Measuring the cost-effectiveness of treatments for people with multiple sclerosis: Beyond quality-adjusted life-years.

BACKGROUND: It is a familiar story. A promising multiple sclerosis (MS) treatment clears the three regulatory hurdles of safety, quality and efficacy, only to fall at the fourth: cost-effectiveness. This has led to concerns about the validity of the measures typically used to quantify treatment effects in cost-effectiveness analyses and in 2012, in the United Kingdom, the National Institute for Health and Care Excellence called for an improvement in the cost-effectiveness framework for assessing MS treatments. OBJECTIVE AND METHODS: This review describes what is meant by cost-effectiveness in health/social care funding decision-making, and usual practice for assessing treatment benefits. RESULTS: We detail the use of the quality-adjusted life-year (QALY) in resource allocation decisions, and set out limitations of this approach in the context of MS. CONCLUSION: We conclude by highlighting methodological and policy developments which should aid addressing these limitations.

Epistemic justice in public involvement and engagement: Creating conditions for impact.

INTRODUCTION: Patient and public involvement in research is anchored in moral and epistemological rationales. Moral rationales relate to the public having a right to influence how knowledge about them is generated. Epistemological rationales relate to how research design and implementation can improve when informed by experiential, as well as technical, knowledge. In other words, public involvement can increase the epistemological resources of researchers, and contribute to research that is fit for purpose and has high external validity. METHODS: This article presents an analysis of 3 meetings and 11 interviews with public collaborators and researchers in three UK-based health research studies. Data comprised transcripts of audio-recorded research meetings and interviews with public collaborators and researchers. Data were first analysed to develop a data-informed definition of experiential knowledge, then thematically to investigate how this experiential knowledge was considered and received within the research space. RESULTS: At meetings, public collaborators shared their experiential knowledge as stories, comments, questions, answers and when referring to their own roles. They were aware of crossing a boundary from everyday life, and some adapted their contributions to fit within the research space. Although researchers and public collaborators made efforts to create an inclusive climate, obstacles to impact were identified. CONCLUSIONS: Considering experiential knowledge as a boundary object highlights that this knowledge has a different form to other kinds of knowledge that contribute to research. To enable impact from experiential knowledge, researchers need to create a space where public collaborators experience epistemic justice. PATIENT AND PUBLIC CONTRIBUTION: The Peninsula Public Engagement Group (PenPEG) was involved in the planning and conceptualization of the study, including the development of the ethics application and the interview schedules. One member of this group (Richard Fitzgerald) and one from outside the group (Leon Farmer), were full members of the author team and were involved in the data analysis. Leon Farmer has since become a member of PenPEG. Richard Fitzgerald and Leon Farmer were not involved in the three research studies sampled for this study. Sadly Richard Fitzgerald died during the course of this study.

Development and testing of a medline search filter for identifying patient and public involvement in health research.

BACKGROUND: Research involving the public as partners often proves difficult to locate due to the variations in terms used to describe public involvement, and inability of medical databases to index this concept effectively. OBJECTIVE: To design a search filter to identify literature where patient and public involvement (PPI) was used in health research. METHODS: A reference standard of 172 PPI papers was formed. The references were divided into a development set and a test set. Search terms were identified from common words, phrases and synonyms in the development set. These terms were combined as a search strategy for medline via OvidSP, which was then tested for sensitivity against the test set. The resultant search filter was then assessed for sensitivity, specificity and precision using a previously published systematic review. RESULTS: The search filter was found to be highly sensitive 98.5% in initial testing. When tested against results generated by a 'real-life' systematic review, the filter had a specificity of 81%. However, sensitivity dropped to 58%. Adjustments to the population group of terms increased the sensitivity to 73%. CONCLUSION: The PPI filter designed for medline via OvidSP could aid information specialists and researchers trying to find literature specific to PPI.

Establishing local priorities for a health research agenda.

AIM/BACKGROUND: To describe the two-stage prioritization process being used by the UK National Institute for Health Research's Collaboration for Leadership in Applied Health Research and Care for the South-West Peninsula (or PenCLAHRC) - a joint health service and university partnership and reflect on implications for the wider context of priority setting in health-care research. METHOD: PenCLAHRC's process establishes the priorities of Stakeholders including service users across a regional health system for locally relevant health services research and implementation. Health research questions are collected from clinicians, academics and service users in Devon and Cornwall (UK) using a web-based question formulation tool. There is a two-stage prioritization process which uses explicit criteria and a wide Stakeholder group, including service users to identify important research questions relevant to the south-west peninsula locality. RESULTS: To date, a wide variety of health research topics have been prioritized by the PenCLAHRC Stakeholders. The research agenda reflects the interests of academics, clinicians and service users in the local area. Potential challenges to implementation of the process include time constraints, variable quality of questions (including the language of research) and initiating and maintaining engagement in the process. Shared prioritization of local health research needs can be achieved between Stakeholders from a wide range of perspectives. CONCLUSIONS: The processes developed have been successful and, with minor changes, will continue to be used during subsequent rounds of prioritization. Engagement of Stakeholders in establishing a research agenda encourages the most relevant health questions to be asked and may improve implementation of research findings and take up by service users.

Gynaecological cancer surveillance for women with Lynch syndrome: systematic review and cost-effectiveness evaluation.

Background: Lynch syndrome is an inherited condition which leads to an increased risk of colorectal, endometrial and ovarian cancer. Risk-reducing surgery is generally recommended to manage the risk of gynaecological cancer once childbearing is completed. The value of gynaecological colonoscopic surveillance as an interim measure or instead of risk-reducing surgery is uncertain. We aimed to determine whether gynaecological surveillance was effective and cost-effective in Lynch syndrome. Methods: We conducted systematic reviews of the effectiveness and cost-effectiveness of gynaecological cancer surveillance in Lynch syndrome, as well as a systematic review of health utility values relating to cancer and gynaecological risk reduction. Study identification included bibliographic database searching and citation chasing (searches updated 3 August 2021). Screening and assessment of eligibility for inclusion were conducted by independent researchers. Outcomes were prespecified and were informed by clinical experts and patient involvement. Data extraction and quality appraisal were conducted and results were synthesised narratively. We also developed a whole-disease economic model for Lynch syndrome using discrete event simulation methodology, including natural history components for colorectal, endometrial and ovarian cancer, and we used this model to conduct a cost-utility analysis of gynaecological risk management strategies, including surveillance, risk-reducing surgery and doing nothing. Results: We found 30 studies in the review of clinical effectiveness, of which 20 were non-comparative (single-arm) studies. There were no high-quality studies providing precise outcome estimates at low risk of bias. There is some evidence that mortality rate is higher for surveillance than for risk-reducing surgery but mortality is also higher for no surveillance than for surveillance. Some asymptomatic cancers were detected through surveillance but some cancers were also missed. There was a wide range of pain experiences, including some individuals feeling no pain and some feeling severe pain. The use of pain relief (e.g. ibuprofen) was common, and some women underwent general anaesthetic for surveillance. Existing economic evaluations clearly found that risk-reducing surgery leads to the best lifetime health (measured using quality-adjusted life-years) and is cost-effective, while surveillance is not cost-effective in comparison. Our economic evaluation found that a strategy of surveillance alone or offering surveillance and risk-reducing surgery was cost-effective, except for path_PMS2 Lynch syndrome. Offering only risk-reducing surgery was less effective than offering surveillance with or without surgery. Limitations: Firm conclusions about clinical effectiveness could not be reached because of the lack of high-quality research. We did not assume that women would immediately take up risk-reducing surgery if offered, and it is possible that risk-reducing surgery would be more effective and cost-effective if it was taken up when offered. Conclusions: There is insufficient evidence to recommend for or against gynaecological cancer surveillance in Lynch syndrome on clinical grounds, but modelling suggests that surveillance could be cost-effective. Further research is needed but it must be rigorously designed and well reported to be of benefit. Study registration: This study is registered as PROSPERO CRD42020171098. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129713) and is published in full in Health Technology Assessment; Vol. 28, No. 41. See the NIHR Funding and Awards website for further award information.

Lynch syndrome is an inherited condition which puts people at a higher risk of getting bowel cancer, womb cancer and ovarian cancer. Although people with Lynch syndrome are more likely to get these cancers, they are more likely to survive cancer if they get it. People diagnosed with Lynch syndrome get regular testing (surveillance) using a camera to check for bowel cancer or polyps. For womb and ovarian cancer, surveillance may also be an option, but it is less well studied in these cancers. This means that many women are not offered surveillance. Women with Lynch syndrome are recommended to have risk-reducing surgery when their risk starts rising, if they do not want any more children. We wanted to find out whether surveillance for womb and ovarian cancer would work and would be good value for money. Doctors and patients have said that these are important research questions. We searched for published research on this subject and found a lot of studies, but these studies were often small or not well designed, so they could only tell us a limited amount. Studies did not always measure the things that patients want to know. There was some evidence that people having surveillance might live longer than people not having surveillance, but there was also some evidence that risk-reducing surgery is better than surveillance. Surveillance has detected some cancers which had no symptoms, but there are also cancers diagnosed soon after a surveillance visit where nothing was found. People often find surveillance painful, but experiences vary. Our work shows that surveillance and surgery could be good value for money for many women with Lynch syndrome. We need better research to help patients and doctors decide whether surveillance is right for them.

Patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review of patient reported outcomes and patient and clinician satisfaction.

BACKGROUND: The cost to the NHS of missed or inappropriate hospital appointments is considerable. Alternative methods of appointment scheduling might be more flexible to patients' needs without jeopardising health and service quality. The objective was to systematically review evidence of patient initiated clinics in secondary care on patient reported outcomes among patients with chronic/recurrent conditions. METHODS: Seven databases were searched from inception to June 2013. Hand searching of included studies references was also conducted. Studies comparing the effects of patient initiated clinics with traditional consultant led clinics in secondary care for patients with long term chronic or recurrent diseases on health related quality of life and/or patient satisfaction were included. Data was extracted by one reviewer and checked by a second. Results were synthesised narratively. RESULTS: Seven studies were included in the review, these covered a total of 1,655 participants across three conditions: breast cancer, inflammatory bowel disease and rheumatoid arthritis. Quality of reporting was variable. Results showed no significant differences between the intervention and control groups for psychological and health related quality of life outcomes indicating no evidence of harm. Some patients reported significantly more satisfaction using patient-initiated clinics than usual care (p < 0.001). CONCLUSIONS: The results show potential for patient initiated clinics to result in greater patient and clinician satisfaction. The patient-consultant relationship appeared to play an important part in patient satisfaction and should be considered an important area of future research as should the presence or absence of a guidebook to aid self-management. Patient initiated clinics fit the models of care suggested by policy makers and so further research into long term outcomes for patients and service use in this area of practice is both relevant and timely.

The patient voice: More than a tick box exercise?

BACKGROUND: Patient and public involvement (PPI) in healthcare professional education is important, yet publications often provide insufficient detail about the types of involvement patients undertake and the level of autonomy that they have. This study details the factors that promote or hinder PPI within a university healthcare professional education setting and the types of activities members conducted. METHODS: PPI activities were described and mapped against a framework for PPI in healthcare professional education. Semi-structured interviews with PPI group members explored the motivators, enablers and barriers that influence involvement. FINDINGS: The framework highlighted that the PPI group were involved in a range of activities, yet they received limited training for their role and were infrequently involved in planning the activities. When interviewed, PPI members did not consider that these factors were the important promoters or barriers to involvement, instead emphasising five themes: (1) their individual characteristics, (2) factors relating to the university organisation, (3) relationships between themselves, faculty and students, (4) time in their role and (5) evidence of their impact. DISCUSSION AND CONCLUSION: Supporting PPI members whilst working, rather than provision of formal training was considered most empowering for group members. This was mediated through having enough time in their role to develop supportive relationships with faculty, which in turn promoted self-confidence and increased autonomy. This should be considered when making PPI appointments. Small changes in processes during education planning can make it easier for PPI members to bring their own agenda forward and promote equity during education decision making.

Evaluation of variation in special educational needs provision and its impact on health and education using administrative records for England: umbrella protocol for a mixed-methods research programme.

INTRODUCTION: One-third of children in England have special educational needs (SEN) provision recorded during their school career. The proportion of children with SEN provision varies between schools and demographic groups, which may reflect variation in need, inequitable provision and/or systemic factors. There is scant evidence on whether SEN provision improves health and education outcomes. METHODS: The Health Outcomes of young People in Education (HOPE) research programme uses administrative data from the Education and Child Health Insights from Linked Data-ECHILD-which contains data from all state schools, and contacts with National Health Service hospitals in England, to explore variation in SEN provision and its impact on health and education outcomes. This umbrella protocol sets out analyses across four work packages (WP). WP1 defined a range of 'health phenotypes', that is health conditions expected to need SEN provision in primary school. Next, we describe health and education outcomes (WP1) and individual, school-level and area-level factors affecting variation in SEN provision across different phenotypes (WP2). WP3 assesses the impact of SEN provision on health and education outcomes for specific health phenotypes using a range of causal inference methods to account for confounding factors and possible selection bias. In WP4 we review local policies and synthesise findings from surveys, interviews and focus groups of service users and providers to understand factors associated with variation in and experiences of identification, assessment and provision for SEN. Triangulation of findings on outcomes, variation and impact of SEN provision for different health phenotypes in ECHILD, with experiences of SEN provision will inform interpretation of findings for policy, practice and families and methods for future evaluation. ETHICS AND DISSEMINATION: Research ethics committees have approved the use of the ECHILD database and, separately, the survey, interviews and focus groups of young people, parents and service providers. These stakeholders will contribute to the design, interpretation and communication of findings.

How common is patient and public involvement (PPI)? Cross-sectional analysis of frequency of PPI reporting in health research papers and associations with methods, funding sources and other factors.

OBJECTIVES: Patient and public involvement (PPI) in health research is required by some funders and publications but we know little about how common it is. In this study we estimated the frequency of PPI inclusion in health research papers and analysed how it varied in relation to research topics, methods, funding sources and geographical regions. DESIGN: Cross-sectional. METHODS: Our sample consisted of 3000 research papers published in 2020 in a general health-research journal (BMJ Open) that requires a statement on whether studies included PPI. We classified each paper as 'included PPI' or 'did not include PPI' and analysed the association of this classification with location (country or region of the world), methods used, research topic (journal section) and funding source. We used adjusted regression models to estimate incident rate ratios of PPI inclusion in relation to these differences. RESULTS: 618 (20.6%) of the papers in our sample included PPI. The proportion of papers including PPI varied in relation to location (from 44.5% (95% CI 40.8% to 48.5%) in papers from the UK to 3.4% (95% CI 1.5% to 5.3%) in papers from China), method (from 38.6% (95% CI 27.1% to 50.1%) of mixed-methods papers to 5.3% (95% CI -1.9% to 12.5%) of simulation papers), topic (from 36.9% (95% CI 29.1% to 44.7%) of papers on mental health to 3.4% (95% CI -1.3% to 8.2%) of papers on medical education and training, and funding source (from 57.2% (95% CI 51.8% to 62.6%) in papers that received funding from the UK's National Institute for Health Research to 3.4% (95% CI 0.7% to 6.0%) in papers that received funding from a Chinese state funder). CONCLUSIONS: Most research papers in our sample did not include PPI and PPI inclusion varied widely in relation to location, methods, topic and funding source.

Higher Arm Versus Lower Arm Systolic Blood Pressure and Cardiovascular Outcomes: a Meta-Analysis of Individual Participant Data From the INTERPRESS-IPD Collaboration.

BACKGROUND: Guidelines recommend measuring blood pressure (BP) in both arms, adopting the higher arm readings for diagnosis and management. Data to support this recommendation are lacking. We evaluated associations of higher and lower arm systolic BPs with diagnostic and treatment thresholds, and prognosis in hypertension, using data from the Inter-arm Blood Pressure Difference-Individual Participant Data Collaboration. METHODS: One-stage multivariable Cox regression models, stratified by study, were used to examine associations of higher or lower reading arm BPs with cardiovascular mortality, all-cause mortality, and cardiovascular events, in individual participant data meta-analyses pooled from 23 cohorts. Cardiovascular events were modelled for Framingham and atherosclerotic cardiovascular disease risk scores. Model fit was compared throughout using Akaike information criteria. Proportions reclassified across guideline recommended intervention thresholds were also compared. RESULTS: We analyzed 53 172 participants: mean age 60 years; 48% female. Higher arm BP, compared with lower arm, reclassified 12% of participants at either 130 or 140 mm Hg systolic BP thresholds (both P<0.001). Higher arm BP models fitted better for all-cause mortality, cardiovascular mortality, and cardiovascular events (all P<0.001). Higher arm BP models better predicted cardiovascular events with Framingham and atherosclerotic cardiovascular disease risk scores (both P<0.001) and reclassified 4.6% and 3.5% of participants respectively to higher risk categories compared with lower arm BPs). CONCLUSIONS: Using BP from higher instead of lower reading arms reclassified 12% of people over thresholds used to diagnose hypertension. All prediction models performed better when using the higher arm BP. Both arms should be measured for accurate diagnosis and management of hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: CRD42015031227.

Cupping for treating pain: a systematic review.

The objective of this study was to assess the evidence for or against the effectiveness of cupping as a treatment option for pain. Fourteen databases were searched. Randomized clinical trials (RCTs) testing cupping in patients with pain of any origin were considered. Trials using cupping with or without drawing blood were included, while trials comparing cupping with other treatments of unproven efficacy were excluded. Trials with cupping as concomitant treatment together with other treatments of unproven efficacy were excluded. Trials were also excluded if pain was not a central symptom of the condition. The selection of studies, data extraction and validation were performed independently by three reviewers. Seven RCTs met all the inclusion criteria. Two RCTs suggested significant pain reduction for cupping in low back pain compared with usual care (P < .01) and analgesia (P < .001). Another two RCTs also showed positive effects of cupping in cancer pain (P < .05) and trigeminal neuralgia (P < .01) compared with anticancer drugs and analgesics, respectively. Two RCTs reported favorable effects of cupping on pain in brachialgia compared with usual care (P = .03) or heat pad (P < .001). The other RCT failed to show superior effects of cupping on pain in herpes zoster compared with anti-viral medication (P = .065). Currently there are few RCTs testing the effectiveness of cupping in the management of pain. Most of the existing trials are of poor quality. Therefore, more rigorous studies are required before the effectiveness of cupping for the treatment of pain can be determined.

Involving Patients in Health Economics Research: "The PACTS Principles".

Discussion of public and patient involvement (PPI) in health economics (HE) research is growing. There is much literature on PPI principles and standards, but little specifically regarding involving patients in HE research. Here, we outline "PACTS", a set of principles, developed with a PPI group, for considering patient involvement in HE research. Planning: Involvement is best built in to research plans from the outset. This includes setting specific goals for involvement activities, and clearly communicating the background and purpose of involvement. Approach selection: We describe two main approaches to involvement-discussion-based and task-based. Discussion-based approaches are useful for generating broad insights and revealing "unknown unknowns". Task-based approaches offer a more focused means of shedding light on "known unknowns". Continuous involvement: Involving patients throughout the research process and across a range of projects helps build expertise for patients and insight for HE researchers. Team building: Meaningful involvement creates a shared sense of ownership of the research and, over time, helps to develop a team ethos, enhancing the positive impacts of involvement. Sensitivity: HE research can be perceived as technical and impersonal. Addressing this requires sensitivity, clarity, and an honest and open approach. There is increased recognition that patient contributors are experts at providing a "lived experience" perspective, in the way that clinicians are experts at providing an overview of conditions and HEs are experts in the methodology of their discipline. We hope these "PACTS Principles" complement existing PPI approaches and provide a useful foundation for health economists considering patient involvement.

Moving through Motherhood: Involving the Public in Research to Inform Physical Activity Promotion throughout Pregnancy and Beyond.

Information received by women regarding physical activity during and after pregnancy often lacks clarity and may be conflicting and confusing. Without clear, engaging, accessible guidance centred on the experiences of pregnancy and parenting, the benefits of physical activity can be lost. We describe a collaborative process to inform the design of evidence-based, user-centred physical activity resources which reflect diverse experiences of pregnancy and early parenthood. Two iterative, collaborative phases involving patient and public involvement (PPI) workshops, a scoping survey (n = 553) and stakeholder events engaged women and maternity, policy and physical activity stakeholders to inform pilot resource development. These activities shaped understanding of challenges experienced by maternity and physical activity service providers, pregnant women and new mothers in relation to supporting physical activity. Working collaboratively with women and stakeholders, we co-designed pilot resources and identified important considerations for future resource development. Outcomes and lessons learned from this process will inform further work to support physical activity during pregnancy and beyond, but also wider health research where such collaborative approaches are important. We hope that drawing on our experiences and sharing outcomes from this work provide useful information for researchers, healthcare professionals, policy makers and those involved in supporting physical activity behaviour.

Arm Based on LEg blood pressures (ABLE-BP): can systolic leg blood pressure measurements predict systolic brachial blood pressure? Protocol for an individual participant data meta-analysis from the INTERPRESS-IPD Collaboration.

INTRODUCTION: Blood pressure (BP) is normally measured on the upper arm, and guidelines for the diagnosis and treatment of high BP are based on such measurements. Leg BP measurement can be an alternative when brachial BP measurement is impractical, due to injury or disability. Limited data exist to guide interpretation of leg BP values for hypertension management; study-level systematic review findings suggest that systolic BP (SBP) is 17 mm Hg higher in the leg than the arm. However, uncertainty remains about the applicability of this figure in clinical practice due to substantial heterogeneity. AIMS: To examine the relationship between arm and leg SBP, develop and validate a multivariable model predicting arm SBP from leg SBP and investigate the prognostic association between leg SBP and cardiovascular disease and mortality. METHODS AND ANALYSIS: Individual participant data (IPD) meta-analyses using arm and leg SBP measurements for 33 710 individuals from 14 studies within the Inter-arm blood pressure difference IPD (INTERPRESS-IPD) Collaboration. We will explore cross-sectional relationships between arm and leg SBP using hierarchical linear regression with participants nested by study, in multivariable models. Prognostic models will be derived for all-cause and cardiovascular mortality and cardiovascular events. ETHICS AND DISSEMINATION: Data originate from studies with prior ethical approval and consent, and data sharing agreements are in place-no further approvals are required to undertake the secondary analyses proposed in this protocol. Findings will be published in peer-reviewed journal articles and presented at conferences. A comprehensive dissemination strategy is in place, integrated with patient and public involvement. PROSPERO REGISTRATION NUMBER: CRD42015031227.

Associations Between Systolic Interarm Differences in Blood Pressure and Cardiovascular Disease Outcomes and Mortality: Individual Participant Data Meta-Analysis, Development and Validation of a Prognostic Algorithm: The INTERPRESS-IPD Collaboration.

Systolic interarm differences in blood pressure have been associated with all-cause mortality and cardiovascular disease. We undertook individual participant data meta-analyses to (1) quantify independent associations of systolic interarm difference with mortality and cardiovascular events; (2) develop and validate prognostic models incorporating interarm difference, and (3) determine whether interarm difference remains associated with risk after adjustment for common cardiovascular risk scores. We searched for studies recording bilateral blood pressure and outcomes, established agreements with collaborating authors, and created a single international dataset: the Inter-arm Blood Pressure Difference - Individual Participant Data (INTERPRESS-IPD) Collaboration. Data were merged from 24 studies (53 827 participants). Systolic interarm difference was associated with all-cause and cardiovascular mortality: continuous hazard ratios 1.05 (95% CI, 1.02-1.08) and 1.06 (95% CI, 1.02-1.11), respectively, per 5 mm Hg systolic interarm difference. Hazard ratios for all-cause mortality increased with interarm difference magnitude from a ≥5 mm Hg threshold (hazard ratio, 1.07 [95% CI, 1.01-1.14]). Systolic interarm differences per 5 mm Hg were associated with cardiovascular events in people without preexisting disease, after adjustment for Atherosclerotic Cardiovascular Disease (hazard ratio, 1.04 [95% CI, 1.00-1.08]), Framingham (hazard ratio, 1.04 [95% CI, 1.01-1.08]), or QRISK cardiovascular disease risk algorithm version 2 (QRISK2) (hazard ratio, 1.12 [95% CI, 1.06-1.18]) cardiovascular risk scores. Our findings confirm that systolic interarm difference is associated with increased all-cause mortality, cardiovascular mortality, and cardiovascular events. Blood pressure should be measured in both arms during cardiovascular assessment. A systolic interarm difference of 10 mm Hg is proposed as the upper limit of normal. Registration: URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42015031227.

Public involvement in health research: what does 'good' look like in practice?

PLAIN ENGLISH SUMMARY: Background Patient and public involvement means researchers working with members of the public, patients or carers to jointly plan and carry out research.Aim This article is written by members of three involvement groups, and the university employees that they work with. We wanted to jointly reflect on what enables our collaborative work, and what the challenges are for everyone involved.What we did and how we did it We wanted to establish what the literature defines as 'good' public involvement and compare this with processes and practices in our involvement groups. We therefore carried out a literature review and each group met separately to discuss what characterises good involvement, and what the challenges are. From these discussions we developed a set of descriptions about each group. We compared the literature review findings with what came out of the discussions within the involvement groups.Findings Some of the involvement principles from the literature were similar to the priorities of the involvement groups. In addition, the groups identified characteristics of 'good' involvement practice that were not reported in the literature: passion and enthusiasm, informal and welcoming meeting spaces, and opportunities to share lived experiences. In this article we present examples of how principles for good involvement are practiced in these groups, and difficulties we have experienced. ABSTRACT: Background Patient and public involvement is important for producing relevant and accessible health research. Evidence of impact from involvement is growing, but there is also a need for research on how to create conditions for meaningful collaborations between researchers and public advisers.Objective We report on a co-produced self-reflective evaluation of involvement practices in three UK research programmes.Methods A structured review identified research-based principles for 'good' public involvement in research. In parallel, members of three involvement groups co-developed statements on how the groups work, and enablers and challenges to collaborative research. The author team analysed these statements using the findings from the review.Results We identified 11 international articles reporting research-based principles for involvement published between 2013 and 2017. We identified five 'values' and seven 'practice principles' for 'good' involvement. There was convergence between these principles and the priorities of the involvement groups. But the groups also identified additional good involvement practice that were not reported by the literature: passion, enthusiasm, informal and welcoming meeting spaces, and opportunities to share lived experiences. We present examples of how principles for good involvement are practiced in these groups, and highlight principles that have been challenging to implement.Conclusions Ongoing appraisal of public involvement is crucial. We present a process for self-evaluation, illuminate what 'good' means to researchers and public advisers involved in research, and identify areas for improvement. We conclude that provision of resources that enable support to public advisers in turn enable universities and research teams to implement other principles of good involvement.

"Are you doing your pelvic floor?" An ethnographic exploration of the interaction between women and midwives about pelvic floor muscle exercises (PFME) during pregnancy.

OBJECTIVE: Many women experience urinary incontinence (UI) during and after pregnancy. Pelvic floor muscle exercises (PFME) can prevent and reduce the symptoms of UI. The objective of the study was to explore challenges, opportunities and concerns for women and health care professionals (HCPs), related to the implementation of PFME training for women in current antenatal care. DESIGN: An ethnographic study design was used. Researchers also formed and collaborated with a public advisory group, consisting of seven women with recent experiences of pregnancy, throughout the study. PARTICIPANTS: Seventeen midwife-woman interactions were observed in antenatal clinics. In addition, 23 midwives and 15 pregnant women were interviewed. Repeat interviews were carried out with 12 of the women postnatally. Interviews were also carried out with other HCPs; four physiotherapists, a linkworker/translator and two consultant obstetricians. Additional data sources included field notes, photographs, leaflets, policy and other relevant documents. SETTING: Data were collected in three geographical areas of the UK spanning rural, urban and suburban areas. Data collection took place in antenatal clinics, in primary and secondary care settings, and the majority of women were interviewed in their homes. FINDINGS: Three broad and inter-related themes of "ideological commitment", "confidence" and "assumptions, stigma and normalisation" were identified. The challenges, opportunities and concerns regarding PFME implementation were explored within these themes. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Although HCPs and some women knew that PFME were important, they were not prioritised and the significant benefits of doing PFME may not have been communicated by midwives or recognised by women. There was a lack of confidence amongst midwives to teach PFME and manage UI within the antenatal care pathway and amongst women to ask about PFME or UI. A perceived lack of consistent guidelines and policy at local and national levels may have impeded clear communication and prioritisation of PFME. Furthermore, assumptions made by both women and midwives, for example, women regarding UI as a normal outcome of pregnancy, or midwives' perception that certain women were more likely to do PFME, may have exacerbated this situation. Training for midwives to help women in the antenatal period to engage in PFME could address challenges and concerns and to help prevent opportunities for women to learn about PFME from being missed.

Review of reliable information sources related to integrative oncology.

Health care professionals, patients, and care givers require access to good quality, reliable information about integrative oncology. Despite the vast resources available, it can be difficult to find objective, evidence-based information. This article provides an overview of reliable integrative oncology information from various resources. Selection methods are detailed and evaluation performed using a validated instrument. Resources that met the selection criteria and produced high evaluation scores are reviewed in detail. Resources include research databases, clinical databases, online information systems, and print media.

Involving Members of the Public in Health Economics Research: Insights from Selecting Health States for Valuation to Estimate Quality-Adjusted Life-Year (QALY) Weights.

Over recent years, public involvement in health research has expanded considerably. However, public involvement in designing and conducting health economics research is seldom reported. Here we describe the development, delivery and assessment of an approach for involving people in a clearly defined piece of health economics research: selecting health states for valuation in estimating quality-adjusted life-years (QALYs). This involvement formed part of a study to develop a condition-specific preference-based measure of health-related quality of life, the Multiple Sclerosis Impact Scale (MSIS-8D), and the work reported here relates to the identification of plausible, or realistic, health states for valuation. An Expert Panel of three people with multiple sclerosis (MS) was recruited from a local involvement network, and two health economists designed an interactive task that enabled the Panel to identify health states that were implausible, or unlikely to be experienced. Following some initial confusion over terminology, which was resolved by discussion with the Panel, the task worked well and can be adapted to select health states for valuation in the development of any preference-based measure. As part of the involvement process, five themes were identified by the Panel members and the researchers which summarised our experiences of public involvement in this health economics research example: proportionality, task design, prior involvement, protectiveness and partnerships. These are described in the paper, along with their practical implications for involving members of the public in health economics research. Our experience demonstrates how members of the public and health economists can work together to improve the validity of health economics research. Plain Language Summary It has become commonplace to involve members of the public in health service research. However, published reports of involving people in designing health economics research are rare. We describe how we designed a way of involving people in a particular piece of health economics research.The aim of the work was to produce descriptions of different states of health experienced by people with multiple sclerosis (MS). These descriptions have since been rated in terms of how good or bad they are in a way that can be used by the National Institute for Health and Care Excellence (NICE) to make decisions about what services to fund on the NHS.We formed a panel of three people with MS, and designed a task to help the group produce health descriptions likely to be experienced by people with MS. After discussion about jargon, and working together to find more layman's terms, the task worked well, and can be adapted to produce health descriptions for any condition.We identified some key themes about working together that give insights into how members of the public can be involved in health economics research, and show the importance of their involvement in improving the relevance of this research.