bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol for a qualitative study exploring the perception of need, importance and acceptability of a digital diabetes prevention intervention for women with gestational diabetes mellitus during and after pregnancy in Malaysia (Explore-MYGODDESS)
Authors: Sobri Nur Hafizah Mahamad , Ismail Irmi Zarina , Hassan Faezah , Papachristou Nadal Iliatha , Forbes Angus , Ching Siew Mooi , Ali Hanifatiyah , Goldsmith Kimberley , Murphy Helen , Guess Nicola , Mohd Yusof Barakatun Nisak , Basri Nurul Iftida , Salim Mazatulfazura Sf , Azmiyaty Choiriyatul , Mohd Sa"id Iklil Iman , Chew Boon How , Ismail Khalida 
Published: August 2021

IntroductionWomen who develop gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes, and to reduce this risk the women have to adopt healthy behaviour changes. Although previous studies have explored the challenges and facilitators to initiate behaviour change among women with GDM, there is limited data from Malaysian women. Thus, this study will explore the factors affecting the uptake of healthy behaviour changes and the use of digital technology among women and their healthcare providers (HCPs) to support healthy behaviour changes in women with GDM.Methods and analysisThe study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5–8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.Ethics and disseminationThe project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.
Codesign and implementation of an equity-promoting national health literacy programme for people living with inflammatory bowel disease (IBD): a protocol for the application of the Optimising Health Literacy and Access (Ophelia) process
Authors: Hawkins Melanie , Massuger Wayne , Cheng Christina , Batterham Roy , Moore Gregory T , Knowles Simon , Nadarajah Ranjit G , Raven Leanne , Osborne Richard H 
Published: August 2021

IntroductionNon-government organisations (NGOs) often represent people who are underserved or experiencing vulnerability. Crohn’s & Colitis Australia (CCA) is aware that many Australians with inflammatory bowel disease (IBD) are not reached by current communication and engagement activities. The aim of the CCA IBD project is to implement the Optimising Health Literacy and Access (Ophelia) process over 3 years to collaboratively codesign ways to improve delivery of information, services and resources for people with IBD and their carers.Methods and analysisHealth literacy and other data for phase 1 will be collected using the Health Literacy Questionnaire, eHealth Literacy Questionnaire, IBD-related questions and qualitative interviews with people with IBD and their carers to ascertain their lived experience. Quantitative data will be analysed using descriptive statistics and cluster analysis. Identified clusters will be combined with qualitative data to develop vignettes (narratives of people’s experiences of living with IBD) for stakeholder workshops to generate ideas for useful, accessible and sustainable solutions for identified health literacy needs. Selection and testing of health literacy actions happens in phase 2 and implementation and evaluation in phase 3 (2021–2023). Outcomes of this project include giving voice to people living with IBD, their carers and frontline healthcare practitioners. Genuine codesign informs the development and implementation of what is needed and wanted to improve access to and availability and quality of information and resources that support people to manage their health. There is potential for other NGOs to use the CCA Ophelia model in other health contexts to improve engagement with and understanding of the needs of the people they serve and to reduce health inequalities and improve health outcomes.Ethics and disseminationEthics approval for Ophelia phase 1 has been obtained from the Human Research Ethics Committee of Swinburne University of Technology (Ref: 20202968–4652) and by the South West Sydney Local Health District Research and Ethics Office for the purposes of questionnaire recruitment at Liverpool Hospital (Ref: 20202968–4652). Dissemination of the study findings will be the national codesign process and ownership development across the CCA community and through the genuine engagement of clinicians and relevant managers across Australia. The model and process will be directly distributed to international IBD associations and to other NGOs. It will also be disseminated through publication in a peer-reviewed journal, conference presentations and public reports on the CCA and Swinburne University of Technology website.
Can the Robson 10 Group Classification System help identify which groups of women are driving the high caesarean section rate in major private hospitals in eastern Ethiopia? A cross-sectional study
Authors: Geze Shegaw , Tura Abera Kenay , Fage Sagni Girma , van den Akker Thomas 
Published: August 2021

ObjectiveThe rates of caesarean section (CS) in Ethiopian private hospitals are high compared with those in public facilities, and there are limited descriptions of groups of women contributing to these high rates. The objective of this study was to describe the groups contributing to increased CS rates using the Robson classification in two major private hospitals in eastern Ethiopia.DesignCross-sectional study.SettingTwo major private hospitals in eastern Ethiopia.ParticipantsAll women who gave birth from 9 January 2019 to 8 January 2020 in two major private hospitals in eastern Ethiopia.Primary and secondary outcome measuresThe primary outcome was the Robson 10 Group Classification System. The secondary outcome was indication for CS as recorded in the medical files.ResultsOf 1203 births in both hospitals combined during the study period, 415 (34.5%) were by CS. Women with a uterine scar due to previous CS (group 5), single cephalic term multiparous women in spontaneous labour (group 3) and single cephalic term nulliparous women in spontaneous labour (group 1) were the leading groups contributing 33%, 27.5% and 17.1%, respectively. The leading documented indications were fetal compromise (29.4%), previous CS (27.2%) and obstructed labour (12.3%).ConclusionMore than three-fourths of CS were performed among Robson groups 5, 3 and 1, indicating inadequate trial of labour after CS or management of labour among relatively low-risk groups (3 and 1). Improving management of spontaneous labour and strengthening clinical practice around safely providing the option of vaginal birth after CS practice are strategies required to reduce the high CS rates in these private facilities.
A clinical risk score to predict in-hospital mortality in critically ill patients with COVID-19: a retrospective cohort study
Authors: Alkaabi Salem , Alnuaimi Asma , Alharbi Mariam , Amari Mohammed A , Ganapathy Rajiv , Iqbal Imran , Nauman Javaid , Oulhaj Abderrahim 
Published: August 2021

ObjectivesTo identify factors influencing the mortality risk in critically ill patients with COVID-19, and to develop a risk prediction score to be used at admission to intensive care unit (ICU).DesignA multicentre cohort study.Setting and participants1542 patients with COVID-19 admitted to ICUs in public hospitals of Abu Dhabi, United Arab Emirates between 1 March 2020 and 22 July 2020.Main outcomes and measuresThe primary outcome was time from ICU admission until death. We used competing risk regression models and Least Absolute Shrinkage and Selection Operator to identify the factors, and to construct a risk score. Predictive ability of the score was assessed by the area under the receiver operating characteristic curve (AUC), and the Brier score using 500 bootstraps replications.ResultsAmong patients admitted to ICU, 196 (12.7%) died, 1215 (78.8%) were discharged and 131 (8.5%) were right-censored. The cumulative mortality incidence was 14% (95% CI 12.17% to 15.82%). From 36 potential predictors, we identified seven factors associated with mortality, and included in the risk score: age (adjusted HR (AHR) 1.98; 95% CI 1.71 to 2.31), neutrophil percentage (AHR 1.71; 95% CI 1.27 to 2.31), lactate dehydrogenase (AHR 1.31; 95% CI 1.15 to 1.49), respiratory rate (AHR 1.31; 95% CI 1.15 to 1.49), creatinine (AHR 1.19; 95% CI 1.11 to 1.28), Glasgow Coma Scale (AHR 0.70; 95% CI 0.63 to 0.78) and oxygen saturation (SpO2) (AHR 0.82; 95% CI 0.74 to 0.91). The mean AUC was 88.1 (95% CI 85.6 to 91.6), and the Brier score was 8.11 (95% CI 6.74 to 9.60). We developed a freely available web-based risk calculator (https://icumortalityrisk.shinyapps.io/ICUrisk/).ConclusionIn critically ill patients with COVID-19, we identified factors associated with mortality, and developed a risk prediction tool that showed high predictive ability. This tool may have utility in clinical settings to guide decision-making, and may facilitate the identification of supportive therapies to improve outcomes.
Risk of aortic dissection or aneurysm in patients with gallstone disease: a retrospective cohort study in Taiwan
Authors: Chen Chien-Hua , Lin Cheng-Li , Kao Chia-Hung 
Published: August 2021

ObjectiveThis nationwide population-based cohort study was to compare the risk of aortic dissection (AD) or aortic aneurysm (AN) between the subjects with and without gallstone disease (GD). We also compare the risk of AD/AN between the patients with GD with and without cholecystectomy.SettingThis nationwide population-based cohort study.ParticipantsWe extracted the hospitalisation database from the National Health Insurance Research Database of Taiwan and identified a total of 343 300 patients aged ≥20 years with GD newly diagnosed between 2000 and 2010 as the study cohort, including 191 111 with cholecystectomy and 152 189 without cholecystectomy, respectively. We randomly selected those without GD as the control cohort, by 1:1 propensity score matching with the study cohort based on age, sex, comorbidities and year of the index date for GD diagnosis.ResultsThe incidence of AD/AN was 6.65/10 000 person-years for the GD cohort and 6.24/10 000 person-years for the non-GD cohort (adjusted HR (aHR)=1.11, 95% CI=1.09 to 1.13), respectively (p<0.001). Furthermore, the incidence of AD/AN in the patients with GD was 9.93/10 000 person-years for the non-cholecystectomy patients (aHR=1.24, 95% CI=1.22 to 1.26) and 4.63/10 000 person-years for the cholecystectomy patients (aHR=0.97, 95% CI=0.95 to 0.99), respectively (p<0.05).ConclusionsThe GD cohort was associated with and greater risk of AD/AN than the non-GD cohort, but the risk of AD/AN in the patients with GD would decrease after cholecystectomy.
Using patient-reported outcome measures during the management of patients with end-stage kidney disease requiring treatment with haemodialysis (PROM-HD): a qualitative study
Authors: Anderson Nicola Elzabeth , McMullan Christel , Calvert Melanie , Dutton Mary , Cockwell Paul , Aiyegbusi Olalekan L , Kyte Derek 
Published: August 2021

ObjectivesPatients undergoing haemodialysis report elevated symptoms and reduced health-related quality of life, and often prioritise improvements in psychosocial well-being over long-term survival. Systematic collection and use of patient-reported outcomes (PROs) may help support tailored healthcare and improve outcomes. This study investigates the methodological basis for routine PRO assessment, particularly using electronic formats (ePROs), to maximise the potential of PRO use, through exploration of the experiences, views and perceptions of patients and healthcare professionals (HCPs) on implementation and use of PROs in haemodialysis settings.Study designQualitative study.Setting and participantsSemistructured interviews with 22 patients undergoing haemodialysis, and 17 HCPs in the UK.Analytical approachTranscripts were analysed deductively using the Consolidated Framework for Implementation Research (CFIR) and inductively using thematic analysis.ResultsFor effective implementation, the potential value of PROs needs to be demonstrated empirically to stakeholders. Any intervention must remain flexible enough for individual and aggregate use, measuring outcomes that matter to patients and clinicians, while maintaining operational simplicity. Any implementation must sit within a wider framework of education and support for both patients and clinicians who demonstrate varying previous experience of using PROs and often confuse related concepts. Implementation plans must recognise the multidimensionality of end-stage kidney disease and treatment by haemodialysis, while acknowledging the associated challenges of delivering care in a highly specialised environment. To support implementation, careful consideration needs to be given to barriers and facilitators including effective leadership, the role of champions, effective launch and ongoing evaluation.ConclusionsUsing the CFIR to explore the experiences, views and perceptions of key stakeholders, this study identified key factors at organisational and individual levels which could assist effective implementation of ePROs in haemodialysis settings. Further research will be required to evaluate subsequent ePRO interventions to demonstrate the impact and benefit to the dialysis community.
Long COVID and the mental and physical health of children and young people: national matched cohort study protocol (the CLoCk study)
Authors: Stephenson Terence , Shafran Roz , De Stavola Bianca , Rojas Natalia , Aiano Felicity , Amin-Chowdhury Zahin , McOwat Kelsey , Simmons Ruth , Zavala Maria , Consortium CLoCk , Ladhani Shamez N 
Published: August 2021

IntroductionThere is uncertainty surrounding the diagnosis, prevalence, phenotype, duration and treatment of Long COVID. This study aims to (A) describe the clinical phenotype of post-COVID symptomatology in children and young people (CYP) with laboratory-confirmed SARS-CoV-2 infection compared with test-negative controls, (B) produce an operational definition of Long COVID in CYP, and (C) establish its prevalence in CYP.Methods and analysisA cohort study of SARS-CoV-2-positive CYP aged 11–17 years compared with age, sex and geographically matched SARS-CoV-2 test-negative CYP. CYP aged 11–17 testing positive and negative for SARS-CoV-2 infection will be identified and contacted 3, 6, 12 and 24 months after the test date. Consenting CYP will complete an online questionnaire. We initially planned to recruit 3000 test positives and 3000 test negatives but have since extended our target. Data visualisation techniques will be used to examine trajectories over time for symptoms and variables measured repeatedly, separately by original test status. Summary measures of fatigue and mental health dimensions will be generated using dimension reduction methods such as latent variables/latent class/principal component analysis methods. Cross-tabulation of collected and derived variables against test status and discriminant analysis will help operationalise preliminary definitions of Long COVID.Ethics and disseminationResearch Ethics Committee approval granted. Data will be stored in secure Public Health England servers or University College London’s Data Safe Haven. Risks of harm will be minimised by providing information on where to seek support. Results will be published on a preprint server followed by journal publication, with reuse of articles under a CC BY licence. Data will be published with protection against identification when there are small frequencies involved.Trial registration numberISRCTN34804192; Pre-results.
Spironolactone for adult female acne (SAFA): protocol for a double-blind, placebo-controlled, phase III randomised study of spironolactone as systemic therapy for acne in adult women
Authors: Renz Susanne , Chinnery Fay , Stuart Beth , Day Laura , Muller Ingrid , Soulsby Irene , Nuttall Jacqui , Thomas Karen , Thomas Kim Suzanne , Sach Tracey , Stanton Louise , Ridd Matthew J , Francis Nick , Little Paul , Eminton Zina , Griffiths Gareth , Layton Alison M , Santer Miriam 
Published: August 2021

IntroductionAcne is one of the most common inflammatory skin diseases worldwide and can have significant psychosocial impact and cause permanent scarring. Spironolactone, a potassium-sparing diuretic, has antiandrogenic properties, potentially reducing sebum production and hyperkeratinisation in acne-prone follicles. Dermatologists have prescribed spironolactone for acne in women for over 30 years, but robust clinical study data are lacking. This study seeks to evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women.Methods and analysisWomen (≥18 years) with persistent facial acne requiring systemic therapy are randomised to receive one tablet per day of 50 mg spironolactone or a matched placebo until week 6, increasing to up to two tablets per day (total of 100 mg spironolactone or matched placebo) until week 24, along with usual topical therapy if desired. Study treatment stops at week 24; participants are informed of their treatment allocation and enter an unblinded observational follow-up period for up to 6 months (up to week 52 after baseline). Primary outcome is the Acne-specific Quality of Life (Acne-QoL) symptom subscale score at week 12. Secondary outcomes include Acne-QoL total and subscales; participant acne self-assessment recorded on a 6-point Likert scale at 6, 12, 24 weeks and up to 52 weeks; Investigator’s Global Assessment at weeks 6 and 12; cost and cost effectiveness are assessed over 24 weeks. Aiming to detect a group difference of 2 points on the Acne-QoL symptom subscale (SD 5.8, effect size 0.35), allowing for 20% loss to follow-up, gives a sample size of 398 participants.Ethics and disseminationThis protocol was approved by Wales Research Ethics Committee (18/WA/0420). Follow-up to be completed in early 2022. Findings will be disseminated to participants, peer-reviewed journals, networks and patient groups, on social media, on the study website and the Southampton Clinical Trials Unit website to maximise impact.Trial registration numberISRCTN12892056;Pre-results.
MATHEMATICAL MODELING OF PANCREATIC CANCER TREATMENT WITH CANCER STEM CELLS
Authors: YILDIZ TUĞBA AKMAN , KÖSE EMEK , ELLIOTT SAMANTHA L. 
Published: August 2021

Of all cancers, pancreatic cancer has a significantly low rate of survival, mostly due to lack of early screening. Thus, once detected, pancreatic cancer is usually in later stages, reducing the likelihood of full recovery. The most common treatment strategy is chemotherapy, although several immunotherapeutic drugs show promising results in extending the patient’s lifespan. In this paper, we provide a validated mathematical model for the pancreatic cancer after fitting the parameter values, such as tumor growth rate, inverse carrying capacity, activation and decay rate of pancreatic stellate cells, with the use of the experimental data presented by Cioffi et al. cioffi2015inhibition For treatments with the chemotherapeutic drugs, Abraxane and Gemcitabine, and the immunotherapeutic drug, Anti-CD47, we modified the model accurately and compared the simulation results with the experimental data not only to model pancreatic cancer treatment correctly but also to move forward with other drug trials. Then, we include the cancer stem cells, which are known to initiate tumors and cause a relapse post-chemotherapy, per cancer stem cell hypothesis so that cancer progression can be assessed based on this phenomenon. In addition, we investigate optimal drug protocols. We find out that the most effective treatment is dual therapy due to extending survival time when compared to other drugs. Moreover, this study reveals that drug dose is more effectual than frequency of drug injection on account of different treatment scheduling with the same dose over a week. The model could be a starting point to investigate pancreatic cancer progression based on cancer stem cell hypothesis and shed light on novel drug discoveries.
Statins Are Associated With Increased Insulin Resistance and Secretion
Authors: Abbasi Fahim , Lamendola Cindy , Harris Chelsea S. , Harris Vander , Tsai Ming-Shian , Tripathi Pragya , Abbas Fakhar , Reaven Gerald M. , Reaven Peter D. , Snyder Michael P. , Kim Sun H. , Knowles Joshua W. 
Published: August 2021

Objective:
Statin treatment reduces the risk of atherosclerotic cardiovascular disease but is associated with a modest increased risk of type 2 diabetes, especially in those with insulin resistance or prediabetes. Our objective was to determine the physiological mechanism for the increased type 2 diabetes risk.

Approach and Results:

We conducted an open-label clinical trial of atorvastatin 40 mg daily in adults without known atherosclerotic cardiovascular disease or type 2 diabetes at baseline. The co-primary outcomes were changes at 10 weeks versus baseline in insulin resistance as assessed by steady-state plasma glucose during the insulin suppression test and insulin secretion as assessed by insulin secretion rate area under the curve (ISR
AUC
) during the graded-glucose infusion test. Secondary outcomes included glucose and insulin, both fasting and during oral glucose tolerance test. Of 75 participants who enrolled, 71 completed the study (median age 61 years, 37% women, 65% non-Hispanic White, median body mass index, 27.8 kg/m
2
). Atorvastatin reduced LDL (low-density lipoprotein)-cholesterol (median decrease 53%,
P
<0.001) but did not change body weight. Compared with baseline, atorvastatin increased insulin resistance (steady-state plasma glucose) by a median of 8% (
P
=0.01) and insulin secretion (ISR
AUC
) by a median of 9% (
P
<0.001). There were small increases in oral glucose tolerance test glucose
AUC
(median increase, 0.05%;
P
=0.03) and fasting insulin (median increase, 7%;
P
=0.01).

Conclusions:
In individuals without type 2 diabetes, high-intensity atorvastatin for 10 weeks increases insulin resistance and insulin secretion. Over time, the risk of new-onset diabetes with statin use may increase in individuals who become more insulin resistant but are unable to maintain compensatory increases in insulin secretion.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02437084.

Graphic Abstract:
A graphic abstract is available for this article.