bluuebunny/crossref_metadata_2025_split huggingface dataset:
New methodology to assess the excess burden of antibiotic resistance using country-specific parameters: a case study regardingE. coliurinary tract infections
Authors: Godijk Noortje Grejanne , McDonald Scott A , Altorf-van der Kuil Wieke , Schoffelen Annelot F , Franz Eelco , Bootsma Martin C J 
Published: December 2023

ObjectivesAntimicrobial resistant (AMR) infections are a major public health problem and the burden on population level is not yet clear. We developed a method to calculate theexcessburden of resistance which uses country-specific parameter estimates and surveillance data to compare the mortality and morbidity due to resistant infection against a counterfactual (the expected burden if infection was antimicrobial susceptible). We illustrate this approach by estimating the excess burden for AMR (defined as having tested positive for extended-spectrum beta-lactamases) urinary tract infections (UTIs) caused byE. coliin the Netherlands in 2018, which has a relatively low prevalence of AMRE. coli, and in Italy in 2016, which has a relatively high prevalence.DesignExcess burden was estimated using the incidence-based disability-adjusted life-years (DALYs) measure. Incidence of AMRE. coliUTI in the Netherlands was derived from ISIS-AR, a national surveillance system that includes tested healthcare and community isolates, and the incidence in Italy was estimated using data reported in the literature. A systematic literature review was conducted to find country-specific parameter estimates for disability duration, risks of progression to bacteraemia and mortality.ResultsThe annual excess burden of AMRE. coliUTI was estimated at 3.89 and 99.27 DALY/100 0000 population and 39 and 2786 excess deaths for the Netherlands and Italy, respectively.ConclusionsFor the first time, we use country-specific and pathogen-specific parameters to estimate the excess burden of resistant infections. Given the large difference in excess burden due to resistance estimated for Italy and for the Netherlands, we emphasise the importance of using country-specific parameters describing the incidence and disease progression following AMR and susceptible infections that are pathogen specific, and unfortunately currently difficult to locate.
Internal brace augmentation reconstruction versus standard anterior cruciate ligament reconstruction: a randomised controlled clinical trial study protocol
Authors: Lu Wenhao , Liu Di , Cai Zijun , Pan Linyuan , Xie Wenqing , Jin Hongfu , Liu Xu , Li Yusheng , Xiao Wenfeng 
Published: December 2023

IntroductionAnterior cruciate ligament (ACL) rupture is one of the most common knee injuries in sports, and the gold standard for treating ACL rupture is tendon graft reconstruction. Internal brace technology is being used nowadays for ligament repair; however, more relevant in vivo clinical evidence is required for using internal brace technology in ACL reconstruction (ACLR). We conducted a randomised controlled trial to investigate the clinical efficacy of internal brace technology in ACLR.Methods and analysisThis randomised, parallel-controlled trial included patients with ACL rupture who underwent inpatient surgery at the Department of Orthopaedics, Xiangya Hospital, Central South University. Random number table method was used to assign the participants to either the test or the control group. The test group underwent ACLR using the internal brace technique, whereas the control group underwent standard ACLR. Uniform postoperative rehabilitation protocol was used for both the groups. Patient-reported outcomes included preoperative baseline and postoperative recovery at 1, 3, 6, 12 and 24 months. The primary outcome was International Knee Documentation Committee function from baseline (ACL rupture) to 6 months postoperatively. Secondary outcomes included (1) other patient outcome reporting metrics, Lysholm knee score, Knee Injury and Osteoarthritis Outcome Score and Visual Analog Scale; (2) the use of Kneelax3 knee stabiliser to assess knee stability; (3) occurrence of adverse events, such as graft refraction or symptomatic instability, postoperative infection and contralateral injury and (4) magnetic resonance images at 12 and 24 months after ACLR.Ethics and disseminationThis trial was approved by the Medical Ethics Committee of the Xiangya Hospital of Central South University on 26 October 2021. Data will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberChiCTR2200057526.
Comparing the long-term outcomes in chronic coronary syndrome patients with prior ST-segment and non-ST-segment elevation myocardial infarction: findings from the TIGRIS registry
Authors: Krishnamurthy Sibi N , Pocock Stuart , Kaul Prashant , Owen Ruth , Goodman Shaun G , Granger Christopher B , Nicolau Jose Carlos , Simon Tabassome , Westermann Dirk , Yasuda Satoshi , Andersson Karolina , Brandrup-Wognsen Gunnar , Hunt Phillip R , Brieger David B , Cohen Mauricio G 
Published: December 2023

ObjectivesCompared with ST-segment elevation myocardial infarction (STEMI) patients, non-STEMI (NSTEMI) patients have more comorbidities and extensive coronary artery disease. Contemporary comparative data on the long-term prognosis of stable post-myocardial infarction subtypes are needed.DesignLong-Term rIsk, clinical manaGement and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS) was a multinational, observational and longitudinal cohort study.SettingPatients were enrolled from 350 centres, with >95% coming from cardiology practices across 24 countries, from 19 June 2013 to 31 March 2017.ParticipantsThis study enrolled 8277 stable patients 1–3 years after myocardial infarction with ≥1 additional risk factor.Outcome measuresOver a 2 year follow-up, cardiovascular events and deaths and self-reported health using the EuroQol 5-dimension questionnaire score were recorded. Relative risk of clinical events and health resource utilisation in STEMI and NSTEMI patients were compared using multivariable Poisson regression models, adjusting for prognostically relevant patient factors.ResultsOf 7752 patients with known myocardial infarction type, 46% had NSTEMI; NSTEMI patients were older with more comorbidities than STEMI patients. NSTEMI patients had significantly poorer self-reported health and lower prevalence of dual antiplatelet therapy at hospital discharge and at enrolment 1–3 years later. NSTEMI patients had a higher incidence of combined myocardial infarction, stroke and cardiovascular death (5.6% vs 3.9%, p<0.001) and higher all-cause mortality (4.2% vs 2.6%, p<0.001) compared with STEMI patients. Risks were attenuated after adjusting for other patient characteristics. Health resource utilisation was higher in NSTEMI patients, although STEMI patients had more cardiologist visits.ConclusionsPost-NSTEMI chronic coronary syndrome patients had a less favourable risk factor profile, poorer self-reported health and more adverse cardiovascular events during long-term follow-up than individuals post STEMI. Efforts are needed to recognise the risks of stable patients after NSTEMI and optimise secondary prevention and care.Trial registration numberNCT01866904.
What are the determinants of variation in caretaker satisfaction with sick child consultations? A cross-sectional analysis in five low-income and middle-income countries
Authors: Turcotte-Tremblay Anne-Marie , Lee Hwa-Young , Kruk Margaret E 
Published: December 2023

ObjectivesThe objective of this study was to explore determinants of variation in overall caretaker satisfaction with curative care for sick children under the age of 5 in five low-income and middle-income countries.DesignA pooled cross-sectional analysis was conducted using data from the Service Provision Assessment.SettingWe used data collected in five countries (Afghanistan, Democratic Republic of the Congo, Haiti, Malawi and Tanzania) between 2013 and 2018.ParticipantsRespondents were 13 149 caretakers of children under the age of 5 who consulted for a sick child visit.Primary outcomes measuredThe outcome variable was whether the child’s caretaker was very satisfied versus more or less satisfied or not satisfied overall. Predictors pertained to child and caretaker characteristics, health system foundations and process of care (eg, care competence, user experience). Two-level logistic regression models were used to assess the extent to which these categories of variables explained variation in satisfaction. The main analyses used pooled data; country-level analyses were also performed.ResultsProcess of care, including user experience, explained the largest proportion of variance in caretaker satisfaction (13.8%), compared with child and caretaker characteristics (0.9%) and health system foundations (3.8%). The odds of being very satisfied were lower for caretakers who were not given adequate explanation (OR: 0.56, 95% CI 0.46 to 0.67), who had a problem with medication availability (OR: 0.31, 95% CI 0.27 to 0.35) or who encountered a problem with the cost of services (OR: 0.57, 95% CI 0.48 to 0.66). The final model explained only 21.8% of the total variance. Country-level analyses showed differences in variance explained and in associations with predictors.ConclusionsBetter process of care, especially user experience, should be prioritised for its benefit regarding caretaker satisfaction. Unmeasured factors explained the majority of variation in caretaker satisfaction and should be explored in future studies.
Adverse COVID-19 outcomes in American Veterans with age-related macular degeneration: a case–control study
Authors: Armbrust Karen R , Westanmo Anders , Gravely Amy , Chew Emily Y , van Kuijk Frederik J 
Published: December 2023

ObjectivesPrior studies suggest that patients with age-related macular degeneration (AMD) have poorer COVID-19 outcomes. This study aims to evaluate whether AMD is associated with adverse COVID-19 outcomes in a large clinical database.DesignCase–control study.SettingWe obtained demographic and clinical data from a national US Veterans Affairs (VA) database for all Veterans aged 50 years or older with positive COVID-19 testing prior to 2 May 2021.Primary and secondary outcome measuresThe primary outcome measure was hospitalisation. Secondary outcome measures were intensive care unit admission, mechanical ventilation and death. Potential associations between AMD and outcome measures occurring within 60 days of COVID-19 diagnosis were evaluated using multiple logistic regression analyses.ResultsOf the 171 325 patients in the study cohort, 7913 (5%) had AMD and 2152 (1%) had severe AMD, defined as advanced atrophic or exudative AMD disease coding. Multiple logistic regression adjusting for age, Charlson Comorbidity Index, sex, race, ethnicity and COVID-19 timing showed that an AMD diagnosis did not significantly increase the odds of hospitalisation (p=0.11). Using a Bonferroni-adjusted significance level of 0.006, AMD and severe AMD also were not significant predictors for the secondary outcomes, except for AMD being modestly protective for death (p=0.002).ConclusionsAfter adjusting for other variables, neither AMD nor severe AMD was a risk factor for adverse COVID-19 outcomes in the VA healthcare system. These findings indicate that an AMD diagnosis alone should not alter recommended ophthalmic management based on COVID-19 adverse outcome risk.
Influence of perioperative step volume on complication rate and length of hospital stay after colorectal cancer surgery (IPOS trial): study protocol for a randomised controlled single-centre trial at a German university hospital
Authors: Anthuber Lena , Sommer Florian , Wolf Sebastian , Vlasenko Dmytro , Hoffmann Michael , Arndt Tim Tobias , Schiele Stefan , Anthuber Matthias , Schrempf Matthias Christian 
Published: December 2023

BackgroundPerioperative mobilisation and physical activity are critical components of postoperative rehabilitation. Physical inactivity is a significant risk factor for complications and prolonged hospitalisation. However, specific recommendations for preoperative and postoperative physical activity levels are currently lacking. Evidence suggests that daily step count before and after surgery may impact the length of hospital stay and complication rate.The goal of this study is to determine the effectiveness of perioperative step volume recommendations, measured by pedometers, in reducing the length of hospital stay and complication rate for patients undergoing colorectal cancer surgery.MethodsThis study is a single-centre randomised controlled trial with two arms, allocated at a 1:1 ratio. The trial includes individuals undergoing colorectal surgery for either suspected or confirmed colorectal malignancy. A total of 222 patients will be randomly assigned to either an intervention or a control group. Step counts will be measured using a pedometer. Patients assigned to the intervention group will be given a predetermined preoperative and postoperative step count goal. The analysis will be conducted on preoperative and postoperative physical activity, quality of life, health, duration of hospitalisation, complication rate and bowel function, among other factors.Ethics and disseminationThe trial was approved by the ethics committee of the Ludwig-Maximilians-University of Munich, Germany (reference number: 22-0758, protocol version 2022.02). Results will be published in peer-reviewed journals and shared at academic conferences. After the publication of the results, a fully anonymised data set and the statistical code can be made available on justified scientific request and after ethical approval has been granted.Trial registration numberDRKS00030017.
Impact of different surgical and non-surgical interventions on health-related quality of life after thoracolumbar burst fractures without neurological deficit: protocol for a comprehensive systematic review with network meta-analysis
Authors: Lanter Lea , Rutsch Niklas , Kreuzer Sebastian , Albers Christoph Emanuel , Obid Peter , Henssler Jonathan , Torbahn Gabriel , Müller Martin , Bigdon Sebastian Frederick 
Published: December 2023

IntroductionThere is no international consensus on how to treat thoracolumbar burst fractures (TLBFs) without neurological deficits. The planned systematic review with network meta-analyses (NMA) aims to compare the effects on treatment outcomes, focusing on midterm health-related quality of life (HRQoL).Methods and analysisWe will conduct a comprehensive and systematic literature search, identifying studies comparing two or more treatment modalities. We will search MEDLINE, EMBASE, Google Scholar, Scopus and Web of Science from January 2000 until July 2023 for publications. We will include (randomised and non-randomised) controlled clinical trials assessing surgical and non-surgical treatment methods for adults with TLBF. Screening of references, data extraction and risk of bias (RoB) assessment will be done independently by two reviewers. We will extract relevant studies, participants and intervention characteristics. The RoB will be assessed using the revised Cochrane RoB V.2.0 tool for randomised trials and the Newcastle-Ottawa Scale for controlled trials. The OR for dichotomous data and standardised mean differences for continuous data will be presented with their respective 95% CIs. We will conduct a random-effects NMA to assess the treatments and determine the superiority of the therapeutic approaches. Our primary outcomes will be midterm (6 months to 2 years after injury) overall HRQoL and pain. Secondary outcomes will include radiological or clinical findings. We will present network graphs, forest plots and relative rankings on plotted rankograms corresponding to the treatment rank probabilities. The ranking results will be represented by the area under the cumulative ranking curve. Analyses will be performed in Stata V.16.1 and R. The quality of the evidence will be evaluated according to the Grading of Recommendations, Assessment, Development and Evaluations framework.Ethics and disseminationEthical approval is not required. The research will be published in a peer-reviewed journal.
Ultrasound-guided subclavian vein catheterisation with a needle guide (ELUSIVE): protocol for a randomised controlled study
Authors: Naddi Leila , Borgquist Ola , Adrian Maria , Bark Björn P , Kander Thomas 
Published: December 2023

IntroductionCentral venous catheters are indispensable in modern healthcare. Unfortunately, they are accompanied by minor as well as major complications, leading to increased morbidity, mortality and costs. Immediate insertion-related complications (mechanical complications) have decreased due to the implementation of real-time ultrasound guidance, but they still occur and additional efforts to enhance patient safety are warranted. This study aims to investigate whether the use of a needle guide mounted on the ultrasound probe in subclavian catheterisations may decrease the number of catheterisations with >1 skin puncture (primary outcome).Methods and analysisThis is an investigator-initiated, non-commercial, randomised, controlled, parallel-group study conducted at Skåne University Hospital, Lund, Sweden. Adults (≥18 years) with a clinical indication for a subclavian central venous catheter and the ability to give written informed consent will be eligible for inclusion. Exclusion criteria include subclavian catheterisation deemed unsuitable based on the preprocedural ultrasound examination. Patients will be randomised to catheterisation by certified operators using a microconvex probe (long-axis, in-plane technique) with (n=150) or without (n=150) a needle guide. The ultrasound imaging from the procedures will be recorded and assessed by two reviewers individually. The assessors will be blinded for group affiliation. Secondary outcomes include the total number of skin punctures, mechanical complications, time to successful venous puncture, number of failed catheterisations and operator satisfaction with the needle guide at the end of the study period.Recruitment started on 8 November 2022 and will continue until the sample size is achieved.Ethics and disseminationThis study was approved by the Swedish Ethical Review Authority (#2022-04073-01) and the Swedish Medical Products Agency (#5.1-2022-52130; CIV-21-12-038367). The findings will be submitted to an international peer-reviewed journal.Trial registration numberNCT05513378, clinicaltrials.gov.
Stratifying quality of life outcome in subthalamic stimulation for Parkinson’s disease
Authors: Gronostay Alexandra , Jost Stefanie Theresa , Silverdale Monty , Rizos Alexandra , Loehrer Philipp Alexander , Evans Julian , Sauerbier Anna , Indi Donya , Leta Valentina , Reker Paul , Fink Gereon Rudolf , Ashkan Keyoumars , Antonini Angelo , Nimsky Christopher , Visser-Vandewalle Veerle , Martinez-Martin Pablo , Ray Chaudhuri K , Timmermann Lars , Dafsari Haidar S 
Published: December 2023

Background
Subthalamic nucleus deep brain stimulation (STN-DBS) for Parkinson’s disease (PD) improves quality of life (QoL), motor and non-motor symptoms (NMS). However, in previous studies, 43%–49% of patients did not experience clinically relevant postoperative QoL improvement. To inform individualised prediction of postoperative QoL improvement, we developed a stratification analysis of QoL outcomes based on preoperative non-motor total burden, severity of motor progression and motor response in levodopa challenge tests.

Methods
This was a prospective, open-label, multicentre, international study with a 6-month follow-up. A distribution-based threshold identified ‘QoL responders’ in the PDQuestionnaire-8 Summary Index (PDQ-8 SI). After baseline stratification based on the NMS Scale, Hoehn and Yahr Scale and levodopa response assessed with the Unified PD Rating Scale-III, we compared postoperative QoL response between these strata. To assess the clinical usefulness and statistical feasibility of stratifications, we compared cumulative distribution function curves, respectively PDQ-8 within-stratum variation.

Results
All main outcomes improved postoperatively. Based on the 8.1 points threshold for clinically meaningful PDQ-8 SI improvement, only 80/161 patients were classified as ‘QoL responders’. The absolute risk reductions for QoL non-response among respective non-motor, motor progression and levodopa response strata were 23%, 8% and 3%, respectively. Only non-motor stratification reduced PDQ-8 within-stratum variation compared with the overall cohort.

Conclusions
Non-motor stratification, but not motor progression or levodopa response stratification, is clinically useful and statistically feasible for personalised preoperative prediction of postoperative QoL outcome of STN-DBS for PD. Our findings highlight that non-motor assessments are necessary components of a case-based, holistic approach of DBS indication evaluations geared towards optimising postoperative QoL outcomes.

Trial registration number
GermanClinicalTrialsRegister: #6735.
Holistic care needs in an inpatient oncology unit: patients versus professionals
Authors: Cosgrove Dearbhla , Connolly Maya , Monnery Daniel 
Published: December 2023

ObjectiveMacmillan Cancer Support advocates that a Holistic Needs Assessment (HNA) is carried out at diagnosis and re-evaluated at significant key milestones throughout the patient journey. This now includes acute admission. However, evidence describing the use of HNAs and prevalence of unmet holistic needs in the acute oncology setting is lacking. This project aims to identify the prevalence of unmet holistic needs of patients in an acute oncology setting, and discern the differences in perception of needs between patients and healthcare professionals (HCPs).MethodsPatient and HCP surveys were conducted at 2 time points over a 10-month period. Surveys were co-designed with patient representatives based on the Macmillan Cancer Support ‘concerns checklist’ and used a 5-point Likert scale, rating the importance of each domain to the patient and HCP and the degree to which they felt the clinical team were aware of their needs.ResultsIn areas where there was good concordance between patient and HCPs ratings of prevalence, patients still perceived that HCPs were mostly unaware of these needs. Furthermore, HCPs overvalued the importance of advanced care planning and cardiopulmonary resuscitation discussions for patients.ConclusionsThere are discrepancies between patient and HCP perceptions of unmet holistic needs in the acute oncology setting.