bluuebunny/crossref_metadata_2025_split huggingface dataset:
Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study)
Authors: Klee Marc , Hørmann Thomsen Trine , Enggaard Thomas Peter , Bitsch Martin Sabro , Simonsen Louise , Jensen Rigmor Højland , Biering-Sørensen Bo 
Published: January 2024

IntroductionDiabetic neuropathic pain (DNP) is a debilitating complication affecting 15–20% of people with diabetes and is a predictor of depression, poor sleep and decreased quality of life. Current pharmacological treatments are often insufficient and have significant side-effects. Subcutaneous or intradermal botulinumtoxin-A (BonT-A) is an effective and safe treatment for neuropathic pain but is limited by the need to cover the entire affected area with injections. For large cutaneous areas, infiltration of the sensory nerve supply with BonT-A could provide similar effects, with a single injection. We aim to investigate the safety, efficacy, and effects on quality of life, physical activity, depressive symptoms and activities of daily living of perineural injections of BonT-A in patients with DNP of both lower extremities.MethodsThis study is a double-blind, randomised, placebo-controlled clinical trial. 80 participants with moderate to severe DNP of both legs will be randomised 1:1 to receive injections of either 100 units incobotulinumtoxin-A or a saline placebo around each distal sciatic nerve for two cycles of 12 weeks. Average daily pain scores will be recorded once a day from 1 week prior to the first treatment and through the entire study period. Primary outcomes are differences between groups in daily and weekly mean pain scores. Secondary outcomes are levels of physical activity, depression scores, health-related quality of life, activities of daily living, sensory profiles and motor function, recorded at baseline, 4, 12, 16 and 24 weeks. The use of rescue medication and adverse events will be recorded throughout the study period.Ethics and disseminationThe study is approved by the Danish Committee on Health Research Ethics and the Danish Medicines Agency. EU-Clinical Trial Information System (EU: 2022-500727-68-01), clinicaltrials.gov (ID:NCT05623111). Results will be published in peer-reviewed journals in open-access formats and data made available in anonymised form.Trial registration numberNCT05623111.
Disruption of diabetes and hypertension care during the COVID-19 pandemic and recovery approaches in the Latin America and Caribbean region: a scoping review protocol
Authors: Jabakhanji Samira Barbara , Ogungbe Oluwabunmi , Angell Sonia Y , Appel Lawrence , Byrne David , Mehta Roopa , McCaffrey John , Rosman Lori , Gregg Edward W , Matsushita Kunihiro 
Published: January 2024

IntroductionThe COVID-19 pandemic significantly disrupted primary healthcare globally, with particular impacts on diabetes and hypertension care. This review will examine the impact of pandemic disruptions of diabetes and hypertension care services and the evidence for interventions to mitigate or reverse pandemic disruptions in the Latin America and Caribbean (LAC) region.Methods and analysesThis scoping review will examine care delivery disruption and approaches for recovery of primary healthcare in the LAC region during the COVID-19 pandemic, focusing on diabetes and hypertension awareness, detection, treatment and control. Guided by Arksey and O’Malley’s scoping review methodology framework, this protocol adheres to the Joanna Briggs Institute guidelines for scoping review protocols and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance for protocol development and scoping reviews. We searched MEDLINE, CINAHL, Global Health, Embase, Cochrane, Scopus, Web of Science and LILACS for peer-reviewed literature published from 2020 to 12 December 2022 in English, Spanish or Portuguese. Studies will be considered eligible if reporting data on pandemic disruptions to primary care services within LAC, or interventions implemented to mitigate or reverse pandemic disruptions globally. Studies on COVID-19 or acute care will be excluded. Two reviewers will independently screen each title/abstract for eligibility, screen full texts of titles/abstracts deemed relevant and extract data from eligible full-text publications. Conflicts will be resolved through discussion and with the help of a third reviewer. Appropriate analytical techniques will be employed to synthesise the data, for example, frequency counts and descriptive statistics. Quality will be assessed using the Newcastle Ottawa Quality Assessment Scale.Ethics and disseminationNo ethics approval was needed as this is a scoping review of published literature. Results will be disseminated in a report to the World Bank and the Pan American Health Organization, in peer-reviewed scientific journals, and at national and international conferences.
Abdominal massage for chronic constipation in the elderly: a systematic review and meta-analysis protocol
Authors: Yuan Qiang , Wang Xiaoyan , Zhou Li , Li Chuan , Lu Qunwen , Wang Haozhong , Luo Jian 
Published: January 2024

IntroductionChronic constipation (CC) is a highly prevalent health challenge that is particularly challenging to treat in elderly patients. Although lifestyle guidance and laxative therapy often yield positive outcomes, patients occasionally struggle with maintaining dietary control. Therefore, identifying an economical and safe alternative therapy to the existing treatment methods documented in the international literature is necessary. This systematic review and meta-analysis aims to evaluate the efficacy and safety of abdominal massage in elderly patients with CC to provide a basis for future mechanistic research.Methods and analysisElectronic searches will be conducted to identify clinical randomised controlled trials in various databases, including Web of Science, PubMed, Cumulated Index to Nursing and Allied Health Literature, Cochrane Library, Embase, Airiti Library, Chinese National Knowledge Infrastructure Databases, Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database and Wan Fang Database. Relevant data will be extracted, and a meta-analysis will be conducted using Reviewer Manager V.5.4. Quality and risk assessments of the included studies will be performed, and the outcome indicators of the trials will be observed. This review will evaluate abdominal massage as a treatment option for relieving symptoms and improving quality of life in elderly patients with CC. Moreover, it will provide additional insights for clinical treatment and mechanistic studies. The search will be performed following the publication of this protocol (estimated to occur on 30 December 2023).Ethics and disseminationAs this is a literature review, ethics approval will not be required. We will disseminate the findings of this study to publications in peer-reviewed journals as well as presentations at relevant national and international conferences.PROSPERO registration numberCRD42023408629.
Association of habitual physical activity with depression and anxiety: a multicentre cross-sectional study
Authors: Liu Sitong , Mei Yunting , Huang Li , Liu Xudong , Xi Yuandi 
Published: January 2024

ObjectiveDespite the known benefits of physical activity, the effect of habitual physical activity (HPA) on depression and anxiety remains unclear. This study aimed to investigate the association of HPA with the risk of depression and anxiety among Chinese adults, with the consideration of disease severity.MethodsThe participants in this multicentre cross-sectional study were from the nationwide survey of the psychology and behaviour of Chinese residents. Depression and anxiety were measured using the nine-item Patient Health Questionnaire and seven-item Generalised Anxiety Disorder scale. HPA was assessed by the short form of the International Physical Activity Questionnaire. Crude and adjusted ORs with their 95% CIs were estimated by using ordinal logistic regression.ResultsOf the 19 798 participants, 3901 (19.7%) had anxiety and 8914 (45.02%) had depression. Compared with inactive participants, depression risk in individuals reporting low, median and high volume HPA was reduced by 23% (OR 0.77, 95% CI 0.66 to 0.89), 21% (OR 0.79, 95% CI 0.68 to 0.90) and 13% (OR 0.87, 95% CI 0.78 to 0.98), respectively, after adjustment for confounder. No significant association of HPA with anxiety risk was observed.ConclusionParticipation in HPA, whether low, median or high volume, was associated with a lower risk of depression compared with inactive participation, while no significant association was observed between HPA and anxiety.
Vaccine hesitancy among physicians: a qualitative study with general practitioners and paediatricians in Austria and Germany
Authors: Wojczewski Silvia , Leitner Katja M , Hoffmann Kathryn , Kutalek Ruth , Jirovsky-Platter Elena 
Published: January 2024

ObjectiveThis study aims to understand reasons for vaccine hesitancy (VH) among general practioners (GPs) and paediatricians. We aim to analyse how and when the healthcare workers (HCWs) developed vaccine-hesitant views and how they transfer these to patients.Design and settingSemistructured interviews with vaccine-hesitant GPs and paediatricians were conducted in Austria and Germany using an explorative qualitative research design.ParticipantsWe contacted 41 physicians through letters and emails and 10 agreed to participate, five were male and five female.Data collection and analysisTen interviews were recorded, transcribed verbatim and anonymised. The material was analysed inductively following a grounded theory approach with open coding using the software atlas.ti.ResultsKey themes that were identified were education and career path, understanding of medicine and medical profession, experiences with vaccines, doctor–patient interactions and continuous education activities and the link to VH. GPs and paediatricians’ vaccine-hesitant attitudes developed during their medical training and, in particular, during extracurricular training in homeopathy, which most of the participants completed. Most participants work in private practices rather than with contracts with social insurance because they are not satisfied with the health system. Furthermore, they are critical of biomedicine. Most of the interview partners do not consider themselves antivaccination, but are sceptical towards vaccines and especially point out the side effects. Most do not vaccinate in their practices and some do only occasionally. Their vaccine-hesitant views are often fostered through respective online communities of vaccine-hesitant HCWs.ConclusionsMore studies on a connection between complementary medicine and vaccine-hesitant views of HCWs are needed. Education about vaccines and infectious diseases among healthworkers must increase especially tailored towards the use of internet and social media. Physicians should be made aware that through time and empathy towards their patients they could have a positive impact on undecided patients and parents regarding vaccine decisions.
Protocol of an individual participant data meta-analysis to quantify the impact of high ambient temperatures on maternal and child health in Africa (HE2AT IPD)
Authors: Lakhoo Darshnika Pemi , Chersich Matthew Francis , Jack Chris , Maimela Gloria , Cissé Guéladio , Solarin Ijeoma , Ebi Kristie L , Chande Kshama S , Dumbura Cherlynn , Makanga Prestige Tatenda , van Aardenne Lisa , Joubert Bonnie R , McAllister Kimberly A , Ilias Maliha , Makhanya Sibusisiwe , Luchters Stanley 
Published: January 2024

IntroductionGlobally, recognition is growing of the harmful impacts of high ambient temperatures (heat) on health in pregnant women and children. There remain, however, major evidence gaps on the extent to which heat increases the risks for adverse health outcomes, and how this varies between settings. Evidence gaps are especially large in Africa. We will conduct an individual participant data (IPD) meta-analysis to quantify the impacts of heat on maternal and child health in sub-Saharan Africa. A detailed understanding and quantification of linkages between heat, and maternal and child health is essential for developing solutions to this critical research and policy area.Methods and analysisWe will use IPD from existing, large, longitudinal trial and cohort studies, on pregnant women and children from sub-Saharan Africa. We will systematically identify eligible studies through a mapping review, searching data repositories, and suggestions from experts. IPD will be acquired from data repositories, or through collaboration with data providers. Existing satellite imagery, climate reanalysis data, and station-based weather observations will be used to quantify weather and environmental exposures. IPD will be recoded and harmonised before being linked with climate, environmental, and socioeconomic data by location and time. Adopting a one-stage and two-stage meta-analysis method, analytical models such as time-to-event analysis, generalised additive models, and machine learning approaches will be employed to quantify associations between exposure to heat and adverse maternal and child health outcomes.Ethics and disseminationThe study has been approved by ethics committees. There is minimal risk to study participants. Participant privacy is protected through the anonymisation of data for analysis, secure data transfer and restricted access. Findings will be disseminated through conferences, journal publications, related policy and research fora, and data may be shared in accordance with data sharing policies of the National Institutes of Health.PROSPERO registration numberCRD42022346068.
Effects of retirement on inpatient healthcare utilisation: an observational study in China
Authors: Ye Xin , Li Wentao , Wang Yanshang , Hu Mingzheng , Zhu Dawei , Shi Xuefeng , He Ping 
Published: January 2024

ObjectivePrevious studies have presented mixed evidence on retirement and inpatient healthcare utilisation. We aimed to examine the causal effect of retirement on inpatient healthcare utilisation in China and explore the heterogenous effects of sex, disease types and ways of hospital admission.DesignThis was a retrospective observational study from the electronic medical record at 376 tertiary hospitals in China between 2013 and 2018.SettingNationwide data from China.ParticipantsWe included the male sample aged between 50 and 70, and the female sample aged between 40 and 60 and with basic medical insurance system or public medical insurance. Observations with total expenditures per visit at the top or bottom 1% were excluded.Primary and secondary outcome measuresInpatient expenditures per visit and inpatient days per visit.MethodologyWe examined the effects by a non-parametric fuzzy regression discontinuity design, exploiting the mandatory retirement age as a source of exogenous variation in retirement status.ResultsRetirement reduced drug expenditures (β=−467.46, p<0.05) and inpatient days per visit (β=−0.99, p<0.05). The mitigation effect was concentrated on people admitted into hospital due to chronic diseases (β=−551.28, p<0.05 for drug expenditures; β=−1.08, p<0.05 for inpatient days per visit) and people admitted into hospital through outpatient services (β=−353.75, p<0.001 for drug expenditures). For males, retirement significantly reduced diagnostic tests expenditures (β=−302.38, p<0.05) and drug expenditures (β=−728.31, p<0.05). Retirement significantly reduced inpatient days per visit (β=−1.13, p<0.05) for females.ConclusionThe empirical findings suggested that retirement may lead to a reduction in inpatient healthcare utilisation, which underlined the importance for policy-makers to consider the externalities of retirement policies on inpatient healthcare utilisation.
Factors of hospital ethical climate among hospital nurses in Korea: a protocol for systematic review and meta-analysis
Authors: Noh Yoon Goo , Kim Se Young 
Published: January 2024

IntroductionThe hospital ethical climate refers to the ethical work environment within a hospital, which may positively or negatively impact individual nurses, nursing organisations and patient care. Most of studies investigating the hospital ethical climate among Korean nurses have been published in Korean. However, papers addressing the hospital ethical climate in Korean were excluded from the systematic review. To enhance our comprehension of the hospital ethical climate, a systematic review specifically focusing on Korean nurses is imperative. Additionally, it is crucial to ascertain the factors associated with the hospital ethical climate and their respective effect sizes through meta-analyses.Methods and analysisThe systematic search will be conducted for papers published in both Korean and English, encompassing the hospital ethics climate of Korean nurses from 10 database inception to May 2023. Two reviewers will independently review each article based on the inclusion and exclusion criteria, and any differences in opinion will be resolved through discussion and consensus. The study selection process will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Quality assessment will be conducted using the Checklist for Analytical Cross-Sectional Studies provided by Joanna Briggs Institute. Effect size will be analysed using Comprehensive Meta-Analysis software V.2.0. The results of this study will identify factors related to the hospital ethical climate and the effect size of these factors among nurses in Korea.Ethics and disseminationEthical approval is not required, as the data will be collected from existing literature. Findings will be disseminated through peer-reviewed journal.PROSPERO registration numberCRD42022379812.
Trends in forgone medical care and unmet needs among Medicare beneficiaries with a history of depression during the COVID-19 pandemic: a national, repeated cross-sectional study
Authors: Kim Jihye , Kim Yeunkyung , Li Yue 
Published: January 2024

ObjectivesTo investigate trends in forgone medical care, basic needs disruption, financial and mental health disruption, engagement of preventive behaviours guidelines, and perceived severity of COVID-19 among community-living Medicare beneficiaries in the USA with and without a self-reported history of depression from Summer 2020 to Winter 2021.Design/settingA repeated cross-sectional study using a nationally representative sample of Medicare beneficiaries of three rounds of survey data from the Medicare Current Beneficiary Survey COVID-19 Supplement Public Use Files: Summer 2020, Fall 2020 and Winter 2021.ParticipantsA total of 28 480 community-dwelling Medicare beneficiaries.Main outcome measuresForgone medical care, basic needs disruption, financial and mental health disruption, engagement of preventive behaviours guidelines, and perceived severity of COVID-19.ResultsIn the study sample, 7629 (27%) had a history of depression. After adjusting for potential confounders, weighted multivariable logistic regression models showed that Medicare beneficiaries with a history of depression had higher odds of foregone medical care (OR: 1.29, 95% CI 1.16 to 1.42, p<0.001), of basic need disruption (OR: 1.49, 95% CI 1.33 to 1.67, p<0.001), and of financial and mental health disruption (OR: 1.75, 95% CI 1.60 to 1.91, p<0.001) during the COVID-19 pandemic when compared with those without a history of depression. No statistically significant differences were observed in engagement of essential preventive behaviours or perception of COVID-19 severity.ConclusionsCOVID-19 pandemic may exacerbate existing barriers to healthcare access and financial and social needs, possibly leading to persistent unmet needs among Medicare beneficiaries with a history of depression beyond the pandemic.
Determining the feasibility of calculating pancreatic cancer risk scores for people with new-onset diabetes in primary care (DEFEND PRIME): study protocol
Authors: Claridge Hugh , Price Claire A , Ali Rofique , Cooke Elizabeth A , de Lusignan Simon , Harvey-Sullivan Adam , Hodges Catherine , Khalaf Natalia , O’Callaghan Dean , Stunt Ali , Thomas Spencer A , Thomson Joanna , Lemanska Agnieszka 
Published: January 2024

IntroductionWorldwide, pancreatic cancer has a poor prognosis. Early diagnosis may improve survival by enabling curative treatment. Statistical and machine learning diagnostic prediction models using risk factors such as patient demographics and blood tests are being developed for clinical use to improve early diagnosis. One example is the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) model, which employs patients’ age, blood glucose and weight changes to provide pancreatic cancer risk scores. These values are routinely collected in primary care in the UK. Primary care’s central role in cancer diagnosis makes it an ideal setting to implement ENDPAC but it has yet to be used in clinical settings. This study aims to determine the feasibility of applying ENDPAC to data held by UK primary care practices.Methods and analysisThis will be a multicentre observational study with a cohort design, determining the feasibility of applying ENDPAC in UK primary care. We will develop software to search, extract and process anonymised data from 20 primary care providers’ electronic patient record management systems on participants aged 50+ years, with a glycated haemoglobin (HbA1c) test result of ≥48 mmol/mol (6.5%) and no previous abnormal HbA1c results. Software to calculate ENDPAC scores will be developed, and descriptive statistics used to summarise the cohort’s demographics and assess data quality. Findings will inform the development of a future UK clinical trial to test ENDPAC’s effectiveness for the early detection of pancreatic cancer.Ethics and disseminationThis project has been reviewed by the University of Surrey University Ethics Committee and received a favourable ethical opinion (FHMS 22-23151 EGA). Study findings will be presented at scientific meetings and published in international peer-reviewed journals. Participating primary care practices, clinical leads and policy makers will be provided with summaries of the findings.
Flavonoid intake and risk of Parkinson’s disease
Authors: Sandoval-Insausti Helena , Flores-Torres Mario H , Bjornevik Kjetil , Cortese Marianna , Hung Albert Y , Schwarzschild Michael , Yeh Tian-Shin , Ascherio Alberto 
Published: January 2024

Background
Flavonoids have been proposed to reduce the risk of Parkinson’s disease (PD). However, results from epidemiological studies have been inconclusive.

Objective
To prospectively examine the association between the intake of flavonoids and their subclasses and the risk of PD and how pesticides may confound or modify that association.

Methods
The study population comprised 80 701 women (1984–2016) and 48 782 men (1986–2016) from two large US cohorts. Flavonoid intake was ascertained at baseline and every 4 years thereafter using a semiquantitative Food Frequency Questionnaire. We conducted multivariable-adjusted Cox regression models to estimate HRs and 95% CIs of PD according to quintiles of baseline and cumulative average intakes of flavonoids and subclasses. We repeated the analyses, adjusting for intakes of high-pesticide-residue fruits and vegetables (FVs) and stratifying by servings/day of high-pesticide-residue FV intake.

Results
We identified 676 incident PD cases in women and 714 in men after 30–32 years of follow-up. Higher total flavonoid intake at baseline was not associated with a lower PD risk, neither in men (HR comparing highest to lowest quintile: 0.89, 95% CI: 0.69 to 1.14) nor in women (HR comparing highest to lowest quintile: 1.27, 95% CI: 0.98 to 1.64). Similar results were observed for cumulative average intakes and flavonoid subclasses. Results remained similar after adjustment for and stratification by high-pesticide-residue FV and when analyses were restricted to younger PD cases.

Conclusion
These results do not support a protective effect of flavonoid intake on PD risk. Pesticide residues do not confound or modify the association.