bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness of sitagliptin compared to sulfonylureas for type 2 diabetes mellitus inadequately controlled on metformin: a systematic review and meta-analysis
Authors: Sharma Manuj , Beckley Nicholas , Nazareth Irwin , Petersen Irene 
Published: May 2024

ObjectiveTo assess the effectiveness of sitagliptin compared to sulfonylureas as add-on to metformin in adults with type 2 diabetes mellitus from both randomised controlled trials (RCTs) and ‘real-world’ non-randomised studies.Methods and analysesWe conducted a systematic review of EMBASE, MEDLINE, CENTRAL and grey literature for RCTs and non-randomised studies. We reported outcomes relating to change in HbA1c, fasting glucose, weight, blood pressure and lipids from baseline and need for treatment change. No study investigating macrovascular and microvascular diabetes complications was found. Meta-analysis was used where studies were sufficiently homogenous.ResultsSeven RCTs and five non-randomised studies were eligible for inclusion from 1335 articles retrieved. Meta-analysis of three homogenous RCTs revealed a statistically significant decrease in weight with sitagliptin when compared to sulfonylureas (weighted mean difference (WMD) −2.05 kg; 95% CI −2.38 to −1.71); however, a similar change from baseline in HbA1c (WMD 0.05; 95% CI −0.03 to 0.12), fasting glucose (WMD 0.11; 95% CI −0.08 to –0.29), blood pressure, lipids and the proportion achieving HbA1c <7% by study end (OR 0.98; 95% CI 0.85 to 1.13) was observed.Non-randomised studies identified consisted of four prospective and one retrospective cohort study. Three of these five studies were of moderate/high quality, and results though less precise suggested similar real-world comparative glycaemic and weight effectiveness for both treatments. Data from two cohort studies suggested that treatment change (HR 0.65; 95% CI 0.57 to 0.73) and insulin initiation (HR 0.76; 95% CI 0.65 to 0.90) were less likely among those prescribed sitagliptin; however, inadequate reporting of HbA1c at time of treatment change made interpreting results challenging.ConclusionSitagliptin users experienced modest weight loss compared to gain with sulfonylureas; however, this difference was around 2 kg, which may not be of major clinical significance for most individuals. Similar change was observed across most other effectiveness outcomes reported. Further studies are needed to address longer-term effectiveness outcomes for sitagliptin compared to sulfonylureas as add-on to metformin.PROSPERO registration numberCRD42016033983.
Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol
Authors: Day Richard O , Frensham Lauren J , Nguyen Amy D , Baysari Melissa T , Aung Eindra , Lau Annie Y S , Zwar Nicholas , Reath Jennifer , Laba Tracey , Li Ling , McLachlan Andrew , Runciman William B , Buchbinder Rachelle , Clay-Williams Robyn , Coiera Enrico , Braithwaite Jeffrey , McNeil H Patrick , Hunter David J , Pile Kevin D , Portek Ian , WIlliams Kenneth Mapson , Westbrook Johanna I 
Published: May 2024

IntroductionGout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate-lowering therapy (ULT) is poor, with rates of less than 50% 1 year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. We aim to evaluate the effectiveness of use of a personal, self-management, ‘smartphone’ application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT.Methods and analysisSetting and designPrimary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.ParticipantsGP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.InterventionThe intervention group will have access to the Healthy.me app tailored for the self-management of gout. The control group patients will have access to the same app modified to remove all functions except the Gout Attack Diary.Primary and secondary outcomesThe proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes will be proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a ≥30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed ‘dropout’ rate 20%.Ethics and disseminationThis study has been approved by the University of New South Wales Human Research Ethics Committee. Study findings will be disseminated in international conferences and peer-reviewed journal.Trial registration numberACTRN12616000455460.
Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory)
Authors: Myint Phyo Kyaw , Loke Yoon K , Davison William , Mattishent Katharina , Fox George Christopher , Fleetcroft Robert , Turner David , Shepstone Lee , Potter John F 
Published: May 2024

IntroductionStroke is a leading cause of death and disability. The development of dementia after stroke is common. Vascular risk factors (VRF) which contribute to stroke risk can also contribute to cognitive decline, especially in vascular dementia (VaD). There is no established treatment for VaD, therefore strategies for prevention could have major health resource implications. This study was designed to assess whether patients with early cognitive decline after stroke/transient ischaemic attack (TIA) can be easily identified and whether target-driven VRF management can prevent progression to dementia.ObjectivesThe primary objective is to establish the feasibility of recruitment and retention of patients with early cognitive decline to a randomised controlled trial of enhanced VRF management. Secondary objectives include: (a) to determine the potential clinical benefit of the intervention; (b) to estimate the sample size for a future definitive multicentre randomised controlled trial; (c) to inform a future economic evaluation; (d) to explore the link between VRF control and the incidence of cognitive impairment on longitudinal follow-up in a UK population after stroke/TIA with current routine management.Methods100 patients with cognitive decline poststroke/TIA will be recruited from stroke services at the Norfolk and Norwich University Hospital. After collection of baseline data, they will be randomised to intervention (3 monthly follow-up with enhanced management) or control (treatment as usual by the general practitioner). At 12 months outcomes (repeat cognitive testing, VRF assessment) will be assessed. A further 100 patients without cognitive decline will be recruited to a parallel observational group from the same site. At 12 months they will have repeat cognitive testing.Ethics and disseminationEthical approval has been granted in England. Dissemination is planned via publication in peer-reviewed medical journals and presentation at relevant conferences.Trial registration number42688361; Pre-results.
Thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial
Authors: Barnett Adrian Gerard , Stewart Ian , Beevers Andrea , Fraser John F , Platts David 
Published: May 2024

ObjectiveTo examine whether providing thermal clothing improved the health of patients with heart failure during winter.DesignParallel group randomised controlled trial.SettingLarge public hospital in Brisbane during winter 2016.Participants91 patients with systolic or diastolic heart failure who were over 50 years old.Intervention47 patients were randomised to receive thermal clothes (socks, top and hat) and 44 received usual care. Patients could not be blinded to their randomised group. All patients’ data were available for the primary outcome which was collected blind to randomised group.Main outcome measuresThe primary outcome was the mean number of days in hospital during winter. Secondary outcomes included quality of life and sleep, and blood tests were collected for cardiovascular risk factors. Participants completed clothing diaries in midwinter which were used to estimate their overall clothing insulation using the ‘clo’. Monitors inside the participants’ homes recorded indoor temperatures throughout winter.ResultsThe mean number of days in hospital during winter was 4.2 in the usual care group and 3.0 in the thermal clothing group (mean difference –1.2 days, 95% CI –4.8 to 2.5 days). Most participants (85%) in the thermal clothing group reported using the thermals. There was an increase in overall clothing insulation at night in the thermal clothing group (mean difference 0.13 clo, 95% CI 0.03 to 0.23). Most participants in both groups did not wear sufficient clothing (defined as a clo below 1) and regularly experienced indoor temperatures below 18°C during midwinter.ConclusionsThere was no clear statistical improvement in health in the thermal clothing group. Efforts to improve health during winter may need to focus on passive interventions such as home insulation rather than interventions that target behaviour change.Trial registration numberACTRN12615001023549; Results.
Protocol for the melatools skin self-monitoring trial: a phase II randomised controlled trial of an intervention for primary care patients at higher risk of melanoma
Authors: Mills Katie , Emery Jon , Lantaff Rebecca , Radford Michael , Pannebakker Merel , Hall Per , Burrows Nigel , Williams Kate , Saunders Catherine L , Murchie Peter , Walter Fiona M 
Published: May 2024

IntroductionMelanoma is the fifth most common cancer in the UK. Incidence rates have quadrupled over the last 30 years and continue to rise, especially among younger people. As routine screening of the general population is not currently recommended in the UK, a focus on secondary prevention through early detection and prompt treatment in individuals at increased risk of melanoma could make an important contribution to improve melanoma outcomes. This paper describes the protocol for a phase II, multisite, randomised controlled trial, in the primary care setting, for patients at increased risk of melanoma. A skin self-monitoring (SSM) smartphone ‘App’ was used to improve symptom appraisal and encourage help seeking in primary care, thereby promoting early presentation with skin changes suspicious of melanoma.Methods and analysisWe aim to recruit 200 participants from general practice waiting rooms in the East of England. Eligible patients are those identified at higher melanoma risk (using a real-time risk assessment tool), without a personal history of melanoma, aged 18 to 75 years. Participants will be invited to a primary care nurse consultation, and randomised to the intervention group (standard written advice on skin cancer detection and sun protection, loading of an SSM ‘App’ onto the participant’s smartphone and instructions on use including self-monitoring reminders) or control group (standard written advice alone). The primary outcomes are consultation rates for changes to a pigmented skin lesion, and the patient interval (time from first noticing a skin change to consultation). Secondary outcomes include patient sun protection behaviours, psychosocial outcomes, and measures of trial feasibility and acceptability.Ethics and disseminationNHS ethical approval has been obtained from Cambridgeshire and Hertfordshire research ethics committee (REC reference 16/EE/0248). The findings from the MelaTools SSM Trial will be disseminated widely through peer-reviewed publications and scientific conferences.Trial registration numberISRCTN16061621.
Observational study of factors associated with return of home sampling kits for sexually transmitted infections requested online in the UK
Authors: Manavi Kaveh , Hodson James 
Published: May 2024

ObjectivesTo investigate factors associated with the return of home sampling kits for sexually transmitted infections (STIs).SettingOnline STI testing service offered to the residents of Birmingham and Solihull.ParticipantsAll patients requesting STI home sampling kits via the Umbrella sexual health service website between 15 July 2016 and 14 December 2016.InterventionsAssociations between data collected at online registration and the rate of return of STI home sampling kits within 30 days of request was assessed.ResultsA total of 5310 kits were requested, of which 3099 (58.4%) were returned to the medical microbiology laboratory. On multivariable analysis, women and men who have sex with men were similarly likely to return their sampling kits (adjusted OR (ORadj) 1.06, 95% CI 0.86 to 1.30), while heterosexual men were significantly less likely to return their sampling kits (ORadj0.63, 95% CI 0.55 to 0.72, p<0.001 vs women). Patients reporting symptoms were also less likely to return kits (ORadj0.77, 95% CI 0.67 to 0.89, p=0.001 vs asymptomatic patients). Kits that were delivered to the patient’s home, rather than to a clinic or pharmacy (p<0.001), and those requested from less economically deprived neighbourhoods (p=0.029) were significantly more likely to be returned.ConclusionSTI self-sampling testing kits delivered to patients’ homes are most likely to be returned. Heterosexual men and those from more economically deprived areas are the less likely groups to return the kits. Further research on the barriers to return self-sampling STI testing kits of these subgroups of patients is warranted.Trial registration numberRegistered with R&D department at University Hospitals Birmingham; CARMS-13551.
Dementia Population Risk Tool (DemPoRT): study protocol for a predictive algorithm assessing dementia risk in the community
Authors: Fisher Stacey , Hsu Amy , Mojaverian Nassim , Taljaard Monica , Huyer Gregory , Manuel Douglas G , Tanuseputro Peter 
Published: May 2024

IntroductionThe burden of disease from dementia is a growing global concern as incidence increases dramatically with age, and average life expectancy has been increasing around the world. Planning for an ageing population requires reliable projections of dementia prevalence; however, existing population projections are simple and have poor predictive accuracy. The Dementia Population Risk Tool (DemPoRT) will predict incidence of dementia in the population setting using multivariable modelling techniques and will be used to project dementia prevalence.Methods and analysisThe derivation cohort will consist of elderly Ontario respondents of the Canadian Community Health Survey (CCHS) (2001, 2003, 2005 and 2007; 18 764 males and 25 288 females). Prespecified predictors include sociodemographic, general health, behavioural, functional and health condition variables. Incident dementia will be identified through individual linkage of survey respondents to population-level administrative healthcare databases (1797 and 3281 events, and 117 795 and 166 573 person-years of follow-up, for males and females, respectively, until 31 March 2014). Using time of first dementia capture as the primary outcome and death as a competing risk, sex-specific proportional hazards regression models will be estimated. The 2008/2009 CCHS survey will be used for validation (approximately 4600 males and 6300 females). Overall calibration and discrimination will be assessed as well as calibration within predefined subgroups of importance to clinicians and policy makers.Ethics and disseminationResearch ethics approval has been granted by the Ottawa Health Science Network Research Ethics Board. DemPoRT results will be submitted for publication in peer-review journals and presented at scientific meetings. The algorithm will be assessable online for both population and individual uses.Trial registration numberClinicalTrials.govNCT03155815, pre-results.
Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial)
Authors: Knaapen Max , van der Lee Johanna H , Bakx Roel , The Sarah-May L , van Heurn Ernst W E , Heij Hugo A , Gorter Ramon R 
Published: May 2024

IntroductionBased on epidemiological, immunological and pathology data, the idea that appendicitis is not necessarily a progressive disease is gaining ground. Two types are distinguished: simple and complicated appendicitis. Non-operative treatment (NOT) of children with simple appendicitis has been investigated in several small studies. So far, it is deemed safe. However, its effectiveness and effect on quality of life (QoL) have yet to be established in an adequately powered randomised trial. In this article, we provide the study protocol for the APAC (Antibiotics versus Primary Appendectomy in Children) trial.Methods and analysisThis multicentre, non-inferiority, randomised controlled trial randomises children aged 7–17 years with imaging-confirmed simple appendicitis between appendectomy and NOT. Patients are recruited in 15 hospitals. The intended sample size, based on the primary outcome, rate of complications and a non-inferiority margin of 5%, is 334 patients.NOT consists of intravenous antibiotics for 48–72 hours, daily blood tests and ultrasound follow-up. If the patient meets the predefined discharge criteria, antibiotic treatment is continued orally at home. Primary outcome is the rate of complications at 1-year follow-up. An independent adjudication committee will assess all complications and their relation to the allocated treatment. Secondary outcomes include, but are not limited to, delayed appendectomies, QoL, pain and (in)direct costs.The primary outcome will be analysed both according to the intention-to-treat principle and the per-protocol principle, and is presented with a one-sided 97.5% CI. We will use multiple logistic and linear regression for binary and continuous outcomes, respectively, to adjust for stratification factors.Ethics and disseminationThe protocol has been approved by the Medical Ethics Review Committee of the Academic Medical Center, Amsterdam. Data monitoring is performed by an independent institute and a Data Safety Monitoring Board has been assigned. Results will be presented in peer-reviewed academic journals and at (international) conferences.Trial registration numberNCT02848820; NTR5977; Pre-results.
Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intraocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial
Authors: van der Aa Hilde P A , van Rens Ger H M B , Verbraak Frank D , Bosscha Machteld , Koopmanschap Marc A , Comijs Hannie C , Cuijpers Pim , van Nispen Ruth M A 
Published: May 2024

IntroductionBecause of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients’ mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive–behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner.Methods and analysisAn economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months.Ethics and disseminationThe study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations.Trial registrationhttp://www.trialregister.nl, identifier: NTR6337.
What are the experiences of seeking, receiving and providing FGM-related healthcare? Perspectives of health professionals and women/girls who have undergone FGM: protocol for a systematic review of qualitative evidence
Authors: Evans Catrin , Tweheyo Ritah , McGarry Julie , Eldridge Jeanette , McCormick Carol , Nkoyo Valentine , Higginbottom Gina Marie Awoko 
Published: May 2024

IntroductionFemale genital mutilation (FGM) is an issue of global concern. High levels of migration mean that healthcare systems in higher-income western countries are increasingly being challenged to respond to the care needs of affected communities. Research has identified significant challenges in the provision of, and access to, FGM-related healthcare. There is a lack of confidence and competence among health professionals in providing appropriate care, suggesting an urgent need for evidence-based service development in this area. This study will involve two systematic reviews of qualitative evidence to explore the experiences, needs, barriers and facilitators to seeking and providing FGM-related healthcare in high-income (Organisation for Economic Cooperation and Development) countries, from the perspectives of: (1) women and girls who have undergone FGM and (2) health professionals.Review methodsTwelve databases including MEDLINE, EMBASE, PsycINFO, ASSIA, Web of Science, ERIC, CINAHL, and POPLINE will be searched with no limits on publication year. Relevant grey literature will be identified from digital sources and professional networks.Two reviewers will independently screen, select and critically appraise the studies. Study quality will be assessed using the Joanna Briggs Institute Qualitative Assessment and Review Instrument appraisal tool. Findings will be extracted into NVivo software. Synthesis will involve inductive thematic analysis, including in-depth reading, line by line coding of the findings, development of descriptive themes and re-coding to higher level analytical themes. Confidence in the review findings will be assessed using the CERQual approach. Findings will be integrated into a comprehensive set of recommendations for research, policy and practice.DisseminationThe syntheses will be reported as per the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) statement. Two reviews will be published in peer-reviewed journals and an integrated report disseminated at stakeholder engagement events.PROSPERO registration numberCRD42015030001: 2015 and CRD42015030004: 2015.