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The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study

BACKGROUND: More accurate methods of prognostication are likely to lead to improvements in the quality of care of patients approaching the ends of their lives. The Prognosis in Palliative care Scales (PiPS) are prognostic models of survival. The scores are calculated using simple clinical data and o...

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Autores principales: Kalpakidou, Anastasia K., Todd, Chris, Keeley, Vaughan, Griffiths, Jane, Spencer, Karen, Vickerstaff, Victoria, Omar, Rumana Z., Stone, Patrick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6090599/
https://www.ncbi.nlm.nih.gov/pubmed/30103711
http://dx.doi.org/10.1186/s12904-018-0352-y
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author Kalpakidou, Anastasia K.
Todd, Chris
Keeley, Vaughan
Griffiths, Jane
Spencer, Karen
Vickerstaff, Victoria
Omar, Rumana Z.
Stone, Patrick
author_facet Kalpakidou, Anastasia K.
Todd, Chris
Keeley, Vaughan
Griffiths, Jane
Spencer, Karen
Vickerstaff, Victoria
Omar, Rumana Z.
Stone, Patrick
author_sort Kalpakidou, Anastasia K.
collection PubMed
description BACKGROUND: More accurate methods of prognostication are likely to lead to improvements in the quality of care of patients approaching the ends of their lives. The Prognosis in Palliative care Scales (PiPS) are prognostic models of survival. The scores are calculated using simple clinical data and observations. There are two separate PiPS models; PiPS-A for patients without blood test results and PiPS-B for patients with blood test results. Both models predict whether a patient is likely to live for “days”, “weeks” or “months” and have been shown to perform as well as clinicians’ estimates of survival. PiPS-B has also been found to be significantly better than doctors’ estimates of survival. We report here a protocol for the validation of PiPS and for the evaluation of the accuracy of other prognostic tools in a new, larger cohort of patients with advanced cancer. METHODS: This is a national, multi-centre, prospective, observational cohort study, aiming to recruit 1778 patients via palliative care services across England and Wales. Eligible patients have advanced, incurable cancer and have recently been referred to palliative care services. Patients with or without capacity are included in the study. The primary outcome is the accuracy of PiPS predictions and the difference in accuracy between these predictions and the clinicians’ estimates of survival; with PiPS-B being the main model of interest. The secondary outcomes include the accuracy of predictions by the Palliative Prognostic Index (PPI), Palliative Performance Scale (PPS), Palliative Prognostic score (PaP) and the Feliu Prognostic Nomogram (FPN) compared with actual patient survival and clinicians’ estimates of survival. A nested qualitative sub-study using face-to-face interviews with patients, carers and clinicians is also being undertaken to assess the acceptability of the prognostic models and to identify barriers and facilitators to clinical use. DISCUSSION: The study closed to recruitment at the end of April 2018 having exceeded the required sample size of 1778 patients. The qualitative sub-study is nearing completion. This demonstrates the feasibility of recruiting large numbers of participants to a prospective palliative care study. TRIAL REGISTRATION: ISRCTN13688211 (registration date: 28/06/2016).
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spelling pubmed-60905992018-08-17 The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study Kalpakidou, Anastasia K. Todd, Chris Keeley, Vaughan Griffiths, Jane Spencer, Karen Vickerstaff, Victoria Omar, Rumana Z. Stone, Patrick BMC Palliat Care Study Protocol BACKGROUND: More accurate methods of prognostication are likely to lead to improvements in the quality of care of patients approaching the ends of their lives. The Prognosis in Palliative care Scales (PiPS) are prognostic models of survival. The scores are calculated using simple clinical data and observations. There are two separate PiPS models; PiPS-A for patients without blood test results and PiPS-B for patients with blood test results. Both models predict whether a patient is likely to live for “days”, “weeks” or “months” and have been shown to perform as well as clinicians’ estimates of survival. PiPS-B has also been found to be significantly better than doctors’ estimates of survival. We report here a protocol for the validation of PiPS and for the evaluation of the accuracy of other prognostic tools in a new, larger cohort of patients with advanced cancer. METHODS: This is a national, multi-centre, prospective, observational cohort study, aiming to recruit 1778 patients via palliative care services across England and Wales. Eligible patients have advanced, incurable cancer and have recently been referred to palliative care services. Patients with or without capacity are included in the study. The primary outcome is the accuracy of PiPS predictions and the difference in accuracy between these predictions and the clinicians’ estimates of survival; with PiPS-B being the main model of interest. The secondary outcomes include the accuracy of predictions by the Palliative Prognostic Index (PPI), Palliative Performance Scale (PPS), Palliative Prognostic score (PaP) and the Feliu Prognostic Nomogram (FPN) compared with actual patient survival and clinicians’ estimates of survival. A nested qualitative sub-study using face-to-face interviews with patients, carers and clinicians is also being undertaken to assess the acceptability of the prognostic models and to identify barriers and facilitators to clinical use. DISCUSSION: The study closed to recruitment at the end of April 2018 having exceeded the required sample size of 1778 patients. The qualitative sub-study is nearing completion. This demonstrates the feasibility of recruiting large numbers of participants to a prospective palliative care study. TRIAL REGISTRATION: ISRCTN13688211 (registration date: 28/06/2016). BioMed Central 2018-08-13 /pmc/articles/PMC6090599/ /pubmed/30103711 http://dx.doi.org/10.1186/s12904-018-0352-y Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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 Study Protocol
Kalpakidou, Anastasia K.
Todd, Chris
Keeley, Vaughan
Griffiths, Jane
Spencer, Karen
Vickerstaff, Victoria
Omar, Rumana Z.
Stone, Patrick
The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
title The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
title_full The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
title_fullStr The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
title_full_unstemmed The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
title_short The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
title_sort prognosis in palliative care study ii (pips2): study protocol for a multi-centre, prospective, observational, cohort study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6090599/
https://www.ncbi.nlm.nih.gov/pubmed/30103711
http://dx.doi.org/10.1186/s12904-018-0352-y
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