Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial.

Background: Leprosy leads to nerve damage and slow-healing ulcers, which are treatable with routine therapy. There has been a recent resurgence of interest in the use of honey for the treatment of different kinds of wounds. Objective: The aim of this study, Honey Experiment on Leprosy Ulcer (HELP), is to evaluate the healing properties of raw, unadulterated African honey in comparison with normal saline dressing for the treatment leprosy ulcers. Methods: This is a multicenter, comparative, prospective, single-blinded, parallel-group, and 1:1 individually randomized controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga in Minna, Niger State, North Central Nigeria, and St. Benedict Tuberculosis and Leprosy Rehabilitation Hospital in Ogoja, Cross River State, South-South Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of eligible, consenting participants in the intervention group, whereas those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days after randomization. Follow-up will be conducted 6 months after randomization. We aim to enroll 90-130 participants into the study. Blinded observers will examine photographs of ulcers to determine the outcomes. Results: The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months. Conclusions: Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.

Autologous blood products: Leucocyte and Platelets Rich Fibrin (L-PRF) and Platelets Rich Plasma (PRP) gel to promote cutaneous ulcer healing - a systematic review.

OBJECTIVE: To summarise evidence on the effectiveness of Platelet-Rich Plasma (PRP) gel and Leucocyte and Platelet Rich Fibrin (L-PRF) gel as agents promoting ulcer healing compared with the standard wound dressing techniques alone. DESIGN: Systematic review. ELIGIBILITY CRITERIA: Individual patient randomised controlled trials on skin ulcers of all types excluding traumatic lesions.Intervention group: treatment with topical application of L-PRF gel or PRP gel to the wound surface. CONTROL GROUP: treatment with standard skin ulcer care using normal saline, normgel or hydrogel dressings. INFORMATION SOURCES: Medline (Ovid), Excerpta Medica Database (EMBASE), Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science and manual search of studies from previous systematic reviews and meta-analyses. The papers published from 1946 to 2022 with no restriction on geography and language were included. The last date of the search was performed on 29 August 2022. DATA EXTRACTION AND SYNTHESIS: Independent reviewers identified eligible studies, extracted data, assessed risk of bias using V.2 of the Cochrane risk-of-bias tool for randomised trials tool and assessed certainty of evidence by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. MAIN OUTCOME MEASURES: Time to complete healing, proportion healed at a given time and rate of healing. RESULTS: Seven studies met the inclusion criteria, five using PRP gel and two using L-PRF gel. One study showed a better proportion of complete healing, three reported reduced meantime to complete healing and five showed improved rate of healing per unit of time in the intervention group. The risk of bias was high across all studies with one exception and the GRADE showed very low certainty of evidence. CONCLUSION: The findings show potential for better outcomes in the intervention; however, the evidence remains inconclusive highlighting a large research gap in ulcer treatment and warrant better-designed clinical trials. PROSPERO REGISTRATION NUMBER: CRD42022352418.

Bad research is not all bad.

In this commentary, we discuss a recent article in Trials that raised concerns about the number of poorly performed randomised trials in the medical literature and discuss the trials literature more widely. Although we all aim for higher methodological standards in trials, we argue that (i) the idea that 'most randomised trials are bad', which the recent article concludes is an overly simplistic representation of the situation, and (ii) the suggestion that an increased focus on methodological review during trial development (e.g. ethical boards performing some assessment of the methodologists on a trial), while well meaning, may have negative unintended consequences. We therefore propose that (a) trials should be assessed on their merits and weaknesses, including an assessment of risk of bias but placing that in a wider context; (b) we should recognise that although the methodological conduct of trials is of utmost importance, interventions that aim to improve this could have unintended consequences-such as bureaucracy-that have an overall negative effect; and (c) we should therefore generate an evidence base for policy interventions to improve conduct of trials rather than applying arbitrary rules.

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.

Unintended consequences of the 18-week referral to treatment standard in NHS England: a threshold analysis.

OBJECTIVE: In 2012, an '18-week referral to treatment standard' was introduced in England. Among people on the list of those waiting for hospital treatment at a point in time, the standard states that at least '92% of patients should have been waiting for less than 18 weeks'. Targets can have unintended consequences, where patients are prioritised based on the target rather than clinical need. Such an effect will be evident as a spike in the number of hospital trusts at the target threshold, referred to as a threshold effect. This study examines for threshold effects across all non-specialist acute NHS England hospital trusts by financial year. METHODS: A retrospective observational study of publicly available data examined waiting times for patients on the waiting list. We examined trust performance against the 92% target by financial year, from 2015/16 to 2021/22, using Cattaneo et al's manipulation density test (test for discontinuity/spike in data around target threshold) for all patients and by type of treatment. RESULTS: The proportion of NHS hospital trusts meeting the 92% target deteriorated over time. From 2015/16 to 2019/20, there was strong evidence of a threshold effect at the 92% target (p<0.001). There was no evidence of a threshold effect in 2020/21 (p=0.063) or 2021/22 (p=0.090). Threshold effects were present across most types of treatment in 2016/17 and fewer types from 2017/18 onwards. CONCLUSION: We observed striking evidence of a threshold effect suggesting that while targets change behaviour, they do so in a selective way, focusing on the threshold rather than a pervasive improvement in practice. However, at the height of the pandemic, as almost no trusts could reach the target, the threshold effect disappeared.

Oral health in an urban slum, Nigeria: residents' perceptions, practices and care-seeking experiences.

BACKGROUND/INTRODUCTION: One of the key recommendations for the new WHO global strategy for oral health is inclusion of disadvantaged populations and their engagement in policy dialogues such that their needs and views are addressed in policy decisions. OBJECTIVES: This study explored oral health perceptions, practices and care-seeking experiences of slum residents in Ibadan, Nigeria. METHOD: Focus group discussions (FGD) were conducted with family health-decision makers in an urban slum site. Oral health perceptions, practices, and care-seeking experiences were discussed. FGDs were recorded, transcribed, and translated. ATLAS.ti qualitative research software was deployed for analysis using thematic analysis. RESULTS: Six FGD sessions, divided by gender and age, were conducted between September-October 2019, (N = total 58 participants, aged 25 to 59 years). Common dental ailments mentioned were dental pain, tooth sensitivity, bleeding gums, tooth decay, mouth odor, gum disease, and tooth fracture. Perceived causes of dental conditions included poor dental hygiene and habits, sugary diets, ignorance, and supernatural forces. Mouth cleaning was mostly done once daily using toothbrush and paste. Other cleaning tools were ground glass, wood ash, charcoal, "epa Ijebu" (a dentrifice), and "orin ata" (a type of chewing stick). Remedies for relieving dental pain included over-the-counter medicines, warm salted water, gin, tobacco (snuff/powdered), cow urine/dung, battery fluid, and various mixtures/ concoctions. Visits to the dentists were mentioned by a few but this was usually as last resort. Main barriers to accessing care from dental care facilities were unaffordability of service charges and fear of extreme treatment measures (extraction). Suggested measures to improve timely access to dental health care included reducing/subsidizing costs of treatments and medications, offering non-extraction treatment options, and oral health education programmes. CONCLUSION: The slum residents experience various forms of dental ailments mostly pain-related. The residents perceived formal dental clinics as unaffordable, thereby engaging in self-care remedies and harmful oral health practices before seeking professional help. Policymakers and decision-makers may leverage this empirical evidence for the people's education on early dental care and address challenges to affordable, available, and acceptable oral healthcare services among slum residents to improve access to care facilities.

Protocol for a cluster randomised waitlist-controlled trial of a goal-based behaviour change intervention for employees in workplaces enrolled in health and wellbeing initiatives.

Many workplaces offer health and wellbeing initiatives to their staff as recommended by international and national health organisations. Despite their potential, the influence of these initiatives on health behaviour appears limited and evaluations of their effectiveness are rare. In this research, we propose evaluating the effectiveness of an established behaviour change intervention in a new workplace context. The intervention, 'mental contrasting plus implementation intentions', supports staff in achieving their health and wellbeing goals by encouraging them to compare the future with the present and to develop a plan for overcoming anticipated obstacles. We conducted a systematic review that identified only three trials of this intervention in workplaces and all of them were conducted within healthcare organisations. Our research will be the first to evaluate the effectiveness of mental contrasting outside a solely healthcare context. We propose including staff from 60 organisations, 30 in the intervention and 30 in a waitlisted control group. The findings will contribute to a better understanding of how to empower and support staff to improve their health and wellbeing. Trial registration: ISRCTN17828539.

Economic evaluation of self-help group interventions for health in LMICs: a scoping review.

This scoping review aims to identify and critically appraise published economic evaluations of self-help group (SHG) interventions in low- and middle-income countries (LMICs) that seek to improve health and potentially also non-health outcomes. Through a systematic search of MEDLINE ALL (Ovid), EMBASE Ovid, PsychINFO, EconLit (Ovid) and Global Index Medicus, we identified studies published between 2014 and 2020 that were based in LMICs, included at least a health outcome, estimated intervention costs and reported the methods used. We critically analysed whether the methods employed can meaningfully inform decisions by ministries of health and other sectors, including donors, regarding whether to fund such interventions, and prioritized the aspects of evaluations that support decision-making and cross-sectoral decision-making especially. Nine studies met our inclusion criteria. Randomized controlled trials were the most commonly used vehicle to collect data and to establish a causal effect across studies. While all studies clearly stated one or more perspectives justifying the costs and effects that are reported, few papers clearly laid out the decision context or the decision maker(s) informed by the study. The latter is required to inform which costs, effects and opportunity costs are relevant to the decision and should be included in the analysis. Costs were typically reported from the provider or health-care sector perspective although other perspectives were also employed. Four papers reported outcomes in terms of a generic measure of health. Contrary to expectation, no studies reported outcomes beyond health. Our findings suggest limitations in the extent to which published studies are able to inform decision makers around the value of implementing SHG interventions in their particular context. Funders can make better informed decisions when evidence is presented using a cross-sectoral framework.

Evaluation of an organisational-level monetary incentive to promote the health and wellbeing of workers in small and medium-sized enterprises: A mixed-methods cluster randomised controlled trial.

We conducted an independent evaluation on the effectiveness of an organisational-level monetary incentive to encourage small and medium-sized enterprises (SMEs) to improve employees' health and wellbeing. This was A mixed-methods cluster randomised trial with four arms: high monetary incentive, low monetary incentive, and two no monetary incentive controls (with or without baseline measurements to examine 'reactivity' The consequence of particpant awareness of being studied, and potential impact on participant behavior effects). SMEs with 10-250 staff based in West Midlands, England were eligible. We randomly selected up to 15 employees at baseline and 11 months post-intervention. We elicited employee perceptions of employers' actions to improve health and wellbeing; and employees' self-reported health behaviours and wellbeing. We also interviewed employers and obtained qualitative data. One hundred and fifty-two SMEs were recruited. Baseline assessments were conducted in 85 SMEs in three arms, and endline assessments in 100 SMEs across all four arms. The percentage of employees perceiving "positive action" by their employer increased after intervention (5 percentage points, pp [95% Credible Interval -3, 21] and 3pp [-9, 17], in models for high and low incentive groups). Across six secondary questions about specific issues the results were strongly and consistently positive, especially for the high incentive. This was consistent with qualitative data and quantitative employer interviews. However, there was no evidence of any impact on employee health behaviour or wellbeing outcomes, nor evidence of 'reactivity'. An organisational intervention (a monetary incentive) changed employee perceptions of employer behaviour but did not translate into changes in employees' self-reports of their own health behaviours or wellbeing. Trial registration: AEARCTR-0003420, registration date: 17.10.2018, retrospectively registered (delays in contracts and identfying a suitable trial registry). The authors confirm that there are no ongoing and related trials for this intervention.

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.

Perceived quality of care and choice of healthcare provider in informal settlements.

When a person chooses a healthcare provider, they are trading off cost, convenience, and a latent third factor: "perceived quality". In urban areas of lower- and middle-income countries (LMICs), including slums, individuals have a wide range of choice in healthcare provider, and we hypothesised that people do not choose the nearest and cheapest provider. This would mean that people are willing to incur additional cost to visit a provider they would perceive to be offering better healthcare. In this article, we aim to develop a method towards quantifying this notion of "perceived quality" by using a generalised access cost calculation to combine monetary and time costs relating to a visit, and then using this calculated access cost to observe facilities that have been bypassed. The data to support this analysis comes from detailed survey data in four slums, where residents were questioned on their interactions with healthcare services, and providers were surveyed by our team. We find that people tend to bypass more informal local services to access more formal providers, especially public hospitals. This implies that public hospitals, which tend to incur higher access costs, have the highest perceived quality (i.e., people are more willing to trade cost and convenience to visit these services). Our findings therefore provide evidence that can support the 'crowding out' hypothesis first suggested in a 2016 Lancet Series on healthcare provision in LMICs.

What influences slum residents' choices of healthcare providers for common illnesses? Findings of a Discrete Choice Experiment in Ibadan, Nigeria.

Urban slum residents have access to a broad range of facilities of varying quality. The choices they make can significantly influence their health outcomes. Discrete Choice Experiments (DCEs) are a widely-used health economic methodology for understanding how individuals make trade-offs between attributes of goods or services when choosing between them. We carried out a DCE to understand these trade-offs for residents of an urban slum in Ibadan, Nigeria. We conducted 48 in-depth interviews with slum residents to identify key attributes influencing their decision to access health care. We also developed three symptom scenarios worded to be consistent with, but not pathegonian of, malaria, cholera, and depression. This led to the design of a DCE involving eight attributes with 2-4 levels for each. A D-efficient design was created, and data was collected from 557 residents between May 2021 and July 2021. Conditional-logit models were fitted to these data initially. Mixed logit and latent class models were also fitted to explore preference heterogeneity. Conditional logit results suggested a substantial Willingness-to-pay (WTP) for attributes associated with quality. WTP estimates across scenarios 1/2/3 were N5282 / N6080 / N3715 for the government over private ownership, N2599 / N5827 / N2020 for seeing a doctor rather than an informal provider and N2196 / N5421 /N4987 for full drug availability over none. Mixed logit and latent class models indicated considerable preference heterogeneity, with the latter suggesting a substantial minority valuing private over government facilities. Higher income and educational attainment were predictive of membership of this minority. Our study suggests that slum residents value and are willing to pay for high-quality care regarding staff qualifications and drug availability. It further suggests substantial variation in the perception of private providers. Therefore, improved access to government facilities and initiatives to improve the quality of private providers are complementary strategies for improving overall care received.

Practitioners' views on community implementation of point-of-care ultrasound (POCUS) in the UK: a qualitative interview study.

BACKGROUND: Implementing Point-of-care ultrasound (POCUS) in community practice could help to decide upon and prioritise initial treatment, procedures and appropriate specialist referral or conveyance to hospital. A recent literature review suggests that image quality, portability and cost of ultrasound devices are all improving with widening indications for community POCUS, but evidence about community POCUS use is needed in the UK. We aimed to explore views of clinical practitioners, actively using ultrasound, on their experiences of using POCUS and potential facilitators and barriers to its wider implementation in community settings in the UK. METHODS: We conducted a qualitative interview study with practitioners from community and secondary care settings actively using POCUS in practice. A convenience sample of eligible participants from different clinical specialties and settings was recruited using social media adverts, through websites of relevant research groups and snowball sampling. Individual semi-structured interviews were conducted online using Microsoft Teams. These were recorded, transcribed verbatim, and analysed using a Framework approach supported by NVivo 12. RESULTS: We interviewed 16 practitioners aged between 40 and 62 years from different professional backgrounds, including paramedics, emergency physicians, general practitioners, and allied health professionals. Participants identified key considerations and facilitators for wider implementation of POCUS in community settings in the UK: resource requirements for deployment and support of working devices; sufficient time and a skilled workforce; attention to training, education and support needs; ensuring proper governance, guidelines and quality assurance; workforce considerations; enabling ease of use in assisting decision making with consideration of unintended consequences; and more robust evidence to support perceptions of improved patient outcomes and experience. CONCLUSIONS: POCUS could be useful for improving patient journey and health outcomes in community care, but this requires further research to evaluate outcomes. The facilitators identified could help make community POCUS a reality.

Tooth adornment among siblings living in an urban slum in Nigeria: Health implications for a vulnerable population.

Tooth jewelry boosts the appearance and confidence of wearers. However, its use may carry adverse health consequences. This paper creates awareness about a practice not previously reported in Nigeria, to prevent negative health consequences while appropriate measures are taken to quantify and describe the determinants and plan appropriate interventions.

Pathways to care in first-episode psychosis in low-resource settings: Implications for policy and practice.

OBJECTIVE: Developing countries such as India face a major mental health care gap. Delayed or inadequate care can have a profound impact on treatment outcomes. We compared pathways to care in first episode psychosis (FEP) between North and South India to inform solutions to bridge the treatment gap. METHODS: Cross-sectional observation study of 'untreated' FEP patients (n = 177) visiting a psychiatry department in two sites in India (AIIMS, New Delhi and SCARF, Chennai). We compared duration of untreated psychosis (DUP), first service encounters, illness attributions and socio-demographic factors between patients from North and South India. Correlates of DUP were explored using logistic regression analysis (DUP ≥ 6 months) and generalised linear models (DUP in weeks). RESULTS: Patients in North India had experienced longer DUP than patients in South India (ß = 17.68, p < 0.05). The most common first encounter in North India was with a faith healer (45.7%), however, this contact was not significantly associated with longer DUP. Visiting a faith healer was the second most common first contact in South India (23.6%) and was significantly associated with longer DUP (Odds Ratio: 6.84; 95% Confidence Interval: 1.77, 26.49). Being in paid employment was significantly associated with shorter DUP across both sites. CONCLUSIONS: Implementing early intervention strategies in a diverse country like India requires careful attention to local population demographics; one size may not fit all. A collaborative relationship between faith healers and mental health professionals could help with educational initiatives and to provide more accessible care.