bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH)
Authors: Yang Chun , Hui Jiyuan , Xie Li , Feng Junfeng , Jiang Jiyao 
Published: March 2022

IntroductionControversy and variation exist in surgical management for acute epidural haematoma (AEDH). Although craniotomy for AEDH is conventionally employed, no specific evaluation on the necessity of decompressive craniectomy (DC) followed by AEDH evacuation has been performed.Methods and analysisThis is a multicentre prospective, phase III observational study that evaluates different surgical managements for the AEDH. Patients of both genders, aged 18–65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH, complying with other inclusion and exclusion criteria, are enrolled. Clinical information, including diagnosis of AEDH, radiological information, treatment procedures and follow-up data of 1, 3 and 6 months post-injury, is collected on 2000 eligible patients among 263 hospitals in China. Recruitment for the study started in April 2021, and inclusion will be continued until the sample size is obtained, expected is an inclusion period of 24 months. The interventions of concern are surgical treatments for AEDH, including craniotomy and DC. The primary outcome is the Glasgow Outcome Score-Extended 6 months post-injury. Secondary outcomes include the incidence of postoperative cerebral infarction, the incidence of additional craniocerebral surgery and other evaluation indicators within 6 months post-injury.Ethics and disseminationThe study protocol has been approved by the ethics committee and institutional review board of Renji Hospital, School of Medicine, Shanghai Jiao Tong University. All study investigators strictly follow the Declaration of Helsinki and Human Biomedical Research Ethical Issues. Signed written informed consent will be obtained from all enrolled patients. The trial results will be disseminated through academic conferences and published in peer-reviewed journals.Trial registration numberNCT04229966.
Effectiveness of a workplace intervention to reduce workplace bullying and violence at work: study protocol for a two-wave quasi-experimental intervention study
Authors: Ervasti Jenni , Seppälä Piia , Olin Nina , Kalavainen Susanna , Heikkilä Heli , Aalto Ville , Kivimäki Mika 
Published: March 2022

IntroductionBullying and violence at work are relatively common in Finnish public sector workplaces. Previous research has demonstrated their association with increased risk of poor health and well-being, but only few intervention studies exist. The aim of this protocol paper is to describe the development and assessment of the effectiveness of a workplace intervention aimed at reducing these harmful phenomena.Methods and analysisThis protocol describes a two-wave quasi-experimental intervention. Each of the three participating Finnish public sector organisations (cities) will select four work units (a total of 450–500 employees) to participate in an intervention including 2–3 workshops for the work unit, 2–3 consultative meetings with the supervisor of the work unit, a follow-up meeting for the entire work unit (a maximum of 6-month time lag) and online meetings with the supervisor to monitor achievements and discuss about difficult cases, if any. Three age-matched, sex-matched and occupation-matched controls for each participants of the intervention group will be randomly selected, a total 1350–1500 individuals in the control group. For intervention and control groups, premeasurement is based on responses to a survey that was conducted in 2020. Postintervention measurement will be based on survey responses in 2022. Data will be analysed using latent change score modelling or difference-in-difference analysis.Ethics and disseminationEthics approvals are from the Ethics committees of the Helsinki and Uusimaa hospital district and the Finnish institute of Occupational Health. Results will be made available to participating organisations and their employees, the funder and other researchers via open access article in a peer-reviewed journal and subsequent reporting of the results via social media channels and press release to the public.
Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
Authors: Christensen Thomas Decker , Bendixen Morten , Skaarup Søren Helbo , Jensen Jens-Ulrik , Petersen Rene Horsleben , Christensen Merete , Licht Peter , Neckelmann Kirsten , Bibby Bo Martin , Møller Lars B , Bodtger Uffe , Borg Morten Hornemann , Saghir Zaigham , Langfeldt Sten , Harders Stefan M W , Bedawi Eihab O , Naidu Babu , Rahman Najib , Laursen Christian B 
Published: March 2022

IntroductionPleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment.Methods and analysisA national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life.Ethics and disseminationAll patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www.clinicaltrials.gov, and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences.Trial registration numberNCT04095676.
Prevalence and predictors of drug-related hospitalisation among patients visiting emergency departments of Addis Ababa city hospitals in Ethiopia: a multicentre prospective observational study
Authors: Demessie Mulate Belete , Berha Alemseged Beyene 
Published: March 2022

ObjectivesThis study aimed to determine the prevalence, categories and predictors of drug-related hospitalisation (DRH) among patients visiting emergency departments of Addis Ababa city hospitals, Ethiopia.DesignA multicentre prospective observational study was conducted through patients’ interview and chart review.SettingsThe study was undertaken in three tertiary care hospitals in Addis Ababa, Ethiopia.ParticipantsA total of 423 patients fulfilling the inclusion criteria were included.Outcome measuresPrevalence and preventability of DRH, categories of drug-related problems causing DRH, medications and diseases involved in DRH, and factors significantly associated with DRH.ResultMore than half of the patients (216, 51.1%) were female. The mean age (SD) was 47.50 (±17.21) years. The mean length of hospital stay (SD) was 10.29 (±8.99) days. Nearly 60% (249) of them were hospitalised due to drug-related problems, of which 87.8% were preventable. The cause for hospitalisation for more than half (130, 53%) of them was a failure to receive drugs, and 37.85 (94) patients were categorised as untreated indications. Age ≥65 years (adjusted OR (AOR)=7.451, 95% CI: 1.889 to 29.397), tertiary educational level (AOR=0.360, 95% CI: 0.141 to 0.923), participants who did not have any occupation (AOR=3.409, 95% CI: 1.120 to 10.374) and presence of comorbid conditions (AOR=2.004, 95% CI: 1.095 to 3.668) were predictors of DRH.ConclusionNearly 90% of DRH was deemed to be preventable in the study settings. Older age, lower educational level, unemployment and presence of comorbid conditions in hospital as an inpatient were predictors of DRH.
Preventing type 2 diabetes, overweight and obesity in the Norwegian primary healthcare: a longitudinal design with 60 months follow-up results and a cross-sectional design with comparison of dropouts versus completers
Authors: Følling Ingrid Sørdal , Klöckner Christian , Devle Monica Tømmervold , Kulseng Bård 
Published: March 2022

ObjectivesStudies have demonstrated that it is possible to prevent type 2 diabetes for individuals at high risk, but long-term results in the primary healthcare are limited and high dropout rates have been reported.DesignA longitudinal design was used to study changes in participants’ diabetes risk and anthropometrics from baseline to 60 months follow-up. A cross-sectional design was applied to investigate differences between dropouts and completers of the 60 months follow-up.SettingHealthy Life Centres in the Norwegian primary healthcare.Participants189 individuals aged >18 years with a Finnish Diabetes Risk Score ≥12 and/or a body mass index (BMI) ≥25 kg/m2 were included and offered to attend Healthy Life Centre programmes for 12 months. Measurements were performed annually up to 60 months after inclusion.InterventionsHealthy Life Centres arrange behavioural programmes including physical activity offers and dietary courses as part of the primary healthcare. This study offered individuals to attend Healthy Life Centre programmes and followed them for 60 months.Primary outcomeAssess changes in participants’ diabetes risk, cardiovascular measures and anthropometrics from baseline to 60 months.Secondary outcomeInvestigate characteristics of dropouts compared with completers of 60 months follow-up.ResultsFor participants at 60 months follow-up, diabetes risk and anthropometrics decreased (p<0.001). Out of 65 participants classified as high risk for diabetes at baseline, 27 (42%) changed to being at moderate risk at 60 months follow-up. Remission of diabetes was seen for six of nine participants. Of 189 participants enrolled in the programme, 54 (31%) dropped out at any given point before 60 months follow-up. Dropouts were younger with higher, BMI, weight and waist circumference compared with the completers (p<0.001).ConclusionsHaving a long-term commitment for participants in primary healthcare interventions could be beneficial for the reduction of diabetes risk and improvement of anthropometrics as shown at the 60 months follow-up.Trial registration numberNCT01135901.
Behavioural approaches to recruitment and retention in clinical trials: a systematic mapping review
Authors: Coffey Taylor , Duncan Eilidh M , Morgan Heather , Lawrie Louisa , Gillies Katie 
Published: March 2022

ObjectivesTo identify studies that applied behavioural approaches to issues of recruitment and/or retention to trials; to describe these approaches; and to identify gaps for future research.DesignSystematic mapping review of research undertaken in clinical trials within peer-reviewed sources. Review participants were individuals involved in clinical trials, including trial staff, participants, potential participants and former participants.Data sourcesMEDLINE, EMBASE, CINAHL, ERIC, PsycINFO, Web of Science and ASSIA from inception to 15 January 2020 with no date or language restrictions.Eligibility criteriaStudies within the context of clinical trials reporting the barriers/facilitators to recruitment and retention, or developing/evaluating solutions to said barriers/facilitators, using a behavioural approach.Results31 articles were included. Recruitment-focused studies (n=22, 71%) represented the majority. Studies tended to focus on participant behaviours (n=22, 71%). Underserved populations (n=11, 35%) were a notable subset of studies. Most studies (n=23, 74%) were exploratory but those that evaluated interventions (n=8, 26%) often did so within underserved populations (n=6). A majority of studies (n=30, 97%) did not specify their behaviours consistent with guidelines from behavioural scientists. The most used approaches were social cognitive theory (n=8, 26%), the theory of planned behaviour (n=6, 19%) and the theoretical domains framework (n=5, 16%).ConclusionsA range of behavioural approaches have been applied to recruitment and retention to trials. The multitude of recruitment research here is consistent with trials research generally and emphasises the need for research into retention. Authors report target behaviours minimally, which is not conducive to replication. Further research should build on lessons here, such as clearly specifying behaviours. Increased methodological rigour and transparency will lead to robust evidence bases and less research waste in poor recruitment and retention. Overall, trials informed by behavioural approaches promises to be efficient and more participant focused.
What is the definition of acute episodic and chronic pain in critically ill neonates and infants? A global, four-stage consensus and validation study
Authors: Ilhan Emre , Pacey Verity , Brown Laura , Spence Kaye , van Ganzewinkel Christ-jan , Pillai Riddell Rebecca , Campbell-Yeo Marsha , Stevens Bonnie J , Eriksson Mats , Shah Vibhuti , Anand Kanwaljeet J S , Bellieni Carlo , Daly Mandy , Johnston Celeste , Hush Julia 
Published: March 2022

ObjectivesTo define and validate types of pain in critically ill neonates and infants by researchers and clinicians working in the neonatal intensive care unit (NICU) and high dependency unit (HDU).DesignA qualitative descriptive mixed-methods design.Procedure/sEach stage of the study was built on and confirmed the previous stages. Stage 1 was an expert panel to develop definitions; stage 2 was a different expert panel made up of neonatal clinicians to propose clinical characteristics associated with the definitions from stage 1; stage 3 was a focus group of neonatal clinicians to provide clinical case scenarios associated with each definition and clinical characteristics; and stage 4 was a survey administered to neonatal clinicians internationally to test the validity of the definitions using the clinical case scenarios.ResultsIn stage 1, the panel (n=10) developed consensus definitions for acute episodic pain and chronic pain in neonates and infants. In stage 2, a panel (n=8) established clinical characteristics that may be associated with each definition. In stage 3, a focus group (n=11) created clinical case scenarios of neonates and infants with acute episodic pain, chronic pain and no pain using the definitions and clinical characteristics. In stage 4, the survey (n=182) revealed that the definitions allowed an excellent level of discrimination between case scenarios that described neonates and infants with acute episodic pain and chronic pain (area under the receiver operating characteristic=0.87 and 0.89, respectively).ConclusionsThis four-stage study enabled the development of consensus-based and clinically valid definitions of acute episodic pain and chronic pain. There is a need to define and validate other pain types to inform a taxonomy of pain experienced by neonates and infants in the NICU and HDU.
What is the healthcare utilisation and out-of-pocket expenditure associated with osteoarthritis? A cross-sectional study
Authors: Sibbritt David , Sundberg Tobias , Ward Lesley , Broom Alex , Frawley Jane , Bayes Jessica , Adams Jon 
Published: March 2022

ObjectiveTo examine the use and out-of-pocket expenses resulting from consultations, products and practices across conventional, self-care, and complementary medicine (CM) treatments for osteoarthritis (OA) among Australian women.Design, setting and participantsA cross-sectional survey of 800 women from the 45 and Up Study who had reported a clinical diagnosis of OA.Outcome measuresWomen’s use of conventional, CM and self-prescribed treatments for OA and the associated out-of-pocket cost.ResultsCompleted questionnaires were returned by 403 women (50.4%). Their average time since the first diagnosis of OA was 15.4 years, and self-rated severity of OA was 5.1 (out of 10) over the past 12 months. During the previous year, 67.0% of the women consulted a doctor, 39.2% consulted an allied health practitioner and 34.7% consulted a CM practitioner for their OA. Some women (19%) consulted with practitioner(s) from all three practitioner groups, 27% consulted with practitioner(s) from two of the three practitioner groups, while 6% consulted with a CM practitioner only. Women with a greater time since diagnosis had more consultations, as did women who rated their OA as more severe. Women’s average combined out-of-pocket expenditure for OA-related healthcare consultations, prescription medications, products, and practices was $673 per annum. Extrapolated to all Australian women with OA, aged 50 years and over, the total out-of-pocket expenditure for this condition is estimated to be $873 million per annum.ConclusionsAustralian women with OA use a range of conventional and CM consultations, self-care, products and practices to manage their condition, incurring significant out-of-pocket expenses. Given the high individual and societal burden of OA, there is a need for further research into the concurrent use of different healthcare resources with a view to providing safe, cost-effective management of OA across the healthcare system and the wider community.
Psychological stress; knowledge, attitude and practice and acceptance of antiviral therapy in pregnant women with hepatitis B in Zhejiang, China: a case comparison study
Authors: Liu Xiaoxiao , Chen Can , Jiang Daixi , Yan Danying , Zhou Yuqing , Ding Cheng , Lan Lei , Huang Chenyang , Zhang Xiaobao , Li Lanjuan , Yang Shigui 
Published: March 2022

ObjectivesTo determine knowledge, attitude and practice (KAP) and antiviral therapy’s acceptance during pregnancy of pregnant women with hepatitis B and influencing factors.DesignCase-comparison study.SettingThe study was conducted in Zhejiang province, China, from September 2019 to December 2020.ParticipantsPregnant and postpartum women with chronic hepatitis B.Primary and secondary outcome measuresThe stress scores, self-assessed health score, KAP, antiviral therapy’s acceptance rate during pregnancy and influencing factors were analysed. The Perceived Stress Scale-10 was used to assess stress. Logistic regression was used to analyse influencing factors on antiviral therapy.ResultsThe self-assessed health score of pregnant women without liver diseases (82.4±9.3) was significantly higher than that of pregnant women with chronic hepatitis B (75.5±9.5) and postpartum (75.1±14.1). Psychological stress of pregnant women with chronic hepatitis B was significantly high with a 14.9±3.6 score, but there was no significant difference between hepatitis B postpartum and non-liver disease women (12.7±3.5 vs 12.9±3.5, p=0.75). The acceptance rate of pregnant women with hepatitis B for antiviral therapy was 84.2%, while that of postpartum women was even higher. Logistic regression analysis showed that patients with positive hepatitis B e antigen (HBeAg) (OR, 3.35; 95% CI, 1.21 to 9.26) and higher scores on hepatitis B-related knowledge (OR, 3.52, 95% CI, 2.18 to 5.69) were more likely to accept antiviral therapy during pregnancy.ConclusionsPregnant women with hepatitis B in Zhejiang have heavy psychological stress and a high antiviral therapy acceptance rate during pregnancy. Acceptance is related to HBeAg status and level of understanding of hepatitis B during pregnancy. It is necessary to provide education on hepatitis B to reduce psychological stress and increase acceptance of antiviral therapy during pregnancy.
Does left atrial epicardial conduction time reflect atrial fibrosis and the risk of atrial fibrillation recurrence after thoracoscopic ablation? Post hoc analysis of the AFACT trial
Authors: Wesselink R , Neefs J , van den Berg N W E , Meulendijks E R , Terpstra M M , Kawasaki M , Nariswari F A , Piersma F R , van Boven W J P , Driessen A H G , de Groot J R 
Published: March 2022

ObjectivesTo determine the association between left atrial epicardial conduction time (LAECT), fibrosis and atrial fibrillation (AF) recurrence after thoracoscopic surgical ablation of persistent AF.SettingSingle tertiary care centre in the Netherlands.ParticipantsPatients with persistent AF from the randomised Atrial Fibrillation Ablation and Autonomic Modulation via Thoracoscopic Surgery (AFACT)-trial were included. Patients eligible for thoracoscopic AF ablation were included, full inclusion and exclusion criteria were previously published. All patients underwent thoracoscopic ablation, encompassing pulmonary vein isolation with an additional roof and trigone lesion. In patients with conduction block across the roof and trigone lesion, LAECT was measured. LAECT was defined as the time to local activation at one side of the roofline on pacing from the opposite side. Collagen fibre density was quantified from left atrial appendage histology.Outcome measuresPrimary outcome: AF recurrence during 2 years of follow-up.Results121 patients were included, of whom 35(29%) were women, age was 60.4±7.8 and 51% (62) had at least one AF recurrence during 2 years of follow-up. LAECT was longer in patients with versus without AF recurrence (182±43 ms vs 147±29 ms, p<0.001). LAECT was longer in older patients, in patients with a higher body mass index (BMI) and in patients using class IC antiarrhythmic drugs. LAECT was shorter in patients with higher collagen fibre density. A previously failed catheter ablation, LAECT and BMI were independently associated with AF recurrence.ConclusionLAECT is correlated with collagen fibre density and BMI and is independently associated with AF recurrence in patients with persistent AF. In these patients, LAECT appears to reflect substrate characteristics beyond clinical AF type and left atrial volume.Trial registration numberNCT01091389.