bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study protocol for a prospective cohort study examining the predictive potential of dynamic symptom networks for the onset and progression of psychosis: the Mapping Individual Routes of Risk and Resilience (Mirorr) study
Authors: Booij Sanne H , Wichers Marieke , de Jonge Peter , Sytema Sjoerd , van Os Jim , Wunderink Lex , Wigman Johanna T W 
Published: March 2023

IntroductionOur current ability to predict the course and outcome of early psychotic symptoms is limited, hampering timely treatment. To improve our understanding of the development of psychosis, a different approach to psychopathology may be productive. We propose to reconceptualise psychopathology from a network perspective, according to which symptoms act as a dynamic, interconnected system, impacting on each other over time and across diagnostic boundaries to form symptom networks. Adopting this network approach, the Mapping Individual Routes of Risk and Resilience study aims to determine whether characteristics of symptom networks can predict illness course and outcome of early psychotic symptoms.Methods and analysisThe sample consists of n=100 participants aged 18–35 years, divided into four subgroups (n=4×25) with increasing levels of severity of psychopathology, representing successive stages of clinical progression. Individuals representing the initial stage have a relatively low expression of psychotic experiences (general population), whereas individuals representing the end stage are help seeking and display a psychometric expression of psychosis, putting them at ultra-high risk for transition to psychotic disorder. At baseline and 1-year follow-up, participants report their symptoms, affective states and experiences for three consecutive months in short, daily questionnaires on their smartphone, which will be used to map individual networks. Network parameters, including the strength and directionality of symptom connections and centrality indices, will be estimated and associated to individual differences in and within-individual progression through stages of clinical severity and functioning over the next 3 years.Ethics and disseminationThe study has been approved by the local medical ethical committee (ABR no. NL52974.042.15). The results of the study will be published in (inter)national peer-reviewed journals, presented at research, clinical and general public conferences. The results will assist in improving and fine-tuning dynamic models of psychopathology, stimulating both clinical and scientific progress.Trial registration numberNTR6205; Pre-results.
Incidence rate of community-acquired pneumonia in adults: a population-based prospective active surveillance study in three cities in South America
Authors: Lopardo Gustavo Daniel , Fridman Diego , Raimondo Enrique , Albornoz Henry , Lopardo Ana , Bagnulo Homero , Goleniuk Daniel , Sanabria Manuelita , Stamboulian Daniel 
Published: March 2023

ObjectiveTo determine the incidence rate and mortality of community-acquired pneumonia (CAP) in adults in three cities in Latin America during a 3-year period.DesignProspective population-based surveillance study.SettingHealthcare facilities (outpatient centres and hospitals) in the cities of General Roca (Argentina), Rivera (Uruguay) and Concepción (Paraguay).Participants2302 adults aged 18 years and older with CAP were prospectively enrolled between January 2012 and March 2015.Main outcome measuresIncidence rates of CAP in adults, predisposing conditions for disease, mortality at 14 days and at 1 year were estimated. Incidence rate of CAP, within each age group, was calculated by dividing the number of cases by the person-years of disease-free exposure time based on the last census; incidence rates were expressed per 1000 person-years.ResultsMedian age of participants was 66 years, 46.44% were men, 68% were hospitalised. Annual incidence rate was 7.03 (95% CI 6.64 to 7.44) per 1000 person-years in General Roca, 6.33 (95% CI 5.92 to 6.78) per 1000 person-years in Rivera and 1.76 (95% CI 1.55 to 2.00) per 1000 person-years in Concepción. Incidence rates were highest in participants aged over 65 years. 82.4% had at least one predisposing condition and 48% had two or more (multimorbidity). Chronic heart disease (43.6%) and smoking (37.3%) were the most common risk factors. 14-day mortality rate was 12.1% and 1-year mortality was 24.9%. Multimorbidity was associated with an increased risk of death at 14 days (OR 2.91; 95% CI 2.23 to 3.80) and at 1 year (OR 3.00; 95% CI 2.44 to 3.70).ConclusionsWe found a high incidence rate of CAP in adults, ranging from 1.76 to 7.03 per 1000 person-years, in three cities in South America, disclosing the high burden of disease in the region. Efforts to improve prevention strategies are needed.
PlenadrEMA: effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments: a study protocol for an open-label switch pilot study
Authors: Boesen Victor Brun , Christoffersen Thea , Watt Torquil , Borresen Stina Willemoes , Klose Marianne , Feldt-Rasmussen Ulla 
Published: March 2023

IntroductionPatients with adrenal insufficiency have impaired health-related quality of life (QoL). The dual-release hydrocortisone preparation, Plenadren, has been developed to mimic the physiological cortisol release more closely than conventional hydrocortisone treatment. Plenadren has been shown to improve QoL, in particular fatigue, in patients with primary adrenal insufficiency. However, the effect has not been investigated in patients with secondary adrenal insufficiency; furthermore, no study has taken the diurnal variation of fatigue into account. To assess diurnal variations, it is necessary to use repeated daily measurements, such as ecological momentary assessments (EMAs). This study aims to evaluate EMAs of fatigue as outcome in future large-scale randomised clinical trials.Methods and analysisThe PlenadrEMA trial is an investigator-initiated open-label switch pilot trial of the effect of Plenadren versus conventional hydrocortisone on fatigue in patients with secondary adrenal insufficiency. The trial will include 30 participants. After 5 weeks on their usual hydrocortisone treatment, patients will be shifted to Plenadren for 16 weeks. Fatigue will be assessed using momentary versions of the Multidimensional Fatigue Inventory (MFI-20). Items will be administered to participants via a smartphone application four times daily during 20 days. Assessments will be performed before treatment shift and repeated after 12.5 weeks on Plenadren. The study will identify the best suited outcome for future randomised clinical trials, and in addition, estimate the variability and difference in fatigue between the two treatments to perform power calculations.Ethics and disseminationThe trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee in Copenhagen (ID: H-1-2014-073). All patients will receive written and verbal information about the trial and will give informed consent before enrolment. Findings will be published in peer-reviewed journals and presented at international conferences.Trial registration numberEudraCT201400203932.
Normal saline instillation versus no normal saline instillation And lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction: the NARES trial. A study protocol for a pilot, factorial randomised controlled trial
Authors: Schults Jessica A , Cooke Marie , Long Debbie A , Schibler Andreas , Ware Robert S , Mitchell Marion L 
Published: March 2023

IntroductionEndotracheal suction (ETS) is a frequent and necessary airway intervention for the intubated child. The aim of ETS is to clear the endotracheal tube and airways of respiratory secretions; however, the methods of performing ETS are varied. Internationally a number of ETS treatments are in use. Many have not been rigorously evaluated in a randomised controlled trial setting, and it is uncertain whether any are associated with better outcomes for the critically ill child. With approximately 50% of paediatric intensive care admissions requiring intubation, ETS interventions that maximise the efficacy and minimise the complications of ETS could translate to improved health for substantial numbers of critically ill children, and significant cost savings. The primary aim of the study is to examine two ETS interventions, normal saline instillation and lung recruitment, to determine if it is feasible to conduct a full efficacy trial.Methods and analysisNARES (Normal saline instillation versus no normal saline instillation And lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction) is a single-centre, pilot, factorial randomised controlled trial conducted in a tertiary referral paediatric centre in Brisbane, Australia. Children (aged 0–16 years) are eligible if they are intubated with an endotracheal tube and mechanically ventilated. Two intervention pairs will be compared using a 2×2 factorial design: (1) normal saline instillation versus no normal saline instillation; and (2) lung recruitment versus no lung recruitment. The primary outcome is study feasibility measured by a composite analysis of eligibility, recruitment, retention, protocol adherence and missing data. Secondary outcomes are ventilator-associated pneumonia, SpO2/FiO2ratio, lung compliance, end expiratory level and regional tidal volume.Ethics and disseminationEthical approval to conduct the research has been obtained. Dissemination of the research findings will be untaken, guided by the Consolidated Standards of Reporting Trials statement recommendations. Protocol content was guided by the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement.Trial registration numberACTRN12617000609358; Pre-results.
Income and obesity: what is the direction of the relationship? A systematic review and meta-analysis
Authors: Kim Tae Jun , von dem Knesebeck Olaf 
Published: March 2023

ObjectiveIt was repeatedly shown that lower income is associated with higher risks for subsequent obesity. However, the perspective of a potential reverse causality is often neglected, in which obesity is considered a cause for lower income, when obese people drift into lower-income jobs due to labour–market discrimination and public stigmatisation. This review was performed to explore the direction of the relation between income and obesity by specifically assessing the importance of social causation and reverse causality.DesignSystematic review and meta-analysis.MethodsA systematic literature search was conducted in January 2017. The databases Medline, PsycINFO, Sociological Abstracts, International Bibliography of Social Sciences and Sociological Index were screened to identify prospective cohort studies with quantitative data on the relation between income and obesity. Meta-analytic methods were applied using random-effect models, and the quality of studies assessed with the Newcastle-Ottawa Scale.ResultsIn total, 21 studies were eligible for meta-analysis. All included studies originated from either the USA (n=16), the UK (n=3) or Canada (n=2). From these, 14 studies on causation and 7 studies on reverse causality were found. Meta-analyses revealed that lower income is associated with subsequent obesity (OR 1.27, 95% CI 1.10 to 1.47; risk ratio 1.52, 95% CI 1.08 to 2.13), though the statistical significance vanished once adjusted for publication bias. Studies on reverse causality indicated a more consistent relation between obesity and subsequent income, even after taking publication bias into account (standardised mean difference −0.15, 95% CI −0.30 to 0.01). Sensitivity analyses implied that the association is influenced by obesity measurement, gender, length of observation and study quality.ConclusionsFindings suggest that there is more consistent evidence for reverse causality. Therefore, there is a need to examine reverse causality processes in more detail to understand the relation between income and obesity.PROSPERO registration number42016041296.
Cardiovascular toxicity of targeted therapies for cancer: a protocol for an overview of systematic reviews
Authors: van Leeuwen Marina T , Luu Steven , Gurney Howard , Brown Martin R , Webber Kate , Pearson Sallie-Anne , Hunt Lee , Vajdic Claire M 
Published: March 2023

IntroductionThe introduction of targeted therapies for cancer has contributed to dramatic improvements in patient survival. Nevertheless, several targeted therapies have been associated with ‘off-target’ adverse effects, based on varying levels of evidence. To date, this evidence has not been systematically synthesised. We will synthesise published systematic review evidence of cardiovascular toxicity associated with targeted cancer therapies.Methods and analysisWe will include systematic reviews of randomised controlled trials and observational studies that report on cardiovascular outcomes for individual agents. We will identify systematic reviews by applying predeveloped, standardised search strategies within Embase, Medline and Cochrane Central. Two independent reviewers will identify reviews published up to 31 December 2016 using predefined eligibility criteria. They will resolve ambiguous cases through consensus, arbitrated by a third reviewer if required. The reviewers will extract and report data according to methodological guidelines for overviews provided by the Cochrane Collaboration, Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. They will assess the quality of included reviews by applying the Assessment of Multiple Systematic Reviews tool. They will judge the quality of evidence in included reviews based on their assessment of bias and incorporation into the interpretation of findings. In synthesising the evidence, we will classify agents based on systematic review evidence of toxicity (sufficient, probable, possible or indeterminate) for specific cardiovascular outcomes (congestive heart failure, myocardial infarction, ischaemic heart disease, left ventricular ejection fraction decline, cerebrovascular disease, pulmonary embolism, thrombosis and hypertension). This will provide clinicians and patients with an accessible synthesis based on robust methodology.Ethics and disseminationEthics approval is not required for overviews. We will conduct the study in collaboration with consumer representatives. We will submit results for peer-review publication, and disseminate them through established clinical and consumer networks.PROSPERO registration numberCRD42017080014.
Career orientation and its impact factors of general practitioners in Shanghai, China: a cross-sectional study
Authors: Wang Jian , Zhao Qi , Liu Tianwei , An Melissa , Pan Zhigang 
Published: March 2023

ObjectivesTo understand the career orientation and impact factors of general practitioners (GPs) in Shanghai.DesignA cross-sectional study was carried out from August 2014 to December 2015 using the Career Orientations Inventory (short form).Setting and participantsWe conducted a cross-sectional study of 1159 GPs, of which 1067 (92.06%) completed the assessment tools, from 223 community healthcare centres in ShanghaiResultsThe top career orientation was organisational job security (71.60%), followed by technical competence (12.18%). Compared with female GPs, male GPs scored higher in managerial competence (p<0.001), creativity and entrepreneurship (p<0.001), and lower in organisational job security (p=0.034). Compared with GPs younger than 40, those aged 40 years and older scored higher in sense of service (p=0.003) and lower in autonomy (p=0.022) and lifestyle integration (p=0.039). Compared with GPs with lower education levels, those with at least a bachelor’s degree scored higher in managerial competence (p=0.001 and autonomy (p=0.025). In addition, those with fewer than 10 years of work experience scored higher in managerial competence (p=0.008) and scored lower in geographical security (p=0.032) compared with GPs with longer durations of work experience. GPs with senior professional positions scored higher in technical competence (p=0.012) compared with those with lower professional positions.ConclusionsThe search for job stability and the lack of career prospect planning are two factors that impact community GP growth. Individualised skills training and career development planning should be provided to GPs of specific genders, educational background and vocational competence, in order to enhance their job satisfaction and service quality, thereby achieving retention of this staff group.
Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial
Authors: Nordenskjöld Jesper , Lauritzson Anna , Waldén Markus , Kopylov Philippe , Atroshi Isam 
Published: March 2023

IntroductionThere is no definitive cure for Dupuytren disease (DD), and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for recurrence, although associated with a high incidence of complications. Collagenase injection, a non-surgical treatment option, has been shown to be a safe and effective method; however, most studies regarding collagenase have involved first-time treatment. Collagenase efficacy in patients with recurrent DD beyond the immediate effect has not yet been determined. The aim of our study is to compare surgical fasciectomy and collagenase injection in treating recurrent DD.Methods and analysisThe study is a single-centre randomised controlled trial. Inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, and a palpable cord causing the recurrent contracture. A total of 56 patients will be randomised to either surgical fasciectomy or collagenase injection. A hand therapist blinded to patients’ group allocation will measure range of motion at baseline, 3 months, 12 months, 24 months and 60 months. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20° in the treated finger joint at 2 years compared with 3 months. The secondary outcomes include changes in total active motion, active and passive extension deficit from baseline up to 5 years, scores on patient-reported outcome measures, adverse events and costs of treatment.Ethics and disseminationEthical approval has been obtained from the Regional Ethical Review Board, Lund University, Sweden(2017/623). The trial will be conducted according to the Helsinki Declaration of 1975, revised in 2000. The results of the trial will be disseminated as published articles in peer-reviewed journals.Trial registrationNCT03406338; Pre-results.
Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial
Authors: Kjølhede Preben , Bergdahl Olga , Borendal Wodlin Ninnie , Nilsson Lena 
Published: March 2023

ObjectivesWe aimed to determine whether regional analgesia with intrathecal morphine (ITM) in an enhanced recovery programme (enhanced recovery after surgery [ERAS]) gives a shorter hospital stay with good pain relief and equal health-related quality of life (QoL) to epidural analgesia (EDA) in women after midline laparotomy for proven or assumed gynaecological malignancies.DesignAn open-label, randomised, single-centre study.SettingA tertiary referral Swedish university hospital.ParticipantsEighty women, 18–70 years of age, American Society of Anesthesiologists I and II, admitted consecutively to the department of Obstetrics and Gynaecology.InterventionsThe women were allocated (1:1) to either the standard analgesic method at the clinic (EDA) or the experimental treatment (ITM). An ERAS protocol with standardised perioperative routines and standardised general anaesthesia were applied. The EDA or ITM started immediately preoperatively. The ITM group received morphine, clonidine and bupivacaine intrathecally; the EDA group had an epidural infusion of bupivacaine, adrenalin and fentanyl.Primary and secondary outcome measuresPrimary endpoint was length of hospital stay (LOS). Secondary endpoints were QoL and pain assessments.ResultsLOS was statistically significantly shorter for the ITM group compared with the EDA group (median [IQR]3.3 [1.5–56.3] vs 4.3 [2.2–43.2] days; p=0.01). No differences were observed in pain assessment or QoL. The ITM group used postoperatively the first week significantly less opioids than the EDA group (median (IQR) 20 mg (14–35 mg) vs 81 mg (67–101 mg); p<0.0001). No serious adverse events were attributed to ITM or EDA.ConclusionsCompared with EDA, ITM is simpler to administer and manage, is associated with shorter hospital stay and reduces opioid consumption postoperatively with an equally good QoL. ITM is effective as postoperative analgesia in gynaecological cancer surgery.Trial registration numberNCT02026687; Results.
Coaching Ongoing Momentum Building On stroKe rEcovery journeY (’COMBO-KEY'): a randomised controlled trial protocol
Authors: Lo Suzanne Hoi Shan , Chau Janita Pak Chun , Chang Anne Marie , Choi Kai Chow , Wong Rebecca Yee Man , Kwan Jackie Cheuk Yin 
Published: March 2023

IntroductionSystematic reviews reporting self-management interventions are associated with significant improvements in stroke survivors’ self-efficacy, health-related quality of life (HRQoL) and independence. However, common barriers such as transportation and availability of carers were identified. Health coaching is suggested as an innovative and cost-effective care model with potential benefits in managing chronic diseases. A randomised controlled trial is proposed to evaluate the effectiveness of an enhanced self-management programme by health coaches on stroke survivors’ recovery outcomes.Methods and analysisAll adult community-dwelling stroke survivors with a modified Rankin Scale Score ≥3 will be recruited from a community rehabilitation network. Eligible participants will be randomly allocated to receive either the enhanced stroke self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY [COMBO-KEY]) plus usual care or usual care only. COMBO-KEY is an 8-week programme underpinned by Bandura’s principles of self-efficacy and outcome expectation. It consists of four home visits and five phone-coaching sessions delivered by trained health coaches. Each participant will receive a resource package containing a workbook, a quick reference guide, a planning toolkit and 15 videos of peer survivors’ stroke survival experience. Survivors’ outcomes include self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours, HRQoL, depressive symptoms and community reintegration. Assessment will be conducted at baseline and immediately after completing the programme. Generalised estimating equations' model will be used to analyse the data.DiscussionIt is anticipated that the programme will build community capacity in supporting stroke survivors. The results will shed light on integrating the programme into the current stroke rehabilitation services.Ethics and disseminationThe Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has approved this protocol (CREC Ref. No.: 2018.009). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.Trial registration numberClinicalTrials.gov Identifier:NCT03741842; Pre-results