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Benefits of specialist palliative care by identifying active ingredients of service composition, structure, and delivery model: A systematic review with meta-analysis and meta-regression [1]

['Miriam J. Johnson', 'Wolfson Palliative Care Research Centre', 'Hull York Medical School', 'University Of Hull', 'Hull', 'United Kingdom', 'Leah Rutterford', 'St Neots Neurological Centre', 'St Neots', 'Anisha Sunny']

Date: 2024-08

Abstract Background Specialist palliative care (SPC) services address the needs of people with advanced illness. Meta-analyses to date have been challenged by heterogeneity in SPC service models and outcome measures and have failed to produce an overall effect. The best service models are unknown. We aimed to estimate the summary effect of SPC across settings on quality of life and emotional wellbeing and identify the optimum service delivery model. Methods and findings We conducted a systematic review with meta-analysis and meta-regression. Databases (Cochrane, MEDLINE, CINAHL, ICTRP, clinicaltrials.gov) were searched (January 1, 2000; December 28, 2023), supplemented with further hand searches (i.e., conference abstracts). Two researchers independently screened identified studies. We included randomized controlled trials (RCTs) testing SPC intervention versus usual care in adults with life-limiting disease and including patient or proxy reported outcomes as primary or secondary endpoints. The meta-analysis used, to our knowledge, novel methodology to convert outcomes into minimally clinically important difference (MID) units and the number needed to treat (NNT). Bias/quality was assessed via the Cochrane Risk of Bias 2 tool and certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. Random-effects meta-analyses and meta-regressions were used to synthesize endpoints between 2 weeks and 12 months for effect on quality of life and emotional wellbeing expressed and combined in units of MID. From 42,787 records, 39 international RCTs (n = 38 from high- and middle-income countries) were included. For quality of life (33 trials) and emotional wellbeing (22 trials), statistically and clinically significant benefit was seen from 3 months’ follow-up for quality of life, standardized mean difference (SMD in MID units) effect size of 0.40 at 13 to 36 weeks, 95% confidence interval (CI) [0.21, 0.59], p < 0.001, I2 = 60%). For quality of life at 13 to 36 weeks, 13% of the SPC intervention group experienced an effect of at least 1 MID unit change (relative risk (RR) = 1.13, 95% CI [1.06, 1.20], p < 0.001, I2 = 0%). For emotional wellbeing, 16% experienced an effect of at least 1 MID unit change at 13 to 36 weeks (95% CI [1.08, 1.24], p < 0.001, I2 = 0%). For quality of life, the NNT improved from 69 to 15; for emotional wellbeing from 46 to 28, from 2 weeks and 3 months, respectively. Higher effect sizes were associated with multidisciplinary and multicomponent interventions, across settings. Sensitivity analyses using robust MID estimates showed substantial (quality of life) and moderate (emotional wellbeing) benefits, and lower number-needed-to-treat, even with shorter follow-up. As the main limitation, MID effect sizes may be biased by relying on derivation in non-palliative care samples. Conclusions Using, to our knowledge, novel methods to combine different outcomes, we found clear evidence of moderate overall effect size for both quality of life and emotional wellbeing benefits from SPC, regardless of underlying condition, with multidisciplinary, multicomponent, and multi-setting models being most effective. Our data seriously challenge the current practice of referral to SPC close to death. Policy and service commissioning should drive needs-based referral at least 3 to 6 months before death as the optimal standard of care.

Author summary Why was this research done? Specialist palliative care (SPC) services provide a complex intervention that addresses the holistic needs of individuals with life-limiting conditions and their families.

Different intervention models include a variation of different disciplines (doctors, nurses, psychologists, physiotherapists, spiritual care workers, social care workers, etc.), configurations (e.g., whether out-of-hours care is provided), and settings (hospital, hospice, community, inpatient, outpatient, etc.).

The overall effectiveness of SPC on quality of life and emotional wellbeing is undetermined due to large variation in intervention models and heterogeneity in outcome measures used to measure quality of life and emotional wellbeing. What did the researchers do and find? We systematically reviewed randomized controlled trials (RCTs) investigating the effectiveness of SPC, to assess which intervention model components and configurations are most effective in improving quality of life or emotional wellbeing.

We used a method to combine effects across the range of outcome measures by converting raw scores into units of meaningful improvement.

For the summary effects of 39 RCTs, quality of life and emotional outcomes improved from 3 months of follow-up onwards. SPC yielded a clinically meaningful effect on quality of life of moderate size. The effect was larger at 3 to 6 months than at later follow-up. For emotional wellbeing, similar effects were seen. Overall, the effect was larger for quality of life than for emotional wellbeing.

To address the large variation in intervention models, we directly scored the number of professional groups and service elements to understand how this variation relates to outcomes. Higher effect sizes were associated with multidisciplinary and multicomponent SPC interventions, provided across healthcare settings. What do these findings mean? Our findings challenge the current practice of referring patients with life-limiting illness to SPC close to death at the end of life. Policy and service commissioning should drive needs-based referral at least 3 to 6 months before death as the optimal standard of care.

The most effective models are multidisciplinary, multicomponent (i.e., providing more than symptom control or advance care planning) and multi-setting.

Honoring the complex and holistic needs of patients and families by including different service elements offered by various professional groups working across settings is paramount for effective palliative care.

Meaningful changes were not necessarily derived in specified palliative populations. Some of the effects may therefore be under- or overestimated.

Citation: Johnson MJ, Rutterford L, Sunny A, Pask S, de Wolf-Linder S, Murtagh FEM, et al. (2024) Benefits of specialist palliative care by identifying active ingredients of service composition, structure, and delivery model: A systematic review with meta-analysis and meta-regression. PLoS Med 21(8): e1004436. https://doi.org/10.1371/journal.pmed.1004436 Academic Editor: Carol Brayne, University of Cambridge, UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND Received: March 12, 2024; Accepted: June 28, 2024; Published: August 2, 2024 Copyright: © 2024 Johnson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: All data included were derived from publicly available documents cited in the references. All data, a data dictionary and full analysis scripts for R can be obtained on the Open Science Framework website for this project (https://osf.io/h8pmz/). Funding: The University of Hull internship scheme supported LR and AS in contributing to this study. The funder of this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. FM is a UK National Institute for Health and Care Research (NIHR) Senior Investigator. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care (United Kingdom). Competing interests: The authors have declared that no competing interests exist. Abbreviations: CDSR, Cochrane Database of Systematic Reviews; CENTRAL, Cochrane Central Register of Controlled Trials; CI, confidence interval; CINAHL, cumulative index of nursing and allied health literature; DARE, Cochrane Database of Abstracts of Reviews of Effects; GRADE, Grading of Recommendations Assessment, Development and Evaluation; HIV, human immunodeficiency virus; HTA, Health Technology Assessment; ICTRP, International Clinical Trials Registration Plattform; MID, minimally clinically important difference; NHS EED, National Health Service Economic Evaluation Database; NNT, number needed to treat; pCG, proportion of scores in the control group; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; QOL, quality of life; RCT, randomized controlled trial; RR, relative risk; ROB, risk of bias tool; SMD, standardized mean difference; SPC, specialist palliative; e care, UC, usual care; UK, United Kingdom; USA, United States of America

Introduction Palliative and end-of-life care is the active, holistic care of people with advanced illness, focusing on quality of life (QoL) and symptom relief [1], applicable early in the disease course alongside disease-directed treatments [2]. Service models range from nonspecialist approaches with basic symptom management and advance care planning, to specialist services. Specialist palliative care (SPC) services address the needs of individuals and their families [3], usually delivered by a specialist multidisciplinary team (e.g., doctors, nurses, allied health professionals), fostering care coordination and collaboration between specialists and nonspecialists [3,4]. SPC team composition and service components (symptom management, rehabilitation, spiritual care, carer/bereavement support, out-of-hours services) vary dependent on healthcare settings and resources [5]. Attempts to evidence an effective SPC service delivery model are elusive [3,5–9], although various models are suggested [5], and components of service interventions identified [6]. However, a components classification is not provided, nor meta-regression conducted to estimate the summary effect on outcomes associated with specific components. Cost-effective commissioning of palliative care resources is needed given a projected increase of 42% in the number of people requiring palliative care of all those dying by 2040 [10]. Despite 17 systematic reviews of clinical trials for SPC (see Tables A–C in S2 Appendix), these reviews and meta-analyses have been unable to produce a unanimous summary effect. The 7 meta-analyses conducted previously were often based on one quarter of eligible trials only [11–17]. They have been further hampered by major heterogeneity in outcome measures/primary and secondary endpoints, intervention components and service models (and incomplete reporting of models) [3,8,11–17]. Most meta-analyses pool standardized mean differences (SMD) across different QoL and symptom measurement tools [11–17]; an approach challenged in the methodological literature due to issues with construct validity and scaling of different outcome measures [18,19]. The small number of included studies contributes to imprecision around the point estimate and the difficulties in interpreting the clinical relevance of findings; often the lower confidence interval bound represents questionable relevance. Only 3 reviews reported an emotional outcome measure (depression or anxiety) finding negligible (SMD 0.09) [14,15] or small (0.33) [16] effect sizes, respectively. To address the knowledge gap and question regarding the clinical relevance of estimates of benefit, and to inform policy and clinical service commissioning, we conducted this systematic review with meta-analysis and meta-regression, to estimate the overall summary effect on QoL and emotional wellbeing of SPC across settings. We used to our knowledge novel methodology, converting raw scores into units of meaningful improvement, to combine effects across the range of outcome measures used in the original studies. Additionally, we aimed to identify the service delivery model and components associated with moderate to high effect sizes for these outcomes.

Discussion Specialist palliative care, provided in addition to usual care, provided clinically important improvements in QoL and emotional wellbeing, with moderate effect size. For QoL and emotional outcomes, statistically and clinically significant benefit was seen in trials with follow-up for 3 months or more. The NNT for 1 patient to have benefit of at least 1 MID improved for both types of measures in studies with follow-up of between 3 and 6 months. The NNT for QoL outcomes improved from 69 (<3 months) to 15 (12 weeks) and 20 (13+ weeks), and the NNT for emotional outcomes improved from 46 (<3 months) to 19 (13 to 36 weeks). Greater effect sizes were seen in trials of higher quality; with lower attrition; in non-cancer study populations; and with multidisciplinary palliative care interventions providing a range of components (e.g., symptom control, psycho-spiritual care, support for family carers, etc.); and in provision across healthcare settings (hospital, hospice, and community). In the sensitivity analysis, statistically and clinically significant benefit was seen for both types of outcomes even in studies with follow-up of <3 months. We were able to demonstrate a moderate effect size for clinically meaningful benefit, in contrast to the uncertainty in previous published evidence syntheses [3,5–9,11–17], identify the timescale of expected benefit, and present benefit in a clinically relevant format (the NNT). To contextualize the relevance of these results, it is important to understand that currently, SPC services are most accessed within the last days and weeks of life. A systematic review examining SPC duration (169 studies, 23 countries, 11,996,479 patients) found a median duration before death of only 18.9 days (interquartile range 0.1); shorter for people with non-cancer diseases (15 days cancer versus 6 days non-cancer) [69]. Even in countries with well-established SPC with national coverage, most referrals are made less than 3 months before death [70]. For example, a UK national hospice study found a median of 48 days between referral and death; 53 days for cancer versus 27 days for non-cancer [71]. However, early (prognosis of ≥6 months; n = 2) SPC trials showed greater effect sizes than trials of study populations with shorter prognoses (n = 5) [72], especially for those with higher baseline symptom severity [73,74]. Patient benefit from early SPC persisted long-term with better QoL at end-of-life than those receiving SPC only closer to death [72]. Our data showed the relative risk of experiencing a clinically important benefit increased as the duration of trial follow-up increased, and the NNT reduced after at least 3 months’ follow up. For QoL outcomes, this was particularly so for people with non-cancer diseases, perhaps because SPC services have historically worked with cancer services fostering greater general palliative care skills and awareness. Our finding that a non-cancer diagnosis was associated with a higher effect size contrasts with Gaertner and colleagues [11], but their meta-analyses were based on only 2 trials. Previous work—despite the lack of robust conclusions—points to the need for cross-setting, multidisciplinary service models. To our knowledge, our work is the first designed to examine the impact of service model on benefit. Several strengths and limitations applied to this study. As a distinct strength of our work, the—to our knowledge—novel methodology, combining MIDs across different outcomes, allowed us to include more RCTs than previous meta-analyses, by combining different outcomes, and enabled robust conclusions regarding clinical importance of our findings. We presented a clinically understood measure (i.e., NNT) allowing easier comparison with other interventions. Our sensitivity analysis indicated that benefits from SPC may be seen almost immediately. Various limitations still applied. Our findings were still imprecise, but we could conclude that the benefit experienced was clinically important; previous point estimates of studies not using SMDs for MIDs have wide confidence intervals, with clinically questionable benefit for the lower bounds. The issue of contamination in 62% of studies may have led to an underestimation of effect. Effect sizes may have been over or underestimated by relying on a mixture of anchor and distribution-based approaches and thus, MIDs not being derived in palliative care samples. Further, included RCTs of palliative care interventions mainly represented evidence from high- and middle-income countries in which palliative care is often integrated and funded through the main healthcare system. The proportion of non-white participants was specified in 46% of included samples. The proportion of non-white participants ranged from 1% to 100%, with the majority of studies including around 15% of non-white participants. Therefore, the generalizability of our findings is limited to middle- and high-income countries with a majority of white participants. However, we managed to include studies in predominantly older populations with many studies including non-cancer conditions as well. None of the prior proposals of service models [3,5–9,28] provided a summary score capturing both team skill mixes and range of service provision. Our bespoke classification scheme lacks validation and due to variable reporting of interventions, we may have underestimated the score, but results have face validity and support previous narrative findings [3,11–17]. In terms of implications for policy and practice, SPC does what it purports to do [1], providing better QoL and better emotional wellbeing for people with advanced disease. While we confirmed “better late than never,” the usual situation of late referrals needs to be urgently addressed. Service provision should be multidisciplinary and integrated across healthcare settings which has implications for resourcing. Despite the World Health Assembly resolution of 2014 [75], progress towards universal access remains slow or nonexistent; commissioners fail to prioritize palliative care services. We showed an NNT similar to other accepted interventions, such as cardiac rehabilitation (NNT 12) [76]. Our findings will inform policy and service funders about the best model of care, sufficiently resourced to enable the most timely and effective intervention components, and a team with a skill mix able to provide the range of components needed. To do less is to risk the expense of an ill-equipped and ineffective service. Regarding research, we showed higher effect sizes were associated with higher-quality trials with longer follow-up and less attrition. Future trials of palliative care models should include those able to benefit over a longer timescale to enable better demonstration of optimal benefit, with less bias due to missing data [77]. This will reduce research waste, improve the evidence base, and give greater impetus to practice implementation. A future similar meta-analysis with even more trials would improve precision. In conclusion, we showed that SPC had a moderate overall effect in improving QoL and emotional concerns of people with life-limiting illness, regardless of medical condition. The most effective models of SPC service provision were found to be multidisciplinary, multicomponent, and multi-setting. Currently, most SPC referrals occur within weeks of death; our data seriously challenge this practice as too late for optimal benefit. Timely involvement in response to relevant concerns at any point during an individual’s illness should be the standard of care. Ethics committee approval No individual participant data were included in this meta-analysis. Ethics committee approval does not apply.

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[1] Url: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004436

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