Patient and relative experiences of the ReSPECT process in the community: an interview-based study.

BACKGROUND: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) was launched in the UK in 2016. ReSPECT is designed to facilitate meaningful discussions between healthcare professionals, patients, and their relatives about preferences for treatment in future emergencies; however, no study has investigated patients' and relatives' experiences of ReSPECT in the community. OBJECTIVES: To explore how patients and relatives in community settings experience the ReSPECT process and engage with the completed form. METHODS: Patients who had a ReSPECT form were identified through general practice surgeries in three areas in England; either patients or their relatives (where patients lacked capacity) were recruited. Semi-structured interviews were conducted, focusing on the participants' understandings and experiences of the ReSPECT process and form. Data were analysed using inductive thematic analysis. RESULTS: Thirteen interviews took place (six with patients, four with relatives, three with patient and relative pairs). Four themes were developed: (1) ReSPECT records a patient's wishes, but is entangled in wider relationships; (2) healthcare professionals' framings of ReSPECT influence patients' and relatives' experiences; (3) patients and relatives perceive ReSPECT as a do-not-resuscitate or end-of-life form; (4) patients' and relatives' relationships with the ReSPECT form as a material object vary widely. Patients valued the opportunity to express their wishes and conceptualised ReSPECT as a process of caring for themselves and for their family members' emotional wellbeing. Participants who described their ReSPECT experiences positively said healthcare professionals clearly explained the ReSPECT process and form, allocated sufficient time for an open discussion of patients' preferences, and provided empathetic explanations of treatment recommendations. In cases where participants said healthcare professionals did not provide clear explanations or did not engage them in a conversation, experiences ranged from confusion about the form and how it would be used to lingering feelings of worry, upset, or being burdened with responsibility. CONCLUSIONS: When ReSPECT conversations involved an open discussion of patients' preferences, clear information about the ReSPECT process, and empathetic explanations of treatment recommendations, working with a healthcare professional to co-develop a record of treatment preferences and recommendations could be an empowering experience, providing patients and relatives with peace of mind.

Mobilisation towards formal employment in the healthcare system: A qualitative study of community health workers in South Africa.

In low and middle-income countries, community health workers (CHWs) play a critical role in delivering primary healthcare (PHC) services. However, they often receive low stipends, function without resources and have little bargaining power with which to demand better working conditions. Using a qualitative case study methodology, we studied CHWs' conditions of employment, their struggle for recognition as health workers, and their activities to establish labour representation in South Africa. Seven CHW teams located in semi-urban and rural areas of Gauteng and Mpumalanga Provinces were studied. We conducted 43 in-depth interviews, 10 focus groups and 6 observations to gather data from CHWs and their representatives, supervisors and PHC facility staff. The data was analysed using thematic analysis method. In the rural and semi-urban sites, the CHWs were poorly resourced and received meagre remuneration, their employment outsourced, without employment benefits and protection. As a result of these challenges, the CHWs in the semi-urban sites established a task team to represent them. They held meetings and caused disruptions in the health facilities. After numerous unsuccessful attempts to negotiate for improved conditions of employment, the CHWs joined a labour union in order to participate in the local Bargaining Council. Though they were not successful in getting the government to provide permanent employment, the union negotiated an increase in their stipend. After the study ended, during the height of COVID-19 in 2020, when the need for motivated and effective CHWs became more apparent to decision makers, the semi-urban-based teams received permanent employment with a better remuneration. The task team and their protests raised awareness of the plight of the CHWs, and joining a formal union enabled them to negotiate a modest salary increase. However, it was the emergency created by the world-wide COVID-19 pandemic that forced decision-makers to acknowledge their reliance on this community-based cadre.

GPs' views on emergency care treatment plans: an online survey.

BACKGROUND: A holistic approach to emergency care treatment planning is needed to ensure that patients' preferences are considered should their clinical condition deteriorate. To address this, emergency care and treatment plans (ECTPs) have been introduced. Little is known about their use in general practice. AIM: To find out GPs' experiences of, and views on, using ECTPs. DESIGN & SETTING: Online survey of GPs practising in England. METHOD: A total of 841 GPs were surveyed using the monthly online survey provided by medeConnect, a market research company. RESULTS: Forty-one per cent of responders' practices used Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) plans for ECTP, 8% used other ECTPs, and 51% used Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) forms. GPs were the predominant professional group completing ECTPs in the community. There was broad support for a wider range of community-based health and social care professionals being able to complete ECTPs. There was no system for reviewing ECTPs in 20% of responders' practices. When compared with using a DNACPR form, GPs using a ReSPECT form for ECTP were more comfortable having conversations about emergency care treatment with patients (odds ratio [OR] = 1.72, 95% confidence interval [CI] = 1.1 to 2.69) and family members (OR =1.85, 95% CI = 1.19 to 2.87). CONCLUSION: The potential benefits and challenges of widening the pool of health and social care professionals initiating and/or completing the ECTP process needs consideration. ReSPECT plans appear to make GPs more comfortable with ECTP discussions, supporting their implementation. Practice-based systems for reviewing ECTP decisions should be strengthened.

International short-term placements in health professions education-A meta-narrative review.

INTRODUCTION: In order to be prepared for professional practice in a globalised world, health professions students need to be equipped with a new set of knowledge, skills and attitudes. Experiential learning gained during an international placement has been considered as a powerful strategy for facilitating the acquisition of global health competencies. The aim of this review was to synthesise the diverse body of empirical research examining the process and outcomes of international short-term placements in health professions education. METHODS: A systematic review was conducted using a meta-narrative methodology. Six electronic databases were searched between September 2016 and June 2022: Medline, Embase, CINAHL, PsycINFO, Education Research Complete and Web of Knowledge. Studies were included if they reported on international placements undertaken by undergraduate health professions students in socio-economically contrasting settings. Included studies were first considered within their research tradition before comparing and contrasting findings between different research traditions. RESULTS: This review included 243 papers from 12 research traditions, which were distinguished by health profession and paradigmatic approach. Empirical findings were considered in four broad themes: learner, educational intervention, institutional context and wider context. Most studies provided evidence on the learner, with findings indicating a positive impact of international placements on personal and professional development. The development of cultural competency has been more focus in research in nursing and allied health than in medicine. Whereas earlier research has focussed on the experience and outcomes for the learner, more recent studies have become more concerned with relationships between various stakeholder groups. Only few studies have looked at strategies to enhance the educational process. CONCLUSION: The consideration of empirical work from different perspectives provides novel understandings of what research has achieved and what needs further investigation. Future studies should pay more attention to the complex nature of the educational process in international placements.

Preferences for onward health data use in the electronic age among maternity patients and providers in South Africa: a qualitative study.

Despite the expanding digitisation of individual health data, informed consent for the collection and use of health data is seldom explicitly sought in public sector clinics in South Africa. This study aims to identify perceptions of informed consent practices for health data capture, access, and use in Gauteng and the Western Cape provinces of South Africa. Data collection from September to December 2021 included in-depth interviews with healthcare providers (n = 12) and women (n = 62) attending maternity services. Study findings suggest that most patients were not aware that their data were being used for purposes beyond the individualised provision of medical care. Understanding the concept of anonymised use of electronic health data was at times challenging for patients who understood their data in the limited context of paper-based folders and booklets. When asked about preferences for electronic data, patients overwhelmingly were in favour of digitisation. They viewed electronic access to their health data as facilitating rapid and continuous access to health information. Patients were additionally asked about preferences, including delivery of health information, onward health data use, and recontacting. Understanding of these use cases varied and was often challenging to convey to participants who understood their health data in the context of information inputted into their paper folders. Future systems need to be established to collect informed consent for onward health data use. In light of perceived ties to the care received, these systems need to ensure that patient preferences do not impede the content nor quality of care received.

An evaluation protocol of 'Replicability Model' project for detection and treatment of leprosy and related disability in Chhattisgarh, India.

INTRODUCTION: People affected by leprosy are at increased risk of impairments and deformities from peripheral nerve damage. This mostly occurs if diagnosis and treatment is delayed and contributes to continued transmission within the community. Champa district of Chhattisgarh state in India is an endemic area with the highest national annual case detection and disability rates for leprosy. The Replicability Model is a system strengthening intervention implemented by the Leprosy Mission Trust India in Champa that aims to promote early diagnosis and treatment of leprosy, improve on-going management of the effects of leprosy and improve welfare for the people affected by leprosy. This protocol presents a plan to describe the overall implementation of the Replicability Model and describe the barriers and facilitators encountered in the process. We will also quantify the effect of the program on one of its key aims- early leprosy diagnosis. METHODS: The replicability model will be implemented over four years, and the work described in this protocol will be conducted in the same timeframe. We have two Work Packages (WPs). In WP1, we will conduct a process evaluation. This will include three methods i) observations of replicability model implementation teams' monthly meetings ii) key informant interviews (n = 10) and interviews with stakeholders (n = 30) iii) observations of key actors (n = 15). Our purpose is to describe the implementation process and identify barriers and facilitators to successful implementation. WP2 will be a quantitative study to track existing and new cases of leprosy using routinely collected data. If the intervention is successful, we expect to see an increase in cases (with a higher proportion detected at an early clinical stage) followed by a decrease in total cases. CONCLUSION: This study will enable us to improve and disseminate the Replicability Model by identifying factors that promote success. It will also identify its effectiveness in fulfilling one of its aims: reducing the incidence of leprosy by finding and tracking cases at an earlier stage in the disease.

Safety and upscaling of remote consulting for long-term conditions in primary health care in Nigeria and Tanzania (REaCH trials): stepped-wedge trials of training, mobile data allowance, and implementation.

BACKGROUND: In-person health care poses risks to health workers and patients during pandemics. Remote consultations can mitigate these risks. The REaCH intervention comprised training and mobile data allowance provision for mobile phones to support remotely delivered primary care in Africa compared with no training and mobile data allowance. The aim of this study was to estimate the effects of REaCH among adults with non-communicable diseases on remote and face-to-face consultation rates, patient safety, and trustworthiness of consultations. METHODS: In these two independent stepped-wedge cluster randomised controlled trials, we enrolled 20 primary care clusters in each of two settings (Oyo State, Nigeria, and Morogoro Region, Tanzania). Eligible clusters had 100 or more patients with diabetes, hypertension, and cardiovascular or pulmonary disease employing five health workers. Clusters were computer-randomised to one of ten (Nigeria) or one of seven (Tanzania) sequences to receive the REaCH intervention. Only outcome assessors were masked. Primary outcomes were consultation, prescription, and investigation rates, and trustworthiness collected monthly for 12 months (Nigeria) and 9 months (Tanzania) from open cohorts. Ten randomly sampled consulting patients per cluster-month completed patient reported outcome measures. This trial was registered with ISRCTN, ISRCTN17941313. FINDINGS: Overall, 40 clusters comprising 8776 (Nigeria) and 3246 (Tanzania) patients' open cohort data were analysed (6377 [72·7%] of 8776 females in Nigeria, and 2235 [68·9%] of 3246 females in Tanzania). The mean age of the participants was 55·3 years (SD 13·9) in Nigeria and 59·2 years (14·2) in Tanzania. In Nigeria, no evidence of change in face-to-face consulting rate was observed (rate ratio [RR] 1·06, 95% CI 0·98 to 1·09; p=0·16); however, remote consultations increased four-fold (4·44, 1·34 to >10; p=0·01). In Tanzania, face-to-face (0·94, 0·61 to 1·67; p=0·99) and remote consulting rates (1·17, 0·56 to 5·57; p=0·39) were unchanged. There was no evidence of difference in prescribing rates (Nigeria: 1·05, 0·60 to 1·14; p=0·23; Tanzania: 0·92, 0·60 to 1·67; p=0·97), investigation rates (Nigeria: 1·06, 0·23 to 2·12; p=0·49; Tanzania: 1·15, 0·35 to 1·64; 0·58) or trustworthiness scores (Nigeria: mean difference 0·05, 95% CI -0·45 to 0·42; p=0·89; Tanzania: 0·07, -0·15 to 0·76; p=0·70). INTERPRETATION: REaCH can be implemented and could improve intervention versus control health-care access. Remote consultations appear safe and trustworthy, supporting universal health coverage. FUNDING: The UK Research and Innovation Collective Fund. TRANSLATIONS: For the Swahili and Yoruba translations of the abstract see Supplementary Materials section.

Exploring the barriers and facilitators to implementing electronic health records in a middle-income country: a qualitative study from South Africa.

Introduction: As more countries are moving towards universal health care, middle-income countries in particular are trying to expand coverage, often using public funds. Electronic health records (EHR) are useful in monitoring patient outcomes, the performance of providers, and so the use of those public funds. With the multiple institutions or departments responsible for providing care to any individual, rather than a single record, an EHR is the interface through which to view data from a digital health information eco-system that draws on data from many different sources. South Africa plans to establish a National Health Insurance fund where EHRs will be essential for monitoring outcomes, and informing purchasing decisions. Despite various relevant policies and South Africa's relative wealth and digital capability, progress has been slow. In this paper, we explore the barriers and facilitators to implementing electronic health records in South Africa. Methods: In this qualitative study, we conducted in-depth interviews with participants including academics, staff at parastatals, managers in the private health sector, NGO managers and government staff at various levels. Results: The Western Cape provincial government over a 20-year period has managed to develop a digital health information ecosystem by drawing together existing data systems and building new systems. However, despite having the necessary policies in place and a number of stand-alone population level digital health information systems, several barriers still stand in the way of building national electronic health records and an efficient digital health ecosystem. These include a lack of national leadership and conflict, a failure to understand the scope of the task required to achieve scale up, insufficient numbers of technically skilled staff, failure to use the tender system to generate positive outcomes, and insufficient investment towards infrastructural needs such as hardware, software and connectivity. Conclusion: For South Africa to have an effective electronic health record, it is important to start by overcoming the barriers to interoperability, and to develop the necessary underlying digital health ecosystem. Like the Western Cape, provincial governments need to integrate and build on existing systems as their next steps forward.

Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial.

BACKGROUND: Bacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent bacterial vaginosis. METHODS: We undertook an open-label, multicentre, parallel group, randomised controlled trial in nineteen UK sexual health clinics and a university health centre. Women aged ≥ 16 years, with current bacterial vaginosis symptoms and a preceding history of bacterial vaginosis, were randomised in a 1:1 ratio using a web-based minimisation algorithm, to 400 mg twice daily oral metronidazole tablets or 5 ml once daily intravaginal lactic acid gel, for 7 days. Masking of participants was not possible. The primary outcome was participant-reported resolution of symptoms within 2 weeks. Secondary outcomes included time to first recurrence of symptoms, number of recurrences and repeat treatments over 6 months and side effects. RESULTS: Five hundred and eighteen participants were randomised before the trial was advised to stop recruiting by the Data Monitoring Committee. Primary outcome data were available for 79% (204/259) allocated to metronidazole and 79% (205/259) allocated to lactic acid gel. Resolution of bacterial vaginosis symptoms within 2 weeks was reported in 70% (143/204) receiving metronidazole versus 47% (97/205) receiving lactic acid gel (adjusted risk difference -23·2%; 95% confidence interval -32.3 to -14·0%). In those participants who had initial resolution and for whom 6 month data were available, 51 of 72 (71%) women in the metronidazole group and 32 of 46 women (70%) in the lactic acid gel group had recurrence of symptoms, with median times to first recurrence of 92 and 126 days, respectively. Reported side effects were more common following metronidazole than lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively). CONCLUSIONS: Metronidazole was more effective than lactic acid gel for short-term resolution of bacterial vaginosis symptoms, but recurrence is common following both treatments. Lactic acid gel was associated with fewer reported side effects. TRIAL REGISTRATION: ISRCTN14161293 , prospectively registered on 18th September 2017.

Use, characteristics and influence of lay consultation networks on treatment-seeking decisions in slums of Nigeria: a cross-sectional survey.

OBJECTIVES: To describe the use, characteristics and influence of lay consultants on treatment-seeking decisions of adults in slums of Nigeria. DESIGN: Cross-sectional survey using a pre-piloted questionnaire. SETTINGS: Two slum communities in Ibadan city, Nigeria. PARTICIPANTS: 480 adults within the working age group (18-64). RESULTS: Most respondents (400/480, 83.7%) spoke to at least one lay consultant during their last illness/health concern. In total, 683 lay consultants were contacted; all from personal networks such as family and friends. No respondent listed online network members or platforms. About nine in 10 persons spoke to a lay consultant about an illness/health concern without intending to seek any particular support. However, almost all (680/683, 97%) lay consultants who were contacted provided some form of support. Marital status (OR=1.92, 95% CI: 1.10 to 3.33) and perceiving that an illness or health concern had some effects on their daily activities (OR=3.25, 95% CI: 1.94 to 5.46) had a significant independent association with speaking to at least one lay consultant. Age had a significant independent association with having lay consultation networks comprising non-family members only (OR=0.95, 95% CI: 0.92 to 0.99) or mixed networks (family and non-family members) (OR=0.97, 95% CI: 0.95 to 0.99), rather than family-only networks. Network characteristics influenced individual treatment decisions as participants who contacted networks comprising non-family members only (OR=0.23, 95% CI: 0.08 to 0.67) and dispersed networks (combination of household, neighbourhood and distant network members) (OR=2.04, 95% CI: 1.02 to 4.09) were significantly more likely to use informal than formal healthcare, while controlling for individual characteristics. CONCLUSIONS: Health programmes in urban slums should consider engaging community members so, when consulted within their networks, they are able to deliver reliable information about health and treatment-seeking.

Investigating the sustainability of self-help programmes in the context of leprosy and the work of leprosy missions in Nigeria, Nepal and India: a qualitative study protocol.

INTRODUCTION: Leprosy occurs among very poor people who may be stigmatised and pushed further to the margins of society. Programmes to improve social integration and stimulate economic development have been implemented to help break the vicious cycle of poverty, reduced quality of life and ulcer recurrence. These involve forming groups of people, with a common concern, to provide mutual support and form saving syndicates-hence the term 'self-help groups' (SHGs). While there is literature on the existence and effectiveness of SHGs during the funded periods, little is known about their sustainability. We aim to explore the extent to which SHG programme activities have continued beyond the funding period and record evidence of sustained benefits. METHODS AND ANALYSIS: In India, Nepal and Nigeria, we identified programmes funded by international non-governmental organisations, primarily aimed at people affected by leprosy. In each case, financial and technical support was allocated for a predetermined period (up to 5 years).We will review documents, including project reports and meeting minutes, and conduct semistructured interviews with people involved in delivery of the SHG programme, potential beneficiaries and people in the wider environment who may have been familiar with the programme. These interviews will gauge participant and community perceptions of the programmes and barriers and facilitators to sustainability. Data will be analysed thematically and compared across four study sites. ETHICS AND DISSEMINATION: Approval was obtained from the University of Birmingham Biomedical and Scientific Research Ethics Committee. Local approval was obtained from: The Leprosy Mission Trust India Ethics Committee; Federal Capital Territory Health Research Ethics Committee in Nigeria and the Health Research Ethics Committee of Niger State Ministry of Health; University of Nigeria Teaching Hospital and the Nepal Health and Research Council. Results will be disseminated via peer-reviewed journals, conference presentations and community engagement events through the leprosy missions.

Community-orientated primary health care: Exploring the interface between community health worker programmes, the health system and communities in South Africa.

Due to insufficient number of health workers and the evidence of the benefits of community health workers (CHWs), CHWs are being deployed to provide health care services to under-served communities. In this article, we explore to what extent the South African CHW programmes introduced between 2009 and 2011 are attuned to community needs, integrated into the healthcare system and community structures, and also implemented in accordance with community-orientated primary health care principles. Using a case study approach, we studied CHW teams in seven primary healthcare facilities located in semi-urban and rural areas of Gauteng and Mpumalanga provinces, South Africa. We collected data using in-depth interviews involving facility managers, CHW supervisors, community representatives and key informants, and focus groups and observations of CHWs. The implementation of community-orientated health interventions remains complex. In the different sites, there were efforts to integrate the views of stakeholders (e.g., political leaders) into the implementation of the CHW programmes. However, many residents were more concerned about access to housing than health services. The CHWs services' were found to be generally comprehensive, however inefficient training, supervision and mentorship limited their effectiveness. The multidisciplinary approach to care, as introduced by some sites, helped enhance the knowledge and skills of some of the CHWs on complex health topics. The roll out of community orientated primary health care services is crucial in a resource-constrained setting like South Africa. However, significant socio-economic issues disrupt community involvement and the effective provision of services. Governments need to provide sufficient funds for training, supervision, supplies and remuneration to help overcome these barriers.

The effect of a roving nurse mentor on household coverage and quality of care provided by community health worker teams in South Africa: a longitudinal study with a before, after and 6 months post design.

OBJECTIVE: Community health workers (CHW) are undertaking more complex tasks as part of the move towards universal health coverage in many low- and middle-income settings. They are expected to provide promotive and preventative care, make referrals to the local clinic, and follow up on non-attendees for a range of health conditions. CHW programmes can improve access to care for vulnerable communities, but many such programmes struggle due to inadequate supervision, low levels of CHW literacy, and the marginalized status of CHW in the health system. In this paper, we assess the effect of a roving nurse mentor on the coverage and quality of care of the CHW service in two vulnerable communities in South Africa. PARTICIPANTS: CHW, their supervisors, household members. INTERVENTION: Roving professional nurse mentor to build skills of supervisors and CHW teams. METHODS: Three household surveys to assess household coverage of the CHW service (baseline, end of the intervention, and 6 months after end of intervention); structured observations of CHW working in households to assess quality of care. RESULTS: The intervention led to a sustained 50% increase in the number of households visited by a CHW in the last year. While the proportion of appropriate health messages given to household members by CHW remained constant at approximately 50%, CHW performed a greater range of more complex tasks. They were more likely to visit new households to assess health needs and register the household in the programme, to provide care to pregnant women, children and people who had withdrawn from care. CHW were more likely to discuss with clients the barriers they were facing in accessing care and take notes during a visit. CONCLUSION: A nurse mentor can have a significant effect both on the quantity and quality of CHW work, allowing them to achieve their potential despite their marginalised status in the health system and their limited prior educational achievement. Supportive supervision is important in enabling the benefit of having a health cadre embedded in marginalised communities to be realised.

Chronic Headache Education and Self-Management Study (CHESS): a process evaluation.

BACKGROUND: The Chronic Headache Education and Self-Management Study (CHESS) multicentre randomised trial evaluated the impact a group education and self-management support intervention with a best usual care plus relaxation control for people living with chronic headache disorders (tension type headaches or chronic migraine, with or without medication overuse headache). Here we report the process evaluation exploring potential explanations for the lack of positive effects from the CHESS intervention. METHODS: The CHESS trial included 736 (380 intervention: 356 control) people across the Midlands and London UK. We used a mixed methods approach. Our extensive process evaluation looked at context, reach, recruitment, dose delivered, dose received, fidelity and experiences of participating in the trial, and included participants and trial staff. We also looked for evidence in our qualitative data to investigate whether the original causal assumptions underpinning the intervention were realised. RESULTS: The CHESS trial reached out to a large diverse population and recruited a representative sample. Few people with chronic tension type headaches without migraine were identified and recruited. The expected 'dose'of the intervention was delivered to participants and intervention fidelity was high. Attendance ("dose received") fell below expectation, although 261/380 (69%) received at least at least the pre-identified minimum dose. Intervention participants generally enjoyed being in the groups but there was little evidence to support the causal assumptions underpinning the intervention were realised. CONCLUSIONS: From a process evaluation perspective despite our extensive data collection and analysis, we do not have a clear understanding of why the trial outcome was negative as the intervention was delivered as planned. However, the lack of evidence that the intervention causal assumptions brought about the planned behaviour change may provide some insight. Our data suggests only modest changes in managing headache behaviours and some disparity in how participants engaged with components of the intervention within the timeframe of the study. Moving forwards, we need a better understanding of how those who live with chronic headache can be helped to manage this disabling condition more effectively over time. TRIAL REGISTRATION: ISRCTN79708100 .

Supportive Self-Management Program for People With Chronic Headaches and Migraine: A Randomized Controlled Trial and Economic Evaluation.

BACKGROUND AND OBJECTIVES: Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches. METHODS: This was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension-type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management program, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material. The primary outcome was headache related-quality of life using the Headache Impact Test (HIT)-6 at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data. RESULTS: Between April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyzed for primary outcome. There was no between-group difference in HIT-6 (adjusted mean difference = -0.3, 95% CI -1.23 to 0.67) or headache days (0.9, 95% CI -0.29 to 2.05) at 12 months. The Chronic Headache Education and Self-management Study intervention generated incremental adjusted costs of £268 (95% CI, £176-£377) (USD383 [95% CI USD252-USD539]) and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI -0.005 to 0.063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained. DISCUSSION: These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension-type headache with episodic migraine. TRIAL REGISTRATION INFORMATION: Registered on the International Standard Randomized Controlled Trial Number registry, ISRCTN79708100 16th December 2015 doi.org/10.1186/ISRCTN79708100. The first enrollment was April 24, 2017. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine.

Evaluating interventions to improve ethical decision making in clinical practice: a review of the literature and reflections on the challenges posed.

Since the 1980s, there has been an increasing acknowledgement of the importance of recognising the ethical dimension of clinical decision-making. Medical professional regulatory authorities in some countries now include ethical knowledge and practice in their required competencies for undergraduate and post graduate medical training. Educational interventions and clinical ethics support services have been developed to support and improve ethical decision making in clinical practice, but research evaluating the effectiveness of these interventions has been limited. We undertook a systematic review of the published literature on measures or models of evaluation used to assess the impact of interventions to improve ethical decision making in clinical care. We identified a range of measures to evaluate educational interventions, and one tool used to evaluate a clinical ethics support intervention. Most measures did not evaluate the key impact of interest, that is the quality of ethical decision making in real-world clinical practice. We describe the results of our review and reflect on the challenges of assessing ethical decision making in clinical practice that face both developers of educational and support interventions and the regulatory organisations that set and assess competency standards.

The Experiences of Strategic Purchasing of Healthcare in Nine Middle-Income Countries: A Systematic Qualitative Review.

BACKGROUND: Efforts to move towards universal health coverage (UHC) aim to rebalance health financing in ways that increase efficiency, equity, and quality. Resource constraints require a shift from passive to strategic purchasing (SP). In this paper, we report on the experiences of SP in public sector health insurance schemes in nine middle-income countries to understand what extent SP has been established, the challenges and facilitators, and how it is helping countries achieve their UHC goals. METHODS: We conducted a systematic search to identify papers on SP. Nine countries were selected for case study analysis. We extracted data from 129 articles. We used a common framework to compare the purchasing arrangements and key features in the different schemes. The evidence was synthesised qualitatively. RESULTS: Five countries had health technology assessment (HTA) units to research what services to buy. Most schemes had reimbursement mechanisms that enabled some degree of cost control. However, we found evidenced-based changes to the reimbursement mechanisms only in Thailand and China. All countries have some form of mechanism for accreditation of health facilities, although there was considerable variation in what is done. All countries had some strategy for monitoring claims, but they vary in complexity and the extent of implementation; three countries have implemented e-claim processing enabling a greater level of monitoring. Only four countries had independent governance structures to provide oversight. We found delayed reimbursement (six countries), failure to provide services in the benefits package (four countries), and high out-of-pocket (OOP) payments in all countries except Thailand and Indonesia, suggesting the schemes were failing their members. CONCLUSION: We recommend investment in purchaser and research capacity and a focus on strong governance, including regular engagement between the purchaser, provider and citizens, to build trusting relationships to leverage the potential of SP more fully, and expand financial protection and progress towards UHC.

Community health workers' quality of comprehensive care: a cross-sectional observational study across three districts in South Africa.

Background: Community healthcare worker (CHW) training programs are becoming increasingly comprehensive (an expanded range of diseases). However, the CHWs that the program relies on have limited training. Since CHWs' activities occur largely during household visits, which often go unsupervised and unassessed, long-term, ongoing assessment is needed to identify gaps in CHW competency, and improve any such gaps. We observed CHWs during household visits and gave scores according to the proportion of health messages/activities provided for the health conditions encountered in households. We aimed to determine (1) messages/activities scores derived from the proportion of health messages given in the households by CHWs who provide comprehensive care in South Africa, and (2) the associated factors. Methods: In three districts (from two provinces), we trained five fieldworkers to score the messages provided by, and activities of, 34 CHWs that we randomly selected during 376 household visits in 2018 and 2020 using a cross-sectional study designs. Multilevel models were fitted to identify factors associated with the messages/activities scores, adjusted for the clustering of observations within CHWs. The models were adjusted for fieldworkers and study facilities (n = 5, respectively) as fixed effects. CHW-related (age, education level, and phase of CHW training attended/passed) and household-related factors (household size [number of persons per household], number of conditions per household, and number of persons with a condition [hypertension, diabetes, HIV, tuberculosis TB, and cough]) were investigated. Results: In the final model, messages/activities scores increased with each extra 5-min increase in visit duration. Messages/activities scores were lower for households with either children/babies, hypertension, diabetes, a large household size, numerous household conditions, and members with either TB or cough. Increasing household size and number of conditions, also lower the score. The messages/activities scores were not associated with any CHW characteristics, including education and training. Conclusion: This study identifies important factors related to the messages provided by and the activities of CHWs across CHW teams. Increasing efforts are needed to ensure that CHWs who provide comprehensive care are supported given the wider range of conditions for which they provide messages/activities, especially in households with hypertension, diabetes, TB/cough, and children or babies.

Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities.

The increasing digitisation of personal health data has led to an increase in the demand for onward health data. This study sought to develop local language scripts for use in public sector maternity clinics to capture informed consent for onward health data use. The script considered five possible health data uses: 1. Sending of general health information content via mobile phones; 2. Delivery of personalised health information via mobile phones; 3. Use of women's anonymised health data; 4. Use of child's anonymised health data; and 5. Use of data for recontact. Qualitative interviews (n = 54) were conducted among women attending maternity services in three public health facilities in Gauteng and Western Cape, South Africa. Using cognitive interviewing techniques, interviews sought to:(1) explore understanding of the consent script in five South African languages, (2) assess women's understanding of what they were consenting to, and (3) improve the consent script. Multiple rounds of interviews were conducted, each followed by revisions to the consent script, until saturation was reached, and no additional cognitive failures identified. Cognitive failures were a result of: (1) words and phrases that did not translate easily in some languages, (2) cognitive mismatches that arose as a result of different world views and contexts, (3) linguistic gaps, and (4) asymmetrical power relations that influence how consent is understood and interpreted. Study activities resulted in the development of an informed consent script for onward health data use in five South African languages for use in maternity clinics.

In the wake of growing digitisation of personal health data, greater scrutiny is needed on the language of informed consent and the processes for soliciting consent in health care facilities. Qualitative interviews using cognitive interviewing techniques were used to develop and refine consent language in English, Sesotho, isiXhosa, isiZulu and Setswana for the onward use of health data among maternity clients in public sector primary health clinics in the Western Cape and Gauteng provinces of South Africa. We found that translation in local languages and addressing individual words and phrases was only one barrier to requesting informed consent. Other barriers were cognitive mismatches between the question intent and how women understood the question, linguistic gaps that were linked to language and identity, and power dynamics that affected how women understood the consent script. Emerging language scripts used "/" to present words in multiple languages; a reflection of the multi-linguistic nature of communities in this context.

Development and validation of a prediction model for self-reported mobility decline in community-dwelling older adults.

OBJECTIVES: The aim of this study is to develop and validate two models to predict 2-year risk of self-reported mobility decline among community-dwelling older adults. STUDY DESIGN AND SETTING: We used data from a prospective cohort study of people aged 65 years and over in England. Mobility status was assessed using the EQ-5D-5L mobility question. The models were based on the outcome: Model 1, any mobility decline at 2 years; Model 2, new onset of persistent mobility problems over 2 years. Least absolute shrinkage and selection operator logistic regression was used to select predictors. Model performance was assessed using C-statistics, calibration plot, Brier scores, and decision curve analyses. Models were internally validated using bootstrapping. RESULTS: Over 18% of participants who could walk reported mobility decline at year 2 (Model 1), and 7.1% with no mobility problems at baseline, reported new onset of mobility problems after 2 years (Model 2). Thirteen and 6 out of 31 variables were selected as predictors in Models 1 and 2, respectively. Models 1 and 2 had a C-statistic of 0.740 and 0.765 (optimism < 0.013), and Brier score = 0.136 and 0.069, respectively. CONCLUSION: Two prediction models for mobility decline were developed and internally validated. They are based on self-reported variables and could serve as simple assessments in primary care after external validation.