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Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)
BACKGROUND: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit fro...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4190470/ https://www.ncbi.nlm.nih.gov/pubmed/25257804 http://dx.doi.org/10.1186/1745-6215-15-376 |
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author | Johnsen, Anna Thit Petersen, Morten Aagaard Gluud, Christian Lindschou, Jane Fayers, Peter Sjøgren, Per Pedersen, Lise Neergaard, Mette Asbjoern Vejlgaard, Tove Bahn Damkier, Anette Nielsen, Jan Bjoern Strömgren, Annette S Higginson, Irene J Groenvold, Mogens |
author_facet | Johnsen, Anna Thit Petersen, Morten Aagaard Gluud, Christian Lindschou, Jane Fayers, Peter Sjøgren, Per Pedersen, Lise Neergaard, Mette Asbjoern Vejlgaard, Tove Bahn Damkier, Anette Nielsen, Jan Bjoern Strömgren, Annette S Higginson, Irene J Groenvold, Mogens |
author_sort | Johnsen, Anna Thit |
collection | PubMed |
description | BACKGROUND: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to ‘early SPC’. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here. RESULTS: This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient’s ‘primary need’. The ‘primary need’ is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias. CONCLUSIONS: Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based ‘early SPC’ for patients with metastatic cancer from a broad spectrum of cancer diagnosis. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01348048 (May 2011). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-15-376) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4190470 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-41904702014-10-10 Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) Johnsen, Anna Thit Petersen, Morten Aagaard Gluud, Christian Lindschou, Jane Fayers, Peter Sjøgren, Per Pedersen, Lise Neergaard, Mette Asbjoern Vejlgaard, Tove Bahn Damkier, Anette Nielsen, Jan Bjoern Strömgren, Annette S Higginson, Irene J Groenvold, Mogens Trials Update BACKGROUND: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to ‘early SPC’. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here. RESULTS: This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient’s ‘primary need’. The ‘primary need’ is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias. CONCLUSIONS: Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based ‘early SPC’ for patients with metastatic cancer from a broad spectrum of cancer diagnosis. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01348048 (May 2011). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-15-376) contains supplementary material, which is available to authorized users. BioMed Central 2014-09-26 /pmc/articles/PMC4190470/ /pubmed/25257804 http://dx.doi.org/10.1186/1745-6215-15-376 Text en © Johnsen et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Update Johnsen, Anna Thit Petersen, Morten Aagaard Gluud, Christian Lindschou, Jane Fayers, Peter Sjøgren, Per Pedersen, Lise Neergaard, Mette Asbjoern Vejlgaard, Tove Bahn Damkier, Anette Nielsen, Jan Bjoern Strömgren, Annette S Higginson, Irene J Groenvold, Mogens Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) |
title | Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) |
title_full | Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) |
title_fullStr | Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) |
title_full_unstemmed | Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) |
title_short | Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT) |
title_sort | detailed statistical analysis plan for the danish palliative care trial (danpact) |
topic | Update |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4190470/ https://www.ncbi.nlm.nih.gov/pubmed/25257804 http://dx.doi.org/10.1186/1745-6215-15-376 |
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