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

Abstract 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 da...

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Main Authors: Anastasia K. Kalpakidou, Chris Todd, Vaughan Keeley, Jane Griffiths, Karen Spencer, Victoria Vickerstaff, Rumana Z. Omar, Patrick Stone
Format: Article
Language:English
Published: BMC 2018-08-01
Series:BMC Palliative Care
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12904-018-0352-y
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author Anastasia K. Kalpakidou
Chris Todd
Vaughan Keeley
Jane Griffiths
Karen Spencer
Victoria Vickerstaff
Rumana Z. Omar
Patrick Stone
author_facet Anastasia K. Kalpakidou
Chris Todd
Vaughan Keeley
Jane Griffiths
Karen Spencer
Victoria Vickerstaff
Rumana Z. Omar
Patrick Stone
author_sort Anastasia K. Kalpakidou
collection DOAJ
description Abstract 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 doaj.art-6eeb355e877f4782bfcc3f9ac5e99b3c2022-12-21T23:52:26ZengBMCBMC Palliative Care1472-684X2018-08-011711910.1186/s12904-018-0352-yThe Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort studyAnastasia K. Kalpakidou0Chris Todd1Vaughan Keeley2Jane Griffiths3Karen Spencer4Victoria Vickerstaff5Rumana Z. Omar6Patrick Stone7Marie Curie Palliative Care Research Department, Division of Psychiatry, UCLThe School of Nursing, Midwifery and Social Work, University of ManchesterDerby Teaching Hospitals NHS Foundation TrustThe School of Nursing, Midwifery and Social Work, University of ManchesterThe School of Nursing, Midwifery and Social Work, University of ManchesterMarie Curie Palliative Care Research Department, Division of Psychiatry, UCLDepartment of Statistical Science, UCLMarie Curie Palliative Care Research Department, Division of Psychiatry, UCLAbstract 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).http://link.springer.com/article/10.1186/s12904-018-0352-yCancerPalliative carePrognosisObservational study
spellingShingle Anastasia K. Kalpakidou
Chris Todd
Vaughan Keeley
Jane Griffiths
Karen Spencer
Victoria Vickerstaff
Rumana Z. Omar
Patrick Stone
The Prognosis in Palliative care Study II (PiPS2): study protocol for a multi-centre, prospective, observational, cohort study
BMC Palliative Care
Cancer
Palliative care
Prognosis
Observational 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 Cancer
Palliative care
Prognosis
Observational study
url http://link.springer.com/article/10.1186/s12904-018-0352-y
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