. N Engl J Med. 2015;373:747–55.CrossRef
20.
Twycross R. Patient care: past, present, and future. Omega (Westport). 2007;56:7–19.CrossRef
21.
Mazzocato C, Sweeney C, Bruera E. Clinical research in palliative care: patient populations, symptoms, interventions and endpoints. Palliat Med. 2001;15:163–8.CrossRefPubMed
22.
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6 [updated September 2006]. In: The Cochrane Library. Wiley: Chichester; 2006;(4).
23.
Armijo-Olivo S, Stiles CR, Hagen NA, Biondo PD, Cummings GG. Assessment of study quality for systematic reviews: A comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: Methodological research. J. Eval. Clin. Pract. 2012;18:12–8.
24.
Han CJ, Yang GS. Fatigue in irritable bowel syndrome: a systematic review and meta-analysis of pooled frequency and severity of fatigue. Asian Nurs Res (Korean Soc Nurs Sci). 2016;10:1–10. Elsevier.CrossRef
25.
Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013;346:e8668. BMJ Group.CrossRefPubMedPubMedCentral
26.
Albers G, Harding R, Pasman HRW, Onwuteaka-Philipsen BD, Hall S, Toscani F, et al. What is the methodological rigour of palliative care research in long-term care facilities in Europe? A systematic review. Palliat Med. 2012;26:722–33.CrossRefPubMed
27.
Kaasa S, Hjermstad MJ, Loge JH. Methodological and structural challenges in palliative care research: how have we fared in the last decades? Palliat Med. 2006;20:727–34.CrossRefPubMed
28.
Lorenz KA, Lynn J, Morton SC, Ph D, Dy SM, Shugarman LM, et al. Methodological approaches for a systematic review of end-of-life care. J Palliat Med. 2005;8:4–11.CrossRef
29.
Bausewein C, Higginson IJ. Challenges in defining “palliative care” for the purposes of clinical trials. Curr Opin Support Palliat Care. 2012;6:471–82.CrossRefPubMed
30.
Dening T, Dening KH. Palliative care in dementia: does it work? Maturitas Elsevier Ireland Ltd. 2015;83:1–2.
31.
Mitchell G. Decision-making in dementia care. Int J Palliat Nurs. 2013;21:536–41.CrossRef
32.
Hui D, Parsons HA, Damani S, Fulton S, Liu J, Evans A, et al. Quantity, design, and scope of the palliative oncology literature. Oncologist. 2011;16:694–703.CrossRefPubMedPubMedCentral
33.
Sleeman KE, Murtagh FE. Increasing the value of research in palliative care. Palliat Med. 2014;28:1165–6.CrossRefPubMed
34.
Johnston G, Abraham C. The WHO objectives for palliative care: to what extent are we achieving them? Palliat Med. 1995;9:123–37.CrossRefPubMed
35.
Gaertner J, Wolf J, Frechen S, Klein U, Scheicht D, Hellmich M, et al. Recommending early integration of palliative care - does it work? Support Care Cancer. 2012;20:507–13.CrossRefPubMed
36.
Abernethy AP, Currow DC, Wurzelmann J, Janning SW, Bull J, Norris JF, et al. Enhancing enrollment in palliative care trials : key insights from a randomized, Placebo-controlled study. J Support Oncol. 2010;8:139–44.PubMed
37.
Hussain JA, White IR, Langan D, Johnson MJ, Currow DC, Torgerson DJ, et al. Missing data in randomized controlled trials testing palliative interventions pose a significant risk of bias and loss of power: a systematic review and meta-analyses. J Clin Epidemiol. 2016;74:57–65. Elsevier Inc.CrossRefPubMedPubMedCentral
38.
Latronico N, Botteri M, Minelli C, Zanotti C, Bertolini G, Candiani A. Quality of reporting of randomised controlled trials in the intensive care literature. A systematic analysis of papers published in intensive care medicine over 26 years. Intensive Care Med. 2002;28:1316–23.CrossRefPubMed
39.
Agar M, Luckett T. Outcome measures for palliative care research. Curr Opin Support Palliat Care. 2012;6:500–7.
40.
Jassem J, Ramlau R, Santoro A, Schuette W, Chemaissani A, Hong S, et al. Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol. 2008;26:1698–704.CrossRefPubMed
41.
Nipp RD, Currow DC, Cherny NI, Strasser F, Abernethy AP, Zafar SY. Best supportive care in clinical trials: review of the inconsistency in control arm design. Br J Cancer. 2015;113:6–11. Nature Publishing Group.CrossRefPubMedPubMedCentral
42.
Zafar SY, Currow D, Abernethy AP. Defining best supportive care. J Clin Oncol. 2008;5139.
43.
Mayer D. Essential Evidence-Based Medicine - 2nd edition. Kingdom; Cambridge University Press; 2010.
44.
Hardy J. Placebo-controlled trials in palliative care: the argument for. Palliat Med. 1997;11:415–8.CrossRefPubMed
45.
Kirkham SR, Abel J. Placebo-controlled trials in palliative care: the argument against. Palliat Med. 1997;11:489–92.CrossRefPubMed
46.
Chen EK, Riffin C, Reid MC, Adelman R, Warmington M, Mehta SS, et al. Why is high-quality research on palliative care so hard to do? Barriers to improved research from a survey of palliative care researchers. J. Palliat. Med. 2014;17:782–7.
47.
Lai R. Quality of randomized controlled trials reporting in the primary treatment of brain tumors. J Clin Oncol. 2006;24:1136–44.CrossRefPubMed
48.
Latronico N, Metelli M, Turin M, Piva S, Rasulo FA, Minelli C. Quality of reporting of randomized controlled trials published in intensive care medicine from 2001 to 2010. Intensive Care Med. 2013;39:1386–95.CrossRefPubMed
49.
Juni P, Altman DG, Egger M. Assessing the Quality of Randomised Controlled Trials. Syst. Rev. Heal. Care. London: BMJ Publishing Group; p. 87–108.
50.
Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609–13.
51.
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–12.CrossRefPubMed
52.
Colditz GA, Miller JN, Mosteller F. How study design affects outcomes in comparisons of therapy. I: medical. Stat Med. 1989;8:441–54.CrossRefPubMed
53.
Vale CL, Tierney JF, Burdett S. Can trial quality be reliably assessed from published reports of cancer trials: evaluation of risk of bias assessments in systematic reviews. BMJ. 2013;346:f1798–f1798.
54.
Piggott M, McGee H, Feuer D. Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review. Palliat Med. 2004;18:32–8.CrossRefPubMed
Metadata
Title
Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting
Authors
Raquel Bouça-Machado
Madalena Rosário
Joana Alarcão
Leonor Correia-Guedes
Daisy Abreu
Joaquim J. Ferreira
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Palliative Care / Issue 1/2017
Electronic ISSN: 1472-684X
DOI
https://doi.org/10.1186/s12904-016-0181-9

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