bluuebunny/crossref_metadata_2025_split huggingface dataset:
Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders
Authors: Clohessy Sophie , Arvanitis Theodoros N , Rashid Umer , Craddock Carly , Evans Mark , Toro Carla T , Elliott Mark T 
Published: April 2024

ObjectiveThe COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used across all stages of clinical research by stakeholders in clinical, health and social care research and investigate their experience using digital tools.DesignTwo online surveys followed by semistructured interviews were conducted. Interviews were audiorecorded, transcribed and analysed thematically.Setting, participantsTo explore the digital tools used since the pandemic, survey participants (researchers and related staff (n=41), research and development staff (n=25)), needed to have worked on clinical, health or social care research studies over the past 2 years (2020–2022) in an employing organisation based in the West Midlands region of England (due to funding from a regional clinical research network (CRN)). Survey participants had the opportunity to participate in an online qualitative interview to explore their experiences of digital tools in greater depth (n=8).ResultsSix themes were identified in the qualitative interviews: ‘definition of a digital tool in clinical research’; ‘impact of the COVID-19 pandemic’; ‘perceived benefits/drawbacks of digital tools’; ‘selection of a digital tool’; ‘barriers and overcoming barriers’ and ‘future digital tool use’. The context of each theme is discussed, based on the interview results.ConclusionsFindings demonstrate how digital tools are becoming embedded in clinical research, as well as the breadth of tools used across different research stages. The majority of participants viewed the tools positively, noting their ability to enhance research efficiency. Several considerations were highlighted; concerns about digital exclusion; need for collaboration with digital expertise/clinical staff, research on tool effectiveness and recommendations to aid future tool selection. There is a need for the development of resources to help optimise the selection and use of appropriate digital tools for clinical research staff and participants.
Characteristics and treatment for severe postpartum haemorrhage in different midwifery hospitals in one district of Beijing in China: an institution-based, retrospective cohort study
Authors: Yang Yike , Shao Yu , Chen Huan , Guo Xiaoyue , Liang Yingzhi , Wang Yan , Zhao Yangyu 
Published: April 2024

ObjectiveTo identify the characteristics and treatment approaches for patients with severe postpartum haemorrhage (SPPH) in various midwifery institutions in one district in Beijing, especially those without identifiable antenatal PPH high-risk factors, to improve regional SPPH rescue capacity.DesignRetrospective cohort study.SettingThis study was conducted at 9 tertiary-level hospitals and 10 secondary-level hospitals in Haidian district of Beijing from January 2019 to December 2022.ParticipantsThe major inclusion criterion was SPPH with blood loss ≥1500 mL or needing a packed blood product transfusion ≥1000 mL within 24 hours after birth. A total of 324 mothers with SPPH were reported to the Regional Obstetric Quality Control Office from 19 midwifery hospitals.Outcome measuresThe pregnancy characteristics collected included age at delivery, gestational weeks at delivery, height, parity, delivery mode, antenatal PPH high-risk factors, aetiology of PPH, bleeding amount, PPH complications, transfusion volume and PPH management. SPPH characteristics were compared between two levels of midwifery hospitals and their association with antenatal PPH high-risk factors was determined.ResultsSPPH was observed in 324 mothers out of 106 697 mothers in the 4 years. There were 74.4% and 23.9% cases of SPPH without detectable antenatal PPH high-risk factors in secondary and tertiary midwifery hospitals, respectively. Primary uterine atony was the leading cause of SPPH in secondary midwifery hospitals, whereas placental-associated disorders were the leading causes in tertiary institutions. Rates of red blood cell transfusion over 10 units, unscheduled returns to the operating room and adverse PPH complications were higher in patients without antenatal PPH high-risk factors. Secondary hospitals had significantly higher rates of trauma compared with tertiary institutions.ConclusionExamining SPPH cases at various institutional levels offers a more comprehensive view of regional SPPH management and enhances targeted training in this area.
Inpatient midwifery staffing levels and postpartum readmissions: a retrospective multicentre longitudinal study
Authors: Turner Lesley Yvonne , Saville Christina , Ball Jane , Culliford David , Dall'Ora Chiara , Jones Jeremy , Kitson-Reynolds Ellen , Meredith Paul , Griffiths Peter 
Published: April 2024

BackgroundPreventing readmission to hospital after giving birth is a key priority, as rates have been rising along with associated costs. There are many contributing factors to readmission, and some are thought to be preventable. Nurse and midwife understaffing has been linked to deficits in care quality. This study explores the relationship between staffing levels and readmission rates in maternity settings.MethodsWe conducted a retrospective longitudinal study using routinely collected individual patient data in three maternity services in England from 2015 to 2020. Data on admissions, discharges and case-mix were extracted from hospital administration systems. Staffing and workload were calculated in Hours Per Patient day per shift in the first two 12-hour shifts of the index (birth) admission. Postpartum readmissions and staffing exposures for all birthing admissions were entered into a hierarchical multivariable logistic regression model to estimate the odds of readmission when staffing was below the mean level for the maternity service.Results64 250 maternal admissions resulted in birth and 2903 mothers were readmitted within 30 days of discharge (4.5%). Absolute levels of staffing ranged between 2.3 and 4.1 individuals per midwife in the three services. Below average midwifery staffing was associated with higher rates of postpartum readmissions within 7 days of discharge (adjusted OR (aOR) 1.108, 95% CI 1.003 to 1.223). The effect was smaller and not statistically significant for readmissions within 30 days of discharge (aOR 1.080, 95% CI 0.994 to 1.174). Below average maternity assistant staffing was associated with lower rates of postpartum readmissions (7 days, aOR 0.957, 95% CI 0.867 to 1.057; 30 days aOR 0.965, 95% CI 0.887 to 1.049, both not statistically significant).ConclusionWe found evidence that lower than expected midwifery staffing levels is associated with more postpartum readmissions. The nature of the relationship requires further investigation including examining potential mediating factors and reasons for readmission in maternity populations.
Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial
Authors: Barr Laura , Richards Jim , Chapman Graham J 
Published: April 2024

IntroductionCustom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The method of foot shape capture used to produce insoles varies throughout orthotic services. This trial aims to investigate the effectiveness of two common shape-capture techniques on patient-reported outcomes in people who require insoles for a foot or ankle pathology.Methods and analysisThis double-blinded randomised controlled trial will involve two intervention groups recruited from a National Health Service orthotic service. Participants will be randomly assigned to receive a pair of custom CAD/CAM insoles, manufactured either from a direct digital scan or a foam box cast of their feet and asked to wear the insoles for 12 weeks. The primary outcome measure will be the Foot Health Status Questionnaire (FHSQ) pain subdomain, recorded at baseline (immediately after receiving the intervention), 4, 8 and 12 weeks post intervention. Secondary outcome measures will include FHSQ foot function and foot health subdomains recorded at baseline, 4, 8 and 12 weeks. The Orthotic and Prosthetic User Survey Satisfaction with Device will be recorded at 12 weeks. The transit times associated with each arm will be measured as the number of days for each insole to be delivered after foot shape capture. Tertiary outcome measures will include participant recruitment and dropout rates, and intervention adherence measured as the daily usage of the insoles over 12 weeks. The change in FHSQ scores for the subdomains and insole usage will be compared between the groups and time points, and between group differences in time in transit, cost-time analysis and environmental impact will be compared.Ethics and disseminationEthical approval was obtained from the Health Research Authority, London Stanmore Research Ethics Committee (22/LO/0579). Study findings will be submitted for publication in peer-reviewed journals, conference presentations and webinars.Trial registration numberNCT05444192.
Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical centres
Authors: Gao Ruichen , Yin Bohui , Jin Jiabin , Tian Xiaodong , Zhang Yuhua , Wei Jishu , Cao Feng , Wang Zheng , Ma Zhijun , Wang Min , Gou Shanmiao , Cong Lin , Xu Qiang , Wu Wenming , Zhao Yupei 
Published: April 2024

IntroductionThe surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.Methods and analysisThis is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the Χ2test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.Ethics and disseminationThe study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.Trial registration numberNCT05523778.
Practices and outcomes of responsive caregiving on child neurodevelopment and mental health across diverse global populations: a scoping review protocol
Authors: Lobo Eunice , Mahapatra Sandeep , Babu Giridhara Rathnaiah , van Schayck Onno CP , Srinivas Prashanth Nuggehalli , Mukherjee Debarati 
Published: April 2024

IntroductionResponsive caregiving (RC) leads to positive outcomes in children, including secure attachment with caregivers, emotional regulation, positive social interactions and cognitive development. Through our scoping review, we aim to summarise the practices and outcomes of RC in diverse caregiver and child populations from 0 to 8 years.Methods and analysisWe will use the Arksey and O’Malley framework and the Joanna Briggs Institute methodology for scoping reviews. We shall present our findings as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping review. Only peer-reviewed, English-language articles from 1982 to 2022 will be included from PubMed, Web of Science, APA PsychInfo, APA PsycArticles, SocINDEX and Google Scholar databases. Reference lists of included articles will also be screened. The search strategy will be developed for each database, and search results will be imported into Rayyan. Screening will be done in two phases: (1) titles and abstracts will be screened by two authors and conflicts will be resolved by mutual discussion between both or by consulting with a senior author; and (2) full-texts of shortlisted studies from the first phase will then be screened using the same inclusion/exclusion criteria. A data extraction form will be developed to collate relevant information from the final list of included articles. This form will be pilot tested on the first 10 papers and iteratively refined prior to data extraction from the remaining articles. Results will be presented in figures, tables and a narrative summary.Ethics and disseminationNo ethics approval needed as the review shall only use already published data. We shall publish the review in an open-access, peer-reviewed journal and disseminate through newsletters, social media pages, and presentations to relevant audiences.
Experiences and resultant care gaps among women with HIV in Canada: concept mapping the Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) findings
Authors: Medeiros Priscilla , Koebel Jill , Yu Amy , Kazemi Mina , Nicholson Valerie , Frank Peggy , Persad Yasmeen , O'Brien Nadia , Bertozzi Breklyn , Smith Stephanie , Ndung'u Mary , Fraleigh Annette , Gagnier Brenda , Cardinal Claudette , Webster Kath , Sanchez Margarite , Lee Melanie , Lacombe-Duncan A , Logie Carmen H , Gormley Rebecca , de Pokomandy Alexandra , Kaida Angela , Loutfy Mona R 
Published: April 2024

ObjectivesThe community-based, longitudinal, Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) explored the experiences of women with HIV in Canada over the past decade. CHIWOS’ high-impact publications document significant gaps in the provision of healthcare to women with HIV. We used concept mapping to analyse and present a summary of CHIWOS findings on women’s experiences navigating these gaps.DesignConcept mapping procedures were performed in two steps between June 2019 and March 2021. First, two reviewers (AY and PM) independently reviewed CHIWOS manuscripts and conference abstracts written before 1 August 2019 to identify main themes and generate individual concept maps. Next, the preliminary results were presented to national experts, including women with HIV, to consolidate findings into visuals summarising the experiences and care gaps of women with HIV in CHIWOS.SettingBritish Columbia, Ontario and Quebec, Canada.ParticipantsA total of 18 individual CHIWOS team members participated in this study including six lead investigators of CHIWOS and 12 community researchers.ResultsOverall, a total of 60 peer-reviewed manuscripts and conference abstracts met the inclusion criteria. Using concept mapping, themes were generated and structured through online meetings. In total, six composite concept maps were co-developed: quality of life, HIV care, psychosocial and mental health, sexual health, reproductive health, and trans women’s health. Two summary diagrams were created encompassing the concept map themes, one for all women and one specific to trans women with HIV. Through our analysis, resilience, social support, positive healthy actions and women-centred HIV care were highlighted as strengths leading to well-being for women with HIV.ConclusionsConcept mapping resulted in a composite summary of 60 peer-reviewed CHIWOS publications. This activity allows for priority setting to optimise care and well-being for women with HIV.
Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol
Authors: Law Lynette , Heerey Joshua L , Devlin Brooke L , Brukner Peter , Kemp Joanne L , Attanayake Amanda , Hulett Mark D , De Livera Alysha , Mosler Andrea B , Morris Hayden G , White Nathan P , Culvenor Adam G 
Published: April 2024

IntroductionChronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.Methods and analysisThe eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.Ethics and disseminationThe study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.Trial registration numberACTRN12622000440729.
Protocol for a randomised controlled trial: optimisation of perioperative analgesia protocol for uniportal video-assisted thoracoscopic surgery
Authors: Wang Li Fang , Feng Hong Xiang , Shi Yu Hui , Li Yan , Zheng Meng Tao , Bu Tegeleqi , Zhang Zhen Rong 
Published: April 2024

IntroductionPostoperative pain after thoracic surgery impairs patients’ quality of life and increases the incidence of respiratory complications. Optimised analgesia strategies include minimally invasive incisions, regional analgesia and early chest tube removal. However, little is known about the optimal analgesic regimen for uniportal video-assisted thoracoscopic surgery (uVATS).Methods and analysisWe will conduct a single-centre, prospective, single-blind, randomised trial. The effects of postoperative analgesia will be tested using thoracic paravertebral block (PVB) in combination with patient-controlled intravenous analgesia (PVB+PCIA), erector spinae plane block (ESPB) in combination with patient-controlled intravenous analgesia (ESPB+PCIA) or PCIA alone; 102 patients undergoing uVATS will be enrolled in this study. Patients will be randomly assigned to the PVB group (30 mL of 0.33% ropivacaine with dexamethasone), ESPB group (40 mL of 0.25% ropivacaine with dexamethasone) or control groups. PCIA with sufentanil will be administered to all patients after surgery. The primary outcome will be total opioid consumption after surgery. Secondary outcomes include postoperative pain score; postoperative chronic pain at rest and during coughing; sensations of touch and pain in the chest wall, non-opioid analgesic consumption; length of stay; ambulation time, the total cost of hospitalisation and long-term postoperative analgesia. Adverse reactions to analgesics and adverse events related to the regional blocks will also be recorded. The statisticians will be blinded to the group allocation. Comparison of the continuous data among the three groups will be performed using a one-way analysis of variance to assess differences among the means.Ethics and disseminationThe results will be published in patient education courses, academic conferences and peer-reviewed journals.Trial registration numberNCT06016777.
Information needs on type 1 diabetes mellitus (T1DM) and its management in children and adolescents: a qualitative study
Authors: Muhammed Elamin Sasha , Muhamad Arshad Nur Fitrah , Md Redzuan Adyani , Abdul Aziz Siti Azdiah , Hong Joyce , Chua Xin Yun , Bin-Abbas Bassam Saleh , Alsagheir Afaf , Mohamed Shah Noraida 
Published: April 2024

ObjectiveThe objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children’s perspectives as well as their caregivers.DesignQualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.SettingParticipants were recruited from a tertiary care children’s hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.ParticipantsThirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.ResultsFour themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.ConclusionThis study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.