Participant Eligibility Criteria Research Articles

P-62. RSV Immunization Uptake and Barriers to Access Among Eligible Individuals During the First Season of Availability

Abstract Background By fall 2023, RSV immunizations to protect older adults, pregnant people, and infants were recommended in the United States. Our aim was to describe uptake of and barriers to RSV immunization among community-based individuals during the first season of availability.Table 1:Targeted RSV immunization populations, ACIP recommendations, and participant eligibility criteria for this analysis, April 20241. Due to limitations in how data were collected in the parent study, the eligibility criteria used for the analysis may differ from exact ACIP recommended criteria.2. Nirsevimab, a single injection during the infant’s first respiratory season, was recently recommended by ACIP and preferred by American Academy of Pediatrics over palivizumab, which requires monthly injections during the respiratory season and is recommended for a subset of high-risk infants. Palivizumab has been available in the United States since 1998.3. Shared clinical decision-making allows flexibility for providers and patients to consider individual risk for RSV disease, while considering patient preferences.RSV = respiratory syncytial virus; ACIP = Advisory Committee for Immunization Practices Methods Starting January 2024, participants were enrolled in a household transmission study of COVID-19 and RSV. All participants completed questionnaires capturing demographics, household characteristics, vaccination and medical history, and their knowledge, attitudes, and behaviors towards RSV and RSV immunizations. Participants included in this analysis were those eligible for RSV immunizations based on Advisory Committee for Immunization Practices guidelines (Table 1). Participants were considered immunized if they had a verified RSV immunization or plausible self-report i.e., reported an RSV immunization with the date of the immunization and a location or manufacturer (Figure 1). We compared characteristics, knowledge, attitudes, and behaviors stratified by immunization uptake using chi-squared or Fishers exact tests.Figure 1:Participant RSV immunization eligibility and receipt11. Immunization history was self-reported by participants and verified by study staff using medical and pharmacy records. Participants were considered immunized if they had a verified RSV immunization or plausible self-report meaning they self-reported an RSV immunization with the date of the immunization and a location or manufacturer.RSV = respiratory syncytial virus; KAP = Knowledge, Attitudes, and Practices survey Results Among participants enrolled and eligible for this analysis as of April 2024 (n=63), 15 (24%) received RSV immunization: 14/44 (32%) among older adults, 1/16 (6%) among infants/young children, and 0/3 (0%) among pregnant people (Figure 1). Older adults who did not receive the vaccine were more likely to be younger (67 vs 71 years, p=0.009) and less likely to have received an updated 2023-24 COVID-19 vaccine (40% vs 79%, p=0.02; Table 2). Among older adults who replied they would not or were not sure if they would get vaccinated, reasons included that they needed more information (43%; 9/21) or were not sure how/where to get the vaccine (14%, 3/21; Table 3).Table 2:Individual and household characteristics of participants eligible for RSV immunization1 by RSV immunization status21 RSV immunization for older adults is a vaccine and for infants/young children is a monoclonal antibody2 Immunization history was collected self-reported by participants and verified by study staff using medical and pharmacy records. Participants were considered immunized if they had a verified RSV immunization or plausible self-report meaning they self-reported an RSV immunization with the date of the immunization and a location or manufacturer.3 Wilcoxon rank sum test; Fisher's exact test; Pearson's Chi-squared testmAb = monoclonal Antibodies; RSV = respiratory syncytial virus Conclusion A quarter of individuals who were eligible for RSV immunization had received it during the 2023-24 RSV season. Older adults on the younger end of the recommendation were less likely to be vaccinated; it is unclear if this is due to limited awareness of RSV disease, perceived lower risk, or other reasons. Better education and awareness of RSV disease and vaccine safety, effectiveness, and availability may increase uptake among older adults. Ongoing enrollment may allow insight into barriers for infants and pregnant people. Table 3: Individual beliefs and attitudes towards RSV and RSV immunizations of participants eligible for RSV immunization1 by RSV immunization status2 1 RSV immunization for older adults is a vaccine and for infants/young children is a monoclonal antibody 2 Immunization history was collected self-reported by participants and verified by study staff using medical and pharmacy records. Participants were considered immunized if they had a verified RSV immunization or plausible self-report meaning they self-reported an RSV immunization with the date of the immunization and a location or manufacturer. 3 Fisher's exact test 4 Responses provided by a parent/caregiver of infant/young child Disclosures Carlos G. Grijalva, MD, MPH, AHRQ: Grant/Research Support|CDC: Grant/Research Support|FDA: Grant/Research Support|Merck: Advisor/Consultant|NIH: Grant/Research Support|SyneosHealth: Grant/Research Support Jonathan Schmitz, MD, PhD, D(ABMM), Biofire/Biomerieux: Grant/Research Support|Genmark/Roche: Grant/Research Support|Pfizer: Honoraria|Vela: Grant/Research Support Helen Y. Chu, MD, MPH, Abbvie: Advisor/Consultant|Merck: Advisor/Consultant|Vir: Advisor/Consultant Janet A. Englund, MD, Abbvie: Advisor/Consultant|AstraZeneca: Advisor/Consultant|AstraZeneca: Grant/Research Support|GlaxoSmithKline: Advisor/Consultant|GlaxoSmithKline: Grant/Research Support|Meissa Vaccines: Advisor/Consultant|Merck: Advisor/Consultant|Pfizer: Board Member|Pfizer: Grant/Research Support|Pfizer: Speaker at meeting|SanofiPasteur: Advisor/Consultant|Shinogi: Advisor/Consultant

Participant Characteristics for Dysphagia Research: A Proposed Checklist.

Participant characteristics are underreported; however, they impact swallowing impairments and subsequent access to assessment and intervention. Standards for rigorous and transparent reporting of dysphagia research are required. The Framework for RigOr aNd Transparency In REseaRch on Swallowing (FRONTIERS) offers a critical appraisal tool for dysphagia research. This article outlines questions for participant characteristics in dysphagia research as part of the larger FRONTIERS tool. An exploratory literature review was conducted to determine how participant characteristics, eligibility criteria, and definitions of health and dysphagia are reported in the literature. Findings were cross-referenced with other relevant critical appraisal tools. A list of questions was generated and refined iteratively with the entire FRONTIERS collaborative until consensus was met. The participant characteristics portion of the FRONTIERS tool includes eight questions and 16 possible subquestions. Examples for how the tool might be used, as well as rationales for inclusion of all questions, are included. Including detailed characteristics of research participants may support understanding of how best to serve marginalized and underrepresented populations more effectively. Critical appraisal tools, such as FRONTIERS, may help to improve the rigor and transparency in dysphagia research, ultimately improving patient care.

Enhancing retinal disease diagnosis through AI: Evaluating performance, ethical considerations, and clinical implementation

BackgroundThe research problem addresses the need for accurate and efficient detection of retina diseases using artificial intelligence (AI) technologies. The specific aim is to evaluate the performance, ethical considerations, and clinical implementation of AI-driven retina disease detection systems. MethodsThis study is a systematic review. Data sources assessed included various electronic databases searched up to July 31, 2023. The prespecified criteria for study inclusion were studies involving AI algorithms for retina disease detection, including those focused on diabetic retinopathy, age-related macular degeneration, and glaucoma. Participant eligibility criteria encompassed human subjects of all ages, and the interventions assessed were AI-based diagnostic tools compared to traditional diagnostic methods. Only randomized controlled trials and observational studies set in clinical environments were included, covering a time span from the inception of AI technology. FindingsThe search identified 145 studies, of which 61 met the inclusion criteria and were eligible for analysis. The narrative summary of findings indicated that AI algorithms generally demonstrated high accuracy, sensitivity, and specificity in detecting retinal diseases. Deep learning algorithms showed a sensitivity of 90 % and specificity of 98 % for diabetic retinopathy detection. However, several studies highlighted concerns about algorithmic bias, data privacy, and the need for diverse and representative datasets to ensure generalizability across different populations. InterpretationThe AI-driven retina disease detection systems have significant potential to improve diagnostic accuracy and efficiency in clinical practice. Ethical considerations regarding patient privacy, the risk of algorithmic bias, and the challenges of integrating AI into existing healthcare workflows must be addressed. The study underscores the importance of ongoing validation, ethical scrutiny, and interdisciplinary collaboration to harness the benefits of AI while mitigating its risks, ensuring responsible and equitable implementation in clinical settings.

Retraction: Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells.

Retraction: D. M. R. Dakhly, Y. A. Bayoumi, M. Sharkawy, S. H. Gad Allah, M. A. Hassan, H. M. Gouda, A. T. Hashem, D. L. Hatem, M. F. Ahmed, W.El-Khayat. "Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells." International Journal of Gynecology & Obstetrics 135, no. 3 (2016): 324-327. https://doi.org/10.1016/j.ijgo.2016.06.026. The above article, published online on 30 August 2016 in Wiley Online Library (wileyonlinelibrary.com) has been retracted by agreement between the journal's Editor-in-Chief, Michael Geary, International Federation of Gynecology and Obstetrics and John Wiley & Sons Ltd. The retraction has been agreed following an investigation based on concerns raised by a third party. Several discrepancies were found between the information provided during the trial registration and the published article including, the study dates, participant eligibility criteria and the study's focus on natural killer cells. Furthermore, the definition of clinical pregnancy differs between the article and trial registration. Errors were also uncovered in Table2 of the article; the number of spontaneous abortions and ongoing pregnancies do not add up to the total number of clinical pregnancies stated. Additionally, the calculation specified to define implantation rate is not consistent with the values reported in Table2. The authors were unable to provide the original data upon request or provide an explanation for the discrepancies. Given the nature and extent of the discrepancies, the editors have lost confidence in the data and conclusions presented. The author, Waleed El-Khayat, disagrees with the retraction; the other authors were not available for comment.

Identifying brief intervention factors to improve cannabis related outcomes in adolescents and young adults: A systematic review of sample characteristics and intervention components

IntroductionPrior systematic and meta-analytic reviews observed mixed evidence for the efficacy of cannabis brief interventions (BIs). Inconsistent support for cannabis BIs may be the result of intersecting methodological factors, including intervention structure and content, participant eligibility criteria, and outcome assessment measures. The current systematic review of cannabis BI studies narratively synthesizes these data to guide intervention development decision-making in future cannabis BI studies (PROSPERO CRD42022285990). MethodsWe searched PubMed/MEDLINE, PsycINFO, and CINAHL databases in January 2022 and again in June 2023 to capture newly published studies. Studies were included if they were a randomized trial, enrolled adolescents (13–17) and/or young adults (18–30), specified cannabis use and/or problems inclusion criteria, and evaluated a cannabis BI (defined as ≤4 sessions). We extracted and synthesized data on intervention characteristics (e.g., components, length/duration, modality), cannabis inclusion criteria and recruitment setting, baseline cannabis use descriptives and treatment-seeking status, and outcome assessment measures to discern if/how they may intersect to determine intervention efficacy. The Cochrane Risk of Bias Tool 2 assessed study quality. ResultsOur search resulted in a final sample of 25 study records including 4094 participants. Recruitment setting seemed to provide an influential backdrop for how well inclusion criteria determined baseline cannabis use level, as well as for the type/length of the BI evaluated. Motivational interviewing (MI) and personalized feedback (PF) were the most frequently used BI components overall; however, some differences were observed in the proportion of BIs with reported intervention effects using MI vs. PF. Frequency of use days was the most commonly used outcome measure, although this may not be the most sensitive measure for assessing cannabis BI efficacy. ConclusionsOur systematic review indicates that cannabis BI studies require greater precision in their design, giving special attention to matching the content and structure of the BI to the needs of the target population and selecting outcomes commensurate to the goals of the BI and the target population to more accurately reflect the efficacy of the BI. However, consistent with prior reviews, all included studies demonstrated at least some concerns for risk of bias, and most were at high risk.

Safe inhalation pipe provision (SIPP): protocol for a mixed-method evaluation of an intervention to improve health outcomes and service engagement among people who use crack cocaine in England

BackgroundOver 180,000 people use crack cocaine in England, yet provision of smoking equipment to support safer crack use is prohibited under UK law. Pipes used for crack cocaine smoking are often homemade and/or in short supply, leading to pipe sharing and injuries from use of unsafe materials. This increases risk of viral infection and respiratory harm among a marginalised underserved population. International evaluations suggest crack pipe supply leads to sustained reductions in pipe sharing and use of homemade equipment; increased health risk awareness; improved service access; reduction in injecting and crack-related health problems. In this paper, we introduce the protocol for the NIHR-funded SIPP (Safe inhalation pipe provision) project and discuss implications for impact.MethodsThe SIPP study will develop, implement and evaluate a crack smoking equipment and training intervention to be distributed through peer networks and specialist drug services in England. Study components comprise: (1) peer-network capacity building and co-production; (2) a pre- and post-intervention survey at intervention and non-equivalent control sites; (3) a mixed-method process evaluation; and (4) an economic evaluation. Participant eligibility criteria are use of crack within the past 28 days, with a survey sample of ~ 740 for each impact evaluation survey point and ~ 40 for qualitative process evaluation interviews. Our primary outcome measure is pipe sharing within the past 28 days, with secondary outcomes pertaining to use of homemade pipes, service engagement, injecting practice and acute health harms.Anticipated impactSIPP aims to reduce crack use risk practices and associated health harms; including through increasing crack harm reduction awareness among service providers and peers. Implementation has only been possible with local police approvals. Our goal is to generate an evidence base to inform review of the legislation prohibiting crack pipe supply in the UK. This holds potential to transform harm reduction service provision and engagement nationally.ConclusionPeople who smoke crack cocaine in England currently have little reason to engage with harm reduction and drug services. Little is known about this growing population. This study will provide insight into population characteristics, unmet need and the case for legislative reform.Trial registration: ISRCTN12541454 https://doi.org/10.1186/ISRCTN12541454

An Analysis of the Implementation of Diversion in the Juvenile Criminal Court System

Objective: This study delves into the application and effectiveness of diversion programs within the juvenile criminal court system. Diversion, as an alternative to traditional court processing, aims to redirect young offenders away from formal adjudication, emphasizing rehabilitation and community-based interventions. Theoretical framework: It defines work discipline, explains performance management principles, incorporates legal regulations, uses theoretical models, forms research questions, and identifies variables. It also considers contextual factors and shapes expectations regarding work discipline's impact on performance. Methodology: The research employs a mixed-method approach, incorporating qualitative interviews with key stakeholders, including judges, probation officers, and diversion program coordinators, alongside quantitative analysis of case outcomes and recidivism rates. The findings reveal multifaceted insights into the implementation of diversion initiatives. Results and conclusion: Qualitative data highlights the perspectives and experiences of professionals directly involved in the diversion process, shedding light on program design, participant eligibility criteria, and challenges faced in execution. Concurrently, quantitative analysis provides statistical evidence regarding the impact of diversion on reoffending rates, comparative to traditional court processing. Furthermore, this study addresses the equity implications of diversion, exploring disparities in program access and outcomes across demographic, socioeconomic, and geographical dimensions. It examines potential biases in referral, participation, and success rates, aiming to identify areas for improvement in ensuring a fair and just application of diversion practices. Originality/value: It advocates for tailored diversion programming, informed by empirical evidence and stakeholder perspectives, to maximize its potential as an effective tool for juvenile justice. The study also underscores the need for ongoing evaluation and refinement of diversion initiatives to align with evolving best practices and societal needs. This research contributes valuable insights to the discourse surrounding juvenile justice reform and the pivotal role of diversion in creating a more rehabilitative and equitable system for young offenders.

A cross-sectional survey study exploring provision and delivery of expanded community tier 2 behavioural weight management services in England.

Guidelines recommend provision of local behavioural weight management (tier 2) programmes for adults living with overweight and obesity. Following the publication of the UK Government's publication 'Tackling Obesity: empowering adults and children to live healthier lives' in July 2021, Government invested around £30 million of additional funding to support the expansion of local authority commissioned tier 2 provision for adults living with excess weight. We conducted a cross-sectional survey study to scope the types of services available, to whom they were made available, and barriers and facilitators to service delivery. An e-survey was disseminated to local authority commissioned tier 2 service providers in England from September to October 2022. Through a combination of closed and open (qualitative) questions, the survey collected data on referral routes, participant eligibility criteria, service content and format, and challenges and enablers to service delivery. Quantitative data were analysed descriptively whilst thematic content analysis was applied to qualitative data. We received 52 responses (estimated response rate = 59%) representing all nine England regions and 89 unique local authorities. Most services were multi-component (84.3%), were 12 weeks duration (78.0%), were group-based (90.0%), were primarily delivered in-person (86.0%), and were free to participants (90.2%). Five responses indicated provision of support for other health and wellbeing issues, for example, mental health, assistance with debt. To improve future WMS service commissioning and delivery, WMS providers need to be allowed adequate time and resource to properly prepare for service delivery. Referral systems and criteria should be made clear and straightforward to both referrers and service users, and strategies to manage surplus referrals should be explored.

Feasibility and Acceptability of a Physical Exercise Program Embedded Into the Daily Lives of Older Adults Living in Nursing Homes: A Pilot Feasibility Study.

The purpose of this study was to test the feasibility and acceptability of a staff-delivered physical exercise program embedded into the daily lives of older adults living in nursing homes. A randomized controlled pilot feasibility study was carried out, which included quantitative, qualitative, and economic assessments at baseline, 12weeks, and 12months. Two nursing homes (one intervention and one control) took part. The exercise program was carried out on 3days per week for 12weeks and consisted of a program of Morning Movement (walking and sit-to-stand exercises) and Activity Bursts. The results confirm that the intervention and study processes are largely acceptable and feasible to implement in the nursing home setting. Potential short-term improvements in physical mobility and quality of life were noticed as positive mean changes and supported by qualitative assessment. Future randomized controlled trials should consider using the 6-meter walk test and refining nursing home and participant eligibility criteria.

Should antidiabetic medicines be considered to reduce cardiometabolic risk in patients with serious mental illness?

Substantially reduced life expectancy for people with serious mental illness compared with the general population is primarily driven by physical health issues, of which cardiovascular disease is the leading cause. In this narrative review, we examine the evidence base for use of metformin and other antidiabetic agents as a means for reducing this excess cardiometabolic disease burden. Evidence from randomised controlled trials (RCTs) suggests substantial potential for metformin to prevent or manage weight gain and glycaemic impairment induced by atypical antipsychotic medications, whereas the impact of metformin on other cardiometabolic risk factors is less consistent. Evidence from RCTs also suggests potential benefits from glucagon-like peptide-1 receptor agonists (GLP-1RAs), particularly for addressing cardiometabolic risk factors in people using atypical antipsychotic medications, but this is based on a small number of trials and remains an emerging area of research. Trials of both metformin and GLP-1RAs suggest that these medications are associated with a high prevalence of mild-moderate gastrointestinal side effects. The heterogeneous nature of participant eligibility criteria and of antipsychotic and antidiabetic drug regimens, alongside short trial durations, small numbers of participants and paucity of clinical endpoints as trial outcomes, warrants investment in definitive trials to determine clinical benefits for both metformin and GLP-1RAs. Such trials would also help to confirm the safety profile of antidiabetic agents with respect to less common but serious adverse effects. The weight of RCT evidence suggests that an indication for metformin to address antipsychotic-induced weight gain is worth considering in Australia. This would bring us into line with other countries.

Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study

BackgroundThe PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at https://doi.org/10.1186/s40814-020-00702-1). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity.Sixty-two people (aged 18–60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol.MethodsRestrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders.ConclusionsWe present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS.Trial registrationISRCTN45323485 registered on 7 April 2020.

Feasibility of deploying peer coaches to mentor frontline home health aides and promote mobility among individuals recovering from a stroke: pilot test of a randomized controlled trial

BackgroundEach year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as “peer coaches” to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures.MethodsThis was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures.ResultsAchieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants.ConclusionsThe trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures.Trial registrationClinicalTrials.gov, NCT04840407. Retrospectively registered on 9 April 2021

Measurement of patient satisfaction with two different restorative materials in non-aesthetic zone area by using OHIP5: Prospective study.

Many dental restorative materials are used in dental clinics, while in a new practice, many countries are trying to ban dental amalgam for many reasons. Dental mercury is the main issue for suspending the use of dental amalgam. Another restoration method, the composite restoration for posterior and anterior teeth for esthetic porous, became the alternative to amalgam. To measure patient satisfaction with two different materials based on multiple criteria using an oral health impact profile (OHIP) form. This is a prospective study on two groups. The patients visiting the clinic with a vital posterior tooth indicated for restoration were requested to participate in the study. The first group received composite restoration of the posterior teeth. Contrarily, the second group underwent an amalgam restoration application. Patient satisfaction was assessed using the OHIP5 to assess different aspects of patient satisfaction. The patients were asked to fill out a form before starting the procedure, and after 4 weeks, the procedure was reported. The operators were requested to fill out their forms based on the procedure done to determine the participant eligibility criteria. Overall 64 subjects were involved in the study among them 35 participants who received composite restoration, 48.5% were female, whereas 51.5% were male. Under other conditions, the patients who underwent amalgam application were 29, and 41.4% were female. Based on the study results, the participants underwent before and after assessment and showed no demands for different aspects with the two different materials. No significant differences using amalgam or composite restoration regarding appearance, functional, and psychological factors in the posterior teeth were noted.

Building out lifelines for safety, trust, empowerment, and renewal: Development, feasibility, and acceptability of the BOLSTER intervention for patients with gynecologic cancers and their caregivers.

187 Background: Peritoneal carcinomatosis (PC) afflicts over half of women with advanced gynecologic (GYN) cancers. Patients with PC often require ostomies, gastric tubes, or catheters to palliate their symptoms, yet patients and caregivers report feeling unprepared to manage these devices at home. Our aims were to develop and assess the feasibility and acceptability of an intervention (BOLSTER) to support patients with GYN cancers and their caregivers after hospitalization for PC. Methods: We used the ADAPT-ITT approach to adapt components of the Standard Nursing Intervention Protocol for the target population. First, we assembled a team of stakeholders and topical experts to identify gaps in patient resources. Next, we developed patient- and family-centered educational materials. We augmented written materials with illustrations and produced short videos of patients and caregivers managing medical devices. We developed a protocolized manual for a baccalaureate-prepared nurse to provide care coordination, skills training, and symptom management education across several in-person or telehealth visits. We also created a smartphone application to assess patient-reported outcomes, deliver tailored educational content, and trigger clinical action between visits. Finally, we assessed the feasibility and acceptability of two iterations of BOLSTER in single-arm pilot studies of English-speaking adult patients hospitalized for PC and their caregivers. We defined feasibility as a ≥50% consent-to-approach ratio and acceptability as ≥70% of participants recommending BOLSTER. Results: Intervention characteristics during and the results of each single-arm pilot study are shown in Table. In the first single-arm pilot, 2/4 participants declined home visits, 2/4 wished BOLSTER were shorter, and 3/4 desired access to BOLSTER earlier in their disease course. For the second single-arm pilot, we expanded participant eligibility criteria, eliminated home visits, and reduced the duration of the intervention. Conclusions: BOLSTER is a technology-enhanced, nurse-led care management intervention that is feasible and acceptable to patients with GYN cancer-associated PC and their caregivers. A randomized controlled pilot study of BOLSTER represents a logical next step. Clinical trial information: NCT03367247. [Table: see text]

Religious coping and psychological well-being in Latino Alzheimer's caregivers.

Prior research has demonstrated the benefits of religion on caregiver well-being; however, less research exists on the processes underlying this relationship, particularly in Latino Alzheimer's disease (AD) families. This study's aim was therefore to explore the direct and indirect influences of positive religious coping (RC-P) and negative religious coping (RC-N) on caregivers' experiences of depression and anxiety. The data are from the Circulo de Cuidado Study baseline interviews; participant eligibility criteria were that the person identifies as being Latino, providing at least 5h of care weekly, and their relative has an AD diagnosis and neuropsychiatric symptoms. In person at-home interviews were conducted in Spanish with 67 caregivers. Religious coping was assessed with the Brief RCOPE; depression and anxiety were measured with the Center for Epidemiological Studies Depression Scale-Spanish version and State Anxiety Inventory. Multivariate regression analyses, controlling for caregiving stressors, were used to test our core hypotheses. As hypothesized, RC-N had significant direct effect on depression (p<0.001) and anxiety (p<0.001) as well as partially mediated the relationship between caregiver subjective stressor and depression (p<0.01) and anxiety (p<0.01). However, contrary to our hypothesis, RC-P did not have a direct or indirect effects on psychological well-being. Our findings are consistent with other studies linking RC-N to poorer caregiver outcomes. Caregivers who questioned God's power, perceived God punishing them, or felt abandoned by God reported greater levels of depression and anxiety. The results suggest that caregivers experiencing religious distress may feel overwhelmed and view a more hopeless future.

Feasibility of a pharmacist-facilitated medicines review intervention for community-dwelling Māori older adults

BackgroundPharmacist-facilitated medicines review services have been postulated as a way to address current inequities in health outcomes between Māori and non-Māori. These interventions have been shown internationally to improve the appropriate use of medicines but remain underutilised in Aotearoa New Zealand (NZ). By reviewing the literature and engaging with key stakeholders, we developed an intervention, which included collaborative goal-setting, education and medicines optimisation, for testing in a feasibility study. ObjectiveTo determine the feasibility (recruitment, intervention delivery, and data collection methods) of a pharmacist-facilitated medicines review intervention for Māori older adults, and proposed intervention outcomes. MethodsThis study was reported in accordance with the CONSORT 2010 statement: extension to randomised controlled pilot and feasibility trials and the Consolidated criteria for strengthening reporting of health research involving indigenous peoples: the CONSIDER statement. Participant eligibility criteria were: Māori; aged 55-plus; community-dwelling; enrolled in a general practice in Waitematā District Health Board (Auckland, NZ). Consented participants engaged in a medicines education component (participant and pharmacist) and an optional medicines optimisation component (participant, pharmacist and prescriber). Outcomes measures included: the feasibility of data collection tools and methods, time taken to conduct the intervention and research processes; medicines knowledge, medicines appropriateness and quality of life (QoL); pharmacist recommendations and prescriber acceptance rate. ResultsSeventeen consented participants took part in the intervention from December 2019–March 2020 with the majority (n = 12) recruited through general practice mail-outs. Data collection was feasible using the predetermined outcome measure tools and was complete for all patient participants. Pharmacist intervention delivery was feasible. A mean of 9.5 recommendations were made per participant with a prescriber acceptance rate of 95%. These included non-medicine-related recommendations. ConclusionThe feasibility testing of pharmacist-facilitated medicines review intervention developed for (and with) community-dwelling Māori older adults allows for intervention refinement and can be utilised for further studies relating to pharmacist services in primary care.

Reporting quality of abstracts of veterinary randomized controlled trials.

To evaluate the adherence of veterinary randomized controlled trial (RCT) abstracts to the recommendations on minimum abstract information included in the Consolidated Standards of Reporting Trials (CONSORT) checklist for RCT abstracts and to identify characteristics associated with the number of CONSORT items reported. 212 abstracts representing all RCTs published in 5 general veterinary journals in 2013 and 2018. 2 investigators independently assessed whether each of the 15 CONSORT checklist items for abstracts applicable to veterinary medicine was reported. Generalized linear mixed models were built to explore associations of selected variables with the total number of checklist items reported. Abstracts included a median of 5 checklist items (range, 2 to 10 items). None met the recommendations for reporting participant recruitment and funding source. Less than 25% of abstracts met the recommendations for the title, participant eligibility criteria, primary outcome, randomization technique, blinding, numbers analyzed, primary outcome results, and harms to participants. The number of items reported was higher in abstracts of RCTs that included clinical patients (vs other participants; OR, 1.13; 95% CI, 1.05 to 1.22). The number of items reported did not significantly change over time. Results suggested that the reporting quality of abstracts of RCTs in general veterinary journals was suboptimal per CONSORT recommendations. Because abstracts may be the only reference material available in certain settings, improvements are warranted to ensure readers have the information they need to properly interpret reported findings.

The attitude and psychological status of medical staff in China during the COVID-19 outbreak: a cross-sectional survey

BackgroundIn early 2020, the outbreak of coronavirus disease 2019 (COVID-19) in China greatly increased the burden on medical staff. We aimed to investigate the attitudes of medical practitioners towards arranging rotations for medical students during this period of staff shortage and to assess their psychological state. MethodsWe used the self-rating depression scale (SDS) and the self-rating anxiety scale (SAS) to do a psychological assessment of both medical and non-medical staff from 25 centres in different provinces in China. Participants were recruited through hospital departments, online medical-alumni organisations, and open recruitment through online platforms. Participant eligibility criteria for all participants included being older than 18 years and living in China during the survey period, and participant-specific criteria included the following: medical practitioners had to work as a doctor, nurse, or clinical laboratory technician in a medical institution, and work during the COVID-19 outbreak; medical students had to have majored in clinical medicine, nursing, or clinical laboratory diagnosis, and be on an undergraduate internship (phase 1 student) or postgraduate or standardised trainees (phase 2 student), and had to work during the COVID-19 outbreak; non-medical participants had to work in non-medical industries. Medical staff included medical practitioners and medical students. We used WeChat online questionnaires to investigate the attitude of medical practitioners and medical students to arranging for students to be on duty during the epidemic period. The primary outcomes of this study were attitude of medical staff to medical students, depression index (according to the SDS), and anxiety index (according to the SAS). We used descriptive statistics to analyse demographic covariates, SDS scores, and SAS scores, χ2 and Fisher's exact test to compare categorical data, independent t-tests and one-way ANOVA tests to compare numerical data, LSD tests and Tamhane tests to compare significance in multiple groups, Pearson's tests to compare the goodness of fit of numerical data, and Spearman's tests to compare the goodness of fit of two ordinal category data. This study was approved by the medical ethics committee of West China Second University Hospital, Sichuan University (approval number 2020-012). The study was done in accordance with the Declaration of Helsinki and all participants provided informed consent. FindingsWe recruited 506 people (236 medical staff, of which 150 medical practitioners and 86 medical students, and 270 non-medical staff; 130 [26%] men and 376 [74%] women, median age 36 years, IQR 27–45) into our cross-sectional survey. 133 (56%) of 236 medical staff had a positive attitude towards arranging rotations of students on duty, with the most positive being students in phase 2 (34 [68%] of 50 had a positive attitude) and the most negative being senior practitioners (28 [40%] of 70 had a positive attitude). 178 (75%) of 236 medical staff considered students on duty to be high risk, and students in phase 1 (32 [86%] of 37) and senior practitioners (56 [80%] of 70) were particularly worried about this. 160 (68%) of 236 medical staff considered that students who refused to be on duty were excusable, even though some junior practitioners suggested punishing them (17 [22%] of 79). There was no significant difference in SDS and SAS between medical students and medical practitioners, but depression and anxiety was significantly lower than in non-medical staff (SDS 13·69, 95% CI 12·07–15·50, vs SDS 24·20, 21·30–27·11, p=0·0010; SAS 7·54, 5·83–9·46, vs SAS 18·76, 16·22–21·80, p=0·0010). In addition, people with lower education showed a higher index of depression and anxiety than people with higher education (cut-off point for higher education was a bachelor's degree; SDS 14·06, 12·63–15·68, vs SDS 35·03, 30·89–39·09, p=0·0010; SAS 8·52, 6·81–10·34, vs SAS 25·75, 22·41–29·13, p=0·0010). InterpretationNegative psychological states were associated with lower levels of educational attainment, and people with a high education and a medical background could more clearly recognise the development of the epidemic. The more clinically experienced practitioners were, the more worried they were about risks to students. The government should enact permanent bills to guarantee personal safety and accident compensation of students who are willing to go to the front line. FundingNone.

Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia

Long-acting injectable antipsychotics (LAIs) can potentially reduce hospitalization risk by enhancing medication adherence but are rarely considered for early-phase schizophrenia treatment. To determine whether encouraging use of a LAI compared with usual care delays the time to first hospitalization with patients with early-phase illness. The Prevention of Relapse in Schizophrenia (PRELAPSE) trial was cluster randomized with a follow-up duration of 2 years. The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states. Site randomization assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) and 20 to provide treatment as usual (clinician's choice [CC] condition). Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years. The AOM sites identified 576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled. There were no restrictions on treatment at CC sites (including using LAIs) or at AOM sites with the exception that aripiprazole monohydrate had to be prescribed within US Food and Drug Administration-approved guidelines. The primary outcome was time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available. Potential events were adjudicated by an independent committee masked to treatment assignment. The 489 participants (368 men [75.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use. Fifty-two AOM (22%) and 91 CC participants (36%) had at least 1 hospitalization. The mean survival time until first hospitalization was 613.7 days (95% CI, 582.3-645.1 days) for AOM participants and 530.6 days (95% CI, 497.3-563.9 days) for CC participants. For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34- 0.92; P = .02), favoring AOM. Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants. The number needed to treat to prevent 1 additional hospitalization was 7 participants treated with AOM compared with CC. Long-acting injectable antipsychotic use by patients with early-phase schizophrenia can significantly delay time to hospitalization, a personally and economically important outcome. Clinicians should more broadly consider LAI treatment for patients with early-phase illness. ClinicalTrials.gov Identifier: NCT02360319.

Designing antifilarial drug trials using clinical trial simulators

Lymphatic filariasis and onchocerciasis are neglected tropical diseases (NTDs) targeted for elimination by mass (antifilarial) drug administration. These drugs are predominantly active against the microfilarial progeny of adult worms. New drugs or combinations are needed to improve patient therapy and to enhance the effectiveness of interventions in persistent hotspots of transmission. Several therapies and regimens are currently in (pre-)clinical testing. Clinical trial simulators (CTSs) project patient outcomes to inform the design of clinical trials but have not been widely applied to NTDs, where their resource-saving payoffs could be highly beneficial. We demonstrate the utility of CTSs using our individual-based onchocerciasis transmission model (EPIONCHO-IBM) that projects trial outcomes of a hypothetical macrofilaricidal drug. We identify key design decisions that influence the power of clinical trials, including participant eligibility criteria and post-treatment follow-up times for measuring infection indicators. We discuss how CTSs help to inform target product profiles.