The Prognosis in Palliative care Study II (PiPS2): A study validating the PiPS predictive models of survival in patients with advanced care
Clinicians' Estimates of Survival (CES) in patients approaching the ends of their lives are often inaccurate (Glare et al. 2003). Determining more accurately how long these patients have left to live would enable both the patients and their relatives to make plans for their future (Steinhauser et al. 2001). It would also enable doctors to target treatments to those patients most likely to benefit and it would safeguard other patients from receiving treatments that they are unlikely to benefit from (Gwilliam et al. 2011). It would also allow both patients and their doctors to make more informed choices about the best place to receive their care. The number of elderly patients with advanced cancer is anticipated to increase substantially over the next twenty years. The results of our research are therefore expected to remain relevant and important to the needs of the National Health Service (NHS) in the future.
The Prognosis in Palliative care Scales (PiPS) are predictive models of survival and were developed in order to provide an objective aid to clinicians' intuition (Gwilliam et al. 2011). The PiPS models were designed to predict whether a patient is likely to live for "days", "weeks" or "months". These categories were chosen in the first place as they seemed to have the greatest face validity among clinicians. The PiPS scores are calculated using simple clinical data and clinical observations (+/- a blood test) via a standard computerised process (available at www.pips.sgul.ac.uk). PiPS scores have been shown to perform as well as, or better than, CES. Before recommending PiPS for use in routine clinical practice, it is important to check that the models provide accurate and reliable estimates of survival in a new group of patients.
Aims of the study
The aims of the PiPS2 study are to a) validate the PiPS models and b) to evaluate the accuracy of other predictive tools of survival i.e., the Palliative Prognostic (PaP) score, Palliative Prognostic Index (PPI), Palliative Performance Scale (PPS), and the Feliu Prognostic Nomogram (FPN) in a large group of patients across England and Wales.
Study set-up and patient population
This is a multi-centre study, aiming to recruit 1,780 patients via 28 palliative care services (i.e., hospices, hospital support teams and community services) in England and Wales. Patients are eligible to participate in the study if they have advanced, incurable cancer, no longer receive curative treatment for cancer and have recently been referred to palliative care services. The study started in May 2016 and is anticipated to finish in April 2019.
General Data Protection Regulations
Specific information about the study
As part of the study we will collect the following data from patients (directly and/or from their hospice or hospital notes): name, date of birth, date of death (when known), NHS number, address, assessments by clinicians (age, gender, measures of performance status, observer-rated global health status, abbreviated mental test scores, pulse rate, clinician predictions of survival and estimated time since diagnosed with a terminal disease); blood results (white blood count, lymphocyte count, neutrophil count, platelet count albumin, alkaline phosphatase, alanine transaminase, c-reactive protein, lactate dehydrogenase and urea); clinical signs and symptoms (presence or absence of key symptoms; anorexia, delirium, dysphagia, dyspnoea, fatigue, peripheral oedema, decreased oral intake, weight loss); and measures of disease extent (nature and site of primary and sites of metastases).
Some of this data is categorized by the GDPR as special category data because it concerns health. Personal identifiable data needs to be obtained and stored so that dates of death can be obtained from NHS Digital at the end of the study. It will not be possible to identify individual participants from any reports or publications that arise as a result of this research.
The Prognosis in Palliative Care II (PiPS2): Preliminary recruitment data /abstract number PO1-140 - page 387/