What outcomes do studies use to measure the impact of prognostication on people with advanced cancer? Findings from a systematic review of quantitative and qualitative studies

Background: Studies evaluating the impact of prognostication in advanced cancer patients vary in the outcomes they measure, and there is a lack of consensus about which outcomes are most important. Aim: To identify outcomes previously reported in prognostic research with people with advanced cancer, as a first step towards constructing a core outcome set for prognostic impact studies. Design: A systematic review was conducted and analysed in two subsets: one qualitative and one quantitative. (PROSPERO ID: CRD42022320117; 29/03/2022). Data sources: Six databases were searched from inception to September 2022. We extracted data describing (1) outcomes used to measure the impact of prognostication and (2) patients’ and informal caregivers’ experiences and perceptions of prognostication in advanced cancer. We classified findings using the Core Outcome Measures in Effectiveness Trials (COMET) initiative taxonomy, along with a narrative description. We appraised retrieved studies for quality, but quality was not a basis for exclusion. Results: We identified 42 eligible studies: 32 quantitative, 6 qualitative, 4 mixed methods. We extracted 70 outcomes of prognostication in advanced cancer and organised them into 12 domains: (1) survival; (2) psychiatric outcomes; (3) general outcomes; (4) spiritual/religious/existential functioning/wellbeing, (5) emotional functioning/wellbeing; (6) cognitive functioning; (7) social functioning; (8) global quality of life; (9) delivery of care; (10) perceived health status; (11) personal circumstances; and (12) hospital/hospice use. Conclusion: Outcome reporting and measurement varied markedly across the studies. A standardised approach to outcome reporting in studies of prognosis is necessary to enhance data synthesis, improve clinical practice and better align with stakeholders’ priorities

How does receiving a survival estimate affect the general health and wellbeing of people living with terminal cancer and their carers? Findings from a systematic review of qualitative experiences

Introduction: We are developing a core outcome set (COS) for palliative cancer care research into prognostication (prediction of survival). Studies in this field often measure a variety of clinical and service-level outcomes, but do not routinely measure outcomes that are important to patients and carers. The experiences of these stakeholders are essential for producing a meaningful COS. / Aims: To identify and synthesise qualitative data on patients’ and carers’ experiences of prognostication in palliative cancer care. / Methods: We searched five electronic databases (MEDLINE, Embase, CINAHL, PsycINFO, and the Cochrane Library) from inception up to March 2022. The search included qualitative or mixed methods studies exploring how adult cancer patients and/or carers are affected by prognostication. Data describing outcomes and experiences of prognostication were extracted and thematically synthesised, using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy as a framework to develop themes. / Results: From 8,075 results, we identified 9 papers describing patients’ and carers’ experiences of prognostication. We identified 28 themes from these papers and organised these into eight domains within the COMET taxonomy: 1) psychiatric outcomes; 2) spiritual, religious, and/or existential functioning/wellbeing; 3) emotional functioning/wellbeing; 4) social functioning; 5) global quality of life; 6) delivery of care; 7) perceived health status; 8) personal circumstances. The main themes identified were: avoidance/denial, maintaining hope, preparedness for end-of-life, and treatment preferences. / Conclusions: We have identified 28 themes as potential candidates for inclusion in the future COS. The next stage of the study will investigate stakeholders’ perspectives on these themes and other potentially suitable items for inclusion, identified through linked reviews. / Impact: Standardising outcome reporting through a COS will improve the comparability of future prognostic research, and match better with patient and carer experiences. This will lead to better evidence synthesis, clinical practice, and ultimately improve access to support for those living with terminal cancer when receiving a prognosis

Psychological Support for Personality (PSP) versus treatment as usual: study protocol for a feasibility randomized controlled trial of a low intensity intervention for people with personality disorder

Background: Previous research has demonstrated the clinical effectiveness of long-term psychological treatment for people with some types of personality disorder. However, the high intensity and cost of these interventions limit their availability. Lower-intensity interventions are increasingly being offered to people with personality disorder, but their clinical and cost effectiveness have not been properly tested in experimental studies. We therefore set out to develop a low intensity intervention for people with personality disorder and to test the feasibility of conducting a randomized controlled trial to compare the clinical effectiveness of this intervention with that of treatment as usual (TAU). Methods: A two-arm, parallel-group, single-blind, randomized controlled trial of Psychological Support for Personality (PSP) versus TAU for people aged over 18 years, who are using secondary care mental health services and have personality disorder. We will exclude people with co-existing organic or psychotic mental disorders (dementia, bipolar affective disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizotypal disorder), those with cognitive or language difficulties that would preclude them from providing informed consent or compromise participation in study procedures, and those who are already receiving psychological treatment for personality disorder. Participants will be randomized via a remote system in a ratio of PSP to TAU of 1:1. Randomization will be stratified according to the referring team and gender of the participant. A single follow-up assessment will be conducted by masked researchers 24 weeks after randomization to assess mental health (using the Warwick and Edinburgh Well-Being Schedule), social functioning (using the Work and Social Adjustment Scale), health-related quality of life (EQ-5D-5 L), incidence of suicidal behavior, satisfaction with care (Client Satisfaction Questionnaire), and resource use and costs using a modified version of the Adult Service Use Schedule. In addition to this, each participant will be asked to complete the patient version of the Clinical Global Impression Scale. Feasibility and acceptability will primarily be judged by study recruitment rate and engagement and retention in treatment. The analysis will focus principally on descriptive data on the rate of recruitment, characteristics of participants, attrition, adherence to therapy, and follow-up. We will explore the distribution of study outcomes to investigate assumptions of normality in order to plan the analysis and sample size of a future definitive trial. Discussion: Most people with personality disorder do not currently receive evidence-based interventions. While a number of high intensity psychological treatments have been shown to be effective, there is an urgent need to develop effective low intensity approaches to help people unable to use existing treatments. PSP is a low intensity intervention for individuals, which was developed following extensive consultation with users and providers of services for people with personality disorder. This study aims to examine the feasibility of a randomized trial of PSP compared to TAU for people with personality disorder