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Clinical trials are essential for evaluating the safety and efficacy of new medical interventions, ensuring evidence-based advancements in healthcare. They play a critical role in improving patient outcomes and guiding regulatory approvals for new treatments. India has emerged as a key player in clinical trials, owing to its skilled manpower, state-of-art infrastructure and robust regulatory framework. The manuscript has been written with the objectives of summarising the key imperatives of clinical trial administration including strategic planning, focusing on the development of protocol, appropriate study designs and the establishment of SMART objectives. It further emphasises regulatory compliance, ethics and the selection of study sites based on epidemiological and infrastructural factors. The role of data management, especially electronic data capture, and the necessity of robust monitoring, including risk-based approaches, are then highlighted. The document also addresses common challenges such as patient recruitment, retention, budgeting and site coordination, and proposes solutions, such as leveraging technology and ensuring ethical standards. Finally, it examines the complexities of multi-centric clinical trials, offering strategies for overcoming these hurdles.

Abstract US President’s Emergency Plan for HIV/AIDS has been credited with saving 25 million lives in sub-Sahara Africa and, as such, constitutes a preeminent US foreign policy achievement of the twenty-first century. However, the implementation of effective HIV/AIDS pharmacological interventions remains a challenge in rural Kenyan communities. Of particular importance are patient retention and care engagement and their interaction with age disparities that are sensitive to different socioeconomic contexts, as well as time-in-treatment. For the first time, we perform an intermediation and triple interaction intent-to-treat secondary analysis on a social network-based randomized controlled trial. We hypothesize that the temporal interactions of critical demographic features with a treatment/control indicator variable may significantly explain patient retention and that these results are intermediated by social network phenomena. We find that not only does extended time-in-treatment significantly improve primary outcomes, but the threefold interaction along with age and treatment itself is sufficiently flexible to fit the data remarkably well without unnecessary elaboration, an effect that is mediated via internalized stigma. This strongly suggests that patient retention varies by age group. Rather than deploying one-size-fits-all solutions, foreign and public policymakers should invest in research that considers how interventions might be optimized for different ages. Trial registration Clinical Trial Number. NCT02474992 (note: the main trial report was published here https://doi.org/10.1371/journal.pone.0255945 .) Date of submission: June 6, 2015.

US President's Emergency Plan for HIV/AIDS has been credited with saving 25 million lives in sub-Sahara Africa and, as such, constitutes a preeminent US foreign policy achievement of the twenty-first century. However, the implementation of effective HIV/AIDS pharmacological interventions remains a challenge in rural Kenyan communities. Of particular importance are patient retention and care engagement and their interaction with age disparities that are sensitive to different socioeconomic contexts, as well as time-in-treatment. For the first time, we perform an intermediation and triple interaction intent-to-treat secondary analysis on a social network-based randomized controlled trial. We hypothesize that the temporal interactions of critical demographic features with a treatment/control indicator variable may significantly explain patient retention and that these results are intermediated by social network phenomena. We find that not only does extended time-in-treatment significantly improve primary outcomes, but the threefold interaction along with age and treatment itself is sufficiently flexible to fit the data remarkably well without unnecessary elaboration, an effect that is mediated via internalized stigma. This strongly suggests that patient retention varies by age group. Rather than deploying one-size-fits-all solutions, foreign and public policymakers should invest in research that considers how interventions might be optimized for different ages. Trial registration Clinical Trial Number. NCT02474992 (note: the main trial report was published here https://doi.org/10.1371/journal.pone.0255945.) Date of submission: June 6, 2015. [ABSTRACT FROM AUTHOR]

Clinical trials are essential for evaluating the safety and efficacy of new medical interventions, ensuring evidence-based advancements in healthcare. They play a critical role in improving patient outcomes and guiding regulatory approvals for new treatments. India has emerged as a key player in clinical trials, owing to its skilled manpower, state-of-art infrastructure and robust regulatory framework. The manuscript has been written with the objectives of summarising the key imperatives of clinical trial administration including strategic planning, focusing on the development of protocol, appropriate study designs and the establishment of SMART objectives. It further emphasises regulatory compliance, ethics and the selection of study sites based on epidemiological and infrastructural factors. The role of data management, especially electronic data capture, and the necessity of robust monitoring, including risk-based approaches, are then highlighted. The document also addresses common challenges such as patient recruitment, retention, budgeting and site coordination, and proposes solutions, such as leveraging technology and ensuring ethical standards. Finally, it examines the complexities of multi-centric clinical trials, offering strategies for overcoming these hurdles. [ABSTRACT FROM AUTHOR]

BACKGROUND: Among patients who express interest in bariatric surgery, dropout rates from bariatric surgery programs are reported as high as 60%. There is a lack of understanding how we can better support patients to obtain treatment of this serious chronic disease. METHODS: Semi-structured interviews with individuals who dropped out of bariatric surgery programs from three clinical sites were conducted. Transcripts were iteratively analyzed to understand patterns clustering around codes. We mapped these codes to domains of the Theoretical Domains Framework (TDF) which will serve as the basis of future theory-based interventions. RESULTS: Twenty patients who self-identified as 60% female and 85% as non-Hispanic White were included. The results clustered around codes of perceptions of bariatric surgery, reasons for not undergoing surgery, and factors for re-considering surgery. Major drivers of attrition were burden of pre-operative workup requirements, stigma against bariatric surgery, fear of surgery, and anticipated regret. The number and time for requirements led patients to lose their initial optimism about improving health. Perceptions regarding being seen as weak for choosing bariatric surgery, fear of surgery itself, and possible regret over surgery grew as time passed. These drivers mapped to four TDF domains: environmental context and resources, social role and identity, emotion, and beliefs about consequences, respectively. CONCLUSIONS: This study uses the TDF to identify areas of greatest concern for patients to be used for intervention design. This is the first step in understanding how we best support patients who express interest in bariatric surgery achieve their goals and live healthier lives.

Abstract Hypertension is a global health challenge, especially in low‐to‐middle‐income countries, where awareness and control are suboptimal. Despite available treatments, poor medication adherence hampers blood pressure control, leading to adverse outcomes and increased costs. In response, the GOI has initiated national action plans to address noncommunicable diseases, including hypertension. The study aimed to analyze patient retention rates in hypertension treatment across healthcare levels and understand providers' and patients' perspectives on control factors. Using a mixed‐method concurrent design in a North Indian district, retrospective data collection covered hypertensive patients registered from January 2020 to July 2020, followed for a year (August 2020–July 2021). Quantitative data included socio‐demographic characteristics and patient follow‐up rates. Qualitative data comprised focus group discussions (FGD) and in‐depth interviews (IDI) with healthcare providers (HCPs) and patients. Findings identified challenges in patient retention and medication adherence, notably among females and at higher‐level healthcare facilities, leading to substantial loss of follow‐up. Only 63% of hypertensive outpatients maintained controlled blood pressure in the past year. Male patients exhibited more consistent attendance than females. Despite sufficient HCP knowledge, patient retention was better at Health and Wellness Centers (HWCs) levels, while blood pressure control was poorer at higher facilities. Barriers such as medication side effects, pill burden, and limited healthcare access hindered hypertension control, highlighting the need for improved primary care services, including extended clinic hours and diagnostic facilities. Improving hypertension control requires addressing medication adherence and healthcare access barriers. Strengthening primary care services and implementing patient‐centered interventions are crucial steps.

Hypertension is a global health challenge, especially in low‐to‐middle‐income countries, where awareness and control are suboptimal. Despite available treatments, poor medication adherence hampers blood pressure control, leading to adverse outcomes and increased costs. In response, the GOI has initiated national action plans to address noncommunicable diseases, including hypertension. The study aimed to analyze patient retention rates in hypertension treatment across healthcare levels and understand providers' and patients' perspectives on control factors. Using a mixed‐method concurrent design in a North Indian district, retrospective data collection covered hypertensive patients registered from January 2020 to July 2020, followed for a year (August 2020–July 2021). Quantitative data included socio‐demographic characteristics and patient follow‐up rates. Qualitative data comprised focus group discussions (FGD) and in‐depth interviews (IDI) with healthcare providers (HCPs) and patients. Findings identified challenges in patient retention and medication adherence, notably among females and at higher‐level healthcare facilities, leading to substantial loss of follow‐up. Only 63% of hypertensive outpatients maintained controlled blood pressure in the past year. Male patients exhibited more consistent attendance than females. Despite sufficient HCP knowledge, patient retention was better at Health and Wellness Centers (HWCs) levels, while blood pressure control was poorer at higher facilities. Barriers such as medication side effects, pill burden, and limited healthcare access hindered hypertension control, highlighting the need for improved primary care services, including extended clinic hours and diagnostic facilities. Improving hypertension control requires addressing medication adherence and healthcare access barriers. Strengthening primary care services and implementing patient‐centered interventions are crucial steps. [ABSTRACT FROM AUTHOR]

Background Randomised controlled trials (‘trials’) are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures Number of host trials funded. Results Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information. Plain language summary Aims of the research A Study Within A Trial is a research study nested inside a larger ‘host trial’, promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. Background The best way to test health and social care treatments is to do a randomised controlled trial (‘trial’), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Methods Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. Results We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found ‘pre-notifying’ before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Conclusions Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future. Scientific summary Background Many delivery aspects of randomised controlled trials (RCTs) have not been subjected to rigorous evaluation. Strategies to enhance recruitment and retention often tend to not be based on evidence. However, there is an increasing interest in embedding RCTs of such strategies. The Medical Research Council (MRC) funded systematic techniques for assisting recruitment to trials (START), which found it feasible to test two strategies for recruitment and retention across a number of trials by performing randomised ‘Studies Within A Trial (SWATs)’. Aims The aim of the PROMoting THE USE of Studies Within A Trial (PROMETHEUS) programme was to build on the START initiative and make embedding SWATs standard practice across Clinical Trials Units (CTUs). We intended to pump prime and facilitate the start of at least 25 SWATs across multiple CTUs within 30 months. The ultimate aim was to make the inclusion of SWATs routine when conducting a trial in a CTU. We share our experience of delivering the PROMETHEUS programme, along with the lessons learnt for undertaking randomised SWATs of recruitment and retention methods. Methods A network of 10 CTUs and one primary care research centre committed to conducting randomised controlled SWATs of recruitment and/or retention interventions was established by the PROMETHEUS team. We identified promising recruitment and retention interventions from a variety of sources including Cochrane systematic reviews, the Northern Ireland Network for Trial Methodology Research SWAT Repository Store, and existing prioritisation exercises. Promising strategies were reviewed by our patient and public (PPI) members to create an initial priority list of seven recruitment and eight retention interventions. The programme allowed host trial teams to apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement and report SWATs. We also tested the feasibility of undertaking co-ordinated SWATs, across multiple host trials simultaneously. Results The PROMETHEUS programme funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The mean cost of a funded SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT across multiple host trials using a co-ordinated SWAT design and four tested more than one strategy in a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. In the space of just 4 years, PROMETHEUS will add 18% more SWATs to the Cochrane review of global recruitment strategies, and 79% more SWATs to the Cochrane review of global retention strategies. The results from the SWATs reported to date found there was no evidence of a significant difference in recruitment for any of the strategies tested. For retention, pre-notifying participants by card prior to sending questionnaires was effective [risk difference 3.3%, 95% confidence interval (CI) −3.0% to 9.6%]; as was pre-notifying participants by letter or e-mail (risk difference 3.8%, 95% CI −6.1% to 13.6%). Sending personalised text messages was more effective for improving the return of postal questionnaires compared to non-personalised text messages (risk ratio 1.16, 95% CI 1.00 to 1.33); and resulted in fewer completions via telephone compared with a non-personalised text [adjusted odds ratio (OR) 0.44, 95% CI 0.22 to 0.87]. Including a pen with a questionnaire probably increases retention and response rate (pooled OR 1.21, 95% CI 1.09 to 1.35). We highlight key lessons learnt below (see Recommendations section). Conclusions The PROMETHEUS programme significantly increased the international evidence base for both recruitment and retention strategies within RCTs. The funded SWATs evaluated a wide range of recruitment and retention strategies; however, the COVID-19 pandemic negatively impacted five funded SWATs, with two being delayed and three prematurely terminated. Through this project, we identified that when provided with both funding and practical support, host trial teams successfully implemented SWATs. PROMETHEUS led to an overall increase in the evidence base; however, ongoing ‘routine’ application of SWATs across RCTs employing the lessons learnt is required to ensure that efficient trial conduct strategies are identified. Recommendations Recommendations for funders All trial funders should contribute to the effort to improve the efficiency of trials. Funders should encourage the teams that they fund to undertake SWATs. Funding streams specifically designed to support SWATs must be made available to trial teams to continue building the trial process evidence base, for recruitment and retention as well as for other stages of the trial design and delivery process. This includes funding streams for undertaking specific SWATs, as well as infrastructure funding to support CTUs and other centres to undertake co-ordination activities that will support the design, conduct, reporting, and implementation of SWATs and their findings to inform the work of the National Institute for Health and Care Research (NIHR), the MRC, and other funders. PROMETHEUS has demonstrated that co-ordination of activity remains crucial to the delivery of SWATs. A central, national co-ordination point that provides hands-on support needs to continue and funding should be allocated for this. Additionally, CTUs should identify a lead for SWATs, to support SWAT activities and evidence-based trial conduct within the CTU, as well as links with others undertaking SWATs elsewhere to share best practice. The funding for both central and CTU-based support should be ongoing. SWAT priorities need to be identified and communicated clearly to funders, and funders should use these priorities to inform their funding decisions. Funders should develop a mechanism to promote SWAT questions that have been identified as a priority during the funding application process. The mean cost of funding requested for a standalone SWAT within PROMETHEUS was £3535 (range £500–5000). The co-ordinated SWATs cost was £10,668 (training SWAT) and £1306.40 (Christmas cards); however, these did not include costs for central co-ordination, data preparation and sharing by the host trial teams, data cleaning, analysis and write-up. These costs suggest that the £10,000 being offered by the NIHR for trial teams to include a SWAT should be sufficient for most planned SWATs. However, there may be occasions where trial teams may wish to test strategies that may be more expensive. When applying for SWAT funding, trial teams should be asked to indicate whether the question they are addressing is a priority SWAT question, and to provide a clear rationale for selecting that particular question. If teams are unable to undertake a SWAT, funders should ask that recruitment and retention methods are clearly reported to support the evidence base. Recommendations for Sponsors Our experience suggests that there is a need for clear, easily accessible information about the nature of SWATs, as well as the role of the funder in supporting SWATs. Any future changes proposed by the Health Research Authority (HRA) to the approvals process need to be communicated clearly and applied consistently to each SWAT. Recommendations for involving patient and public involvement partners in Studies Within A Trial research PPI should be considered when undertaking a SWAT, in the same way PPI is expected to be undertaken in the main trial. PPI partners should be involved to develop novel and untested recruitment and retention strategies, as well as to adapt existing strategies to the context of their specific host trial and the population being enrolled. Recommendations for oversight committees Our experience suggests that Trial Management Groups (TMGs) play a key role in decisions about whether a SWAT is undertaken and continued in the host trial or not. TMG members should encourage the uptake of SWATs in their trials. While the findings of SWATs may not always directly inform their host trial, the findings of SWATs undertaken during the early, or internal pilot, phase of the trial may inform the decisions about which strategies should be used at a later stage, such as in the main trial. Trial Steering Committees should review the SWAT activity and progress, in the same way that they review substudies in a trial. Data Monitoring Committee review is dependent on the specific host trial and SWAT strategy being evaluated. Recommendations for journals and reviewers Journal peer reviewer profiles should be updated to include methodological interests and expertise, to support evidence of suitability to undertake a peer review for a SWAT. When selecting peer reviewers, the SWAT and methodology interests as registered by reviewers should be used where possible. SWATs are a niche area and so to increase the pool of reviewers, journals should consider being more flexible when assessing reviewer credentials to review a SWAT, such as allowing relevant experience in place of a PhD. Reviewers should be advised that in many instances informed consent from participants need not be obtained when undertaking a SWAT, due to the low risk associated with the intervention and in the case of retention SWATs due to existing consent for further research being in place. This may depend on the jurisdiction. In the UK, this approach is supported by HRA guidance in relation to grading for SWAT interventions and approvals. Robust and transparent reporting is necessary, that is compliant with CONsolidated Standards Of Reporting Trials (CONSORT). Recommendations for trial teams and methodologists undertaking SWAT research There remains a need for continually updated research priorities to allow researchers to address the questions relevant at that time. When SWAT priorities are set, methodologists need to provide enough information to enable teams to make informed decisions about evaluating the priorities set. Further work is needed to help teams identify suitable SWAT strategies for their host trials. SWAT priorities need to be communicated clearly and consistently to trial teams. Recommendation for trial conduct and using SWAT evidence As the evidence base develops for effective and cost-effective recruitment and retention strategies, it will become increasingly important for trial teams to use this evidence base to inform their recruitment and retention activities. Trial teams need to actively engage with the evidence base to inform their practice. Funders will need to actively support the trials they fund to use evidence-informed recruitment and retention strategies. Recommendations for future research There remains a substantial need for more high-quality SWAT evidence and so Chief Investigators should be encouraged to consider the embedding of a SWAT at the funding stage. Further work is therefore needed to increase the awareness of the methodological importance of SWAT research with research teams, and to develop engagement strategies to increase SWAT activity. Future research needs to focus on identifying whether further replications are needed for existing evidence. If so, the gaps in the evidence base should be targeted. More co-ordination and replication of SWAT evaluations are encouraged. A ‘real-time’ and dynamic communication strategy including a clear cost and resource breakdown for each suggested SWAT should be developed. This will alleviate the burden on trials teams to begin costing exercises and enable them to make an informed decision more quickly as to whether they can embed a given SWAT. There is a need to aid teams to identify and select a suitable SWAT for their host trial populations. Pragmatic decisions on which SWAT may be appropriate and feasible to include should be taken as required. A mechanism to communicate SWAT research priorities is needed, and this information needs to be readily accessible for all trialists to refer to. Our findings demonstrate that within an individual host trial, there is often a capacity to address more than one SWAT question, either separately, or simultaneously using a factorial design. This suggests that there is a capacity to significantly speed up and strengthen the evidence base through teams undertaking more than one SWAT in their trials where relevant. For certain strategies, co-ordinated SWATs should be encouraged. This method could be used to rapidly replicate SWAT evaluations to plug the evidence gap, as well as to evaluate more complex recruitment and retention strategies that may be more challenging to undertake using individual SWATs. Materials should be developed to advise teams on how to undertake co-ordinated SWATs, as well as a method of networking to enable teams to promote their co-ordinated SWAT and collaborate. As the evidence base develops, it will become increasingly important for trialists to utilise the evidence base in a systematic way to identify both effective and ineffective strategies to inform their practice. Future work should therefore consider issues around the dissemination and implementation of SWATs and develop guidance to enable the wider trials community to undertake, report and adopt the findings of SWATs. Implementation science, the study of methods to promote the uptake of evidence-based practice, could be used to inform any such future work. Funders can also help by questioning strategies proposed by trial teams that are known to be either ineffective or not cost-effective. Improving the knowledge of the potential ‘harms’ from implementing interventions that have no evidence of benefit is an important next step to help improve uptake. While establishing the effectiveness of recruitment or retention strategies is important, the high costs of research waste and limited public finance mean that cost considerations around SWATs are just as important. With only one retention strategy having high Grading of Recommendations, Assessment, Development and Evaluations (GRADE) certainty of cost effectiveness, we encourage trial teams to undertake streamlined economic evaluations alongside all their SWATs in the future, for strategies shown to be effective, as well as those that are ineffective. For cost effectiveness, trial teams should look to report the cost per additional participant recruited or retained (i.e. the incremental cost-effectiveness ratio). Value of information analyses can help determine the need for further SWAT evidence where several SWATs already exist. Many trial teams wish to contribute to developing the evidence base by undertaking non-randomised SWATs. Future work that informs the development of guidance for undertaking non-randomised SWATs would be helpful. Working with trial teams to develop engagement strategies and training to undertake SWATs would be beneficial. Audience specific guidance should be developed to support SWAT research. Trial teams have expressed they want to undertake SWATs that are important and necessary to increase the evidence base. Collaboration with funders, working groups involved in priority setting, and trial teams is needed to develop a mechanism to communicate this dynamic and evolving information once priority SWATs have been identified. Work is needed to identify the barriers that teams have when undertaking a SWAT, and strategies and solutions for addressing these barriers should be identified and implemented. Continued and proactive collaboration is needed with working groups to enable networking, and collaboration with teams undertaking SWAT research. Reporting guidance is needed to support teams when writing publications to ensure sufficient information is included to GRADE evaluation can be undertaken. Study registration All SWATs in the PROMETHEUS programme had to be registered with the Northern Ireland Network for Trials Methodology Research SWAT Repository. Funding details This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

Abstract Background: We describe a retrospective assessment of practitioner and patient recruitment strategies, patient retention strategies, and rates for five clinical studies conducted in the National Dental Practice-Based Research Network between 2012 and 2019, and practitioner and patient characteristics associated with retention. Methods: Similar recruitment strategies were adopted in the studies. The characteristics of the practitioners and patients are described. The proportion of patients who either attended a follow-up (FU) assessment or completed an online assessment was calculated. For studies with multiple FU visits or questionnaire assessments, rates for completing each FU were calculated, as were the rates for completing any and for completing all FU assessments. The associations of practitioner and patient characteristics with all clinic FU visits, and with the completion of all assessments for a study were ascertained. Results: Overall, 591 practitioners and 12,159 patients were included. FU rates by patients for any assessment varied from 91% to 96.5%, and rates for participating in all assessments ranged from 68% to 87%. The mean total number of patients each practitioner recruited was 21 (sd = 15); the mean number per study was 13 (sd = 7). For practitioners, practice type and patient enrollment were associated with greater clinic retention, while only race was associated with their patients completing post-visit online assessments. For patients, age was associated with clinic retention, while female gender, age, race, and education were all associated with greater completion of post-visit online assessments. Conclusion: The Network efficiently recruited practitioners and patients and achieved high patient retention rates for the five studies.

ObjectivesA subset of patients who require revision rhinoplasty will change surgeons for their second procedure. We sought to investigate the rate of surgeon change and identify associated predictors using a population-based, ambulatory surgery database.Methods/study designIn this retrospective review, 9172 rhinoplasty procedures over a 5-year period were analyzed using the Healthcare Cost and Utilization Project (HCUP) Florida State Ambulatory Surgery and Services Database (SASD). We identified 380 patients who had at least two rhinoplasty procedures between 2009 and 2014. Logistic regression analysis was used to identify predictors of patients changing surgeons for their second documented rhinoplasty.ResultsAmong the 380/8531 (4.4%) patients who underwent a revision rhinoplasty, 117/380 (30.8%) patients changed surgeons for their subsequent procedure within a 5-year period. Multivariable logistic regression identified a lower likelihood of surgeon change in patients undergoing functional or cosmetic cartilage grafting procedures (OR 0.342, 95%CI 0.155-0.714, P = .006) and in patients who self-paid for their procedure (OR 0.476, 95%CI 0.225-0.984, P = .048). One hundred twenty-four patients underwent a cosmetic revision rhinoplasty and were twice as likely to change surgeons as those who underwent functional revision rhinoplasty (OR 2.042 95%CI 1.046-4.050, P = .038). Time elapsed (>2 years) was positively correlated with likelihood of surgeon change (OR 1.236, 95%CI 1.153-1.333, P

Background: Among patients who express interest in bariatric surgery, dropout rates from bariatric surgery programs are reported as high as 60%. There is a lack of understanding how we can better support patients to obtain treatment of this serious chronic disease. Methods: Semi-structured interviews with individuals who dropped out of bariatric surgery programs from three clinical sites were conducted. Transcripts were iteratively analyzed to understand patterns clustering around codes. We mapped these codes to domains of the Theoretical Domains Framework (TDF) which will serve as the basis of future theory-based interventions. Results: Twenty patients who self-identified as 60% female and 85% as non-Hispanic White were included. The results clustered around codes of "perceptions of bariatric surgery," "reasons for not undergoing surgery," and "factors for re-considering surgery." Major drivers of attrition were burden of pre-operative workup requirements, stigma against bariatric surgery, fear of surgery, and anticipated regret. The number and time for requirements led patients to lose their initial optimism about improving health. Perceptions regarding being seen as weak for choosing bariatric surgery, fear of surgery itself, and possible regret over surgery grew as time passed. These drivers mapped to four TDF domains: environmental context and resources, social role and identity, emotion, and beliefs about consequences, respectively. Conclusions: This study uses the TDF to identify areas of greatest concern for patients to be used for intervention design. This is the first step in understanding how we best support patients who express interest in bariatric surgery achieve their goals and live healthier lives. [ABSTRACT FROM AUTHOR]

Abstract Background A minority of the U.S. population comprises a majority of health care expenses. Health system interventions for high-cost populations aim to improve patient outcomes while reducing costly over-utilization. Missed and inconsistent appointments are associated with poor patient outcomes and increased health care utilization. PEAK Health— Mount Sinai’s intensive primary care clinic for high-cost patients— employed a novel behavioral economics-based intervention to reduce the rate of missed appointments at the practice. Behavioral economics has accomplished numerous successes across the health care field; the effect of a clinic-based behavioral economics intervention on reducing missed appointments has yet to be assessed. Methods This was a single-arm, pre-post trial conducted over 1 year involving all active patients at PEAK Health. The intervention consisted of: a) clinic signage, and b) appointment reminder cards containing behavioral economics messaging designed to increase the likelihood patients would complete their subsequent visit; appointment cards (t1) were transitioned to an identical EMR template (t2) at 6 months to boost provider utilization. The primary objective, the success of scheduled appointments, was assessed with visit adherence: the proportion of successful over all scheduled appointments, excluding those cancelled or rescheduled. The secondary objective, the consistency of appointments, was assessed with a 2-month visit constancy rate: the percentage of patients with at least one successful visit every 2 months for 1 year. Both metrics were assessed via a χ2 analysis and together define patient retention. Results The visit adherence rate increased from 74.7% at baseline to 76.5% (p = .22) during t1 and 78.0% (p = .03) during t2. The 2-month visit constancy rate increased from 59.5% at baseline to 74.3% (p = .01) post-intervention. Conclusions A low-resource, clinic-based behavioral economics intervention was capable of improving patient retention within a traditionally high-cost population. A renewed focus on patient retention— employing the metrics described here— could bolster chronic care efforts and significantly improve the outcomes of high-cost programs by reducing the deleterious effects of missed and inconsistent appointments.

A retrospective observational study was conducted for patients 18 years or older presenting to a Midwestern emergency department (ED) in the United States during February 2019–January 2020 to characterize associated subsequent care utilization in patients who left the ED without being seen. Patients were classified as left without being seen (LWBS) based on documented ED disposition. The healthcare system's records were reviewed for any associated utilizations within 3 weeks following the initial ED encounter. During the study period, 45,456 patients presented to the ED, with 2269 (5.0%) classified as LWBS. The median documented time until patients left the ED was 112 min. Of these patients, 1257 (55.4%) had a subsequent encounter within the health system within 3 weeks and 920 (73.2%) of these visits were determined to be related to the LWBS chief complaint. These visits included 67.5% of patients returning to ED or hospital, 27.5% to primary care or an urgent care clinic, and 5.0% to a specialty or other provider appointment. Of patients returning to ED, 78.1% did so within 72 h. Patients without a subsequent health system associated encounter tended to be younger, female, non-White, and present with possible lower-acuity chief complaints. At least one-half of LWBS patients sought care related to the concerns by a health system provider within 3 weeks of the initial encounter within the same system. The high prevalence of ED returns within a narrow turnaround window highlights a missed opportunity to provide services to these patients during their initial encounter. [ABSTRACT FROM AUTHOR]

Background: A minority of the U.S. population comprises a majority of health care expenses. Health system interventions for high-cost populations aim to improve patient outcomes while reducing costly over-utilization. Missed and inconsistent appointments are associated with poor patient outcomes and increased health care utilization. PEAK Health— Mount Sinai's intensive primary care clinic for high-cost patients— employed a novel behavioral economics-based intervention to reduce the rate of missed appointments at the practice. Behavioral economics has accomplished numerous successes across the health care field; the effect of a clinic-based behavioral economics intervention on reducing missed appointments has yet to be assessed. Methods: This was a single-arm, pre-post trial conducted over 1 year involving all active patients at PEAK Health. The intervention consisted of: a) clinic signage, and b) appointment reminder cards containing behavioral economics messaging designed to increase the likelihood patients would complete their subsequent visit; appointment cards (t1) were transitioned to an identical EMR template (t2) at 6 months to boost provider utilization. The primary objective, the success of scheduled appointments, was assessed with visit adherence: the proportion of successful over all scheduled appointments, excluding those cancelled or rescheduled. The secondary objective, the consistency of appointments, was assessed with a 2-month visit constancy rate: the percentage of patients with at least one successful visit every 2 months for 1 year. Both metrics were assessed via a χ2 analysis and together define patient retention. Results: The visit adherence rate increased from 74.7% at baseline to 76.5% (p =.22) during t1 and 78.0% (p =.03) during t2. The 2-month visit constancy rate increased from 59.5% at baseline to 74.3% (p =.01) post-intervention. Conclusions: A low-resource, clinic-based behavioral economics intervention was capable of improving patient retention within a traditionally high-cost population. A renewed focus on patient retention— employing the metrics described here— could bolster chronic care efforts and significantly improve the outcomes of high-cost programs by reducing the deleterious effects of missed and inconsistent appointments. [ABSTRACT FROM AUTHOR]

Background Cancer outcomes in sub-Saharan Africa (SSA) remain suboptimal, in part due to poor patient retention. Many patients travel long distances to receive care, and transportation costs are often prohibitively expensive. These are well-known and established causes of delayed treatment and care abandonment in Malawi and across SSA. Methods We sent visit reminder texts and offered upfront money to cover transportation costs through a mobile money transfer (MMT) platform to lymphoma patients enrolled in a prospective cohort in Malawi. The primary aim was to test the feasibility of upfront MMTs. Results We sent 1034 visit reminder texts to 189 participating patients. Of these texts, 614 (59%) were successfully delivered, with 536 (52%) responses. 320/536 (60%) MMTs were sent to interested patients and 312/320 (98%) came to their appointment on time. Of 189 total patients, 120 (63%) were reached via text and 84 (44%) received MMTs a median of three times (IQR 2–5). Median age of reachable patients was 41 (IQR 30–50), 75 (63%) were male, 62 (52%) were HIV+ and 79 (66%) resided outside of Lilongwe. Conclusion MMTs were a feasible way to cover upfront transportation costs for patients reachable via text, however many of our patients were unreachable. Future studies exploring barriers to care, particularly among unreachable patients, may help improve the efficacy of MMT initiatives and guide retention strategies throughout SSA. [ABSTRACT FROM AUTHOR]

Objectives/Hypothesis: A subset of patients will undergo revision endoscopic sinus surgery (ESS) with a different otolaryngologist than the one who performed their primary surgery. The purpose of this study is to report the incidence of and clinicodemographic factors associated with a change in surgeon for revision ESS. Study Design: Retrospective cohort study. Methods: Adult patients who underwent at least two outpatient ESS procedures between 2009 and 2014 using the State Ambulatory Surgery Database for Florida were included in the study. Change in surgeon was defined by a change in a unique provider identifier for the revision procedure. Multivariable regression analysis was used to determine characteristics associated with a change in surgeon. Results: A total of 2,963 patients were included. For the revision procedure, 47.7% of patients changed their surgeon. On multivariable logistic regression, a medium‐ (odds ratio [OR]: 0.64; 95% confidence interval [CI]: 0.53‐0.77) or high‐volume (OR: 0.50; 95% CI: 0.42‐0.61) surgeon performing the index surgery and advanced age (≥65 years) (OR: 0.79; 95% CI: 0.63‐0.99) were associated with decreased odds of surgeon change for revision ESS. Longer time elapsed between index and revision surgery (OR: 1.15; 95% CI: 1.13‐1.17) was associated with increased odds of surgeon change. Conclusions: Nearly half of patients who undergo revision ESS select a surgeon other than the one who performed their primary procedure. Surgeon volume, age, and time between surgeries affect the likelihood of a change in surgeon for revision ESS. These findings may provide introductory insights into patient preferences and decision making in the surgical management of recalcitrant chronic rhinosinusitis. Level of Evidence: 4 Laryngoscope, 131:E1049–E1053, 2021 [ABSTRACT FROM AUTHOR]

The goal of scheduling within an ambulatory enterprise is to appropriately accommodate patients; extending capacity to fulfill this aim in a large health care organization requires the management of a complex scheduling process. Understanding and handling the appointment lead time, referred to as the scheduling horizon, can positively influence capacity management. The analysis demonstrated an increased chance of nonarrived appointments of 16% for a specialty practice and 11% for a primary care practice for every 30-day delay in the scheduling horizon. By incorporating the management of the scheduling horizon, health care organizations can optimize the capacity of their ambulatory clinics. [ABSTRACT FROM AUTHOR]

There is evidence that transfer of care for older adolescent patients to adult care is associated with a deterioration in health, especially in those with chronic conditions. Because several specific conditions in pediatric and adolescent gynecology continue into adulthood, it is important that patients have a seamless healthcare transition. In this commentary, it is argued that instead of arranging transfer, long-term retention of patients by the same physician or physician team may be the more caring, patient-centered approach. [ABSTRACT FROM AUTHOR]

Background Slow recruitment and poor retention jeopardize the reliability and statistical power of clinical trials, delaying access to effective interventions and increasing costs, as commonly observed in nephrology trials. Involving patients in trial design, recruitment and retention is infrequent but potentially transformational. Methods We conducted three workshops involving 105 patients/caregivers and 43 health professionals discussing patient recruitment and retention in clinical trials in chronic kidney disease. Results We identified four themes. 'Navigating the unknown'—patients described being unaware of the research question, confused by technical terms, sceptical about findings and feared the risk of harm. 'Wary of added burden'—patients voiced reluctance to attend additional appointments, were unsure of the commitment required or at times felt too unwell and without capacity to participate. 'Disillusioned and disconnected'—some patients felt they were taken for granted, particularly if they did not receive trial results. Participants believed there was no culture of trial participation in kidney disease and an overall lack of awareness about opportunities to participate. To improve recruitment and retention, participants addressed 'Building motivation and interest'. Conclusions Investigators should establish research consciousness from the time of diagnosis, consider optimal timing for approaching patients, provide comprehensive information in an accessible manner, emphasize current and future relevance to them and their illness, involve trusted clinicians in recruitment and minimize the burden of trial participation. Participation in clinical trials was seen as an opportunity for people to give back to the health system and for future people in their predicament. [ABSTRACT FROM AUTHOR]

In article the review of modern foreign and Russian researches about value of adherence of patients to medicinal therapy of сardiovascular diseases is carried out. Relevance of a problem of non-compliance with appointments of the doctor is described. Factors of adherence which are associated with drug (the price, quantity, reception frequency, amount of drugs), with personal qualities and medical characteristics of the patient (forgetfulness, age, sex, the diagnosis and the accompanying pathologies, existence of complications in the anamnesis, education, quality of life), with insufficient knowledge of a disease and/or of medicines, side effects, fears and doubts of patients are defined. The review of various methods and ways of rise of adherence, their use in medical practice is provided.

S Sam Lim,1 Alan J Kivitz,2 Doug McKinnell,3 M Edward Pierson,4 Faye S O’Brien4 1Division of Rheumatology, Department of Medicine, Emory University, Atlanta, GA, USA; 2Altoona Center for Clinical Research, Altoona, PA, USA; 3Deloitte Life Sciences Advisory, Basel, Switzerland; 4Clinical Operations, Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA Purpose: We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.Patients and methods: Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.Results: The Atlanta study involved 6 African-American patients (5 female) aged 27–60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32–75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance for clinical trials.Conclusion: Insights from these two studies can be applied to the development and implementation of future clinical trials to improve patient recruitment, retention, compliance, and advocacy. Keywords: systemic lupus erythematosus, lupus nephritis, clinical trial simulation, patient recruitment, patient retention

Introduction: It is common for cancer patients to seek a second opinion for a variety of reasons. Understanding what drives patients to choose to receive treatment with their second opinion provider may uncover opportunities to improve the second opinion process. Therefore, we sought to identify the patient, disease, and treatment characteristics that were associated with second opinion retention rates in patients seeking a second surgical opinion for breast, colon, and pancreatic cancer., Methods: We conducted a retrospective cohort study to evaluate patients who sought a second opinion within a large academic health-care system for breast, colon, and pancreatic cancer. Electronic medical records were reviewed for second opinions. Patient demographics and characteristics were collected and compared between the retained group and the nonretained groups., Results: A total of 237 patients obtained second opinions for breast, colorectal, and pancreatic cancer. Patients that were offered a different treatment plan at their second opinion were more likely to be retained for systemic therapy (P = 0.009) for pancreatic cancer and any treatment for colon cancer (P = 0.003). Seeing a radiation oncologist (P = 0.007) or a plastic surgeon (P = 0.02) during the multidisciplinary consultation increased retention rates for breast cancer., Conclusions: Surgeons can better identify patients that are more likely to be retained after a second opinion by the individual patient characteristics and treatment factors. Understanding the factors that lead to retention for these three cancer types may help physicians provide the best possible resources for most patients presenting for second opinion evaluations., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The United States is in an obesity epidemic. Obesity has multiple common comorbid conditions, including lower extremity arthritis. We sought to examine the course of treatment for a population with body mass index (BMI) ≥40 kg/m2 and osteoarthritis (OA) of the hip or knee. We investigated decision criteria that influenced arthroplasty surgeons to recommend nonoperative management vs total joint arthroplasty (TJA). For those patients who ultimately received TJA, we compared outcomes in this population to those with BMI <40 kg/m2.Methods: This study retrospectively reviewed 158 new patients with BMI ≥40 kg/m2 and moderate/severe OA of the hip or knee. Demographics, comorbidity profiles, and weight loss were compared between groups that underwent TJA and those that did not. The arthroplasty database was used to identify patients who underwent TJA during 2016-2018 (N = 1473). Comorbidities, readmissions, surgical site infections, and overall complications were compared between those with BMI ≥40 kg/m2 and BMI <40 kg/m2.Results: About 51.3% of new patients with BMI ≥40 kg/m2 and moderate/severe OA did not return for a second clinic visit. Of those who did return, 42.9% eventually underwent surgery. BMI was higher in single visit patients vs those with multiple visits (49.5 vs 46.3 kg/m2, P < .001), no difference in those scheduled on an "as-needed" basis vs a specific return date (P = .18), and did not change significantly during the 2-year follow-up (P = .41). Patients who underwent TJA had a lower mean BMI at presentation than their nonoperative counterparts (44.5 vs 47.6 kg/m2, P < .01) and demonstrated significant weight loss prior to surgery (44.5 vs 42.6 kg/m2, P < .05). When comparing patients with BMI ≥40 kg/m2 vs BMI <40 kg/m2, overall complications were not higher in the BMI ≥40 kg/m2 group, although surgical site infections were higher in those undergoing total hip arthroplasty with BMI ≥40 kg/m2 (0.3% vs 3.1%, P < .05).Conclusion: A majority of patients with BMI ≥40 kg/m2 and moderate/advanced OA will be lost to orthopedic follow-up. A relatively lower BMI indicates a greater chance of retention in care, and ultimately surgery, but does not influence surgeons' recommendations to continue orthopedic management. Patients who persist in seeking treatment, lose significant weight, and exhaust nonoperative alternatives may be suitable for TJA despite a BMI ≥40 kg/m2, with an overall complication rate of 4.3%. However, only 9% of patients at 2-year follow-up achieved BMI <40 kg/m2 and only 20% of surgeries were performed on patients who had achieved this proposed cutoff. [ABSTRACT FROM AUTHOR]

Objectives: Benzodiazepine (BZD) use is common in patients who are engaged in methadone as a treatment for opioid use disorder. BZD prescribing is generally discouraged for this patient population due to the increased risk of BZD dependence and BZD use disorder, medication-assisted treatment (MAT) discontinuation, and opioid-overdose death. However, some patients have concurrent mental health disorders, where BZD use may be clinically indicated. This study evaluates the impact of prescribed BZD on MAT outcomes. Methods: Linking urine drug screening data (UDS) and prescribing information from single-payer health records, we conducted a retrospective Kaplan–Meier analysis between patients using prescribed and nonprescribed BZD with methadone treatment retention as the primary outcome. Data are from a network of 52 outpatient clinics in Ontario, Canada, between January 1, 2006 and June 30, 2013. Results: We identified 3692 patients initiating methadone-assisted treatment for the first time; 76% were BZD−/UDS− (no BZD prescription and <30% screens positive for BZD); 13% were BZD+/UDS−; 6% BZD−/UDS+; and 6% BZD+/UDS+. Using 1-year treatment retention as a primary outcome, patients using nonprescribed BZD (BZD−/UDS+) were twice as likely (adjusted odds ratio 0.38, 95% confidence interval 0.27–0.53) to discontinue treatment as those not using BZD (BZD−/UDS−), or those using BZD in a prescribed manner (BZD+/UDS+). Conclusions: Our findings suggest that prescribed BZD can be used during methadone MAT without impacting a patient's retention in MAT, but nonprescribed BZD use is predictive of treatment discontinuation. Importantly, we urge both the physician and patient to seek alternative clinical options to BZD prescribing, due to the potential for developing physical dependence (and BZD use disorder) to BZD and the risks of negative interactions with opioids. [ABSTRACT FROM AUTHOR]

Indian hospital sector is now witnessing cut-throat competition to remain competitive and to attract patients from the foreign countries, they have to change their conventional systems towards more customer-centric approach. Due to the presence of considerable number of super-specialty hospitals, Kolkata is gradually becoming a preferred place in the field of medical tourism in India. Patients from African and Middle East counties are now coming here due to experienced and skilled medical and paramedical staffs, and facilities at an affordable price. The objective of this article is to examine the roles and initiatives of hospital management team in the process of retention of patients. We are also proposing certain strategies based on the value creation strategy for the medical tourism—which will ultimately contribute factors of this aspect. As a part of the qualitative study, we have collected data onto 80 respondents comprising doctors, nurses, supporting staffs and medical superintendent of different private hospitals in Kolkata. The results of this qualitative study indicate that different professional hospital management staffs need to behave like a united team with same organizational goal. [ABSTRACT FROM AUTHOR]

Background: Patient retention in care for HIV/AIDS is a critical challenge for antiretroviral treatment programs. Community-based adherence programs (CBAPs) as compared to health care facility-based adherence programs have been considered as one of the options to provide treatment maintenance support for groups of patients on antiretroviral therapy. Such an approach provides a way of enhancing self-management of the patient's condition. In addition, CBAPs have been implemented to support antiretroviral treatment expansion in resource-limited settings. CBAPs involve 30 patients that are allocated to a group and meet at either a facility or a community venue for less than an hour every 2 or 3 months depending on the supply of medication. Our study aimed to establish perceived challenges in moving adherence clubs from health facilities to communities. Methods: A qualitative study was conducted in 39 clinics in Mpumalanga and Gauteng Provinces in South Africa between December 2015 and January 2016. Purposive sampling method was used to identify nurses, club managers, data capturers, pharmacists and pharmacy assistants who had been involved in facility-based treatment adherence clubs. Key-informant interviews were conducted. Also, semi-structured interviews were used and thematic content analysis was done. Results: A total of 53 health care workers, 12 (22.6%) males and 41 (77.4%) females, participated in the study. Most of them 49 (92.5%) indicated that participating in community adherence clubs were a good idea. Reduction in waiting time at the health facilities, in defaulter rate, improvement in adherence to treatment as well as reduction in stigma were some of the perceived benefits. However, security of medication, storage conditions and transportation of the prepacked medication to the distribution sites were the areas of concern. Conclusion: Health care workers were agreeable to idea of the moving adherence clubs from health facilities to communities. Although some challenges were identified, these could be addressed by the key stakeholders. However, government and nongovernmental organizations need to exercise caution when transitioning to community-based adherence clubs. [ABSTRACT FROM AUTHOR]

Background Despite advances in HIV treatment, gaps in care retention threaten the individual health of people with HIV (people) and public health efforts to end the HIV epidemic. Objective This project aimed to identify and address gaps in retention and support re-engagement in care. Methods A multipronged initiative at five community HIV clinics and community-based organizations (CBOs) included patient, healthcare professional (HCP), and community-focused interventions. Patient-oriented interventions included instructional videos for patients to view before appointments and conversation guides about barriers to care for patients to use with staff during appointments. HCP-oriented interventions included baseline surveys assessing clinic practices and challenges and audit-feedback sessions to review survey findings and devise plans to improve retention strategies. Community-oriented interventions included education sessions co-led by clinics and CBOs, micro-learning engagements at community events, and social media campaigns covering topics related to HIV care. Data were collected through surveys administered before and after patient- and HCP-oriented interventions and community education sessions, follow-up surveys administered after micro-learning engagements, and reach of social media campaigns. Results Patient-oriented interventions led to improvements in patient-reported empowerment and confidence in their ability to remain in care. HCPs also reported improvements in patient intake and follow-up processes after audit-feedback sessions. Community interventions reached over 1,000 community members combined, with education sessions and micro-learning engagements uncovering key barriers to HIV care and leading to improvements in knowledge and awareness of local HIV services. Conclusion This multipronged initiative demonstrates how patient, HCP, and community-oriented education can support retention and re-engagement in care.

Background: Oral health service systems should be designed to promote patient health, protection, and must be in compliance with Indonesian laws that help protect patients from misuse of personal information. Patient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical or dental error that often lead to adverse healthcare events. Purpose: To describe correlation that patient safety would improve patent retention in oral health. Patient safety is an essential component of quality oral health care and dentist is encouraged to consider thoughtfully the environment in which they deliver dental care, while at the same time services and to implement practices that decrease a patient’s risk of injury or harm during the delivery of care. Reviews: Designing oral health care systems that focus on preventing errors is critical to assure patient safety. Some possible sources of error in oral health services are miscommunication, failure to review the patient’s medical history, and lack of standardized records, abbreviations, and processes. Conclusion: Patient safety would support patient satisfaction; therefore oral health services can increase patient retention.

Background: Mental, neurological, and substance-use disorders cause medium to long term disability in all countries. They are amenable to treatment but often treatment is only available in hospitals, as few staff feel competent to give treatment. The WHO developed the "Mental Health GAP" (mhGAP) course to train non-specialist clinical staff in basic diagnosis and treatment. At Bwindi Community Hospital, in south-west Uganda, mental health care was initially only provided at the hospital. It was extended outside the hospital in two implementation phases, initially by establishing 17 clinics in the community, run by qualified mental health staff from the hospital. In the second implementation phase staff in 12 health centers were trained using mhGAP and ran their own clinics under supervision., Methods: Using routine data the defined data variables for the individuals attending the clinics was extracted., Results: A total of 2,617 people attended a mental health care clinic in the study period between January 2016 and March 2020. Of these 1,051 people attended more than once. The number of patients attending clinics increased from 288 during the baseline to 693 in the first implementation phase then to 839 patients in the second implementation phase. After mhGAP training, about 30% of patients were seen locally by mhGAP trained healthcare personnel. The average number of mental health patients seen each month increased from 12 to 65 over the time of the study. The number of patients living >20 km from the hospital increased from 69 in the baseline to 693 in the second implementation phase. The proportion of patients seen at the hospital clinic dropped from 100% to 27%., Conclusions: Providing mental health care in the community at a distance from the hospital substantially increased the number of people accessing mental health care. Training health center-based staff in mhGAP contributed to this. Not all patients could appropriately be managed by non-specialist clinical staff, who only had the five-day training in mhGAP. Supplies of basic medicines were not always adequate, which probably contributed to patients being lost to follow-up. About 50% of patients only attend the clinic once. Further work is required to understand the reasons., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Kuule, Dobson, Mutahunga, Stewart and Wilkinson.)

Introduction Loss-to-follow-up (LTFU) in the prevention of mother-to-child HIV transmission (PMTCT) programmes can occur at multiple stages of antenatal and follow-up care. This paper presents findings from a national assessment aimed at identifying major bottlenecks in Côte d'Ivoire's PMTCT cascade, and to distinguish characteristics of high- and low-performing health facilities. Methods This cross-sectional study, based on a nationally representative sample of 30 health facilities in Côte d'Ivoire used multiple data sources (registries, patient charts, patient booklets, interviews) to determine the magnitude of LTFU in PMTCT services. A composite measure of retention - based on child prophylaxis, maternal treatment and infant testing - was used to identify high- and low-performing sites and determine significant differences using Student's t-tests. Results Among 1,741 pregnant women newly recorded as HIV-positive between June 2011 and May 2012, 43% had a CD4 count taken, 77% received appropriate prophylaxis and 70% received prophylaxis intended for their infant. During that time, 1,054 first infant HIV tests were recorded. A conservative rate of adherence to antiretroviral therapy was estimated at 50% ( n=219 patient charts). Significant differences between high- and low-performing sites included: duration of time elapsed between HIV testing and CD4 results (29.5 versus 56.3 days, p=0.001); and density (number per 100 first antenatal care visits) of full-time physicians (6.7 versus 1.7, p=0.04), laboratory technicians (2.3 versus 0.7, p=0.046), staff trained in PMTCT (10.7 versus 4.7, p=0.01), and staff performing patient follow-up activities (7.9 versus 2.5, p=0.02). Key informants highlighted staff presence and training, the availability of medical supplies and equipment (i.e., on-site CD4 machine), and the adequacy of infrastructure (i.e., space and ventilation) as perceived key factors positively and negatively impacting retention in care. Conclusions Patient LTFU occurred throughout the PMTCT cascade from maternal to infant testing, with retention scores ranging from 0.10 to 0.83. Sites that scored higher had more dedicated and trained frontline health workers, and emphasised patient follow-up through outreach and the reduction of delays in care. Strategies to improve patient retention and decrease transmission should emphasise patient tracking systems that utilise critical human resources to both improve data quality and increase direct patient follow-up. [ABSTRACT FROM AUTHOR]

Background: Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke.Methods: Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention.Results: All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home.Conclusion: Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention. [ABSTRACT FROM AUTHOR]