Understanding the Acceptability of Broadly Neutralizing Antibodies for HIV Prevention Among At-Risk Populations and Feasibility Considerations for Product Introduction in India: Protocol for a Qualitative Study.

BACKGROUND: Acceptability and preference research play a crucial role in the design, evaluation, and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidelines and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products worldwide. As clinical development strategies are being developed for clinical studies of broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring them to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increase access to these products and national policies supportive of access to health care for those in most need. Thus, it is both opportune and important to undertake focused efforts toward informing product development strategies. OBJECTIVE: This study aims to understand preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers, men who have sex with men, transgender women, people who inject drugs, and adolescent girls and young women in India and understand the key health system and programmatic perspectives toward the introduction of bNAb prevention products from health service providers and policy makers in India. METHODS: A multisite study will be conducted in Delhi, Mumbai, and Chennai to capture the differences in perspectives among diverse end-users and key informants across the country. The study will use a multimethods design using focus group discussions, in-depth interviews, simulated behavioral experiments, and key informant interviews. A total of 30 focus group discussions, 45 in-depth interviews, 15 simulated behavioral experiments sessions, and 15 key informant interviews will be conducted across 3 sites. RESULTS: The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social, and structural levels; and relative positioning of bNAb products among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape and what additional efforts and resources are required for potential introduction, delivery, and uptake of the bNAb products in the Indian context. CONCLUSIONS: Insights generated from the abovementioned objectives will represent perspectives of populations of interest across geographies in India, will provide an overview of the acceptability of bNAb products and the feasibility of their introduction in this region, and will inform product development strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47700.

Engagement of vulnerable communities in HIV prevention research in India: a qualitative investigation.

BACKGROUND: Meaningful community engagement (CE) in HIV prevention research is crucial for successful and ethically robust study implementation. We conducted a qualitative study to understand the current CE practices in HIV prevention research and to identify expressed and implicit reasons behind translational gaps highlighted by communities and researchers. METHODS: For this exploratory qualitative study, we recruited a purposive sample of participants from Indian government-recognised key populations such as men who have sex with men, transgender women, people who inject drugs and female sex workers; general population adults and adolescents/youth; and researchers. We conducted 13 virtual focus groups (n = 86) between July and October 2021. Data were explored from a critical realist perspective and framing analysis (i.e., examining how the participants framed the narratives). RESULTS: Participants reported that study communities, especially those from key populations, were primarily involved in data collection, but not necessarily with optimal training. Involvement of communities before the start of the study (e.g., obtaining feedback on the study's purpose/design) or once the study is completed (e.g., sharing of findings) were highlighted as priorities for meaningful engagement. Participants suggested meaningful CE in all stages of the study: (1) before the study-to get inputs in finalising the study design, drafting comprehensible informed consent forms and culturally-appropriate data collection tools, and deciding on appropriate monetary compensation; (2) during the study-adequate training of community field research staff; and (3) after the study-sharing the draft findings to get community inputs, and involving communities in advocacy activities towards converting evidence into action, policy or programs. Timely and transparent communications with communities were explicitly stated as critical for gaining and maintaining trust. Mutual respect, reciprocity (e.g., appropriate monetary compensation) and robust community feedback mechanisms were considered critical for meaningful CE. CONCLUSIONS: The findings highlighted the translational gaps and priority areas for capacity building to strengthen CE in HIV prevention research. It is not only important to engage communities at various stages of research but to understand that trust, dignity, respect, and reciprocity are fundamentally preferred ways of meaningful community engagement.

Engaging communities in HIV prevention research enhances the rigour and impact of research. We sought to understand the current community engagement practices and to identify how communities preferred to get involved in research. We explored these topics with key and general populations and researchers, by conducting 13 focus group discussions with 86 participants. We found that there was limited involvement of communities before the start of the study and after its completion, although trained community members were involved in data collection. Participants strongly suggested that the community should be involved throughout­before initiation, during the study and after study completion. Participants' preferred ways of engaging communities reflected that mutual respect, reciprocity and transparent communications are critical for meaningful and successful community engagement.

The Golden Patient Initiative: A Systematic Review.

Operating theatres and surgical resource consumption comprise a significant proportion of healthcare costs. Inefficiencies in theatre lists remain an important focus for cost management, along with reducing patient morbidity and mortality. With the emergence of the coronavirus disease 2019 (COVID-19) pandemic, the number of patients on theatre waiting lists has surged. Hence, there is a pressing need to utilise the already limited theatre time and fraught resources with innovative methods. In this systematic review, we discuss the Golden Patient Initiative (GPI), in which the first patient on the operating list is pre-assessed the day prior to surgery, and we aim to assess its impact and overall efficacy. A literature search using the following four databases was conducted to identify and select all clinical research concerning the GPI: Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE), and the Cochrane library. Two independent authors screened articles against the eligibility criteria, using a process adapted from the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data extracted included outcomes measured, follow-up period, and study design. The results showed significant heterogeneity, and hence a narrative review was conducted; 13 of the 73 eligible articles were included for analysis. Outcomes included delay in theatre start time, number of surgical case cancellations, and changes to total case numbers. Across the studies, a 19-30-minute improvement in theatre start time was reported (p<0.05), as well as a statistically significant decrease in case cancellations. Our analysis provides encouraging conclusions with regard to greater theatre efficiency following the application of GPI, a low-cost solution that can easily be implemented to help improve patient safety and lead to cost savings. However, at present, it is largely implemented among local trusts, and hence larger multi-centre studies are required to gather conclusive evidence about the efficacy of the initiative.

Evidence and gap map report: Social and Behavior Change Communication (SBCC) interventions for strengthening HIV prevention and research among adolescent girls and young women (AGYW) in low- and middle-income countries (LMICs).

Background: Adolescent girls and young women (AGYW), aged 15-24 years, are disproportionately affected by HIV and other sexual and reproductive health (SRH) risks due to varying social, cultural, and economic factors that affect their choices and shape their knowledge, understanding, and practices with regard to their health. Socio-Behavioral Change Communication (SBCC) interventions targeted at strengthening the capabilities of individuals and their networks have supported the demand and uptake of prevention services and participation in biomedical research. However, despite growing global recognition of the domain, high-quality evidence on the effectiveness of SBCC remains scattered. This evidence and gap map (EGM) report characterizes the evidence base on SBCC interventions for strengthening HIV Prevention and Research among AGYW in low- and middle-income countries (LMICs), identifying evidence gaps and outlining the scope of future research and program design. Objectives: The objectives of the proposed EGM are to: (a) identify and map existing EGMs in the use of diverse SBCC strategies to strengthen the adoption of HIV prevention measures and participation in research among AGYW in LMICs and (b) identify areas where more interventions and evidence are needed to inform the design of future SBCC strategies and programs for AGYW engagement in HIV prevention and research. Methods: This EGM is based on a comprehensive search of systematic reviews and impact evaluations corresponding to a range of interventions and outcomes-aimed at engaging AGYW in HIV prevention and research - that were published in LMICs from January 2000 to April 2021. Based on guidance for producing a Campbell Collaboration EGM, the intervention and outcome framework was designed in consultation with a group of experts. These interventions were categorized across four broad intervention themes: mass-media, community-based, interpersonal, and Information Communication and Technology (ICT)/Digital Media-based interventions. They were further sub-categorized into 15 intervention categories. Included studies looked at 23 unique behavioral and health outcomes such as knowledge attitude and skills, relationship dynamics, household dynamics, health care services, and health outcomes and research engagement. The EGM is presented as a matrix in which the rows are intervention categories/sub-categories, and the columns are outcome domains/subdomains. Each cell is mapped to an intervention targeted at outcomes. Additional filters like region, country, study design, age group, funding agency, influencers, population group, publication status, study confidence, setting, and year of publication have been added. Selection Criteria: To be eligible, studies must have tested the effectiveness of SBCC interventions at engaging AGYW in LMICs in HIV prevention and research. The study sample must have consisted of AGYW between the ages of 15-24, as defined by UNAIDS. Both experimental (random assignment) and quasi-experimental studies that included a comparison group were eligible. Relevant outcomes included those at the individual, influencer, and institutional levels, along with those targeting research engagement and prevention-related outcomes. Results: This EGM comprises 415 impact evaluations and 43 systematic reviews. Interventions like peer-led interactions, counseling, and community dialogues were the most dominant intervention sub-types. Despite increased digital penetration use of media and technology-driven interventions are relatively less studied. Most of the interventions were delivered by peers, health care providers, and educators, largely in school-based settings, and in many cases are part of sex-education curricula. Evidence across geographies was mostly concentrated in Sub-Saharan Africa (70%). Most measured outcomes focused on disease-related knowledge dissemination and enhancing awareness of available prevention options/strategies. These included messaging around consistent condom use, limiting sexual partners, routine testing, and awareness. Very few studies were able to include psychographic, social, and contextual factors influencing AGYW health behaviors and decisions, especially those measuring the impact of social and gender norms, relationship dynamics, and household dynamics-related outcomes. Outcomes related to engagement in the research were least studied. Conclusion: This EGM highlights that evidence is heavily concentrated within the awareness-intent spectrum of behavior change and gets lean for outcomes situated within the intent-action and the action-habit formation spectrum of the behavior change continuum. Most of the evidence was concentrated on increasing awareness, knowledge, and building risk perception around SRH domains, however, fewer studies focused on strengthening the agency and self-efficacy of individuals. Similarly, evidence on extrinsic factors-such as strengthening social and community norms, relationships, and household dynamics-that determine individual thought and action such as negotiation and life skills were also found to be less populated. Few studies explore the effectiveness of these interventions across diverse AGYW identities, like pregnant women and new mothers, sex workers, and people living with HIV, leading to limited understanding of the use of these interventions across multiple user segments including key influencers such as young men, partners, families, religious leaders, and community elders was relatively low. There is a need for better quality evidence that accounts for the diversity of experiences within these populations to understand what interventions work, for whom, and toward what outcome. Further, the evidence for use of digital and mass-media tools remains poorly populated. Given the increasing penetration of these tools and growing media literacy on one end, with widening gender-based gaps on the other, it is imperative to gather more high-quality evidence on their effectiveness. Timely evidence generation can help leverage these platforms appropriately and enable intervention designs that are responsive to changing communication ecologies of AGYW. SBCC can play a critical role in helping researchers meaningfully engage and collaborate with communities as equal stakeholders, however, this remains poorly evidenced and calls for investigation and investment. A full list of abbreviations and acronyms are available in Supporting Information: Appendix F.

Orthopaedics and the gender pay gap: A systematic review.

AIMS: Gender pay gaps are present in a wide range of industries, with the medical profession being no exception. The aim of this systematic review was to analyse the peer-reviewed literature to identify whether there is a gender pay gap in orthopaedics. METHODS: A systematic review was conducted by searching the following databases: MEDLINE, Health & Medical Collection, Nursing & Allied Health Database, Publicly Available Content Database, Consumer Health Database and Healthcare Administration Database. Original research papers pertaining to the earnings of male and female orthopaedic surgeons were included for review. RESULTS: Of 745 papers acquired through the database search, 12 were eligible for inclusion. These were published in the USA, Canada and Taiwan. 6 looked at the relationship between sex and annual income, 4 studied industry payments, one analysed hourly earnings and one compared payments per case between males and females. Men were found to earn significantly higher annual incomes than women, even when confounding factors such as rank, practice setting and subspeciality were accounted for. Men also receive significantly higher payments from industry, and earn more per hour than women. CONCLUSION: This systematic review has demonstrated that there is a gender pay gap in orthopaedics, with women commonly earning significantly less than their male colleagues. The reasons for this, however, remain unclear, and deserve further investigation. It is incumbent upon orthopaedic departments, healthcare providers and orthopaedic associations to raise awareness and ensure that men and women are paid the same for equal work.

Expert clinical consensus in the delivery of hydrodilatation for the management of patients with a primary frozen shoulder : a modified Delphi study.

AIMS: To achieve expert clinical consensus in the delivery of hydrodilatation for the treatment of primary frozen shoulder to inform clinical practice and the design of an intervention for evaluation. METHODS: We conducted a two-stage, electronic questionnaire-based, modified Delphi survey of shoulder experts in the UK NHS. Round one required positive, negative, or neutral ratings about hydrodilatation. In round two, each participant was reminded of their round one responses and the modal (or 'group') response from all participants. This allowed participants to modify their responses in round two. We proposed respectively mandating or encouraging elements of hydrodilatation with 100% and 90% positive consensus, and respectively disallowing or discouraging with 90% and 80% negative consensus. Other elements would be optional. RESULTS: Between 4 August 2020 and 4 August 2021, shoulder experts from 47 hospitals in the UK completed the study. There were 106 participants (consultant upper limb orthopaedic surgeons, n = 50; consultant radiologists, n = 52; consultant physiotherapist, n = 1; extended scope physiotherapists, n = 3) who completed round one, of whom 97 (92%) completed round two. No elements of hydrodilatation were "mandated" (100% positive rating). Elements that were "encouraged" (≥ 80% positive rating) were the use of image guidance, local anaesthetic, normal saline, and steroids to deliver the injection. Injecting according to patient tolerance, physiotherapy, and home exercises were also "encouraged". No elements were "discouraged" (≥ 80% negative rating) although using hypertonic saline was rated as being "disallowed" (≥ 90% negative rating). CONCLUSION: In the absence of rigorous evidence, our Delphi study allowed us to achieve expert consensus about positive, negative, and neutral ratings of hydrodilatation in the management of frozen shoulder in a hospital setting. This should inform clinical practice and the design of an intervention for evaluation.Cite this article: Bone Jt Open 2022;3(9):701-709.

PROTOCOL: Social and behaviour change communication interventions for strengthening HIV prevention and research among adolescent girls and young women in low- and middle-income countries: An evidence and gap map.

Despite progress in several dimensions of the global HIV response, there seems to be a significant gender and age disparity. Numerous organizations consider it a top priority to accelerate HIV prevention programming among Adolescent Girls and Young Women (AGYW) as unequal gender norms, limited agency and voice, and reduced access to resources put them at higher HIV risk. Gender and age have also been identified as critical gaps within prevention research to ensure the development of biomedical interventions that are responsive to the biological and social needs of AGYW. Towards this, the objectives of the proposed evidence and gap map are to; identify and map existing evidence and gaps on the use of diverse Social and Behaviour Change Communication (SBCC) strategies to strengthen adoption of HIV prevention measures and participation in research among AGYW in LMICs; and, identify areas where more interventions and evidence are needed to inform the design of future SBCC strategies and programs for AGYW engagement in HIV prevention and research.

The Ellipse modification of the Friedman method for measuring glenoid version.

AIMS: Accurate measurement of the glenoid version is important in performing total shoulder arthroplasty (TSA). Our aim was to evaluate the Ellipse method, which involves formally defining the vertical mid-point of the glenoid prior to measuring the glenoid version and comparing it with the 'classic' Friedman method. METHODS: This was a retrospective study which evaluated 100 CT scans for patients who underwent a primary TSA. The glenoid version was measured using the Friedman and Ellipse methods by two senior observers. Statistical analyses were performed using the paired t-test for significance and the Bland-Altman plot for agreement. RESULTS: The mean glenoid version was -3.11° (-23.8° to 17.9°) using the Friedman method and -1.95° (-29.8° to 24.6°) using the Ellipse method (p = 0.002). In 16 patients the difference between methods was greater than 5°, which we considered to be clinically significant. There was poor agreement between methods with relatively large 95% limits of agreement. There was excellent inter-rater agreement between the observers for the Ellipse method and similarly, the intrarater agreement was excellent with a repeatability coefficient of 0.94. CONCLUSION: We recommend the use of the Ellipse modification to define the mid glenoid point prior to measuring the glenoid version in patients undergoing TSA. Cite this article: Bone Joint J 2020;102-B(2):232-238.