Results of a brief online group application of the unified protocol for the prevention of emotional disorders in university students: a pilot study with multiple baseline experimental design / Resultados de una aplicación grupal breve en línea del protocolo unificado para la prevención de trastornos emocionales en estudiantes universitarios: un estudio piloto con diseño experimental de línea base múltiple

Los trastornos emocionales (TEs) son los trastornos más comunes entre la población joven. El desarrollo de programas preventivos de los TEs es fundamental para evitar su posible aparición. Los programas de prevención transdiagnósticos podrían presentar una ventaja sobre los existentes para mejorar las estrategias de regulación emocional. Así, el objetivo de este estudio ha sido determinar la viabilidad y eficacia preliminar de un programa breve basado en el Protocolo Unificado (PU). El proyecto consistió en un estudio piloto utilizando un diseño experimental de línea base múltiple. Nueve estudiantes universitarios recibieron un programa de 5 sesiones basado en el PU en formato grupal online. Se encontraron diferencias significativas después de la intervención en la regulación de las emociones, el apoyo social percibido y la evitación, con tamaños del efecto moderados-grandes (r de Cohen = .49 - .59). Estas mejoras mostraron aumentos en los seguimientos al mes y a los 3 meses. Esos resultados están en línea con los que muestran que los programas preventivos transdiagnósticos breves podrían ser útiles para la prevención de los TEs en población universitaria.(AU)

Emotional disorders (EDs) are the most common disorders among the young population. The development of preventive programs for EDs is essential to avoid their possible appearance. Transdiagnostic prevention programs could present an advantage over existing ones to im-prove emotional regulation strategies. Thus, the objective of this study has been to determine the preliminary feasibility and effectiveness of a brief program based on the Unified Protocol (UP). The project consisted of a pilot study using a multiple baseline experimental design. Nine university students received a 5-session program based on the UP in online-group format. Significant differences were found after the intervention for emo-tion regulation, perceived social support and avoidance, with moderate-large effect sizes (Cohen's r= .49-.59). These improvements showed in-creases at 1-month and 3-month follow-ups. Those results are in line with those showing that brief transdiagnostic preventive programs could be use-ful for the prevention of EDs in the university population.(AU)

Prolonged intermittent theta burst stimulation for post-stroke aphasia: protocol of a randomized, double-blinded, sham-controlled trial.

Background: Post-stroke aphasia (PSA) is one of the most devastating symptoms after stroke, yet limited treatment options are available. Prolonged intermittent theta burst stimulation (piTBS) is a promising therapy for PSA. However, its efficacy remains unclear. Therefore, we aim to investigate the efficacy of piTBS over the left supplementary motor area (SMA) in improving language function for PSA patients and further explore the mechanism of language recovery. Methods: This is a randomized, double-blinded, sham-controlled trial. A total of 30 PSA patients will be randomly allocated to receive either piTBS stimulation or sham stimulation for 15 sessions over a period of 3 weeks. The primary outcome is the Western Aphasia Battery Revised (WAB-R) changes after treatment. The secondary outcomes include The Stroke and Aphasia Quality of Life Scale (SAQOL-39 g), resting-state electroencephalogram (resting-state EEG), Event-related potentials (ERP), brain derived neurotrophic factor (BDNF). These outcome measures are assessed before treatment, after treatment, and at 4-weeks follow up. This study was registered in Chinese Clinical Trial Registry (No. ChiCTR23000203238). Discussion: This study protocol is promising for improving language in PSA patients. Resting-state EEG, ERP, and blood examination can be used to explore the neural mechanisms of PSA treatment with piTBS. Clinical trial registration: https://www.chictr.org.cn/index.html, ChiCTR2300074533.

Securing patient data in the healthcare industry: A blockchain-driven protocol with advanced encryption.

BACKGROUND: Ensuring the security and privacy of patient data is a critical concern in the healthcare industry. The growing utilization of electronic data transmission and storage in medical records has amplified apprehensions about data security. However, due to varying stakeholder interests, not all data can be freely shared, necessitating the development of secure protocols. MATERIALS AND METHODS: This study presents a highly secure protocol that integrates blockchain technology, patient biometric information, and robust cryptographic algorithms (elliptic curve cryptography (ECC) and advanced encryption algorithm (AEC)) to facilitate data encryption and decryption. The protocol encompasses secure login, secure key sharing, and data sharing mechanisms among miners, offering comprehensive security measures. To validate the effectiveness of the proposed protocol, both informal and formal security analyses are conducted. The security protocol description language in Scyther is utilized to evaluate the protocol's resilience against attacks. RESULTS: The culmination of this research is a secure protocol that leverages blockchain technology and ECC for the secure storage and sharing of medical records. The protocol covers all stages, including system setup, user registration, login mechanisms, key exchange between users and blockchain, communication between blockchains, and interaction with other miners, with a steadfast emphasis on security. Furthermore, the protocol's communication and computation costs are assessed, with a comparison to existing blockchain-based schemes. Informal proofs establish the protocol's security against common attacks faced by medical institutions. Formal simulation of the protocol using the Scyther tool provides definitive evidence of its resistance to attacks. CONCLUSIONS: As a result, this protocol presents a viable real-time implementation solution for safeguarding patient data within the healthcare domain, representing a significant contribution to data security.

Personal growth initiative across the life span: a systematic review protocol of quantitative studies using the Personal Growth Initiative Scale-II.

BACKGROUND: Personal Growth Initiative (PGI) a multi-dimensional construct, conceptualised as a skill set that helps individuals to intentionally grow is considered an important construct throughout the life span. Coping with the challenges, transitions, experiences and stressors of life requires an active growth orientation. In previous empirical research, the construct has been measured by either the PGIS-I or PGIS-II, of which only the latter takes account of the theoretically established multi-dimensionality of the construct. This paper describes the protocol for conducting a systematic review of published peer-reviewed empirical research articles on the multi-dimensional construct of PGI. The aim of this review is threefold: (1) to better understand the multi-dimensional construct PGI in different contexts and populations, (2) to improve our understanding of the reliability and validity of the PGIS-II in various research populations and (3) to obtain an overview of its associations with relevant psychosocial factors. METHODS: For the development of this protocol, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) reporting guidelines were used. Four databases and one registry will be searched using a predetermined search strategy for relevant studies. Studies will be screened, by two reviewers independently, against the established inclusion criteria. During the data extraction process, the quality of the included studies will be assessed using the Quality Assessment for Survey Studies in Psychology (Q-SSP). The collected data will then be analysed and reported in both narrative and tabular form according to the PRISMA 2020 statement guidelines and flow diagram. DISCUSSION: The findings of this study will increase our understanding of the dynamics of PGI throughout the lifespan, its associations with other psychosocial factors and the psychometric properties of the PGIS-II. It will also clarify where additional research is needed. The objectives of the proposed review can provide a basis for the development of practical applications and interventions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022377342.

Establishment of a Dataset for the Traditional Korean Medicine Examination in Healthy Adults.

We established a protocol for the traditional Korean medicine examination (KME) and methodically gathered data following this protocol. Potential indicators for KME were extracted through a literature review; the first KME protocol was developed based on three rounds of expert opinions. The first KME protocol's feasibility was confirmed, and data were collected over four years from traditional Korean medicine (KM) hospitals, focusing on healthy adults, using the final KME protocol. A literature review identified 175 potential core indicators, condensed into 73 indicators after three rounds of expert consultation. The first KME protocol, which was categorized under questionnaires and medical examinations, was developed after the third round of expert opinions. A pilot study using the first KME protocol was conducted to ensure its validity, leading to modifications resulting in the development of the final KME protocol. Over four years, data were collected from six KM hospitals, focusing on healthy adults; we obtained a dataset comprising 11,036 healthy adults. This is the first protocol incorporating core indicators of KME in a quantitative form and systematically collecting data. Our protocol holds potential merit in evaluating predisposition to diseases or predicting diseases.

The influence of three different primary treatment protocols on 5-year-old maxillary growth in patients with complete unilateral cleft lip and palate.

The study evaluated the effects of three different primary treatment protocols on maxillary growth in patients aged 5 years with complete unilateral cleft lip and palate (UCLP). The secondary objective was to assess the influence of initial cleft severity, family history of class III, and status of permanent lateral incisor on maxillary growth. In total, 54 patients with non-syndromic complete UCLP were included and grouped as follows: group An underwent lip adhesion, cheilorhinoplasty associated with tibial periosteal graft for hard palate repair, and finally veloplasty; group B underwent lip adhesion, then cheilorhinoplasty with intravelar veloplasty, and finally a hard-palate repair; group C underwent cheilorhinoplasty with intravelar veloplasty and then a hard-palate repair. Five-year maxillary growth was assessed on dental models, both clinically and digitally. No difference was found with GOSLON-Yardstick scoring. Five-year measurements showed that group C tended to have the best maxillary arch morphology (p = 0.012). Initial cleft severity did not impact maxillary growth, but status of permanent lateral incisor and family history of class III did (p = 0.019 and p = 0.004, respectively). In patients aged 5 years, the two-stage approach appeared to be the least detrimental to growth development. Predictive factors for growth retardation included the absence of lateral incisor and a family history of class III.

Impact of "hypotension on arrival" on required surgical disciplines and usage of damage control protocols in severely injured patients.

BACKGROUND: For trauma patients with subsequent immediate surgery, it is unclear which surgical disciplines are most commonly required for treatment, and whether and to what extend this might depend on or change with "hypotension on arrival". It is also not known how frequently damage control protocols are used in daily practice and whether this might also be related to "hypotension on arrival". METHODS: A retrospective analysis of trauma patients from a German level 1 trauma centre and subsequent "immediate surgery" between 01/2017 and 09/2022 was performed. Patients with systolic blood pressure > 90 mmHg (group 1, no-shock) and < 90 mmHg (group 2, shock) on arrival were compared with regard to (a) most frequently required surgical disciplines, (b) usage of damage control protocols, and (c) outcome. A descriptive analysis was performed, and Fisher's exact test and the Mann‒Whitney U test were used to calculate differences between groups where appropriate. RESULTS: In total, 98 trauma patients with "immediate surgery" were included in our study. Of these, 61 (62%; group 1) were normotensive, and 37 (38%, group 2) were hypotensive on arrival. Hypotension on arrival was associated with a significant increase in the need for abdominal surgery procedures (group 1: 37.1 vs. group 2: 54.5%; p = 0.009), more frequent usage of damage control protocols (group 1: 59.0 vs. group 2: 75.6%; p = 0.019) and higher mortality (group 1: 5.5 vs. group 2: 24.3%; p 0.027). CONCLUSION: Our data from a German level 1 trauma centre proof that abdominal surgeons are most frequently required for the treatment of trauma patients with hypotension on arrival among all surgical disciplines (> thoracic surgery > vascular surgery > neurosurgery). Therefore, surgeons from these specialties must be available without delay to provide optimal trauma care.

Can on-line gait training improve clinical practice? Study protocol for feasibility randomised controlled trial of an on-line educational intervention to improve clinician's gait-related decision-making in ambulant children and young people with cerebral palsy.

BACKGROUND: Instrumented gait analysis (IGA) is an assessment and research tool with proven impacts on clinical decision-making for the management of ambulant children and young people with cerebral palsy (CYPwCP) but is underused and variably understood by relevant clinicians. Clinicians' difficulties in gaining expertise and confidence in using IGA are multifactorial and related to access for clinical decision-making, limited training opportunities and inability to translate this training into clinical practice. METHODS: The primary aim of this study is to test the feasibility of an educational intervention to advance clinicians' application of gait analysis in CYPwCP, to inform a definitive trial. The secondary aim is to measure the effect that appropriate IGA training has on physiotherapists' knowledge, skills, confidence and behaviours. This will be a two-arm feasibility randomised controlled trial with an experimental and control group. The 6-week on-line intervention uses a multicomponent approach grounded in behavioural change techniques. A repeated measures design will be adopted, whereby participants will complete outcome measures at baseline, immediately after the intervention and at 4 months. The primary outcome measures (trial feasibility-related outcomes) are recruitment and engagement. The secondary outcome measures (trial research-related outcomes) are knowledge, skills, confidence and practice change. Outcome measures will be collected via online questionnaires and during observed skill assessments. Analysis of data will use descriptive statistics, two-way mixed ANOVA model and qualitative content analysis. DISCUSSION: This study will determine feasibility of the definitive randomised control trial of educational intervention delivered to advance clinicians' application of gait analysis in CYPwCP. This study offers the shift in emphasis from regarding IGA as a tool to a focus on clinicians' requirements for access, training and a well-defined role to optimise utilisation of IGA. The impact of this should be better engagement with IGA and clinical practice change. This study will contribute to a body of educational research into clinical education of healthcare professionals and IGA training offering insight into high levels of evaluation evidence including clinical behaviour change. TRIAL REGISTRATION: Protocol has been registered with the Open Science Framework (osf.io/nweq6) in June 2023.

Prospective phase II trial of preoperative hypofractionated proton therapy for extremity and truncal soft tissue sarcoma: the PRONTO study rationale and design.

BACKGROUND: Oncologic surgical resection is the standard of care for extremity and truncal soft tissue sarcoma (STS), often accompanied by the addition of pre- or postoperative radiation therapy (RT). Preoperative RT may decrease the risk of joint stiffness and fibrosis at the cost of higher rates of wound complications. Hypofractionated, preoperative RT has been shown to provide acceptable outcomes in prospective trials. Proton beam therapy (PBT) provides the means to decrease dose to surrounding organs at risk, such as the skin, bone, soft tissues, and adjacent joint(s), and has not yet been studied in patients with extremity and truncal sarcoma. METHODS: Our study titled "PROspective phase II trial of preoperative hypofractionated protoN therapy for extremity and Truncal soft tissue sarcOma (PRONTO)" is a non-randomized, prospective phase II trial evaluating the safety and efficacy of preoperative, hypofractionated PBT for patients with STS of the extremity and trunk planned for surgical resection. Adult patients with Eastern Cooperative Group Performance Status ≤ 2 with resectable extremity and truncal STS will be included, with the aim to accrue 40 patients. Treatment will consist of 30 Gy radiobiological equivalent of PBT in 5 fractions delivered every other day, followed by surgical resection 2-12 weeks later. The primary outcome is rate of major wound complications as defined according to the National Cancer Institute of Canada Sarcoma2 (NCIC-SR2) Multicenter Trial. Secondary objectives include rate of late grade ≥ 2 toxicity, local recurrence-free survival and distant metastasis-free survival at 1- and 2-years, functional outcomes, quality of life, and pathologic response. DISCUSSION: PRONTO represents the first trial evaluating the use of hypofractionated PBT for STS. We aim to prove the safety and efficacy of this approach and to compare our results to historical outcomes established by previous trials. Given the low number of proton centers and limited availability, the short course of PBT may provide the opportunity to treat patients who would otherwise be limited when treating with daily RT over several weeks. We hope that this trial will lead to increased referral patterns, offer benefits towards patient convenience and clinic workflow efficiency, and provide evidence supporting the use of PBT in this setting. TRIAL REGISTRATION: NCT05917301 (registered 23/6/2023).

AMPlifying metabolic screening for inpatients on antipsychotic medications with a nurse-driven protocol.

INTRODUCTION: Patients on antipsychotic medications are at higher risk of developing metabolic syndrome; nevertheless, metabolic screening for patients on antipsychotics is suboptimal. METHODS: This project developed and implemented AMP (Antipsychotic Metabolic screening Protocol), a nurse-driven protocol on inpatient psychiatric units that allowed nursing staff to collect all components of a metabolic screening. Nurses working on units with AMP were surveyed pre- and post-implementation on perception of AMP and empowerment. RESULTS: AMP significantly increased overall metabolic screening as well as the most frequently missing component (lipid panel). The screening rates pre-intervention were similar to those found in the literature (on average, only two-thirds of patients were screened). However, AMP improved the rate such that nine out of every ten patients on the units were screened. Nurses had a negative perception and no change in empowerment from AMP implementation. CONCLUSIONS: AMP can be used to increase metabolic screening for patients on antipsychotics. Further research is needed to better understand adoptability of nurse-driven protocols in the psychiatric inpatient setting as well as other applications, such as smoking cessation or safety sitters.

Effectiveness of Different Noninvasive Physiotherapy in Relieving Postlaparoscopic Shoulder pain: A Protocol for Systematic Review and Network Meta-Analysis.

Background: Shoulder pain is one of the most common symptoms after laparoscopic surgery, which seriously affects people's health and quality of life. Many clinical studies have shown that noninvasive physiotherapy is the most beneficial treatment for patients, but the best approach for various noninvasive physiotherapy is unclear. The purpose of this study protocol is to compare the effectiveness of different noninvasive physiotherapy in relieving postlaparoscopic shoulder pain (PLSP). Methods: We will search ten electronic databases including PubMed, Web of Science, Medline, Scopus, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), CNKI, WanFang Data and VIP databases from their inception to November 2023. We will select randomized controlled trials (RCTs) to evaluate the effectiveness of noninvasive physiotherapy on PLSP. Our primary outcome will be to measure the intensity of shoulder pain at 24 and 48 hours after the end of the noninvasive intervention in the included study. Secondary outcomes include incidence of shoulder pain at 24 and 48 hours, postoperative nausea / vomiting and incidence of other complications after noninvasive intervention. Then, standard network meta-analysis will be conducted using Review Manager 5.4 and STATA 18. Results: Our systematic review and network meta-analysis will identify the best noninvasive physiotherapy for PLSP patients. Conclusion: This systematic review will address the existing knowledge gap regarding best practice for relieving PLSP with noninvasive physiotherapy. The results of this network meta-analysis will help medical staff and patients choose the best method to relieve the PLSP. Furthermore, we hope that the results of this study will provide evidence-based for the improvement of guidelines and facilitate the decision sharing process. Systematic review registration: PROSPERO CRD42023481829.

Investigating knowledge of DRLs, image quality and radiation dose in PET/CT and CT imaging among medical imaging professionals.

Objective: To investigate the knowledge of diagnostic reference levels (DRLs), image quality, radiation dose and protocol parameters among Jordanian medical imaging professionals (MIPs) involved in PET/CT and CT scan procedures. Materials and methods: A questionnaire was designed and distributed to MIPs in Jordan. The survey comprised four sections: demographic data, MIP knowledge on dose/protocol parameters, image quality, and DRLs. Statistical analyses were performed utilizing Pearson's correlation, t-tests, ANOVA, and linear regression, with a significance level of 95 % and a p-value threshold of <0.05. Results: The study involved 147 participants. Most respondents were male (76.2 %), and most were aged 26-35 years (44.2 %). Approximately 51 % held a bachelor's degree, and the most common range of experience was 3-5 years (28.6 %). Participants showed a moderate level of knowledge regarding dose and protocol parameters, with a mean score of 61.8 %. The mean scores for knowledge of image quality and DRLs were 45.2 % and 44.8 %, respectively. The age group of the MIPs and the total experience were found to have a significant impact on the knowledge of the dose and protocol parameters, as well as the DRLs. Additionally, experience was found to have a significant influence on knowledge of the dose and protocol parameters. The study revealed a positive and significant effect of MIPs' knowledge of dose/protocol parameters and image quality on their knowledge of DRLs. Conclusions: This study indicates that professionals across five specialties who are engaged in PET/CT and CT imaging possess a moderate understanding of dosage and protocol parameters. However, there is a notable gap in knowledge regarding DRLs and image quality. To address this issue, it is recommended that MIPs actively engage in educational programs emphasizing exposure parameters and their impact on image quality. Additionally, access to comprehensive education and training programs will enable MIPs to grasp the complexities of DRLs and their implications, facilitating their implementation in clinical practice.

Enhanced recovery urinary protocol for patients undergoing hip surgery: a quasi-experimental study.

INTRODUCTION: Postoperative urinary retention (POUR) is a common complication after hip surgery. The enhanced recovery urinary protocol (ERUP) is a tool that employs several perioperative strategies to facilitate optimal conditions for surgery and recovery. The aim of this study was to evaluate the effect of ERUP on POUR in patients undergoing hip surgery. METHODOLOGY: A controlled pre- and post-quasi-experimental study was conducted. Data was collected between May 2018 and January 2019 at the orthopedic department of one of the largest teaching hospitals affiliated with Menoufia University in Egypt. A convenience sample of 100 Egyptian patients (of both genders) undergoing elective hip surgery was equally allocated into two groups. The control group (n = 50) was given traditional routine perioperative nursing care, while the intervention group (n = 50) was subjected to ERUP. Data was collected from socio-demographic, medical, and surgical data sheets, preoperative medication assessment sheets, postoperative data sheets, and fluid balance charts. RESULTS: ERUP application significantly reduced the length of hospital stay and the incidence of POUR in the intervention group. CONCLUSIONS: Implementation of the ERUP is recommended for patients undergoing hip surgery, as it has a significantly positive effect on reducing the incidence of POUR.

Harmonized analysis of PBMC by mass cytometry.

Mass cytometry permits the high dimensional analysis of cellular systems at single-cell resolution with high throughput in various areas of biomedical research. Here, we provide a state-of-the-art protocol for the analysis of human peripheral blood mononuclear cells (PBMC) by mass cytometry. We focus on the implementation of measures promoting the harmonization of large and complex studies to aid robustness and reproducibility of immune phenotyping data.

Understanding the meaning of the lived experience "maternal role" in women with multiple sclerosis and planning a supportive program: a combined exploratory study protocol.

BACKGROUND: The maternal role is one of the most challenging yet rewarding roles that women experience in their lives. It begins when a woman becomes pregnant, and as the pregnancy progresses, she prepares to fulfill her role as a mother. A woman's health plays a crucial role in her ability to fulfill the maternal role. Multiple sclerosis (MS), as an autoimmune disease, presents unique challenges in achieving this role. Failing to fulfill the maternal role can have lasting consequences for both the mother and the baby. Given the increasing number of women with MS of reproductive age in Iran and the absence of specific programs for this group during pregnancy and postpartum, researchers have decided to develop a supportive program by exploring the meaning of the maternal role and identifying the needs of these women during this period. METHODS/MATERIALS: This study will be conducted in 3 stages. The first stage involves a qualitative study to explore the meaning of the "maternal role" in women with MS through a descriptive and interpretive phenomenological approach based on Van Manen's method. Data will be collected through semi-structured interviews with pregnant women with MS and mothers with MS who have children under one-year-old, recruited from the Multiple Sclerosis Society of Mashhad, Iran. The second stage will involve designing a support program based on the findings of the phenomenological study, literature review, and exploratory interviews. A logical model will guide the development of the program, and validation will be conducted using the nominal group technique. DISCUSSION: This study is the first of its kind in Iran to explore the meaning of the maternal role and develop a support program for women with MS. It is hoped that the results of this study will help address the challenges of motherhood faced by these women.

The maternal role is considered one of the most significant roles a woman will undertake in her lifetime. It is a process in which a woman, as a mother, attains competency in her role and eventually becomes comfortable with her identity as a mother. However, there are various factors, such as diseases, that can impede a mother from fully embracing her role. Multiple sclerosis (MS), an autoimmune disease that predominantly affects women of reproductive age, is one such condition.Given the lack of research in Iran regarding the experiences of women with MS in their maternal role, a study was developed in three phases. The first phase involves interviewing pregnant women with MS and mothers with MS who have children under one-year-old to explore the meaning of the maternal role. In the second phase, utilizing the findings from the initial interviews and the experts' opinions, a support program will be created to assist women with MS during pregnancy and after giving birth, and in the last stage, this program will be evaluated by nominal group technique.

Engaging patient and community stakeholders in the optimization of the Compassionate And Loving Mindset towards heart health risk (CALM Hearts) physical activity intervention: a description of initial work and protocol for future engagement activities.

BACKGROUND: Participatory research approaches systematically integrate the perspectives of individuals, organizations, or communities that have a direct interest in a study's processes and outcomes (i.e., stakeholders) in research design and implementation. This supports interventions that are developed "by, not for" end-users, thereby increasing acceptability, uptake, and adherence. However, participatory approaches are relatively under-utilized in intervention development and behavioral change intervention research, in part, due to inadequate reporting of methodology. Therefore, to improve transparency in planning and reporting, we (a) describe how we engaged patients and community organizations (i.e., patient and community partners) in grant development for a self-compassion and physical activity behaviour change intervention for women with cardiovascular risk factors and (b) present a protocol for engaging patient and community partners in the optimization and implementation of the intervention moving forward. METHODS: Our participatory research approach was guided by the Strategy for Patient-Oriented Research patient engagement framework and our prior stakeholder engagement work. Four patients and three community partners were engaged at the level of Involve, meaning their perspectives informed directions, processes, and decisions at major project milestones. Specifically, patient and community partners engaged in three separate meetings during grant development wherein they: (a) established a Terms of Reference to guide engagement activities and expectations; (b) shaped the grant through guided conversations about research priorities, outcomes, and intervention delivery components that could be targeted for optimization and (c) co-developed a protocol that specifies how relationships will be initiated with future patient partners, proposes engagement activities across the research cycle, and includes plans for formal evaluation of engagement processes. CONCLUSIONS: Participatory research approaches provide valuable insights into the development of behavioural interventions, especially when stakeholders can partner early and have a meaningful impact. By detailing our engagement activities to date, we hope to model an approach to engaging stakeholders in behavioral intervention development and demonstrate the impacts of doing so.

BACKGROUND: Participatory research engages individuals, organizations, or communities affected by a study's outcomes ("stakeholders"), in its design and conduct. Participatory research approaches are not commonly used in intervention development and behavioral intervention research, in part due to a lack of studies describing ways to engage stakeholders in this work. Therefore, our study aimed to (a) describe how we engaged patients and community organizations ("patient and community partners") in developing a grant application for a behaviour intervention for women with cardiovascular risk factors and (b) present a protocol for engaging patient and community partners in the future intervention. METHODS: Our approach was guided by the Strategy for Patient-Oriented Research patient engagement framework and our prior engagement work. Four patient and three community partners were engaged at the level of Involve, meaning their perspectives informed directions, processes, and decisions at project milestones. Across three sets of meetings, patient and community partners: (a) established a Terms of Reference to guide engagement activities and expectations; (b) shaped the grant through guided conversations about research priorities, outcomes, and intervention design; and (c) co-developed a protocol that described how relationships will be initiated with future patient partners, potential engagement activities across the research cycle, and evaluation plans. CONCLUSIONS: Participatory research approaches provide valuable insights into the development of behavioural interventions, especially when stakeholders can partner early and have a meaningful impact. By detailing our engagement activities, we hope to model an approach to engaging stakeholders in behavioral intervention development and demonstrate the impacts of doing so.

Risk factors and long-term outcomes of oropharyngeal dysphagia in persons with multiple sclerosis: a systematic review protocol.

BACKGROUND: Oropharyngeal dysphagia (OPD) can be functionally debilitating in persons with multiple sclerosis (pwMS). OPD induces alterations in safety and efficiency of food and/or liquid ingestion and may incur negative sequalae such as aspiration pneumonia or malnutrition/dehydration. Early detection and timely management of OPD in pwMS could prevent such complications and reduce mortality rates. Identifying risk factors of OPD relative to its onset or repeat manifestation will enable the development of care pathways that target early assessment and sustained management. The aims of this systematic review are to compile, evaluate, and summarize the existing literature reporting potential risk factors and associated long-term outcomes (e.g., aspiration pneumonia, malnutrition, dehydration, and/or death) of OPD in pwMS. METHODS: We will undertake a systematic review to identify studies that describe patterns and complications of OPD in pwMS. Variables of interest include predictors of OPD along with long-term outcomes. We will search MEDLINE, Embase, CINAHL, AMED, the Cochrane Library, Web of Science, and Scopus. We will consider studies for inclusion if they involve at least 30 adult participants with MS and report risk factors for OPD and/or its long-term outcomes. Studies will be excluded if they refer to esophageal or oropharyngeal dysphagia induced by causes other than multiple sclerosis. Study selection and data extraction will be performed by two independent assessors for abstract and full article review. We will present study characteristics in tables and document research findings for dysphagia-related risk factors or its complications via a narrative format or meta-analysis if warranted (e.g., mean difference and/or risk ratio measurements). All included studies will undergo risk-of-bias assessment conducted independently by two authors with consensus on quality ratings. DISCUSSION: There is a lacune for systematic reviews involving risk factors and long-term outcomes of dysphagia in pwMS to date. Our systematic review will provide the means to develop accurate and efficient management protocols for careful monitoring and evaluation of dysphagia in pwMS. The results of this systematic review will be published in a peer-reviewed journal. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022340625.

Investigating the impact of storage duration and temperature on vitamin C in various citrus genotypes: A meta-analysis method.

The present work disseminates a solid scientific meta-analysis method to investigate the impact of storage duration and temperature on vitamin C of citrus. This work is initiated by designing of the PICO framework, collecting, and organizing the articles, creating selection criteria, sorting articles, identifying factors influencing moderation effects and sources of diversity, tabulating data, and employing analysis in the form of a linear mixed model. Using this method, we identified 54 distinct studies from a pool of 289 eligible peer-reviewed publications, focusing on variations of vitamin C in citrus. The method provides mean values in both quadratic and linear regression forms.•This method provides a detailed description starting from topic selection to statistical methodologies intended for performing meta-analysis.•All guidelines for conducting this method have been approved by all authors and adhere to the standard PRISMA-P guidelines.•Disseminating this method in a peer-reviewed publication aims to facilitate scholarly discussions and promote transparency, ultimately improving the standard for performing meta-analysis on vitamin C levels in citrus concerning various genotypes, storage temperatures, and durations.

Examining the Effectiveness of Interactive Webtoons for Premature Birth Prevention: Protocol for a Randomized Controlled Trial.

BACKGROUND: Premature birth poses significant health challenges globally, impacting infants, families, and society. Despite recognition of its contributing factors, efforts to reduce its incidence have seen limited success. A notable gap exists in the awareness among women of childbearing age (WCA) regarding both the risks of premature birth and the preventative measures they can take. Research suggests that enhancing health beliefs and self-management efficacy in WCA could foster preventive health behaviors. Interactive webtoons offer an innovative, cost-effective avenue for delivering engaging, accessible health education aimed at preventing premature birth. OBJECTIVE: This protocol describes a randomized controlled trial to assess the effectiveness and feasibility of a novel, self-guided, web-based intervention-Pregnancy Story I Didn't Know in Interactive Webtoon Series (PSIDK-iWebtoons)-designed to enhance self-management efficacy and promote behaviors preventing premature birth in WCA. METHODS: Using an explanatory sequential mixed methods design, this study first conducts a quantitative analysis followed by a qualitative inquiry to evaluate outcomes and feasibility. Participants are randomly assigned to 2 groups: one accessing the PSIDK-iWebtoons and the other receiving Pregnancy Story I Didn't Know in Text-Based Information (PSIDK-Texts) over 3 weeks. We measure primary efficacy through the self-management self-efficacy scale for premature birth prevention (PBP), alongside secondary outcomes including perceptions of susceptibility, severity, benefits, and barriers based on the health belief model for PBP and PBP intention. Additional participant-reported outcomes are assessed at baseline, the postintervention time point, and the 4-week follow-up. The feasibility of the intervention is assessed after the end of the 3-week intervention period. Outcome analysis uses repeated measures ANOVA for quantitative data, while qualitative data are explored through content analysis of interviews with 30 participants. RESULTS: The study received funding in June 2021 and institutional review board approval in October 2023. Both the PSIDK-iWebtoons and PSIDK-Texts interventions have been developed and pilot-tested from July to November 2023, with the main phase of quantitative data collection running from November 2023 to March 2024. Qualitative data collection commenced in February 2024 and will conclude in May 2024. Ongoing analyses include process evaluation and data interpretation. CONCLUSIONS: This trial will lay foundational insights into the nexus of interactive web-based interventions and the improvement of knowledge and practices related to PBP among WCA. By demonstrating the efficacy and feasibility of a web-based, interactive educational tool, this study will contribute essential evidence to the discourse on accessible and scientifically robust digital platforms. Positive findings will underscore the importance of such interventions in fostering preventive health behaviors, thereby supporting community-wide efforts to mitigate the risk of premature births through informed self-management practices. TRIAL REGISTRATION: Korea Disease Control and Prevention Agency (KDCA) KCT0008931; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25857. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58326.

Best Practices and Recommendations for Research Using Virtual Real-Time Data Collection: Protocol for Virtual Data Collection Studies.

BACKGROUND: The COVID-19 pandemic and the subsequent need for social distancing required the immediate pivoting of research modalities. Research that had previously been conducted in person had to pivot to remote data collection. Researchers had to develop data collection protocols that could be conducted remotely with limited or no evidence to guide the process. Therefore, the use of web-based platforms to conduct real-time research visits surged despite the lack of evidence backing these novel approaches. OBJECTIVE: This paper aims to review the remote or virtual research protocols that have been used in the past 10 years, gather existing best practices, and propose recommendations for continuing to use virtual real-time methods when appropriate. METHODS: Articles (n=22) published from 2013 to June 2023 were reviewed and analyzed to understand how researchers conducted virtual research that implemented real-time protocols. "Real-time" was defined as data collection with a participant through a live medium where a participant and research staff could talk to each other back and forth in the moment. We excluded studies for the following reasons: (1) studies that collected participant or patient measures for the sole purpose of engaging in a clinical encounter; (2) studies that solely conducted qualitative interview data collection; (3) studies that conducted virtual data collection such as surveys or self-report measures that had no interaction with research staff; (4) studies that described research interventions but did not involve the collection of data through a web-based platform; (5) studies that were reviews or not original research; (6) studies that described research protocols and did not include actual data collection; and (7) studies that did not collect data in real time, focused on telehealth or telemedicine, and were exclusively intended for medical and not research purposes. RESULTS: Findings from studies conducted both before and during the COVID-19 pandemic suggest that many types of data can be collected virtually in real time. Results and best practice recommendations from the current protocol review will be used in the design and implementation of a substudy to provide more evidence for virtual real-time data collection over the next year. CONCLUSIONS: Our findings suggest that virtual real-time visits are doable across a range of participant populations and can answer a range of research questions. Recommended best practices for virtual real-time data collection include (1) providing adequate equipment for real-time data collection, (2) creating protocols and materials for research staff to facilitate or guide participants through data collection, (3) piloting data collection, (4) iteratively accepting feedback, and (5) providing instructions in multiple forms. The implementation of these best practices and recommendations for future research are further discussed in the paper. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53790.