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Background: Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking., Objective: The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation., Methods: The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs., Results: The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026., Conclusions: The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs will create a systematic link between CPGs, SDM, and PDAs, which may facilitate SDM in clinical practice., International Registered Report Identifier (irrid): DERR1-10.2196/57611., (©Lena Fischer, Fülöp Scheibler, Corinna Schaefer, Torsten Karge, Thomas Langer, Leon Vincent Schewe, Ivan D Florez, Andrew Hutchinson, Sheyu Li, Marta Maes-Carballo, Zachary Munn, Lilisbeth Perestelo-Perez, Livia Puljak, Anne Stiggelbout, Dawid Pieper. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.11.2024.)

Background: Rapid and flexible data collection efforts are necessary for effective monitoring and research on tobacco and nicotine product use in a constantly evolving marketplace. The Rutgers Omnibus Survey (1) provides timely data on awareness and use of new and emerging tobacco products among adults in a rapid manner, (2) provides a platform for measurement experiments to help develop and refine measures of tobacco use that reflect the current marketplace, and (3) generates pilot data for grant applications and scientific manuscripts., Objective: This study aims to document the first 2 years of the Rutgers Omnibus Study through the reporting of methodology, fielding summaries, and sample characteristics., Methods: Launched in February 2022 and fielded quarterly thereafter, we survey convenience samples of 2000 to 3000 US adults aged 18-45 years recruited from Amazon Mechanical Turk (MTurk) using the MTurk Toolkit by CloudResearch. The questionnaire includes core and rotating modules and is designed to take approximately 10 minutes to complete through Qualtrics. The fielding duration is approximately 10 days per wave. Each wave includes both unique and repeating participants, and responses can be linked across waves by an anonymous ID., Results: Sample sizes ranged from 2082 (wave 8, December 2023) to 2989 (wave 1, February 2022), and the 8-wave longitudinal dataset included 10,334 participants, of whom 2477 had 3 or more data points. The cost per complete at each wave was low, ranging from US $2.46 to US $3.27 across waves. Key demographics were consistent across waves and similar to that of the general population, while tobacco product trial and past-30-day use were generally higher., Conclusions: The Rutgers Omnibus Study is a quarterly survey that is effective for rapidly assessing the use of emerging tobacco and nicotine products and can also be leveraged to conduct survey experiments, generate pilot data, and address both cross-sectional and longitudinal research questions., International Registered Report Identifier (irrid): RR1-10.2196/58203., (©Michelle T Bover Manderski, William J Young, Ollie Ganz, Cristine D Delnevo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.10.2024.)

Background: Nurses face high levels of stress and emotional exhaustion due to heavy workloads and demanding work environments. Prolonged exposure to these stressors predisposes nurses to burnout, which can adversely affect patient care. Addressing burnout among nurses requires a multifaceted approach, involving both personal and organizational strategies. While organizational strategies target systemic workplace issues, personal interventions are often favored for their ease of implementation, immediate benefits, and empowerment of health care workers through stress management and resilience-building. Prioritizing evidence-based interventions to mitigate burnout among nurses is crucial for managing occupational stress and promoting well-being. Person-directed psychoeducation is an effective personal intervention strategy used to equip nurses with the appropriate knowledge and skills to handle stressors, thereby safeguarding their mental health and ensuring high-quality patient care., Objective: This protocol proposes a systematic review that aims to identify and assess the effectiveness of person-directed psychoeducational interventions for nurses. The review aims to pinpoint effective interventions that can be implemented to manage burnout and support the mental health of nurses., Methods: This systematic review will follow the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. In total of 5 electronic databases (PubMed-MEDLINE, EBSCOhost, Ovid MEDLINE, Scopus, and ScienceDirect) will be searched for studies published between January 1, 2014, and December 31, 2023. The search will encompass 3 main keywords: "nurses," "burnout intervention," and "burnout." Predefined eligibility criteria will guide the screening process. Data will be extracted to address the objectives of the review. The risk of bias for each study will be assessed using Joanna Briggs Institute Critical Appraisal Tools., Results: Preliminary searches have been initiated since February 2024, with the review expected to be completed by June 2024. The expected results will include a comprehensive list of psychoeducational interventions and their effectiveness in reducing burnout among nurses. The review will highlight interventions that demonstrate significant impact in published studies from various countries., Conclusions: Given the rising prevalence of burnout among nurses and its detrimental effects on individuals and health care organizations, the findings from this systematic review are expected to inform health care policy and practice. By evaluating different interventions, it will provide insights into the most effective strategies, contributing to evidence-based practices that support nurses' mental health and well-being. The findings can support stakeholders in developing and implementing targeted strategies to combat nurse burnout, ultimately enhancing the quality of patient care and health care delivery. In addition, the findings will also offer valuable information for researchers, guiding future practice and research in this area., Trial Registration: PROSPERO CRD42024505762; https://tinyurl.com/4p84dk3d., International Registered Report Identifier (irrid): DERR1-10.2196/58692., (©Ili Abdullah Sharin, Norehan Jinah, Pangie Bakit, Izzuan Khirman Adnan, Nor Haniza Zakaria, Shazwani Mohmad, Siti Zubaidah Ahmad Subki, Nursyahda Zakaria, Kun Yun Lee. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.09.2024.)

Background: Approximately 1 in 6 cannabis users develop a cannabis use disorder (CUD) and the odds increase to 1 in 2 for daily users., Objective: The Dual use of Cannabis and Tobacco Monitoreing through a Gamified Web app (DuCATA_GAM-CaT) project aims to identify cannabis-tobacco patterns of use and withdrawal symptoms among individuals with CUD who are attending substance abuse programs., Methods: The project uses a mixed methods approach consisting of 3 studies. First, a participatory qualitative study involves focus groups comprising individuals with CUD, clinicians, project researchers, and an expert gamification company to co-design a gamified web app. Second, a longitudinal prospective study to follow up individuals over 6 weeks with CUD attending substance abuse programs . Participants report their cannabis-tobacco usage patterns, type and frequency of tobacco use, nicotine dependence, withdrawal symptoms, psychoemotional factors, and motivation to quit both substances. Predictive analysis techniques are used to analyze clinical, demographic, psychological, and environmental data to predict the probability of achieving abstinence. Third, homogeneous focus groups to explore participants' experiences during their CUD treatment., Results: By June 2024, the project had completed the first study, defining eligible cannabis user profiles, developed the initial web app prototype, and initiated recruitment across 10 centers, with 74 participants enrolled, aiming to reach 150 participants in total., Conclusions: All participants are required to provide informed consent, and their information is kept confidential and anonymized following confidentiality rules. The research team is committed to disseminating the results obtained to professional and patient groups, as well as informing public health agents, to positively influence political and social decision makers and design programmers. Additionally, we aim to prioritize the publication of the results in high-impact journals specialized in drug abuse, public health, and health care services research., Trial Registration: ClinicalTrials.gov NCT05512091; https://clinicaltrials.gov/study/NCT05512091., International Registered Report Identifier (irrid): DERR1-10.2196/58335., (©Judith Saura, Ariadna Feliu, Marta Enríquez-Mestre, Marcela Fu, Montse Ballbè, Yolanda Castellano, Margarida Pla, Nathalia Rosa, Petia Radeva, Elena Maestre-González, Carmen Cabezas, Joan Colom, Josep M Suelves, Silvia Mondon, Pablo Barrio, Magalí Andreu, Antònia Raich, Jordi Bernabeu, Jordi Vilaplana, Xavier Roca Tutusaus, Joseph Guydish, Esteve Fernández, Cristina Martínez. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.09.2024.)

Background: The practice of dental surgery requires a few different skills, including mental rotation of an object, precision of movement with good hand-eye coordination, and speed of technical movement. Learning these different skills begins during the preclinical phase of dental student training. Moreover, playing a musical instrument or video game seems to promote the early development of these skills. However, we found that studies specifically addressing this issue in the field of dental education are lacking., Objective: The main aims of this study are to evaluate whether the ability to mentally represent a volume in 3D, the precision of gestures with their right and left hand, or the speed of gesture execution is better at baseline or progresses faster for players (video games or music or both)., Methods: A prospective monocentric controlled and longitudinal study will be conducted from September 2023 and will last until April 2025 in the Faculty of Dental Surgery of Nantes. Participants were students before starting their preclinical training. Different tests will be used such as Vandenberg and Kuse's mental rotation test, the modified Precision Manual Dexterity (PMD), and performing a pulpotomy on a permanent tooth. This protocol was approved by the Ethics, Deontology, and Scientific Integrity Committee of Nantes University (institutional review board approval number IORG0011023)., Results: A total of 86 second-year dental surgery students were enrolled to participate in the study in September 2023. They will take part in 4 iterations of the study, the last of which will take place in April 2025., Conclusions: Playing video games or a musical instrument or both could be a potential tool for initiating or facilitating the learning of certain technical skills in dental surgery., International Registered Report Identifier (irrid): DERR1-10.2196/55738., (©Roselyne Clouet, Alexis Gaudin, Jeanne Tourtelier, Claire Gogendeau, Samuel Serisier, Tony Prud'homme. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.09.2024.)

Background: Diabetes and prediabetes are diagnosed differentially by Western and Chinese medicine. While Western medicine uses objective laboratory analysis of biochemical parameters to define the severity of diabetes and prediabetes, Chinese medicine uses a comprehensive approach that integrates observation, inquiry, pulse palpation, and tongue diagnosis. The medical information collected is then categorized into different syndromes. However, traditional methods of pulse and tongue diagnoses used to determine syndrome differentiation are highly subjective and skill dependent., Objective: This study aims to identify the gap in conventional traditional Chinese medicine (TCM) diagnostic techniques for syndrome differentiation analysis using contemporary diagnostic devices. We devised a protocol for a nonrandomized, exploratory, observational case-control study with equal allocations in 5 arms to investigate the syndrome differentiation of diabetes and prediabetes. We hypothesize that the TCM syndrome differentiation of diabetes and prediabetes in the tropical climate may differ from that defined based on the Chinese demographic. We also speculate that the high-frequency spectral energy may reflect a difference in pulse wave intensity and density between the healthy and diabetes groups., Methods: A total of 250 eligible participants will be equally assigned to 1 of 5 arms (healthy or subhealthy, prediabetes, diabetes, prediabetes with hypertension and dyslipidemia, and diabetes with hypertension and dyslipidemia). Participants aged 21-75 years, of any sex or race, and have been diagnosed with diabetes (fasting plasma glucose [FPG] of 7 mmol/L, or 2-hour plasma glucose [2hPG] of 11.1 mmol/L) or prediabetes (impaired FPG of 6.1-6.9 mmol/L, or impaired glucose tolerance with an 2hPG of 7.8-11 mmol/L) will be included. The Health Evaluation Questionnaire, Physical Activity Questionnaire, sugar intake assessment, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis, and tongue diagnosis will be performed in a single visit. ANOVA for continuous data and chi-square tests of independence will be used for categorical data assessments, with a level of P<.05 considered significant., Results: The recruitment is in progress. We anticipate that the study will conclude in June 2025. As of July 15, 2024, we have enrolled 140 individuals., Conclusions: To the best of our knowledge, this is the first study to use contemporary TCM diagnostic instruments to map expert and empirical knowledge of TCM to its scientific equivalents for the purpose of evaluating the syndrome differentiation of diabetes. We designed this protocol with the exploratory goal to examine objectively the syndrome differentiation of patients with diabetes and those with prediabetes using TCM diagnostic technologies. The data collected and evaluated under standardized conditions using these contemporary diagnostic devices will exhibit a higher degree of stability, hence yielding dependable and unbiased results for syndrome differentiation. Thus, our findings may potentially increase the accuracy of identification, diagnosis, treatment, and prevention of diabetes and prediabetes through a system of targeted treatment., Trial Registration: ClinicalTrials.gov NCT05563090; https://clinicaltrials.gov/ct2/show/NCT05563090., International Registered Report Identifier (irrid): DERR1-10.2196/56024., (©Hui Ping Ng, Shu Yun Chong, Yi Huan Li, Tong Hwee Goh, Ka Yii Pang, Michelle Jessica Pereira, Chin-Ming Huang. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.09.2024.)

Background: The global community has set an ambitious goal to end HIV/AIDS as a public health threat by 2030. Significant progress has been achieved in pursuing these objectives; however, concerns remain regarding the lack of disaggregated routine data for key populations (KPs) for a targeted HIV response. KPs include female sex workers, transgender populations, gay men and other men who have sex with men, people who are incarcerated, and people who use drugs. From an epidemiological perspective, KPs play a fundamental role in shaping the dynamics of HIV transmission due to specific behaviors. In South Africa, routine health information management systems (RHIMS) do not include a unique identifier code (UIC) for KPs. The purpose of this protocol is to develop the framework for improved HIV monitoring and programming through piloting the inclusion of KPs UIC in the South African RHIMS., Objective: This paper aims to describe the protocol for a multiphased study to pilot the inclusion of KPs UIC in RHIMS., Methods: We will conduct a multiphased study to pilot the framework for the inclusion of KPs UIC in the RHIMS. The study has attained the University of Johannesburg Research Ethics Committee approval (REC-2518-2023). This study has four objectives, including a systematic review, according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (objective 1). Second, policy document review and in-depth stakeholder interviews using semistructured questionnaires (objective 2). Third, exploratory data analysis of deidentified HIV data sets (objective 3), and finally, piloting the framework to assess the feasibility of incorporating KPs UIC in RHIMS using findings from objectives 1, 2, and 3 (objective 4). Qualitative and quantitative data will be analyzed using ATLAS.ti (version 6; ATLAS.ti Scientific Software Development GmbH) and Python (version 3.8; Python Software Foundation) programming language, respectively., Results: The results will encompass a systematic review of literature, qualitative interviews, and document reviews, along with exploratory analysis of deidentified routine program data and findings from the pilot study. The systematic review has been registered in PROSPERO (International Prospective Register of Systematic Reviews; CRD42023440656). Data collection is planned to commence in September 2024 and expected results for all objectives will be published by December 2025., Conclusions: The study will produce a framework to be recommended for the inclusion of the KP UIC national rollout. The study results will contribute to the knowledge base around the inclusion of KPs UIC in RHIMS data., Trial Registration: PROSPERO CRD42023440656; https://tinyurl.com/msnppany., International Registered Report Identifier (irrid): PRR1-10.2196/55092., (©Mashudu Rampilo, Edith Phalane, Refilwe Nancy Phaswana-Mafuya. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.09.2024.)

Background: Sedation at the end of life is used to relieve distressing symptoms including agitation and delirium. Standard care may include infused benzodiazepines or antipsychotics. These agents often result in deep sedation with loss of interaction with loved ones, which may be distressing., Objective: The DREAMS (Dexmedetomidine for the Reduction of End-of-life Agitation and for optiMised Sedation) trial aimed to compare the sedative and antidelirium effects of the alpha-2 agonist dexmedetomidine, a novel palliative care sedative, compared with midazolam, a benzodiazepine when administered by subcutaneous infusion at the end of life, with doses of both agents targeting lighter, or potentially interactive sedation., Methods: Participants were recruited from adult inpatients admitted for end-of-life care under a palliative care team in regional New South Wales, Australia. Inclusion criteria included patients older than 18 years, with a preference for lighter sedation at the end of life. Exclusion criteria included severe cardiac dysfunction (contraindication to dexmedetomidine). Participants consented and were placed on a treatment-pending list. Upon experiencing terminal deterioration, patients were randomized to either arm 1 (dexmedetomidine) or arm 2 (midazolam) as their treatment arm. These treatments were administered by continuous subcutaneous infusion. The level of consciousness and agitation of the patients were measured by the Richmond Agitation-Sedation Scale-Palliative version and the Memorial Delirium Assessment Score. Richmond Agitation-Sedation Scale-Palliative version assessments were performed by both nursing and medical staff, while Memorial Delirium Assessment Score assessments were carried out by medical staff only. Families and patients were asked to complete, as able, a patient comfort assessment form, to gauge perceptions of distress. Data were collected and matched with the breakthrough medication doses administered, along with qualitative comments in the medical record. In addition, the study tracked symptoms and patient functional status that were recorded as part of the Palliative Care Outcomes Collaborative, a national tracking project for monitoring symptom outcomes in palliative care., Results: The DREAMS trial was funded in May 2020, approved by the ethics committee in November 2020, and started recruiting participants in May 2021. Data collection commenced in May 2021 and is anticipated to continue until December 2024. Publication of results is anticipated from 2024 to 2026., Conclusions: The evidence base for sedative dosing in palliative care for distress and agitation is not robust, with standard care based primarily on clinical experience and not robust scientific evidence. This study is important because it will compare a standard and a novel sedative used in end-of-life treatment. By assessing the potential efficacy and benefits of both, it seeks to optimize the quality of dying by providing targeted sedation that can improve the communication between dying patients and their loved ones., Trial Registration: Australia New Zealand Clinical Trials Register ACTRN12621000052831; https://uat.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380889., International Registered Report Identifier (irrid): DERR1-10.2196/55129., (©Benjamin Thomas, Greg Barclay, Wing-Shan Angela Lo, Judy Mullan, Kylie Mansfield. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.09.2024.)

Background: In attention-deficit/hyperactivity disorder (ADHD), poor inhibitory control is one of the main characteristics, with oculomotor inhibition impairments being considered a potential biomarker of the disorder. While auditory white noise has demonstrated the ability to enhance working memory in this group, visual white noise is still unexplored and so are the effects of both types of white noise stimulation on oculomotor inhibition., Objective: This crossover study aims to explore the impact of auditory and visual white noise on oculomotor inhibition in children with ADHD and typically developing (TD) children. The study will investigate the impact of different noise levels (25% and 50% visual, 78 dB auditory), and performance will be evaluated both with and without noise stimulation. We hypothesize that exposure to white noise will improve performance in children with ADHD and impair the performance for TD children., Methods: Memory-guided saccades and prolonged fixations, known for their sensitivity in detecting oculomotor disinhibition in ADHD, will be used to assess performance. Children diagnosed with ADHD, withdrawing from medication for 24 hours, and TD children without psychiatric disorders were recruited for the study., Results: Data collection was initiated in October 2023 and ended in February 2024. A total of 97 participants were enrolled, and the first results are expected between September and November 2024., Conclusions: This study will examine whether cross-modal sensory stimulation can enhance executive function, specifically eye movement control, in children with ADHD. In addition, the study will explore potential differences between auditory and visual noise effects in both groups. Our goal is to identify implications for understanding how noise can be used to improve cognitive performance., Trial Registration: ClinicalTrials.gov NCT06057441; https://clinicaltrials.gov/study/NCT06057441., International Registered Report Identifier (irrid): DERR1-10.2196/56388., (©Erica Jostrup, Marcus Nyström, Pia Tallberg, Göran Söderlund, Peik Gustafsson, Emma Claesdotter-Knutsson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.08.2024.)

Background: Immunocompromised individuals are known to respond inadequately to SARS-CoV-2 vaccines, placing them at high risk of severe or fatal COVID-19. Thus, immunocompromised individuals and their caregivers may still practice varying degrees of social or physical distancing to avoid COVID-19. However, the association between physical distancing to avoid COVID-19 and quality of life has not been comprehensively evaluated in any study., Objective: We aim to measure physical distancing behaviors among immunocompromised individuals and the association between those behaviors and person-centric outcomes, including health-related quality of life (HRQoL) measures, health state utilities, anxiety and depression, and work and school productivity impairment., Methods: A patient-informed protocol was developed to conduct the EAGLE Study, a large cross-sectional, observational study, and this paper describes that protocol. EAGLE is designed to measure distancing behaviors and outcomes in immunocompromised individuals, including children (aged ≥6 mo) and their caregivers, and nonimmunocompromised adults in the United States and United Kingdom who report no receipt of passive immunization against COVID-19. We previously developed a novel self- and observer-reported instrument, the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19), to measure physical distancing behavior levels cross-sectionally and retrospectively. Using an interim or a randomly selected subset of the study population, the PDS-C19 psychometric properties will be assessed, including structural validity, internal consistency, known-group validity, and convergent validity. Associations (correlations) will be assessed between the PDS-C19 and validated HRQoL-related measures and utilities. Structural equation modeling and regression will be used to assess these associations, adjusting for potential confounders. Participant recruitment and data collection took place from December 2022 to June 2023 using direct-to-patient channels, including panels, clinician referral, patient advocacy groups, and social media, with immunocompromising diagnosis confirmation collected and assessed for a randomly selected 25% of immunocompromised participants. The planned total sample size is 3718 participants and participant-caregiver pairs. Results will be reported by immunocompromised status, immunocompromising condition category, country, age group, and other subgroups., Results: All data analyses and reporting were planned to be completed by December 2023. Results are planned to be submitted for publication in peer-reviewed journals in 2024-2025., Conclusions: This study will quantify immunocompromised individuals' physical distancing behaviors to avoid COVID-19 and their association with HRQoL as well as health state utilities., International Registered Report Identifier (irrid): RR1-10.2196/52643., (©Paul Williams, Timothy A Herring, Renata T C Yokota, Tiago Maia, Sudhir Venkatesan, James C Marcus, Gabriella Settergren, Sofie Arnetorp, Andrew Lloyd, Johan L Severens, James W Varni, Sharon Dixon, Lweendo Hamusankwa, Philip A Powell, Sylvia Taylor, John E Ware Jr, Marieke Krol. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.08.2024.)

Background: Older Latino adults with HIV are at increased risk for mild cognitive impairment and earlier onset of aging-related cognitive decline. Improvements in cognitive functioning and cognitive outcomes are possible among people with HIV who adopt health promotion behaviors. However, health promotion interventions for older Latino adults with HIV have not been extensively used or widely recognized as viable treatment options. Happy Older Latinos are Active (HOLA) is a multicomponent, health promotion intervention that is uniquely tailored for older Latino adults with HIV., Objective: This study aims to (1) determine the feasibility and acceptability of an adapted version of HOLA aimed at improving cognitive functioning among older Latino adults with HIV; (2) explore whether HOLA will produce changes in cognitive functioning; (3) explore whether HOLA will produce changes in activity, psychosocial functioning, or biomarkers of cognition; and (4) explore whether changes in activity, psychosocial functioning or cognitive biomarkers correlate with changes in cognition, while accounting for genetic risk for dementia., Methods: A single-arm pilot trial with 30 Latino (aged 50 years and older) men and women with HIV was conducted to assess feasibility, acceptability, and preliminary effects on cognition. Participants were assessed at 2 time points (baseline and postintervention) on measures of neurocognitive and psychosocial functioning. In addition, blood samples were collected to determine biomarkers of cognition at baseline and postintervention. Successful recruitment was defined as meeting 100% of the targeted sample (N=30), with 20% (n=6) or less of eligible participants refusing to participate. Adequate retention was defined as 85% (n=25) or more of participants completing the postintervention assessment and acceptability was defined as 80% (n=38) or more of sessions attended by participants., Results: Participant recruitment began on February 22, 2022, and was completed on August 15, 2022. The last study visit took place on February 20, 2023. Data analysis is currently ongoing., Conclusions: Encouraging findings from this exploratory study may provide a blueprint for scaling up the HOLA intervention to a larger cohort of older Latino adults with HIV who may be currently experiencing or are at risk for HIV-related cognitive challenges., Trial Registration: ClinicalTrials.gov NCT04791709; https://clinicaltrials.gov/study/NCT04791709., International Registered Report Identifier (irrid): DERR1-10.2196/55507., (©Daniel E Jimenez, Emily J Ross, Elliott Weinstein, Hetta Gouse, Yue Pan, David Martinez Garza, Shanna L Burke, Jin Hui Joo, Victoria Behar-Zusman. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.08.2024.)

Background: Prepubertal transgender, nonbinary, and gender-diverse (TGD) children (ie, those asserting gender identity, expressing gender-role behavior outside of culturally defined norms for their sex registered at birth, or both) are presenting in greater numbers to pediatric gender clinics across the United States and abroad. A large subset of TGD children experiences gender dysphoria, that is, distress that arises from the incongruence between gender identity and sex registered at birth. A lack of consensus exists regarding care for prepubertal TGD children due, in part, to a dearth of empirical research on longitudinal developmental trajectories of gender identity, role behavior, and gender dysphoria (when present)., Objective: The objective of this National Institutes of Health-funded study is to provide evidence to inform clinical care for prepubertal TGD children by establishing a US longitudinal cohort (N=248) of prepubertal TGD children and their caregivers that is followed prospectively at 6-month intervals across 18 months., Methods: At each timepoint, clinical and behavioral data are collected via web-based visit from child and caregiver reporters. Latent class analysis, among other methods, is used to identify subgroups and longitudinally characterize the gender identity and gender-role behavior of TGD children. These models will define longitudinal patterns of gender identity stability and characterize the relationship between TGD classes and mental and behavioral health outcomes, including the moderating role of social gender transition (when present), on these associations., Results: Baseline data collection (N=248) is complete, and the identification of TGD subgroups based on gender identity and expression using latent class analysis is anticipated in 2024. The completion of all 4 waves of data collection is anticipated in July 2024, coinciding with the start of a no-cost study extension period. We anticipate longitudinal analyses to be completed by winter 2024., Conclusions: Through a longitudinal observational design, this research involving prepubertal TGD children and their caregivers aims to provide empirical knowledge on gender development in a US sample of TGD children, their mental health symptomology and functioning over time, and how family initiated social gender transition may predict or alleviate mental health symptoms or diagnoses. The research findings have promise for clinicians and families aiming to ensure the best developmental outcome for these children as they develop into adolescents., International Registered Report Identifier (irrid): DERR1-10.2196/55558., (©Marco A Hidalgo, Diane Chen, Amy C Tishelman, Johanna Olson-Kennedy, Yee-Ming Chan, Robert Garofalo, Hanno Petras, Stephen M Rosenthal, Diane Ehrensaft. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.08.2024.)

Background: The integration of smart technologies, including wearables and voice-activated devices, is increasingly recognized for enhancing the independence and well-being of older adults. However, the long-term dynamics of their use and the coadaptation process with older adults remain poorly understood. This scoping review explores how interactions between older adults and smart technologies evolve over time to improve both user experience and technology utility., Objective: This review synthesizes existing research on the coadaptation between older adults and smart technologies, focusing on longitudinal changes in use patterns, the effectiveness of technological adaptations, and the implications for future technology development and deployment to improve user experiences., Methods: Following the Joanna Briggs Institute Reviewer's Manual and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, this scoping review examined peer-reviewed papers from databases including Ovid MEDLINE, Ovid Embase, PEDro, Ovid PsycINFO, and EBSCO CINAHL from the year 2000 to August 28, 2023, and included forward and backward searches. The search was updated on March 1, 2024. Empirical studies were included if they involved (1) individuals aged 55 years or older living independently and (2) focused on interactions and adaptations between older adults and wearables and voice-activated virtual assistants in interventions for a minimum period of 8 weeks. Data extraction was informed by the selection and optimization with compensation framework and the sex- and gender-based analysis plus theoretical framework and used a directed content analysis approach., Results: The search yielded 16,143 papers. Following title and abstract screening and a full-text review, 5 papers met the inclusion criteria. Study populations were mostly female participants and aged 73-83 years from the United States and engaged with voice-activated virtual assistants accessed through smart speakers and wearables. Users frequently used simple commands related to music and weather, integrating devices into daily routines. However, communication barriers often led to frustration due to devices' inability to recognize cues or provide personalized responses. The findings suggest that while older adults can integrate smart technologies into their lives, a lack of customization and user-friendly interfaces hinder long-term adoption and satisfaction. The studies highlight the need for technology to be further developed so they can better meet this demographic's evolving needs and call for research addressing small sample sizes and limited diversity., Conclusions: Our findings highlight a critical need for continued research into the dynamic and reciprocal relationship between smart technologies and older adults over time. Future studies should focus on more diverse populations and extend monitoring periods to provide deeper insights into the coadaptation process. Insights gained from this review are vital for informing the development of more intuitive, user-centric smart technology solutions to better support the aging population in maintaining independence and enhancing their quality of life., International Registered Report Identifier (irrid): RR2-10.2196/51129., (©Kristina Marie Kokorelias, Alisa Grigorovich, Maurita T Harris, Umair Rehman, Louise Ritchie, AnneMarie M Levy, Kerstin Denecke, Josephine McMurray. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 07.08.2024.)

Background: Understanding mild behavioral impairment, a relatively recent notion in neuropsychological studies, provides significant insights into early behavioral indicators of cognitive decline and predicts the onset of dementia in older adults. Although the importance of understanding mild behavioral impairment is acknowledged, comprehensive reviews of its correlates with older adults are limited., Objective: This scoping review aims to identify the impact of mild behavioral impairment on health outcomes in older adults and the factors associated with mild behavioral impairment., Methods: The review will adhere to the Joanna Briggs Institute's methodological principles for scoping reviews. We will include studies focusing mainly on mild behavioral impairment in older adults, with the literature on this topic being limited to the period from 2003 to the present. Other clinical diagnoses, such as cognitive impairment, Parkinson disease, and multiple sclerosis, will not be included. We will use databases including PubMed (MEDLINE), CINAHL, Web of Science, Embase, PsycINFO, Cochrane, and Scopus for relevant articles published in English. Both gray literature and peer-reviewed articles will be considered during screening. Three independent reviewers will extract data using a predefined data extraction tool. Extracted data will be presented using tables, figures, and a narrative summary aligned with review questions, accompanied by an analysis of study characteristics and categorization of mild behavioral impairment correlates., Results: The results will be presented as a descriptive summary, structured according to the associated factors related to mild behavioral impairment, and the health outcomes. Additionally, the data on study characteristics will be presented in tabular format. An exploratory search was conducted in July 2023 to establish a comprehensive search strategy, and iterative refinements to the scoping review protocol and formalization of methods were completed. A follow-up search is planned for May 2024, with the aim of submitting the findings for publication in peer-reviewed journals., Conclusions: To our knowledge, this would be the first study to map the literature on the health-related factors and outcomes of mild behavioral impairment. The findings will support the development of interventions to prevent the occurrence of mild behavioral impairment and mitigate the negative outcomes of mild behavioral impairment., International Registered Report Identifier (irrid): DERR1-10.2196/60009., (©Seolah Yoon, Innhee Jeong, Jennifer Ivy Kim, Dahye Hong, Bada Kang. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.07.2024.)

Background: The Hispanic and Latinx community is disproportionately affected by Alzheimer disease and related dementias (ADRDs). In the United States, approximately 8.5 million caregivers of individuals with ADRDs identify as Hispanic and Latinx people, and caregiving-related stress and burden place caregivers at elevated risk for poor mental health outcomes, as well as loneliness and social isolation. To date, there is limited knowledge about the daily stress experiences of Hispanic and Latinx caregivers. Given this knowledge gap, it is critical to examine how personal, cultural, and contextual factors influence daily stress, mental health, and resilience over time among Hispanic and Latinx ADRD caregivers., Objective: The goal of this protocol report is to present the rationale, methodology, planned analytical strategy, progress completed to date, and implications of future findings for "Nuestros Días" (Spanish for "our days"), a fully remote daily diary (DD), observational cohort study examining the day-to-day experiences of Hispanic and Latinx ADRD caregivers., Methods: The study will recruit a cohort of up to 500 Hispanic and Latinx caregivers of individuals living with ADRD. Participants will complete measures assessing contextual, individual-level, and cultural factors at 3 intervals (enrollment, 6 months, and 12 months). Each of the timepoints will be followed by 21 days of DD surveys to report on daily stress, stress moderators, and mental health variables., Results: Data collection began in March 2023 and is projected to end in December 2026. As of March 2024, we have enrolled 60 caregivers in the Nuestros Días study, 78.9% (n=15) of whom are Spanish speakers. The current completion rate for DD surveys is 79.4%, averaging approximately 18 surveys out of 21 completed. We expect to enroll 10 to 15 participants per month moving forward to achieve our enrollment goal., Conclusions: Results from this study will identify which Hispanic and Latinx ADRD caregivers, and under what circumstances, appear to be at the greatest risk of experiencing poor mental health outcomes over time. This study represents a critical step forward in providing key guidance to develop effective, culturally sensitive interventions to support the health and well-being of Hispanic and Latinx ADRD caregivers, a historically underrepresented and underserved population in aging and caregiving research., International Registered Report Identifier (irrid): DERR1-10.2196/55216., (©Sofía Mildrum Chana, Lorelí Álvarez, Abigail Poe, Natashia Bibriescas, Danny Hai Wang, Stephanie DiFiglia, Andrés Azuero, Michael Crowe, Frank Puga. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.06.2024.)

Background: The population is constantly aging, and most older adults will experience many potential physiological changes as they age, leading to functional decline. Urinary and bowel dysfunction is the most common obstacle in older people. At present, the analysis of pelvic floor histological changes related to aging has not been fully elucidated, and the mechanism of improving intestinal control ability in older people is still unclear., Objective: The purpose of this study is to describe how the finite element method will be used to understand the mechanical characteristics of and physiological changes in the pelvic cavity during the rehabilitation process, providing theoretical support for the mechanism for improving urination and defecation dysfunction in older individuals., Methods: We will collect magnetic resonance imaging (MRI) and computed tomography (CT) data of the pelvic cavity of one male and one female volunteer older than 60 years and use the finite element method to construct a 3D computer simulation model of the pelvic cavity. By simulating different physiological states, such as the Valsalva maneuver and bowel movement, we will verify the accuracy of the constructed model, investigate the effects of different neuromuscular functional changes, and quantify the impact proportions of the pelvic floor muscle group, core muscle group, and sacral nerve., Results: At present, we have registered the study in the Chinese Clinical Trial Registry and collected MRI and CT data for an older male and an older female patient. Next, the construction and analysis of the finite element model will be accomplished according to the study plan. We expect to complete the construction and analysis of the finite element model by July 2024 and publish the research results by October 2025., Conclusions: Our study will build finite element models of the pelvic floor of older men and older women, and we shall elucidate the relationship between the muscles of the pelvic floor, back, abdomen, and hips and the ability of older adults to control bowel movements. The results of this study will provide theoretical support for elucidating the mechanism for improving urination and defecation dysfunction through rehabilitation., Trial Registration: Chinese Clinical Trial Registry ChiCTR2400080749; https://www.chictr.org.cn/showproj.html?proj=193428., International Registered Report Identifier (irrid): DERR1-10.2196/56333., (©Rui Wang, Guangtian Liu, Liwei Jing, Jing Zhang, Chenyang Li, Lichao Gong. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.05.2024.)

Background: Multimorbidity, defined as the coexistence of multiple chronic conditions, poses significant challenges to health care systems on a global scale. It is associated with increased mortality, reduced quality of life, and increased health care costs. The burden of multimorbidity is expected to worsen if no effective intervention is taken. Machine learning has the potential to assist in addressing these challenges since it offers advanced analysis and decision-making capabilities, such as disease prediction, treatment development, and clinical strategies., Objective: This paper represents the protocol of a scoping review that aims to identify and explore the current literature concerning the use of machine learning for patients with multimorbidity. More precisely, the objective is to recognize various machine learning models, the patient groups involved, features considered, types of input data, the maturity of the machine learning algorithms, and the outcomes from these machine learning models., Methods: The scoping review will be based on the guidelines of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). Five databases (PubMed, Embase, IEEE, Web of Science, and Scopus) are chosen to conduct a literature search. Two reviewers will independently screen the titles, abstracts, and full texts of identified studies based on predefined eligibility criteria. Covidence (Veritas Health Innovation Ltd) will be used as a tool for managing and screening papers. Only studies that examine more than 1 chronic disease or individuals with a single chronic condition at risk of developing another will be included in the scoping review. Data from the included studies will be collected using Microsoft Excel (Microsoft Corp). The focus of the data extraction will be on bibliographical information, objectives, study populations, types of input data, types of algorithm, performance, maturity of the algorithms, and outcome., Results: The screening process will be presented in a PRISMA-ScR flow diagram. The findings of the scoping review will be conveyed through a narrative synthesis. Additionally, data extracted from the studies will be presented in more comprehensive formats, such as charts or tables. The results will be presented in a forthcoming scoping review, which will be published in a peer-reviewed journal., Conclusions: To our knowledge, this may be the first scoping review to investigate the use of machine learning in multimorbidity research. The goal of the scoping review is to summarize the field of literature on machine learning in patients with multiple chronic conditions, highlight different approaches, and potentially discover research gaps. The results will offer insights for future research within this field, contributing to developments that can enhance patient outcomes., International Registered Report Identifier (irrid): PRR1-10.2196/53761., (©Danny Jeganathan Anthonimuthu, Ole Hejlesen, Ann-Dorthe Olsen Zwisler, Flemming Witt Udsen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.05.2024.)

Background: The COVID-19 pandemic highlighted the importance of robust public health data systems and the potential utility of data dashboards for ensuring access to critical public health data for diverse groups of stakeholders and decision makers. As dashboards are becoming ubiquitous, it is imperative to consider how they may be best integrated with public health data systems and the decision-making routines of diverse audiences. However, additional progress on the continued development, improvement, and sustainability of these tools requires the integration and synthesis of a largely fragmented scholarship regarding the purpose, design principles and features, successful implementation, and decision-making supports provided by effective public health data dashboards across diverse users and applications., Objective: This scoping review aims to provide a descriptive and thematic overview of national public health data dashboards including their purpose, intended audiences, health topics, design elements, impact, and underlying mechanisms of use and usefulness of these tools in decision-making processes. It seeks to identify gaps in the current literature on the topic and provide the first-of-its-kind systematic treatment of actionability as a critical design element of public health data dashboards., Methods: The scoping review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. The review considers English-language, peer-reviewed journal papers, conference proceedings, book chapters, and reports that describe the design, implementation, and evaluation of a public health dashboard published between 2000 and 2023. The search strategy covers scholarly databases (CINAHL, PubMed, Medline, and Web of Science) and gray literature sources and uses snowballing techniques. An iterative process of testing for and improving intercoder reliability was implemented to ensure that coders are properly trained to screen documents according to the inclusion criteria prior to beginning the full review of relevant papers., Results: The search process initially identified 2544 documents, including papers located via databases, gray literature searching, and snowballing. Following the removal of duplicate documents (n=1416), nonrelevant items (n=839), and items classified as literature reviews and background information (n=73), 216 documents met the inclusion criteria: US case studies (n=90) and non-US case studies (n=126). Data extraction will focus on key variables, including public health data characteristics; dashboard design elements and functionalities; intended users, usability, logistics, and operation; and indicators of usefulness and impact reported., Conclusions: The scoping review will analyze the goals, design, use, usefulness, and impact of public health data dashboards. The review will also inform the continued development and improvement of these tools by analyzing and synthesizing current practices and lessons emerging from the literature on the topic and proposing a theory-grounded and evidence-informed framework for designing, implementing, and evaluating public health data dashboards., International Registered Report Identifier (irrid): DERR1-10.2196/52843., (©Itzhak Yanovitzky, Gretchen Stahlman, Justine Quow, Matthew Ackerman, Yehuda Perry, Miriam Kim. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.05.2024.)

Background: Patients with gastric cancer experience different degrees of fear of cancer recurrence. The fear of cancer recurrence can cause and worsen many physical and psychological problems. We considered the "intimacy and relationship processes in couples' psychosocial adaptation" model., Objective: The study aims to examine the effectiveness of a marital self-disclosure intervention for improving the level of fear of cancer recurrence and the dyadic coping ability among gastric cancer survivors and their spouses., Methods: This is a quasiexperimental study with a nonequivalent (pretest-posttest) control group design. The study will be conducted at 2 tertiary hospitals in Taizhou City, Jiangsu Province, China. A total of 42 patients with gastric cancer undergoing chemotherapy and their spouses will be recruited from each hospital. Participants from Jingjiang People's Hospital will be assigned to an experimental group, while participants from Taizhou People's Hospital will be assigned to a control group. The participants in the experimental group will be involved in 4 phases of the marital self-disclosure (different topics, face-to-face) intervention. Patients will be evaluated at baseline after a diagnosis of gastric cancer and reassessed 2 to 4 months after baseline. The primary outcome is the score of the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) for patients. The secondary outcomes are the scores of the FoP-Q-SF for partners and the Dyadic Coping Inventory., Results: Research activities began in October 2022. Participant enrollment and data collection began in February 2023 and are expected to be completed in 12 months. The primary results of this study are anticipated to be announced in June 2024., Conclusions: This study aims to assess a marital self-disclosure intervention for improving the fear of cancer recurrence in Chinese patients with gastric cancer and their spouses. The study is likely to yield desirable positive outcomes as marital self-disclosure is formulated based on evidence and inputs obtained through stakeholder interviews and expert consultation. The study process will be carried out by nurses who have received psychological training, and the quality of the intervention will be strictly controlled., Trial Registration: ClinicalTrials.gov NCT05606549; https://clinicaltrials.gov/study/NCT05606549., International Registered Report Identifier (irrid): DERR1-10.2196/55102., (©Haiyan Zhao, Ye Zhou, Chong Chin Che, Mei Chan Chong, Yu Zheng, Yuzhu Hou, Canjuan Chen, Yantao Zhu. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.04.2024.)

Background: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources., Objective: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety., Methods: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients' self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits., Results: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024., Conclusions: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits., Trial Registration: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368., International Registered Report Identifier (irrid): DERR1-10.2196/57878., (©Yan Xiao, Kimberley G Fulda, Richard A Young, Z Noah Hendrix, Kathryn M Daniel, Kay Yut Chen, Yuan Zhou, Jennifer L Roye, Ludmila Kosmari, Joshua Wilson, Anna M Espinoza, Kathleen M Sutcliffe, Samantha I Pitts, Alicia I Arbaje, Michelle A Chui, Somer Blair, Dawn Sloan, Masheika Jackson, Ayse P Gurses. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.04.2024.)

Background: Conducting a health needs assessment for older adults is important, particularly for early detection and management of frailty. Such assessments can help to improve health outcomes, maintain overall well-being, and support older adults in retaining their independence as they age at home., Objective: In this study, a systematic approach to health needs assessment is adopted in order to reflect real-world practices in municipal health care and capture the nuances of frailty. The aim is to assess changes in frailty levels in home-living older adults over 5 months and to examine the observable functional changes from a prestudy baseline (t1) to a poststudy period (t2). Additionally, the study explores the feasibility of conducting the health needs assessment from the perspective of home-living older adults and their informal caregivers., Methods: Interprofessional teams of registered nurses, physiotherapists, and occupational therapists will conduct 2 health needs assessments covering physical, cognitive, psychological, social, and behavioral domains. The study includes 40 home-living older adults of 75 years of age or older, who have applied for municipal health and care services in Norway. A quantitative approach will be applied to assess changes in frailty levels in home-living older adults over 5 months. In addition, we will examine the observable functional changes from t1 to t2 and how these changes correlate to frailty levels. Following this, a qualitative approach will be used to examine the perspectives of participants and their informal caregivers regarding the health needs assessment and its feasibility. The final sample size for the qualitative phase will be determined based on the participant's willingness to be interviewed. The quantitative data consist of descriptive statistics, simple tests, and present plots and correlation coefficients. For the qualitative analysis, we will apply thematic analysis., Results: The initial baseline assessments were completed in July 2023, and the second health needs assessments are ongoing. We expect the results to be available for analysis in the spring of 2024., Conclusions: This study has potential benefits for not only older adults and their informal caregivers but also health care professionals. Moreover, it can be used to inform future studies focused on health needs assessments of this specific demographic group. The study also provides meaningful insights for local policy makers, with potential future implications at the national level., Trial Registration: ClinicalTrials.gov NCT05837728; https://clinicaltrials.gov/study/NCT05837728., International Registered Report Identifier (irrid): DERR1-10.2196/55192., (©Fifi Kvalsvik, Bente Hamre Larsen, Grethe Eilertsen, Helle K Falkenberg, Ingvild Dalen, Stine Haaland, Marianne Storm. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.04.2024.)

Background: Artificial intelligence (AI) has emerged as a transformative force across the health sector and has garnered significant attention within sexual and reproductive health and rights (SRHR) due to polarizing views on its opportunities to advance care and the heightened risks and implications it brings to people's well-being and bodily autonomy. As the fields of AI and SRHR evolve, clarity is needed to bridge our understanding of how AI is being used within this historically politicized health area and raise visibility on the critical issues that can facilitate its responsible and meaningful use., Objective: This paper presents the protocol for a scoping review to synthesize empirical studies that focus on the intersection of AI and SRHR. The review aims to identify the characteristics of AI systems and tools applied within SRHR, regarding health domains, intended purpose, target users, AI data life cycle, and evidence on benefits and harms., Methods: The scoping review follows the standard methodology developed by Arksey and O'Malley. We will search the following electronic databases: MEDLINE (PubMed), Scopus, Web of Science, and CINAHL. Inclusion criteria comprise the use of AI systems and tools in sexual and reproductive health and clear methodology describing either quantitative or qualitative approaches, including program descriptions. Studies will be excluded if they focus entirely on digital interventions that do not explicitly use AI systems and tools, are about robotics or nonhuman subjects, or are commentaries. We will not exclude articles based on geographic location, language, or publication date. The study will present the uses of AI across sexual and reproductive health domains, the intended purpose of the AI system and tools, and maturity within the AI life cycle. Outcome measures will be reported on the effect, accuracy, acceptability, resource use, and feasibility of studies that have deployed and evaluated AI systems and tools. Ethical and legal considerations, as well as findings from qualitative studies, will be synthesized through a narrative thematic analysis. We will use the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) format for the publication of the findings., Results: The database searches resulted in 12,793 records when the searches were conducted in October 2023. Screening is underway, and the analysis is expected to be completed by July 2024., Conclusions: The findings will provide key insights on usage patterns and evidence on the use of AI in SRHR, as well as convey key ethical, safety, and legal considerations. The outcomes of this scoping review are contributing to a technical brief developed by the World Health Organization and will guide future research and practice in this highly charged area of work., Trial Registration: OSF Registries osf.io/ma4d9; https://osf.io/ma4d9., International Registered Report Identifier (irrid): PRR1-10.2196/53888., (©Tigest Tamrat, Yu Zhao, Denise Schalet, Shada AlSalamah, Sameer Pujari, Lale Say. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.04.2024.)

Background: Heart failure (HF) is a leading cause of morbidity and mortality globally, with a high disease burden. The prevalence of HF in Ghana is increasing rapidly, but epidemiological profiles, treatment patterns, and survival data are scarce. The national capacity to diagnose and manage HF appropriately is also limited. To address the growing epidemic of HF, it is crucial to recognize the epidemiological characteristics and medium-term outcomes of HF in Ghana and improve the capability to identify and manage HF promptly and effectively at all levels of care., Objective: This study aims to determine the epidemiological characteristics and medium-term HF outcomes in Ghana., Methods: We conducted a prospective, multicenter, multilevel cross-sectional observational study of patients with HF from January to December 2023. Approximately 5000 patients presenting with HF to 9 hospitals, including teaching, regional, and municipal hospitals, will be recruited and evaluated according to a standardized protocol, including the use of an echocardiogram and an N-terminal pro-brain natriuretic peptide (NT-proBNP) test. Guideline-directed medical treatment of HF will be initiated for 6 months, and the medium-term outcomes of interventions, including rehospitalization and mortality, will be assessed. Patient data will be collated into a HF registry for continuous assessment and monitoring., Results: This intervention will generate the necessary information on the etiology of HF, clinical presentations, the diagnostic yield of various tools, and management outcomes. In addition, it will build the necessary capacity and support for HF management in Ghana. As of July 30, 2023, the training and onboarding of all 9 centers had been completed. Preliminary analyses will be conducted by the end of the second quarter of 2024, and results are expected to be publicly available by the middle of 2024., Conclusions: This study will provide the necessary data on HF, which will inform decisions on the prevention and management of HF and form the basis for future research., Trial Registration: ISRCTN Registry (United Kingdom) ISRCTN18216214; https:www.isrctn.com/ISRCTN18216214., International Registered Report Identifier (irrid): DERR1-10.2196/52616., (©Felix Awindaogo, Emmanuel Acheamfour-Akowuah, Alfred Doku, Collins Kokuro, Francis Agyekum, Isaac Kofi Owusu. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.04.2024.)

Background: Cutaneous T-cell lymphoma (CTCL) is a rare group of lymphomas that primarily affects the skin. Mycosis fungoides (MF) is the most common form of CTCL and Sézary syndrome (SS) is more infrequent. Early stages (IA-IIA) have a favorable prognosis, while advanced stages (IIB-IVB) have a worse prognosis. Around 25% of patients with early stages of the disease will progress to advanced stages. Malignant skin-infiltrating T-cells in CTCL are accompanied by infiltrates of nonmalignant T-cells and other immune cells that produce cytokines that modulate the inflammation. Skin infection, often with Staphylococcus aureus, is frequent in advanced stages and can lead to sepsis and death. S. aureus has also been reported to contribute to the progression of the disease. Previous reports indicate a shift from Th1 to Th2 cytokine production and dysfunction of the skin barrier in CTCL. Treatment response is highly variable and often unpredictable, and there is a need for new predictive and prognostic biomarkers., Objective: This prospective translational study aims to identify prognostic biomarkers in the blood and skin of patients with MF and SS., Methods: The Predictive and Prognostic Biomarkers in Patients With MF and SS (BIO-MUSE) study aims to recruit 120 adult patients with MF or SS and a control group of 20 healthy volunteers. The treatments will be given according to clinical routine. The sampling of each patient will be performed every 3 months for 3 years. The blood samples will be analyzed for lactate dehydrogenase, immunoglobulin E, interleukins, thymus and activation-regulated chemokine, and lymphocyte subpopulations. The lymphoma microenvironment will be investigated through digital spatial profiling and single-cell RNA sequencing. Microbiological sampling and analysis of skin barrier function will be performed. The life quality parameters will be evaluated. The results will be evaluated by the stage of the disease., Results: Patient inclusion started in 2021 and is still ongoing in 2023, with 18 patients and 20 healthy controls enrolled. The publication of selected translational findings before the publication of the main results of the trial is accepted., Conclusions: This study aims to investigate blood and skin with a focus on immune cells and the microbiological environment to identify potential new prognostic biomarkers in MF and SS., Trial Registration: ClinicalTrials.gov NCT04904146; https://www.clinicaltrials.gov/study/NCT04904146., International Registered Report Identifier (irrid): DERR1-10.2196/55723., (©Emma Belfrage, Sara Ek, Åsa Johansson, Hanna Brauner, Andreas Sonesson, Kristina Drott. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.04.2024.)

Background: Maternal pushing during the second stage of labor could influence labor progress and maternal-neonatal outcomes. Although the image of health care providers directing the laboring women to push during the second stage of labor could be commonly observed globally, this practice is not sufficiently researched and is questioned regarding its effectiveness and outcomes on the mother and baby. Meanwhile, a strategy referred to as "spontaneous pushing," which supports women to push by following their bodily urges, has been evaluated in several trials. However, in China, spontaneous pushing is not common practice. Notwithstanding the evaluation of spontaneous pushing, there is a lack of high-quality evidence to support either strategies of directed pushing or spontaneous pushing., Objective: This study aims to test the feasibility of a future randomized controlled trial to compare the effects of spontaneous pushing and directed pushing during the second stage of labor for maternal and neonatal outcomes in China., Methods: A nonrandomized, single-group, noninferiority feasibility study will be conducted in a public hospital in Hebei Province, China. In total, 105 women meeting the selection criteria will be recruited to receive the intervention (spontaneous pushing), while 105 sets of medical notes from women who received routine care (directed pushing) will be identified and reviewed to compare outcomes for both cohorts. A mixed methods approach will be used to assess primary outcomes (feasibility and acceptability) and secondary outcomes (effectiveness)., Results: Data collection took place between May and October 2023. A total of 110 women were invited to participate in the intervention of spontaneous pushing. Midwives' interviews were conducted and will be transcribed for analysis in March 2024. The data analysis is planned to be completed by May 2024., Conclusions: This feasibility study will provide important information by conducting a full-scale clinical trial in the future as well as the potential facilitators and barriers of it. A future randomized controlled trial is likely to have considerable policy and funding impacts regarding pushing management during the second stage of labor and improvement in women's childbirth experience., Trial Registration: Chinese Clinical Trial Register ChiCTR2300071178; https://tinyurl.com/mudtnbft., International Registered Report Identifier (irrid): DERR1-10.2196/55701., (©Jiasi Yao, Heike Roth, Debra Anderson, Hong Lu, Huijuan Rong, Kathleen Baird. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.03.2024.)

Background: Vaccine hesitancy is a growing concern in Saudi Arabia, impacting even well-educated parents. The decision-making process involves various factors such as accessibility, trustworthy information, and the influence of social networks, reflecting a complex interplay of emotional, cultural, social, spiritual, and political dimensions., Objective: This review seeks to evaluate the prevalence and trends of vaccine hesitancy, identify contributing factors, and explore potential solutions to enhance immunization rates. This review aligns with global concerns, as the World Health Organization has identified vaccine hesitancy as a top global health threat., Methods: Our systematic review will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and PICOS (Population, Intervention, Comparison, Outcomes, and Study) criteria for comprehensive assessment. We will conduct a thorough search across various databases, encompassing a wide range of vaccines, and pay special attention to vaccination campaigns and refusals. Inclusion criteria involve descriptive, observational, and analytical studies focusing on factors influencing vaccine acceptance or hesitancy. The study will use the Crowe Critical Appraisal Tool for quality assessment and perform a narrative synthesis to summarize findings thematically., Results: This systematic review is expected to unveil the prevalence and trends of vaccine hesitancy in diverse populations in Saudi Arabia, shedding light on cultural, religious, and social factors contributing to hesitancy. It aims to assess the effectiveness of implemented strategies, enable regional and global comparisons, and provide implications for tailored vaccination policies. Additionally, the review may pinpoint research gaps, guiding future investigations to address and mitigate vaccine hesitancy effectively., Conclusions: The findings are expected to have direct policy implications and guide interventions to strengthen vaccination programs and improve public health outcomes., International Registered Report Identifier (irrid): PRR1-10.2196/54680., (©Mohammed Kanan, Samar Abdulrahman, Abdulaziz Alshehri, Renad AlSuhaibani, Nawaf M Alotaibi, Azhar Alsaleh, Bushra Nasser, Rana Baowaydhan, Ibrahim Alredaini, Taif Khalid, Fatima Almukhtar, Nourah Altoaimi, Almaha Alhneshel, Shouq Alanazi, Shahad Algmaizi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.03.2024.)

Background: Psychological interventions, along with antipsychotic medications, are recommended for adults diagnosed with a psychotic disorder. While initially designed to mitigate positive symptoms, psychological interventions targeting personal recovery were developed and aligned with the recovery framework that many mental health services have adopted. Acceptance and Commitment Therapy (ACT) for psychosis is one such intervention that shows promise when delivered in an individual format. There is preliminary evidence that ACT for psychosis in a group format improves recovery., Objective: This trial aims to evaluate the effectiveness of the "Recovery ACT" group program on personal recovery among adults living with a psychotic disorder., Methods: Our unfunded study is a multiagency, prospective, nonrandomized, waitlist control, single-group trial of the Recovery ACT group program. The program involves 7 weekly group sessions of 90 minutes duration and a 90-minute booster session held 1 month later. We intend to recruit 160 adults living with a psychotic disorder who enroll in a group that is offered as a routine clinical service at participating public mental health services in Melbourne, Victoria, Australia. The 4 assessment time points are 4-6 weeks before the start of the group program, at the start of the group program, at the end of the group program, and at the booster session. There is an optional midgroup assessment and follow-up study. The primary outcome is personal recovery. Secondary outcomes include participants' well-being and psychological flexibility processes. Qualitative data are also collected from participants and facilitators., Results: Recruitment began in September 2019 and is ongoing until 2024, subsequent to a 24-month disruption due to the COVID-19 pandemic. As of the submission of this paper, 93 participants consented to the evaluation, 65 completed T1 measures, and 40 had a complete data set for the proposed analyses., Conclusions: This is the first trial evaluating the effectiveness of the Recovery ACT group program on personal recovery for adults living with a psychotic disorder. Findings will contribute to knowledge about psychosocial interventions for adults living with psychosis. This trial may also serve as an example of a partnership between clinicians and academics that can facilitate the translation of research into practice., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000223932; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000223932., International Registered Report Identifier (irrid): DERR1-10.2196/49849., (©Marilyn L Cugnetto, Eric M J Morris, Siobain F Bonfield, Jesse Gates, Ilona Morrison, Ellie R Newman, Julia D Nicholls, Lisa M Soares, Megan T Antonucci, Jacinta R Clemente, Claire L M Garratt, Eliot Goldstone, David A Pavone, John Farhall. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.03.2024.)

Background: Chronic pain is a highly prevalent condition that requires multidisciplinary treatment. However, in the United Kingdom, access to specialist pain clinics where patients can receive medical multidisciplinary treatment is limited, and provision varies between health boards. As such, self-management of chronic pain using digital tools has been gaining traction recently, but evidence of its effectiveness from clinical-based trials focuses mainly on quantitative outcomes., Objective: This systematic review aims to identify, appraise, and synthesize qualitative evidence on patients' experiences with digital health interventions (DHIs) for the management of chronic pain., Methods: This systematic review will consider qualitative and mixed methods studies that explore the experience of patients (aged 18 years and older) with chronic pain engaging in DHIs to manage their pain. MEDLINE Ovid, PubMed, Embase, CINAHL, PsycINFO, and Scopus databases will be searched for published studies. The systematic review will be conducted in accordance with the ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) guidelines. Following the 3-step thematic synthesis methodology of Thomas and Harden, titles and abstracts will be screened by 2 independent reviewers (AM and HM), and a third reviewer (MI or FM) will resolve any conflict that arises before the full-text screening. The Critical Appraisal Skills Programme checklist tool will be used to critically appraise the included studies. The extracted data will be imported to NVivo (QSR International), where thematic synthesis will be used to derive analytical themes from the included studies., Results: Themes that encapsulate the patient experience will be identified from qualitative evidence, and these themes will shed light on the perceived benefits and disadvantages, usability, acceptability, and the overall impact digital tools can have on the lives of those with chronic pain., Conclusions: This systematic review will identify, appraise, and synthesize the overall experience of patients engaging in DHI to manage a diverse range of chronic pain conditions. By elaborating the patient experience through qualitative analysis, the findings from this review will enhance our current understanding of the experiences of patients with chronic pain using digital tools for the self-management of their pain and highlight what person-centered elements are essential for future DHI development., Trial Registration: PROSPERO CRD42023445100; http://tinyurl.com/4z77khfs., International Registered Report Identifier (irrid): DERR1-10.2196/52469., (©Ashleigh Main, Haruno McCartney, Maryam Ibrar, Harleen Kaur Rai, Fiona Muirhead, Alexandra Mavroeidi, Roma Maguire. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.03.2024.)

Background: Chronic abdominal pain is the hallmark symptom of chronic pancreatitis (CP), with 50% to 80% of patients seeking medical attention for pain control. Although several management options are available, outcomes are often disappointing, and opioids remain a mainstay of therapy. Opioid-induced hyperalgesia is a phenomenon resulting in dose escalation, which may occur partly because of the effects of opioids on voltage-gated sodium channels associated with pain. Preclinical observations demonstrate that the combination of an opioid and the antiseizure drug lacosamide diminishes opioid-induced hyperalgesia and improves pain control., Objective: In this phase 1 trial, we aim to determine the safety, tolerability, and dose-limiting toxicity of adding lacosamide to opioids for the treatment of painful CP and assess the feasibility of performance of a pilot study of adding lacosamide to opioid therapy in patients with CP. As an exploratory aim, we will assess the efficacy of adding lacosamide to opioid therapy in patients with painful CP., Methods: Using the Bayesian optimal interval design, we will conduct a dose-escalation trial of adding lacosamide to opioid therapy in patients with painful CP enrolled in cohorts of size 3. The initial dose will be 50 mg taken orally twice a day, followed by incremental increases to a maximum dose of 400 mg/day, with lacosamide administered for 7 days at each dose level. Adverse events will be documented according to Common Terminology Criteria for Adverse Events (version 5.0)., Results: As of December 2023, we have currently enrolled 6 participants. The minimum number of participants to be enrolled is 12 with a maximum of 24. We expect to publish the results by March 2025., Conclusions: This trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of opioids in treating painful CP. It is anticipated that lacosamide will prove to be safe and well tolerated, supporting a subsequent phase 2 trial assessing the efficacy of lacosamide+opioid therapy in patients with painful CP, and that lacosamide combined with opiates will lower the opioid dose necessary for pain relief and improve the safety profile of opioid use in treating painful CP., Trial Registration: Clinicaltrials.gov NCT05603702; https://clinicaltrials.gov/study/NCT05603702., International Registered Report Identifier (irrid): PRR1-10.2196/50513., (©Evan L Fogel, Jeffrey J Easler, Ying Yuan, Dhiraj Yadav, Darwin L Conwell, Santhi Swaroop Vege, Samuel Y Han, Walter Park, Vanessa Patrick, Fletcher A White. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.03.2024.)

Background: Telemonitoring of activities of daily living (ADLs) offers significant potential for gaining a deeper insight into the home care needs of older adults experiencing cognitive decline, particularly those living alone. In 2016, our team and a health care institution in Montreal, Quebec, Canada, sought to test this technology to enhance the support provided by home care clinical teams for older adults residing alone and facing cognitive deficits. The Support for Seniors' Autonomy program (SAPA [Soutien à l'autonomie des personnes âgées]) project was initiated within this context, embracing an innovative research approach that combines action research and design science., Objective: This paper presents the research protocol for the SAPA project, with the aim of facilitating the replication of similar initiatives in the future. The primary objectives of the SAPA project were to (1) codevelop an ADL telemonitoring system aligned with the requirements of key stakeholders, (2) deploy the system in a real clinical environment to identify specific use cases, and (3) identify factors conducive to its sustained use in a real-world setting. Given the context of the SAPA project, the adoption of an action design research (ADR) approach was deemed crucial. ADR is a framework for crafting practical solutions to intricate problems encountered in a specific organizational context., Methods: This project consisted of 2 cycles of development (alpha and beta) that involved cyclical repetitions of stages 2 and 3 to develop a telemonitoring system for ADLs. Stakeholders, such as health care managers, clinicians, older adults, and their families, were included in each codevelopment cycle. Qualitative and quantitative data were collected throughout this project., Results: The first iterative cycle, the alpha cycle, took place from early 2016 to mid 2018. The first prototype of an ADL telemonitoring system was deployed in the homes of 4 individuals receiving home care services through a public health institution. The prototype was used to collect data about care recipients' ADL routines. Clinicians used the data to support their home care intervention plan, and the results are presented here. The prototype was successfully deployed and perceived as useful, although obstacles were encountered. Similarly, a second codevelopment cycle (beta cycle) took place in 3 public health institutions from late 2018 to late 2022. The telemonitoring system was installed in 31 care recipients' homes, and detailed results will be presented in future papers., Conclusions: To our knowledge, this is the first reported ADR project in ADL telemonitoring research that includes 2 iterative cycles of codevelopment and deployment embedded in the real-world clinical settings of a public health system. We discuss the artifacts, generalization of learning, and dissemination generated by this protocol in the hope of providing a concrete and replicable example of research partnerships in the field of digital health in cognitive aging., International Registered Report Identifier (irrid): RR1-10.2196/52284., (©Maxime Lussier, Mélanie Couture, Sylvain Giroux, Aline Aboujaoudé, Hubert Kenfack Ngankam, Hélène Pigot, Sébastien Gaboury, Kevin Bouchard, Carolina Bottari, Patricia Belchior, Guy Paré, Nathalie Bier. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.02.2024.)

Background: Electronic medical records (EMRs) streamline medical processes, improve quality control, and facilitate data sharing among hospital departments. They also reduce maintenance costs and storage space needed for paper records, while saving time and providing structured data for future research., Objective: This study aimed to investigate whether the integration of the radiation oncology information system and the hospital information system enhances the efficiency of the department of radiation oncology., Methods: We held multidisciplinary discussions among physicians, physicists, medical radiation technologists, nurses, and engineers. We integrated paper records from the radiation oncology department into the existing hospital information system within the hospital. A new electronic interface was designed. A comparison was made between the time taken to retrieve information from either the paper records or the EMRs for radiation preparation. A total of 30 cases were randomly allocated in both the old paper-based system and the new EMR system. The time spent was calculated manually at every step during the process, and we performed an independent 1-tailed t test to evaluate the difference between the 2 systems., Results: Since the system was launched in August 2020, more than 1000 medical records have been entered into the system, and this figure continues to increase. The total time needed for the radiation preparation process was reduced from 286.8 minutes to 154.3 minutes (P<.001)-a reduction of 46.2%. There was no longer any need to arrange for a nurse to organize the radiotherapy paper records, saving a workload of 16 hours per month., Conclusions: The implementation of the integrated EMR system has resulted in a significant reduction in the number of steps involved in radiotherapy preparation, as well as a decrease in the amount of time required for the process. The new EMR system has provided numerous benefits for the department, including a decrease in workload, a simplified workflow, and conserving more patient data within a confined space., (©Hao-Shen Cheng, Weir-Chiang You, Ni-Wei Chen, Mu-Chih Hsieh, Che-Fu Tsai, Chia-Jing Ho, Chien-Chih Chen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.02.2024.)

Background: Protected areas are crucial for the maintenance of human health and well-being. They aim to preserve biodiversity and natural resources to secure various ecosystem services that are beneficial to human health. Their ecological characteristics can influence local health literacy. Typically, communities surrounding protected areas have limited economic opportunities due to restriction policies to protect the ecosystem, resulting in socioeconomic disparities. The local community faces obstacles in gaining access to health care facilities and health information due to these limitations. It is difficult for them to locate, comprehend, and apply information and services to make better health-related decisions for themselves and others., Objective: This study protocol examines the impact of the ecosystem on health literacy among rural communities in protected areas., Methods: This study comprises 5 phases. In phase 1, we conduct a systematic review to identify the issue of health literacy in protected areas. In phase 2, we will collect data from stakeholders in a protected area of Pahang National Park and analyze the results using Net-Map analysis. In phase 3, we will conduct a survey among the adult community in Pahang National Park related to health literacy, socioeconomic status, health expenditure, and quality of life. In phase 4, informed by the results of the survey, we will determine suitable intervention programs to improve health literacy through a focus group discussion. Finally, in phase 5, we will conduct a costing analysis to analyze which intervention program is the most cost-effective., Results: This study was funded by Universiti Sains Islam Malaysia (USIM) and strategic research partnership grants, and enrollment is ongoing. The first results are expected to be submitted for publication in 2024., Conclusions: This is one of the first studies to explore health literacy among rural communities in protected areas and will provide the first insights into the overall level of health literacy in the protected community, potential determinants, and a suitable intervention program with expected cost analysis. The results can be used to promote health literacy in other protected areas and populations., Trial Registration: International Standard Randomized Controlled Trial Number Registry ISRCTN40626062; http://tinyurl.com/4kjxuwk5., International Registered Report Identifier (irrid): PRR1-10.2196/51851., (©Nor Aziah Abd Kadir, Amirah Azzeri, Hafiz Jaafar, Mohd Iqbal Mohd Noor, Zurina Kefeli. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.01.2024.)

Background: The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS., Objective: This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS., Methods: In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications., Results: Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024., Conclusions: Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS., Trial Registration: ClinicalTrials.gov NCT04441411; https://clinicaltrials.gov/study/NCT04441411., International Registered Report Identifier (irrid): DERR1-10.2196/47222., (©Anne Mareille Post, Hanneke I Berends, Barend J van Royen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.12.2023.)

Background: The effects of reinforcement are still controversial in bariatric surgery, and variations may exist in using this technique., Objective: This protocol describes a study that aims to survey the views of bariatric surgeons on reinforcement techniques and evaluate the effects of applying reinforcement techniques in sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB)., Methods: This study is composed of 2 parts. Part 1 will investigate the differences of using reinforcement techniques among surgeons worldwide who perform SG or RYGB through a survey. The survey will be conducted by email and social media. Part 2 will evaluate the safety and effectiveness of using omentopexy or staple line reinforcement in SG and RYGB by systematic review and meta-analysis. In this part, literature searches will be performed in English databases, including CENTRAL, EMBASE CINAHL, Web of Science, and PubMed, and Chinese databases, including Wanfang, China National Knowledge Infrastructure, Database of Chinese Technical Periodicals, and Chinese Biological Medicine, from their establishment to November 2023. Randomized controlled trials and case-control studies will be included. The primary outcomes are rates of postoperative bleeding and gastric leakage. The secondary outcomes include anastomotic stenosis, surgical site infection, reoperation, estimated intraoperative blood loss, operative time (minutes), length of hospital stay (days), overall complications, and 30-day mortality. The meta-analysis will be conducted using RevMan 5.4 under the random-effects model, as well as through extensive subgroup and sensitivity analyses. P values <0.05 will be considered statistically significant. This study was registered with PROSPERO (Prospective Register of Systematic Reviews) in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols)., Results: The results of this study will be published in a peer-reviewed journal. The web-based survey and initial title or abstract review of papers identified by the search strategy will be completed in November 2023. The second round of title or abstract review and downloading of the papers for full-text inclusion will be completed in January 2024. We aim to complete data extraction and meta-analysis by February 2024 and expect to publish the findings by the end of March 2024., Conclusions: This study aims to investigate the impact of reinforcement techniques on reducing the incidence of postoperative complications in SG and RYGB procedures and provide assistance for standardizing the procedures of SG and RYGB operations for bariatric surgeons., Trial Registration: PROSPERO CRD42022376438; https://tinyurl.com/2d53uf8n., International Registered Report Identifier (irrid): PRR1-10.2196/50677., (©Yunhui Xie, Jun Wen, Hongmei Zhu, Yanjun Liu. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.12.2023.)

Background: The phenomenon of sexual harassment (SH) is a complex issue with multiple prongs that concerns all members of academia and raises serious challenges, particularly regarding prevention and response. SH in tertiary institutions remains a huge problem worldwide, leading to severe emotional, academic, and career difficulties, as well as undue suffering. Institutions have responded in various ways to alleviate the burden of SH with little success, especially in Nigeria. The prevalence is high but reportage is low because of the culture of silence around SH in most educational institutions. This study aims to identify factors associated with SH in tertiary institutions in Nigeria and explore factors surrounding reportage or nonreportage following the experience of SH, the institutional mechanisms to prevent and respond to SH, and the lived experience of survivors of SH., Objective: The objective of this study was to present a study protocol that is designed to identify factors associated with the experience of SH in tertiary institutions in Nigeria, the institutional mechanisms to prevent and respond to SH, and the lived experience of survivors of SH., Methods: A mixed (quantitative and qualitative) methods approach is used consisting of a policy review of existing antisexual harassment policies in the selected universities, a quantitative survey to determine the correlates of SH, focus group discussions to explore the perspectives of the university community concerning SH, in-depth interviews to explore the lived experiences of survivors of SH, and key informant interviews to understand the perspectives of people who provide interventions to survivors., Results: This study was funded in July 2022 by the Consortium for Advanced Research Training in Africa, and data collection started in November 2022. The SH policies were comprehensive, with clear policy statements and definitions, and recognized a wide range of survivors and perpetrators. However, there was no clear mention of prevention and response to same-sex SH. Lived experiences showed negative psychological and social sequelae and little institutional support., Conclusions: This is the first study that has a component investigating same-sex SH in tertiary institutions in Nigeria. This is also one of the first studies to explore the lived experiences of survivors of SH in Nigerian universities. The findings from this study suggest that periodic evaluation of SH policy implementation will improve institutional support, thus creating safe spaces for survivors and will thereby encourage reportage and support; prevention and response strategies need to be more inclusive; and more interventions should focus on strengthening prosocial skills and healthy, equitable relationships., International Registered Report Identifier (irrid): DERR1-10.2196/49126., (©Boladale Mapayi, Ibidun Oloniniyi, Olakunle Oginni, Abigail Harrison. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.12.2023.)

Background: Competency-based education (CBE) for midwifery programs is a system of academic instruction and evaluation that aims to achieve proficiency in midwifery student learning outcomes, which is based on students' ability to demonstrate the knowledge, attitudes, self-perceptions, and skills of a predetermined set of educational activities in theory and practice. CBE focuses on ensuring that midwifery students can develop critical thinking abilities, values, and the clinical decision-making abilities needed for the delivery of safe care in future practice., Objective: The objective of this scoping review is to map and synthesize existing literature on the implementation of CBE for midwifery programs and its sustainability in Africa., Methods: We will use the Arksey and O'Malley approach for scoping reviews for the research methodology. The 3-stage search process, proposed by the Joanna Briggs Institute, will be used to determine the eligibility of published and unpublished studies. PubMed, Science Direct, Web of Science, CINAHL, PsycINFO, and Scopus will be searched to screen published articles. ProQuest Dissertations and Theses and Google Scholar will be used to search for unpublished studies. Findings will only apply to studies conducted in Africa from 2010 to the present year in English. The 2 reviewers will work independently to carefully screen and compare the full text of the selected citations to the inclusion criteria. In the event of any disagreements between the 2 reviewers at any stage of the selection process regarding the inclusion of an article, this will be settled by discussion or consultation with a third reviewer. The extracted data will be presented using a PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review) flow diagram with an attached narrative summary. The review will summarize and disseminate findings on the implementation of the CBE for midwifery programs and its sustainability in Africa., Results: It is intended that this scoping review will be completed within 6 months following the publication of this protocol., Conclusions: The conclusions from this scoping review will inform midwifery educators, institutions, policy makers, and other stakeholders on the strategies to implement and sustain CBE for midwifery programs in Africa., International Registered Report Identifier (irrid): PRR1-10.2196/47603., (©Waleola Bukola Ige, Winnie Baphumelele Ngcobo, Opeyemi Afolabi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.12.2023.)

Background: Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after completing treatment. In addition to potential health consequences, insomnia can interrupt social, educational, and vocational development just as they are trying to "make up" for time lost to cancer. Cognitive behavioral therapy for insomnia (CBTI) is recommended as first-line treatment for insomnia but remains largely unavailable to YACS due to several barriers (ie, shortage of trained providers, geographic limitations, financial limitations). Traditional CBTI has not been adapted to meet YACS' unique developmental and circadian challenges. To improve availability of effective behavioral insomnia treatment for this population, we developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA), a low-intensity educational intervention delivered virtually online., Objective: In this phase 2 "proof of concept" trial, primary aims are to test the efficacy of STEP-YA to improve insomnia symptoms and mood in YACS and assess the utility of individualized coaching to improve treatment effects. A secondary aim will explore participant variables associated with clinically significant response to STEP-YA., Methods: This 2-arm randomized prospective trial will enroll 74 off-treatment YACS aged 20 years to 39 years with clinically significant insomnia. Each participant completes the STEP-YA intervention in a 1-on-1 synchronous online session led by a trained interventionist following a structured outline. The 90-minute intervention presents educational information on the development of insomnia after cancer and offers specific suggestions for improving insomnia symptoms. During the session, participants review the suggestions and develop a personalized sleep action plan for implementing them. After the session, participants are randomized to either the coaching condition, in which they receive 2 telephone coaching sessions, or the no-coaching condition, which offers no subsequent coaching. The Insomnia Severity Index (ISI) and the Profile of Mood States: Short Form (POMS-SF) are assessed at baseline and 4 and 8 weeks postintervention., Results: Enrollment began in November 2022, with 28 participants currently enrolled. We anticipate recruitment will be completed in 2024. The primary endpoint is a change in ISI score from baseline to 8 weeks postintervention. The secondary endpoint is change in mood symptoms (POMS-SF) from baseline to 8 weeks postintervention. Change scores will be treated as continuous variables. Primary analyses will use ANOVA methods. A within-subjects analysis will examine if the STEP-YA intervention is associated with significant changes in insomnia and mood over time. A 2-way ANOVA will be used to evaluate the utility of coaching sessions to improve treatment effects., Conclusions: Chronic insomnia has significant negative effects on YACS' medical, educational, and psychological functioning. STEP-YA aims to address their needs; study results will determine if the intervention warrants future effectiveness and dissemination studies and if individualized coaching is necessary for adequate treatment response., Trial Registration: ClinicalTrials.gov NCT05358951: https://clinicaltrials.gov/study/NCT05358951., International Registered Report Identifier (irrid): DERR1-10.2196/52315., (©Alexis L Michaud, Briana Bice, Eva Miklos, Katherine McCormick, Cheryl Medeiros-Nancarrow, Eric S Zhou, Christopher J Recklitis. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.11.2023.)

Background: Health anxiety (HA) by proxy is described as parents' obsessive worries that their child is severely ill although this is not medically confirmed. Research on HA by proxy suggests that it is highly distressing for the parent and that the child may be at risk of developing maladaptive symptom coping strategies. No targeted treatment for this group exists. We developed PROXY, an 8-week psychological internet-delivered treatment for parents with HA by proxy. The treatment components of PROXY are informed by cognitive behavioral therapy as well as acceptance and commitment therapy, and it was developed in collaboration with parents experiencing HA by proxy and clinical experts., Objective: This paper describes the protocol for a study investigating the potential effects of PROXY on parents' worries about their children's health using a single-case experimental design (SCED)., Methods: Five parents clinically evaluated as experiencing HA by proxy will be included. A replicated randomized SCED study will be conducted in which each participant will be randomized to receive treatment after a baseline period of between 7 and 26 days (phase A). The treatment phase duration is 8 weeks for all participants (phase B), followed by a follow-up phase lasting between 14 and 33 days (phase C), ensuring that all participants remain in the study for 96 days. Participants will report daily anxiety level by SMS text message throughout the study. They will also answer self-report questionnaires, including questions on HA by proxy and own HA, 4 times during the study. Data will be submitted to structured visual analysis to inspect anxiety level, the variability of anxiety, trends, the overlap of data points among phases, when effects occur, and the consistency of data patterns across participants. Furthermore, randomization tests will be conducted for each participant to test the null hypothesis that PROXY will have no effect on participants' anxiety., Results: The recruitment of parents began in June 2022. As of March 2, 2023, a total of 4 parents have been included in the study. Data collection was expected to cease in April 2023., Conclusions: To the best of our knowledge, this protocol describes the only study of treatment for HA by proxy. As the prevalence of this condition is still unknown, a SCED was chosen because this method allows the inclusion of very few participants while still providing information on effects and treatment courses. Conducting the study with a replicated randomized phase design enables methodologically sound testing despite the inclusion of very few participants. The results will inform researchers on individual treatment courses and effects, which may direct future research in terms of the possible mechanisms of change, ideas for how to refine the treatment content, and how the treatment may be offered to patients in the future., Trial Registration: ClinicalTrials.gov NCT04830605; https://clinicaltrials.gov/study/NCT04830605., International Registered Report Identifier (irrid): DERR1-10.2196/46927., (©Katrine Ingeman, Lisbeth Frostholm, Kaare Bro Wellnitz, Kristi Wright, Ditte Hoffmann Frydendal, Patrick Onghena, Charlotte Ulrikka Rask. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.11.2023.)

Background: Academic procrastination is a widespread problem among college students. It is linked to poor academic performance and increased college dropout intentions, as well as several mental health problems such as depression, anxiety, and stress. Guided web-based interventions can help reduce procrastination. However, guidance by professional clinicians draws upon valuable and limited societal resources, and a more efficient, scalable form of guidance is needed. Guidance by trained clinical psychology students has not yet been examined., Objective: The aim of this open trial is to examine the feasibility and acceptability of a web-based procrastination intervention for college students under the guidance of student digital coaches (e-coaches)., Methods: We developed a single-arm trial of a guided web-based intervention targeting procrastination for the Dutch student population. Guidance is delivered by trained clinical psychology students asynchronously in the form of textual feedback on intervention progress, with the aim of supporting and motivating the participant. Participants are recruited at 7 Dutch universities. Primary outcomes are intervention satisfaction, usability, and adherence, which are assessed by the Client Satisfaction Scale (CSQ-8), System Usability Scale (SUS-10), and number of completed modules, respectively. The primary outcomes will be examined by calculating descriptive statistics. Secondary outcomes are e-coach satisfaction and changes to procrastination, depression, stress, and quality of life from pre- to posttest and follow-up., Results: The project was funded in 2019, and recruitment began in January 2021. As of May 2023, a total of 985 participants were enrolled, of which 372 had completed the posttest and 192 had completed the follow-up. The expected date of analysis and publication of the results is 2024., Conclusions: The results are expected to contribute to the body of literature regarding eHealth in 3 ways. First, we will examine whether students who procrastinate adhere to and are satisfied with an eHealth intervention targeting this problem. Second, we will explore whether an intervention targeting procrastination can also decrease depression and stress. Lastly, we will investigate whether trained psychology students can effectively guide their peers in web-based interventions. Given the shortage of licensed psychologists, exploring alternative sources of guidance is much needed in order to provide students with the mental health support they need., International Registered Report Identifier (irrid): DERR1-10.2196/44907., (©Sevin Ozmen, Arpana Amarnath, Sascha Struijs, Leonore de Wit, Pim Cuijpers. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.11.2023.)

Background: Gestational weight gain (GWG) exceeding the recommendations of the Institute of Medicine (in the United States) is associated with numerous adverse maternal and infant health outcomes. While many behavioral interventions targeting nutrition and physical activity have been developed to promote GWG within the Institute of Medicine guidelines, engagement and results are variable. Technology-mediated interventions can potentially increase the feasibility, acceptability, and reach of interventions, particularly for pregnant women, for whom integration of interventions into daily life may be critical to retention and adherence. Previous reviews highlight GWG self-monitoring as a common intervention component, and emerging work has begun to integrate digital self-monitoring into technology-mediated interventions. With rapid advances in technology-mediated interventions, a focused synthesis of literature examining the role of digital self-monitoring tools in managing GWG is warranted to guide clinical practice and inform future studies., Objective: The proposed review aims to synthesize the emerging research base evaluating digital GWG self-monitoring interventions, primarily focusing on whether the intervention is effective in managing GWG. Depending on the characteristics of the included research, secondary focus areas will comprise intervention recruitment and retention, feasibility, acceptability, and differences between stand-alone and multicomponent interventions., Methods: This protocol was developed following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines for systematic review protocols. The proposed review would use a planned and systematic approach to identify, evaluate, and synthesize relevant and recent empirical quantitative studies (reported in English) examining the use of digital weight self-monitoring tools in the context of technology-mediated interventions to manage GWG in pregnant US adults, with at least 2 instances of data collection. Literature eligible for inclusion will have a publication date between January 2010 and July 2020. The Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies will be used to assess the methodological quality of included studies across various domains, and results will be synthesized and summarized per the synthesis without meta-analysis guidelines., Results: The initial queries of 1150 records have been executed and papers have been screened for inclusion. Data extractions are expected to be finished by December 2023. Results are expected in 2024. The systematic review that will be generated from this protocol will offer evidence for the use of digital self-monitoring tools in the management of GWG., Conclusions: The planned, focused synthesis of relevant literature has the potential to inform the use of digital weight self-monitoring tools in the context of future technology-mediated interventions to manage GWG. In addition, the planned review has the potential to contribute as part of a broader movement in research toward empirically supporting the inclusion of specific components within more extensive, multicomponent interventions to balance parsimony and effectiveness., Trial Registration: PROSPERO CRD42020204820; https://tinyurl.com/ybzt6bvr., International Registered Report Identifier (irrid): PRR1-10.2196/50145., (©Jan Mooney, Alicia A Dahl. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.10.2023.)

Background: Feeding intolerance (FI), frequently resulting from gastrointestinal immaturity, is prevalent among premature infants. Current practices are gradually prioritizing nonpharmacological treatments, such as massage or "Tui na," considering the potential side effects of prolonged medication use. Pediatric Tui na, a specialized massage therapy based on traditional Chinese medicine, has been widely studied for treating FI in premature infants. However, to our knowledge, no systematic review specifically focusing on the effectiveness and safety of traditional Chinese medicine-based pediatric Tui na for FI in premature infants has been published yet., Objective: This study aims to develop a protocol for a systematic review and meta-analysis for evaluating the safety and efficacy of pediatric Tui na for premature infants with FI., Methods: We will perform a comprehensive search in the following databases: Springer, Cochrane Library, Embase, MEDLINE, Clarivate Analytics, Physiotherapy Evidence Database (PEDro), CINAHL, PubMed, Scopus, World Health Organization (WHO) International Clinical Trials Registry Platform, and Chinese biomedical databases (Wanfang database, the China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Chinese Biomedical Literature Databases), limited to studies published in Chinese and English languages between January 2000 and January 2023. The search strategy will use MeSH (Medical Subject Headings) terms and database-specific keywords. A total of 2 independent reviewers will initially screen the studies based on titles and abstracts, followed by a full-text evaluation of the eligible studies. Studies will include any nonrandomized controlled trials, nonrandomized clinical studies, randomized controlled trials, and quasi-experimental studies wherein the treatment group involves premature infants with FI given pediatric Tui na. Primary outcomes will be necrotizing enterocolitis, gastric residual volume, emesis, and stool blood. Secondary outcomes will be abdominal distension weight gain, time to achieve full enteral feeding, any adverse effects associated with pediatric Tui na, and length of hospital stay. The Cochrane Collaboration Risk of Bias Tool will be used to assess the risk of bias and methodological quality. Funnel plots will be used for evaluating publication bias. Meta-analysis will be conducted using the Review Manager software (version 5.4; Cochrane Collaboration). Subgroup analyses will be considered according to treatment received, country or setting, sex, and birth weight of premature infants (if heterogeneity is high, I 2 ≥50%)., Results: This is a systematic review and meta-analysis protocol, so the results are not yet available. The protocol has been registered with PROSPERO (CRD42023390021). We are currently in the study selection phase. Results are expected to be completed by the end of 2023., Conclusions: Following this protocol, a comprehensive and rigorous literature synthesis will be developed to assess the impact of pediatric Tui na treatment on premature infants with FI, enabling the determination of its efficacy and safety., Trial Registration: PROSPERO CRD42023390021; https://tinyurl.com/bdf4kn23., International Registered Report Identifier (irrid): PRR1-10.2196/46375., (©Zirong Bai, Xiaoxiao Lyu, Yichuan Tang, Meng Wang. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.10.2023.)

Background: Informal caregivers (ie, individuals who provide assistance to a known person with health or functional needs, often unpaid) experience high levels of stress. Caregiver stress is associated with negative outcomes for both caregivers and care recipients. Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer disease and related dementias (ADRD). Commercially available mobile mindfulness apps can deliver MBIs to caregivers of persons with ADRD in a feasible and cost-effective manner., Objective: We are conducting a single-blind feasibility proof-of-concept randomized controlled trial (RCT; National Institutes of Health [NIH] stage 1B) comparing 2 free mobile apps: the active intervention Healthy Minds Program (HMP) with within-app text tailored for addressing stress among caregivers of persons with ADRD, versus Wellness App (WA), a time- and dose-matched educational control also tailored for caregivers of persons with ADRD., Methods: We aim to recruit 80 geographically diverse and stressed caregivers of persons with ADRD. Interested caregivers use a link or QR code on a recruitment flyer to complete a web-based eligibility screener. Research assistants conduct enrollment phone calls, during which participants provide informed consent digitally. After participants complete baseline surveys, we randomize them to the mindfulness-based intervention (HMP) or educational control podcast app (WA) and instruct them to listen to prescribed content for 10 minutes per day (70 minutes per week) for 12 weeks. Caregivers are blinded to intervention versus control. The study team checks adherence weekly and contacts participants to promote adherence as needed. Participants complete web-based self-report measures at baseline, posttest, and follow-up; weekly process measures are also completed. Primary outcomes are a priori set feasibility benchmarks. Secondary outcomes are stress, emotional distress, sleep disturbance, caregiver burden, mindfulness, awareness, connection, insight, and purpose. We will calculate 1-sided 95% CI to assess feasibility benchmarks. Effect sizes of change in outcomes will be used to examine the proof of concept., Results: Recruitment started on February 20, 2023. We have enrolled 27 caregivers (HMP: n=14; WA: n=13) as of June 2023. Funding began in August 2022, and we plan to finish enrollment by December 2023. Data analysis is expected to begin in May 2024 when all follow-ups are complete; publication of findings will follow., Conclusions: Through this trial, we aim to establish feasibility benchmarks for HMP and WA, as well as establish a proof of concept that HMP improves stress (primary quantitative outcome), emotional distress, sleep, and mindfulness more than WA. Results will inform a future efficacy trial (NIH stage II). HMP has the potential to be a cost-effective solution to reduce stress in caregivers of persons with ADRD, benefiting caregiver health and quality of care as well as patient care., Trial Registration: ClinicalTrials.gov NCT05732038; https://clinicaltrials.gov/study/NCT05732038., International Registered Report Identifier (irrid): DERR1-10.2196/50108., (©Emily C Woodworth, Ellie A Briskin, Evan Plys, Eric Macklin, Raquel G Tatar, Jennifer Huberty, Ana-Maria Vranceanu. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.10.2023.)

Background: Semivolatile organic compounds (SVOCs) comprise several different chemical families used mainly as additives in many everyday products. SVOCs can be released into the air as aerosols and deposit on particulate matter during use by dispersion, evaporation, or abrasion. Phthalates are SVOCs of growing concern due to their endocrine-disrupting effects. Human data on the absorption, distribution, metabolism, and excretion (ADME) of these compounds upon inhalation are almost nonexistent., Objective: The goal of this study is to develop a method for repeated inhalation exposures to SVOCs to characterize their ADME in humans., Methods: We will use diethylhexyl phthalate (DEHP), a major indoor air pollutant, as a model SVOC in this novel protocol. The Swiss official Commission on Ethics in Human Research, Canton de Vaud, approved the study on October 14, 2020 (project-ID 2020-01095). Participants (n=10) will be repeatedly exposed (2 short daily exposures over 4 days) to isotope-labeled DEHP (DEHP-d4) to distinguish administered exposures from background exposures. DEHP-d4 aerosols will be generated with a small, portable, aerosol-generating device. Participants will inhale DEHP-d4-containing aerosols themselves with this device at home. Air concentrations of the airborne phthalates will be less than or equal to their occupational exposure limit (OEL). DEHP-d4 and its metabolites will be quantified in urine and blood before, during, and after exposure., Results: Our developed device can generate DEHP-d4 aerosols with diameters of 2.5 μm or smaller and a mean DEHP-d4 mass of 1.4 (SD 0.2) μg per puff (n=6). As of May 2023, we have enrolled 5 participants., Conclusions: The portable device can be used to generate phthalate aerosols for repeated exposure in human studies., International Registered Report Identifier (irrid): DERR1-10.2196/51020., (©Elena Reale, Nancy B Hopf, Florian Breider, Dominique Grandjean, Catherine Pirard, Corinne Charlier, Holger M Koch, Aurélie Berthet, Guillaume Suarez, Myriam Borgatta. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.10.2023.)

Background: The Internet of Things (IoT) has gained significant attention due to advancements in technology and has potential applications in meeting the needs of an aging population. Smart technologies, a subset of IoT, can support older adults in aging in place, promoting independent living and improving their quality of life. However, there is a lack of research on how older adults and smart technologies coadapt over time to maximize their benefits and sustain adoption., Objective: We will aim to comprehensively review and analyze the existing scientific literature pertaining to the coadaptation between smart technologies and older adults. The primary focus will be to investigate the extent and nature of this coadaptation process and explore how older adults and technology coevolve over time to enhance older adults' experience with technology., Methods: This scoping review will follow the methodology outlined in the Joanna Briggs Institute Reviewer's Manual and adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews) guidelines for reporting. Peer-reviewed articles will be searched in databases like Ovid MEDLINE, OVID Embase, PEDro, OVID PsycINFO, EBSCO CINAHL, the Cochrane Library, Scopus, IEEE Xplore, Web of Science, and Global Index Medicus. The research team will create a data extraction form covering study characteristics, participant characteristics, underlying models and frameworks, research findings, implications for technology coadaptation, and any identified study limitations. A directed content analysis approach will be used, incorporating the Selection, Optimization, and Compensation framework and Sex- and Gender-Based Analysis Plus theoretical framework., Results: The results of this study are expected in January 2024., Conclusions: This scoping review endeavors to present a thorough overview of the available evidence concerning how smart technologies interact with older adults over an extended period. The insights gained from this review will lay the groundwork for a research program that explores how older adults adapt to and use smart technologies throughout their lives, ultimately leading to improved user satisfaction and experience and facilitating aging in place with tailored support and user-centered design principles., International Registered Report Identifier (irrid): PRR1-10.2196/51129., (©Kristina Marie Kokorelias, Alisa Grigorovich, Maurita T Harris, Umair Rehman, Louise Ritchie, AnneMarie Levy, Kerstin Denecke, Josephine McMurray. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.10.2023.)

Background: Hypertension and diabetes are among the most common noncommunicable diseases in Zimbabwe. These 2 conditions are largely prevented and controlled by lifestyle modifications, such as healthy eating habits, physical activity, and avoiding the use of tobacco and alcohol., Objective: This study aims to evaluate the effects of a community health worker (CHW)-led health literacy intervention on lifestyle modification among patients with diabetes and hypertension in the City of Harare, Zimbabwe, in terms of (1) adherence to recommended lifestyle changes, (2) blood pressure and blood glucose levels, and (3) medication adherence., Methods: This is a 6-month-long cluster randomized controlled trial, which will be conducted in primary health care clinics in the city of Harare. A total of 14 clinics will be randomly allocated into either the intervention or control group. A total of 680 (49 participants per clinic) adult patients with hypertension and diabetes will be enrolled for the trial. Participants in the intervention arm will receive a simple health literacy intervention on lifestyle modification, which will be delivered by trained CHWs, while those in the control arm will receive usual care. The intervention consists of 4 face-to-face interactive educational sessions and monthly support visits by trained CHWs and will be carried out over a period of 6 months. The primary study outcomes will be blood pressure and blood glucose levels and levels of adherence to the recommended lifestyle modifications. Other outcomes will include adherence to medication. Data management and analysis will be done using Epi Info software, and the data will be analyzed using the intention-to-treat principle., Results: Recruitment of study participants commenced on June 1, 2023, and was completed on July 30, 2023. Baseline data are being collected after participants' recruitment, and the final data collection will be completed by January 31, 2024., Conclusions: There is an information dearth regarding the effectiveness of CHW-led interventions for the management and control of hypertension in Zimbabwe. Our study offers an opportunity to show the effectiveness of CHWs in addressing the gaps in the management of hypertension and diabetes. The findings from our study will provide crucial evidence on the effectiveness and feasibility of a simple intervention delivered by CHWs in resource-constrained areas., International Registered Report Identifier (irrid): PRR1-10.2196/47512., (©Nyaradzai Arster Katena, Shepherd Shamu, Golden Tafadzwa Fana, Simbarashe Rusakaniko. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.10.2023.)

Background: Individual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT., Objective: This paper presents a research protocol for strategies to examine the effects of guided ICBT., Methods: This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis., Results: This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022., Conclusions: This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN., Trial Registration: University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr&#95;e/ctr&#95;view.cgi?recptno=R000055522., International Registered Report Identifier (irrid): DERR1-10.2196/49828., (©Sayo Hamatani, Kazuki Matsumoto, Gerhard Andersson, Yukiko Tomioka, Shusuke Numata, Rio Kamashita, Atsushi Sekiguchi, Yasuhiro Sato, Shin Fukudo, Natsuki Sasaki, Masayuki Nakamura, Ryoko Otani, Ryoichi Sakuta, Yoshiyuki Hirano, Hirotaka Kosaka, Yoshifumi Mizuno. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.09.2023.)

Background: The United States faces a nursing shortage driven by a burnout epidemic among nurses and nursing students. Nursing students are an integral population to fuel the nursing workforce at high risk of burnout and increased rates of perceived stress., Objective: The aim of this paper is to describe WellNurse, a holistic, interdisciplinary, multidimensional longitudinal research study that examines evidence-based interventions intended to reduce burnout and increase resilience among graduate and undergraduate nursing students., Methods: Graduate and undergraduate nursing students matriculated at a large public university in the northeastern United States are eligible to enroll in this ongoing, longitudinal cohort study beginning in March 2021. Participants complete a battery of health measurements twice each semester during the fourth week and the week before final examinations. The measures include the Perceived Stress Scale, the Satisfaction with Life Scale, the Oldenburg Burnout Inventory, the Brief Resilience Scale, and the Pittsburgh Sleep Quality Index. Participants are eligible to enroll in a variety of interventions, including mindfulness-based stress reduction, mindful eating, fitness training, and massage therapy. Those who enroll in specific, targeted interventions complete additional measures designed to target the aim of the intervention. All participants receive a free Fitbit device. Additional environmental changes are being implemented to further promote a culture that supports academic well-being, including recruiting a diverse student population through evidence-based holistic admissions, inclusive teaching design, targeted resilience and stress reduction workshops, and cultural shifts within classrooms and curricula. The study design protocol is registered at Open Science Framework (DOI 10.17605/OSF.IO/NCBPE)., Results: The project was funded on January 1, 2022. Data collection started in March 2022. A total of 267 participants have been recruited. Results will be published after each semester starting in December 2023. WellNurse evaluation follows the Rapid Cycle Quality Improvement framework to continuously monitor ongoing project processes, activity outcomes, and progress toward reducing burnout and increasing resilience. Rapid Cycle Quality Improvement promotes the ability to alter WellNurse interventions, examine multiple interventions, and test their effectiveness among the nursing education population to identify the most effective interventions., Conclusions: Academic nursing organizations must address student burnout risk and increase resilience to produce a future workforce that provides high-quality patient care to a diverse population. Findings from WellNurse will support evidence-based implementations for public baccalaureate and master's nursing programs in the United States., International Registered Report Identifier (irrid): DERR1-10.2196/49020., (©Kelley Strout, Rebecca Schwartz-Mette, Jade McNamara, Kayla Parsons, Dyan Walsh, Jen Bonnet, Liam M O'Brien, Kathryn Robinson, Sean Sibley, Annie Smith, Maile Sapp, Lydia Sprague, Nima Sajedi Sabegh, Kaitlin Robinson, Amanda Henderson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.09.2023.)

Background: Although the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, postpartum care of the mother receives much less attention in transitional countries., Objective: We describe the protocol for a randomized controlled trial to implement and evaluate a postpartum care delivery model titled Focused-PPC (Focused Postpartum Care)., Methods: Focused-PPC is an integrated group postpartum care model that meets the clinical care, education, and support needs of mothers up to 1 year after birth. The Focused-PPC intervention is a parallel randomized controlled trial with a total of 192 postpartum women at 4 health centers in Tamale, Ghana. Participants will be randomized into 1 of 2 trial arms at a 1:1 allocation ratio: (1) the control arm, which receives the standard postnatal care currently delivered in health facilities, or (2) the intervention arm, which receives the Focused-PPC model of care. Women enrolled in the intervention arm will receive postpartum clinical assessments and education for the first 6 weeks and will continue to receive education, measures of vital signs, and peer support for 12 months post partum during child welfare visits. Led by trained midwives, each postpartum group in the intervention arm will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year post partum, following the Ghana Health Service postnatal care schedule., Results: The Focused-PPC guide, data collection tools, and audiovisual education materials were successfully developed and translated into the local language. We have enrolled and conducted baseline surveys for 192 women (sample size met) in the Focused-PPC trial who have been randomized into intervention and control arms. We have established a total of 12 Focused-PPC groups in the intervention arm, 3 groups from each site, all of which have sessions underway., Conclusions: Focused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond., Trial Registration: ClinicalTrials.gov NCT05280951; https://clinicaltrials.gov/study/NCT05280951., International Registered Report Identifier (irrid): DERR1-10.2196/47519., (©Yenupini Joyce Adams, John Stephen Agbenyo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.08.2023.)

Background: The syndemic of mental health (MH) and substance use disorders (SUDs) is common among persons living with HIV and jeopardizes HIV treatment adherence, engagement in care, and viral load suppression. Electronic patient-reported outcomes (ePROs), completed through tablet or computer, and telemedicine are evidence- and technology-based interventions that have been used to successfully increase screening and treatment, respectively, a model that holds promise for persons living with HIV. To date, there is limited guidance on implementing ePROs and telemedicine into HIV clinical practice even though it is well known that these evidence-based tools improve diagnosis and access to care., Objective: To address this, we aim to conduct a multicomponent intervention for persons living with HIV, including the delivery of HIV services and telemedicine through effective ePROs (+STEP), to increase screening and treatment of MH and SUD in Ryan White HIV/AIDS Program (RWHAP)-funded clinics in Alabama., Methods: Through this intervention, we will conduct a readiness, acceptability, and accessibility assessment and implement +STEP to improve the diagnosis and treatment of MH and SUD at RWHAP clinics in Alabama. To describe implementation strategies that address barriers to the uptake of +STEP in RWHAP clinics, we will conduct qualitative interviews in years 1 (early implementation), 2 (scale up), and 4 (maintenance) with patients and key staff to evaluate barriers, facilitators, and implementation strategies. Our Results will enable us to modify strategies to enhance +STEP penetration over time and inform the implementation blueprint, which we will develop for both RWHAP clinics in Alabama and future sites. We will assess the impact of implementing +STEP on diagnoses, referrals, and health care use related to MH, SUD, and HIV by comparing clinical outcomes from patients receiving these interventions (ePROs and telemedicine) with historical controls., Results: The first study site began implementation in April 2022. A total of 2 additional sites have initiated ePROs. Final results are expected in 2026. The results of this study will provide a foundation for future research expanding access to ePROs for improved diagnosis linked to telemedicine access to accelerate patients along the continuum of care from MH and SUD diagnosis to treatment., Conclusions: Achieving the end of the HIV epidemic in the United States necessitates programs that accelerate movement across the MH and SUD care continuum from diagnosis to treatment for persons living with HIV. Scaling these services represents a path toward improved treatment outcomes with both individual health and population-level prevention benefits of sustained HIV viral suppression in the era of undetectable=untransmittable (U=U). This study will address this evidence gap through the evaluation of the implementation of +STEP to establish the necessary systems and processes to screen, identify, and better treat substance use and MH for people living with HIV., International Registered Report Identifier (irrid): DERR1-10.2196/40470., (©Kelly W Gagnon, Stefan Baral, Dustin Long, Alfredo L Guzman, Bernadette Johnson, Greer Burkholder, James Willig, Michael Mugavero, Margaret Baldwin, Susanne Fogger, Thomas Creger, Karen Cropsey, Ellen Eaton. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.08.2023.)