Category: Statistics

Phys Ther. 2025 Jan 21:pzaf006. doi: 10.1093/ptj/pzaf006. Online ahead of print.

ABSTRACT

IMPORTANCE: Rotator cuff tendinopathy represents the most prevalent cause of shoulder pain, the third most common musculoskeletal disorder after low back pain and knee pain.

OBJECTIVE: The objective of this study was to determine the effectiveness of corticosteroid injection(s), alone or in combination with anesthetic injection or any other physical therapist interventions, compared to physical therapist interventions alone in adults with rotator cuff tendinopathy.

DESIGN: This study was a systematic review and meta-analysis of randomized controlled trials. PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Web of Science, and Physiotherapy Evidence Database (PEDro) were searched from inception to March 2023. Meta-analysis using a random-effects model was performed. Risk of bias and certainty of the evidence for the primary outcomes were assessed using the Cochrane risk-of-bias tool and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, respectively. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42021240882).

PARTICIPANTS: Participants were adults with rotator cuff tendinopathy.

INTERVENTIONS: Corticosteroid injection(s), alone or in combination with anesthetic injection or with any other physical therapist interventions, was compared to physical therapist interventions alone.

MAIN OUTCOMES: Pain, function, quality of life, patient-rated overall improvement, and adverse events were the main outcomes.

RESULTS: Fifteen randomized controlled trials (1785 participants) met the inclusion criteria. At short term, corticosteroid injection coupled with physical therapist interventions and compared to the same interventions alone might have resulted in some small to moderate improvements in pain and function. Conversely, corticosteroid injection alone seemed not to be more effective than physical therapist interventions in improving pain and function in most of the studies included. At mid- and long-term follow-up assessments corticosteroid injection seemed not to be more effective than any physical therapist interventions.

CONCLUSIONS: This study highlights the potential effectiveness of corticosteroid injection(s) in rotator cuff tendinopathy for pain and function at short term at best, especially in combination with physical therapist interventions. However, the evidence is of moderate to mostly very low certainty. Additional high-quality research considering core outcomes is therefore needed.

RELEVANCE: Corticosteroid injection(s) seems not to be superior to physical therapist interventions, other than resulting in some transient improvements at short term if provided together with other physical therapist interventions, in adults with rotator cuff tendinopathy. Furthermore, considering the potential adverse events associated with the injections, physical therapist interventions may be an important stand-alone treatment option.

PMID:39836429 | DOI:10.1093/ptj/pzaf006

JAMA Netw Open. 2025 Jan 2;8(1):e2455251. doi: 10.1001/jamanetworkopen.2024.55251.

ABSTRACT

IMPORTANCE: Using albumin-adjusted calcium is commonly recommended for for measuring calcium, but with little empirical evidence to support the practice.

OBJECTIVE: To assess the correlation between total calcium measurements (with or without adjustment) vs the ionized calcium level as a reference standard.

DESIGN, SETTING, AND PARTICIPANTS: This was a population-based cross-sectional study in the province of Alberta, Canada, including adults tested for serum total calcium and ionized calcium simultaneously between January 1, 2013, and October 31, 2019. Statistical analysis was performed from March 2023 to October 2024.

MAIN MEASURES AND OUTCOMES: The correlation between unadjusted and adjusted total calcium measurements (using 10 formulas) and the ionized calcium level was evaluated, along with the potential association with the classification of calcium status.

RESULTS: Among 22 658 patients included, 11 889 (52.5%) were female and 10 769 (47.5%) were male; the median (IQR) age was 60 (47-72) years. The unadjusted total calcium (R2 = 71.7%; 95% CI, 71.1%-72.2%) had a stronger correlation with ionized calcium than the commonly used simplified Payne formula (ie, total calcium [mmol/L] + 0.02 [40 – albumin (g/L)]) (R2 = 68.9%; 95% CI, 68.0%-69.6%) and correlated similarly to other formulas (Payne: lowest R2 = 60.3%; 95% CI, 59.3%-61.3%; and James: highest R2 = 76.7%; 95% CI, 76.1%-77.3%). When classifying patients into categories of hypocalcemia, normocalcemia, or hypercalcemia, unadjusted total calcium had the best overall agreement (74.5%) with ionized calcium compared with albumin-adjusted calcium using the original Payne and simplified Payne formulas (agreement 63.0% and 58.7%, respectively). Misclassification using the adjustment formulas was worse in the presence of hypoalbuminemia (albumin level <30 g/L).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study drawn from a contemporaneous population, there appeared to be heavy reliance on adjustment formulas for calcium in clinical practice with little gain but considerable risk of misclassification of true calcium status, especially in the presence of hypoalbuminemia. These results suggest that unadjusted total calcium was the best and most practical alternative to ionized calcium.

PMID:39836424 | DOI:10.1001/jamanetworkopen.2024.55251

JAMA Netw Open. 2025 Jan 2;8(1):e2455258. doi: 10.1001/jamanetworkopen.2024.55258.

ABSTRACT

IMPORTANCE: Timely access to care is a key metric for health care systems and is particularly important in conditions that acutely worsen with delays in care, including surgical emergencies. However, the association between travel time to emergency care and risk for complex presentation is poorly understood.

OBJECTIVE: To evaluate the impact of travel time on disease complexity at presentation among people with emergency general surgery conditions and to evaluate whether travel time was associated with clinical outcomes and measures of increased health resource utilization.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used administrative statewide inpatient and emergency department databases with linkage across encounters, including nearly every inpatient or emergency department encounter in the states of Florida and California in 2021. Participants included adult patients who presented to an emergency department with 1 of 5 common emergency surgical conditions. Data were collected from January to December 2021 and analyzed from June to December 2023.

EXPOSURE: The primary exposure was travel time from the patient’s home to the facility where they initially received emergency care.

MAIN OUTCOMES AND MEASURES: The primary outcome of interest was surgical disease complexity at the time of presentation to emergency care. Secondary outcomes included inpatient complications, mortality, and indicators of health system resource utilization. Multivariable logistic regression models were used, and adjusted odds ratios (aOR) and 95% CIs were reported.

RESULTS: Among 190 311 adults with emergency general surgery conditions, 7138 (3.8%) lived further than 60 minutes from the facility where they sought emergency care. Longer travel times were associated with higher odds of complex disease presentation for travel time of more than 120 minutes vs 15 minutes or less (aOR, 1.28; 95% CI, 1.17-1.40). Patients with a travel time 60 minutes or more were more likely to require operative intervention (aOR, 1.17; 95% CI, 1.10-1.26), inpatient admission (aOR, 1.41; 95% CI, 1.33-1.50), interfacility transfer (aOR, 1.32; 95% CI, 1.15-1.51), and longer inpatient stay (adjusted mean difference, 0.47 days; 95% CI, 0.35-0.59), and had higher charges (adjusted mean difference, $8284; 95% CI, $5532-$11 035).

CONCLUSIONS AND RELEVANCE: In this cohort study of patients with emergency surgical conditions, travel time to emergency care was associated with markers of delayed presentation and increased facility resource utilization. As opposed to static measures, such as rurality, travel time may serve as a more useful metric to inform policy efforts aimed at preserving access to care amidst rural hospital closures and regionalization.

PMID:39836423 | DOI:10.1001/jamanetworkopen.2024.55258

JAMA Netw Open. 2025 Jan 2;8(1):e2455388. doi: 10.1001/jamanetworkopen.2024.55388.

ABSTRACT

IMPORTANCE: There is limited evidence regarding the association between age at menopause and incident type 2 diabetes (T2D).

OBJECTIVE: To investigate whether age at menopause and premature menopause are associated with T2D incidence in postmenopausal Korean women.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study was conducted among a nationally representative sample from the Korean National Health Insurance Service database of 1 125 378 postmenopausal women without T2D who enrolled in 2009. The median (IQR) follow-up was 8.4 (8.1-8.7) years. Data were analyzed in March 2024.

EXPOSURES: Age at menopause and premature menopause (menopause onset at age <40 years).

MAIN OUTCOMES AND MEASURES: The primary outcome was incident T2D. Multivariable Cox proportional hazards regression analysis was used to estimate hazard ratios (HRs) and 95% CIs for incident T2D by age at menopause, adjusting for potential confounders.

RESULTS: Of 1 125 378 participants (mean [SD] age at enrollment, 61.2 [8.4] years), 113 864 individuals (10.1%) were diagnosed with T2D at least 1 year after enrollment. Women with menopause onset at ages younger than 40 years (premature menopause; HR, 1.13; 95% CI, 1.08-1.18) and ages 40 to 44 years (HR, 1.03; 95% CI, 1.00-1.06) had increased risk of T2D compared with those with onset at age 50 years or older, with adjustment for sociodemographic, lifestyle, cardiometabolic, psychiatric, and reproductive factors; a younger age at menopause was associated with increased risk of developing T2D (P for trend <.001). Body mass index, depressive disorder, and prediabetes modified the association in subgroup analyses; for example, for individuals with premature menopause vs those with menopause at ages 50 years or older, HRs were 1.54 (95% CI, 1.14-2.06) for a BMI less than 18.5 and 1.14 (95% CI, 1.00-1.30) for a BMI of 30 or greater (P < .001), 1.28 (95% CI, 1.12-1.45) for individuals with depression and 1.11 (95% CI, 1.07-1.16) for those without depression (P = .01), and 1.25 (95% CI, 1.18-1.33) for individuals who were not prediabetic and 1.04 (95% CI, 0.99-1.11) those who were prediabetic (P < .001).

CONCLUSIONS AND RELEVANCE: In this study, premature and early menopause were associated with a higher risk of T2D, highlighting the need for targeted public health strategies aimed at preventing or delaying T2D among postmenopausal women.

PMID:39836420 | DOI:10.1001/jamanetworkopen.2024.55388

Antivir Ther. 2025 Feb;30(1):13596535241313244. doi: 10.1177/13596535241313244.

ABSTRACT

BACKGROUND: Molnupiravir (MOV) is an orally bioavailable ribonucleoside with antiviral activity against all tested SARS-CoV-2 variants. We describe the demographic, clinical, and treatment characteristics of non-hospitalized Danish patients treated with MOV and their clinical outcomes following MOV initiation.

METHOD: Among all adults (>18 years) who received MOV between 16 December 2021 and 30 April 2022 in an outpatient setting in Denmark, we summarized their demographic and clinical characteristics at baseline and post-MOV outcomes using descriptive statistics. Outcomes were emergent hospitalization and all-cause mortality during the 28 days after MOV initiation. We estimated the odds ratios (OR) of outcomes by time from positive test to treatment using logistic regression.

RESULTS: We identified 3691 MOV-treated patients, of whom 45.8% were male and mean age was 70.1 years. Most patients (76.2%) initiated MOV within 0-2 days after a positive SARS-CoV-2 test and 16.8% within 3-5 days. Over a 28-day period, rates for all-cause, respiratory- or COVID-19-related, and COVID-19-related hospitalization were 4.8%, 2.6% and 1.5%, respectively. All-cause mortality was 1.6%. Initiation of MOV 3-5 days after a positive SARS-CoV-2 test compared to 1-2 days was associated with an increased risk of all-cause (OR 1.85, 95% CI 1.29-2.67) and respiratory or COVID-19-related (OR 1.78, 95% CI 1.07-2.94) hospitalization, and all-cause mortality (OR 2.90, 95% CI 1.64-5.15).

CONCLUSION: MOV was primarily prescribed to vaccinated elderly persons with multiple comorbidities. The all-cause hospitalization and mortality rates in this population were low. Early initiation of MOV reduced the risk of hospitalization and death compared with late initiation.

PMID:39836400 | DOI:10.1177/13596535241313244

Am J Sports Med. 2025 Jan 21:3635465241309307. doi: 10.1177/03635465241309307. Online ahead of print.

ABSTRACT

BACKGROUND: Anterior glenoid bone defects significantly influence surgical outcomes in shoulder instability cases. Various measurement methods based on 3-dimensional computed tomography (3D-CT) have been developed. Recently, the simple linear formula method, which establishes a correlation between glenoid height and width, has emerged as a promising technique.

PURPOSE: This study aimed to assess the differences in glenoid morphology between patients with anterior shoulder instability and healthy controls within a specific East Asian population (Han Chinese). The objectives included establishing linear formulas specific to both groups and comparing the efficacy of the simple linear formula method with traditional methods for measuring glenoid defects using 3D-CT.

STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 3.

METHODS: 3D-CT images of both the affected and unaffected shoulders of patients with anterior shoulder instability, as well as one shoulder of healthy controls, were analyzed. Glenoid height and width were measured, and linear formulas were established for this specific Han Chinese population. P values were determined using linear regression analysis to assess the statistical significance of the relationship between glenoid height (H) and width (W). A P value <.05 indicated a statistically significant relationship. R² values were calculated to determine the strength of the relationship, with higher values (closer to 1) indicating a stronger correlation. The glenoid defect ratio was calculated using the simple linear formula method and compared with traditional methods: the Griffith, linear-based best-fit circle, and area-based best-fit circle methods. Interrater agreement was assessed using intraclass correlation coefficients (ICCs).

RESULTS: There were 206 patients in the patient group and 206 participants in the healthy control group. In the patient group, the mean glenoid height and width of the unaffected shoulders were 35.21 ± 3.39 and 24.26 ± 2.74 mm, respectively (formula: W = 0.75H – 2.12; R² = 0.86; P < .001). In the male patient subgroup, they were 37.57 ± 1.35 and 26.23 ± 0.91 mm, respectively (formula: W = 0.47H + 8.60; R² = 0.79; P < .001). In the female patient subgroup, they were 31.63 ± 2.21 and 21.26 ± 1.65 mm, respectively (formula: W = 0.52H + 4.78; R² = 0.74; P < .001). In the healthy control group, the mean glenoid height and width were 33.48 ± 3.32 and 24.18 ± 3.02 mm, respectively (formula: W = 0.86H – 4.58; R² = 0.89; P < .001). In the male healthy control subgroup, they were 36.43 ± 1.35 and 26.89 ± 1.17 mm, respectively (formula: W = 0.67H + 2.63; R² = 0.58; P < .001). In the female healthy control subgroup, they were 30.54 ± 1.70 and 21.47 ± 1.49 mm, respectively (formula: W = 0.61H + 2.90; R² = 0.69; P < .001). The actual glenoid defect in the entire patient cohort averaged 12.3% ± 5.9%. The simple linear formula method demonstrated an ICC of 0.82, with a glenoid defect ratio averaging 15.7% ± 6.9%. The Griffith method had an ICC of 0.85, yielding a glenoid defect ratio of 16.5% ± 5.8%. The linear-based and area-based best-fit circle methods had ICCs of 0.73 and 0.77, respectively, with glenoid defect ratios of 16.9% ± 6.0% and 13.1% ± 6.2%, respectively.

CONCLUSION: Glenoid morphology in patients with anterior shoulder instability, particularly among male patients, was characterized by elongation and narrowing compared with healthy participants. The simple linear formula method demonstrated excellent reliability and accuracy, comparable with traditional methods, offering an efficient approach to measuring glenoid defects. Further validation across diverse populations is warranted.

PMID:39836389 | DOI:10.1177/03635465241309307

Arch Environ Occup Health. 2025 Jan 21:1-8. doi: 10.1080/19338244.2025.2451910. Online ahead of print.

ABSTRACT

During the COVID-19 pandemic, the need for computer-users to work-from-home (WFH) has increased world-wide. This study aims to explore how the COVID-19 lockdown has affected pain in the lower-back of adult computer professionals. Individuals aged 20-55, both male and female, meeting inclusion criteria (computer/laptop WFH, worked more than an hour on a computer/laptop) were invited to participate voluntarily after providing informed consent. A Google Forms survey was distributed, including self-reported demographic questions, work hours on a computer/laptop during-lockdown, and Oswestry-Low-Back-Disability-Questionnaire (OLBDQ) to assess low-back-pain (LBP) pre- and during-lockdown. The mean OLBDQ score, pre-lockdown 3.681 with 95% confidence interval (CI) [2.621, 4.741] and during-lockdown 4.893 with 95% CI [3.317, 6.470]. A relevant difference was identified among the working hours’ scores from the pre-lockdown and during-lockdown of the OLBDQ for low back pain. The obtained p-value in this context is 0.005, signifying that the observed negative difference is statistically significant for the study. WFH increases LBP of working females and males during the COVID-19 lockdown, poor ergonomics at home is one possible source. Therefore, it is essential to enhance awareness among employed individuals regarding proper ergonomic practices when using a computer both at home and in the workplace.

PMID:39836374 | DOI:10.1080/19338244.2025.2451910

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