bluuebunny/crossref_metadata_2025_split huggingface dataset:
LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty
Authors: Löwik Claudia A M , Wagenaar Frank-Christiaan , van der Weegen Walter , Poolman Rudolf W , Nelissen Rob G H H , Bulstra Sjoerd K , Pronk Yvette , Vermeulen Karin M , Wouthuyzen-Bakker Marjan , van den Akker-Scheek Inge , Stevens Martin , Jutte Paul C 
Published: May 2024

IntroductionTotal hip arthroplasty (THA) and total knee arthroplasty (TKA) are highly successful treatment modalities for advanced osteoarthritis. However, prolonged wound leakage after arthroplasty is linked to prosthetic joint infection (PJI), which is a potentially devastating complication. On the one hand, wound leakage is reported as a risk factor for PJI with a leaking wound acting as aporte d’entréefor micro-organisms. On the other hand, prolonged wound leakage can be a symptom of PJI. Literature addressing prolonged wound leakage is scarce, contradictory and of poor methodological quality. Hence, treatment of prolonged wound leakage varies considerably with both non-surgical and surgical treatment modalities. There is a definite need for evidence concerning the best way to treat prolonged wound leakage after joint arthroplasty.Methods and analysisA prospective nationwide randomised controlled trial will be conducted in 35 hospitals in the Netherlands. The goal is to include 388 patients with persistent wound leakage 9–10 days after THA or TKA. These patients will be randomly allocated to non-surgical treatment (pressure bandages, (bed) rest and wound care) or surgical treatment (debridement, antibiotics and implant retention (DAIR)). DAIR will also be performed on all non-surgically treated patients with persistent wound leakage at day 16–17 after index surgery, regardless of amount of wound leakage, other clinical parameters or C reactive protein. Clinical data are entered into a web-based database. Patients are asked to fill in questionnaires about disease-specific outcomes, quality of life and cost effectiveness at 3, 6 and 12 months after surgery. Primary outcome is the number of revision surgeries due to infection within a year of arthroplasty.Ethics and disseminationThe Review Board of each participating hospital has approved the local feasibility. The results will be published in peer-reviewed scientific journals.Trial registration numberNTR5960;Pre-results.
Can weSave the rectum by watchful waiting orTransAnal microsurgery following (chemo)Radiotherapy versusTotal mesorectal excision for earlyREctalCancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study
Authors: Rombouts Anouk J M , Al-Najami Issam , Abbott Natalie L , Appelt Ane , Baatrup Gunnar , Bach Simon , Bhangu Aneel , Garm Spindler Karen-Lise , Gray Richard , Handley Kelly , Kaur Manjinder , Kerkhof Ellen , Kronborg Camilla Jensenius , Magill Laura , Marijnen Corrie A M , Nagtegaal Iris D , Nyvang Lars , Peters Femke P , Pfeiffer Per , Punt Cornelis , Quirke Philip , Sebag-Montefiore David , Teo Mark , West Nick , de Wilt Johannes H W 
Published: May 2024

IntroductionTotal mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.Methods and analysisSTAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.Ethics and disseminationThe medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.Trial registration numberISRCTN14240288, 20 October 2016.NCT02945566; Pre-results, October 2016.
Exercise and adiposity in overweight and obese children and adolescents: protocol for a systematic review and network meta-analysis of randomised trials
Authors: Kelley George A , Kelley Kristi S , Pate Russell R 
Published: May 2024

IntroductionOverweight and obesity is a worldwide public health problem among children and adolescents. However, the magnitude of effect, as well as hierarchy of exercise interventions (aerobic, strength training or both), on selected measures of adiposity is not well established despite numerous trials on this issue. The primary purposes of this study are to use the network meta-analytical approach to determine the effects and hierarchy of exercise interventions on selected measures of adiposity in overweight and obese children and adolescents.Methods and analysisRandomised exercise intervention trials >4 weeks, available in any language up to 31 August 2017 and which include direct and/or indirect evidence, will be included. Studies will be located by searching seven electronic databases, cross-referencing and expert review. Dual selection and abstraction of data will occur. The primary outcomes will be changes in body mass index (in kg/m2), fat mass and percent body fat. Risk of bias will be assessed using the Cochrane Risk of Bias assessment instrument while confidence in the cumulative evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation instrument for network meta-analysis. Network meta-analysis will be performed using multivariate random-effects meta-regression models. The surface under the cumulative ranking curve will be used to provide a hierarchy of exercise treatments (aerobic, strength or both).Ethics and disseminationThis study does not require ethics approval. Findings will be presented at a professional conference and published in a peer-reviewed journal.PROSPERO registration numberCRD42017073103.
Interrupted versus continuous suturing for vesicourethral anastomosis during radical prostatectomy: protocol for a systematic review and meta-analysis
Authors: Kowalewski Karl Friedrich , Tapking Christian , Hetjens Svetlana , Nickel Felix , Mandel Philipp , Ritter Manuel , Kriegmair Maximilian Christian 
Published: May 2024

IntroductionRadical prostatectomy is the mainstay of treatment for prostate cancer. The vesicourethral anastomosis is a critical step, which most likely impacts urinary continence and urethral stenosis. To date, it still remains unclear whether interrupted and continuous suturing for the anastomosis have different outcomes. Therefore, the aim of this systematic review and meta-analysis is to compare different suture techniques for vesicourethral anastomosis in terms of surgical and functional parameters.Methods and analysisA comprehensive literature search will be conducted covering MEDLINE, Embase, Web of Science, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov. Studies comparing interrupted versus continuous suturing will be included in the analyses. No language restrictions will be applied. Screening, data extraction, statistical analysis and reporting will be done in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Quality assessment will be performed with the help of the Cochrane Collaboration’s tool for assessing risk of bias and the Newcastle-Ottawa Scale for assessing quality of non-randomised studies. The quality of evidence will be evaluated with the Grading of Recommendations Assessment, Development and Evaluation. The primary outcome will be the time until removal of the urinary catheter. Secondary outcomes include rate of extravasation, length of hospital stay, time needed to perform the anastomosis, continence level at defined postoperative intervals and development of urethral strictures. Quantitative analysis will be calculated if meaningful.Ethics and disseminationIn order to meet the highest ethical and methodological standards. we followed the PRISMA Protocol 2015 checklist. Each item was answered appropriately. For systematic reviews the ethical issues are strictly methodological as only data that were published earlier will be used. The full manuscript will be submitted to a peer-reviewed journal. Furthermore, the results will be presented on national and international congresses.Trial registration numberInternational prospective register of systematic reviews PROSPERO CRD42017076126.
DARE-ISC model for prediction of 1-year ischaemic stroke risk in the general population and atrial fibrillation patients: a Danish nationwide cohort study
Authors: Bruun-Jensen Mikkel , Winther Simon , Schmidt Samuel Emil , Møller Dahl Christian 
Published: May 2024

ObjectivesTo develop a risk assessment model (DAnish REgister Ischaemic Stroke Classifier, DARE-ISC) for predicting 1-year primary ischaemic stroke/systemic embolism (SE) in the general population. Secondly, to validate the accuracy DARE-ISC in atrial fibrillation (AF) patients where well-established models and risk scores exist.DesignRetrospective cohort study. DARE-ISC was developed using gradient boosting decision trees with information from 375 covariates including baseline information on relevant diagnoses, demographic characteristics, registered health-services, lifestyle-related covariates, hereditary stroke components, drug prescriptions and stress proxies.SettingDanish nationwide registries.ParticipantsAll Danish individuals aged ≥18 from 2010 to 2017 (n=35 519 348 person-years). The model was trained on the 2010–2016 cohorts with validation in the 2017 cohort.Primary and secondary outcome measuresModel optimisation and validation were performed through comparison of the area under the receiver operating characteristic curve (AUC) and average precision scores. Additionally, the relative importance of the model covariates was derived using SHAP values.ResultsDARE-ISC had an AUC (95% CI) of 0.874 (0.871 to 0.876) in the general population. In AF patients, DARE-ISC was superior to the GARFIELD-AF risk model and CHA2DS2-VASc score with AUC of 0.779 (95% CI 0.75 to 0.806), 0.704 (95% CI 0.674 to 0.732) and 0.681 (95% CI 0.652 to 0.709), respectively. Furthermore, in AF patients, DARE-ISC had an average threefold and fourfold higher ratio of correctly identified strokes compared with the GARFIELD-AF risk model and CHA2DS2-VASc score, as indicated by average precision scores of 0.119, 0.041 and 0.034, respectively.ConclusionsDARE-ISC had a very high stroke prediction accuracy in the general population and was superior to the GARFIELD-AF risk model and CHA2DS2-VASc score for predicting ischaemic stroke/SE in AF patients.
Anaesthetic and perioperative considerations for extrapleural pneumonectomy and extended pleurectomy/decortication: a scoping review protocol
Authors: Yip Sui Wah Sean , Weinberg Laurence , Gooi Julian , Sivenayagam Siven , Coulson Tim G , Barnett Stephen A , Knight Simon R , Ludski Jarryd , Lee Dong Kyu 
Published: May 2024

IntroductionExtrapleural pneumonectomy (EPP) and extended pleurectomy/decortication (ePD) are surgical cytoreductive techniques aimed at achieving macroscopic resection in malignant pleural tumours such as pleural mesothelioma, non-mesothelioma pleural malignancies such as thymoma and sarcoma, and rarely for pleural tuberculosis, in a more limited fashion. Despite extensive studies on both surgical techniques and consequences, a significant knowledge gap remains regarding how best to approach the perioperative anaesthesia challenges for EPP and ePD.It is unknown if the risk stratification processes for such surgeries are standardised or what types of functional and dynamic cardiac and pulmonary tests are employed preoperatively to assist in the perioperative risk stratification. Further, it is unknown whether the types of anaesthesia and analgesia techniques employed, and the types of haemodynamic monitoring tools used, impact on outcomes. It is also unknown whether individualised haemodynamic protocols are used to guide the rational use of fluids, vasoactive drugs and inotropes.Finally, there is a dearth of evidence regarding how best to monitor these patients postoperatively or what the most effective enhanced recovery protocols are to best mitigate postoperative complications and accelerate hospital discharge. To increase our knowledge of the perioperative and anaesthetic treatment for patients undergoing EPP/ePD, this scoping review attempts to synthesise the literature and identify these knowledge gaps.Methods and analysisThis scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols methodology. Electronic databases, OVID Medline, EMBASE and the Cochrane Library, will be systematically searched for relevant literature corresponding to EPP or ePD and perioperative or anaesthetic management. Data will be analysed and summarised descriptively and organised according to the three perioperative stages: preoperative, intraoperative and postoperative factors in clinical care.Ethics and disseminationEthics approval was not required. The findings will be disseminated through professional networks, conference presentations and publications in scientific journals.
Effect of metformin use on graft and patient survival in kidney transplant recipients with type 2 diabetes: a systematic review protocol
Authors: Shamshad Farooq , Tungsanga Somkanya , Senior Peter , Shojai Soroush , Ghimire Anukul , Ye Feng , Kung Janice Y , Hariramani Vinash K , Abdulrahman Abdullah , Penney Matthew , Sultana Naima , Muneer Shezel , Okpechi Ikechi , Bello Aminu K 
Published: May 2024

IntroductionMetformin is a first-line antihyperglycaemic agent for type 2 diabetes (T2DM). In addition to glycaemic control, it offers benefits related to cardiovascular health, weight neutrality and metabolic syndrome. However, its benefits in kidney transplant recipients remain unclear as metformin use is controversial in this population due to a lack of evidence and there are recommendations against its use in patients with poor kidney function. Hence, we seek to describe a protocol for a systematic review, which will assess the impact of metformin use on graft survival and mortality in kidney transplant recipients.MethodsThis protocol was guided by the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015. We will search empirical databases such as MEDLINE, Embase, Cochrane Library, CINAHL and Web of Science Core Collection for relevant studies conducted in kidney transplant recipients using metformin, which report outcomes related to graft and patient survival. All studies meeting these criteria in adults and published in English from inception to 2023 will be included in our review. We will employ the Cochrane Risk of Bias Tool 2 for randomised controlled trials and the Risk of Bias in Non-randomised Studies of Intervention for non-randomised studies. We will present our data and study characteristics in a table format and determine if a meta-analysis can be performed by clinical and methodological heterogeneity, using the I2statistics. If a meta-analysis cannot be performed, we will provide a narrative synthesis of included studies using the Synthesis Without Meta-Analysis Reporting Guideline.Ethics and disseminationEthical approval will not be required for this review as the data used will be extracted from already published studies with publicly accessible data. As this study will assess the impact of metformin use on graft and patient survival in kidney transplant recipients, evidence gathered through it will be disseminated using traditional approaches that include open-access peer-reviewed publication, scientific presentations and a report. We will also disseminate our findings to appropriate academic bodies in charge of publishing guidelines related to T2DM and transplantation, as well as patient and research centred groups.PROSPERO registration numberCRD42023421799.
Birang Daruganora: what do Aboriginal and Torres Strait Islander communities need in a new hospital? A qualitative study
Authors: Austin Elizabeth E , Carrigan Ann , Holden Narelle , Grigg Shai , Maka Katherine , Clay-Williams Robyn , Hibbert Peter D , Loy Graeme , Braithwaite Jeffrey 
Published: May 2024

ObjectivesTo elicit the Aboriginal community’s cultural and healthcare needs and views about six prominent and emerging models of care, to inform the development of a new hospital.DesignCross-sectional qualitative study co-designed and co-implemented by Aboriginal team members.SettingWestern Sydney, New South Wales, Australia.ParticipantsAboriginal and Torres Strait Islander healthcare providers (n=2) and community members (n=18) aged between 21 and 60+ years participated in yarning circles (20 participants; 14 female, 6 male).ResultsHandwritten notes from yarning circles were inductively analysed to synthesise the cultural and healthcare needs of providers and community members in relation to a new hospital and six models of care. Three primary themes emerged in relation to future hospitals. These were ‘culturally responsive spaces’, ‘culturally responsive systems’ and ‘culturally responsive models of care’. Strengths (eg, comfort, reduced waiting time, holistic care), barriers (eg, logistics, accessibility, literacy) and enablers (eg, patient navigator role, communication pathways, streamlined processes) were identified for each of the six models of care.ConclusionsAboriginal and Torres Strait Islander community members and providers are invested in the co-creation of an innovative, well-integrated hospital that meets the needs of the community. Common themes of respect and recognition, relationships and partnering, and capacity building emerged as important consumer and provider considerations when developing and evaluating care services. Participants supported a range of models citing concerns about accessibility and choice when discussing evidence-based models of care.
Explorative observational study of Dutch patient–clinician interactions: operationalisation of personal perspective elicitation as part of shared decision-making in real-life audio-recorded consultations
Authors: Rake Ester A , Meinders Marjan J , Brand Guus , Dreesens Dunja , Kremer Jan A M , Elwyn Glyn , Aarts Johanna W M 
Published: May 2024

ObjectivesPatients’ preferences, values and contexts are important elements of the shared decision-making (SDM) process. We captured those elements into the concept of ‘personal perspective elicitation’ (PPE), which reflects the need to elicit patients’ preferences, values and contexts in patient–clinician conversations. We defined PPE as: ‘the disclosure (either elicited by the clinician or spontaneously expressed by the patient) of information related to the patient’s personal preferences, values and/or contexts potentially relevant to decision-making’. Our goal was to operationalise the concept of PPE through the evaluation of preferences, values and contexts and explore how PPE occurs in clinical encounters.DesignCross-sectional study: observational coding based on a novel coding scheme of audio-recorded outpatient clinical encounters where encounter patient decision aids were applied.SettingWe audio-recorded patient–clinician interactions at three Dutch outpatient clinics. PPE was analysed using a novel observational coding scheme, distinguishing preferences, contexts and four Armstrong taxonomy value types (global, decisional, external and situational). We measured SDM using the Observer OPTION5.ParticipantsTwenty patients who suffered from psoriasis or ovarian cysts; four clinicians.ResultsWe included 20 audio-recordings. The mean Observer OPTION5score was 57.5 (SD:10.1). The audio-recordings gave a rich illustration of preferences, values and contexts that were discussed in the patient–clinician interactions. Examples of identified global values: appearance, beliefs, personality traits. Decisional values were related to the process of decision-making. External values related to asking advice from for example, the clinician or significant others. An identified situational value: a new job ahead. Contexts related to how the illness impacted the life (eg, sexuality, family, sports, work life) of patients.ConclusionsThe operationalisation of PPE, an important aspect of SDM, explores which preferences, values and contexts were discussed during patient–clinician interactions where an ePDA was used. The coding scheme appeared feasible to apply but needs further refinement.
Effectiveness of combining prevention psychological interventions with interventions that address the social determinants of mental health in low and middle-income countries: protocol of a systematic review and meta-analysis
Authors: Prina Eleonora , Bano Beatrice , Singh Rakesh , Albanese Emiliano , Trujillo Daniela , Dedios Sanguineti María Cecilia , Sorsdahl Katherine , Luitel Nagendra P , Garman Emily C , Purgato Marianna , Barbui Corrado , Jordans Mark J D , Lund Crick 
Published: May 2024

IntroductionCommon mental health conditions (CMHCs), including depression, anxiety and post-traumatic stress disorder (PTSD), are highly prevalent in low and middle-income countries (LMICs). Preventive strategies combining psychological interventions with interventions addressing the social determinants of mental health may represent a key strategy for effectively preventing CMHCs. However, no systematic reviews have evaluated the effectiveness of these combined intervention strategies for preventing CMHCs.Methods and analysisThis systematic review will include randomised controlled trials (RCTs) focused on the effectiveness of interventions that combine preventive psychological interventions with interventions that address the social determinants of mental health in LMICs. Primary outcome is the frequency of depression, anxiety or PTSD at postintervention as determined by a formal diagnostic tool or any other standardised criteria. We will search Epistemonikos, Cochrane Controlled Trials Register (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL, Global Index Medicus, ClinicalTrials.gov (Ctgov), International Clinical Trials Registry Platform (ICTRP). Two reviewers will independently extract the data and evaluate the risk of bias of included studies using the Cochrane risk of bias tool 2. Random-effects meta-analyses will be performed, and certainty of evidence will be rated using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationThis study uses data from published studies; therefore, ethical review is not required. Findings will be presented in a published manuscript.Trial registration numberCRD42023451072