Search

Abstract Background In recent years, a significant change has taken place in the health care delivery systems due to the availability of smartphones and mobile software applications. The use of mobile technology can help to reduce a number of barriers for mental health care such as providers’ workload, lack of qualified personnel, geographical and attitudinal barriers to seek treatment. This study assessed the perception of Nepali primary healthcare workers about the feasibility, acceptability, and benefits of using a mobile app-based clinical guideline for mental health care. Method A qualitative study was conducted in two districts Chitwan and Ramechhap of Nepal with purposively selected medical officers (n = 8) and prescribing primary healthcare workers (n = 35) who were trained in the World Health Organization mental health Gap Action Program Intervention Guide. Semi-structured interviews and focus group discussions were conducted in Nepali, audio recorded, transcribed and translated into English for data analysis. Data were analysed manually using a thematic analysis approach. Results The majority of the healthcare workers and medical officers reported a high level of interest, motivation and positive attitudes towards the mobile app-based clinical guidelines for detection and treatment of people with mental disorders in primary care. They respondents suggested that several features and functions should be included in the app: suggestive diagnosis and treatment options; clinical data recording system; sending messages to patients to promote follow-up visits; allow offline functions; minimal typing options and content to be available in Nepali language. The study participants reported that the app could help in bringing uniformity in diagnosis and management of mental disorders across all health facilities, enabling remote supervision, helping verification of health workers’ diagnosis and treatment; and increasing patients’ trust in the treatment. Lack of reliable internet connection in health facilities, possibility of distracting interaction between patient and provider, and confidentiality were the key factors potentially hindering the use of the app. Conclusion The suggested functions and features as well as the potential risk factors highlighted by the health workers, will be considered when further developing the mobile app-based clinical guidelines, training modality and materials, and the supervision system.

Background: Qualitative data on how the COVID-19 pandemic has affected the lives of people with rheumatic and musculoskeletal diseases (RMDs) in different European countries are lacking. Objectives: To describe the impact of the first two waves of the COVID-19 pandemic on people with inflammatory RMDs concerning (self)management of their disease, interaction with the health care team, emotional well-being and overall health. Methods: A mixed-methods study of adults (>18 years) with RMDs on immunosuppression from Cyprus, England, Greece, and Portugal took part on online focus groups (FG) after the first wave (July-August, 2020). The data was transcribed verbatim and thematically analyzed. Informed by the qualitative findings, a follow-up survey was developed for the same participants after the second wave, allowing to compare the perceived impact. Results: Twenty-four patients (6 from each country; 21 women; 33-74 years range) participated. Three key themes were identified (with 3-7 subthemes each), focusing on the impact of COVID-19 on the: (i) individual, (ii) health settings, and (iii) work and community. Overall, qualitative results were similar across countries. The follow-up survey during the second wave highlighted a worsening of psychosocial aspects, e.g. sleep problems, stress, and isolation. Conclusions: People with RMDs felt vulnerable and anxious, specifically about how to cope with isolation and difficulties in communicating with healthcare providers. The second wave had a more significant impact on patients. Healthcare providers and policymakers need to consider measures to ameliorate the longer-term impact that many may still face. [ABSTRACT FROM AUTHOR]

Background: Persistently active rheumatoid arthritis (pactiveRA) may be due to the interplay between biological and non-biological factors. The role of socioeconomic factors remains unclear., Objectives: To explore which biological and non-biological factors associate with pactiveRA., Methods: Adults with early RA in the National Early Inflammatory Arthritis Audit, recruited from May 2018 to October 2022, were included if having pactiveRA or persistently low RA (plowRA). The pactiveRA was defined as three consecutive Disease Activity Score-28 joints (DAS28) of >3.2 at baseline, 3 and 12 months. The plowRA was defined as DAS28 ≤3.2 at 3 and 12 months. Stepwise forward logistic regression was used to explore associations with pactiveRA (outcome). Age and gender were included a priori, with socioeconomic factors and comorbidities as exposure variables., Results: 682 patients with pactiveRA and 1026 plowRA were included. Compared with plowRA, patients with pactiveRA were younger (58, IQR: 49-67) versus (62, IQR: 52-72), and included more women (69% vs 59%). The pactiveRA was associated with worse scores in patient-reported outcomes at baseline, and anxiety and depression screens. Overall, there was clear social patterning in pactiveRA, with age-by-gender interaction. Logistic regression indicated age, gender, social deprivation and previous or current smoking, were independently associated with pactiveRA, after controlling for disease severity markers (seropositivity). Depression, lung disease, gastric ulcers and baseline corticosteroid use, were also associated with pactiveRA (p<0.05 for all)., Conclusion: Socioeconomic factors and deprivation were associated with pactiveRA, independent of clinical and disease characteristics. Identifying 'adverse' socioeconomic drivers of pactiveRA can help tailor interventions according to individual need., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Inflammatory arthritis causes significant work disability. Studies regarding this frequently fail to report important contextual information such as employment type. Our objective was to explore work participation, by gender and occupation type, in early inflammatory arthritis., Methods: Data are from the National Early Inflammatory Arthritis Audit for 2018-2020. At diagnosis, clinicians collected information on demographics, inflammatory arthritis disease activity, and working status. Participants completed patient-reported outcomes at baseline, 3 months and 12 months, including occupation and Work Productivity and Activity Impairment (WPAI). Descriptive analyses of work participation and WPAI scores by occupational class at all time points were performed. Regression models were used to examine associations between WPAI score and occupation., Results: In all, 12 473 people received a diagnosis of inflammatory arthritis and reported employment status, among whom 5999 (47%) were in paid work for at least 20 hours/week. At diagnosis, the working cohort had statistically significant lower measures of disease activity (P < 0.001). Occupational data were available for 3694 individuals. At diagnosis, 2793 completed a WPAI; 200 (7.2%) had stopped work and 344 (12.3%) changed jobs because of inflammatory arthritis symptoms. There was a high burden of absenteeism (30%) and presenteeism (40%). Compared with managerial or professional workers, the burden of work disability was greater among those in routine (manual) occupations. During follow-up, 9.4% of WPAI completers stopped work and 14.6% changed roles. Work drop-out occurred almost entirely among people doing routine jobs., Conclusion: It is easier to retain work in certain employment sectors. Participation in routine jobs is more affected, which may widen health inequalities., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR)., Methods: A systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies., Results: Of 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid., Conclusion: There is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level., Competing Interests: Competing interests: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Fresenius-Kabi, Lilly and holds research grants from Pfizer and Lilly., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study aims to explore patients' and clinicians' experiences in managing and living with refractory disease (RD) and persistent physical and emotional symptoms (PPES) in patients with RA or polyarticular JIA from their perspectives through interviews and/or focus groups., Methods: A qualitative exploration with 25 patients and 32 multidisciplinary rheumatology healthcare professionals (HCPs) was conducted to obtain participants respective understanding and experiences of managing RD/PPES and its impact on the patient-professional relationship. A pragmatic epistemology approach with framework analysis was employed., Results: Four key themes were identified from both patients and professionals in the management of RD/PPES: risk/perpetuating factors/triggers; need for a patient-centred holistic approach to care, diagnosis and treatment; discordance and impact on the patient-practitioner relationship and current problems in managing RD/PPES. These themes covered 22 subthemes, with none being patient specific and seven being HCP specific. Suggestions for potential management strategies were highlighted throughout, such as involving other specialties or a multidisciplinary team, assessing/treating patient-reported outcome measures and psychosocial factors, patient (re)education, need for adjustments/aids or adaptations, checking the diagnosis and further investigations/imaging and optimizing medications., Conclusion: Management strategies need to be developed that enable appropriate treatment plans for those with RD/PPES that account for wider biopsychosocial factors beyond inflammation and reduce discordance in the patient-practitioner relationship., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Social contact refers to the facilitation of connection and interactions between people with and without mental health conditions. It can be achieved, for example, through people sharing their lived experience of mental health conditions, which is an effective strategy for stigma reduction. Meaningful involvement of people with lived experience (PWLE) in leading and co-leading anti-stigma interventions can/may promote autonomy and resilience. Our paper aimed to explore how PWLE have been involved in research and anti-stigma interventions to improve effective means of involving PWLE in stigma reduction activities in LMICs. A qualitative collective case study design was adopted. Case studies from four LMICs (China, Ethiopia, India and Nepal) are summarized, briefly reflecting on the background of the work, alongside anticipated and experienced challenges, strategies to overcome these, and recommendations for future work. We found that the involvement of PWLEs in stigma reduction is commonly a new concept in LMIC. Experienced and anticipated challenges were similar, such as identifying suitable persons to engage in the work and sustaining their involvement. Such an approach can be difficult because PWLE might be apprehensive about the negative consequences of disclosure. In many case studies, we found that long-standing professional connectedness, continued encouragement, information sharing, debriefing and support helped the participants' involvement. We recommend that confidentiality of the individual, cultural norms and family concerns be prioritized and respected during the implementation. Taking into account socio-cultural contextual factors, it is possible to directly involve PWLEs in social contact-based anti-stigma interventions., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2024.)

Background: The identification of pain originating from distinct biological processes may lead to individualised pain treatment. In this study, we aimed to explore the pain experiences of patients with rheumatoid arthritis (RA), differentiating between those predominantly exhibiting features of peripheral inflammatory versus centrally mediated pain., Methods: Through a multimethods approach we (i) quantitatively analysed the differences in pain descriptors between patients diagnosed with RA experiencing peripheral inflammatory and centrally mediated pain, utilising the Short Form-McGill Pain Questionnaire which includes the pain visual analogue scale (VAS) and (ii) qualitatively explored their subjective pain experiences grounded in the biopsychosocial model, commonly applied in chronic pain., Results: Participants with centrally mediated pain reported higher pain scores on the VAS, used a wider range of pain descriptors, and a higher proportion selected each descriptor compared to those with inflammatory pain (p < .001). The qualitative analysis revealed the centrally mediated pain group's experiences were overwhelming and relentless, struggling to precisely articulate the nature of their pain. In contrast, individuals with inflammatory pain expressed their pain in more tangible terms and shared their adaptive and coping strategies. Importantly, both groups revealed the substantial psychological, functional and social impacts of their pain, highlighting the often 'invisible' and misunderstood nature of their symptoms., Conclusion: This study has gained a deeper insight into the pain experiences of patients living with RA, particularly in differentiating between centrally mediated and inflammatory types of pain, potentially facilitating a more individualised approach to pain treatment., Patient Contribution: Patients actively participated in the study conception and design. This engagement includes collaboration with key stakeholders, such as members of the National Rheumatoid Arthritis Society and Patient Research Partners (PRPs), who provided continuous feedback and guidance throughout the research process. Specifically, the qualitative element was coproduced with two PRPs, who were involved in co-leading the focus groups and data analysis., (© 2024 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Background: People living with human immunodeficiency virus (HIV) are disproportionately impacted by socioeconomic deprivation and are at increased risk of developing other long-term conditions (LTCs). These illnesses require transformative action to tackle the adverse effects on their health. Data on lived experiences of LTCs among people living with HIV of Black African and Black Caribbean ethnicities are sparse, and how people with LTCs are impacted by social determinants of health (SDoH)., Methods: Through a phenomenological study design this qualitative study, conducted in 2022, comprised four focus group discussions (FGDs) with 20 people of Black ethnicities living with HIV were purposively invited from a community organisation (CO) in London, including four semistructured interviews with CO staff. Following transcription, qualitative data were analysed thematically and measures to validate the findings were implemented., Results: The findings are presented in terms of the following four levels of SDoH: (1) individual determinants (such as the impact of SDoH on lifestyle modification and self-management); (2) interpersonal determinants (such as positive experiences of accessing healthcare for LTCs); (3) clinical determinants (such as care pathway barriers) and (4) systemic determinants (such as systemic barriers related to race/ethnicity)., Conclusions: It is necessary to provide ongoing and interactive education to community members who live with HIV, focusing on risks and management of LTCs. Additionally, individuals would benefit from support to navigate increasingly complex and fragmented health services. Health Service staff require cultural competence when caring for patients of Black African and Black Caribbean ethnicities with complex health and psychosocial needs., Patient or Public Contribution: The research team collaborated with an HIV CO in South London from the very start of the project to agree the study design and learn about the realities of their daily lived experiences. Community collaborators helped to develop the semistructured interview and FGD topic guides, and were directly involved in the data gathering, analysis and validation., (© 2024 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Introduction: There are around 250 million adolescents (10-19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor living conditions, financial difficulty and limited access to support services. Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) is a cluster randomised controlled trial of an intervention that intends to improve the mental health of adolescents living in slum communities in India. The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes and understand how and why the intervention worked or did not work. It will identify contextual factors, intervention barriers and facilitators and the adaptations required for optimising implementation., Methods: Case study method will be used and the data will include a mix of quantitative metrics and qualitative data. The UK Medical Research Council's guidance on evaluating complex interventions, the Reach, Efficacy, Adoption, Implementation and Maintenance Framework and the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Safety/Side Effects and, Equity criteria will be used to develop a conceptual framework and a priori codes for qualitative data analysis. Quantitative data will be analysed using descriptive statistics. Implementation fidelity will also be measured., Discussion: The process evaluation will provide an understanding of outcomes and causal mechanisms that influenced any change in trial outcomes., Ethics and Dissemination: Ethics Committee of the George Institute for Global Health India (project number 17/2020) and the Research Governance and Integrity Team, Imperial College, London (ICREC reference number: 22IC7718) have provided ethics approval. The Health Ministry's Screening Committee has approved to the study (ID 2020-9770)., Trial Registration Number: CTRI/2022/02/040307., Competing Interests: Competing interests: We declare that the George Institute for Global Health has a part-owned social enterprise, George Health Enterprises, which has commercial relationships involving digital health innovations., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: Social determinants of health (SDH) are important determinants of long-term conditions and multimorbidity in the general population. The intersecting relationship between SDH and multimorbidity in people with HIV remains poorly studied., Design: A cross-sectional study investigating the relationships between eight socio-economic parameters and prevalent comorbidities of clinical significance and multimorbidity in adults of African ancestry with HIV aged 18-65 years in South London, UK., Methods: Multivariable logistic regression analysis was used to evaluate associations between SDH and comorbidities and multimorbidity., Results: Between September 2020 and January 2022, 398 participants (median age 52 years, 55% women) were enrolled; 85% reported at least one SDH and 72% had at least one comorbidity. There were no associations between SDH and diabetes mellitus or kidney disease, few associations between SDH (job and food insecurity) and cardiovascular or lung disease, and multiple associations between SDH (financial, food, housing and job insecurity, low educational level, social isolation, and discrimination) and poor mental health or chronic pain. Associations between SDH and multimorbidity mirrored those for constituent comorbidities., Conclusion: We demonstrate strong associations between SDH and poor mental health, chronic pain and multimorbidity in people of black ethnicities living with HIV in the UK. These findings highlight the likely impact of enduring socioeconomic hardship in these communities and underlines the importance of holistic health and social care for people with HIV to address these adverse psychosocial conditions., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: According to epidemiological studies, psychosocial factors are known to be associated with disease activity, physical activity, pain, functioning, treatment help-seeking, treatment waiting times and mortality in people with rheumatoid arthritis (RA). Limited qualitative inquiry into the psychosocial factors that add to RA disease burden and potential synergistic interactions with biological parameters makes it difficult to understand patients' perspectives from the existing literature., Aim: This study aimed to gather in-depth patient perspectives on psychosocial determinants that drive persistently active disease in RA, to help guide optimal patient care., Methods: Patient research partners collaborated on the research design and materials. Semistructured interviews and focus groups were conducted online (in 2021) with patients purposively sampled from diverse ethnicities, primary languages, employment status and occupations. Data were analysed using inductive thematic analysis., Results: 45 patients participated across 28 semistructured interviews and three focus groups. Six main themes on psychosocial determinants that may impact RA management were identified: (1) healthcare systems experiences, (2) patient education and health literacy, (3) employment and working conditions, (4) social and familial support, (5) socioeconomic (dis)advantages, and (6) life experiences and well-being practices., Conclusion: This study emphasises the importance of clinicians working closely with patients and taking a holistic approach to care that incorporates psychosocial factors into assessments, treatment plans and resources. There is an unmet need to understand the relationships between interconnected biopsychosocial factors, and how these may impact on RA management., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: Efforts to understand the mechanisms and consequences of mental health-related stigma and discrimination need to center the perspectives of people affected by these negative impacts, through research efforts that are led or co-led by people with lived experience (PWLE) of mental health conditions., Methods: This study used co-production principles to explore global perspectives of stigma and discrimination among people meeting the inclusion criteria of identifying as PWLEs and being willing to share their experiences of stigma and discrimination resulting from a diagnosis of a mental health condition, and who had also participated in anti-stigma activities. Participants were recruited online via a self-selecting snowball sampling method. Qualitative data were collected from respondents via an anonymous global online survey conducted between 12/01/2021 and 02/28/2022. The main outcomes assessed were open-ended, qualitative responses to questions exploring experiences of stigma and discrimination, experiences regarding diagnoses, language/terminology related to mental health, impact of stigma and discrimination, and involvement with anti-stigma interventions. Data were synthesised through digital text network analysis and thematic content analysis., Findings: A total of 198 respondents from over 30 countries across Europe, the Americas, Africa, Asia, and Australia/Oceania were included in the study. The results reflected five themes: 1) the role of language and words; 2) the role of media in perpetuating and reducing stigma; 3) societal reactions to mental health conditions and strategies to cope with these; 4) knowledge about activities to reduce stigma and discrimination and their impact; and 5) personal involvement in activities to reduce stigma and discrimination., Interpretation: The findings highlight that people with mental health conditions are aware of and experience stigma and discrimination across core domains of daily life. The importance of recognising the key role PWLEs can play in efforts to reduce stigma and discrimination was highlighted, and how they can be appropriately supported to contribute and have their experiential expertise recognised. Meaningful and authentic collaborations between PWLEs and other stakeholders can enhance the quality and relevance of strategies to reduce stigma and discrimination. This is, to our knowledge, the first study of its kind to use a co-production approach to explore experiences and reflections of stigma and discrimination related to mental health from a global perspective. However, the results are not broadly representative of the general PWLE population or suggestive of globally uniform experiences of stigma and discrimination., Funding: None., Competing Interests: All authors declare no competing interests., (© 2024 The Authors.)

Introduction: This paper presents the study protocol for a feasibility study of a manualised mental health awareness and stigma reduction intervention for Black faith communities, as part of the Outcomes and Needs of Traditional Religious And Complementary practitioners (ON TRAC) project. The primary objective is to assess the feasibility and acceptability of the intervention and the secondary objectives include assessment of the feasibility of: recruiting participants to take part in the intervention, delivering the intervention, and conducting qualitative assessments, and use of the selected scales. The findings from this study will be used to inform the development of a subsequent trial which will focus on exploring the potential impact of the intervention on stigma-related knowledge, attitudes, and behaviour., Methods and Analysis: The study uses a mixed-methods approach. A total of 80 participants from four Black Majority Churches in South London will be recruited. Randomisation of the participants will be at an individual level to either the intervention group (who will participate in the 10 week Mental Health Awareness Course intervention) or to the waiting list control group (who will receive the same intervention, 8 weeks after the intervention group). Outcomes for both arms will be collected at baseline, postintervention, and at 4 week follow-up. In addition, focus group discussions will be conducted with participants in the intervention group, a week following the end of the 10 week session course, to investigate the feasibility and acceptability of the mental health awareness course., Ethics and Dissemination: The results of this research will be disseminated at local, national, and international levels., Trial Registration Number: ISRCTN12253092., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Adolescents are vulnerable to stressors because of the rapid physical and mental changes that they go through during this life period. Young people residing in slum communities experience additional stressors due to living conditions, financial stress, and limited access to healthcare and social support services. The Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) study, is testing an intervention intended to improve mental health outcomes for adolescents living in urban slums in India combining an anti-stigma campaign with a digital health intervention to identify and manage depression, self-harm/suicide risk or other significant emotional complaints., Methods: In the formative phase, we developed tools and processes for the ARTEMIS intervention. The two intervention components (anti-stigma and digital health) were implemented in purposively selected slums from the two study sites of New Delhi and Vijayawada. A mixed methods formative evaluation was undertaken to improve the understanding of site-specific context, assess feasibility and acceptability of the two components and identify required improvements to be made in the intervention. In-depth interviews and focus groups with key stakeholders (adolescents, parents, community health workers, doctors, and peer leaders), along with quantitative data from the digital health platform, were analysed., Results: The anti-stigma campaign methods and materials were found to be acceptable and received overall positive feedback from adolescents. A total of 2752 adolescents were screened using the PHQ9 embedded into a digital application, 133 (4.8%) of whom were identified as at high-risk of depression and/or suicide. 57% (n = 75) of those at high risk were diagnosed and treated by primary health care (PHC) doctors, who were guided by an electronic decision support tool based on WHO's mhGAP algorithm, built into the digital health application., Conclusion: The formative evaluation of the intervention strategy led to enhanced understanding of the context, acceptability, and feasibility of the intervention. Feedback from stakeholders helped to identify key areas for improvement in the intervention; strategies to improve implementation included engaging with parents, organising health camps in the sites and formation of peer groups., Trial Registration: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries, Reference number: CTRI/2022/02/040307. Registered 18 February 2022., (© 2024. The Author(s).)

Long-term conditions and accompanied co-morbidities now affect about a quarter of the UK population. Enabling patients and caregivers to communicate their experience of illness in their own words is vital to developing a shared understanding of the condition and its impact on patients' and caregivers' lives and in delivering person-centred care. Studies of patient language show how metaphors provide insight into the physical and emotional world of the patient, but such studies are often limited by their focus on a single illness. The authors of this study undertook a secondary qualitative data analysis of 25 interviews, comparing the metaphors used by patients and parents of patients with five longterm conditions. Analysis shows how similar metaphors can be used in empowering and disempowering ways as patients strive to accept illness in their daily lives and how metaphor use depends on the manifestation, diagnosis, and treatment of individual conditions. The study concludes with implications for how metaphorical expressions can be attended to by healthcare professionals as part of shared care planning., Competing Interests: Conflict of interest: The authors declare no conflict of interests., (Copyright © 2023, the Author(s).)

Objectives: Disease management in rheumatoid arthritis (RA) requires holistic assessment. We aimed to design personalised care packages suitable for people with RA., Methods: This study was conducted using a mixed-methods approach and exploratory sequential design. Consensus workshops were held, involving people with RA and healthcare professionals (HCPs) treating them. Subsequently, an online survey sought views on future care packages for people with RA at relevant disease progression/stages, based on (1) results from previous quantitative data analyses (eg, socioeconomic/clinical factors), and (2) themes identified during workshops., Results: Two conceptual care pathways were identified: (1) around the time of RA diagnosis, an early opportunity to influence the disease course; (2) for individuals with established RA, emphasising the importance of 'the right MDT member at the right time'.Three care packages were suggested: (1) early care package (around RA diagnosis): introduction to MDT; (2) continuity of care package (established RA): primary/secondary providers; and (3) personalised holistic care package: integral to packages 1 and 2, implemented alongside allied health professionals.The survey received 41 responses; 82.9% agreed that people with RA need a consistent 'early care package' at diagnosis. 85.4% approved of additional care packages tailored to individuals' clinical, psychological and social needs when moving to different stages of their long-term disease. Fleiss' Kappa calculations demonstrated fair level of agreement among respondents., Conclusion: Two care pathways, with three tailored care packages, were identified, with potential to improve management of people with RA. Future research will help to determine if such care packages can impact clinical (including patient-reported) outcomes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Online peer support programs could address mental wellbeing concerns reported by Black students. The current evaluation explored Black university students' motivations, experiences, and perceived impacts of an online mental wellbeing peer support group (Black Students Talk [BST]) in England and Wales. We conducted two focus groups with Black Students Talk attendees and one with facilitators. Data were analyzed using inductive thematic analysis. Three main themes and eight sub-themes where identified related to (i) Motivation: Impact of racism on mental wellbeing; (ii) Experience: The Black Students Talk experience; and (iii) Impact: Mental wellbeing outcomes. Benefits of Black Students Talk for Black students included advice, rest, validation, and support in the context of their race and experiences of racism. Facilitators had a unique sub-theme concerning their training and support. While racism exists at universities, online peer support can offer valuable benefits for Black students' mental wellbeing, social connectedness, and Black-only networks. Programs need to be co-created and delivered by trained Black students who receive reflective practice with a Black practitioner. Further independent evaluations using insights from survey and interview data are needed., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

This study assessed perception and experience of trained primary health care workers in using a mobile app-based version of the WHO mental health gap action programme (mhGAP) Intervention Guide in the assessment and management of people with mental health conditions in primary care in Nepal. A qualitative study was conducted with primary healthcare workers who were trained in using the WHO mhGAP mobile application in Jhapa, a district in eastern Nepal. Semi-structured interviews were carried out with 15 healthcare workers (3 females and 12 males) nine months after the training. Interviews were audio recorded, transcribed and translated into English for the thematic qualitative data analysis. Health care workers (HCWs) found the mobile app helpful to verify and confirm their assessment and diagnosis. The other benefits reported by the participants were: bringing uniformity in diagnosis and management of mental health conditions across primary healthcare facilities; reminding the HCWs specific assessment questions; creating awareness on the importance of psychosocial intervention; improving the interaction between patients and service providers; and the importance of follow-up care. Despite these advantages, lack of clarity about report submission modality; lack of electricity or internet connectivity; and low technology literacy among older HCWs were some of the barriers in using the app. The major recommendation made by the HCWs for the guide included revision of the assessment process and system; inclusion of a chat function with supervisors; minimizing the amount of patients' data to be collected in the app; and addition of conversion and anxiety disorders to the app. This study concludes that the mobile decision support application could be acceptable and feasible in primary care settings if the suggested modifications are incorporated, in addition to addressing other systemic issues facing the primary care-based delivery of mental health services., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 Published by Elsevier Ltd.)

Background: Building partnerships between mental health services and Black faith communities to co-produce culturally tailored interventions is an essential step towards improving access to services and reducing stigma among the Black population. Given that Black faith organisations are considered a primary source of emotional and psychological support they are well positioned as 'gatekeepers' for services, to overcome barriers to engagement and build trusting relationships with the Black community. The aim of this paper is to pilot a manualised mental health awareness and stigma reduction intervention for Black faith communities in the UK, and to make an initial assessment of feasibility, acceptability and outcomes., Methods: This study employed a mixed methods pre-post-design, based upon the Medical Research Council Framework (MRC) for complex interventions, and the Implementation Science Research Development., Results: The qualitative assessments indicate that the intervention was found overall to be acceptable and feasible to the Black faith community population. This pilot study did not find statistically significant changes for the Mental Health Knowledge schedule (MAKS), Reported and Intended Behaviour Scale (RIBS), intended help-seeking or willingness to disclose (Attitudes to Mental Illness Survey) measures. However, the direction of all the non-significant changes in these measures suggests positive changes in mental health knowledge, a reduction in participants' desire for social distance, and greater willingness to disclose personal experiences of mental health problems. A statistically significant improvement in the Community Attitudes towards Mental Illness (CAMI) scale results indicated a lower level of stigmatising attitudes towards people with lived experience of mental health conditions (PWLE), and an increase in tolerance and support towards PWLE after the intervention. Significant improvement in the willingness to disclose measure suggests increased preparedness to seek help amongst participants, a lesser desire for social distance, and greater willingness to engage with PWLE after the intervention. Three key themes, including 9 subthemes were identified from the qualitative data analysis: (i) initial implementation and intention to adopt; (ii) perceived suitability and usefulness of intervention to address cultural issues relating to mental health in the Black community; and (iii) strengthening the capacity of faith leaders., Conclusions: This ON TRAC pilot study shows that the intervention was feasible and acceptable, and that it has promising positive impacts and next requires larger scale evaluation. These results demonstrate that the intervention was a culturally acceptable way to potentially increase mental health awareness and reduce stigma in Black faith communities., Trial Registration: ISRCTN12253092., (© 2023. The Author(s).)

Background: The psychological burden in people with inflammatory arthritis is substantial, yet little is known about the disease-related affect experienced by individuals with axial Spondyloarthritis (axial SpA). The aim of this study was to conduct a qualitative evidence synthesis and a review of social media to explore the emotional impact of living with axial SpA., Methods: We searched nine databases for studies reporting qualitative data about participants' emotional experience of living with axial SpA. In addition, we searched social media platforms for posts from people with axial SpA based in the UK that offered insights into emotional responses to living with the condition. We employed a thematic approach to synthesise the data., Results: We included 27 studies (1314 participants; 72% men) in our qualitative evidence synthesis and developed seven descriptive themes from the data: 1) delayed diagnosis: a barrier to emotional wellbeing; 2) disruptive symptoms: a source of mood swings; 3) work disability: a loss of self-esteem; 4) obstacles in interpersonal relationships: a trigger of distress; 5) taking up exercise: personal pride or unwelcomed reminders; 6) anti-TNF therapy: hope reignited despite concerns and 7) a journey of acceptance: worry mixed with hope. Posts extracted from social media fora (537; 48% from women) for the most part supported the seven themes. One additional theme-COVID-19, uncertainty and anxiety during the pandemic, was developed, reflecting common emotions expressed during the UK's first wave of the coronavirus pandemic., Conclusion: This study highlights a preponderance of negative affect experienced by people living with axial SpA, conditioned through existing and anticipated symptoms, failed expectations, and lost sense of self. Given the bidirectional relationships between negative emotions and inflammation, negative emotions and perceptions of pain, and the influence of affect in self-care behaviours, this finding has important implications for treatment and management of people with axial SpA., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objective: Various definitions have been proposed for Refractory Disease in people with Rheumatoid Arthritis; however, none were generated for Polyarticular Juvenile Idiopathic Arthritis or involving adult and paediatric multidisciplinary healthcare professionals and patients. The study aim is to redefine Refractory Disease, using Delphi methodology., Methods: Three rounds of surveys (one nominal group and two online (2019-2020)) to achieve consensus using a predetermined cut-off were conducted voting on: a) name, b) treatment and inflammation, c) symptoms and impact domains, and d) rating of individual components within domains. Theoretical application of the definition was conducted through a scoping exercise., Results: Votes were collected across three rounds from Patients, Researchers and nine multi-disciplinary healthcare professional groups (n = 106). Refractory Inflammatory Arthritis was the most popular name. Regarding treatment and inflammation, these were voted to be kept broad rather than specifying numbers/cut-offs. From 10 domains identified to capture symptoms and disease impact, six domains reached consensus for inclusion: 1) Disease Activity, 2) Joint Involvement, 3) Pain, 4) Fatigue, 5) Functioning and Quality of Life, and 6) Disease-Modifying Anti-Rheumatic Drug Experiences. Within these domains, 18 components, from an initial pool (n = 73), were identified as related and important to capture multi-faceted presentation of Refractory Inflammatory Arthritis, specifically in Rheumatoid Arthritis and Polyarticular Juvenile Idiopathic Arthritis. Feasibility of the revised definition was established (2022-2023) with good utility as was applied to 82% of datasets (n = 61) incorporating 20 outcome measures, with two further measures added to increase its utility and coverage of Pain and Fatigue., Conclusion: Refractory Inflammatory Arthritis has been found to be broader than not achieving low disease activity, with wider biopsychosocial components and factors incorporating Persistent Inflammation or Symptoms identified as important. This definition needs further refinement to assess utility as a classification tool to identify patients with unmet needs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Chaplin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Qualitative data on how the COVID-19 pandemic has affected the lives of people with rheumatic and musculoskeletal diseases (RMDs) in different European countries are lacking., Objectives: To describe the impact of the first two waves of the COVID-19 pandemic on people with inflammatory RMDs concerning (self)management of their disease, interaction with the health care team, emotional well-being and overall health., Methods: A mixed-methods study of adults (>18 years) with RMDs on immunosuppression from Cyprus, England, Greece, and Portugal took part on online focus groups (FG) after the first wave (July-August, 2020). The data was transcribed verbatim and thematically analyzed. Informed by the qualitative findings, a follow-up survey was developed for the same participants after the second wave, allowing to compare the perceived impact., Results: Twenty-four patients (6 from each country; 21 women; 33-74 years range) participated. Three key themes were identified (with 3-7 subthemes each), focusing on the impact of COVID-19 on the: (i) individual, (ii) health settings, and (iii) work and community. Overall, qualitative results were similar across countries. The follow-up survey during the second wave highlighted a worsening of psychosocial aspects, e.g. sleep problems, stress, and isolation., Conclusions: People with RMDs felt vulnerable and anxious, specifically about how to cope with isolation and difficulties in communicating with healthcare providers. The second wave had a more significant impact on patients. Healthcare providers and policymakers need to consider measures to ameliorate the longer-term impact that many may still face.

Objective: To assess variability in care quality and treatment outcomes across ethnicities in early inflammatory arthritis (EIA)., Methods: We conducted an observational cohort study in England and Wales from May 2018 to March 2020, including patients with a suspected/confirmed EIA diagnosis. Care quality was assessed against six metrics defined by national guidelines. Clinical outcomes were measured using DAS28. Outcomes between ethnic groups ('White', 'Black', 'Asian', 'Mixed', 'Other') were compared, and adjusted for confounders., Results: A total of 35 807 eligible patients were analysed. Of those, 30 643 (85.6%) were White and 5164 (14.6%) were from ethnic minorities: 1035 (2.8%) Black; 2617 (7.3%) Asian; 238 (0.6%) Mixed; 1274 (3.5%) Other. In total, 12 955 patients had confirmed EIA, of whom 11 315 were White and 1640 were from ethnic minorities: 314 (2.4%) Black; 927 (7.1%) Asian; 70 (0.5%) Mixed; 329 (2.5%) Other. A total of 14 803 patients were assessed by rheumatology within three weeks, and 5642 started treatment within six weeks of referral. There were no significant differences by ethnicity. Ethnic minority patients had lower odds of disease remission at three months [adjusted odds ratio 0.79 (95% CI: 0.65, 0.96)] relative to White patients. Ethnic minorities were significantly less likely to receive initial treatment withMTX[0.68 (0.52, 0.90)] or with glucocorticoids [0.63 (0.49, 0.80)]., Conclusion: We demonstrate that some ethnic minorities are less likely to achieve disease remission in three months following EIA diagnosis. This is not explained by delays in referral or time to treatment. Our data highlight the need for investigation into the possible drivers of these inequitable outcomes and reappraisal of EIA management pathways., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: Quantify differential attainment by ethnicity in undergraduate medical assessments and evaluate whether institutional efforts to reduce the attainment gap have had impact., Design: Observational cohort study., Setting: A single UK MBBS medical programme., Participants: Pseudonymised data of adults aged ≥18 years enrolled in one of the UK MBBS medical programmes between 2012 and 2018. Ethnicity was self-declared during enrolment as White, Asian, Black, mixed and other., Main Outcome Measure: Module mark (distinction, merit, pass, fail) graded according to a variety of assessments, including single best answer examinations, objective structured clinical examinations and coursework submissions. All modular assessments are graded as a percentage. Logistic regression models were used to calculate relative risk ratio to study the association between ethnicity and attainment gap over a calendar and scholastic year. Models were adjusted for age, gender, social deprivation and scholastic year of study., Results: 3714 student records were included. In the sample, 2134 students (57%) were non-white. The proportion of non-white students increased from 2007 (49%) to 2018 (70%). Mean age was 18 (IQR 18-21) and 56.6% were females. Higher proportion of non-white students 218 (24.8%) were from more deprived backgrounds versus white 76 (14.8%). Compared with non-white, there were no significant differences in the proportion of students failing assessments. However, white students were more likely to achieve merit (relative risk ratio 1.29 (95% CI 1.08 to 1.45)) or distinction (1.69 (95% CI 1.37 to 2.08)). Differences in attainment gap have remained unchanged over time, and for black students, attainment gap grew between their first and final year of study., Conclusion: A similar proportion (97%) of non-white and white students had a passing score, but attainment gap for higher grades persists over years despite widespread efforts in medical schools to diminish the attainment gap linked to ethnicity. Our findings are from a single institution, thus affecting generalisability., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Mental health and other health professionals working in mental health care may contribute to the experiences of stigma and discrimination among mental health service users but can also help reduce the impact of stigma on service users. However, few studies of interventions to equip such professionals to be anti-stigma agents took place in high-income countries. This study assesses the feasibility, potential effectiveness and costs of Responding to Experienced and Anticipated Discrimination training for health professionals working in mental health care (READ-MH) across low- and middle-income countries (LMICs)., Methods: This is an uncontrolled pre-post mixed methods feasibility study of READ-MH training at seven sites across five LMICs (China, Ethiopia, India, Nepal and Tunisia)., Outcome Measures: knowledge based on course content, attitudes to working to address the impact of stigma on service users and skills in responding constructively to service users' reports of discrimination. The training draws upon the evidence bases for stigma reduction, health advocacy and medical education and is tailored to sites through situational analyses. Its content, delivery methods and intensity were agreed upon through a consensus exercise with site research teams. READ-MH will be delivered to health professionals working in mental health care immediately after baseline data collection; outcome measures will be collected post-training and 3 months post-baseline, followed by qualitative data collection analysed using a combined deductive and inductive approach. Fidelity will be rated during the delivery of READ-MH, and data on training costs will be collected. Quantitative data will be assessed using generalised linear mixed models. Qualitative data will be evaluated by thematic analysis to identify feedback about the training methods and content, including the implementability of the knowledge and skills learned. Pooled and site-specific training costs per trainee and per session will be reported., Conclusions: The training development used a participatory and contextualised approach. Evaluation design strengths include the diversity of settings, the use of mixed methods, the use of a skills-based measure and the knowledge and attitude measures aligned to the target population and training. Limitations are the uncertain generalisability of skills performance to routine care and the impact of COVID-19 restrictions at several sites limiting qualitative data collection for situational analyses., (© 2022. The Author(s).)

Background: Involving patients and members of the public in healthcare planning is beneficial for many reasons including that the outcomes focus on topics relevant to service users. The National Early Inflammatory Arthritis Audit (NEIAA) aims to improve care quality for patients with inflammatory arthritis., Case Study: This paper presents a case study detailing how the NEIAA Patient Panel worked with NEIAA governance groups, the National Rheumatoid Arthritis Society and the National Axial Spondyloarthritis Society to co-create an outpatient clinic visit framework for rheumatology professionals. A framework was co-created, divided into nine sections: pre-appointment preparation, waiting area (face-to-face appointments), face-to-face consultations, physical examination, establishing a forward plan, post consultation, annual holistic reviews, virtual appointments and key considerations. Providing insight into how the multi-disciplinary team can meet the diverse needs of patients with inflammatory arthritis, this framework now informs the teaching content about people who live with physical and mental disability for Year 3 and 4 undergraduate medical students at King's College London., Conclusion: Patients play an important role in helping to address gaps in health service provision in England/Wales. The co-production of a clinic visit framework, informed by their own lived experience and their own expectations can lead to improved and relevant outcomes for the benefit of patients and raises awareness to medical students what matters to patients with physical disabilities when attending outpatient care., (© 2022. The Author(s).)

Background: Taking advantage of the rapidly increasing access to digital technology in low- and middle-income countries, the World Health Organization has launched an electronic version of the mental health Gap Action Programme intervention guide (emhGAP-IG). This is suitable for use on smartphones or tablets by non-specialist primary healthcare providers (PHCWs) to deliver evidence-based intervention for priority mental, neurological and substance use disorders. We assessed the perceptions of PHCWs on the feasibility, acceptability, and benefits of using smartphone-based clinical guidance and the emhGAP-IG in the management of people with mental health conditions in Nigeria.  METHODS: Exploration of the views of PHCWs from 12 rural and urban primary health clinics (PHCs) in South-Western Nigeria were carried out using 34 in-depth key informant qualitative interviews with nurses (n = 10), community health officers (n = 13) and community health extension workers (n = 11). An additional two focus group discussions, each comprising eight participants drawn from across the range of characteristics of PHCWs, were also conducted. Thematic analysis was conducted using a three-staged constant comparison technique to refine and categorise the data., Results: Three overall themes were identified around the use of clinical guidance and mobile applications (apps) in PHCs. Apps were deployed for purposes other than clinical consultation and decision making. Although paper-based guidance was the expected practice, its utilization is not fully embedded in routine care. An app-based decision-making tool was preferred to paper by PHCWs. Future usage of the emhGAP-IG would be facilitated by training and supporting of staff, helpful design features, and obtaining patients' buy-in., Conclusion: Our findings suggest that the emhGAP-IG could be a viable way to embed clinical guidance and decision-making tools in the management of people with mental health conditions in Nigerian PHCs., (© 2022. The Author(s).)

Purpose: Pain has psychological, social, physical and spiritual dimensions and therefore this experience is influenced by culture. The aim of this study was to explore the experiences and beliefs of Arab Muslim patients with low back pain (LBP) in Bahrain., Methods: We recruited Arab Muslim patients attending physiotherapy with LBP ≥3 months, and ≥18 years of age. Socio-demographic information and a Visual Analogue Scale (VAS) score for pain intensity were collected. Focus groups were conducted between 2013-2014, using pre-determined semi-structured interview questions. Qualitative content analysis was applied with single counting and inclusion of negative instances., Results: 18 participants attended three focus groups (14 females and 4 males) with a mean VAS(SD) = 5.28(±1.97). Five themes were identified; (1) loss of independence, (2)change in identity causes distress, (3) beliefs and attitudes towards low back pain, (4)trying to cope with LBP, and (5)experiences within the healthcare system., Conclusions: Religious and cultural beliefs influenced pain-related beliefs, fear-avoidance beliefs and catastrophizing. We recommend addressing cultural gender roles and using "active" forms of religious coping to inform treatment. Participants' experiences within and experiences of the healthcare system were similar to Western cultures. This encourages the application of Western findings into practice to facilitate the management of these patients.IMPLICATIONS FOR REHABILITATIONA qualitative exploration was undertaken to explore the experiences of Muslim and/or Arab patients with LBP.Our findings show that females have prioritised family needs over their own, primarily due to perceived gender roles.Contrary to previous findings labelling religious coping as a passive strategy, our findings suggest that religious coping strategies can be both positive and active strategies; such as participation in religious occasions and frequenting mosques.We support recommendations from Western literature to manage LBP; such as prioritising patient education and joint decision-making.

Purpose: Studies of mental illness stigma reduction interventions have been criticised for failing to evaluate behavioural outcomes and mechanisms of action. This project evaluates training for medical students entitled 'Responding to Experienced and Anticipated Discrimination' (READ), developed to focus on skills in addition to attitudes and knowledge. We aimed to (i) evaluate the effectiveness of READ with respect to knowledge, attitudes, and clinical communication skills in responding to mental illness-related discrimination, and (ii) investigate whether its potential effectiveness was mediated via empathy or/and intergroup anxiety., Methods: This is an international multisite non-randomised pre- vs post-controlled study. Eligible medical students were currently undertaking their rotational training in psychiatry. Thirteen sites across ten countries (n = 570) were included in the final analysis., Results: READ was associated with positive changes in knowledge (mean difference 1.35; 95% CI 0.87 to 1.82), attitudes (mean difference - 2.50; 95% CI - 3.54 to - 1.46), skills (odds ratio 2.98; 95% CI 1.90 to 4.67), and simulated patient perceived empathy (mean difference 3.05; 95% CI 1.90 to 4.21). The associations of READ with knowledge, attitudes, and communication skills but not with simulated patient perceived empathy were partly mediated through student reported empathy and intergroup anxiety., Conclusion: This is the first study to identify mediating effects of reduced intergroup anxiety and increased empathy in an evaluation of anti-stigma training that includes behavioural measures in the form of communication skills and perceived empathy. It shows the importance of both mediators for all of knowledge, skills, and attitudes, and hence of targeting both in future interventions., (© 2022. The Author(s).)

Background: There are around 250 million adolescents in India. Adolescents are vulnerable to common mental disorders with depression and self-harm accounting for a major share of the burden of death and disability in this age group. Around 20% of children and adolescents are diagnosed with/ or live with a disabling mental illness. A national survey has found that suicide is the third leading cause of death among adolescents in India. The authors hypothesise that an intervention involving an anti-stigma campaign co-created by adolescents themselves, and a mobile technology-based electronic decision support system will help reduce stigma, depression, and suicide risk and improve mental health for high-risk adolescents living in urban slums in India., Methods: The intervention will be implemented as a cluster randomised control trial in 30 slum clusters in each of the cities of Vijayawada and New Delhi in India. Adolescents aged 10 to 19 years will be screened for depression and suicide ideation using the Patient Health Questionnaire (PHQ-9). Two evaluation cohorts will be derived-a high-risk cohort with an elevated PHQ-9 score ≥ 10 and/or a positive response (score ≥ 2) to the suicide risk question on the PHQ-9, and a non-high-risk cohort comprising an equal number of adolescents not at elevated risk based on these scores., Discussion: The key elements that ARTEMIS will focus on are increasing awareness among adolescents and the slum community on these mental health conditions as well as strengthening the skills of existing primary healthcare workers and promoting task sharing. The findings from this study will provide evidence to governments about strategies with potential for addressing the gaps in providing care for adolescents living in urban slums and experiencing depression, other significant emotional or medically unexplained complaints or increased suicide risk/self-harm and should have relevance not only for India but also for other low- and middle-income countries., Trial Status: Protocol version - V7, 20 Dec 2021 Recruitment start date: tentatively after 15th July 2022 Recruitment end date: tentatively 14th July 2023 (1 year after the trial start date) TRIAL REGISTRATION: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries ( https://www.who.int/clinical-trials-registry-platform/network/primary-registries ) Reference No. CTRI/2022/02/040307 . Registered on 18 February 2022. The tentative start date of participant recruitment for the trial will begin after 15th July 2022., (© 2022. The Author(s).)