Category: Statistics

Trials. 2025 Apr 2;26(1):116. doi: 10.1186/s13063-025-08822-w.

ABSTRACT

BACKGROUND: Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears.

METHODS: The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40-75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including-as indicated-bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.

DISCUSSION: The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears.

TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).

PMID:40176135 | DOI:10.1186/s13063-025-08822-w

Implement Sci Commun. 2025 Apr 2;6(1):33. doi: 10.1186/s43058-025-00720-1.

ABSTRACT

BACKGROUND: Home-based care for patients diagnosed in emergency departments (EDs) with low-risk pulmonary embolism (PE) is an evidence-based, guideline-recommended practice that is not widely adopted in the US. Few studies demonstrate how this care pathway can be implemented effectively or test whether implementation strategies can address known barriers. Further, prior studies have lacked diversity in population and health system type and did not integrate theory-informed implementation frameworks. Although essential for establishing the evidence base for safe home management of low-risk acute PE, these studies have thus fallen short of guiding broad dissemination and equitable implementation. To bridge this gap, we are conducting a pragmatic multi-site implementation trial, guided by implementation science theory and frameworks, across twelve diverse hospital settings to assess the effectiveness of new care pathways for patients with low-risk PE presenting to EDs.

METHODS/DESIGN: The study uses a cluster-randomized stepped wedge trial design to investigate a set of implementation strategies to support establishing low-risk PE pathways in 12 EDs. Clusters of three hospitals were randomly assigned to one of four start dates, staggered over a 12-month period. During an initial three-month pre-implementation period, we will work with site champions to identify key site personnel and understand site barriers and facilitators. We will then tailor the care pathway to local needs and capabilities. During the six-month active implementation period, we will provide coaching to help sites implement a multi-component intervention informed by behavioral economics intended to address multi-level (site, provider, patient) barriers and integrate the new care pathway for discharging low-risk PE patients. Sites are then followed for a minimum of 12 months post-implementation. Our primary aim is to assess the change in discharge rates of patients with acute PE pre- and post-implementation. Secondary and exploratory aims will assess change in patient safety outcomes along with other key implementation outcomes guided by the RE-AIM framework.

DISCUSSION: This study expands upon prior effectiveness research to tailor, implement, and robustly evaluate a multi-component implementation intervention for diverse health systems aiming to increase guideline-based outpatient management of low-risk PE. Broad-scale implementation in the US could avert up to 100,000 hospitalizations annually.

TRIAL REGISTRATION: Clinicaltrials.gov (NCT06312332), registered on March 13, 2024.

PMID:40176133 | DOI:10.1186/s43058-025-00720-1

Eur J Med Res. 2025 Apr 2;30(1):229. doi: 10.1186/s40001-025-02441-6.

ABSTRACT

OBJECTIVES: The albumin-globulin ratio (AGR) is considered an important indicator reflecting an individual’s immune function and nutritional status, and it is closely associated with various health conditions. However, despite its widely studied correlations in numerous health fields, the link between AGR and Overactive Bladder (OAB) is still not completely comprehended.

METHODS: Data were sourced from the National Health and Nutrition Examination Survey (NHANES) database, selecting adult samples spanning from 2007 to 2018. Through comprehensive questionnaires and laboratory tests, we gathered data pertinent to OAB and the AGR. To explore the association between AGR levels and the likelihood of developing OAB, we utilized advanced statistical techniques, such as weighted multivariate logistic regression and restricted cubic spline (RCS) models. Furthermore, we carried out subgroup analyses to assess the uniformity of this association across various demographics.

RESULTS: After adjusting for relevant covariates, we discovered a marked negative correlation between AGR levels and the risk of OAB. As AGR increased, the incidence of OAB showed a declining trend (OR = 0.69; 95% CI 0.56-0.85). Furthermore, significant nonlinear dose-response relationship was observed between AGR levels and the risk of OAB (P < 0.001), and this association remained stable in stratified analyses.

CONCLUSIONS: Our results indicate that elevated AGR levels could be linked to a reduced risk of OAB. This observation highlights the potential role of AGR in assessing and preventing the occurrence of OAB.

PMID:40176132 | DOI:10.1186/s40001-025-02441-6

Acta Vet Scand. 2025 Apr 2;67(1):16. doi: 10.1186/s13028-025-00795-9.

ABSTRACT

BACKGROUND: Antibiotic treatments of diarrhoea in suckling piglets and in pigs after weaning are common worldwide and contribute to antimicrobial resistance (AMR) in Escherichia coli from pigs. In Sweden, during the last decades, resistance to trimethoprim-sulphonamide and ampicillin has increased markedly in E. coli from routine clinical samples from piglets with diarrhoea, hereafter referred to as “clinical submissions”. This has occurred despite a comparatively low use of antibiotics in Swedish pig production. However, clinical submissions might be biased towards farms with treatment failures and therefore overestimate occurrence of AMR. To explore the representativeness of data from such samples we compared occurrence of AMR in E. coli from clinical submissions and from concurrent samples collected from piglets with diarrhoea by convenience, referred to as “study samples”. We also investigated associations between farm-related potential risk factors and AMR using farm data collected through a questionnaire. Data were evaluated using univariable and multivariable statistical models, as well as a multivariate model.

RESULTS: In all, 158 study samples from 97 herds and questionnaires from 83 herds were analysed. Resistance to streptomycin (37%), trimethoprim-sulphonamide (32%), ampicillin (30%), and tetracycline (18%) were the most frequent traits. Occurrence of AMR in 158 E. coli isolates from study samples was not significantly different from occurrence in 57 isolates from concurrent clinical submissions (P > 0.05). In 70% of herds, more than 10% of the sows were treated with antibiotics in the first week after farrowing, and trimethoprim-sulphonamide was the most common first choice antibiotic. Trimethoprim-sulphonamide resistance was associated with the proportion of sows receiving post-farrowing treatment. Resistance to ampicillin, tetracycline, and streptomycin resistances were indirectly associated with sow treatments, likely via co-resistance to trimethoprim-sulphonamide. There was no significant association between high dose zinc oxide supplementation and AMR (P > 0.05).

CONCLUSIONS: Clinical submissions do not overestimate occurrence of AMR in E. coli from Swedish piglets with diarrhoea and are therefore relevant for AMR monitoring. Even at low treatment rates, post-farrowing treatment of sows increases the risk for AMR in piglets. This applies especially for trimethoprim-sulphonamide resistance, but also for resistance to other antibiotics, and indicates that antibiotic use must be reduced substantially to achieve a reduction of AMR.

PMID:40176081 | DOI:10.1186/s13028-025-00795-9

BMC Surg. 2025 Apr 3;25(1):130. doi: 10.1186/s12893-025-02866-0.

ABSTRACT

BACKGROUND: As the population continues to age, the occurrence of intertrochanteric femoral fractures (IFFs) has steadily increased. The main aims of this investigation were to evaluate and compare the clinical outcomes, ambulatory ability, overall survival, and all-cause mortality between two cephalic screws combined with compression proximal-femoral intramedullary nailing internal fixation (IF) and long-stemmed cemented bipolar hemiarthroplasty (LCHA) in patients aged 75 years and older. The secondary objective was to investigate the relative independent risk factors contributing to postoperative all-cause mortality.

METHODS: A retrospective analysis was conducted on 251 elderly patients with IFF who underwent IF or LCHA between January 2018 and October 2022. We employed generalized estimation equations along with univariate and multivariate analyses to examine the impact of various surgical interventions and other pertinent factors on postoperative ambulatory ability and all-cause mortality outcomes. Associations between sex, age, number of comorbidities, aspartate aminotransferase (AST) levels, total blood transfusions, and mortality were analyzed via Cox proportional hazards models.

RESULTS: The analysis included a cohort of 120 patients from the IF group and 121 patients from the LCHA group. Statistically significant differences were not observed in the clinical outcomes, ambulatory ability, overall survival, or all-cause mortality after surgical treatment between the groups receiving IF and LCHA (p > 0.05). Nevertheless, among patients aged ≥ 85 years, the IF group demonstrated a lower rate of all-cause mortality than the LCHA group did (p < 0.05). As age increases and the number of preoperative comorbidities and the amount of perioperative transfusion increase, the preoperative AST level decreases, which is associated with a greater risk of postoperative death. (p < 0.05).

CONCLUSIONS: In elderly patients aged 75-84 years with intertrochanteric femur fractures, both internal fixation (IF) and long-stemmed cemented hemiarthroplasty (LCHA) are viable treatment options. However, for patients aged 85 years and older, IF is associated with a relatively lower postoperative all-cause mortality rate and should be prioritized as a treatment modality. Additionally, preoperative AST levels may serve as a valuable predictor of postoperative all-cause mortality in elderly patients undergoing surgery for intertrochanteric femur fractures.

PMID:40176053 | DOI:10.1186/s12893-025-02866-0

BMC Health Serv Res. 2025 Apr 3;25(1):498. doi: 10.1186/s12913-025-12632-w.

ABSTRACT

BACKGROUND: Between 25% and 45% of women experience urinary incontinence. The Tät^® app is intended to treat stress urinary incontinence in women, and has been evaluated for efficacy and effectiveness. The level of usage of digital healthcare differs depending on demographics, and this might lead to unequal access to healthcare. This study aims to analyse the change in level of education and area of residence of users of the Tät app over time, and compare this with overall demographic data for Sweden.

METHODS: When the app was downloaded, the user was invited to respond anonymously to a questionnaire. We included women aged 18-89 years living in Sweden. We weighted the app data to reflect the age distribution of the general female population of Sweden. We then compared the users’ level of education and area of residence with data from Statistics Sweden.

RESULTS: The study encompassed 153,819 users between 2016 and 2021. The percentage of Tät users with university education decreased from 63.14% (95% CI 62.16-64.11) to 61.07% (95% CI 60.53-61.61), and the percentage of users with fewer than 7 years of education increased from 0.02% (95% CI 0.006-0.077) to 1.94% (95% CI 1.80-2.10). In contrast to this, the Statistics Sweden data comparing 2016 with 2020, showed an increase in the category “university or higher education institution” from 38.94 to 42.10% and a decrease in the other categories. Comparing Tät users’ area of residence between 2018 and 2021 showed an increase in the amount of users living in rural areas from 16.90% (95% CI 16.44-17.37) to 20.53% (95% CI 20.08-20.98). Data from Statistics Sweden did not show any significant change, and in 2020 6.23% of women in Sweden lived in rural areas.

CONCLUSIONS: The proportion of Tät users in both the highest and the lowest educational categories had changed to be more like the overall Swedish female population. The proportion of Tät users living in rural areas had increased and was considerably larger than for the population in general. We thus see positive trends in the distribution of users, although users with a university education are still over-represented.

PMID:40176033 | DOI:10.1186/s12913-025-12632-w

BMC Complement Med Ther. 2025 Apr 2;25(1):124. doi: 10.1186/s12906-025-04837-7.

ABSTRACT

INTRODUCTION: Cancer is currently the second most common cause of death worldwide and is often treated with chemotherapy. Music therapy is a widely used adjunct therapy offered in oncology settings to attenuate negative impacts of treatment on patient’s physical and mental health; however, music therapy research during chemotherapy is relatively scarce. The aim of this study is to evaluate the impact of group music therapy sessions with patients and caregivers on their perceived anxiety, stress, and wellbeing levels and the perception of chemotherapy-induced side effects for patients.

MATERIALS AND METHODS: This is a retrospective cohort study following the STROBE guidelines. From April to October 2022, 41 group music therapy sessions including 141 patients and 51 caregivers were conducted. Participants filled out pre- and post-intervention Visual Analogue Scales (VAS) assessing their anxiety, stress, and wellbeing levels, and for patients the intensity of chemotherapy-induced side effects.

RESULTS: The results show a statistically significant decrease of anxiety and stress levels (p < .001), an increase in well-being of patients and caregivers (p < .001, p = .009), and a decrease in patients’ perceived intensity of chemotherapy-induced side effects (p = .003). Calculated effect sizes were moderate for anxiety, stress, and well-being levels, and small for chemotherapy-induced side effects.

DISCUSSION: This is the first study regarding group music therapy sessions for cancer patients and their caregivers during chemotherapy in Colombia. Music therapy has been found to be a valuable strategy to reduce psychological distress in this population and to provide opportunities for fostering self-care and social interaction.

CONCLUSIONS: Music therapy should be considered as a valuable complementary therapy during chemotherapy. However, it is crucial to conduct prospective studies with parallel group designs to confirm these preliminary findings.

PMID:40176020 | DOI:10.1186/s12906-025-04837-7

BMC Med Educ. 2025 Apr 2;25(1):474. doi: 10.1186/s12909-025-07039-4.

ABSTRACT

BACKGROUND: Learning the anatomy of extraocular muscles and their coordination in eye movements is challenging for undergraduate medical students. We developed a dynamic extraocular muscle simulation model and integrated it into the undergraduate ophthalmic curriculum to evaluate its educational impact.

METHODS: A custom simulation model of binocular muscles was developed and assessed for educational effectiveness in undergraduate education. In a comparative study, 84 students from Peking Union Medical College were assigned to either the simulation group (one-hour didactic lecture followed by a half-hour simulator practice) or the traditional teaching group (one-hour didactic teaching followed by a half-hour video review). All students were given 5-point quizzes on the anatomical and functional basics of extraocular muscles before the lecture(Q1), after the lecture(Q2), and after simulator practice/video-review(Q3). Within each group, the scores of Q2 were compared with Q1, and the scores of Q3 were compared with Q2. The effectiveness of the simulation model was evaluated by comparing the improvements in scores from Q2 to Q3 between the two groups. Nonparametric tests were used for statistical analysis.

RESULTS: The simulation and traditional teaching groups were well-matched in terms of age, gender, Grade Point Average (GPA), and average Q1 and Q2 scores. The simulation group demonstrated significant improvements after both the didactic lecture and simulator practice. In contrast, the traditional teaching group showed significant improvement only after the lecture, not after the video review. The simulation model led to greater learning improvements compared to video review (mean(standard deviation)): 0.64(1.23) vs 0.05(0.79), P = 0.006.

CONCLUSIONS: The extraocular muscle simulation model is a valuable adjunct to traditional teaching methods in undergraduate medical education. Simulation-based education should be encouraged for teaching complex anatomical topics.

PMID:40176008 | DOI:10.1186/s12909-025-07039-4

BMC Womens Health. 2025 Apr 2;25(1):154. doi: 10.1186/s12905-025-03680-9.

ABSTRACT

BACKGROUND: Reproductive health has broad implications for individuals, families, and society. This study aims to explore how an educational intervention, centered around PMT, can enhance reproductive health protective behaviors among female students.

METHODS: This quasi-experimental study was conducted on female students of Khomein University of Medical Sciences in Markazi Province, Iran, from December 2023 to August 2024. A random cluster sampling method was used for sampling, resulting in 51 female students being selected for the intervention group and 54 female students for the control group. The data collection tool was a researcher-developed questionnaire, which included demographic information and PMT constructs with confirmed validity and reliability. The educational intervention for the intervention group consisted of three one-hour sessions spaced one week apart, incorporating methods such as lectures, group discussions, Q&A sessions, brainstorming, role-playing exercises, as well as distribution of educational booklets. The collected data was then analyzed using various statistical methods including independent t-tests, t-tests, chi-square tests, simple linear regression, and multiple linear regression models.

RESULTS: After the intervention, the mean score for all constructs in the intervention group was higher than that of the control group, except for perceived cost. A statistically significant difference was noted in the mean scores of most constructs, such as perceived susceptibility, perceived severity, perceived self-efficacy, protection motivation, fear, and behavior, between the two groups being studied (p < 0.05).

CONCLUSION: The PMT-based educational intervention has proven to be effective in promoting reproductive health protective behaviors among female students. Given the significance of infertility issues and the value of preserving fertility in young women, it is recommended to implement PMT-based educational programs to safeguard women’s reproductive health.

PMID:40175998 | DOI:10.1186/s12905-025-03680-9

J Plast Reconstr Aesthet Surg. 2025 Feb 17;104:407-413. doi: 10.1016/j.bjps.2025.02.022. Online ahead of print.

ABSTRACT

PURPOSE: Careful patient selection and optimal surgical timing are essential to the success of nerve transfers. It is important to understand what factors contribute to this decision-making. The purpose of this study was to describe the characteristics of patients referred to interdisciplinary peripheral nerve clinics with traumatic upper extremity injuries and compare those who went on to nerve transfer surgery with those who did not.

METHODS: Patient and injury characteristics, preoperative physical examination and electrodiagnostic findings, and patient-reported outcome measures were examined. Inclusion criteria were subjects ≥18 years of age presenting to an interdisciplinary peripheral nerve clinic with traumatic upper extremity peripheral nerve injuries. Subjects were stratified into surgical and non-surgical groups for comparison.

RESULTS: Eighty-three subjects met the inclusion criteria, and 36 subjects received nerve transfer surgery. More male subjects went on to have surgery than female subjects. The surgical group demonstrated a significantly higher ratio of weak and denervated muscle groups than the non-surgical group (p < 0.05). No other statistically significant differences were identified between operative and non-operatively managed subjects.

CONCLUSION: Subjects that received nerve transfer surgery demonstrated a significantly higher ratio of weak and denervated muscles than those managed non-surgically, and males were disproportionately represented in the surgical group. These findings suggest that anticipated motor recovery is the most important factor driving surgical decision-making and that male subjects may be more likely to proceed with surgery. Understanding which patients undergo nerve transfer surgery allows clinicians to interrogate their decision-making, address patient-related barriers to surgery, and better understand surgical outcomes.

PMID:40174258 | DOI:10.1016/j.bjps.2025.02.022