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De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease

Por: Sanchez · A. · Pijoan · J. I. · Sainz de Rozas · R. · Lekue · I. · San Vicente · R. · Quindimil · J. A. · Rotaeche · R. · Etxeberria · A. · Mozo · C. · Martinez-Cengotitabengoa · M. · Monge · M. · Gomez-Ramirez · C. · Samper · R. · Ogueta Lana · M. · Celorrio · S. · Merino-Inda · N.
Introduction

This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.

Methods and analysis

A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR

Ethics and dissemination

The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.

Trial registration number

NCT04022850.

Missed nursing care and its associated factors in public hospitals of Bahir Dar City, Northwest Ethiopia: a cross-sectional study

Por: Abere · Y. · Biresaw · H. · Misganaw · M. · Netsere · B. · Adal · O.
Objectives

The aim of this study was to investigate the prevalence of missed nursing care and its associated factors among public hospitals in Bahir Dar City, Northwest Ethiopia.

Design

An institution-based cross-sectional study was conducted among 369 randomly selected nurses.

Setting

The study was conducted in primary and secondary-level public hospitals in Bahir Dar City.

Participants

Nurses who had worked in hospitals in Bahir Dar City were included.

Intervention

No intervention was needed in this study.

Primary and secondary outcome measures

A binary logistic regression model was used for statistical analysis. Statistical significance of the association between outcome variables and independent variables was declared at a p value of

Results

The prevalence of missed nursing care in this study was 46.3% (95% CI: 41.7% to 50.9%). The activities most frequently missed were physical examination (56.4%), patient discharge planning and teaching (50.9%), providing emotional support to the patient and family (50.8%), monitoring input and output (50.2%), assisting with patient ambulation (48.5%) and documentation (48%). Factors associated with missed nursing care include: male professionals (adjusted OR (AOR): 2.9, 95% CI: 1.8 to 4.8), those who had not received on-the-job training (AOR: 2.2, 95% CI: 1.4 to 3.6), those who worked full 24-hour shifts (AOR: 3.7, 95% CI: 2.0 to 6.5), those who were dissatisfied with the level of teamwork (AOR: 4.6, 95% CI: 2.8 to 7.6) and those who had an intention to leave the nursing profession (AOR: 1.8, 95% CI: 1.1 to 2.9). These factors were statistically associated with missed nursing care.

Conclusion

A significant proportion of nurses missed essential nursing care activities. Efforts should be made to enhance training, improve teamwork among nurses, provide stability and adjust work shifts to mitigate this issue.

Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial

Por: Barr · L. · Richards · J. · Chapman · G. J.
Introduction

Custom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The method of foot shape capture used to produce insoles varies throughout orthotic services. This trial aims to investigate the effectiveness of two common shape-capture techniques on patient-reported outcomes in people who require insoles for a foot or ankle pathology.

Methods and analysis

This double-blinded randomised controlled trial will involve two intervention groups recruited from a National Health Service orthotic service. Participants will be randomly assigned to receive a pair of custom CAD/CAM insoles, manufactured either from a direct digital scan or a foam box cast of their feet and asked to wear the insoles for 12 weeks. The primary outcome measure will be the Foot Health Status Questionnaire (FHSQ) pain subdomain, recorded at baseline (immediately after receiving the intervention), 4, 8 and 12 weeks post intervention. Secondary outcome measures will include FHSQ foot function and foot health subdomains recorded at baseline, 4, 8 and 12 weeks. The Orthotic and Prosthetic User Survey Satisfaction with Device will be recorded at 12 weeks. The transit times associated with each arm will be measured as the number of days for each insole to be delivered after foot shape capture. Tertiary outcome measures will include participant recruitment and dropout rates, and intervention adherence measured as the daily usage of the insoles over 12 weeks. The change in FHSQ scores for the subdomains and insole usage will be compared between the groups and time points, and between group differences in time in transit, cost-time analysis and environmental impact will be compared.

Ethics and dissemination

Ethical approval was obtained from the Health Research Authority, London Stanmore Research Ethics Committee (22/LO/0579). Study findings will be submitted for publication in peer-reviewed journals, conference presentations and webinars.

Trial registration number

NCT05444192.

Investigating patient engagement associations between a postdischarge texting programme and patient experience, readmission and revisit rates outcomes

Por: Bruce · C. · Pinn-Kirkland · T. · Meyers · A. · Javaluyas · E. · Osborn · J. · Kelkar · S. · Bruchhaus · L. · McLaury · K. · Sauceda · K. · Carr · K. · Garcia · C. · Arabie · L. A. · Williams · T. · Vozzella · G. · Nisar · T. · Schwartz · R. L. · Sasangohar · F.
Objectives

This study aimed (1) to examine the association between patient engagement with a bidirectional, semiautomated postdischarge texting programme and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey outcomes, readmissions and revisit rates in a large health system and (2) to describe operational and clinical flow considerations for implementing a postdischarge texting programme.

Setting

The study involved 1 main academic hospital (beds: 2500+) and 6 community hospitals (beds: 190–400, averaging 300 beds per hospital) in Houston, Texas.

Methods

Retrospective, observational cohort study between non-engaged patients (responded with 0–2 incoming text messages) and engaged patients (responded with 3+ incoming, patient-initiated text messages) between December 2022 and May 2023. We used the two-tailed t-test for continuous variables and 2 test for categorical variables to compare the baseline characteristics between the two cohorts. For the binary outcomes, such as the revisit (1=yes, vs 0=no) and readmissions (1=yes vs 0=no), we constructed mixed effect logistic regression models with the random effects to account for repeated measurements from the hospitals. For the continuous outcome, such as the case mix index (CMI), a generalised linear quantile mixed effect model was built. All tests for significance were two tailed, using an alpha level of 0.05, and 95% CIs were provided. Significance tests were performed to evaluate the CMI and readmissions and revisit rates.

Results

From 78 883 patients who were contacted over the course of this pilot implementation, 49 222 (62.4%) responded, with 39 442 (50%) responded with 3+ incoming text messages. The engaged cohort had higher HCAHPS scores in all domains compared with the non-engaged cohort. The engaged cohort used significantly fewer 30-day acute care resources, experiencing 29% fewer overall readmissions and 20% fewer revisit rates (23% less likely to revisit) and were 27% less likely to be readmitted. The results were statistically significant for all but two hospitals.

Conclusions

This study builds on the few postdischarge texting studies, and also builds on the patient engagement literature, finding that patient engagement with postdischarge texting can be associated with fewer acute care resources. To our knowledge, this is the only study that documented an association between a text-based postdischarge programme and HCAHPS scores, perhaps owing to the bidirectionality and ease with which patients could interact with nurses. Future research should explore the texting paradigms to evaluate their associated outcomes in a variety of postdischarge applications.

Impact of evidence-based guidelines on healthcare utilisation and costs for disc related sciatica in the Netherlands: a population-based, cross-sectional study

Por: van Munster · J. · Noordenbos · M. W. · Halperin · I. J. Y. · van den Hout · W. B. · van Benthem · P. P. · Seinen · I. · Moojen · W. A. · Peul · W.
Objective

The aim of this study was to assess the impact of high-quality evidence supporting surgical treatment of lumbar disc herniation (LDH) on healthcare practice in the Netherlands by examining changes in healthcare utilisation, including the timing of surgery, and the healthcare costs for patients with LDH.

Design

A retrospective, cross-sectional study was performed using population-based, longitudinal data obtained from the Dutch Healthcare Authority (2007–2020) and NIVEL’s primary care (2012–2020) administrative databases.

Setting

The study was conducted within the healthcare system of the Netherlands.

Participants

We included adults (≥18 years) who visited a Dutch hospital or a general practitioner (GP) for lumbar degenerative disc disease. Patients with LDH were identified based on registered diagnosis code, type of surgery (discectomy) and age (

Main outcome measures

The primary outcome measure was the difference in the annual number of LDH procedures following the publication of evidence-based guidelines in 2009 (comparing the periods 2007–2009 to 2017–2019). Secondary outcome measures focused on the timing of surgery and associated healthcare costs. To validate the outcomes, secondary outcomes also include the number of discectomies and the number of procedures in the younger age group (discectomies, laminectomies, and fusion surgery).

Results

The number of patients suffering from LDH increased from 55 581 to 68 997 (+24%) between 2007 and 2019. A decrease was observed in the annual number of LDH procedures (–18%), in the number of discectomies (–22%) and in the number of procedures for patients aged

Conclusions

Healthcare utilisation for LDH changed tremendously in the Netherlands between 2007 and 2020 and seemed to be associated with the publication and implementation of evidence-based guidelines. The observed decrease in the number of procedures has been accompanied by a corresponding reduction in healthcare costs. These findings underscore the importance of adhering to evidence-based guidelines to optimise the management of patients with LDH.

Survival outcomes following complete mediastinal lymphadenectomy or selective mediastinal lymphadenectomy in patients with stage I-IIIA non-small cell lung cancer: protocol for a systematic review and meta-analysis

Por: Xu · J. · Lai · J. · Huang · X. · Ren · Y. · Chen · Q. · Li · W.
Introduction

Lung cancer remains the largest cause of cancer-related deaths worldwide. Surgical removal of non-small cell lung cancer (NSCLC) has the potential to achieve a cure, although there is ongoing debate regarding the significance of removing mediastinal nodes and the optimal extent of lymph node excision. The purpose of this research is to assess the survival outcomes in patients diagnosed with stage I–IIIA NSCLC who received either complete mediastinal lymphadenectomy (CML) or selective mediastinal lymphadenectomy (SML).

Methods and analysis

The protocol follows the guidelines recommended in Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols, and this meta-analysis will be conducted in accordance with the standard methodology recommended by the Cochrane Collaboration and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidance. We will conduct a comprehensive search for randomised controlled trials and non-randomised studies examining the effectiveness of CML compared with SML in patients with stage I–IIIA NSCLC. Two authors will perform a comprehensive search of the MEDLINE/PubMed, Embase, the Cochrane Library, CNKI, WanFang, Sinomed, VIP and Web of Science databases. There will be no restrictions on language or publication date, and the search will be conducted on 10 April 2024, with ongoing searches for new research. Reference lists will also be checked and pertinent journals will be hand searched. The primary outcomes include overall survival (OS) and disease-free survival (DFS), while the secondary outcomes consist of 1-year, 3-year and 5-year OS rates and 1-year, 3-year and 5-year DFS rates. Two independent reviewers will screen, extract data, assess quality and evaluate the potential for bias in the selected research, with a third acting as arbitrator. Subgroup analyses and sensitivity analyses are planned. The quality of the evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Review Manager V.5.4 will be used for the analysis and synthesis process.

Ethics and dissemination

Ethical review and approval are not necessary for this study because it is based on a secondary analysis of the literature. The results will be submitted for reporting in a peer-reviewed publication.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/PN7UQ).

Prevalence and correlates of paediatric guideline non-adherence for initial empirical care in six low and middle-income settings: a hospital-based cross-sectional study

Por: Shawon · R. A. · Denno · D. · Tickell · K. D. · Atuhairwe · M. · Bandsma · R. · Mupere · E. · Voskuijl · W. · Mbale · E. · Ahmed · T. · Chisti · M. J. · Saleem · A. F. · Ngari · M. · Diallo · A. H. · Berkley · J. · Walson · J. · Means · A. R.
Objectives

This study evaluated the prevalence and correlates of guideline non-adherence for common childhood illnesses in low-resource settings.

Design and setting

We used secondary cross-sectional data from eight healthcare facilities in six Asian and African countries.

Participants

A total of 2796 children aged 2–23 months hospitalised between November 2016 and January 2019 with pneumonia, diarrhoea or severe malnutrition (SM) and without HIV infection were included in this study.

Primary outcome measures

We identified children treated with full, partial or non-adherent initial inpatient care according to site-specific standard-of-care guidelines for pneumonia, diarrhoea and SM within the first 24 hours of admission. Correlates of guideline non-adherence were identified using generalised estimating equations.

Results

Fully adherent care was delivered to 32% of children admitted with diarrhoea, 34% of children with pneumonia and 28% of children with SM when a strict definition of adherence was applied. Non-adherence to recommendations was most common for oxygen and antibiotics for pneumonia; fluid, zinc and antibiotics for diarrhoea; and vitamin A and zinc for SM. Non-adherence varied by site. Pneumonia guideline non-adherence was more likely among patients with severe disease (OR 1.82; 95% CI 1.38, 2.34) compared with non-severe disease. Diarrhoea guideline non-adherence was more likely among lower asset quintile groups (OR 1.16; 95% CI 1.01, 1.35), older children (OR 1.10; 95% CI 1.06, 1.13) and children presenting with wasting (OR 6.44; 95% CI 4.33, 9.57) compared with those with higher assets, younger age and not wasted.

Conclusions

Non-adherence to paediatric guidelines was common and associated with older age, disease severity, and comorbidities, and lower household economic status. These findings highlight opportunities to improve guidelines by adding clarity to specific recommendations.

Impact of the design of adult mental health inpatient facilities on healthcare staff: a mixed methods systematic review

Por: Rodriguez-Labajos · L. · Kinloch · J. · Nicol · L. · Grant · S. · O'Brien · G.
Objectives

Mental health inpatient facilities are increasingly focusing on creating therapeutic, person-centred care environments. However, research shows that this focus may have unintended consequences for healthcare staff. Designs that do not pay attention to staff needs may risk contributing to stress, burnout, job dissatisfaction and mental exhaustion in the work environment. This systematic review aims to identify and synthesise current research on the design factors of adult mental health inpatient facilities that impact healthcare staff.

Design

A mixed method systematic review was conducted to search for empirical, peer-reviewed studies using the databases CINAHL, Embase, PsycINFO, PubMed and Web of Science from their inception up to 5 September 2023. The Joanna Briggs Institute’s critical appraisal checklists were used to assess the methodological quality of the eligible studies. Data were extracted and grouped based on the facility design factors.

Results

In our review, we included 29 peer-reviewed empirical studies that identified crucial design factors impacting healthcare staff in adult mental health inpatient facilities. Key factors included layouts providing optimal visibility, designated work and respite areas, and centrally located nursing stations. Notably, mixed perceptions regarding the benefits and challenges of open and glass-enclosed nursing stations suggest areas requiring further research. Facilities in geographically remote locations also emerged as a factor influencing staff dynamics. Additionally, although only supported by a limited number of studies, the significance of artwork, sensory rooms for respite, appropriate furniture and equipment, and access to alarms was acknowledged as contributory factors.

Conclusion

Through the synthesis of existing research, this review identified that the design of mental health facilities significantly impacts staff well-being, satisfaction, performance and perception of safety. Concluding that, in order to create a well-designed therapeutic environment, it is essential to account for both service users and staff user needs.

PROSPERO registration number

CRD42022368155.

Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses

Por: Zavalis · E. A. · Rameau · A. · Saraswathula · A. · Vist · J. · Schuit · E. · Ioannidis · J. P.
Objectives

This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured.

Design

Systematic review of systematic reviews (umbrella review).

Data sources

Cochrane Database of Systematic Reviews.

Eligibility criteria

Systematic reviews attempt to compare surgical to drug interventions.

Data extraction

We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review.

Synthesis

The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger’s test and excess significance were assessed.

Results

Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance.

Conclusions

Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed.

Association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer: a systematic review and meta-analysis

Por: Liu · Q. · Huang · M. · Yang · J. · Jiang · M. · Zhao · Z. · Zhao · H. · He · T. · Bai · Y. · Zhang · R. · Zhang · M.
Objective

Clinical practice guidelines recommend retrieving at least 12 lymph nodes for correct staging in colorectal cancer. However, it is difficult to retrieve adequate lymph nodes because of various factors. We aimed to evaluate the association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer.

Design

Systematic review and meta-analysis of primary studies.

Data sources

PubMed, Embase, Cochrane and Web of Science were searched from January 2016 to June 2023.

Eligibility criteria for selecting studies

Studies that evaluated the association between retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer were included.

Data extraction and synthesis

OR with 95% conference intervals was extracted and pooled.

Results

A total of 54 studies containing 2 05 821 patients were included in this meta-analysis. The results showed that fewer nodes were retrieved from elderly patients (OR=0.70, 95% CI (0.54 to 0.90), p=0.005), and from tumours located in the left colon than in the right colon (OR=0.43, 95% CI (0.33 to 0.56), p

Conclusions

The study results suggest that clinicians have an increased opportunity to retrieve sufficient lymph nodes for accurate pathological staging to guide treatment decisions in patients with colorectal cancer who are young, female, with tumours located in the right colon, advanced T stage and N2 stage.

Predictive value of machine learning on fracture risk in osteoporosis: a systematic review and meta-analysis

Por: Wu · Y. · Chao · J. · Bao · M. · Zhang · N.
Objectives

Early identification of fracture risk in patients with osteoporosis is essential. Machine learning (ML) has emerged as a promising technique to predict the risk, whereas its predictive performance remains controversial. Therefore, we conducted this systematic review and meta-analysis to explore the predictive efficiency of ML for the risk of fracture in patients with osteoporosis.

Methods

Relevant studies were retrieved from four databases (PubMed, Embase, Cochrane Library and Web of Science) until 31 May 2023. A meta-analysis of the C-index was performed using a random-effects model, while a bivariate mixed-effects model was used for the meta-analysis of sensitivity and specificity. In addition, subgroup analysis was performed according to the types of ML models and fracture sites.

Results

Fifty-three studies were included in our meta-analysis, involving 15 209 268 patients, 86 prediction models specifically developed for the osteoporosis population and 41 validation sets. The most commonly used predictors in these models encompassed age, BMI, past fracture history, bone mineral density T-score, history of falls, BMD, radiomics data, weight, height, gender and other chronic diseases. Overall, the pooled C-index of ML was 0.75 (95% CI: 0.72, 0.78) and 0.75 (95% CI: 0.71, 0.78) in the training set and validation set, respectively; the pooled sensitivity was 0.79 (95% CI: 0.72, 0.84) and 0.76 (95% CI: 0.80, 0.81) in the training set and validation set, respectively; and the pooled specificity was 0.81 (95% CI: 0.75, 0.86) and 0.83 (95% CI: 0.72, 0.90) in the training set and validation set, respectively.

Conclusions

ML has a favourable predictive performance for fracture risk in patients with osteoporosis. However, most current studies lack external validation. Thus, external validation is required to verify the reliability of ML models.

PROSPERO registration number

CRD42022346896.

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