Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’

Clinical trials in palliative care are challenging to design and conduct. Burden on patients should be minimized, while gatekeeping by professionals and next-of kin needs to be avoided. Clinical deterioration due to disease progression affects attrition unrelated to intervention, and different care...

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Autores principales:	Maria Helde Frankling, Caritha Klasson, Linda Björkhem-Bergman
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	randomized controlled trial placebo-controlled palliative care palliative care research research clinical trial Science Q
Acceso en línea:	https://doaj.org/article/8ac5af1f82f34e0981653989c2f315af
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spelling	oai:doaj.org-article:8ac5af1f82f34e0981653989c2f315af2021-11-25T18:11:24ZSuccessful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’10.3390/life111112332075-1729https://doaj.org/article/8ac5af1f82f34e0981653989c2f315af2021-11-01T00:00:00Zhttps://www.mdpi.com/2075-1729/11/11/1233https://doaj.org/toc/2075-1729Clinical trials in palliative care are challenging to design and conduct. Burden on patients should be minimized, while gatekeeping by professionals and next-of kin needs to be avoided. Clinical deterioration due to disease progression affects attrition unrelated to intervention, and different care settings complicate comparisons and reduce the generalizability of the results. The aim of this review is to provide advice for colleagues planning to perform clinical trials in palliative care based on our own experiences from performing the Palliative-D study and by a thorough literature review on this topic. The Palliative-D study was a double-blind trial with 244 randomized patients comparing the effect of vitamin D<sub>3</sub> to placebo in patients with advanced or metastatic cancer in the palliative phase of their disease trajectory who were enrolled in specialized palliative home care teams. Endpoints were opioid and antibiotic use, fatigue, and QoL. Recruitment was successful, but attrition rates were higher than expected, and we did not reach targeted power. For the 150 patients who completed the study, the completeness of the data was exceptionally high. Rather than patient reported pain, we choose the difference in the mean change in opioid dose between groups after twelve weeks compared to baseline as the primary endpoint. In this paper we discuss challenges in palliative care research based on lessons learned from the “Palliative-D” trial regarding successful strategies as well as areas for improvement.Maria Helde FranklingCaritha KlassonLinda Björkhem-BergmanMDPI AGarticlerandomized controlled trialplacebo-controlledpalliative carepalliative care researchresearchclinical trialScienceQENLife, Vol 11, Iss 1233, p 1233 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	randomized controlled trial placebo-controlled palliative care palliative care research research clinical trial Science Q
spellingShingle	randomized controlled trial placebo-controlled palliative care palliative care research research clinical trial Science Q Maria Helde Frankling Caritha Klasson Linda Björkhem-Bergman Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’
description	Clinical trials in palliative care are challenging to design and conduct. Burden on patients should be minimized, while gatekeeping by professionals and next-of kin needs to be avoided. Clinical deterioration due to disease progression affects attrition unrelated to intervention, and different care settings complicate comparisons and reduce the generalizability of the results. The aim of this review is to provide advice for colleagues planning to perform clinical trials in palliative care based on our own experiences from performing the Palliative-D study and by a thorough literature review on this topic. The Palliative-D study was a double-blind trial with 244 randomized patients comparing the effect of vitamin D<sub>3</sub> to placebo in patients with advanced or metastatic cancer in the palliative phase of their disease trajectory who were enrolled in specialized palliative home care teams. Endpoints were opioid and antibiotic use, fatigue, and QoL. Recruitment was successful, but attrition rates were higher than expected, and we did not reach targeted power. For the 150 patients who completed the study, the completeness of the data was exceptionally high. Rather than patient reported pain, we choose the difference in the mean change in opioid dose between groups after twelve weeks compared to baseline as the primary endpoint. In this paper we discuss challenges in palliative care research based on lessons learned from the “Palliative-D” trial regarding successful strategies as well as areas for improvement.
format	article
author	Maria Helde Frankling Caritha Klasson Linda Björkhem-Bergman
author_facet	Maria Helde Frankling Caritha Klasson Linda Björkhem-Bergman
author_sort	Maria Helde Frankling
title	Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’
title_short	Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’
title_full	Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’
title_fullStr	Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’
title_full_unstemmed	Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’
title_sort	successful strategies and areas of improvement–lessons learned from design and conduction of a randomized placebo-controlled trial in palliative care, ‘palliative-d’
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/8ac5af1f82f34e0981653989c2f315af
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Successful Strategies and Areas of Improvement–Lessons Learned from Design and Conduction of a Randomized Placebo-Controlled Trial in Palliative Care, ‘Palliative-D’

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