Category: Statistics

J Bone Joint Surg Am. 2024 Jun 28. doi: 10.2106/JBJS.23.00957. Online ahead of print.

ABSTRACT

BACKGROUND: Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients’ perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-term follow-up RSA studies.

METHODS: Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up.

RESULTS: No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized.

CONCLUSIONS: Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants.

LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

PMID:38941476 | DOI:10.2106/JBJS.23.00957

Medicine (Baltimore). 2024 Jun 28;103(26):e38379. doi: 10.1097/MD.0000000000038379.

ABSTRACT

BACKGROUND: This study aimed to evaluate the clinical and radiological features of the patella fixation technique using Toggleloc suspension system in a single ellipsoidal blind patellar tunnel during medial patellofemoral ligament (MPFL) reconstruction.

METHODS: This study included 52 patients (25 men, 27 women) who underwent MPFL reconstruction using a semitendinosus tendon graft. The graft was fixed to the ellipsoidal single blind tunnel opened on the medial side of the patella with an endobutton and was fixed to the femoral tunnel by using bioabsorbable screw. Clinical scores (Kujala score, Lysholm score, Tegner activity score and the visual analog scale [VAS] score) were evaluated preoperatively and at the end-follow up. Preoperative and postoperative radiological measurements (trochlea depth, sulcus angle, patellar height, patellar congruence angle, patellar tilt angle and lateral patellofemoral angle) were evaluated with X-ray (Merchant X-ray, anteroposterior and lateral radiography) and computed tomography (CT) of the knee.

RESULTS: Postoperative patellar redislocation or subluxation was not observed in any patient. Patellar congruence angle, patellar tilt angle and lateral patellofemoral angle mean values were found to return to normal values in the postoperative period and the results were statistically significant. Also statistically significant improvement in all clinical scores postoperatively. According to the Insall-Salvati index (ISI) and Caton-Deschamps index (CDI) on lateral radiography of the knee at 30° flexion, patellar height decreased in the postoperative period statistically significant. The CDI was above 1.3 in 17 (%32) of our patients. Thirteen of these values decreased to normal values. No radiological progression of patellofemoral osteoarthritis was observed in all patients at the final follow-up evaluation.

CONCLUSION: In cases of patellofemoral instability, fixation of the tendon graft in blind ellipsoid tunnel using the Toggleloc suspension system provides satisfactory patellar graft fixation strength, significant functional improvement and a low failure rate.

PMID:38941440 | DOI:10.1097/MD.0000000000038379

Medicine (Baltimore). 2024 Jun 28;103(26):e38642. doi: 10.1097/MD.0000000000038642.

ABSTRACT

Idiopathic inflammatory myopathies, especially antisynthetase syndrome, often appear outside of the muscles as interstitial lung disease (ILD). Another typical finding is the presence of mechanic’s hands. The aim of the present study was to describe the clinical, functional, tomographic, and serological data of patients with ILD and mechanic’s hands and their response to treatment and survival rates. This is a retrospective study of ILD with concurrent myopathy. Among the 119 patients initially selected, 51 had mechanic’s hands. All the patients were screened for anti-Jo-1 antibodies. An expanded panel of myopathy autoantibodies was also performed in 27 individuals. Of the 51 patients, 35 had 1 or more antibodies. The most common were anti-Jo-1, anti-PL-7, and anti-PL-12, while of the associated antibodies, anti-Ro52 was present in 70% of the 27 tested individuals. A significant response to treatment was characterized by an increase in predicted forced vital capacity (FVC) of at least 5% in the last evaluation done after 6 to 24 months of treatment. A decrease in predicted FVC of at least 5%, the need for oxygen therapy, or death were all considered treatment failures. All patients were treated with corticosteroids, and 71% with mycophenolate. After 24 months, 18 patients had an increase in FVC, 11 had a decrease, and 22 remained stable. After a median follow-up of 58 months, 48 patients remained alive and three died. Patients with honeycombing on high-resolution chest tomography (log-rank = 34.65; P < .001) and a decrease in FVC ≥5% (log-rank = 18.28, P < .001) had a poorer survival rate. Patients with ILD and mechanic’s hands respond well to immunosuppressive treatment.

PMID:38941439 | DOI:10.1097/MD.0000000000038642

Medicine (Baltimore). 2024 Jun 28;103(26):e38650. doi: 10.1097/MD.0000000000038650.

ABSTRACT

Previous studies have reported an association between physical activity and the occurrence and progression of knee osteoarthritis (KOA). However, the existing evidence remains limited and of low-quality. This study aimed to examine the causal relationship between different levels of physical activity and KOA. Instrumental variables, represented by single nucleotide polymorphisms (SNPs), were utilized to capture sedentary behavior, appropriate physical exercise, and excessive physical activity. Aggregated statistics from the UK Biobank genome-wide association study dataset were used to assess the impact of these SNPs on KOA. Causality was estimated using inverse variance weighting (IVW), MR Egger, simple model, weighted median, and weighted model approaches. The stability of the results was assessed through heterogeneity and sensitivity analyses. Mendelian randomization (MR) analysis revealed a strong association between sedentary behavior and KOA, with an odds ratio (OR) of 2.096 (95% CI: 1.506-2.917) and a P value of 1.14 × 10-5. Appropriate physical exercise behavior exhibited a strong negative association with KOA, with an OR of 0.147 (95% CI: 0.037-0.582) and a P value of 0.006. Conversely, excessive physical activity behavior showed a significant positive association with KOA, with an OR of 2.162 (95% CI: 1.327-3.521) and a P value of .002. Our findings indicate that sedentary behavior and excessive physical activity are identified as risk factors for KOA, whereas engaging in appropriate physical exercise emerges as a protective factor against the development of KOA.

PMID:38941438 | DOI:10.1097/MD.0000000000038650

Medicine (Baltimore). 2024 Jun 28;103(26):e38494. doi: 10.1097/MD.0000000000038494.

ABSTRACT

To explore the effects of tracking linkage self-management mode on the compliance of prenatal examinations and delivery modes in primiparas. A total of 270 primiparas undergoing prenatal examinations in Shijiazhuang Obstetrics and Gynecology Hospital were enrolled for prospective study between January 2021 and January 2022. They were divided into control group and observation group, 135 cases in each group. The control group was given routine management mode, while observation group was given tracking linkage self-management mode. All were intervened till discharge. The compliance (time and frequency of prenatal examinations), cognition of prenatal examinations, score of exercise of self-care agency scale, self-rating anxiety scale and self-rating depression scale, delivery modes and the occurrence of neonatal adverse outcomes were compared between the 2 groups. After intervention, total compliance rate of prenatal examinations in observation group was higher than that in control group (84.44% vs 72.59%) (P < .05). The scores of pregnancy care, genetic diseases counseling, prevention of birth defects and reasonable nutrition during pregnancy in observation group were higher than those in control group (P < .05), scores of health cognition, self-care skills, self-care responsibility and self-concept were higher than those in control group (P < .05), scores of self-rating anxiety scale and self-rating depression scale were lower than those in control group (P < .05), natural delivery rate was higher than that in control group (85.93% vs 74.81%) (P < .05), and incidence of neonatal adverse outcomes was lower than that in control group (0.74% vs 5.93%) (Fisher exact probability = 0.036). The application of tracking linkage self-management mode can significantly improve cognition to prenatal examinations, improve compliance of prenatal examinations and self-care ability, relieve anxiety and depression, increase natural delivery rate and reduce the incidence of neonatal adverse outcomes in primiparas.

PMID:38941437 | DOI:10.1097/MD.0000000000038494

Medicine (Baltimore). 2024 Jun 28;103(26):e37064. doi: 10.1097/MD.0000000000037064.

ABSTRACT

BACKGROUND: Acute pancreatitis (AP) is a common emergency condition with high morbidity, mortality, and socio-economic impact. Soluble urokinase plasminogen activator receptor (suPAR) is a potential biomarker for AP prognosis. This study systematically reviews the literature on suPAR’s prognostic roles in assessing AP severity, organ failure, mortality, and other pathological markers.

METHODS: A comprehensive search of 5 databases up to March 19, 2023, was conducted, selecting cohort studies that examined suPAR’s relationship with AP outcomes. Outcome variables included AP severity, organ failure, mortality, hospital stay length, and suPAR’s association with other inflammatory markers. Our paper has been registered on Prospero (ID: CRD42023410628).

RESULTS: Nine prospective observational studies with 1033 AP patients were included. Seven of eight studies found suPAR significantly elevated in severe acute pancreatitis (P < .05). Four studies showed suPAR effectively predicted organ failure risk, and 4 studies concluded suPAR significantly predicted mortality (P < .05). The review had no high-risk studies, enhancing credibility.

CONCLUSION: suPAR is a valuable prognostic marker in AP, significantly predicting severity, organ failure, hospital stay length, and mortality. Further large-scale studies are needed to explore suPAR’s role in other clinical outcomes related to AP disease course, to establish it as a mainstay of AP prognosis.

PMID:38941433 | DOI:10.1097/MD.0000000000037064

Medicine (Baltimore). 2024 Jun 28;103(26):e38626. doi: 10.1097/MD.0000000000038626.

ABSTRACT

Primary sclerosing cholangitis (PSC), a chronic cholestatic liver condition, is frequently associated with inflammatory bowel disease. Specific immune cells have been implicated in PSC pathogenesis with the emergence of the “microbiota” and “gut lymphocyte homing” hypotheses, albeit their identities remain controversial. The first genome-wide association analysis leveraged nonoverlapping data from 3757 Europeans to evaluate 731 immunophenotypes. A genome-wide association analysis comprising 2871 cases and 12,019 controls yielded summary statistics for PSC. An inverse-variance weighted (IVW) analysis was performed to identify immunophenotypes causally related to PSC, and the results were validated using weighted mode, MR-Egger, and weighted median methods. Comprehensive sensitivity analyses were performed to verify the robustness, heterogeneity, and horizontal pleiotropy of the results. IVW analysis revealed 26 immune traits exhibiting causal associations with PSC. CD3 on HLA-DR+ CD4+ (IVW odds ratio [OR]: 0.904; 95% confidence interval [CI]: 0.828-0.986, P = .023) and CD3 on secreting Treg (IVW OR: 0.893; 95% CI: 0.823-0.969, P = .007) were negatively associated with PSC susceptibility and demonstrated high consistency across the 3 validation methods. Moreover, 7 other immune traits, including CD39+ resting Treg absolute cell (IVW OR = 1.083, 95% CI: 1.013-1.157, P = .019), CD39+ secreting Treg absolute cell (IVW OR = 1.063, 95% CI: 1.012-1.118, P = .015), CD3 on naive CD8br (IVW OR = 0.907, 95% CI: 0.835-0.986, P = .022), CD3 on CD39+ activated Treg (IVW OR = 0.927, 95% CI: 0.864-0.994, P = .034), CD28 on resting Treg (IVW OR = 0.724, 95% CI: 0.630-0.833, P = 5.95E-06), and CD39 on CD39+ CD4+ (IVW OR = 1.055, 95% CI: 1.001-1.112, P = .044) exhibited consistent results in the Weighted Median and Weighted Mode validation methods. Moreover, no significant heterogeneity or horizontal pleiotropy was observed across the single nucleotide polymorphisms. The leave-one-out results revealed that sequentially eliminating each single nucleotide polymorphism had no significant influence on model effect estimates or qualitative inference. This study evaluated potential causal links between 731 immune traits and PSC susceptibility. Twenty-six immune traits were identified using the IVW method. Verification across multiple methods revealed 9 immune traits with a plausible causal connection to PSC. These findings may uncover mechanistic pathways and novel therapeutic approaches.

PMID:38941430 | DOI:10.1097/MD.0000000000038626

JAMA Netw Open. 2024 Jun 3;7(6):e2418213. doi: 10.1001/jamanetworkopen.2024.18213.

ABSTRACT

IMPORTANCE: Unintended pregnancy is a major health risk for adolescents in the US, and adolescents face many barriers to obtaining effective and reliable contraception.

OBJECTIVE: To measure and describe the use of contraception, pregnancy risk index (PRI), and emergency contraception (EC) prescriptions among female adolescents accessing the emergency department (ED) for care.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study is a planned secondary analysis of a multicenter trial from April 2021 through April 2022 that used a tablet-based, content-validated, confidential sexual health survey at 6 urban, pediatric tertiary care EDs affiliated with the Pediatric Emergency Care Applied Research Network. Participants were individuals aged 15 to 21 years presenting to the ED who completed the confidential sexual health survey and indicated female sex assigned at birth and prior penile-vaginal sexual intercourse. Data analysis was performed from January 2023 to February 2024.

MAIN OUTCOMES AND MEASURES: The primary outcomes were the type and proportion of contraception use, the PRI, and provision of EC. Separate multivariable logistic regression models were performed to identify sociodemographic factors associated with these outcomes.

RESULTS: A total of 1063 participants (median [IQR] age, 17.5 [16.5-18.3] years) were included in this analysis; 219 (20.8%) identified as Hispanic, 464 (44.1%) identified as non-Hispanic Black, 308 (29.3%) identified as non-Hispanic White, and 61 (5.8%) identified as other races and ethnicities. In total, 756 participants (71.1%) reported contraception use during their last sexual encounter. Long-acting reversible contraception use (LARC) was the least used (164 participants [15.4%]), and 307 (28.9%) reported no contraception use. Sociodemographic factors associated with overall contraception use, and LARC use specifically, included insurance and race and ethnicity. The overall PRI was 7.89, or an expected 8 pregnancies per 100 female individuals per year. Although 108 participants (10.2%) were eligible for EC, EC was ordered for only 6 (5.6%) of those eligible.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of sexually active adolescents presenting to the ED, the majority of participants reported using at least 1 form of contraception; however, LARCs were the least used option, and 28.9% of participants reported no contraceptive use. The unintended pregnancy risk was almost 8% in the study population. Few patients eligible for EC received it. These data suggest a high need and potential opportunity for provision of contraception services in the ED setting.

PMID:38941097 | DOI:10.1001/jamanetworkopen.2024.18213

JAMA Netw Open. 2024 Jun 3;7(6):e2419029. doi: 10.1001/jamanetworkopen.2024.19029.

ABSTRACT

IMPORTANCE: Studies on the familial effects of body mass index (BMI) status have yielded a wide range of data on its heritability.

OBJECTIVE: To assess the heritability of obesity by measuring the association between the BMIs of fathers, mothers, and their offspring at the same age.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from population-wide mandatory medical screening before compulsory military service in Israel. The study included participants examined between January 1, 1986, and December 31, 2018, whose both parents had their BMI measurement taken at their own prerecruitment evaluation in the past. Data analysis was performed from May to December 2023.

MAIN OUTCOMES AND MEASURES: Spearman correlation coefficients were calculated for offsprings’ BMI and their mothers’, fathers’, and midparental BMI percentile (the mean of the mothers’ and fathers’ BMI cohort- and sex-specific BMI percentile) to estimate heritability. Logistic regression models were applied to estimate the odds ratios (ORs) and 95% CIs of obesity compared with healthy BMI, according to parental BMI status.

RESULTS: A total of 447 883 offspring (235 105 male [52.5%]; mean [SD] age, 17.09 [0.34] years) with both parents enrolled and measured for BMI at 17 years of age were enrolled in the study, yielding a total study population of 1 343 649 individuals. Overall, the correlation between midparental BMI percentile at 17 years of age and the offspring’s BMI at 17 years of age was moderate (ρ = 0.386). Among female offspring, maternal-offspring BMI correlation (ρ = 0.329) was somewhat higher than the paternal-offspring BMI correlation (ρ = 0.266). Among trios in which both parents had a healthy BMI, the prevalence of overweight or obesity in offspring was 15.4%; this proportion increased to 76.6% when both parents had obesity and decreased to 3.3% when both parents had severe underweight. Compared with healthy weight, maternal (OR, 4.96; 95% CI, 4.63-5.32), paternal (OR, 4.48; 95% CI, 4.26-4.72), and parental (OR, 6.44; 95% CI, 6.22-6.67) obesity (midparent BMI in the ≥95th percentile) at 17 years of age were associated with increased odds of obesity among offspring.

CONCLUSIONS AND RELEVANCE: In this cohort study of military enrollees whose parents also underwent prerecruitment evaluations, the observed correlation between midparental and offspring BMI, coupled with a calculated narrow-sense heritability of 39%, suggested a substantive contribution of genetic factors to BMI variation at 17 years of age.

PMID:38941093 | DOI:10.1001/jamanetworkopen.2024.19029

JAMA Netw Open. 2024 Jun 3;7(6):e2419245. doi: 10.1001/jamanetworkopen.2024.19245.

ABSTRACT

IMPORTANCE: Significant evidence gaps exist regarding the safety of smoking cessation pharmacotherapies during pregnancy, especially for the risk of congenital malformations. Consequently, professional bodies advise against the use of varenicline and bupropion and recommend caution with nicotine replacement therapy (NRT). Contemporary estimates of the use of smoking cessation pharmacotherapies during pregnancy are lacking.

OBJECTIVE: To quantify the proportion of individuals using prescribed smoking cessation pharmacotherapies during pregnancy and during the first trimester specifically, in 4 countries.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, population-based cohort study used linked birth records, hospital admission records, and dispensing records of prescribed medications from all pregnancies resulting in birth between 2015 and 2020 in New South Wales, Australia; New Zealand; Norway; and Sweden. Data analyses were conducted in October and November 2023.

EXPOSURE: Prescribed smoking cessation pharmacotherapy use (varenicline, NRT, and bupropion) during pregnancy was defined as days’ supply overlapping the period from date of conception to childbirth.

MAIN OUTCOMES AND MEASURES: Prevalence of use among all pregnancies and pregnancies with maternal smoking were calculated. Among women who used a pharmacotherapy, the proportion of women with use during the first trimester of pregnancy was also calculated.

RESULTS: Among 1 700 638 pregnancies in 4 countries, 138 033 (8.1%) had maternal smoking and 729 498 (42.9%) were younger than 30 years. The prevalences ranged from 0.02% to 0.14% for varenicline, less than 0.01% to 1.86% for prescribed NRT, and less than 0.01% to 0.07% for bupropion. Among pregnant individuals who smoked, use of pharmacotherapies was up to 10 times higher, with maximum prevalences of 1.25% for varenicline in New South Wales, 11.39% for NRT in New Zealand, and 0.39% for bupropion in New Zealand. Use in the first trimester occurred among more than 90% of individuals using varenicline, approximately 60% among those using NRT, and 80% to 90% among those using bupropion.

CONCLUSIONS AND RELEVANCE: In this cohort study of pregnant individuals in 4 high-income countries, the low prevalence of varenicline and bupropion use during pregnancy and higher prevalence of NRT use aligned with current clinical guidelines. As most use occurred in the first trimester, there is a need for evidence on the risk of congenital malformations for these medications.

PMID:38941092 | DOI:10.1001/jamanetworkopen.2024.19245