Category: Statistics

Am J Sports Med. 2025 Jan 21:3635465241302797. doi: 10.1177/03635465241302797. Online ahead of print.

ABSTRACT

BACKGROUND: Views surrounding acromioplasty at the time of arthroscopic rotator cuff repair (RCR) have shifted dramatically over time. In recent years, various studies have argued against acromioplasty, citing equivocal functional outcomes after arthroscopic RCR with or without acromioplasty.

PURPOSE: To assess the statistical fragility of functional outcomes after arthroscopic RCR with and without acromioplasty using the reverse continuous fragility index (RCFI).

STUDY DESIGN: Systematic review and meta-analysis; Level of evidence, 3.

METHODS: A systematic review and meta-analysis was performed including all randomized controlled trials through February 5, 2024 investigating arthroscopic RCR with and without acromioplasty. The RCFI, defined as the number of qualifying data points required to be moved from the lower mean group to the higher mean group to alter the significance, was calculated for the Welch t test, Student t test, and Wilcoxon rank-sum test under various data assumptions. The reverse continuous fragility quotient (RCFQ) was determined by dividing the RCFI by the sample size.

RESULTS: A total of 6 clinical trials consisting of 609 patients with functional outcome scores were analyzed. Using the Welch t test, the median RCFI across all study outcomes was 20 (interquartile range [IQR], 17-24). For the Student t test, the median RCFI across all study outcomes was 14 (IQR, 13-19), with a median RCFQ of 0.18 (IQR, 0.15-0.20). For the Wilcoxon rank-sum test, the median RCFI was 14 (IQR, 13-17), with a median RCFQ of 0.17 (IQR, 0.13-0.19). While using the Welch t test, 64% of study outcomes had an RCFI greater than the loss to follow-up (LTFU). When using the other tests, 32% of study outcomes had an RCFI greater than the LTFU.

CONCLUSION: The fragility of these studies was largely dependent on the statistical test used to analyze the results. The Wilcoxon rank-sum test and Student t test appeared to be most appropriate to find differences in treatment arms. When using these tests, we found the results to be fragile. This, in combination with a small number of studies and the LTFU close to or exceeding 20%, indicates an overall lack of strong evidence to support previously accepted conclusions.

PMID:39836369 | DOI:10.1177/03635465241302797

Minerva Anestesiol. 2024 Dec;90(12):1098-1107. doi: 10.23736/S0375-9393.24.18245-4.

ABSTRACT

BACKGROUND: Frail elderly patients have a higher risk of postoperative morbidity and mortality. Prehabilitation is a potential intervention for optimizing postoperative outcomes in frail patients. We studied the impact of a prehabilitation program on length of stay (LOS) in frail elderly patients undergoing elective surgery.

METHODS: An RCT study was conducted. Frail patients scheduled for elective surgery were randomized to receive either pre-surgical conditioning protocol (PCP) or standard preoperative care. PCP included nursing, anesthetic, and geriatric assessment, nutritional intervention, and physical training for 4-weeks preoperatively. A nurse followed both groups until discharge criteria were met. The primary outcome was postoperative LOS. Secondary outcomes were nutritional status, preoperative frailty status (frailty phenotype-FP) after PCP, and postoperative complications up to three months categorized according to the Clavien-Dindo Classification. Means and medians between the control and intervention groups were compared, with statistical significance set at α=5%.

RESULTS: Thirty-four patients were to intervention and Thirty-seven to the control group. In the intervention group, adherence to prehabilitation was 90%. The median LOS after surgery was three days in both groups, without finding statistically significant differences between groups (P=0.754), although there was a trend towards lower LOS in the urologic surgery subgroup. We found a significant reduction in frailty status after PCP (FP<inf>pre</inf>=2.4±0.5 and FP<inf>post</inf>=1.7±0.5, P<0.001). Nutritional status significantly improved in frail patients after prehabilitation (MNA<inf>basal</inf>=9.0±2.5 and MNA<inf>post</inf>=10.6±2.6), P=0.028. The intervention group had less severe postoperative complications, which were not statistically significant.

CONCLUSIONS: The PCP conducted both in-person and online, for older frail patients undergoing elective colorectal and urological surgery was not associated with shorter LOS. However, frailty status significantly improved after completing PCP.

PMID:39836361 | DOI:10.23736/S0375-9393.24.18245-4

Minerva Anestesiol. 2024 Dec;90(12):1065-1073. doi: 10.23736/S0375-9393.24.18416-7.

ABSTRACT

BACKGROUND: Surgical fear is present in many patients awaiting surgery. However, a validated Italian version of the Surgical Fear Questionnaire (SFQ) was not available yet. Therefore, the aim of this study was to translate the SFQ into Italian and to test its reliability and validity.

METHODS: Design: prospective cohort study on Italian-speaking Swiss patients scheduled for a minimally invasive spinal procedure or spinal surgery. After forward and back translation and a pilot test, reliability and validity of the 8-item SFQ was assessed using the intraclass correlation coefficient, (ICC), Cronbach’s alpha, confirmatory factor analysis (CFA), and Spearman’s correlation coefficient.

RESULTS: Results on 63 patients revealed median SFQ-total scores of 22 (minimum-maximum: 0-68) at inclusion and 22.5 (0-70) one week before surgery. Test-retest reliability between first and second SFQ-total score was high, ICC=0.947 (95% CI: 0.912-0.968). Internal consistency of the SFQ-total score at both assessment times were high, Cronbach’s alphas 0.916 and 0.931 respectively. This was also the case for the subscale short-term fear, item 1-4 and long-term fear, item 5-8 (range 0.853-0.909). CFA-results for a one-factor and a two-factor model favored the two-factor model. Correlations with pain catastrophizing, other anxiety measures, and health status were weak and only state anxiety assessed by PROMIS reached statistical significance.

CONCLUSIONS: We conclude that the Italian version of the SFQ is suitable for use in practice and has a high reliability. Validity and sensitivity need additional testing on a larger population.

PMID:39836360 | DOI:10.23736/S0375-9393.24.18416-7

Rheumatol Ther. 2025 Jan 21. doi: 10.1007/s40744-025-00744-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Prescribable digital health applications (DiGAs) present scalable solutions to improve patient self-management in rheumatology, however real-world evidence is scarce. Therefore, we aimed to assess the effectiveness, usage, and usability of DiGAs prescribed by rheumatologists, as well as patient satisfaction.

METHODS: The DiGAReal registry includes adult patients with rheumatic conditions who received a DiGA prescription. Data at baseline (T0) and the 3-month follow-up (T1) were collected through electronic questionnaires. Study outcomes included DiGA-specific outcome assessments as well as generic outcome assessments, including the Patient Global Impression of Change (PGIC), Patient Activation Measure (PAM®), and the German Telehealth Usability and Utility Short Questionnaire (TUUSQ). Changes between T0 and T1 were analyzed using descriptive statistics and paired tests.

RESULTS: A total of 191 patients were included between June 2022 and April 2023. Of these, 127 completed the 3-month follow-up, and 114 reported using the prescribed DiGA, with 66% reporting weekly use and 15% completing the full DiGA program. The most commonly prescribed DiGAs targeted pain management (53%). Symptom improvement was reported by 51% of patients using a DiGA, with significant reductions in exhaustion levels (p = 0.03). Significant DiGA-specific improvements were observed for DiGAs addressing back pain (p = 0.05) and insomnia (p = 0.006). However, no overall significant changes were detected in patient activation, health literacy, pain, overall health, or disease activity. Back pain and weight management DiGAs were the most effective, frequently used, and best-rated DiGAs, with symptom improvements reported by 50% to 82% of patients.

CONCLUSION: The findings suggest that DiGAs can improve symptom management in rheumatic patients, especially for conditions like back pain and weight control. Further real-world evidence is needed and may support value-based digital health efforts and reimbursement frameworks.

PMID:39836353 | DOI:10.1007/s40744-025-00744-y

Clin Rheumatol. 2025 Jan 21. doi: 10.1007/s10067-025-07316-z. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the long-term course of aortic regurgitation (AR) and the width of the proximal ascending aorta (PAA) in patients with ankylosing spondylitis (AS).

METHOD: This is a follow-up cohort study of patients with AS examined with echocardiography at inclusion (2009 to 2011). Out of the initial 187, a subgroup of 52 patients (54% men, mean age 62 years) was selected for follow-up based on presence/absence of AR at baseline; 26 with AR (18 mild, 7 moderate, 1 severe) and 26 age/sex-matched without AR. These patients were re-examined with echocardiography in 2014 by an independent observer. Severity of AR and PAA diameter were assessed. Related samples Wilcoxon signed rank and Mann-Whitney U tests were used to analyze the change (Δ) in PAA diameter.

RESULTS: Regarding the 26 patients with AR at baseline, two had an aggravated grade, 16 an unchanged grade, and eight a less severe AR versus baseline. Two of the 26 patients with no AR at baseline had a mild grade of AR at follow-up. The mean (SD) ΔPAA diameter was 0 (3) mm, and no statistically significant ΔPAA diameter was found overall or in analyses stratified by sex and baseline presence of AR.

CONCLUSIONS: Most patients with AS had an unchanged grade of AR and PAA diameter at follow-up 3 to 5 years after the initial echocardiography. These findings suggest that the average progress of AR in patients with AS is slow and that progression of PAA dilatation seems rare. Key points • Aortic regurgitation (AR) is not uncommon in patients with ankylosing spondylitis (AS) and caused by aortic root dilatation and/or cusp fibrosis/retraction, but little is known about its course. • According to this repeated echocardiography study in median 4.3 years after the baseline evaluation, the majority of patients had no progress of AR or increase in the proximal ascending aorta diameter. • AR in AS is rarely rapidly progressive.

PMID:39836332 | DOI:10.1007/s10067-025-07316-z

J Patient Rep Outcomes. 2025 Jan 21;9(1):10. doi: 10.1186/s41687-025-00837-w.

ABSTRACT

BACKGROUND: Patient Reported Outcomes Measurement Information System Fatigue Short-Form (PROMIS-F-SF) is a self-administered, patient reported outcome (PRO) designed to assess fatigue in healthy and clinical populations and for tracking progress during treatment for disorders complicated with fatigue.

METHODS: Patients in the Mental Health Service Outpatient Clinics and healthy volunteers were invited to complete a survey, which included the Danish translation of the PROMIS-F-SF, the Chalder Fatigue Scale (CFS-11), and measures of depression and anxiety. We conducted a confirmatory factor analysis of the previously suggested single-factor structure of the instrument. We furthermore evaluated the construct validity of the PROMIS-F-SF by means of its relationship with the CFS-11. Finally, we evaluated the utility of the PROMIS-F-SF to identify patient-status by conducting receiver operating characteristic curves.

RESULTS: 70 healthy volunteers and 62 patients completed the instruments. The PROMIS-F-SF had a average fit to the previously reported single-factor structure. Cronbach’s alpha and McDonald’s omega showed good internal reliability (α = 0.96, ωtotal = 0.97). PROMIS-F-SF score was positively correlated with the CFS-11 (r =.76) and it correlated highly with depression (r =.78) and anxiety (r =.74) score. The optimal cut-off point in the ROC-analyses was 15, which yielded a sensitivity of 89% and a specificity of 67% in the prediction of patient status.

CONCLUSIONS: Level of fatigue among psychiatric outpatients is high in patients with psychiatric illness, compared to levels measured in healthy volunteers. The Danish PROMIS-F-SF shows good psychometric properties in this combined sample of healthy adults and psychiatric patients with non-psychotic disorders and it is recommended as PRO measure for psychiatric populations. Examination of psychometric properties in patient populations with somatic disorder could be a natural next step.

PMID:39836326 | DOI:10.1186/s41687-025-00837-w

Ophthalmol Ther. 2025 Jan 21. doi: 10.1007/s40123-024-01091-x. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aimed to compare changes in retinal oxygen saturation 1 month after femtosecond-assisted laser in situ keratomileusis (FS-LASIK) in Chinese adults with myopia using retinal oximetry.

METHODS: In this prospective, observational, single-center cohort study, Chinese adults aged 18-45 years with myopia were categorized into four groups according to spherical equivalent (SE), with 66 eyes characterized as low myopia (LM -3.00D < SE ≤ -0.50D), 68 eyes as moderate myopia (MM -6.00D < SE ≤ -3.00D), 68 eyes as high myopia (HM -9.00D < SE ≤ -6.00D), and 65 eyes as super-high myopia (SHM: SE ≤ -9.00D). The following were measured before and 1 month after FS-LASIK: SE, intraocular pressure (IOP), average keratometry (Km), and axial length (AL). Other ocular biological parameters included retinal arterial oxygen saturation (SaO₂) and retinal venous oxygen saturation (SvO₂); parameter difference values are expressed as ∆.

RESULTS: Of the 267 participants, 63.30% were female and 36.70% were male. The mean SE, AL, SaO₂, and SvO₂ were -5.93 ± 3.24 D, 26.01 ± 1.35 mm, 93.49% ± 1.67%, and 62.97% ± 4.52%, respectively. Before FS-LASIK, SaO₂ was significantly correlated with AL and SE (r_s = -0.305, P < 0.001; r_s = 0.385, P < 0.001). Significant differences were found in SaO₂ across myopia categories (P < 0.001). The changes in the retinal arterial oxygen saturation decreased significantly after FS-LASIK (F = 24.948, P < 0.001). After surgery, SaO₂ demonstrated a statistically significant but weak negative relationship with refractive correction (ΔSE) (r_s = -0.380, P < 0.001) and axial length (r_s = -0.404, P < 0.001), a significant but weak positive correlation with average keratometry cutting value (ΔKm) (r_s = 0.354, P < 0.001), and no correlation with the change in IOP (ΔIOP) (P > 0.05).

CONCLUSION: Ruling out the influence of refractive error, SaO₂ was significantly decreased 1 month after FS-LASIK, while there was no significant change in SvO₂. We conjecture that retinal amplification may affect differences in retinal oxygen saturation.

PMID:39836318 | DOI:10.1007/s40123-024-01091-x

Eur J Health Econ. 2025 Jan 21. doi: 10.1007/s10198-024-01749-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Cesarean deliveries account for approximately one-third of all births in Germany, prompting ongoing discussions on cesarean section rates and their connection to medical staffing and birth volume. In Germany, the majority of departments integrate obstetric and gynecological care within a single department.

METHODS: The analysis utilized quality reports from German hospitals spanning 2015 to 2019. The outcome variable was the annual risk-adjusted cesarean section ratio-a metric comparing expected to observed cesarean sections. Explanatory variables included annual counts of physicians, midwives, and births. To account for case number-related staffing variations, full-time equivalent midwife and physician staff positions were normalized by the number of deliveries. Uni- and multivariate panel models were applied, complemented by multiple instrument variable analyses, including two-stage least square and generalized method of moments models.

RESULTS: Incorporating data from 509 integrated obstetric departments and 2089 observations, representing 2,335,839 deliveries with 720,795 cesarean sections (over 60% of all inpatient births in Germany), multivariate model with fixed effects revealed a statistically significant positive association between the number of physicians per birth and the risk-adjusted cesarean section ratio (0.004, p = 0.004). Two-stage least square instrument variable analysis (0.020, p < 0.001) and a system GMM estimator models (0.004, p < 0.001) validated these results, providing compelling evidence for a causal relationship.

CONCLUSION: The study established a robust connection between the number of physicians per birth and the risk-adjusted cesarean section ratio in integrated obstetric and gynecological departments in Germany. While the cause of the effect remains unclear, one possible explanation is a lack of specialization within these departments due to the combined provision of both obstetric and gynecological care.

PMID:39836312 | DOI:10.1007/s10198-024-01749-0

Odontology. 2025 Jan 21. doi: 10.1007/s10266-024-01052-7. Online ahead of print.

ABSTRACT

We aimed to investigate the wound-healing, antioxidant, and anti-inflammatory effects of pterostilbene (PTS) on human gingival fibroblasts (GF). Different concentrations of PTS were applied to GFs and cell viability was evaluated by MTT assay. GFs were stimulated by lipopolysaccharide (LPS) and the study groups were determined as LPS, LPS + 1 μM PTS, LPS + 10 μM PTS, and control. The most effective PTS concentrations were applied in a wound-healing model, with cell counts in the wound area assessed at 0, 24, 48, and 72 h. The effect of PTS on the release of interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), transforming growth factor-β (TGF-β), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), basic fibroblast growth factor (bFGF), and collagen type I (COL I) was assessed at 24 and 48 h by ELISA. The data was statistically analyzed. Our results showed that PTS had a dose-dependently negative effect on wound healing and cell proliferation at 10 μM concentration, but not at low concentration (1 μM). PTS exhibited a potent anti-inflammatory effect by reducing IL-6 and TNF-α levels, while also enhancing antioxidant activity, as evidenced by increased GSH-Px levels in the LPS + 1 μM PTS group (P < 0.05). According to our results, PTS could be a potential and promising substance with anti-inflammatory and antioxidant effects on LPS-stimulated GF. Therefore our results have merit in terms of providing pioneering data for future studies.

PMID:39836293 | DOI:10.1007/s10266-024-01052-7

Eur J Clin Microbiol Infect Dis. 2025 Jan 21. doi: 10.1007/s10096-025-05041-8. Online ahead of print.

ABSTRACT

PURPOSE: Infective endocarditis (IE) can be complicated by vertebral osteomyelitis (VO). This study investigates risk factors associated with VO in patients with infective endocarditis, and 6-month mortality and relapse rates in patients with IE and concomitant VO.

METHODS: We performed a observational study in two hospitals between September 2016 and October 2022. Patients with possible or definite IE according European Society of Cardiology (2015) modified criteria were retrieved from the local endocarditis team registries. The VO diagnosis was based on radiological signs, irrespective of clinical symptoms. Multivariable logistic regression analysis was performed to identify risk factors for vertebral osteomyelitis.

RESULTS: We included 633 consecutive patients with IE. A total of 229 (36.2%) patients had prosthetic valves and 127 (20.1%) had cardiac implantable electronic devices. The most frequent causative micro-organism was Streptococcus species (217, 34.3%), followed by Staphylococcus aureus (167, 26.4%). VO was diagnosed in 73 patients (11.5%, 95% CI 9.0%-14.0%). Enterococcus spp.(OR 2.48, 95% CI 1.31-4.52) and age (OR 1.04 per year, 95% CI 1.02-1.06) were independently associated with concomitant VO. The 6-month mortality risk did not differ between patients with (16/73, 21.9%) or without (110/560, 19.6%) VO (HR 1.13, 95% CI 0.67-1.91). Relapse rate was higher in patients with VO but the difference was not statistically significant (16.1 vs. 7.5%, OR 3.62, 95% CI 0.94-13.34).

CONCLUSIONS: Twelve percent of patients with IE also had VO. Among older patients and patients with IE caused by enterococci, there should be a higher index of suspicion for vertebral infection.

PMID:39836291 | DOI:10.1007/s10096-025-05041-8