bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomised controlled trial comparing hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures: a protocol for the WHITE 5 study
Authors: Fernandez Miguel Antonio , Achten Juul , Lerner Robin Gillmore , Mironov Katy , Parsons Nicholas , Dritsaki Melina , Png May E , McGibbon Alwin , Gould Jenny , Griffin Xavier , Costa Matthew L 
Published: April 2023

IntroductionHip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture.Methods and analysisMulticentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4 months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12 months and health resource use. A within-trial economic analysis will be conducted.Ethics, dissemination and fundingWales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215–36043 and PB-PG-1216–20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres.Trial registration numberNCT18393176
The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study
Authors: Breitborde Nicholas J K , Guirgis Hossam , Stearns Walter , Carpenter Kristen M , Lteif Ghada , Pine Jacob G , Storey Nichole , Wastler Heather , Moe Aubrey M 
Published: April 2023

IntroductionIn October 2018, the Substance Abuse and Mental Health Services Administration funded 21 sites throughout the USA to develop, implement and evaluate specialised care programmes for individuals at clinical high risk for developing a psychotic disorder (CHR-P). Per the funding requirements, such programmes were required to provide ‘step-based care’—a model in which individuals are initially provided with low-intensity, non-psychosis-specific and more benign (ie, least side effects) interventions and only progress onto higher-intensity, psychosis-specific interventions with a greater risk of more severe side effects should they not meet a priori criteria for clinical response to such lower-intensity interventions. Here, we outline the evaluation component of the step-based care programme for individuals at CHR-P at The Ohio State University Early Psychosis Intervention Center (EPICENTER).Methods and analysesThe EPICENTER CHR-P programme provides a step-based care model comprising psychotherapy, medication management, family support/education, peer support and vocational/educational support. All participants who opt to receive care at the EPICENTER will complete a standardised assessment battery as part of usual care. This battery will be administered on enrolment and will be re-administered at 6-month intervals throughout individuals’ participation in EPICENTER clinical services. Participants will have the opportunity to allow for data from these usual care assessments to be used as part of an evaluation project for this new clinical service. The primary outcome for this evaluation project is time to remission of symptomatic and functional deficits commonly experienced by individuals at CHR-P. Participants will also have the opportunity to participate in a supplemental research project designed to further evaluate treatment outcomes and patient characteristics among individuals participating in EPICENTER clinical services.Ethics and disseminationThis project was approved by The Ohio State University Institutional Review Board. Results from this project will be disseminated through publications and presentations.Trial registration numberNCT03970005.
Barriers and facilitators to uptake and retention of inner-city ethnically diverse women in a postnatal weight management intervention: a mixed-methods process evaluation within a feasibility trial in England
Authors: Taylor Cath , Bhavnani Vanita , Zasada Magdalena , Ussher Michael , Bick Debra 
Published: April 2023

ObjectivesTo understand the barriers and facilitators to uptake and retention of postnatal women randomised to a commercial group weight management intervention using the COM-B (capability, opportunity, motivation and behaviour) behaviour change model.DesignConcurrent mixed-methods (qualitative dominant) process evaluation nested within a feasibility randomised controlled trial, comprising questionnaires and interviews at 6 and 12 months postbirth.SettingOne National Health Service maternity unit in an inner city area in the south of England.Participants98 postnatal women with body mass indices>25 kg/m2(overweight/obese) at pregnancy commencement.InterventionTwelve-week Slimming World (SW) commercial group weight management programme, commencing anytime from 8 to 16 weeks postnatally.Primary and secondary outcome measuresData regarding uptake and retention from questionnaires and interviews conducted 6 and 12 months postbirth analysed thematically and mapped to the COM-B model.ResultsBarriers to SW uptake mostly concerned opportunity issues (eg, lack of time or childcare support) though some women also lacked motivation, not feeling that weight reduction was a priority, and a few cited capability issues such as lacking confidence. Weight loss aspirations were also a key factor explaining retention, as were social opportunity issues, particularly in relation to factors such as the extent of group identity and relationship with the group consultant; and physical opportunity such as perceived support from and fit with family lifestyle. In addition, barriers relating to beliefs and expectations about the SW programme were identified, including concerns regarding compatibility with breastfeeding and importance of exercise. Women’s understanding of the SW approach, and capability to implement into their lifestyles, appeared related to level of attendance (dose–response effect).ConclusionsUptake and retention in commercial weight management programmes may be enhanced by applying behaviour change techniques to address the barriers impacting on women’s perceived capability, motivation and opportunity to participate.Trial registration numberNCT39186148.
Evaluation of the For Our Children’s Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial
Authors: Norman Asa , Enebrink Pia 
Published: April 2023

IntroductionChildren of incarcerated parents comprise a greatly disadvantaged group in society and positive parenting constitutes an important factor for children’s healthy development. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.This study aims to investigate the effects of the parenting programme currently offered in prisons in Sweden, For Our Children’s Sake (FOCS), through a controlled trial with a parallel implementation process evaluation.Methods and analysisThe effectiveness trial is carried out as a non-blinded controlled trial with a parallel investigation of the implementation process using mixed methods. Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents. Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent. The FOCS intervention is carried out in group format over 10 weeks. The primary outcome is closeness in parent-child relationship measured with the Child Parent Relationship Scale. Secondary outcomes comprise parent-child contact, parental criminal attitude and interest in other treatment programmes. Mediators comprise attitude to parenting, and self-efficacy. Outcome data are self-reported and collected over four time points: baseline (September to December 2019), mid and after intervention, and at 3 months follow-up. Implementation data is collected during and after intervention. Intervention fidelity is monitored through audio recordings, dose is registered per participant, reach comprise included versus eligible number of parents and acceptability is investigated through semi-structured interviews. Factors influencing implementation will be investigated using a questionnaire.Ethics and disseminationEthical permission has been obtained by the Swedish Ethical Review Authority 2019–04227. Findings will be published in peer-reviewed journals, presented at scientific conferences and presented to participants in writing.Trial registration numberNCT04101799.
Adaptability to acute stress among women survivors of intimate partner violence: protocol for a mixed-methods cross-sectional study in a laboratory setting (BRAW study)
Authors: Goldberg Ximena , Espelt Carme , Palao Diego , Nadal Roser , Armario Antonio 
Published: April 2023

IntroductionIntimate partner violence (IPV) is the most common and alarming form of violence against women, affecting around 30% of all women around the world. Using an integrative methodology, we approach IPV as a form of chronic exposure to severe stress that alters the stress-response system of exposed women. The aim of this study is to test the hypothesis that sustained exposure to IPV in women confers a vulnerability-to-stress profile characterised by higher neuroendocrine and behavioural responsiveness associated with a selective attentional processing bias towards threat.Methods and analysisWomen between 21 and 50 years old from the area of Barcelona (Spain) will be invited to participate. A sample of 82 women exposed to IPV and 41 women not exposed to IPV will be included and assessed for attentional bias and response to acute stress in a laboratory condition (the Trier Social Stress Task). The study will include quantitative and qualitative measures of cognitive performance, neuroendocrine activity and face-to-face interviews to obtain an integrative description of the stress-response profile of these women. Results are expected to help build resilience strategies with a long-lasting impression on women’s healthy functioning.Ethics and disseminationThe study has obtained the approval of the local Ethics Committee (‘Comité de Ética de Investigación Parc Taulí de Sabadell’; 2 018 551 V.1.2 June 2018). Besides the communication of results in peer-reviewed papers and scientific congresses, the project will inform guidelines and recommendations through policy-dialogues and workshops with relevant regional and national representatives for future work and prevention strategies. Participants will be invited to be an active part in the dissemination strategy focussed on raising awareness of coping limitations and abilities that women themselves will be able to identify throughout the study.Trial registration detailsThe study has been registered at the ClinicalTrails.gov database (Identifier number:NCT03623555).
Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the Mama Aweza trial protocol
Authors: Tickell Kirkby D , Diakhate Mareme M , Goodman Jeanne L , Unger Jennifer A , Richardson Barbra A , Rubin Means Arianna , Ronen Keshet , Levin Carol , Choo Esther M , Achieng Catherine , Masheti Mary , Singa Benson O , McGrath Christine J 
Published: April 2023

IntroductionOver 52 million children under 5 years of age become wasted each year, but only 17% of these children receive treatment. Novel methods to identify and deliver treatment to malnourished children are necessary to achieve the sustainable development goals target for child health. Mobile health (mHealth) programmes may provide an opportunity to rapidly identify malnourished children in the community and link them to care.Methods and analysisThis randomised controlled trial will recruit 1200 children aged 6–12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya. Caregiver–infant dyads will be randomised to either a maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC). Study staff will train all caregivers to measure their child’s mid-upper arm circumference (MUAC). Caregivers in the MAMMS arm will be given two colour coded and graduated insertion MUAC tapes and be enrolled in a mHealth system that sends weekly short message service (SMS) messages prompting caregivers to measure and report their child’s MUAC by SMS. Caregivers in the SOC arm will receive routine monitoring by community health volunteers coupled with a quarterly visit from study staff to ensure adequate screening coverage. The primary outcome is identification of childhood malnutrition, defined as MUAC <12.5 cm, in the MAMMS arm compared with the SOC arm. Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6–18 months of age. Finally, we will explore the acceptability, fidelity and feasibility of implementing the MAMMS within existing nutrition programmes.Ethics and disseminationThe study was approved by review boards at the University of Washington and the Kenya Medical Research Institute. A data and safety monitoring board has been convened, and the results of the trial will be published in peer-reviewed scientific journals, presented at appropriate conferences and to key stakeholders.Trial registration numberNCT03967015.
Protocol of a natural experiment to evaluate a supermarket intervention to improve food purchasing and dietary behaviours of women (WRAPPED study) in England: a prospective matched controlled cluster design
Authors: Vogel Christina , Crozier Sarah , Dhuria Preeti , Shand Calum , Lawrence Wendy , Cade Janet , Moon Graham , Lord Joanne , Ball Kylie , Cooper Cyrus , Baird Janis 
Published: April 2023

IntroductionPoor diet is a leading risk factor for non-communicable diseases and costs the National Health Service £5.8 billion annually. Product placement strategies used extensively in food outlets, like supermarkets, can influence customers’ preferences. Policy-makers, including the UK Government, are considering legislation to ensure placement strategies promote healthier food purchasing and dietary habits. High-quality scientific evidence is needed to inform future policy action. This study will assess whether healthier placement strategies in supermarkets improve household purchasing patterns and the diets of more than one household member.Methods and analysesThis natural experiment, with a prospective matched controlled cluster design, is set in discount supermarkets across England. The primary objective is to investigate whether enhanced placement of fresh fruit and vegetables improves household-level purchasing of these products after 6 months. Secondary objectives will examine: (1) differences in intervention effects on purchasing by level of educational attainment, (2) intervention effects on the dietary quality of women and their young children, (3) intervention effects on store-level sales of fruit and vegetables and (4) cost-effectiveness of the intervention from individual, retailer and societal perspectives. Up to 810 intervention and 810 control participants will be recruited from 18 intervention and 18 matched control stores. Eligible participants will be women aged 18–45 years, who hold a loyalty card and shop in a study store. Each control store will be matched to an intervention store on: (1) sales profile, (2) neighbourhood deprivation and (3) customer profile. A detailed process evaluation will assess intervention implementation, mechanisms of impact and, social and environmental contexts.Ethics and disseminationEthical approval was obtained from the University of Southampton, Faculty of Medicine Ethics Committee (ID 20986.A5). Primary, secondary and process evaluation results will be submitted for publication in peer-reviewed scientific journals and shared with policy-makers.Trial registration numberNCT03573973.
Trial Of Neurostimulation In Conversion Symptoms (TONICS): a feasibility randomised controlled trial of transcranial magnetic stimulation for functional limb weakness
Authors: Pick Susannah , Hodsoll John , Stanton Biba , Eskander Amy , Stavropoulos Ioannis , Samra Kiran , Bottini Julia , Ahmad Hena , David Anthony S , Purves Alistair , Nicholson Timothy R 
Published: April 2023

ObjectivesTranscranial magnetic stimulation (TMS) has been used therapeutically for functional (conversion) motor symptoms but there is limited evidence for its efficacy and the optimal protocol. We examined the feasibility of a novel randomised controlled trial (RCT) protocol of TMS to treat functional limb weakness.DesignA double-blind (patient, outcome assessor) two parallel-arm, controlled RCT.SettingSpecialist neurology and neuropsychiatry services at a large National Health Service Foundation Trust in London, UK.ParticipantsPatients with a diagnosis of functional limb weakness (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition). Exclusion criteria included comorbid neurological or major psychiatric disorder, contraindications to TMS or previous TMS treatment.InterventionsPatients were randomised to receive either active (single-pulse TMS to primary motor cortex (M1) above resting motor threshold) or inactive treatment (single-pulse TMS to M1 below resting motor threshold). Both groups received two TMS sessions, 4 weeks apart.Outcome measuresWe assessed recruitment, randomisation and retention rates. The primary outcome was patient-rated symptom change (Clinical Global Impression–Improvement scale, CGI-I). Secondary outcomes included clinician-rated symptom change, psychosocial functioning and disability. Outcomes were assessed at baseline, both TMS visits and at 3-month follow-up.ResultsTwenty-two patients were recruited and 21 (96%) were successfully randomised (active=10; inactive=11). Nineteen (91%) patients were included at follow-up (active=9; inactive=10). Completion rates for most outcomes were good (80%–100%). Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%). Adverse events were not more common for the active treatment. Treatment effect sizes for patient-rated CGI-I scores were small-moderate (Cliff’s delta=−0.1–0.3, CIs−0.79 to 0.28), reflecting a more positive outcome for the active treatment (67% and 44% of active arm-rated symptoms as ‘much improved’ at session 2 and follow-up, respectively, vs 20% inactive group). Effect sizes for secondary outcomes were variable.ConclusionsOur protocol is feasible. The findings suggest that supramotor threshold TMS of M1 is safe, acceptable and potentially beneficial as a treatment for functional limb weakness. A larger RCT is warranted.Trial registration numberNCT51225587.
Rationale and design of a randomised controlled trial testing the effect of personalised diet in individuals with pre-diabetes or type 2 diabetes mellitus treated with metformin
Authors: Htet Thaw D , Godneva Anastasia , Liu Zhixin , Chalmers Eliza , Kolobkov Dmitry , Snaith Jennifer R , Richens Renee , Toth Krisztina , Danta Mark , Hng Tien-Ming , Elinav Eran , Segal Eran , Greenfield Jerry R , Samocha-Bonet Dorit 
Published: April 2023

IntroductionMetformin and diets aimed at promoting healthy body weight are the first line in treating type 2 diabetes mellitus (T2DM). Clinical practice, backed by clinical trials, suggests that many individuals do not reach glycaemic targets using this approach alone. The primary aim of the Personalised Medicine in Pre-diabetes—Towards Preventing Diabetes in Individuals at Risk (PREDICT) Study is to test the efficacy of personalised diet as adjuvant to metformin in improving glycaemic control in individuals with dysglycaemia.Methods and analysisPREDICT is a two-arm, parallel group, single-masked randomised controlled trial in adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication. PREDICT is conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney). Enrolment of participants commenced in December 2018 and expected to complete in December 2021. Participants are commenced on metformin (Extended Release, titrated to a target dose of 1500 mg/day) and randomised with equal allocation to either (1) the Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction (75%) in individuals with body mass index >25 kg/m2. Treatment duration is 6 months and participants visit the Clinical Research Facility five times over approximately 7 months. The primary outcome measure is HbA1c. The secondary outcomes are (1) time of interstitial glucose <7.8 mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan).Ethics and disseminationThe study has been approved by the St Vincent’s Hospital Human Research Ethics Committee (File 17/080, Sydney, Australia) and the Weizmann Institutional Review Board (File 528-3, Rehovot, Israel). The findings will be published in peer-reviewed open access medical journals.Trial registration numberNCT03558867.