Nancy Preston

Evaluating complex interventions in End of Life Care: the MORECare Statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews

BackgroundDespite being a core business of medicine, end of life care (EoLC) is neglected. It is hampered by research that is difficult to conduct with no common standards. We aimed to develop evidence-based guidance on the best methods for the design and conduct of research on EoLC to further knowledge in the field.MethodsThe Methods Of Researching End of life Care (MORECare) project built on the Medical Research Council guidance on the development and evaluation of complex circumstances. We conducted systematic literature reviews, transparent expert consultations (TEC) involving consensus methods of nominal group and online voting, and stakeholder workshops to identify challenges and best practice in EoLC research, including: participation recruitment, ethics, attrition, integration of mixed methods, complex outcomes and economic evaluation. We synthesised all findings to develop a guidance statement on the best methods to research EoLC.ResultsWe integrated data from three systematic reviews and five TECs with 133 online responses. We recommend research designs extending beyond randomised trials and encompassing mixed methods. Patients and families value participation in research, and consumer or patient collaboration in developing studies can resolve some ethical concerns. It is ethically desirable to offer patients and families the opportunity to participate in research. Outcome measures should be short, responsive to change and ideally used for both clinical practice and research. Attrition should be anticipated in studies and may affirm inclusion of the relevant population, but careful reporting is necessitated using a new classification. Eventual implementation requires consideration at all stages of the project.ConclusionsThe MORECare statement provides 36 best practice solutions for research evaluating services and treatments in EoLC to improve study quality and set the standard for future research. The statement may be used alongside existing statements and provides a first step in setting common, much needed standards for evaluative research in EoLC. These are relevant to those undertaking research, trainee researchers, research funders, ethical committees and editors.

Towards integration of palliative care in patients with chronic heart failure and chronic obstructive pulmonary disease: A systematic literature review of European guidelines and pathways

BackgroundDespite the positive impact of Palliative Care (PC) on the quality of life for patients and their relatives, the implementation of PC in non-cancer health-care delivery in the EU seems scarcely addressed. The aim of this study is to assess guidelines/pathways for integrated PC in patients with advanced Chronic Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD) in Europe via a systematic literature review.MethodsSearch results were screened by two reviewers. Eligible studies of adult patients with CHF or COPD published between 01/01/1995 and 31/12/2013 in Europe in 6 languages were included. Nine electronic databases were searched, 6 journals were hand-searched and citation tracking was also performed. For the analysis, a narrative synthesis was employed.ResultsThe search strategy revealed 26,256 studies without duplicates. From these, 19 studies were included in the review; 17 guidelines and 2 pathways. 18 out of 19 focused on suffering reduction interventions, 13/19 on a holistic approach and 15/19 on discussions of illness prognosis and limitations. The involvement of a PC team was mentioned in 13/19 studies, the assessment of the patients’ goals of care in 12/19 and the advance care planning in 11/19. Only 4/19 studies elaborated on aspects such as grief and bereavement care, 7/19 on treatment in the last hours of life and 8/19 on the continuation of goal adjustment.ConclusionThe results illustrate that there is a growing awareness for the importance of integrated PC in patients with advanced CHF or COPD. At the same time, however, they signal the need for the development of standardized strategies so that existing barriers are alleviated.

MORECare research methods guidance development: Recommendations for ethical issues in palliative and end-of-life care research

Background: There is little guidance on the particular ethical concerns that research raises with a palliative care population. Aim: To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. Design: Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. Setting/participants: Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. Results: The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. Conclusions: The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: Part of the MORECare research method guidance on statistical issues

Background: Statistical analysis in palliative and end-of-life care research can be problematic due to high levels of missing data, attrition and response shift as disease progresses. Aim: To develop recommendations about managing missing data, attrition and response shift in palliative and end-of-life care research data. Design: We used the MORECare Transparent Expert Consultation approach to conduct a consultation workshop with experts in statistical methods in palliative and end-of-life care research. Following presentations and discussion, nominal group techniques were used to produce recommendations about attrition, missing data and response shift. These were rated online by experts and analysed using descriptive statistics for consensus and importance. Results: In total, 20 participants attended the workshop and 19 recommendations were subsequently ranked. There was broad agreement across recommendations. The top five recommendations were as follows: A taxonomy should be devised to define types of attrition. Types and amount of missing data should be reported with details of imputation methods. The pattern of missing data should be investigated to inform the imputation approach. A statistical analysis plan should be pre-specified in the protocol. High rates of attrition should be assumed when planning studies and specifying analyses. The leading recommendation for response shift was for more research. Conclusions: When designing studies in palliative and end-of-life care, it is recommended that high rates of attrition should not be seen as indicative of poor design and that a clear statistical analysis plan is in place to account for missing data and attrition.

Recommendations for managing missing data, attrition and response shift in palliative and end of life care research (P&EoLC): Part of the MORECare research methods guidance development

Background: Statistical analysis in palliative and end-of-life care research can be problematic due to high levels of missing data, attrition and response shift as disease progresses. Aim: To develop recommendations about managing missing data, attrition and response shift in palliative and end-of-life care research data. Design: We used the MORECare Transparent Expert Consultation approach to conduct a consultation workshop with experts in statistical methods in palliative and end-of-life care research. Following presentations and discussion, nominal group techniques were used to produce recommendations about attrition, missing data and response shift. These were rated online by experts and analysed using descriptive statistics for consensus and importance. Results: In total, 20 participants attended the workshop and 19 recommendations were subsequently ranked. There was broad agreement across recommendations. The top five recommendations were as follows: A taxonomy should be devised to define types of attrition. Types and amount of missing data should be reported with details of imputation methods. The pattern of missing data should be investigated to inform the imputation approach. A statistical analysis plan should be pre-specified in the protocol. High rates of attrition should be assumed when planning studies and specifying analyses. The leading recommendation for response shift was for more research. Conclusions: When designing studies in palliative and end-of-life care, it is recommended that high rates of attrition should not be seen as indicative of poor design and that a clear statistical analysis plan is in place to account for missing data and attrition.

Platinum-Taxol non-cross resistance in epithelial ovarian cancer

The aim of this study was to assess the clinical evidence for platinum-Taxol non-cross-resistance in patients with epithelial ovarian cancer. Unlike other studies, only patients who had demonstrably progressive disease on platinum therapy were analysed. Patients received 135-200 mg m-2 of Taxol over 3 or 24 h and all patients were assessed for response by computerised axial tomography. The overall response rate was 22.2% (8/36 patients, 95% CI 10-39%). Only patients who received > or = 175 mg m-2 of Taxol responded (26.7%; 8/30 patients, 95% CI 12-46%). No complete responses were seen and the duration of response was short, median 7 months (range 5-9+). Response was associated with a short treatment-free interval (P = 0.02); only those who were treated immediately after they had progressed on their previous platinum therapy responded. Response duration was associated with a good performance status (P < 0.05). Platinum and Taxol are non-cross-resistant in a proportion of patients and therefore patients who are resistant to platinum compounds may benefit from Taxol although the duration of any response is short. These data support current strategies that involve combining Taxol with platinum compounds as first-line therapy in advanced epithelial ovarian cancer.

Integrated palliative care in Europe: a qualitative systematic literature review of empirically-tested models in cancer and chronic disease

BackgroundIntegrated Palliative Care (PC) strategies are often implemented following models, namely standardized designs that provide frameworks for the organization of care for people with a progressive life-threatening illness and/or for their (in)formal caregivers. The aim of this qualitative systematic review is to identify empirically-evaluated models of PC in cancer and chronic disease in Europe. Further, develop a generic framework that will consist of the basis for the design of future models for integrated PC in Europe.MethodsCochrane, PubMed, EMBASE, CINAHL, AMED, BNI, Web of Science, NHS Evidence. Five journals and references from included studies were hand-searched. Two reviewers screened the search results. Studies with adult patients with advanced cancer/chronic disease from 1995 to 2013 in Europe, in English, French, German, Dutch, Hungarian or Spanish were included. A narrative synthesis was used.Results14 studies were included, 7 models for chronic disease, 4 for integrated care in oncology, 2 for both cancer and chronic disease and 2 for end-of-life pathways. The results show a strong agreement on the benefits of the involvement of a PC multidisciplinary team: better symptom control, less caregiver burden, improvement in continuity and coordination of care, fewer admissions, cost effectiveness and patients dying in their preferred place.ConclusionBased on our findings, a generic framework for integrated PC in cancer and chronic disease is proposed. This framework fosters integration of PC in the disease trajectory concurrently with treatment and identifies the importance of employing a PC-trained multidisciplinary team with a threefold focus: treatment, consulting and training.

Mixed Methods Research in the Development and Evaluation of Complex Interventions in Palliative and End-of-Life Care: Report on the MORECare Consensus Exercise

BACKGROUND Complex interventions are common in palliative and end-of-life care. Mixed methods approaches sit well within the multiphase model of complex intervention development and evaluation. Generic mixed methods guidance is useful but additional challenges in the research design and operationalization within palliative and end-of-life care may have an impact on the use of mixed methods. OBJECTIVE The objective of the study was to develop guidance on the best methods for combining quantitative and qualitative methods for health and social care intervention development and evaluation in palliative and end-of-life care. METHODS A one-day workshop was held where experts participated in facilitated groups using Transparent Expert Consultation to generate items for potential recommendations. Agreement and consensus were then sought on nine draft recommendations (DRs) in a follow-up exercise. RESULTS There was at least moderate agreement with most of the DRs, although consensus was low. Strongest agreement was with DR1 (usefulness of mixed methods to palliative and end-of-life care) and DR5 (importance of attention to respondent burden), and least agreement was with DR2 (use of theoretical perspectives) and DR6 (therapeutic effects of research interviews). Narrative comments enabled recommendation refinement. Two fully endorsed, five partially endorsed, and two refined DRs emerged. The relationship of these nine to six key challenges of palliative and end-of-life care research was analyzed. CONCLUSIONS There is a need for further discussion of these recommendations and their contribution to methodology. The recommendations should be considered when designing and operationalizing mixed methods studies of complex interventions in palliative care, and because they may have wider relevance, should be considered for other applications.

Defining priorities in prognostication research : results of a consensus workshop

Purpose: To establish consensus among palliative care researchers on the priorities for prognostication research. Methods: A nominal group technique was employed involving palliative care researchers attending a workshop within a scientific meeting on prognostication. Participants worked in small facilitated groups to generate future research questions which were amalgamated and rated according to importance. Results: Twenty-five meeting delegates took part in the workshop including 10 palliative care physicians and four nurses, one dietician, and 10 academic researchers, all of whom had experience and/or interest in prognosis research. A total of 40 research questions were generated and after prioritization ratings, the top five questions were: (1) How valid are prognostic tools? (=2) Can we use prognostic criteria as entry criteria for research? (=2) How do we judge the impact of a prognostic score in clinical practice? (4) What is the best way of presenting survival data to patients? (5) What is the most user-friendly validated tool? Conclusions: Although a wide range of research questions relating to prognostication were identified, the strongest priority to emerge from the consensus data concerned the validity of prognostic tools. Further research to validate existing tools is essential to ensure their clinical value.

What are the views of hospital-based generalist palliative care professionals on what facilitates or hinders collaboration with in-patient specialist palliative care teams? A systematically constructed narrative synthesis:

Background: Hospital-based specialist palliative care services are common, yet existing evidence of inpatient generalist providers’ perceptions of collaborating with hospital-based specialist palliative care teams has never been systematically assessed. Aim: To assess the existing evidence of inpatient generalist palliative care providers’ perceptions of what facilitates or hinders collaboration with hospital-based specialist palliative care teams. Design: Narrative literature synthesis with systematically constructed search. Data sources: PsycINFO, PubMed, Web of Science, Cumulative Index of Nursing and Allied Health Literature and ProQuest Social Services databases were searched up to December 2014. Individual journal, citation and reference searching were also conducted. Papers with the views of generalist inpatient professional caregivers who utilised hospital-based specialist palliative care team services were included in the narrative synthesis. Hawker’s criteria were used to assess the quality of the included studies. Results: Studies included (n = 23) represented a variety of inpatient generalist palliative care professionals’ experiences of collaborating with specialist palliative care. Effective collaboration is experienced by many generalist professionals. Five themes were identified as improving or decreasing effective collaboration: model of care (integrated vs linear), professional onus, expertise and trust, skill building versus deskilling and specialist palliative care operations. Collaboration is fostered when specialist palliative care teams practice proactive communication, role negotiation and shared problem-solving and recognise generalists’ expertise. Conclusion: Fuller integration of specialist palliative care services, timely sharing of information and mutual respect increase generalists’ perceptions of effective collaboration. Further research is needed regarding the experiences of non-physician and non-nursing professionals as their views were either not included or not explicitly reported.