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Beyond order‐based nursing workload: A retrospective cohort study in intensive care units

Abstract

Introduction

In order to be positioned to address the increasing strain of burnout and worsening nurse shortage, a better understanding of factors that contribute to nursing workload is required. This study aims to examine the difference between order-based and clinically perceived nursing workloads and to quantify factors that contribute to a higher clinically perceived workload.

Design

A retrospective cohort study was used on an observational dataset.

Methods

We combined patient flow, nurse staffing and assignment, and workload intensity data and used multivariate linear regression to analyze how various shift, patient, and nurse-level factors, beyond order-based workload, affect nurses' clinically perceived workload.

Results

Among 53% of our samples, the clinically perceived workload is higher than the order-based workload. Factors associated with a higher clinically perceived workload include weekend or night shifts, shifts with a higher census, patients within the first 24 h of admission, and male patients.

Conclusions

The order-based workload measures tended to underestimate nurses' clinically perceived workload. We identified and quantified factors that contribute to a higher clinically perceived workload, discussed the potential mechanisms as to how these factors affect the clinically perceived workload, and proposed targeted interventions to better manage nursing workload.

Clinical Relevance

By identifying factors associated with a high clinically perceived workload, the nurse manager can provide appropriate interventions to lighten nursing workload, which may further reduce the risk of nurse burnout and shortage.

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Por: Meng · M. · Ge · B. · Lei · W. · Wu · Y. · Tian · M. · Lu · Y. · Shao · T. · Yang · Y. · Luo · X. · Luo · J. · Gao · Y. · Li · Q. · Chen · Y.
Objective

To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.

Design

The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.

Setting

A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.

Results

We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.

Conclusion

Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Standard cardiopulmonary resuscitation versus chest compressions only after out-of-hospital cardiac arrest: a protocol for a systematic review and meta-analysis

Por: An · S. · Liu · Y. · Xi · Q. · Zhang · Y. · Gao · Y. · Zhang · W.
Introduction

The 2020 American Heart Association guidelines encourage lay rescuers to provide chest compression-only cardiopulmonary resuscitation to simplify the process and encourage cardiopulmonary resuscitation initiation. However, recent clinical trials had contradictory results about chest compression-only cardiopulmonary resuscitation. This study will aim to compare standard and chest compressions-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest.

Methods and analysis

This study will retrieve only randomised and quasi-randomised controlled trials from the Cochrane Library, PubMed, Web of Science and Embase databases. Data on study design, participant characteristics, intervention details and outcomes will be extracted by a unified standard form. Primary outcomes to be assessed are hospital admission, discharge, and 30-day survival, and return of spontaneous circulation. The Grading of Recommendations, Assessment, Development and Evaluation framework will evaluate the quality of evidence. Cochrane’s tool for assessing the risk of bias will evaluate risk deviation. If the I2 statistic is lower than 40%, the fixed-effects model will be used for meta-analysis. Otherwise, the random-effects model will be used. The search will be performed following the publication of this protocol (estimated to occur on 30 December 2024).

Discussion

This study will evaluate the effect of chest compression-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest and provide evidence for cardiopulmonary resuscitation guidelines.

Ethics and dissemination

No patient or public entity will be involved in this study. Therefore, the study does not need to be ethically reviewed. The results of the study will be disseminated through peer-reviewed journal publications and committee conferences.

PROSPERO registration number

CRD42021295507.

Cohort profile: the Environmental Reproductive and Glucose Outcomes (ERGO) Study (Boston, Massachusetts, USA) -- a prospective pregnancy cohort study of the impacts of environmental exposures on parental cardiometabolic health

Por: Preston · E. V. · Quinn · M. R. · Williams · P. L. · McElrath · T. F. · Cantonwine · D. E. · Seely · E. W. · Wylie · B. J. · Hacker · M. R. · O'Brien · K. · Brown · F. M. · Powe · C. E. · Bellavia · A. · Wang · Z. · Tomsho · K. S. · Hauser · R. · James-Todd · T. · the Environmental Rep
Purpose

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Participants

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

Findings to date

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future plans

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

Patient, caregiver and other knowledge user engagement in consensus-building healthcare initiatives: a scoping review protocol

Por: Munce · S. E. P. · Wong · E. · Luong · D. · Rao · J. · Cunningham · J. · Bailey · K. · John · T. · Barber · C. · Batthish · M. · Chambers · K. · Cleverley · K. · Crabtree · M. · Diaz · S. · Dimitropoulos · G. · Gorter · J. W. · Grahovac · D. · Grimes · R. · Guttman · B. · Hebert · M. L. · He
Introduction

Patient engagement and integrated knowledge translation (iKT) processes improve health outcomes and care experiences through meaningful partnerships in consensus-building initiatives and research. Consensus-building is essential for engaging a diverse group of experienced knowledge users in co-developing and supporting a solution where none readily exists or is less optimal. Patients and caregivers provide invaluable insights for building consensus in decision-making around healthcare, policy and research. However, despite emerging evidence, patient engagement remains sparse within consensus-building initiatives. Specifically, our research has identified a lack of opportunity for youth living with chronic health conditions and their caregivers to participate in developing consensus on indicators/benchmarks for transition into adult care. To bridge this gap and inform our consensus-building approach with youth/caregivers, this scoping review will synthesise the extent of the literature on patient and other knowledge user engagement in consensus-building healthcare initiatives.

Methods and analysis

Following the scoping review methodology from Joanna Briggs Institute, published literature will be searched in MEDLINE, EMBASE, CINAHL and PsycINFO databases from inception to July 2023. Grey literature will be hand-searched. Two independent reviewers will determine the eligibility of articles in a two-stage process, with disagreements resolved by a third reviewer. Included studies must be consensus-building studies within the healthcare context that involve patient engagement strategies. Data from eligible studies will be extracted and charted on a standardised form. Abstracted data will be analysed quantitatively and descriptively, according to specific consensus methodologies, and patient engagement models and/or strategies.

Ethics and dissemination

Ethics approval is not required for this scoping review protocol. The review process and findings will be shared with and informed by relevant knowledge users. Dissemination of findings will also include peer-reviewed publications and conference presentations. The results will offer new insights for supporting patient engagement in consensus-building healthcare initiatives.

Protocol registration

https://osf.io/beqjr

Immediate versus delayed single blastocyst transfer following the first stimulated IVF cycle in the freeze-all strategy: a study protocol for a randomised controlled trial

Por: Li · H. · Zhang · W. · Chen · J. · Lu · X. · Li · L. · Sun · X. · Ng · E. H.
Introduction

In recent years, the use of frozen embryo transfers (FET) has rapidly increased following the freeze-all strategy due to the advantages of increased maternal safety, improved pregnancy rates, lower ectopic pregnancy rates and better obstetric and neonatal outcomes. Currently, there is still no good scientific evidence to support when to perform FET following a stimulated in vitro fertilisation (IVF) cycle in the freeze-all strategy.

Methods/analysis

This will be a randomised controlled trial. A total of 828 women undergoing their first FET following their first stimulated IVF cycle in the freeze-all strategy will be enrolled and randomised into one of the following groups according to a computer-generated randomisation list: (1) the immediate group, in which FET will be performed in the first menstrual cycle following the stimulated IVF cycle; or (2) the delayed group, in which FET will be performed at least in the second menstrual cycle following the stimulated IVF cycle. The primary outcome will be live birth, which is defined as the delivery of any infants at ≥22 gestational weeks with heartbeat and breath.

Ethics/dissemination

Ethical approval was granted by the Ethics Committee of Assisted Reproductive Medicine at the Shanghai JiAi Genetics & IVF Institute (JIAI E2019-15). Written informed consent will be obtained from each woman before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal.

Trial registration number

NCT04371783

Diversity, equity and inclusion considerations in mental health apps for young people: protocol for a scoping review

Por: Figueroa · C. A. · Perez-Flores · N. J. · Guan · K. W. · Stiles-Shields · C.
Introduction

After COVID-19, a global mental health crisis affects young people, with one in five youth experiencing mental health problems worldwide. Delivering mental health interventions via mobile devices is a promising strategy to address the treatment gap. Mental health apps are effective for adolescent and young adult samples, but face challenges such as low real-world reach and under-representation of minoritised youth. To increase digital health uptake, including among minoritised youth, there is a need for diversity, equity and inclusion (DEI) considerations in the development and evaluation of mental health apps. How well DEI is integrated into youth mental health apps has not been comprehensively assessed. This scoping review aims to examine to what extent DEI considerations are integrated into the design and evaluation of youth mental health apps and report on youth, caregiver and other stakeholder involvement.

Methods and analysis

We will identify studies published in English from 2009 to 29 September 2023 on apps for mental health in youth. We will use PubMed, Global Health, APA PsycINFO, SCOPUS, CINAHL PLUS and the Cochrane Database and will report according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review Extension guidelines. Papers eligible for inclusion must be peer-reviewed publications in English involving smartphone applications used by adolescents or young adults aged 10–25, with a focus on depression, anxiety or suicidal ideation. Two independent reviewers will review and extract articles using a template developed by the authors. We will analyse the data using narrative synthesis and descriptive statistics. This study will identify gaps in the literature and provide a roadmap for equitable and inclusive mental health apps for youth.

Ethics and dissemination

Ethics approval is not required. Findings will be disseminated through academic, industry, community networks and scientific publications.

Experiences of living with overweight/obesity and early type 2 diabetes in Singapore--a qualitative interview study

Por: Lee · M. · Khoo · H. S. · Krishnasamy · C. · Loo · M. E. · Wong · S. K. W. · Cheng · S. C. · Bei · E. · Tan · S. Y. · Xie · P. · Lee · E. S. · Tang · W. E.
Objectives

To understand the lived experience of adults with overweight/obesity and early type 2 diabetes in a modern urban environment, and the interrelations among the various aspects of these experiences and participants’ attitudes to weight management.

Design

Qualitative inductive approach to analysing data thematically from semistructured interviews and interpreted from a socioecological perspective.

Setting

Primary care clinics located in northern and central Singapore.

Participants

21 patients between 29 and 59 years old who are living with overweight/obese (Body Mass Index of 25.3–44.0kg/m2) and type 2 diabetes for 6 years or less.

Results

The main themes everyday life, people around me and within me pointed to a combination of barriers to weight and health management for participants. These included environmental factors such as easy physical and digital access to unhealthy food, and high-stress work environments; social factors such as ambiguous family support and dietary practices of peers; and individual factors such as challenges with self-regulation, prioritising work, dealing with co-existing medical conditions and the emotional significance of food. While lack of motivation and cultural dietary practices are hard to change, a problem-solving attitude, and presence of role models, may enable behaviour change.

Conclusion

An exploration of the lifeworld of patients with overweight/obese and early type 2 diabetes revealed that work demands, dietary practices in the workplace and at home, and the easy availability of calorie-dense foods afforded by a technology-infused environment hindered the individual’s efforts at maintaining a healthy weight and lifestyle. Policy and initiatives promoting work-life balance as well as individualised interventions can support participants’ stress management, and problem-solving capability for behaviour change. These barriers stemmed from the various domains of the environmental, interpersonal and intrapersonal but were interrelated. They underscored the need for an integrated approach to weight and diabetes management.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A.
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

Do patients with nephrotic syndrome have an increased risk of osteoporosis? A nationwide population-based retrospective cohort study in Taiwan

Por: Liao · C.-Y. · Chung · C.-H. · Wei · K.-Y. · Tseng · M.-F. · Lin · F.-H. · Tsao · C.-H. · Chien · W.-C. · Chu · P. · Wu · C.-C.
Objectives

To evaluate whether nephrotic syndrome (NS) and further corticosteroid (CS) use increase the risk of osteoporosis in Asian population during the period January 2000–December 2010.

Design

Nationwide population-based retrospective cohort study.

Setting

All healthcare facilities in Taiwan.

Participants

A total of 28 772 individuals were enrolled.

Interventions

26 614 individuals with newly diagnosed NS between 2000 and 2010 were identified and included in out study. 26 614 individuals with no NS diagnosis prior to the index date were age matched as controls. Diagnosis of osteoporosis prior to the diagnosis of NS or the same index date was identified, age, sex and NS-associated comorbidities were adjusted.

Primary outcome measure

To identify risk differences in developing osteoporosis among patients with a medical history of NS.

Results

After adjusting for covariates, osteoporosis risk was found to be 3.279 times greater in the NS cohort than in the non-NS cohort, when measured over 11 years after NS diagnosis. Stratification revealed that age older than 18 years, congestive heart failure, hyperlipidaemia, chronic kidney disease, liver cirrhosis and NS-related disease including diabetes mellitus, hepatitis B infection, hepatitis C infection, lymphoma and hypothyroidism, increased the risk of osteoporosis in the NS cohort, compared with the non-NS cohort. Additionally, osteoporosis risk was significantly higher in NS patients with CS use (adjusted HR (aHR)=3.397). The risk of osteoporosis in NS patients was positively associated with risk of hip and vertebral fracture (aHR=2.130 and 2.268, respectively). A significant association exists between NS and subsequent risk for osteoporosis.

Conclusion

NS patients, particularly those treated with CS, should be evaluated for subsequent risk of osteoporosis.

Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study

Por: Rolfsen · M. P. · Gammelsrud · K. W. · Espeland · A. · Braten · L. C. · Mjones · S. B. · Austevoll · I. · Dolatowski · F. C. · Arrestad · M. B. · Toppe · M. K. · Orlien · I. E. · Holberg-Petersen · M. · Fagerland · M. · Zwart · J.-A. · Storheim · K. · Hellum · C.
Introduction

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

Methods and analysis

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

Ethics and dissemination

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

Trial registration number

NCT03406624.

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial

Por: Little · R. B. · Carter · S. J. · Motl · R. W. · Hunter · G. · Cook · A. · Liu · N. · Krontiras · H. · Lefkowitz · E. J. · Turan · B. · Schleicher · E. · Rogers · L. Q.
Introduction

Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response.

Methods and analysis

The research is a randomised controlled trial among breast cancer survivors aged 18–74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale.

Ethics and dissemination

The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov, NCT04088708.

Prevalence and health effects of post-COVID-19 condition in Africa: a scoping review protocol

Por: Ansah · E. W. · Salu · P. K. · Daanko · M. S. · Banaaleh · D. N. · Amoadu · M.
Introduction

SARS-CoV-2 pandemic has caused global devastations in the social, economic and health systems of every nation, but disproportionately the nations in Africa. Apart from its grave effects on the global systems, is the persistence of post-COVID-19 condition in individuals infected with the virus. Therefore, the aim of this scoping review is to collate and summarise the existing research evidence about the prevalence and health effects of post-COVID-19 infection conditions in Africa.

Methods and analysis

Five main databases will be thoroughly searched from 1 September 2023 to 30 April 2024, for eligible articles based on the inclusion and exclusion criteria. These databases include PubMed, Central, Scopus, Dimensions AI and JSTOR. Meanwhile, Arksey and O’Malley guidelines will guide this scoping review using article published between 1 January 2020 and 30 April 2024. This review will provide a useful insight into the prevalence of the post-COVID-19 symptoms and their health effects within the population in Africa. The results and findings of the review will be valuable for health system interventions, including restructuring and reorientation of health systems in the continent.

Ethics and dissemination

This scoping review will involve analysis of secondary data, therefore, no ethical approval is needed. Dissemination of the results will be done through international journals and available research conferences.

Saxon Epidemiological Study in General Practice-6 (SESAM-6): protocol of a cross-sectional study

Por: Gräfe · W. · Liebig · L. · Deutsch · T. · Schübel · J. · Bergmann · A. · Bleckwenn · M. · Frese · T. · Brütting · C. · Riemenschneider · H.
Introduction

General practitioners (GPs) are mostly the first point of contact for patients with health problems in Germany. There is only a limited epidemiological overview data that describe the GP consultation hours based on other than billing data. Therefore, the aim of Saxon Epidemiological Study in General Practice-6 (SESAM-6) is to examine the frequency of reasons for encounter, prevalence of long-term diagnosed diseases and diagnostic and therapeutic decisions in general practice. This knowledge is fundamental to identify the healthcare needs and to develop strategies to improve the GP care. The results of the study will be incorporated into the undergraduate, postgraduate and continuing medical education for GP.

Methods and analysis

This cross-sectional study SESAM-6 is conducted in general practices in the state of Saxony, Germany. The study design is based on previous SESAM studies. Participating physicians are assigned to 1 week per quarter (over a survey period of 12 months) in which every fifth doctor–patient contact is recorded for one-half of the day (morning or afternoon). To facilitate valid statements, a minimum of 50 GP is required to document a total of at least 2500 doctor–patient contacts. Univariable, multivariable and subgroup analyses as well as comparisons to the previous SESAM data sets will be conducted.

Ethics and dissemination

The study was approved by the Ethics Committee of the Technical University of Dresden in March 2023 (SR-EK-7502023). Participation in the study is voluntary and will not be remunerated. The study results will be published in peer-reviewed scientific journals, preferably with open access. They will also be disseminated at scientific and public symposia, congresses and conferences. A final report will be published to summarise the central results and provided to all study participants and the public.

Status of the midwifery workforce and childbirth services and the impact of midwife staffing on birth outcomes in China: a multicentre cross-sectional study

Por: Zhu · W. · Zhu · C. · Min · H. · Li · L. · Wang · X. · Wu · J. · Zhu · X. · Gu · C.
Objective

To investigate the status of the midwifery workforce and childbirth services in China and to identify the association between midwife staffing and childbirth outcomes.

Design

A descriptive, multicentre cross-sectional survey.

Setting

Maternity hospitals from the eastern, central and western regions of China.

Participants

Stratified sampling of maternity hospitals between 1 July and 31 December 2021.

The sample hospitals received a package of questionnaires, and the head midwives from the participating hospitals were invited to fill in the questionnaires.

Results

A total of 180 hospitals were selected and investigated, staffed with 4159 midwives, 412 obstetric nurses and 1007 obstetricians at the labour and delivery units. The average efficiency index of annual midwifery services was 272 deliveries per midwife. In the sample hospitals, 44.9% of women had a caesarean delivery and 21.4% had an episiotomy. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery (adjusted β –0.032, 95% CI –0.115 to –0.012, p

Conclusion

The rates of childbirth interventions including the overall caesarean section in China and the episiotomy rate, especially in the central region, remain relatively high. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery and episiotomy, indicating that further investments in the midwifery workforce could produce better childbirth outcomes.

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial

Por: Holbrook · A. · Troyan · S. · Telford · V. · Koubaesh · Y. · Vidug · K. · Yoo · L. · Deng · J. · Lohit · S. · Giilck · S. · Ahmed · A. · Talman · M. · Leonard · B. · Refaei · M. · Tarride · J.-E. · Schulman · S. · Douketis · J. · Thabane · L. · Hyland · S. · Ho · J. M.-W. · Siegal · D.
Objectives

To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.

Design

Randomised, parallel design.

Setting

Medical wards at six hospital sites in southern Ontario, Canada.

Participants

Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.

Interventions

Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.

Outcomes measures

Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.

Results

Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).

Conclusion

This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.

Trial registration number

NCT02777047.

Is the QCI framework suited for monitoring outcomes and costs in a teaching hospital using value-based healthcare principles? A retrospective cohort study

Por: van Veghel · W. · van Dijk · S. C. · Klem · T. M. · Weel · A. E. · Bügel · J.-B. · Birnie · E.
Objectives

The objective is to develop a pragmatic framework, based on value-based healthcare principles, to monitor health outcomes per unit costs on an institutional level. Subsequently, we investigated the association between health outcomes and healthcare utilisation costs.

Design

This is a retrospective cohort study.

Setting

A teaching hospital in Rotterdam, The Netherlands.

Participants

The study was performed in two use cases. The bariatric population contained 856 patients of which 639 were diagnosed with morbid obesity body mass index (BMI)

Primary and secondary outcome measures

The quality cost indicator (QCI) was the primary measures and was defined as

QCI = (resulting outcome * 100)/average total costs (per thousand Euros)

where average total costs entail all healthcare utilisation costs with regard to the treatment of the primary diagnosis and follow-up care. Resulting outcome is the number of patients achieving textbook outcome (passing all health outcome indicators) divided by the total number of patients included in the care path.

Results

The breast cancer and bariatric population had the highest resulting outcome values in 2020 Q4, 0.93 and 0.73, respectively. The average total costs of the bariatric population remained stable (avg, 8833.55, min 8494.32, max 9164.26). The breast cancer population showed higher variance in costs (avg, 12 735.31 min 12 188.83, max 13 695.58). QCI values of both populations showed similar variance (0.3 and 0.8). Failing health outcome indicators was significantly related to higher hospital-based costs of care in both populations (p

Conclusions

The QCI framework is effective for monitoring changes in average total costs and relevant health outcomes on an institutional level. Health outcomes are associated with hospital-based costs of care.

Myopia prevalence and ocular biometry in children and adolescents at different altitudes: a cross-sectional study in Chongqing and Tibet, China

Por: Xiang · Y. · Cheng · H. · Sun · K. · Zheng · S. · Du · M. · Gao · N. · Zhang · T. · Yang · X. · Xia · J. · Huang · R. · Wan · W. · Hu · K.
Objective

To investigate the differences in myopia prevalence and ocular biometry in children and adolescents in Chongqing and Tibet, China.

Design

Cross-sectional study.

Setting

The study included children and adolescents aged 6–18 years in Chongqing, a low-altitude region, and in Qamdo, a high-altitude region of Tibet.

Participants

A total of 448 participants in Qamdo, Tibet, and 748 participants in Chongqing were enrolled in this study.

Methods

All participants underwent uncorrected visual acuity assessment, non-cycloplegic refraction, axial length (AL) measurement, intraocular pressure (IOP) measurement and corneal tomography. And the participants were grouped according to age (6–8, 9–11, 12–14 and 15–18 years group), and altitude of location (primary school students: group A (average altitude: 325 m), group B (average altitude: 2300 m), group C (average altitude: 3250 and 3170 m) and group D (average altitude: 3870 m)).

Results

There was no statistical difference in mean age (12.09±3.15 vs 12.2±3.10, p=0.549) and sex distribution (males, 50.4% vs 47.6%, p=0.339) between the two groups. The Tibet group presented greater spherical equivalent (SE, –0.63 (–2.00, 0.13) vs –0.88 (–2.88, –0.13), p

Conclusions

Myopia prevalence in Tibet was comparable with that in Chongqing for students aged 6–8 and 9–11 years but was lower and myopia progressed more slowly for students aged 12–14 and 15–18 years than in Chongqing, and AL was the main contributor for this difference, which may be related to higher ultraviolet radiation exposure and lower IOP in children and adolescents at high altitude in Tibet. Differences in AL and AL/CR between Tibet and Chongqing children and adolescents manifested earlier than in SE, underscoring the importance of AL measurement in myopia screening.

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