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Background: The advantages of patient-held portable health files (PHF) and personal health records (PHR), paper or electronic, are said to include improved health-care provider continuity-of-care and patient empowerment in maintaining health. Top-down approaches are favored by public sector government and health managers. Bottom-up approaches include systems developed directly by health-care providers, consumers and industry, implemented locally on devices carried by patient-consumers or shared via web-based portals. These allow individuals to access, manage and share their health information, and that of others for whom they are authorized, in a private, secure and confidential environment. Few medical record technologies have been evaluated in randomized trials to determine whether there are important clinical benefits of these interventions. The COMMUNICATE trial will assess the acceptability and long-term clinical outcomes of an electronic and paper patient-held PHF. Methods/Design: This is a 48-month, open-label pragmatic, superiority, parallel-group design randomized controlled trial. Subjects (n=792) will be randomized in a 1:1:1 ratio to each of the trial arms: the electronic PHF added to usual care, the paper PHF added to usual care and usual care alone (no PHF). Inclusion criteria include those 60 years or older living independently in the community, but who have two or more chronic medical conditions that require prescription medication and regular care by at least three medical practitioners (general and specialist care). The primary objective is whether use of a PHF compared to usual care reduces a combined endpoint of deaths, overnight hospitalizations and blindly adjudicated serious out-of-hospital events. All primary analyses will be undertaken masked to randomized arm allocation using intention-to-treat principles. Secondary outcomes include quality of life and health literacy improvements. Discussion: Lack of blinding creates potential for bias in trial conduct and ascertainment of clinical outcomes. Mechanisms are provided to reduce bias, including balanced study contact with all participants, a blinded adjudication committee determining which out-of-hospital events are serious and endpoints that are objective (overnight hospitalizations and mortality). The PRECIS tool provides a summary of the trial's design on the Pragmatic-Explanatory Continuum. Trial registration: Registered with Clinicaltrials.gov (identifier: NCT01082978) on 8 March 2010. [ABSTRACT FROM AUTHOR]

Background Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed. Methods/design The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (escreening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paperbased form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health escreening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening. Trial registration ClinicalTrials.gov Identifier: NCT01899534 [ABSTRACT FROM AUTHOR]

Background: Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals' quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention ("NeuroNation MED") in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability. Methods: This study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT ("NeuroNation MED") for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed. Discussion: This study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision. Trial registration: German Clinical Trials Register DRKS00025133. Registered on November 5, 2021. [ABSTRACT FROM AUTHOR]

Background: Poor early childhood development (ECD) is a major global health concern that is associated with various adverse outcomes over the lifecourse. Parenting interventions especially during the earliest years of life can benefit ECD. However, there is limited evidence from Kenya about the effectiveness of parenting interventions for improving ECD outcomes especially across rural disadvantaged communities. This paper describes the study protocol for an impact and implementation evaluation of a community-based group parenting program that aims to improve ECD in rural Kenya. Methods: We will conduct a cluster-randomized controlled trial to determine the effectiveness of a parenting program for caregivers of young children in Homabay and Busia counties in Western Kenya. Sixty-four village clusters will be randomly assigned to either the parenting intervention arm or the waitlist control arm with stratification by county. In each village, 10 primary caregivers with a child aged 0–24 months will be enrolled. The parenting program will be delivered through existing peer groups within communities whereby caregivers will receive counseling and psychosocial support to enhance their parenting skills and wellbeing to in turn promote ECD. The intervention curriculum comprises 21 sessions targeting various nurturing care messages, including early learning, responsive caregiving, child nutrition, health, protection, and caregiver mental health. Group sessions are facilitated by a trained volunteer biweekly for a total of 11 months. The primary trial outcome is an overall measure of ECD using the Global Scales of Early Development long form version. Secondary outcomes include various caregiver outcomes (e.g., parenting practices, mental health) and other child outcomes (e.g., socioemotional development, dietary diversity). All outcomes will be assessed at baseline and endline. We will also conduct a qualitative implementation evaluation at endline and interview various stakeholders to assess program fidelity, quality, and sustainability. Discussion: This trial will evaluate the effectiveness of a parenting intervention on ECD and caregiving outcomes and assess program implementation quality as delivered through existing community-based peer groups. This study will provide rigorous evidence that can be used to inform scale-up of this program model that leverages existing community social networks and resources for improving caregivers' parenting skills and promoting ECD in rural Kenya and other similar settings across LMICs. Trial registration: ClinicalTrials.gov #NCT06165315. Registered on December 11, 2023. [ABSTRACT FROM AUTHOR]

Background: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics. Trial registration: Clinicaltrials.gov – NCT05628207. Prospectively registered 11/28/2022, https://classic.clinicaltrials.gov/ct2/show/NCT05628207. [ABSTRACT FROM AUTHOR]

Background: More new randomized controlled trials (RCTs) on acupuncture have been published in Japan since our last updated systematic review (2010). This systematic review aimed to evaluate the quality of RCTs on acupuncture conducted in Japan and understand the decade-wise changes in the methodological characteristics of the relevant RCTs. Methods: The literature search was performed using Ichushi Web, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and our team's compilation of relevant papers. We included full-length papers reporting RCTs that examined the clinical effects of acupuncture on patients in Japan published in or before 2019. We assessed the risk of bias (RoB), sample size, control setting, negative trial reporting, informed consent, ethics approval, trial registration, and adverse event reporting. Results: A total of 99 articles reporting 108 eligible RCTs were identified. The number of RCTs published in each decade was 1, 6, 9, 5, 40, and 47 in the 1960s, 1970s, 1980s, 1990s, 2000s, and 2010s, respectively. Quality assessment using the Cochrane RoB tool revealed that "sequence generation" improved in and after 1990 (73%–80% of RCTs were rated as "low") and "blinding of outcome assessors" slightly improved in and after the 2000s (40%–50% judged as "low"). However, "high" or "unclear" remained the dominant grades in other domains. Clinical trial registration and adverse events were reported only in 9% and 28% of the included RCTs even in the 2010s, respectively. A different acupuncture method or different point selection (e.g., deep vs. shallow insertion) was the most dominant control setting before 1990, while sham (or "placebo") needling and/or sham acupoints became the most dominant in the 2000s. The proportion of RCTs with positive results was 80% in the 2000s and 69% in the 2010s. Conclusions: The quality of RCTs on acupuncture conducted in Japan did not appear to have improved over the decades except for "sequence generation." While the culture of submitting negative trial reports was prevalent in the Japanese acupuncture research milieu as late as the 1990s, the overall quality of the relevant trials needs to be further improved. [ABSTRACT FROM AUTHOR]

Background: Human papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently approved HPV vaccine, Gardasil-9, protects against HPV infection and can prevent HPV-associated invasive cancers. However, Gardasil-9 is one of the most underused vaccines in the US today. Young adults are at risk for HPV infection, but many are not vaccinated. This study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. In this paper, we describe the research protocol. Methods: The study uses a two by three factorial design. A total of 1200 young adults in Texas, age 18–26 years, who have not been previously fully vaccinated against HPV will be randomly assigned to one of six conditions to receive: (1) standard CDC information about HPV vaccination (control); (2) video narratives about HPV vaccination; (3) written narratives about HPV vaccination; or (4–6) enhanced access to HPV vaccine combined with (4) standard CDC information, (5) video narratives, or (6) written narratives. The two primary outcomes are the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-ups. We will determine the impact of the individual level intervention (i.e., persuasive narratives through video or written format), the systemic level intervention (i.e., enhanced access to HPV vaccines), and the combination of both levels, on HPV vaccination initiation and completion. We will also use purposive sampling to select participants to take part in semi-structured interviews/focus groups to better understand the mechanisms of the intervention. Discussion: Recruitment and data collection began in March 2022. We expect to complete data collection by March 2026. We expect that narratives, enhanced access, and the combination of both will improve HPV vaccination initiation and completion rates among young adults. If proven successful, these individual- and system-level interventions can be easily disseminated in regions with low HPV vaccination rates to improve HPV vaccination, and ultimately decrease HPV-related cancer burden. Trial Registration: NCT05057312. [ABSTRACT FROM AUTHOR]

Background: This paper describes the protocols for a randomized controlled trial using a parallel-group trial design that includes an intervention designed to address social isolation and loneliness among people experiencing homelessness known as Miracle Friends and an intervention that combines Miracles Friends with an economic poverty-reduction intervention known as Miracle Money. Miracle Friends pairs an unhoused person with a volunteer "phone buddy." Miracle Money provides guaranteed basic income of $750 per month for 1 year to Miracle Friends participants. The study will examine whether either intervention reduces social isolation or homelessness compared to a waitlist control group. Methods: Unhoused individuals who expressed interest in the Miracle Friends program were randomized to either receive the intervention or be placed on a waitlist for Miracle Friends. Among those randomized to receive the Miracle Friends intervention, randomization also determined whether they would be offered Miracle Money. The possibility of receiving basic income was only disclosed to study participants if they were randomly selected and participated in the Miracle Friends program. All study participants, regardless of assignment, were surveyed every 3 months for 15 months. Results: Of 760 unhoused individuals enrolled in the study, 256 were randomized to receive Miracle Friends, 267 were randomized to receive Miracle Money, and 237 were randomized to the waitlist control group. In the two intervention groups, 360 of 523 unhoused individuals were initially matched to a phone buddy. Of the 191 study participants in the Miracle Money group who had been initially matched to a volunteer phone buddy, 103 were deemed to be participating in the program and began receiving monthly income. Discussion: This randomized controlled trial will determine whether innovative interventions involving volunteer phone support and basic income reduce social isolation and improve housing outcomes for people experiencing homelessness. Although we enrolled unhoused individuals who initially expressed interest in the Miracle Friends program, the study team could not reach approximately 30% of individuals referred to the study. This may reflect the general lack of stability in the lives of people who are unhoused or limitations in the appeal of such a program to some portion of the unhoused population. Trial registration: ClinicalTrials.gov NCT05408884 (first submitted on May 26, 2022). [ABSTRACT FROM AUTHOR]

Background: Caring for a loved one with Alzheimer’s disease can be stressful, resulting in poorer emotional and physical health among family caregivers. Although supportive resources for caregivers are available, distance, caregiver health, and the daily demands of caregiving are barriers to access. Based on research demonstrating the importance of positive emotions in coping with stress, our previous trial showed that dementia caregivers who participated in facilitated, web-based delivery of a positive emotion regulation intervention called LEAF (Life Enhancing Activities for Family caregivers) experienced increased positive emotion and decreased depression and anxiety. Building on this evidence, the LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer’s disease. Methods: This paper presents the design and methods for LEAF 2.0, a 3-arm web-based randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer’s disease (AD) are randomized to (1) the LEAF intervention facilitated remotely via the web (N = 200), (2) the LEAF intervention self-guided online (N = 200), or (3) an emotion reporting control (N = 100), which then crosses over to the intervention after approximately 6 months, half to the facilitated arm and half to the self-guided arm. We aim to (1) compare the effect of the facilitated and self-guided LEAF positive emotion interventions to an emotion reporting control condition on AD caregiver well-being (positive emotion, depression, anxiety, and perceived stress) and secondary outcomes (caregiving burden, caregiving self-efficacy, positive aspects of caregiving, quality of care, and AD patient quality of life); (2) assess whether effects are mediated by improvements in positive emotion or other aspects of caregiver well-being; and (3) test whether caregiver age or gender or the care recipient’s dementia severity moderates the effects of the intervention. Discussion: If demonstrated to be effective, LEAF can be widely disseminated and ultimately have a significant impact on the stress experienced by AD caregivers and the well-being of people living with Alzheimer’s disease. Trial Registration: ClinicalTrials.gov NCT03610698. [ABSTRACT FROM AUTHOR]

Background: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. This protocol paper describes a two-arm, multi-center, randomized controlled trial on the short- and longer-term effectiveness and cost-effectiveness of a brief, individually tailored behavioral parent training program for children with behavioral difficulties. Methods: Parents of children aged 2–12 years referred to a child mental healthcare center are randomized to (i) three sessions of behavioral parent training with optional booster sessions or (ii) care as usual. To evaluate effectiveness, our primary outcome is the mean severity of five daily ratings by parents of four selected behavioral difficulties. Secondary outcomes include measures of parent and child behavior, well-being, and parent–child interaction. We explore whether child and parent characteristics moderate intervention effects. To evaluate cost-effectiveness, the use and costs of mental healthcare and utilities are measured. Finally, parents' and therapists' satisfaction with the brief program are explored. Measurements take place at baseline (T0), one week after the brief parent training, or eight weeks after baseline (in case of care as usual) (T1), and six months (T2) and twelve months (T3) after T1. Discussion: The results of this trial could have meaningful societal implications for children with behavioral difficulties and their parents. If we find the brief behavioral parent training to be more (cost-)effective than care as usual, it could be used in clinical practice to make parent training more accessible. Trial registration: The trial is prospectively registered at ClinicalTrials.gov (NCT05591820) on October 24th, 2022 and updated throughout the trial. [ABSTRACT FROM AUTHOR]

Background: The results of germline genetic testing for hereditary cancer are of importance not only to the patients under investigation but also to their genetic at-risk relatives. Standard care is to encourage the proband (first family member under investigation) to pass on this risk information to the relatives. Previous research suggests that with family-mediated disclosure, only about a third of at-risk relatives contact health care to receive genetic counselling. In some studies, complementing family-mediated risk disclosure with healthcare-assisted risk disclosure almost doubles the uptake of genetic counselling in at-risk relatives. In this study, we evaluate healthcare-assisted direct letters to relatives at risk of hereditary cancer syndromes in a randomized controlled trial. Methods: Probands are recruited from Swedish outpatient cancer genetics clinics to this two-arm randomized controlled trial. The study recruits probands with either a pathogenic variant in a cancer susceptibility gene (BRCA1, BRCA2, PALB2, MLH1, MSH2, MSH6, PMS2) or probands with familial breast and colorectal cancer based on clinical and pedigree criteria. In both arms, probands receive standard care, i.e., are encouraged and supported to pass on information to relatives. In the intervention arm, the proband is also offered to have direct letters sent to the at-risk relatives. The primary outcome measure is the proportion of at-risk relatives contacting a Swedish cancer genetics clinic within 12 months of the proband receiving the test results. Discussion: This paper describes the protocol of a randomized controlled clinical trial evaluating a healthcare-assisted approach to risk disclosure by offering the probands to send direct letters to their at-risk relatives. The results of this study should be informative in the future development of risk disclosure practices in cancer genetics clinics. Trial registration: ClinicalTrials.gov. Identifier NCT04197856 (pre-trial registration on December 13, 2019). Also registered at the website "RCC Cancerstudier i Sverige" as study #86719. [ABSTRACT FROM AUTHOR]

Background: Sexual violence (SV) is a significant, global public health problem, particularly among young adults. Promising interventions exist, including prosocial bystander intervention programs that train bystanders to intervene in situations at-risk for SV. However, these programs suffer from critical weaknesses: (1) they do not address the proximal effect of alcohol use on bystander decision-making and (2) they rely on self-report measures to evaluate outcomes. To overcome these limitations, we integrate new content specific to alcohol use within the context of prosocial bystander intervention into an existing, evidence-based program, RealConsent1.0. The resulting program, RealConsent2.0, aims to facilitate bystander behavior among sober and intoxicated bystanders and uses a virtual reality (VR) environment to assess bystander behavior in the context of acute alcohol use. Methods: This protocol paper presents the design of a randomized controlled trial (RCT) in which we evaluate RealConsent2.0 for efficacy in increasing alcohol- and non-alcohol-involved bystander behavior compared to RealConsent1.0 or to an attention-control program ("Taking Charge"). The RCT is being implemented in Atlanta, GA, and Lincoln, NE. Participants will be 605, healthy men aged 21–25 years recruited through social media, community-based flyers, and university email lists. Eligible participants who provide informed consent and complete the baseline survey, which includes self-reported bystander behavior, are then randomized to one of six conditions: RealConsent2.0/alcohol, RealConsent2.0/placebo, RealConsent1.0/alcohol, RealConsent1.0/placebo, Taking Charge/alcohol, or Taking Charge/placebo. After completing their assigned program, participants complete a laboratory session in which they consume an alcohol (target BrAC:.08%) or placebo beverage and then engage in the Bystanders in Sexual Assault Virtual Environments (BSAVE), a virtual house party comprising situations in which participants have opportunities to intervene. Self-reported bystander behavior across alcohol and non-alcohol contexts is also assessed at 6- and 12-months post-intervention. Secondary outcomes include attitudes toward, outcome expectancies for, and self-efficacy for bystander behavior via self-report. Discussion: RealConsent2.0 is the first web-based intervention for young men that encourages and teaches skills to engage in prosocial bystander behavior to prevent SV while intoxicated. This is also the first study to assess the proximal effect of alcohol on bystander behavior via a VR environment. Trial registration: Clinicaltrials.gov, NCT04912492. Registered on 05 February 2021 [ABSTRACT FROM AUTHOR]

While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of behavioral influences during recruitment is in tension with the ethical principle of respect for persons, as at least some of these influences could be used to manipulate potential participants. In this paper, we examine this tension by discussing two types of behavioral influences: one example involves physician recommendations, and the other involves framing of information to exploit cognitive biases. We argue that despite the apparent tension with ethical principles, influencing trial participants through behavior change strategies can be ethically acceptable. However, we argue that trialists have a positive obligation to analyze their recruitment strategies for behavioral influences and disclose these upfront to the research ethics committee. But we also acknowledge that since neither trialists nor ethics committees are presently well equipped to perform these analyses, additional resources and guidance are needed. We close by outlining a path toward the development of such guidance. [ABSTRACT FROM AUTHOR]

Background: Electroencephalography (EEG)-based brain-computer interfaces (BCIs) allow to modulate the sensorimotor rhythms and are emerging technologies for promoting post-stroke motor function recovery. The Promotoer study aims to assess the short and long-term efficacy of the Promotoer system, an EEG-based BCI assisting motor imagery (MI) practice, in enhancing post-stroke functional hand motor recovery. This paper details the statistical analysis plan of the Promotoer study. Methods: The Promotoer study is a randomized, controlled, assessor-blinded, single-centre, superiority trial, with two parallel groups and a 1:1 allocation ratio. Subacute stroke patients are randomized to EEG-based BCI-assisted MI training or to MI training alone (i.e. no BCI). An internal pilot study for sample size re-assessment is planned. The primary outcome is the effectiveness of the Upper Extremity Fugl-Meyer Assessment (UE-FMA) score. Secondary outcomes include clinical, functional, and user experience scores assessed at the end of intervention and at follow-up. Neurophysiological assessments are also planned. Effectiveness formulas have been specified, and intention-to-treat and per-protocol populations have been defined. Statistical methods for comparisons of groups and for development of a predictive score of significant improvement are described. Explorative subgroup analyses and methodology to handle missing data are considered. Discussion: The Promotoer study will provide robust evidence for the short/long-term efficacy of the Promotoer system in subacute stroke patients undergoing a rehabilitation program. Moreover, the development of a predictive score of response will allow transferring of the Promotoer system to optimal clinical practice. By carefully describing the statistical principles and procedures, the statistical analysis plan provides transparency in the analysis of data. Trial registration: ClinicalTrials.gov NCT04353297. Registered on April 15, 2020. [ABSTRACT FROM AUTHOR]

Background: Vibration therapy (VT), a treatment of musculoskeletal disorders, has been developed for clinical applications in the past decade. However, its effect on relieving chronic low back pain (CLBP) and improving lumbar function is still illusive, lacking sufficient evidence-based medical data. Objective: This systematic review aimed to evaluate the efficacy of vibration therapy on pain and function in people with CLBP. Methods: PubMed, Cochrane Library, Web of Science, Embase, CNKI, Wanfang Date, VIP, and CBM were applied to search for clinical randomized controlled trials (RCTs) on vibration therapy for people with CLBP. The electronic databases were searched from the establishment of the database until July 1, 2023. Two researchers assessed the quality of the included studies and extracted data. The outcome indicators included the pain intensity index, Oswestry dysfunction index (ODI) score, and Roland–Morris dysfunction questionnaire (RMDQ) score. GRADE was used to evaluate the certainty of evidence of each outcome indicator. The meta-analysis was conducted using RevMan 5.3 software. Results: Fourteen papers met the inclusion criteria with 860 subjects (VT group n = 432 and control group n = 428). VT for patients with CLBP reduced the pain intensity index [SMD = − 0.71, 95% CI (− 1.02, − 0.39), I2 = 76%, P < 0.0001], the ODI score value [MD = − 4.24, 95% CI (− 8.10, − 0.38), I2 = 88%, P = 0.03], and the RMDQ score value [MD = − 2.21, 95% CI (− 3.41, − 1.01), I2 = 0%, P = 0.0003]. Subgroup analysis displayed that the pain intensity index was lower in the whole-body vibration (WBV) group than in the control group [SMD = − 0.49, 95% CI (− 0.79, − 0.19), I2 = 58%, P = 0.001] and the local vibration (LV) group [SMD = − 1.07, 95% CI (− 1.60, − 0.53), I2 = 76%, P < 0.0001]. The ODI scores in the WBV group were lower than those in the control group [MD = − 3.30, 95% CI (− 5.76, − 0.83), I2 = 36%, P = 0.009]. There was no statistically significant difference in ODI scores between the LV group and the control group [MD = − 5.78, 95% CI (− 16.23, 4.66), I2 = 97%, P = 0.28]. Conclusion: The data from this study suggest that VT can reduce pain and improve lumbar function in patients with CLBP. However, we still need to carefully interpret the results of this study, as the certainty of evidence was low, and the clinical relevance of the results is questionable. Further RCTs are needed in the future to ascertain this. [ABSTRACT FROM AUTHOR]

Background: Mobile Health ("mHealth") interventions have shown promise in improving HIV treatment outcomes for stigmatized populations. This paper presents the findings from a randomized controlled trial to assess the efficacy, participant-level feasibility and acceptability of a theory-informed mHealth intervention, Motivation Matters!, designed to improve viral suppression and ART adherence among HIV-seropositive women who engage in sex work in Mombasa, Kenya. Methods: A total of 119 women were randomized between the intervention and standard of care control. The primary outcome examined viral suppression (≤ 30 copies/mL) six months following ART initiation. ART adherence was assessed monthly using a visual analogue scale. Participant-level feasibility was measured through response rates to study text messages. Acceptability was assessed through qualitative exit interviews. Results: Six months following treatment initiation, 69% of intervention and 63% of control participants were virally suppressed (Risk Ratio [RR] = 1.09, 95% Confidence Interval [95% CI] (0.83, 1.44). Among women who were viremic at baseline and endorsed engagement in sex work, 74% of women in the intervention arm compared with 46% of women in the control arm achieved viral suppression at month six RR = 1.61, 95% CI (1.02, 2.55). Adherence was higher in intervention versus control participants every month. All participants responded to at least one message, and there was a 55% overall response rate to intervention text messages. Qualitative exit interviews suggested high acceptability and perceived impact of the intervention. Conclusion: The improvements in ART adherence and viral suppression, combined with encouraging data on feasibility and acceptability, provides preliminary evidence that Motivation Matters! could support ART adherence and viral suppression in women who engage in sex work. Trial registration: This trial was registered with ClinicalTrials.gov (NCT02627365, 10/12/2015; http://clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background: Platelet-rich plasma (PRP) contains various growth factors and inflammatory regulators, which can effectively reduce inflammation in joints and promote tissue repair. Multiple studies have proved its effectiveness in the treatment of knee osteoarthritis (KOA). Low-intensity focused ultrasound (LIFU) and transcutaneous electrical nerve stimulation (TENS) are non-invasive and safe physical therapy methods for KOA. This study is the first to propose the treatment of KOA with physical stimulation after PRP treatment, and to observe the clinical efficacy of the treatment method. Methods: This is a protocol paper that outlines a randomized controlled trial, patients will be assigned randomly to the PRP group, PRP+LIFU group, PRP+TENS group, and PRP+LIFU combined TENS group. The patients will be followed at 12-week and 24-week time points to evaluate the primary and secondary outcomes of the study. The primary outcome is the VAS pain score. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and International Knee Documentation Committee scores (IKDC). After baseline examination, all patients will sign a written informed consent for study participation after a full explanation of the treatment protocol. We have planned a total of 120 patients (30 patients per group). Discussion: The objective of this clinical trial is to evaluate the effect of different physical stimulation after PRP treatment for KOA. The data will be published after the completion of the study. Trial registration: This study has been registered with the Chinese Clinical Trials Registry. Registration number: ChiCTR2200065119 (registered date: 10/28/2022). [ABSTRACT FROM AUTHOR]

Background: The majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application for patients to self-record pain and nausea when at home after day care surgery might improve patient's recovery. Currently patient experiences with smartphone applications are promising; however, we do not know whether remote monitoring with such an application also improves the patient's recovery. This study aims to evaluate the experienced quality of recovery after day care surgery between patients provided with the smartphone application for remote monitoring and patients receiving standard care without remote monitoring. Methods: This non-blinded randomized controlled trial with mixed methods design will include 310 adult patients scheduled for day care surgery. The intervention group receives the smartphone application with text message function for remote monitoring that enables patients to record pain and nausea. An anaesthesia professional trained in empathetic communication, who will contact the patient in case of severe pain or nausea, performs daily monitoring. The control group receives standard care, with post-discharge verbal and paper instructions. The main study endpoint is the difference in perceived quality of recovery, measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are the overall score on the Quality of Recovery-15 at day 1, 4 and 7-post discharge, the perceived quality of hospital aftercare and experienced psychological effects of remote monitoring during postoperative recovery from day care surgery. Discussion: This study will investigate if facilitating patients and healthcare professionals with a tool for accessible and empathetic communication might lead to an improved quality of the postoperative recovery period. Trial registration: The 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial' is approved and registered on 23 February 2022 by Research Ethics Committees United with registration number R21.076/NL78144.100.21. The protocol NL78144.100.21, 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial', is registered at the ClinicalTrials.gov public website (registration date 16 February 2022; NCT05244772) [ABSTRACT FROM AUTHOR]

Background: The disease burden of musculoskeletal disorders necessitates multidisciplinary and patient-centered models of care. Exercise therapy represents a first-line treatment strategy and a central component of medical rehabilitation. In order to realize the goals of long-term physical activity and participation as proposed by the ICF, exercise therapy can be supplemented by interventional techniques from the field of psychotherapy. Although psychotherapist feedback has been shown to improve therapeutic outcome and patient satisfaction, feedback use in exercise therapy is mostly limited to motor learning and exercise instruction. The present paper therefore describes the use of multidimensional exercise therapy feedback in medical rehabilitation. The aims of the trial presented in this study protocol are to evaluate the effects of this novel feedback approach on rehabilitation outcomes in comparison to usual care. Methods: The study is designed as a prospective, mono-centric, randomized controlled, superiority trial (RCT) with two parallel groups and three measuring points: T0 = start of three-week inpatient rehabilitation, T1 = end of three-week inpatient rehabilitation, T2 = 12-week follow-up. In total, 132 patients suffering from chronic neck, shoulder and/or lumbar spine disorders will be recruited. The intervention involves multidimensional exercise therapy feedbacks during the initial and final physical therapist examination, as well as short exercise therapy feedbacks during the course units of the mandatory group-based exercise therapy program. Primary outcomes are the subjective treatment outcome, assessed by BPI and indication-specific questionnaires, as well as patient satisfaction, assessed by ZUF-8 and an intervention-specific questionnaire. The final data collection is expected by May 2023. Discussion: This study may provide a valuable insight into the effectiveness of multidimensional exercise therapy feedback to improve treatment outcomes and patient satisfaction in medical rehabilitation. This could contribute to rehabilitation quality assurance and the long-term physical activity behavior of rehabilitation patients. Trial registration The trial has been registered with the German Clinical Trial Register (DRKS) under the Registration Number DRKS00027263. [ABSTRACT FROM AUTHOR]

Background: The purpose of the present study was to systematically delve into the efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) on the quality of recovery after general anesthesia. Methods: Randomized controlled trials related to TEAS improving postoperative recovery quality were searched in Cochrane Library, Web of Science, Embase, PubMed, CNKI, VIP, Wanfang and Chinese biomedical database from the inception of each database to June 2023. After literature screening and data extraction, Stata15 software was employed for meta-analysis, and the quality of the included literature was evaluated utilizing ROB2. Results: The study included 10 articles involving 2,383 patients in total. The meta-analysis results unveiled that TEAS could improve 24-hour and 48-hour postoperative QoR-40 scores as well as 24-hour postoperative QoR-40 dimension scores [WMD = 8.52, 95%CI (5.12, 11.91), P < 0.001; WMD = 1.99, 95%CI (0.91, 3.07), P < 0.001], emotional state [WMD = 1.38, 95%CI (0.66, 2.09), P < 0.001], physical comfort [WMD = 2.99, 95%CI (1.59, 4.39), P < 0.001], psychological support [WMD = 0.63, 95%CI (0.36, 0.90), P < 0.001], and physical independence [WMD = 0.76, 95%CI (0.22, 1.30), P = 0.006]; pain [WMD = 1.81, 95%CI (0.87, 2.75), P < 0.001]; decrease 24-hour postoperative VAS pain scores [WMD = -0.84, 95%CI (-1.45, -0.23), P = 0.007] and the incidence of postoperative nausea and vomiting [RR = 0.88, 95%CI (0.81, 0.97), P = 0.006; RR = 0.62, 95%CI (0.52, 0.73), P < 0.001]. Conclusion: TEAS can improve postoperative QoR-40 scores and the quality of recovery, relieve pain, and decrease the incidence of nausea and vomiting after surgery in patients who underwent general anesthesia. Trial registration: CRD42023433959. [ABSTRACT FROM AUTHOR]

Background: The Harambee study is a cluster randomized trial in Western Kenya that tests the effect, mechanisms, and cost-effectiveness of integrating community-based HIV and non-communicable disease care within microfinance groups on chronic disease treatment outcomes. This paper documents the stages of our feasibility study conducted in preparation for the Harambee trial, which include (1) characterizing the target population and gauging recruitment capacity, (2) determining community acceptability of the integrated intervention and study procedures, and (3) identifying key implementation considerations prior to study start. Methods: Feasibility research took place between November 2019 and February 2020 in Western Kenya. Mixed methods data collection included surveys administered to 115 leaders of 105 community-based microfinance groups, 7 in-person meetings and two workshops with stakeholders from multiple sectors of the health system, and ascertainment of field notes and geographic coordinates for group meeting locations and HIV healthcare facilities. Quantitative survey data were analyzed using STATA IC/13. Longitude and latitude coordinates were mapped to county boundaries using Esri ArcMap. Qualitative data obtained from stakeholder meetings and field notes were analyzed thematically. Results: Of the 105 surveyed microfinance groups, 77 met eligibility criteria. Eligible groups had been in existence from 6 months to 18 years and had an average of 22 members. The majority (64%) of groups had at least one member who owned a smartphone. The definition of "active" membership and model of saving and lending differed across groups. Stakeholders perceived the community-based intervention and trial procedures to be acceptable given the minimal risks to participants and the potential to improve HIV treatment outcomes while facilitating care integration. Potential challenges identified by stakeholders included possible conflicts between the trial and existing community-based interventions, fear of group disintegration prior to trial end, clinicians' inability to draw blood for viral load testing in the community, and deviations from standard care protocols. Conclusions: This study revealed that it was feasible to recruit the number of microfinance groups necessary to ensure that our clinical trial was sufficient powered. Elicitation of stakeholder feedback confirmed that the planned intervention was largely acceptable and was critical to identifying challenges prior to implementation. Trial registration: The original trial was prospectively registered with ClinicalTrials.gov (NCT04417127) on 4 June 2020. [ABSTRACT FROM AUTHOR]

Background: Surgical site infection (SSI), as one of the most common hospital-acquired infection, is usually associated with increased morbidity, mortality, and health care burden. SSI is a significant perioperative complication after colon cancer surgery, particularly for left-sided colon cancer. This paper describes the background and design of the "Surgical Site Infection after intracorporeal anastomosis for Left-sided Colon Cancer: study protocol for a non-inferiority multicenter Randomized Controlled Trial (STARS)." The STARS trial aims to compare the incidence of SSI after intracorporeal anastomosis and extracorporeal anastomosis after radical resection of colon cancer and to explore the risk factors of SSI.Methods: A total of 354 left colon cancer patients from 8 hospitals in China will be enrolled in this multi-center randomized controlled study. The primary outcome of this study is the incidence of SSI 30 days after left-sided colon cancer surgery. Secondary outcome measures include operation time, blood loss, conversion rate, incidence of perioperative complications, completeness of resection, number of lymph nodes collected and postoperative recovery characteristics, 3-year disease-free survival, and 5-year overall survival. The first patient was enrolled in January 2021.Discussion: To our knowledge, this is the first prospective multicenter study to investigate whether there is a difference in the SSI incidence after intracorporeal and extracorporeal anastomosis for left-sided colon cancer in China. The results may provide more evidence that supports performing total laparoscopic left-sided colon cancer surgery.Trial Registration: The trial has been registered on ClinicalTrials.gov website (ID: NCT04201717). Registered on September 22, 2020. [ABSTRACT FROM AUTHOR]

Background: Infection is one of the most common causes of death in patients with hematological malignancies during chemotherapy. Due to its special location, local warmth and humidity, repeated pollution with stool and urine, and characteristically wrinkled anatomical structure within which bacteria can hide, the perianal becomes a site with a high incidence of infection. Such infection also has a high recurrence rate and high mortality, increasing the economic burden of patients, delaying the time of treatment and reducing the quality of life. In severe cases, sepsis occurs and endangers the patient's life. Previous studies have confirmed the effectiveness of povidone iodine (PI) in the prevention of perianal infection in patients with hematological malignancies during chemotherapy, but these reports have not documented in detail the adverse events associated with sitz bathing and the lack of randomized controlled trials of different concentrations of dilute povidone iodine sitz bathing. Therefore, the evidence is insufficient. Hence, the objective of this paper is to determine whether a povidone iodine diluent sitz bath can reduce the incidence of perianal infection compared with conventional perianal cleaning care and to observe the incidence of perianal infection, the severity of perianal infection, and the complications related to the sitz bath among groups treated with different concentrations of povidone iodine diluent, especially in high-risk patients prone to perianal infection, to screen for the optimal concentration.Methods: The trial is designed as a single-center, parallel, randomized, controlled and intervention trial with four parallel groups, and a primary endpoint of perianal infection occurred after this hospitalization chemotherapy. Randomization will be performed as simple randomization with a 1:1:1:1 allocation. This study received full ethics committee approval. The first patient was enrolled on May 1, 2021. A total of 268 patients with hematological malignancies undergoing chemotherapy who have risk factors for perianal infection will be enrolled with informed consent and randomly allocated to one of the four arms receiving (1) perianal cleaning care (control group D), (2) 1:100 PI diluted sitz bath (intervention group A), (3) 1:200 PI diluted sitz bath (intervention group B), and (4) 1:300 PI diluted sitz bath (intervention group C). The primary endpoint of the trial was the incidence of perianal infection. The secondary endpoints of the study will be the results of anal swab bacterial culture, the severity of perianal infection, the incidence of perianal adverse events (dryness, peeling, pigmentation, burning sensation), and pain scores. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment.Discussion: We hypothesized that patients with hematological malignancies during chemotherapy would benefit from a povidone iodine diluted sitz bath. This study will provide evidence-based recommendations for clinicians and nurses.Trial Registration: Chinese Clinical Trial Registry (registration ID: ChiCTR2000041073). Registered on December 17, 2020. The protocol version number is V1.0,20201217. http://www.chictr.org.cn/edit.aspx?pid=66044&htm=4. [ABSTRACT FROM AUTHOR]

Background: Arterial stiffness and calcification propensity are associated with high cardiovascular risk and increased mortality in chronic kidney disease (CKD). Both magnesium and phosphate are recognized as modulators of vascular calcification and chronic inflammation, both features of CKD that contribute to arterial stiffness. In this paper, we outline the rationale and design of a randomized controlled trial (RCT) investigating whether 24 weeks of oral magnesium supplementation with or without additional phosphate-binding therapy can improve arterial stiffness and calcification propensity in patients with stage 3-4 CKD.Methods: In this multi-center, placebo-controlled RCT, a total of 180 participants with an estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m2 without phosphate binder therapy will be recruited. During the 24 weeks intervention, participants will be randomized to one of four intervention groups to receive either magnesium citrate (350 mg elemental magnesium/day) or placebo, with or without the addition of the phosphate binder sucroferric oxyhydroxide (1000 mg/day). Primary outcome of the study is the change of arterial stiffness measured by the carotid-femoral pulse wave velocity over 24 weeks. Secondary outcomes include markers of calcification and inflammation, among others calcification propensity (T50) and high-sensitivity C-reactive protein. As explorative endpoints, repeated 18F-FDG and 18F-NaF PET-scans will be performed in a subset of participants (n = 40). Measurements of primary and secondary endpoints are performed at baseline, 12 and 24 weeks.Discussion: The combined intervention of magnesium citrate supplementation and phosphate-lowering therapy with sucroferric oxyhydroxide, in stage 3-4 CKD patients without overt hyperphosphatemia, aims to modulate the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness and to establish to what extent this is mediated by T50 changes. The results of this combined intervention may contribute to future early interventions for CKD patients to reduce the risk of CVD and mortality.Trial Registration: Netherlands Trial Register, NL8252 (registered December 2019), EU clinical Trial Register 2019-001306-23 (registered November 2019). [ABSTRACT FROM AUTHOR]

Background: There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.Methods: The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.Discussion: This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.Trial Registration: ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020. [ABSTRACT FROM AUTHOR]

Background: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings.Methods/design: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes.Discussion: This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery.Trial Registration: ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020. [ABSTRACT FROM AUTHOR]

Background: In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Common Elements Treatment Approach (CETA) is an evidence-based, flexible, transdiagnostic intervention delivered by lay counselors to address comorbid mental and behavioral health conditions, though its effectiveness has not yet been tested among AYA. This paper describes the protocol for a randomized controlled trial that will test the effectiveness of traditional in-person delivered CETA and a telehealth-adapted version of CETA (T-CETA) in reducing mental and behavioral health problems among AYA in Zambia. Non-inferiority of T-CETA will also be assessed.Methods: This study is a hybrid type 1 three-arm randomized trial to be conducted in Lusaka, Zambia. Following an apprenticeship model, experienced non-professional counselors in Zambia will be trained as CETA trainers using a remote, technology-delivered training method. The new CETA trainers will subsequently facilitate technology-delivered trainings for a new cohort of counselors recruited from community-based partner organizations throughout Lusaka. AYA with mental and behavioral health problems seeking services at these same organizations will then be identified and randomized to (1) in-person CETA delivery, (2) telehealth-delivered CETA (T-CETA), or (3) treatment as usual (TAU). In the superiority design, CETA and T-CETA will be compared to TAU, and using a non-inferiority design, T-CETA will be compared to CETA, which is already evidence-based in other populations. At baseline, post-treatment (approximately 3-4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline), we will assess the primary outcomes such as client trauma symptoms, internalizing symptoms, and externalizing behaviors and secondary outcomes such as client substance use, aggression, violence, and health utility. CETA trainer and counselor competency and cost-effectiveness will also be measured as secondary outcomes. Mixed methods interviews will be conducted with trainers, counselors, and AYA participants to explore the feasibility, acceptability, and sustainability of technology-delivered training and T-CETA provision in the Zambian context.Discussion: Adolescents and young adults in LMIC are a priority population for the treatment of mental and behavioral health problems. Technology-delivered approaches to training and intervention delivery can expand the reach of evidence-based interventions. If found effective, CETA and T-CETA would help address a major barrier to the scale-up and sustainability of mental and behavioral treatments among AYA in LMIC.Trial Registration: ClinicalTrials.gov NCT03458039 . Prospectively registered on May 10, 2021. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) survivors are at increased risk of developing the disease again. Surveillance guidelines are aimed at maximising the early detection of recurring or new cancers and pre-cancerous polyps. The frequency and type of surveillance recommended depends on the type of treatment for the initial CRC, the extent of colonoscopic investigation prior to treatment and the results of previous surveillance tests. This paper aimed to test the effect of a paper-based educational intervention to improve adherence to colonoscopy following treatment for colorectal cancer.Methods: People with a diagnosis of colorectal cancer within the last 10 months, aged ≥18 and English speaking were recruited through a population-based cancer registry in Australia. Participants were randomly allocated to either the intervention or control. Participants completed an interview at baseline. Self-reported participation in colonoscopy was obtained at 12 month followup by survey. Those allocated to the control received a generic pamphlet on colorectal cancer treatment; while intervention participants received a letter which provided specific information about guideline recommendations for surveillance colonoscopy. Rates of guideline adherence were compared between groups. The guideline recommendations for the timing of surveillance colonoscopy changed part way through the study. This change occurred after all intervention materials had been sent, but prior to all participants completing the 12 month follow up. Post hoc analyses were conducted to assess adherence to the new guidelines.Results: Of the 767 participants, 604 (79%) had had surgery, had stage I - III disease and completed the baseline interview within 12 months of diagnosis (intervention = 305; control = 299). There was no significant difference between those adherent to surveillance colonoscopy guidelines, in the control (67, 27%) and intervention groups (80, 31%) at followup (difference = 4.3% (95%CI:-3.7%, 12%), χ 2(1df) = 1.09, P = 0.296). Overall, 246 (49%) participants were adherent to the new guidelines, compared to 147 (29%) adherent to the old guidelines.Conclusions: Results indicate the paper-based educational intervention is not effective in improving adherence to colorectal cancer surveillance guidelines for colonoscopy.Trial Registration Number: ACTRN12609000628246 Registration date: 28/07/2009. [ABSTRACT FROM AUTHOR]

Background: Though Internet- and mobile-based interventions (IMIs) and mindfulness-based interventions (generally delivered in-situ) appear effective for people with substance use disorders, IMIs incorporating mindfulness are largely missing, including those targeting frequent cannabis use. Methods: This paper details the protocol for a three-arm randomized controlled trial comparing a mindfulness-based self-help IMI (arm 1) and cognitive-behavioral therapy (CBT)-based self-help IMI (arm 2) versus being on a waiting list (arm 3) in their effectiveness reducing cannabis use in frequent cannabis users. Predictors of retention, adherence and treatment outcomes will be identified and similarities between the two active intervention arms explored. Both active interventions last six weeks and consist of eight modules designed to reduce cannabis use and common mental health symptoms. With a targeted sample size of n = 210 per treatment arm, data will be collected at baseline immediately before program use is initiated; at six weeks, immediately after program completion; and at three and six months post baseline assessment to assess the retention of any gains achieved during treatment. The primary outcome will be number of days of cannabis use over the preceding 30 days. Secondary outcomes will include further measures of cannabis use and use of other substances, changes in mental health symptoms and mindfulness, client satisfaction, intervention retention and adherence, and adverse effects. Data analysis will follow ITT principles and primarily employ (generalized) linear mixed models. Discussion: This RCT will provide important insights into the effectiveness of an IMI integrating mindfulness to reduce cannabis use in frequent cannabis users. Trial registration: International Standard Randomized Controlled Trial Number Registry: ISRCTN14971662; date of registration: 09/09/2021. [ABSTRACT FROM AUTHOR]

Background: People with post-stroke aphasia commonly receive speech-language therapy (SLT) when they are admitted to hospitals. Commonly, these patients reported communication difficulties in in-patient settings. Augmentative and alternative communication (AAC) has been reported as an effective treatment approach to improve communication effectiveness, language performance, decreasing depression, and improving quality of life for this population. However, little evidence has demonstrated the use of AAC intervention (AACT) in early recovery from people with post-stroke aphasia in in-patient rehabilitation settings for improving these patients' communication effectiveness. The pilot randomized controlled trial (RCT) will explore the effectiveness and feasibility of including AACT in regular SLT for in-patient people with post-stroke aphasia.Method: This pilot RCT is a single-blind, randomized controlled trial with two parallel groups. Both groups receive a 1-h treatment session, including either both AACT and SLT or SLT only for ten consecutive days. We aim to include 22 in-patient participants with post-stroke aphasia in each group. Participants will be assessed at pre- and post-intervention and 2 weeks after intervention. The primary outcomes are the ability of communication measured by the communication of basic needs subtest in the Functional Assessment of Communication Skills for Adult (FACS) and the overall language performance measured by the Chinese Standard Aphasia Battery (ABC). The secondary outcomes include a 10-min conversation, the 10-item Hospital version of the Stroke Aphasic Depression Questionnaire (SADQH-10), the Stroke-Specific Quality of Life Scale (SS-QOL), and a patient and caregiver satisfaction questionnaire.Discussion: This pilot RCT will contribute to new scientific evidence to the field of aphasia rehabilitation in early recovery during the in-patient period. The paper describes the trial, which will explore the effect of combining AACT and SLT and SLT only, our choice of primary and secondary outcome measures, and proposed analyses. The study results will provide information for implementing AACT in the regular in-patient SLT of future RCTs.Trial Registration: Chinese Clinical Trial Registry database (ChiCTR) ChiCTR2000028870 . Registered on 5 January 2020. [ABSTRACT FROM AUTHOR]

Background: Unmet need for family planning and unintended pregnancies are high in developing countries. Home pregnancy tests help women determine their pregnancy status earlier and the confirmation of a negative pregnancy status can facilitate the adoption of family planning. This study provides the first experimental evidence of the effect of access to pregnancy tests on women's demand for modern family planning. Methods: A randomized controlled trial was conducted among 810 women of reproductive age in northern Uganda. During a baseline survey, women were randomly allocated to either: (1) an offer to take a hCG urine pregnancy test during the survey (on-the-spot pregnancy test) (N = 170), (2) an offer of a home pregnancy test kit to be used at any time in the future (future-use pregnancy test) (N = 163), (3) offers of both on-the-spot and future-use pregnancy tests (N = 153), or (4) a control group (N = 324). Future-use pregnancy tests were offered either for free, or randomly assigned prices. Approximately 4 weeks after the baseline survey, a follow-up survey was conducted; modern contraception methods were made available at no charge at local community outreach centers. Results: When offered a free, on-the-spot pregnancy test, 62 percent of women accepted (N = 200). Almost all, 97 percent (N = 69), of women offered a free future-use pregnancy test strip, accepted it. Purchases of future-use pregnancy tests declined with price. The offer of either on-the-spot, future-use tests, or both, have no overall large or statistically significant effects on the take-up of modern family planning. Conclusion: Demand for pregnancy tests is high and access to pregnancy tests has the potential to facilitate the demand for family planning. At the same time, more research is needed to understand underlying beliefs about pregnancy status and risk that guide behaviors ultimately important for maternal and neonatal health. Trial registration The study was pre-registered in July 2018 for AEA RCT registry (AEARCTR-0003187) and clinicaltrials.gov (NCT03975933). Registered 05 June 2019, https://clinicaltrials.gov/ct2/show/record/NCT03975933 Plain Language Summary: Women in developing countries, especially in Africa, have high-unmet needs for family planning as well as high-unintended rates of pregnancy. At the same time, they may learn their pregnancy status later than women in higher-income countries due to irregular menstrual periods, malnutrition, or limited access to home pregnancy tests. Better awareness of pregnancy status can lead to the facilitation of family planning uptake. This paper experimentally evaluates the effect of the provision of home pregnancy tests on family planning take-up among Ugandan women. We find high demand for pregnancy tests among women when offered. At the same time, we find no impact of pregnancy tests on the take-up of free family planning at local community outreach centers. Demand for pregnancy tests is high and access to pregnancy tests has the potential to facilitate the demand for family planning. This study suggests that more research is needed to understand underlying beliefs about pregnancy status and risk that guide behaviors ultimately important for maternal and neonatal health. [ABSTRACT FROM AUTHOR]

Background: Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care unit (NICU) are limited to pacifier use or bottle-feeding exercises. Skin contact has been shown to be beneficial to start and maintain lactation and provide preterm infants with the opportunity to suck on the mother's breast, which may promote further development of the preterm infant's suckling patterns. The objective of this study is to compare and evaluate the effects of skin contact combined with breastfeeding (suck on the mother's empty breast) as compared to the routine pacifier suckling training model in achieving full oral feeding for infants whose gestational age are ≤ 30 weeks.Methods: This is a single-center, randomized controlled clinical trial conducted in the NICU and designed according to the SPIRIT Statement. The subjects included in the study are premature infants born between April 2020 and July 2021 with a gestational age of ≤30 weeks, birth weight of <1500 g, admission age of <72 h, and absence of congenital malformations. Those with oxygenation indices of >40 and those born to mothers with poor verbal communication skills will be excluded. A sample of 148 infants is needed. The infants will be randomized to the intervention (skin contact combined with mother's breastfeeding model) or control group (routine pacifier sucking training model). The primary outcome is the time required to achieve full oral feeding. The secondary outcomes are the breastfeeding abilities of preterm infants as assessed by the Preterm Infant Breastfeeding Behavior Scale (PIBBS), breastfeeding rates at 3 and 6 months corrected gestational age, complication rates, duration of oxygen requirement, days of hospital stay, and satisfaction of parents.Discussion: This paper describes the first single-center, open-label, randomized clinical trial on this topic and will provide crucial information to support the implementation of skin contact combined with the breastfeeding model in the NICU setting.Trial Registration: ClinicalTrials.gov NCT04283682. Registered on 8 February 2020. [ABSTRACT FROM AUTHOR]

Background: Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge.Methods: The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm).Discussion: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic.Trial Registration: This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors' institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov ( NCT04394169 ). [ABSTRACT FROM AUTHOR]

Background: Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of seasonal malaria chemoprophylaxis (SMC), an intervention aimed at reducing malaria incidence among children aged 3-59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. Malnutrition, in particular micronutrient deficiency, appears to be one of the potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the incidence of malaria in highly prevalent malaria zone such as rural settings. Therefore, we hypothesized that a combined strategy of SMC together with a daily oral nutrients supplement will enhance the immune response and decrease the incidence of malaria and malnutrition among children under SMC coverage.Methods: Children (6-59 months) under SMC coverage receiving vitamin A supplementation will be randomly assigned to one of the three study arms (a) SMC + vitamin A alone, (b) SMC + vitamin A + zinc, or (c) SMC + vitamin A + Plumpy'Doz™ using 1:1:1 allocation ratio. After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed-up for 1 year. Anthropometric indicators will be recorded at each visit and blood samples will be collected for microscopy slides, haemoglobin measurement, and spotted onto filter paper for further PCR analyses. The primary outcome measure is the incidence of malaria in each arm. Secondary outcome measures will include mid-upper arm circumference and weight gain from baseline measurements, coverage and compliance to SMC, occurrence of adverse events (AEs), and prevalence of molecular markers of antimalarial resistance comprising Pfcrt, Pfmdr1, Pfdhfr, and Pfdhps.Discussion: This study will demonstrate an integrated strategy of malaria and malnutrition programmes in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels.Trial Registration: ClinicalTrials.gov NCT04238845 . Registered on 23 January 2020 https://clinicaltrials.gov/ct2/show/NCT04238845. [ABSTRACT FROM AUTHOR]