Category: Statistics

J Orthop Traumatol. 2023 Jan 9;24(1):2. doi: 10.1186/s10195-022-00681-4.

ABSTRACT

BACKGROUND: Patient-reported outcome measures (PROMs) were developed to examine patients’ perceptions of functional health. Most studies compare the responsiveness of each type of questionnaire. However, reports of patient preferences among PROMs commonly used with patients with hand/wrist injuries or disorders are limited. This study aimed to compare patient preferences, factors associated with those preferences and responsiveness among the Disability of the Arm, Shoulder, and Hand (DASH), Michigan Hand Outcomes Questionnaire (MHQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and EQ-5D in patients with hand/wrist injuries or disorders.

MATERIAL AND METHODS: This retrospective cohort study collected data on 183 patients with hand/wrist injuries or diseases who had visited a hand/wrist outpatient clinic or were hospitalized for surgery between 2017 and 2020. Patients had to be at least 18 years old and able to complete the four questionnaires included in the study. The four PROMs (DASH, MHQ, PRWHE and EQ-5D) were administered to the patients prior to treatment. After completing the questionnaires, patients were asked to answer two open-ended questions regarding their preferences. Multinomial logistic regression was used to identify factors related to patient preferences. Results are presented as the relative risk ratio (RRR). The standardized response mean (SRM) was used to evaluate questionnaire responsiveness.

RESULTS: Of the 183 patients, most preferred the PRWHE questionnaire (n = 74, 41%), with the main reasons cited being “specific to injuries/diseases and reflects hand/wrist function (n = 23, 31%)” and “easy to complete (n = 22, 30%).” Sex was found to be associated with patient preference after adjusting for demographic data and reasons for choosing a PROM as confounders (RRR = 0.46, P value = 0.049). The PRWHE had the highest SRM, followed by DASH (0.92 and 0.88, respectively).

CONCLUSIONS: The PRWHE is the most preferred by patients and is the most responsive questionnaire. It is recommended for use in clinical practice in situations where a clinician would like to use only one PROM for evaluating patients with various types of hand/wrist problems.

LEVEL OF EVIDENCE: Prognostic III.

PMID:36622514 | DOI:10.1186/s10195-022-00681-4

Cell Tissue Bank. 2023 Jan 9. doi: 10.1007/s10561-022-10066-w. Online ahead of print.

ABSTRACT

Skeletal problems are an increasing issue due to the increase in the global aging population. Different statistics reports show that today, the global population is aging that results in skeletal problems, increased health system costs, and even higher mortality associated with skeletal problems. Common treatments such as surgery and bone grafts are not always effective and in some cases, they can even cause secondary problems such as infections or improper repair. Cell therapy is a method that can be utilized along with common treatments independently. Mesenchymal stem cells (MSCs) are a very important and efficient source in terms of different diseases, especially bone problems. These cells are present in different tissues such as bone marrow, adipose tissue, umbilical cord, placenta, dental pulp, peripheral blood, amniotic fluid and others. Among the types of MSCs, bone marrow mesenchymal stem cells (BMMSCs) are the most widely used source of these cells, which have appeared to be very effective and promising in terms of skeletal diseases, especially compared to the other sources of MSCs. This study focuses on the specific potential and content of BMMSCs from which the specific capacity of these cells originates, and compares their osteogenic potential with other types of MSCs, and also the future directions in the application of BMMSCs as a source for cell therapy.

PMID:36622494 | DOI:10.1007/s10561-022-10066-w

Pediatr Surg Int. 2023 Jan 9;39(1):77. doi: 10.1007/s00383-023-05364-7.

ABSTRACT

PURPOSE: To identify prognostic factors of postoperative Hirschsprung-associated enterocolitis (HAEC).

METHOD: A retrospective cohort study of Hirschsprung patients between 2006 and 2021 was conducted. Patients with anorectal malformation and non-definitive surgery were excluded. Associated factors for postoperative HAEC were reported with hazard ratio (HR) and 95% confidence interval (CI).

RESULTS: Forty-nine patients were excluded due to concurrent anorectal malformation and incomplete data. Of 274 patients, 75 patients (27.4%) had at least one episode of postoperative HAEC. There were 28 patients (37.3%) who had multi-episodes of HAEC. The total episodes of post-operative HAEC in this study were 121 episodes (36.8%). In multivariable survival analysis, significant factors associated with postoperative HAEC were the aganglionic level above sigmoid colon (HR = 3.47, p = 0.023, 95% CI 1.19-10.09), and total colonic aganglionosis (HR = 14.83, p = 0.004, 95% CI 2.33-94.40). The patients who experienced clinical enterocolitis before 2 weeks after surgery significantly developed more postoperative HAEC (HR = 5.32, p = 0.038, % CI 1.09-25.92). The incidence of postoperative HAEC was increase in patients with postoperative obstructive symptoms (48.0%). One patient died due to severe sepsis from postoperative HAEC, while three others required intensive care.

CONCLUSIONS: The long involvement of aganglionic segment and early postoperative HAEC was significantly associated with postoperative HAEC. Frequent follow-up, parental education, and early treatment are recommended in these individuals, particularly in the first year after surgery.

PMID:36622463 | DOI:10.1007/s00383-023-05364-7

Eur Spine J. 2023 Jan 9. doi: 10.1007/s00586-023-07525-7. Online ahead of print.

ABSTRACT

PURPOSE: To provide better evidence of the efficacy and safety of preoperative halo-pelvic traction on the improvements of deformity and pulmonary functions in patients with severe scoliosis.

METHODS: Electronic database searches were conducted including the Cochrane Library, PubMed, Web of Science and Embase. All studies of halo-pelvic traction for the management of severe spinal deformity were included. We referred to a list of four criteria developed by the Agency for Healthcare Research and Quality (AHRQ) to assess the quality of included studies. The meta-analysis was performed using RevMan 5.4 software.

RESULTS: Based on the study selection criteria, a total of eight articles consisting of a total of 210 patients were included. Statistically significant differences were found in coronal Cobb angle (P < 0.001), sagittal Cobb angle (P < 0.001) and height (P < 0.001) between pre- and post-traction. Sensitivity analysis was conducted, and there were substantial changes in heterogeneity with preoperative thoracoplasty subgroup in coronal Cobb angle (P < 0.001). Three trials including 74 subjects reported FVC and FEV1 predicted value between pre- and post-traction. There were statistically significant differences in FVC, FVC%, FEV1 and FEV1% (P < 0.001). The complication rate was 6.6-26.7%, and symptoms disappeared after reasonable traction strategy and intensive care.

CONCLUSIONS: Preoperative halo-pelvic traction achieved significant improvements in spinal deformity and pulmonary functions, with minor and curable complications. Thus, it is an effective and safe solution before surgery and may be the optimal choice for severe scoliosis. In light of the heterogeneity and limitations, future researches are needed to better determine the long-term efficacy on comprehensive assessment and to explore the appropriate traction system.

PMID:36622456 | DOI:10.1007/s00586-023-07525-7

Clin Oral Investig. 2023 Jan 9. doi: 10.1007/s00784-022-04841-y. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the impact of the age of resin-based composite (RBC) restorations used for deep margin elevation (DME) on the marginal quality and fracture resistance of inlays.

MATERIALS AND METHODS: Permanent human molars with direct RBC restorations, involving the mesial, occlusal, and distal surface (MOD), were allocated to four groups (each n = 12). Half of the teeth underwent thermomechanical loading including 240,000 occlusal load cycles and 534 thermal cycles (TML, 5 °C/55 °C; 49 N, 1.7 Hz). With RBC left in one proximal box as DME, all teeth received MOD inlays, made from lithium disilicate (LDS) or a polymer-infiltrated ceramic network material (PICN). The restored teeth underwent TML including 1.2 million occlusal cyclic loadings and 2673 thermal cycles. The marginal quality was assessed at baseline and after both runs of TML. Load-to-fracture tests were performed. The statistical analysis comprised multiple linear regressions (α = 0.05).

RESULTS: Simulated aging of RBC restorations had no significant effect on the marginal quality at the interface between the RBC and the tooth and the RBC and the inlay (p ≥ 0.247). Across time points, higher percentages of non-continuous margin were observed between the inlay and the tooth than between the tooth and the RBC (p ≤ 0.039). The age of the DME did not significantly affect the fracture resistance (p ≥ 0.052).

CONCLUSIONS: Artificial aging of RBC restorations used for DME had no detrimental effect on the marginal quality and fracture resistance of LDS and PICN inlays.

CLINICAL RELEVANCE: This laboratory study suggests that-in select cases-intact, direct RBC restorations not placed immediately before the delivery of an indirect restoration may be used for DME.

PMID:36622446 | DOI:10.1007/s00784-022-04841-y

Pediatr Nephrol. 2023 Jan 9. doi: 10.1007/s00467-022-05862-1. Online ahead of print.

ABSTRACT

BACKGROUND: Coexisting genetic variants in patients with anti-factor H (FH)-associated atypical hemolytic uremic syndrome (aHUS) have implications for therapy. We estimated the prevalence of complement genetic variants in children with anti-FH aHUS from a prospective nationwide cohort and determined if significant genetic variants impact long-term kidney outcomes.

METHODS: Of 436 patients in the database, 77 consecutive patients, 21 with a relapse and 9 with kidney failure and/or death were included. Targeted sequencing, using a 27-gene panel including CFH, CFI, CFB, C3, CD46, PLG, DGKE, and THBD and multiplex ligation-dependent probe amplification of CFH-CFHR region, was performed. The adverse outcome was eGFR < 30 ml/min/1.73 m² or death.

RESULTS: Patients had high anti-FH titers 5670 (2177-13,545) AU/ml, relapsing course (42.1%), and adverse outcomes (19.6%). Variants, chiefly of unknown significance, were found in 7 (6.5%; 95% CI 3.1-13.2%); a pathogenic variant was found in one patient. Homozygous deletion of CFHR1 was present in 91.6% compared to 9.8% in 184 healthy controls. Plasma exchanges and immunosuppression showed a trend of improving outcomes, independent of genetic defects (HR 0.32; P = 0.070). Meta-analysis of 18 studies (384 patients) showed that the pooled prevalence of pathogenic and likely pathogenic variants was 3% (95% CI 0-8%). Of 37 total variants in the meta-analysis, 7 (18.9%) each were pathogenic and likely pathogenic; others were variants of unknown significance.

CONCLUSIONS: Significant variants in complement regulatory genes are rare in patients with anti-FH-associated aHUS. Irrespective of genetic defects, plasma exchanges and immunosuppression showed a statistical trend to improved outcomes. A higher resolution version of the Graphical abstract is available as Supplementary information.

PMID:36622444 | DOI:10.1007/s00467-022-05862-1

Pediatr Nephrol. 2023 Jan 9. doi: 10.1007/s00467-022-05855-0. Online ahead of print.

ABSTRACT

BACKGROUND: Pediatric ANCA vasculitis is a rare group of diseases with a scarcity of data in children. Annual incidence appeared to increase in the last several years, placing higher interest in the clinical and therapeutical outcomes of the disorder. Also, the growing use of rituximab questions the latest outcomes in these diseases. We therefore conducted a retrospective study to better understand the current characteristics, management, and the latest outcomes of the disorder.

METHODS: We conducted a 9-year retrospective study of 46 children in 14 different centers across France to describe their clinical and laboratory presentations, therapeutic regimens, and kidney outcome.

RESULTS: P-ANCA appeared to be a potential marker for higher relapse risk. Compared to adults, we found that ear-nose-throat presentations were frequent (45.7%) and more severe. Despite an evolution in the treatment management, kidney outcome remained poor with a substantial proportion of chronic kidney disease (54.8% at 1 year). Mortality stays low with 3 patients (6.5%) deceased at the end of our study.

CONCLUSION: Clinical presentation was as previously described and time to diagnosis remains long. P-ANCA is a statistically significant marker for increased relapse risk. We observed a modification in the treatment regimens over the past several years with a growing use of rituximab and a decreasing use of cyclophosphamide. Despite these changes, kidney outcome remains poor and prospective studies should be conducted to assess the most appropriate therapeutic modality for each patient. A higher resolution version of the Graphical abstract is available as Supplementary information.

PMID:36622443 | DOI:10.1007/s00467-022-05855-0

Eur J Pediatr. 2023 Jan 9. doi: 10.1007/s00431-022-04769-1. Online ahead of print.

ABSTRACT

An undescended testis is the most common genitourinary disease in boys. The German guidelines, first published in 2009, proposed the timing of orchidopexy to be before 12 months of age. The aim of the study was to analyze the implementation of these guidelines 10 years after publication. The national cumulative statistics of hospital admissions, provided by the Institute for the Remuneration System in Hospitals (InEK), and the statistics concerning procedures performed in private pediatric surgical practices of the professional association of pediatric surgeons (BNKD) regarding the time of surgeries for the year 2019 were analyzed. Data from InEK included all German hospital admissions. Data from BNKD included data from 48 private pediatric surgical practices. The hospitals treated 6476 inpatients with undescended testis, and 3255 patients were operated in private practices. Regarding the age at treatment, 15% of the hospital patients and 5% of the private practice patients were younger than 1 year and fulfilled the guideline recommendations. Forty percent of the hospital patients and 29% of the private practice patients were 1 or 2 years of age. All other patients were 3 years of age or older at the time of orchidopexy. Conclusions: The rate of orchidopexy within the first 12 months of life is remarkably low even 10 years after the publication of the guidelines. Awareness of the existing guideline must be increased for both referring pediatric and general practitioners. What is Known: • In Germany, orchidopexy is performed by pediatric surgeons and urologists either in hospital settings or in private practices. • Most international guidelines set the age for surgical treatment of undescended testis between 12 and 18 months of age. The German guidelines, published in 2009, sets the time-limit at one year of age. Until five years after publication of the German guidelines, the number of patients treated before the first year of life was low; studies show an orchidopexy ratebetween 8% and 19% during this time. What is New: • This study the first to cover all administered hospital patients in Germany and a large group of patients treated in private practices. It contains the largest group of German patients with undescended testis. • Although almost all children participate in the routine check-up at the age of seven months, which includes investigation for undescended testis, adherence to the orchidopexy guidelines is still low. Only 15% of the hospital patients and 5% of the patients in private practice were treated before their first birthdays.

PMID:36622430 | DOI:10.1007/s00431-022-04769-1

Eur Radiol. 2023 Jan 9. doi: 10.1007/s00330-022-09378-y. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the diagnostic performance of a commercial artificial intelligence (AI)-assisted ultrasonography (US) for thyroid nodules and to validate its value in real-world medical practice.

MATERIALS AND METHODS: From March 2021 to July 2021, 236 consecutive patients with 312 suspicious thyroid nodules were prospectively enrolled in this study. One experienced radiologist performed US examinations with a real-time AI system (S-Detect). US images and AI reports of the nodules were recorded. Nine residents and three senior radiologists were invited to make a “benign” or “malignant” diagnosis based on recorded US images without knowing the AI reports. After referring to AI reports, the diagnosis was made again. The diagnostic performance of AI, residents, and senior radiologists with and without AI reports were analyzed.

RESULTS: The sensitivity, accuracy, and AUC of the AI system were 0.95, 0.84, and 0.753, respectively, and were not statistically different from those of the experienced radiologists, but were superior to those of the residents (all p < 0.01). The AI-assisted resident strategy significantly improved the accuracy and sensitivity for nodules ≤ 1.5 cm (all p < 0.01), while reducing the unnecessary biopsy rate by up to 27.7% for nodules > 1.5 cm (p = 0.034).

CONCLUSIONS: The AI system achieved performance, for cancer diagnosis, comparable to that of an average senior thyroid radiologist. The AI-assisted strategy can significantly improve the overall diagnostic performance for less-experienced radiologists, while increasing the discovery of thyroid cancer ≤ 1.5 cm and reducing unnecessary biopsies for nodules > 1.5 cm in real-world medical practice.

KEY POINTS: • The AI system reached a senior radiologist-like level in the evaluation of thyroid cancer and could significantly improve the overall diagnostic performance of residents. • The AI-assisted strategy significantly improved ≤ 1.5 cm thyroid cancer screening AUC, accuracy, and sensitivity of the residents, leading to an increased detection of thyroid cancer while maintaining a comparable specificity to that of radiologists alone. • The AI-assisted strategy significantly reduced the unnecessary biopsy rate for thyroid nodules > 1.5 cm by the residents, while maintaining a comparable sensitivity to that of radiologists alone.

PMID:36622410 | DOI:10.1007/s00330-022-09378-y

Graefes Arch Clin Exp Ophthalmol. 2023 Jan 9. doi: 10.1007/s00417-022-05944-8. Online ahead of print.

ABSTRACT

PURPOSE: The study aims to evaluate changes in contrast sensitivity (CS) during therapy with intravitreal vascular endothelial growth factor (VEGF) inhibitors in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

METHODS: Prospective, uncontrolled, multicenter study on patients with neovascular AMD or DME who underwent intravitreal injection therapy with Ranibizumab, Aflibercept, or Bevacizumab was conducted. Best corrected visual acuity (BCVA) and CS measured by Mars Letter Contrast Sensitivity Test (MLCS) and Freiburg Visual Acuity and Contrast Test (FrACT) in logCS were evaluated before 3 consecutive VEGF inhibitor injections, which followed the pro renata regimen in treatment-naïve and pretreated eyes with a maximum of 9 injections. Correlation of MLCS and FrACT was calculated by the Spearman’s rank correlation coefficient.

RESULTS: Eighty eyes of 74 patients (mean age 72.7; SD ± 9.96) were included. BCVA improved significantly from 0.44 (SD ± 0.21) logMAR to 0.38 (SD ± 0.23) logMAR by 0.06 (SD ± 0.14) logMAR values (p < 0.001). CS measured by MLCS increased significantly from 1.27 (SD ± 0.25) logCS to 1.39 (SD ± 0.22) logCS (p < 0.001). CS measured by FrACT also improved significantly from 1.22 (SD ± 0.32) logCS to 1.30 (SD ± 0.29) logCS (p = 0.035). A positive correlation between MLCS and FrACT was found (r = 0.389; p < 0.001). Despite statistical significance, results for BCVA, MLCS, and FrACT failed clinical significance. Overall best test results were achieved with MLCS.

CONCLUSIONS: Intravitreal injection therapy with VEGF inhibitors led to an improvement of BCVA and CS measured by MLCS and FrACT. MLCS was superior and more sensitive compared to FrACT and even BCVA to evaluate CS in elderly patients with macular pathology.

PMID:36622409 | DOI:10.1007/s00417-022-05944-8