Controlled Intervention Trial Research Articles

Supporting Error Management and Safety Climate in Ambulatory Care Practices: The CIRSforte Study.

To improve patient safety, it is important that healthcare facilities learn from critical incidents. Tools such as reporting and learning systems and team meetings structure error management and promote learning from incidents. To enhance error management in ambulatory care practices, it is important to promote a climate of safety and ensure personnel share views on safety policies and procedures. In contrast to the hospital sector, little research has been dedicated to developing feasible approaches to supporting error management and safety climate in ambulatory care. In this study, we developed, implemented, and evaluated a multicomponent intervention to address how error management and safety climate can be improved in ambulatory care practices. In a prospective 1-group pretest-posttest implementation study, we sought to encourage teams in German ambulatory practices to use proven methods such as guidelines, workshops, e-learning, (online) meetings, and e-mail newsletters. A pretest-posttest questionnaire was used to evaluate level and strength of safety climate and psychological behavioral determinants for systematic error management. Using 3 short surveys, we also assessed the state of error management in the participating practices. In semistructured interviews, we asked participants for their views on our intervention measures. Overall, 184 ambulatory care practices nationwide agreed to participate. Level of safety climate and safety climate strength (rwg) improved significantly. Of psychological behavioral determinants, significant improvements could be seen in "action/coping planning" and "action control." Seventy-six percent of practices implemented a new reporting and learning system or modified their existing system. The exchange of information between practices also increased over time. Interviews showed that the introductory workshop and provided materials such as report forms or instructions for team meetings were regarded as helpful. A significant improvement in safety climate level and strength, as well as participants' knowledge of how to analyze critical incidents, derive preventive measures and develop concrete plans suggest that it is important to train practice teams, to provide practical tips and tools, and to facilitate the exchange of information between practices. Future randomized and controlled intervention trials should confirm the effectiveness of our multicomponent intervention.Trial registration: Retrospectively registered on 18. November 2019 in German Clinical Trials Register No. DRKS00019053.

Global malaria predictors at a localized scale

Malaria is a life-threatening disease caused by Plasmodium parasites transmitted by Anopheles mosquitoes. In 2022, more than 249 million cases of malaria were reported worldwide, with an estimated 608,000 deaths. While malaria incidence has decreased globally in recent decades, some public health gains have plateaued, and many endemic hotspots still face high transmission rates. Understanding local drivers of malaria transmission is crucial but challenging due to the complex interactions between climate, entomological and human variables, and land use. This study focuses on highly climatically suitable and endemic areas in Côte d’Ivoire to assess the explanatory power of coarse climatic predictors of malaria transmission at a fine scale. Using data from 40 villages participating in a randomized controlled trial of a household malaria intervention, the study examines the effects of climate variation over time on malaria transmission. Through panel regressions and statistical modeling, the study investigates which variable (temperature, precipitation, or entomological inoculation rate) and its form (linear or unimodal) best explains seasonal malaria transmission and the factors predicting spatial variation in transmission. The results highlight the importance of temperature and rainfall, with quadratic temperature and all precipitation models performing well, but the causal influence of each driver remains unclear due to their strong correlation. Further, an independent, mechanistic temperature-dependent R0 model based on laboratory data, which predicts that malaria transmission peaks at 25°C and declines at lower and higher temperatures, aligns well with observed malaria incidence rates, emphasizing the significance and predictability of temperature suitability across scales. By contrast, entomological variables, such as entomological inoculation rate, were not strong predictors of human incidence in this context. Finally, the study explores the predictors of spatial variation in malaria, considering land use, intervention, and entomological variables. The findings contribute to a better understanding of malaria transmission dynamics at local scales, aiding in the development of effective control strategies in endemic regions.

A Pilot Randomized Controlled Trial of Motivation-Based Social Skills Group Treatment with Parent Training.

Despite the popularity of social skills groups, there remains a need for empirical investigation of treatment effects, especially when targeting pivotal aspects of social functioning such as initiations to peers. The goal of the present study was to conduct a randomized controlled trial of a 12-week social intervention (SUCCESS), which combined an inclusive social group with a parent education program. Twenty-five 4- to 6-year-olds with Autism Spectrum Disorder (ASD) were randomized to SUCCESS (N = 11) or to treatment as usual (N = 14). Combining a peer group model with a parent training program, the SUCCESS intervention used naturalistic behavioral techniques (e.g., environmental arrangement, natural reinforcement) to increase social initiations to peers. After 12 weeks, children participating in the SUCCESS program made more frequent initiations to peers than children in the treatment-as-usual group, including more prompted and unprompted initiations to request. Additional gains in clinician-rated social functioning were observed in children randomized to SUCCESS, while differential treatment effects were not detected in parent-rated measures. However, lower baseline social motivation was associated with greater parent-reported initiation improvement. This study provides preliminary support for the efficacy of a naturalistic, behavioral social skills intervention to improve peer initiations for children with ASD. The findings suggest that using a motivation-based social skills group was effective in increasing both prompted and spontaneous initiations to peers, and highlights the need for further research into the role of baseline social motivation in predicting social skills treatment response.

Medical-surgical patients with untreated hazardous drinking: Randomized controlled trial of the DO-MoST intervention to improve health outcomes over 12-month follow-up

IntroductionHigh prevalence and harmful consequences of hazardous drinking among medical-surgical patients underscore the importance of intervening with drinking to improve patients’ health. This study evaluated a novel intervention, “Drinking Options - Motivate, Shared Decisions, Telemonitor” (DO-MoST). MethodsIn a randomized design, 155 medical-surgical patients with untreated hazardous drinking were assigned to enhanced usual care or DO-MoST, and followed 3, 6, and 12 months later. We conducted intent-to-treat and per-protocol analyses. ResultsFor the primary outcome, percent days of alcohol abstinence in the past 30 days, intent-to-treat analyses did not find superior effectiveness of DO-MoST. However, per-protocol analyses found abstinence increased between 3 and 12 months among participants assigned to DO-MoST who engaged with the intervention (n=46). Among DO-MoST-assigned participants who did not engage (n=27), abstinence stayed stable during follow-up. Group comparisons showed an advantage on abstinence for Engaged compared to Non-Engaged participants on change over time. Intent-to-treat analyses found that DO-MoST was superior to usual care on the secondary outcome of physical health at 12 months; per-protocol analyses found that Engaged DO-MoST-assignees had better physical health at 12 months than Non-Engaged DO-MoST-assignees. DO-MoST-assignees had lower odds of receiving substance use care during follow-up than usual care-assignees. DiscussionPatients engaged in DO-MoST showed a greater degree of abstinence and better physical health relative to the non-engaged or usual care group. DO-MoST may be a source of alcohol help in itself rather than only a linkage intervention. Work is needed to increase DO-MoST engagement among medical-surgical patients with untreated hazardous drinking.

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

BackgroundHarms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts on recording harms in BCI trials.MethodsData were collected through fifteen in-depth semi-structured qualitative interviews and three focus groups with thirty-two participants who work in the delivery and oversight of clinical trials. Participants included multi-disciplinary staff from eight CTUs, Chief investigators, and patient and public representatives. Interviews and focus group recordings were transcribed verbatim and thematic analysis was used to analyse the transcripts.ResultsFive themes were identified, namely perception and understanding of harm, proportionate reporting and plausibility, the need for a multi-disciplinary approach, language of BCI harms and complex harms for complex interventions. Participants strongly believed harms should be recorded in BCI trials; however, making decisions on “how and what to record as harms” was difficult. Recording irrelevant harms placed a high burden on trial staff and participants, drained trial resources and was perceived as for little purpose. Participants believed proportionate recording was required that focused on events with a strong plausible link to the intervention. Multi-disciplinary trial team input was essential for identifying and collecting harms; however, this was difficult in practice due to lack of knowledge on harms from BCIs, lack of input or difference in opinion. The medical language of harms was recognised as a poor fit for BCI trial harms but was familiar and established within internal processes. Future guidance on this topic would be welcomed and could include summarised literature.ConclusionsRecording harms or adverse events in behaviour change intervention trials is complex and challenging; multi-disciplinary experts in trial design and implementation welcome forthcoming guidance on this topic. Issues include the high burden of recording irrelevant harms and use of definitions originally designed for drug trials. Proportionate recording of harms focused on events with a strong plausible link to the intervention and multi-disciplinary team input into decision making are essential.

The efficacy and safety of tonifying-kidney and invigorating-blood circulation (Bushen-Huoxue) formula on renal fibrosis in patients with chronic kidney disease: A protocol for systematic review and meta-analysis

Background: The incidence of chronic kidney disease (CKD) is increasing and the progression of renal interstitial fibrosis (RIF) in end-stage renal disease is attributed to the development of various CKD. One of the treatments for RIF is an oral treatment known as Bushen-Huoxue (BSHX), which stimulates blood circulation and tonifies the kidney. Randomized controlled trials of BSHX treatment of RIF have been reported, but their efficacy and safety have not been comprehensively examined. Therefore, our study aims to describe the efficacy and safety of oral application of the traditional Chinese medicine (TCM) formula of BSHX on treating RIF in CKD by systematic analysis and meta-analysis. Methods: A total of 13 databases, including PubMed, EMBASE, MEDLINE, Web of Science, Cochrane Library, SpringerLink, WHO International Clinical Trials Registry Platform, Wanfang China database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and China’s Conference Papers Database and China Dissertation database will be searched from inception to July 2023. In addition, other suitable search strategies will be used as well to complete this review. All randomized controlled trials that use the BSHX formula for RIF to apply TCM treatments externally for CKD will be included. The eligible studies will be selected to enroll by 2 independent researchers following a predetermined protocol. The review manager software (Rev-Man 5.3) will be used to assess the risk of bias, reporting bias, and data synthesis. Result: We will compile and discuss the recent examples of the TCM BSHX formula treatment for RIF in CKD. Conclusion: We will provide strong evidences for evaluating the efficacy and safety of the TCM BSHX formula treatment for RIF in CKD.

Effectiveness of mHealth interventions to promote physical activity and reduce sedentary behaviours on work-related productivity and performance: a systematic review protocol

IntroductionTechnologies such as health and fitness applications (apps) and wearable activity trackers have recently gained popularity and may play a key role in promoting physical activity and reducing sedentary behaviours....

Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study)

IntroductionAndrogen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care...

Maternal prebiotic supplementation during pregnancy and lactation modifies the microbiome and short chain fatty acid profile of both mother and infant

Background & AimsImproving maternal gut health in pregnancy and lactation is a potential strategy to improve immune and metabolic health in offspring and curtail the rising rates of inflammatory diseases linked to alterations in gut microbiota. Here, we investigate the effects of a maternal prebiotic supplement (galacto-oligosaccharides and fructo-oligosaccharides), ingested daily from <21 weeks’ gestation to six months’ post-partum, in a double-blinded, randomised placebo-controlled trial. MethodsStool samples were collected at multiple timepoints from 74 mother-infant pairs as part of a larger, double-blinded, randomised controlled allergy intervention trial. The participants were randomised to one of two groups; with one group recieving 14.2 g per day of prebiotic powder (galacto-oligosaccharides GOS and fructo-oligosaccharides FOS in ratio 9:1), and the other receiving a placebo powder consisting of 8.7 g per day of maltodextrin. The faecal microbiota of both mother and infants were assessed based on the analysis of bacterial 16S rRNA gene (V4 region) sequences, and short chain fatty acid (SCFA) concentrations in stool. ResultsSignificant differences in the maternal microbiota profiles between baseline and either 28-weeks’ or 36-weeks’ gestation were found in the prebiotic supplemented women. Infant microbial beta-diversity also significantly differed between prebiotic and placebo groups at 12-months of age. Supplementation was associated with increased abundance of commensal Bifidobacteria in the maternal microbiota, and a reduction in the abundance of Negativicutes in both maternal and infant microbiota. There were also changes in SCFA concentrations with maternal prebiotics supplementation, including significant differences in acetic acid concentration between intervention and control groups from 20 to 28-weeks’ gestation. ConclusionMaternal prebiotic supplementation of 14.2 g per day GOS/FOS was found to favourably modify both the maternal and the developing infant gut microbiome. These results build on our understanding of the importance of maternal diet during pregnancy, and indicate that it is possible to intervene and modify the development of the infant microbiome by dietary modulation of the maternal gut microbiome.

Achieving Better Understanding of Obstructive Sleep Apnea Treatment Effects on Cardiovascular Disease Outcomes through Machine Learning Approaches: A Narrative Review.

Obstructive sleep apnea (OSA) affects almost a billion people worldwide and is associated with a myriad of adverse health outcomes. Among the most prevalent and morbid are cardiovascular diseases (CVDs). Nonetheless, randomized controlled trials (RCTs) of OSA treatment have failed to show improvements in CVD outcomes. A major limitation in our field is the lack of precision in defining OSA and specifically subgroups with the potential to benefit from therapy. Further, this has called into question the validity of using the time-honored apnea-hypopnea index as the ultimate defining criteria for OSA. Recent applications of advanced statistical methods and machine learning have brought to light a variety of OSA endotypes and phenotypes. These methods also provide an opportunity to understand the interaction between OSA and comorbid diseases for better CVD risk stratification. Lastly, machine learning and specifically heterogeneous treatment effects modeling can help uncover subgroups with differential outcomes after treatment initiation. In an era of data sharing and big data, these techniques will be at the forefront of OSA research. Advanced data science methods, such as machine-learning analyses and artificial intelligence, will improve our ability to determine the unique influence of OSA on CVD outcomes and ultimately allow us to better determine precision medicine approaches in OSA patients for CVD risk reduction. In this narrative review, we will highlight how team science via machine learning and artificial intelligence applied to existing clinical data, polysomnography, proteomics, and imaging can do just that.

Perinatal Outcomes in Early and Late Gestational Diabetes Mellitus After Treatment From 24-28 Weeks' Gestation: A TOBOGM Secondary Analysis.

In most gestational diabetes mellitus (GDM) studies, cohorts have included women combined into study populations without regard to whether hyperglycemia was present earlier in pregnancy. In this study we sought to compare perinatal outcomes between groups: women with early GDM (EGDM group: diagnosis before 20 weeks but no treatment until 24-28 weeks if GDM still present), with late GDM (LGDM group: present only at 24-28 weeks), and with normoglycemia at 24-28 weeks (control subjects). This is a secondary analysis of a randomized controlled treatment trial where we studied, among women with risk factors, early (<20 weeks' gestation) GDM defined according to World Health Organization 2013 criteria. Those receiving early treatment for GDM treatment were excluded. GDM was treated if present at 24-28 weeks. The primary outcome was a composite of birth before 37 weeks' gestation, birth weight ≥4,500 g, birth trauma, neonatal respiratory distress, phototherapy, stillbirth/neonatal death, and shoulder dystocia. Comparisons included adjustment for age, ethnicity, BMI, site, smoking, primigravity, and education. Women with EGDM (n = 254) and LGDM (n = 467) had shorter pregnancy duration than control subjects (n = 2,339). BMI was lowest with LGDM. The composite was increased with EGDM (odds ratio [OR] 1.59, 95% CI 1.18-2.12)) but not LGDM (OR 1.19, 95% CI 0.94-1.50). Induction of labor was higher in both GDM groups. In comparisons with control subjects there were higher birth centile, higher preterm birth rate, and higher rate of neonatal jaundice for the EGDM group (but not the LGDM group). The greatest need for insulin and/or metformin was with EGDM. Adverse perinatal outcomes were increased with EGDM despite treatment from 24-28 weeks' gestation, suggesting the need to initiate treatment early, and more aggressively, to reduce the effects of exposure to the more severe maternal hyperglycemia from early pregnancy.

A randomized controlled trial of oral antipyretic treatment to reduce overheating during exercise in adults with multiple sclerosis.

Some people with multiple sclerosis (pwMS) avoid exercise due to overheating. Evidence from a variety of cooling treatments shows benefits for pwMS. Conduct a randomized controlled trial of antipyretic treatment before exercise in pwMS. Adults over age 18 diagnosed with relapsing-remitting MS reporting heat sensitivity during exercise were randomly assigned to one of six sequences counterbalancing aspirin, acetaminophen, placebo. At each of three study visits separated by ≥ one week, participants received 650-millograms of aspirin, acetaminophen, or placebo before completing a maximal exercise test. Primary outcomes were body temperature change and total time-to-exhaustion (TTE), secondary outcomes were physiological and patient-reported outcomes (PROs). Sixty participants were enrolled and assigned to treatment sequence; 37 completed ≥ one study visit. After controlling for order effects, we found that body temperature increase was reduced after aspirin (+ 0.006 ± 0.32 degrees Fahrenheit, p < 0.001) and after acetaminophen (+ 0.31 ± 0.35; p = 0.004) compared to placebo (+ 0.68 ± 0.35). TTE after aspirin (331.6 ± 76.6s) and acetaminophen (578.2 ± 82.1) did not differ significantly from placebo (551.0 ± 78.4; p's > 0.05). Aspirin benefited all secondary outcomes compared to placebo (all p's < 0.001); acetaminophen showed broadly consistent benefits. These results support antipyretic treatment as effective for reducing overheating during exercise in pwMS and failed to support antipyretics for increasing TTE in the context of a maximal exercise test. Benefits were shown for physiological markers of exercise productivity and PROs of fatigue, pain, and perceived exertion.

Effect of high-frequency (5Hz) rTMS stimulating left DLPFC combined with galantamine on cognitive impairment after ischemic stroke and serum homocysteine and neuron-specific enolase.

To investigate the efficacy of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) combined with galantamine in patients with cognitive impairment after stroke and its effect on serum homocysteine (Hcy) and neuron-specific enolase (NSE) levels. A total of 90 patients with cognitive impairment after the first ischemic stroke were enrolled. They were randomly divided into rTMS+ cognitive rehabilitation group, Galantamine + cognitive rehabilitation group, and rTMS+ Galantamine + cognitive rehabilitation group. All groups received routine medical treatment and limb rehabilitation treatment. The rTMS stimulation site was the left dorsolateral prefrontal cortex (left DLPFC), the magnetic stimulation frequency was 5 Hz, the magnetic stimulation intensity was 80% of the motor threshold level, and 3,000 pulses were given every day. The Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Fugl-Meyer scale, and modified Barthel index, as well as rehabilitation scale and serum NSE and Hcy were evaluated before and after treatment (after 4 weeks). After 4 weeks of treatment, the scores of MMSE, MoCa scale, Fugl-Meyer scale, and modified Barthel index in the three groups were significantly higher than those before treatment (all p < 0.05), while the serum NSE and Hcy levels of the three groups were decreased. rTMS+ Galantamine + cognitive rehabilitation group had higher scale scores, and the difference between the three groups was statistically significant compared with the other two groups (all p < 0.05). Cognitive rehabilitation combined with HF-rTMS and galantamine could improve the cognitive function of patients to the greatest extent, promote the recovery of physical activity, improve the self-care ability of daily life, and effectively reduce the serum HCY and NSE levels in patients with cognitive impairment after stroke. No randomized controlled trials of similar combination treatments have been reported. The better therapeutic effect may be related to the fact that galantamine combined with repetitive transcranial magnetism can activate the brain cholinergic system more extensively, promote brain neural remodeling through long-term potentiation and inhibit local neuroinflammatory responses in brain injury.

Treatments for Cannabis Use Disorder across the Lifespan: A Systematic Review.

Cannabis use disorder (CUD) is a growing public health concern, with rising prevalence and significant impact on individuals across age groups. This systematic review examines 24 studies investigating pharmacological and non-pharmacological interventions for CUD among adolescents (up to 17), young adults (18-24), and older adults (25-65). Database searches were conducted for randomized controlled trials of CUD interventions reporting outcomes such as cannabis use, abstinence, withdrawal symptoms, and treatment retention. For adolescents, interventions such as contingent rewards and family engagement have shown promise, while young adults benefit from technology-based platforms and peer support. In older adults, pharmacological adjuncts combined with counseling have shown promise in enhancing treatment outcomes. However, optimal treatment combinations remain uncertain, highlighting the need for further research. Addressing CUD requires tailored interventions that acknowledge developmental stages and challenges across the lifespan. Although promising interventions exist, further comparative effectiveness research is needed to delineate the most efficacious approaches.

Relationship Between Acculturation and Mental Health in Korean American Family Caregivers of Community-Dwelling Persons Living with Dementia.

Despite the growing number of Korean American (KA) family caregivers for persons with dementia, little is known about how acculturation might affect caregiving stress in this population. Acculturation is a variable of considerable interest in caregiving research due to its significance in understanding the impact of cultural perceptions and expectations on the caregiving role and its relation to mental health outcomes. A cross-sectional descriptive study using baseline data from an ongoing randomized controlled trial of dementia caregiver intervention was performed to examine the association between acculturation and mental health outcomes among KA caregivers (n = 32) for persons with dementia. Self-report survey questionnaires including a bidirectional acculturation scale, Center for Epidemiologic Studies Depression Scale, the Perceived Stress Scale, and the Zarit Burden Interview were administered in person in English or Korean by trained bilingual community health workers. The primary independent variable, acculturation, was assessed using a 24-item inventory. It measured two sets of cultural orientation: Korean orientation and American orientation. The mean age was 67 years (SD = 11.8) and 87% were women. Half of the caregivers were spouses of persons with dementia, while the other half were offspring caregivers. In the multiple linear regression model, caregiver acculturation toward Korean cultural orientation had a significant and positive association with depressive symptoms (β = .62; SE = 0.25; p-value = .02) and perceived stress (β = .29; SE = 0.13; p-value = .03) after adjusting for age and self-efficacy. No significant effect of American cultural orientation was found for caregiver burden, perceived stress, or depressive symptoms. Our findings suggest that exploring the role of acculturation in caregiving and its relation to outcomes, particularly caregiver distress, may be valuable for future studies aiming to understand specific elements of cultural values and practices in the acculturation process related to mental health outcomes among immigrant Korean American caregivers.

Urokinase in the treatment of tuberculous pleurisy: a systematic review and meta-analysis

ObjectiveTo evaluate the efficacy of urokinase (UK) treatment for tuberculous pleural effusion (TPE).MethodsWe searched Chinese biomedical literature database, WanFang data, CNKI, PubMed, EMbase, Web of Science and The Cochrane Library for the randomized controlled trials (RCTs) of urokinase treatment for tuberculous pleurisy from January 2000 to February 2023. Pleural tuberculosis, urokinase and randomized controlled trial were used as keywords. The eligible studies were meta-analyzed by using Revman 5.4.1: risk of bias was assessed, mean difference (MD) and 95% CI were used for continuous variables, pooled studies were conducted using random-effects or fixed-effects models, forest plots were drawn to analyze efficacy, and funnel plots were drawn to discuss publication bias.ResultsTwenty-nine RCTs were included. The meta-analyzed results showed that, on the basis of routine anti-tuberculosis, comparison between the treatment group treated with urokinase and the control group treated with antituberculosis alone, the time of pleural effusion absorption [MD-5.82, 95%CI (− 7.77, − 3.87); P<0.00001] and the residual pleural thickness [MD-1.31, 95%CI (− 1.70, − 0.91); P<0.00001], pleural effusion drainage volume [MD 822.81, 95%CI (666.46,977.96); P<0.00001], FVC%pred [MD 7.95, 95%CI (4.51,11.40); P<0.00001], FEV1%pred [MD 12.67, 95%CI (10.09,15.24); P<0.00001] were significantly different.ConclusionThe clinical effect of urokinase is better than that of antituberculous therapy alone: it can increase total pleural effusion, decrease residual pleural thickness, improve the pulmonary function, and shorten the time of pleural effusion absorption.

REST 2.0: Protocol for a randomised controlled trial of a preventative psychological skills training intervention for employee wellbeing and productivity

The workplace has been identified as a pertinent and sustainable setting for providing mental wellbeing support at scale, whilst overcoming the many barriers to accessing timely treatment through traditional healthcare pathways. Given the consequences of delayed treatment on exacerbation of symptoms and costs to both the employer and wider economy, there is a demand for preventative approaches to strengthen individuals’ protective characteristics (e.g., resilience, emotion regulation skills) against poor mental health outcomes. Following on from a feasibility phase, this study will evaluate the efficacy of the revised REST 2.0 intervention, an integrative digital psychological skills training intervention, on improving measures relating to wellbeing and organisational outputs. A multi-centre, mixed-method randomised waitlist controlled trial will be conducted with working individuals recruited from across the Midlands (England), who express an interest in learning coping skills to improve their resilience and wellbeing. Participants will be randomised to the intervention group or waitlist control group with no active treatment. REST 2.0 is an 8-week digital intervention based on integrated, evidence-based psychological approaches. Participants will complete outcome measures at pre-intervention, post-intervention and three months follow-up, with self-efficacy as the primary outcome measure. Secondary outcomes will explore changes (if any) in levels of wellbeing and organisational outputs. A mixed-method participant experiences assessment at post-intervention and follow-up will also explore in more depth usage of newly learnt skills and their impact. Ethical approval has been granted by the University of Warwick Biomedical and Research Ethics Committee and this trial is registered with the Open Science Framework.

Trial protocol for the Building Resilience through Socio-Emotional Training (ReSET) programme: a cluster randomised controlled trial of a new transdiagnostic preventative intervention for adolescents

BackgroundAdolescence is a period of heightened vulnerability to developing mental health problems, and rates of mental health disorder in this age group have increased in the last decade. Preventing mental health problems developing before they become entrenched, particularly in adolescents who are at high risk, is an important research and clinical target. Here, we report the protocol for the trial of the ‘Building Resilience through Socioemotional Training’ (ReSET) intervention. ReSET is a new, preventative intervention that incorporates individual-based emotional training techniques and group-based social and communication skills training. We take a transdiagnostic approach, focusing on emotion processing and social mechanisms implicated in the onset and maintenance of various forms of psychopathology.MethodsA cluster randomised allocation design is adopted with randomisation at the school year level. Five-hundred and forty adolescents (aged 12–14) will be randomised to either receive the intervention or not (passive control). The intervention is comprised of weekly sessions over an 8-week period, supplemented by two individual sessions. The primary outcomes, psychopathology symptoms and mental wellbeing, will be assessed pre- and post-intervention, and at a 1-year follow-up. Secondary outcomes are task-based assessments of emotion processing, social network data based on peer nominations, and subjective ratings of social relationships. These measures will be taken at baseline, post-intervention and 1-year follow-up. A subgroup of participants and stakeholders will be invited to take part in focus groups to assess the acceptability of the intervention.DiscussionThis project adopts a theory-based approach to the development of a new intervention designed to target the close connections between young people’s emotions and their interpersonal relationships. By embedding the intervention within a school setting and using a cluster-randomised design, we aim to develop and test a feasible, scalable intervention to prevent the onset of psychopathology in adolescence.Trial registrationISRCTN88585916. Trial registration date: 20/04/2023.

Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines

The Consolidated Standards of Reporting Trials extension for Artificial Intelligence interventions (CONSORT-AI) was published in September 2020. Since its publication, several randomised controlled trials (RCTs) of AI interventions have been published but their completeness and transparency of reporting is unknown. This systematic review assesses the completeness of reporting of AI RCTs following publication of CONSORT-AI and provides a comprehensive summary of RCTs published in recent years. 65 RCTs were identified, mostly conducted in China (37%) and USA (18%). Median concordance with CONSORT-AI reporting was 90% (IQR 77–94%), although only 10 RCTs explicitly reported its use. Several items were consistently under-reported, including algorithm version, accessibility of the AI intervention or code, and references to a study protocol. Only 3 of 52 included journals explicitly endorsed or mandated CONSORT-AI. Despite a generally high concordance amongst recent AI RCTs, some AI-specific considerations remain systematically poorly reported. Further encouragement of CONSORT-AI adoption by journals and funders may enable more complete adoption of the full CONSORT-AI guidelines.

Strategies for recruitment of adolescent girls into physical activity programmes: a systematic review protocol.

Physical activity is essential for youth physical and mental health, yet just 15% of adolescent girls versus 22% of adolescent boys worldwide meet the World Health Organization guideline of 60 minutes of moderate-to-vigorous physical activity per day. As activity patterns established in adolescence often persist into adulthood, there is a looming risk of adverse health outcomes due to insufficient physical activity. A persistent challenge faced by physical activity providers, however, is recruiting adolescent girls into their programmes. This systematic review will quantitatively synthesise existing knowledge surrounding the recruitment of adolescent girls into physical activity interventions and aims to provide evidence-based recommendations for optimal recruitment practices. Five electronic databases will be searched to identify randomised controlled trials of physical activity interventions for adolescent girls worldwide. Hand-searches of reference lists of included randomised controlled trials, relevant systematic reviews, and author publications will also be conducted. Data will be extracted regarding study, participant, and intervention characteristics, pre-determined recruitment goals, recruitment strategies employed, and the number of participants screened, eligible, approached, randomised, and retained. Outcomes will include whether pre-determined recruitment goals were met, recruitment rate, and any adapted or extended recruitment measures required mid-study. Descriptive statistics, including the median recruitment rate for all included studies, will be calculated and stratified by subgroups such as the type or setting of physical activity. Recruitment strategies will be categorised, and the percentage of studies using each category, along with their associated recruitment rates, will be documented. If sufficient studies are found, multi-variable regression will be employed to determine if the use of a specific recruitment strategy increases enrolment. Application of the findings of this review by physical activity programme providers may enhance their recruitment processes, potentially increasing teenage girls' physical activity enrolment worldwide. PROSPERO CRD#42023475858.