bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pain Neuroscience Education in elective surgery patients: study protocol for a randomised controlled trial
Authors: de Souza Raquel Pereira , Lopes Laura Borges , Carmo Anne Caroline Nunes , Machado Paula Muniz , de Andrade Joanlise Marco Leon , Funez Mani Indiana 
Published: March 2024

BackgroundPain Neuroscience Education (PNE) consists of an educational strategy that seeks to understand the biological processes of pain and how to control it. The main objective of this study will be to evaluate the impact of PNE on outcomes related to the postoperative period. The hypothesis is that the intervention may positively influence postoperative recovery, contributing to pain control, clinical indications, acceptance and consumption of analgesics and other pharmacological drugs that contribute to its control, as well as psychological aspects, such as anxiety, depression and pain catastrophising.Methods and analysisThis will be an open, parallel, multicentre and randomised controlled clinical trial. A total of 100 participants aged between 18 and 59 years of age, of both genders, who are going to have elective general surgery will be evaluated. The intervention group will participate in a preoperative pain neuroscience educational session and also receive usual preoperative care, while the control group receives usual preoperative care as well. The educational session will last 30 min and consists of a video (5:20 min), a questionnaire about the content, time for participants to express their beliefs, thoughts and doubts. Participants will be evaluated preoperatively and there will be one postintervention evaluation. The intensity and characteristics of pain and anxiety are evaluated as primary outcomes. As secondary outcomes, pain catastrophising and depression are taken into account.Ethics and disseminationThe project was approved by the Research Ethics Committee of the Faculty of Ceilandia, the Research Ethics Committee of the Institute of Strategic Health Management of the Federal District and the Research Council of the Hospital of Brasília—Rede Dasa (CAAE: 28572420.3.0000.8093). Recruitment began in June of 2023. All participants were included in the study only after their written consent. All data obtained will be analysed and distributed through publication in journals and at scientific events.Trial registration numberBrazilian Registry of Clinical Trials (ReBEC) (RBR-23mr7yy).
Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care
Authors: Kurotschka Peter K , Borgulya Gábor , Bucher Eva , Endrich Isabell , Figueiras Adolfo , Gensichen Jochen , Hay Alastair D , Hapfelmeier Alexander , Kretzschmann Christian , Kurzai Oliver , Lam Thien-Tri , Massidda Orietta , Sanftenberg Linda , Schmiemann Guido , Schneider Antonius , Simmenroth Anne , Stark Stefanie , Warkentin Lisette , Ebell Mark H , Gágyor Ildikó 
Published: March 2024

IntroductionUncomplicated urinary tract infections (uUTIs) in women are common infections encountered in primary care. Evidence suggests that rapid point-of-care tests (POCTs) to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to identify women with uUTIs in whom antibiotics can be withheld without influencing clinical outcomes. This pilot study aims to provide preliminary evidence on whether a POCT informed management of uUTI in women can safely reduce antibiotic use.Methods and analysisThis is an open-label two-arm parallel cluster-randomised controlled pilot trial. 20 general practices affiliated with the Bavarian Practice-Based Research Network (BayFoNet) in Germany were randomly assigned to deliver patient management based on POCTs or to provide usual care. POCTs consist of phase-contrast microscopy to detect bacteria and urinary dipsticks to detect erythrocytes in urine samples. In both arms, urine samples will be obtained at presentation for POCTs (intervention arm only) and microbiological analysis. Women will be followed-up for 28 days from enrolment using self-reported symptom diaries, telephone follow-up and a review of the electronic medical record. Primary outcomes are feasibility of patient enrolment and retention rates per site, which will be summarised by means and SDs, with corresponding confidence and prediction intervals. Secondary outcomes include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, number of recurrent and upper UTIs and re-consultations and diagnostic accuracy of POCTs versus urine culture as the reference standard. These outcomes will be explored at cluster-levels and individual-levels using descriptive statistics, two-sample hypothesis tests and mixed effects models or generalised estimation equations.Ethics and disseminationThe University of Würzburg institutional review board approved MicUTI on 16 December 2022 (protocol n. 109/22-sc). Study findings will be disseminated through peer-reviewed publications, conferences, reports addressed to clinicians and the local citizen’s forums.Trial registration numberClinicalTrials.govNCT05667207.
Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial
Authors: Nascimento Isabella de Oliveira , Geisel Patrícia Paulino , de Faria Valéria Cristina , Ferreira Ana Paula , Passos Bruno Rezende , Prado Déborah , Parreira Veronica Franco , Gomes Pereira Danielle 
Published: March 2024

IntroductionPeripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this study was to compare a home-based exercise programme (HBEP) and a centre-based exercise (CBE) in terms of their effects on functional capacity, peripheral muscle oxygenation and quality of life in individuals with PAD.Methods and analysisThis single-blind, parallel randomised clinical trial will consist of two groups: HBEP and CBE. A qualitative analysis will be carried out to investigate acceptability and satisfaction. The primary outcome will be functional capacity, assessed by the incremental shuttle walk test. Secondary outcomes will include functional capacity, assessed by a treadmill walking test; peripheral muscle oxygenation and quality of life; and self-reported functional impairment, risk factors, morbidity, level of physical activity, adherence, acceptability and satisfaction. The intervention protocols will consist of 12 weeks of intermittent walking until claudication symptoms, three times a week. Participants randomly assigned to the CBE group will participate in supervised face-to-face sessions. The HBEP group will perform exercises at home with remote supervision, monitored by a pedometer and heart rate monitor, and subjective perception of effort during each session will be recorded by participants in a training diary; follow-up will be conducted by telephone calls. Statistical analyses will follow the intention-to-treat principle. Participants allocated to the HBEP group will be interviewed about their experience of remote treatment using a qualitative approach.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Universidade Federal de Minas Gerais. The results will be disseminated in a peer-reviewed journal and presented at international congresses. This research has the potential to improve the care of people with PAD because if home-based rehabilitation demonstrates effectiveness, it could be considered an alternative or support resource to the usual centre-based treatment models, expanding access, coverage and participation in vascular physiotherapyTrial registrationhttps://ensaiosclinicos.gov.br/rg/RBR-97vy9n7on 14 April 2022.
Cross-sectional study of the burden and determinants of non-medical and opportunity costs of accessing chronic disease care in rural Tanzania
Authors: Verjans Anna , Hooley Brady , Tani Kassimu , Mhalu Grace , Tediosi Fabrizio 
Published: March 2024

ObjectivesCountries in sub-Saharan Africa are seeking to improve access to healthcare through health insurance. However, patients still bear non-medical costs and opportunity costs in terms of lost work days. The burden of these costs is particularly high for people with chronic diseases (CDs) who require regular healthcare. This study quantified the non-medical and opportunity costs faced by patients with CD in Tanzania and identified factors that drive these costs.MethodsFrom November 2020 to January 2021, we conducted a cross-sectional patient survey at 35 healthcare facilities in rural Tanzania. Using the human capital approach to value the non-medical cost of seeking healthcare, we employed multilevel linear regression to analyse the impact of CDs and health insurance on non-medical costs and negative binomial regression to investigate the factors associated with opportunity costs of illness among patients with CDs.ResultsAmong 1748 patients surveyed, 534 had at least one CD, 20% of which had comorbidities. Patients with CDs incurred significantly higher non-medical costs than other patients, with an average of US$2.79 (SD: 3.36) compared with US$2.03 (SD: 2.82). In addition, they incur a monthly illness-related opportunity cost of US$10.19 (US$0–59.34). Factors associated with higher non-medical costs included multimorbidities, hypertension, health insurance and seeking care at hospitals rather than other facilities. Patients seeking hypertension care at hospitals experienced 35% higher costs compared with those visiting other facilities. Additionally, patients with comorbidities, older age, less education and those requiring medication more frequently lost workdays.ConclusionOutpatient care in Tanzania imposes considerable non-medical costs, particularly for people with CDs, besides illness-related opportunity costs. Despite having health insurance, patients with CDs who seek outpatient care in hospitals face higher financial burdens than other patients. Policies to improve the availability and quality of CD care in dispensaries and health centres could reduce these costs.
Prognostic impact of combined non-severe aortic stenosis and mitral regurgitation on clinical outcomes: a single-centre retrospective study
Authors: Granot Yoav , Sapir Orly Ran , Laufer-Perl Michal , Viskin Dana , Banai Shmuel , Topilsky Yan , Havakuk Ofer 
Published: March 2024

ObjectivesThough the concomitant occurrence of non-severe aortic stenosis (AS) and mitral regurgitation (MR) is highly prevalent, there are limited data to guide clinical decision-making in this condition. Here, we attempt to determine an aortic valve area (AVA) cut-off value associated with worse clinical outcomes in patients with combined non-severe AS and MR.MethodsSingle-centre, retrospective analysis of consecutive patients who underwent echocardiography examination between 2010 and 2021 with evidence of combined non-severe AS and MR. We excluded patients with ≥moderate aortic valve regurgitation or mitral stenosis, as well as patients who underwent any aortic or mitral intervention either prior or following our assessment (n=372).ResultsThe final cohort consisted of 2933 patients with non-severe AS, 506 of them with >mild MR. Patients with both pathologies had lower cardiac output and worse diastolic function.Patients with an AVA ≤1.35 cm² in the presence of >mild MR had the highest rates of heart failure (HF) hospitalisations (HR 3.1, IQR 2.4–4, p<0.001) or mortality (HR 2, IQR 1.8–2.4, p<0.001), which remained significant after adjusting for clinical and echocardiographic parameters.ConclusionPatients with combined non-severe AS and MR have a higher rate of HF hospitalisations and mortality. An AVA≤1.35 cm² in the presence of >mild MR is associated with worse clinical outcomes.
Mixed-methods feasibility outcomes for a novel ACT-based video game ‘ACTing Minds’ to support mental health
Authors: Gordon Tom C , Kemp Andrew H , Edwards Darren J 
Published: March 2024

ObjectivesTo determine the feasibility and acceptability of ‘ACTing Minds’, a novel single-player adventure video game based on acceptance and commitment therapy (ACT).DesignA single-arm, mixed-methods repeated measures feasibility study.SettingIntervention and questionnaires were completed at home by participants. Semistructured interviews were also conducted at home via the Zoom platform.ParticipantsThirty-six participants were recruited into the study, 29 completed all phases of the feasibility design. Eligibility criteria required participants to be over the age of 18 and self-reporting experiencing ongoing depression, anxiety or stress.InterventionParticipants completed a single session of the ‘ACTing Minds’ video game, lasting approximately 1 hour, designed to educate users on key principles from ACT.Primary outcome measuresParticipant recruitment and retention, questionnaire completion, long-term intervention adherence and acceptability of the intervention. Reflexive thematic analysis was conducted on semistructured interviews run immediately postintervention and 3 weeks later.Secondary outcome measuresMeasures of depression, anxiety, stress, psychological flexibility, social connectedness and well-being were assessed at baseline, immediately following intervention completion, and after a 3-week follow-up period. We used a standardised battery of questionnaires.Primary resultsTwenty-nine participants completed the study. A reflexive thematic analysis indicated that participants responded positively to the intervention and the study at all stages. Themes reflect participants’ desire for an engaging therapeutic experience, use of game for exploring emotions, as well as their perspectives on how they had applied their learning to the real world.Secondary resultsQuantitative results indicated small to large effect sizes associated with decreases in depression (ηp2 = 0.011), anxiety (ηp2 = 0.096) and stress (ηp2 = 0.108), and increases in psychological flexibility (ηp2 = 0.060), social connectedness (ηp2 = 0.021), well-being (ηp2 = 0.011) and participation in usual activities (ηp2 = .307).ConclusionsImplementation of the ‘ACTing Minds’ intervention is warranted, based on both qualitative and quantitative outcomes.Trial registration numberNCT04566042ClinicalTrials.gov
Clinical variables associated with immune checkpoint inhibitor outcomes in patients with metastatic urothelial carcinoma: a multicentre retrospective cohort study
Authors: Labidi Soumaya , Meti Nicholas , Barua Reeta , Li Mengqi , Riromar Jamila , Jiang Di Maria , Fallah-Rad Nazanin , Sridhar Srikala S , Del Rincon Sonia V , Pezo Rossanna C , Ferrario Cristiano , Cheng Susanna , Sacher Adrian G , Rose April A N 
Published: March 2024

ObjectivesImmune checkpoint inhibitors (ICIs) are indicated for metastatic urothelial cancer (mUC), but predictive and prognostic factors are lacking. We investigated clinical variables associated with ICI outcomes.MethodsWe performed a multicentre retrospective cohort study of 135 patients who received ICI for mUC, 2016–2021, at three Canadian centres. Clinical characteristics, body mass index (BMI), metastatic sites, neutrophil-to-lymphocyte ratio (NLR), response and survival were abstracted from chart review.ResultsWe identified 135 patients and 62% had received ICI as a second-line or later treatment for mUC. A BMI ≥25 was significantly correlated to a higher overall response rate (ORR) (45.4% vs 16.3%, p value=0.020). Patients with BMI ≥30 experienced longer median overall survival (OS) of 24.8 vs 14.4 for 25≤BMI<30 and 8.5 months for BMI <25 (p value=0.012). The ORR was lower in the presence of bone metastases (16% vs 41%, p value=0.006) and liver metastases (16% vs 39%, p value=0.013). Metastatic lymph nodes were correlated with higher ORR (40% vs 20%, p value=0.032). The median OS for bone metastases was 7.3 versus 18 months (p value <0.001). Patients with liver metastases had a median OS of 8.6 versus 15 months (p value=0.006). No difference for lymph nodes metastases (13.5 vs 12.7 months, p value=0.175) was found. NLR ≥4 had worse OS (8.2 vs 17.7 months, p value=0.0001). In multivariate analysis, BMI ≥30, bone metastases, NLR ≥4, performance status ≥2 and line of ICI ≥2 were independent factors for OS.ConclusionsOur data identified BMI and bone metastases as novel clinical biomarkers that were independently associated with ICI outcomes in mUC. External and prospective validation are warranted.
Hyperbaric oxygen therapy for poststroke insomnia: a systematic review and meta-analysis protocol
Authors: Shi Rui , Meng Wenyi , Liu Zhaozheng , Chang Liping , Lu Ruozhu , Chen Xingyu , Xue Wen , Deng Yue 
Published: March 2024

IntroductionInsomnia stands as a frequent consequence of a cerebrovascular event, afflicting a substantial fraction of those who endure the aftermath of stroke. The ramifications of insomnia following a stroke can further exacerbate cognitive and behavioural anomalies while hindering the process of neurological convalescence. While several randomised controlled trials (RCTs) have scrutinised the effects of hyperbaric oxygen therapy (HBOT) on poststroke insomnia, the advantages and drawbacks persist in a state of ambiguity. We advocate for a systematic review and meta-analysis of randomised clinical trials to comprehensively evaluate the effectiveness and safety of HBOT in the context of poststroke insomnia.Methods and analysisA systematic search will be conducted from nine major databases (PubMed, Web of Science, EMBASE, VIP Information Database, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, China Biomedical Literature Database and Wanfang Database, Physiotherapy Evidence Database (PEDro)) for HBOT for poststroke insomnia of RCTs. The search procedures will adhere to a rigorous approach, commencing from the inception date of each database and continuing until 1 November 2023, with inquiries conducted exclusively in English and Chinese. The primary outcome will focus on the alteration in the quality of sleep while secondary outcomes will encompass the evaluation of adverse events and the rate of reoccurrence. The process of selecting studies, extracting data and evaluating the quality of research will be carried out independently by two reviewers. The quality of the included literature will be assessed using the tools of the Cochrane Collaboration. Meta-analysis will be performed by using RevMan V.5.4 and STATA V.16.0.b software. Finally, the quality of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation method.Ethics and disseminationAs all data are derived from published investigations via databases without direct patient contact, ethical approval is obviated in this study. The scientific studies will be published in professional academic publications.PROSPERO registration numberCRD42023468442.
Maternal outcomes of pre-eclampsia with severe features and its determinants at Abebech Gobena Mothers and Childrens Health and Saint Peter’s Specialized Hospital, Addis Ababa, Ethiopia: a cross-sectional study
Authors: Tadese Mesfin , Damesa Wogene Asefa , Solomon Gebeyehu Shumet , Wakie Getu Engida , Tessema Saba Desta , Endale Agizew 
Published: March 2024

ObjectiveThe main objective of this study was to determine the prevalence and factors associated with unfavourable maternal outcomes among pregnant women with pre-eclampsia with severity features (PEWSF) at Abebech Gobena Maternal and Children’s Health and St. Peter’s Hospital, Addis Ababa, Ethiopia, 2023.DesignA hospital-based cross-sectional study was conducted from 1 January 2023 to July 2023. The data was collected using a structured and pre-tested questionnaire through face-to-face interviews and a review clinical chart. Data was entered using EpiData V.4.6 and analysed using SPSS V.26.0 statistical software. Binary logistic regression analysis was run to identify predictors of maternal outcome.SettingTwo hospitals in Addis Ababa, Ethiopia.Participants348 pregnant women with PEWSF were included.Outcome measuresUnfavourable maternal outcome was defined as mothers with PEWSF that develop at least one complication, that is, eclampsia, abruption placenta, Haemolysis, Elevated Liver Enzymes and Low Platelet Count (HELLP) syndrome, acute renal failure, disseminated intravascular coagulation, cardiac failure, stroke, postpartum haemorrhage, pulmonary oedema and death.ResultsThe overall prevalence of unfavourable maternal outcomes was 33.9% (N=118) (95% CI=28.7 to 38.8). Abruptio placenta (17.2%), HELLP syndrome (15.5%) and postpartum haemorrhage (13.8%) were common complications that occurred among mothers with PEWSF. Age above 35 years (adjusted OR (AOR) (95% CI)=2.70 (1.31 to 5.59)), rural residence (AOR (95% CI)=1.94 (1.07 to 3.53)), unemployment (AOR (95% CI)=0.35 (0.20 to 0.62)), severe blood pressure on admission (AOR (95% CI)=2.32 (1.03 to 5.19)) and complain of severe headache (AOR (95% CI)=1.91 (1.16 to 3.16)) were significant associates of unfavourable maternal outcomes.ConclusionsThe prevalence of unfavourable maternal outcomes was high compared with other studies in Ethiopia. Maternal age, residence, occupation, blood pressure on admission and severe headache have shown a statistically significant association with unfavourable maternal outcomes. Socioeconomic development and early identification of severe signs and symptoms of pre-eclampsia are needed to reduce unfavourable outcomes.
Assessment of rehabilitation following acute ischaemic stroke in China: a registry-based retrospective observational study
Authors: Yin Zhike , Deng Yongmei , Li Zixiao , Gu Hongqiu , Zhou Qi , Wang Yongjun , Wang Chunjuan 
Published: March 2024

ObjectivesThis study aimed to describe the frequency, determinants and outcomes for assessment of patients who had an acute ischaemic stroke (AIS) for rehabilitation during hospitalisation in China.DesignA registry-based retrospective observational study.Study design and settingsData regarding assessment or rehabilitation were extracted from the Chinese Stroke Center Alliance database from 1 August 2015 to 31 July 2019. Univariate and multivariate analyses were conducted to identify patient and hospital characteristics associated with rehabilitation assessment during acute hospitalisation as well as discharge outcomes.Study cohortWe included 837 897 patients who had a stroke in this study with patient characteristics, admission location, medical history, hospital characteristics and hospital designation.Primary and secondary outcome measuresRehabilitation assessment and discharge outcomes.ResultsAmong 837 897 patients who had a stroke admitted to 1473 hospitals, 615 991 (73.5%) underwent rehabilitation assessment. There were significant variations in the rates of rehabilitation assessment across hospitals (IQR 61.3% vs 92.9%). According to multivariate analysis, guideline recommended care delivery was associated with a higher rehabilitation assessment rate, whereas high/low body mass index, ambulation (OR 0.88; 95% CI 0.87 to 0.90), history of stroke (OR 0.94; 95% CI 0.93 to 0.95), coronary heart disease (OR 0.84; 95% CI 0.82 to 0.85) and atrial fibrillation (OR 0.91; 95% CI 0.89 to 0.94) were associated with a lower rate. Additionally, rehabilitation assessment during hospitalisation was significantly associated with lower in-hospital mortality (OR 0.38; 95% CI 0.35 to 0.41) and a higher probability of discharge to a rehabilitation centre (OR 2.66; 95% CI 2.5 to 2.82).ConclusionsNearly one-quarter of patients who had an AIS do not undergo documented rehabilitation assessment and compliance across hospitals varies. Thus, it is necessary to improve adherence to rehabilitation assessment to improve the quality of medical care for patients who had an AIS.