bluuebunny/crossref_metadata_2025_split huggingface dataset:
Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol
Authors: Angkurawaranon Chaisiri , Papachristou Nadal Iliatha , Mallinson Poppy Alice Carson , Pinyopornpanish Kanokporn , Quansri Orawan , Rerkasem Kittipan , Srivanichakorn Supattra , Techakehakij Win , Wichit Nutchanath , Pateekhum Chanapat , Hashmi Ahmar H , Hanson Kara , Khunti Kamlesh , Kinra Sanjay 
Published: October 2020

IntroductionType 2 diabetes mellitus is among the foremost health challenges facing policy makers in Thailand as its prevalence has more than tripled over the last two decades, accounting for considerable death, disability and healthcare expenditure. Diabetes self-management education (DSME) programmes show promise in improving diabetes outcomes, but this is not routinely used in Thailand. This study aims to test a culturally tailored DSME model in Thailand, using a three-arm cluster randomised controlled trial comparing a nurse-led model, a peer-assisted model and standard care. We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.Methods and analysis21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients. The primary care units will be randomised (1:1:1) to participate in a culturally-tailored DSME intervention for 12 months. The three-arm trial design will compare effectiveness of nurse-led, peer-assisted (Thai village health volunteers) and standard care. The primary trial outcomes are changes in haemoglobin A1c and cardiovascular risk score. A process evaluation and cost effectiveness evaluation will be conducted to produce policy relevant guidance for the Thai Ministry of Public Health. The planned trial period will start in January 2020 and finish October 2021.Ethics and disseminationEthical approval has been obtained from Thailand and the UK. We will share our study data with other researchers, advertising via our publications and web presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand and other low-income and middle-income countries.Trial registration numberNCT03938233.
Patient and public involvement in the development of clinical practice guidelines: a scoping review protocol
Authors: Bryant Elizabeth Ann , Scott Anna Mae , Thomas Rae 
Published: October 2020

IntroductionClinical practice guidelines (CPGs) are intended to optimise patient care by recommending care pathways based on the best available research evidence and practice experience. Patient and public involvement (PPI) in healthcare is recommended based on the expectation that it will improve the quality and relevance of outcomes. There is no consensus on what constitutes meaningful and effective PPI in CPG. We will conduct a scoping review to identify and synthesise knowledge in four key areas: who have been the patients and public previously involved in CPG development, how were they recruited, at what stage in the CPG process were they involved and how were they involved. This knowledge will inform a general model of PPI in CPG to inform CPGs development.Methods and analysisWe will conduct a scoping review using the Methodology for Scoping Reviews refined by the Joanna Briggs Institute. Searches will be conducted in electronic databases (PubMed, Embase, CINAHL and PsycINFO). National standards for developing CPGs from Australia, UK, Canada and the USA will also be identified. A forward and backward citation search will be conducted on the included studies and national standards. Abstracts and full-text studies will be independently screened by two researchers. Extracted data will include study details, type of clinical guideline and the four key areas, which patients and public were involved, how were they recruited, at what stage were they included and how they were involved. Data will be narratively synthesised.Ethics and disseminationAs a scoping review, this study does not require ethics approval. We intend to disseminate the results through publication in a peer-reviewed journal and conference presentations. Furthermore, we will use the findings from our scoping review to inform future research to fill key evidence gaps identified by this review.
Information sharing challenges in end-of-life care: a qualitative study of patient, family and professional perspectives on the potential of an Electronic Palliative Care Co-ordination System
Authors: Standing Holly , Patterson Rebecca , Lee Mark , Dalkin Sonia Michelle , Lhussier Monique , Bate Angela , Exley Catherine , Brittain Katie 
Published: October 2020

ObjectivesTo explore current challenges in interdisciplinary management of end-of-life care in the community and the potential of an Electronic Palliative Care Co-ordination System (EPaCCS) to facilitate the delivery of care that meets patient preferences.DesignQualitative study using interviews and focus groups.SettingHealth and Social Care Services in the North of England.Participants71 participants, 62 health and social care professionals, 9 patients and family members.ResultsFour key themes were identified: information sharing challenges; information sharing systems; perceived benefits of an EPaCCS and barriers to use and requirements for an EPaCCS. Challenges in sharing information were a source of frustration for health and social care professionals as well as patients, and were suggested to result in inappropriate hospital admissions. Current systems were perceived by participants to not work well—paper advance care planning (ACP) documentation was often unavailable or inaccessible, meaning it could not be used to inform decision-making at the point of care. Participants acknowledged the benefits of an EPaCCS to facilitate information sharing; however, they also raised concerns about confidentiality, and availability of the increased time and resources required to access and maintain such a system.ConclusionsEPaCCS offer a potential solution to information sharing challenges in end-of-life care. However, our findings suggest that there are issues in the initiation and documentation of end-of-life discussions that must be addressed through investment in training in order to ensure that there is sufficient information regarding ACP to populate the system. There is a need for further qualitative research evaluating use of an EPaCCS, which explores benefits and challenges, uptake and reasons for disparities in use to better understand the potential utility and implications of such systems.
Cognitive behavioural therapy in groups for medicated adults with attention deficit hyperactivity disorder: protocol for a randomised controlled trial
Authors: Pan Mei-Rong , Zhao Meng-Jie , Liu Lu , Li Hai-Mei , Wang Yu-Feng , Qian Qiu-Jin 
Published: October 2020

IntroductionCognitive behavioural therapy (CBT) is an evidence-based treatment for adults with attention deficit hyperactivity disorder (ADHD). However, it is still inconsistent whether a combination of CBT would have additive effects in medicated ADHD in adulthood. And if CBT would have additional effects, what kind and which dimension would CBT play a part? This study estimates the efficacy of CBT in stable medicated adult ADHD, using long-term outcomes and multidimensional evaluations.Methods and analysisIt is a two-armed, randomised controlled trial on the superiority of the efficacy of 12 weeks of CBT on medicated adult ADHD. We compare the short-term and long-term outcomes between CBT combined with medication (CBT+M) group and the medication-only (M) group, including ADHD core symptoms, emotional symptoms, executive function, self-esteem, life quality and brain function using functional near-infrared spectroscopy data. Participants are outpatients of the Peking University Sixth Hospital and those recruited online, diagnosed as adult ADHD and with stable medication treatment. We estimate ADHD core symptoms and combined symptoms at baseline (T1) and week 12 (T2), week 24 (T3), week 36 (T4) and week 48 (T5).Ethics and disseminationThis trial has been approved by the Ethics and Clinical Research Committees of Peking University Sixth Hospital and will be performed under the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results will be disseminated in a peer-reviewed journal and a conference presentation.Trial registration numberChiCTR (ChiCTR1900021705).
5-HT3receptor antagonists for the prevention of perioperative shivering undergoing spinal anaesthesia: a systematic review and meta-analysis of randomised controlled trials
Authors: Shen Qi-Hong , Li Hui-Fang , Zhou Xuyan , Lu Yaping , Yuan Xiao-Zong 
Published: October 2020

ObjectivePerioperative shivering (POS) is a common complication in patients undergoing spinal anaesthesia. The present study investigated the efficacy of 5-HT3receptor antagonists in preventing POS following spinal anaesthesia.DesignSystematic review and meta-analysis.Data sourcesPubmed, Embase, the Web of Science and Cochrane Library were searched from database establishment on 31 July 2019.Eligibility criteriaRandomised controlled trials that reported the effects of 5-HT3receptor antagonists in the prevention of POS in patients after spinal anaesthesia.Data extraction and synthesisTwo reviewers independently extracted data. The primary outcome of the present study was the incidence of POS. The risk of bias for the included studies was assessed according to the Cochrane Handbook. The quality of primary outcome was evaluated by Grading of Recommendations Assessment, Development and Evaluation. Trial sequential analysis for the primary outcome was performed to reduce the type 1 error caused by repeated meta-analysis and the required information size was calculated.ResultsA total of 13 randomised controlled trials consisting of 1139 patients were included. The overall incidence of POS was significantly lower in the 5-HT3receptor antagonists group (risk ratio 0.31; 95% CI 0.26 to 0.38; p<0.01; I2=0%). Subgroup analysis for different types of 5-HT3receptor antagonists and timing of administration produced similar results. Also, patients had a lower incidence of postoperative nausea and vomiting after administrating 5-HT3 receptor antagonists. No statistically significant differences in drug-related adverse effects were observed. Grading of Recommendations Assessment, Development and Evaluation revealed a high level of evidence. The cumulative z-curve crossed the trial sequential monitoring boundary.ConclusionsThe present study revealed that prophylactic 5-HT3receptor antagonists were an effective measure for reducing the incidence of POS in patients after spinal anaesthesia. However, further studies investigating the different types of surgeries are required.PROSPERO registration numberCRD42019148191.
Incremental effect of non-invasive oscillating device on chest physiotherapy in critically ill children: a cross-over randomised trial
Authors: Kawaguchi Atsushi , Bernier Gabrielle , Adler Andy , Emeriaud Guillaume , Jouvet Philippe A 
Published: October 2020

IntroductionChest physiotherapy (CPT) and intrathoracic percussion ventilation have been recognised as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proven to be sufficient.Method and analysesThis study aims to examine the tolerance, feasibility and physiological effects in airway clearance by using a novel extrathoracic non-invasive oscillating transducer device (NIOD) in critically ill children. A two-stage cross-over randomised controlled study in a paediatric intensive care unit in a Canadian Academic Children’s Hospital will be applied. Children under 24 months old, for whom CPT is prescribed for airway clearance, will be included. The study consists of two stages; (1) Stage 1 ‘Frequency Level’: we will apply two different frequencies of the NIOD (40 Hz vs 60 Hz) for 12 min each, on each patient 3 hours apart, and (2) Stage 2 ‘NIOD versus CPT’: we will implement NIOD and CPT alternatingly for 3 hours apart. The order of the procedures will be randomly allocated for each case. We will compare the average Δchanges of tidal lung volume measured by a 3D imaging system and regional lung functions using electrical impedance tomography, between the two different frequencies and between the NIOD periods and the CPT periods. We will also examine tolerance by seeing COMFORT Scales and related complications during the procedures. We estimate necessary sample size as 6 for each arm (Total 12 cases) for stage 1 and 48 cases for Stage 2, with power of 0.8 and alpha of 0.05.Ethics and disseminationThis study has been approved by the Health Research Ethics Board of University of Montreal, Canada (REB number: 2020-2471). We will disseminate our findings through peer-reviewed publications and conference presentations in paediatric or/and critical care fields.Trial registration numberClinicalTrials.gov Registry (NCT03821389).
Social work leadership competencies in health and mental healthcare: a scoping review protocol
Authors: Hussain Amina , Ashcroft Rachelle 
Published: October 2020

IntroductionLeadership skills are an integral part of effective social work practice in health and mental healthcare settings. Social workers require critical leadership skills to effectively support, treat and advocate for the complex needs of those most vulnerable. Despite an increasing focus on social work leadership within the last decade, there has been a paucity of research on social work leadership competencies within the realm of health and mental health service provision. To bridge this gap, this scoping review will synthesise and map the current literature on social work leadership competencies in health and mental healthcare.Methods and analysisArksey and O’Malley’s five-stage framework for scoping reviews will guide our search of six academic databases including: PsycINFO, OVID Social Work Abstracts, OVID Medline, Sociological Abstracts, Social Services Abstracts and CINAHL Plus with Full Text. Selected articles that meet inclusion criteria will then be reviewed and charted. Recurrent themes will be reviewed through a qualitative thematic analysis, and reported in both text and figures.Ethics and disseminationFindings will highlight key social work leadership competencies as they relate to social work practice, team dynamics, and client outcomes within health and mental healthcare. Material retrieved in this scoping review was selected from publicly available sources, and thus as an obtrusive research method, this review does not warrant ethics approval. Findings from this review will be disseminated through published scholarly material, as well as presented at conferences pertaining to social work research, practice and education.
A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol
Authors: Hodgson Kate A , Owen Louise S , Kamlin Camille Omar , Roberts Calum T , Donath Susan M , Davis Peter G , Manley Brett James 
Published: October 2020

IntroductionNeonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.Methods and analysisThe Stabilisation with nasal High flow during Intubation of NEonates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks’ gestation; ≥28 weeks’ gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).Ethics and disseminationThe SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women’s Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.Trial registration numberACTRN12618001498280.
Marriage-based pilot clean household fuel intervention in India for improved pregnancy outcomes
Authors: Pillarisetti Ajay , Roy Sudipto , Diamond-Smith Nadia , Ghorpade Makarand , Dhongade Arun , Balakrishnan Kalpana , Sambandam Sankar , Patil Rutuja , Levine David I , Juvekar Sanjay , Smith Kirk R 
Published: October 2020

IntroductionHealth interventions often target pregnant women and their unborn children. Interventions in rural India targeting pregnant women, however, often do not cover the critical early windows of susceptibility during the first trimester and parts of the second trimester. This pilot seeks to determine if targeting newlyweds could protect entire pregnancies with a clean stove and fuel intervention.MethodsWe recruited 50 newlywed couples who use biomass as a cooking fuel into a clean cooking intervention that included a liquefied petroleum gas (LPG) stove, two gas cylinders, a table to place the stove on and health education. We first evaluated whether community health workers in this region could identify and recruit couples at marriage. We quantified how many additional days of pregnancy could be covered by an intervention if we recruited at marriage versus recruiting after detection of pregnancy.ResultsOn average, we identified and visited newlywed couples within 40 (SD 21) days of marriage. Of the 50 couples recruited, 25 pregnancies and 18 deliveries were identified during this 1-year study. Due to challenges securing fuel from the LPG supply system, not all couples received their intervention prior to pregnancy. Regardless, couples recruited in the marriage arm had substantially more days with the intervention than couples recruited into a similar arm recruited at pregnancy (211 SD 46 vs 120 SD 45). At scale, a stove intervention targeting new marriages would cover about twice as many weeks of first pregnancies as an intervention recruiting after detection of pregnancy.ConclusionsWe were able to recruit in early marriage using existing community health workers. Households recruited early in marriage had more days with clean fuel coverage than those recruited at pregnancy. Our findings indicate that recruitment at marriage is feasible and warrants further exploration for stove and other interventions targeting pregnancy-related outcomes.
How achievable are COVID-19 clinical trial recruitment targets? A UK observational cohort study and trials registry analysis
Authors: Cunniffe Nick G , Gunter Simon J , Brown Michael , Burge Sarah W , Coyle Clare , De Soyza Anthony , Dymond Tom , Esmail Hanif , Francis Darrel P , Galloway Jacqui , Galloway James B , Gkrania-Klotsas Effrossyni , Greenaway Jane , Katritsis George , Kanagaratnam Prapa , Knolle Martin D , Leonard Kelly , McIntyre Zoe C , Prudon Ben , Rampling Tommy , Torok Mili Estee , Warne Ben , Yates Mark , Matheson Nicholas J , Su Li , Villar Sofia , Stewart Grant D , Toshner Mark 
Published: October 2020

ObjectivesTo analyse enrolment to interventional trials during the first wave of the COVID-19 pandemic in England and describe the barriers to successful recruitment in the circumstance of a further wave or future pandemics.DesignWe analysed registered interventional COVID-19 trial data and concurrently did a prospective observational study of hospitalised patients with COVID-19 who were being assessed for eligibility to one of the RECOVERY, C19-ACS or SIMPLE trials.SettingInterventional COVID-19 trial data were analysed from the clinicaltrials.gov and International Standard Randomized Controlled Trial Number databases on 12 July 2020. The patient cohort was taken from five centres in a respiratory National Institute for Health Research network. Population and modelling data were taken from published reports from the UK government and Medical Research Council Biostatistics Unit.Participants2082 consecutive admitted patients with laboratory-confirmed SARS-CoV-2 infection from 27 March 2020 were included.Main outcome measuresProportions enrolled, and reasons for exclusion from the aforementioned trials. Comparisons of trial recruitment targets with estimated feasible recruitment numbers.ResultsAnalysis of trial registration data for COVID-19 treatment studies enrolling in England showed that by 12 July 2020, 29 142 participants were needed. In the observational study, 430 (20.7%) proceeded to randomisation. 82 (3.9%) declined participation, 699 (33.6%) were excluded on clinical grounds, 363 (17.4%) were medically fit for discharge and 153 (7.3%) were receiving palliative care. With 111 037 people hospitalised with COVID-19 in England by 12 July 2020, we determine that 22 985 people were potentially suitable for trial enrolment. We estimate a UK hospitalisation rate of 2.38%, and that another 1.25 million infections would be required to meet recruitment targets of ongoing trials.ConclusionsFeasible recruitment rates, study design and proliferation of trials can limit the number, and size, that will successfully complete recruitment. We consider that fewer, more appropriately designed trials, prioritising cooperation between centres would maximise productivity in a further wave.