Tag: nevin manimala

Acta Orthop. 2022 Jul 5;93:634-642. doi: 10.2340/17453674.2022.3909.

ABSTRACT

BACKGROUND AND PURPOSE: Developing meaningful thresholds for the Oxford Knee Score (OKS) advances its clinical use. We determined the minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) values as meaningful thresholds for the OKS at 3-, 12-, and 24-month follow-up in patients undergoing unicompartmental knee arthroplasty (UKA).

PATIENTS AND METHODS: This is a cohort study with data from patients undergoing UKA collected at a hospital in Denmark between February 2016 and September 2021. The OKS was completed preoperatively and at 3, 12, and 24 months postoperatively. Interpretation threshold values were calculated with the anchor-based adjusted predictive modeling method. Non-parametric bootstrapping was used to derive 95% confidence intervals (CI).

RESULTS: Complete 3-, 12-, and 24-month postoperative data was obtained for 331 of 423 (78%), 340 of 479 (71%), and 235 of 338 (70%) patients, median age of 68-69 years (58-59% females). Adjusted OKS MIC values were 4.7 (CI 3.3-6.0), 7.1 (CI 5.2-8.6), and 5.4 (CI 3.4- 7.3), adjusted OKS PASS values were 28.9 (CI 27.6-30.3), 32.7 (CI 31.5-33.9), and 31.3 (CI 29.1-33.3), and adjusted OKS TF values were 24.4 (CI 20.7-27.4), 29.3 (CI 27.3-31.1), and 28.5 (CI 26.0-30.5) at 3, 12, and 24 months postoperatively, respectively. All values statistically significantly increased from 3 to 12 months but not from 12 to 24 months.

INTERPRETATION: The UKA-specific measurement properties and clinical thresholds for the OKS can improve the interpretation of UKA outcome and assist quality assessment in institutional and national registries.

PMID:35819794 | DOI:10.2340/17453674.2022.3909

JAMA Netw Open. 2022 Jul 1;5(7):e2221140. doi: 10.1001/jamanetworkopen.2022.21140.

ABSTRACT

IMPORTANCE: Platform trial design allows the introduction of new interventions after the trial is initiated and offers efficiencies to clinical research. However, limited guidance exists on the economic resources required to establish and maintain platform trials.

OBJECTIVE: To compare cost (US dollars) and time requirements of conducting a platform trial vs a series of conventional (nonplatform) trials using a real-life example.

DESIGN, SETTING, AND PARTICIPANTS: For this economic evaluation, an online survey was administered to a group of international experts (146 participants) with publication records of platform trials to elicit their opinions on cost and time to set up and conduct platform, multigroup, and 2-group trials. Using the reported entry dates of 10 interventions into Systemic Therapy in Advancing Metastatic Prostate Cancer: Evaluation of Drug Efficacy, the longest ongoing platform trial, 3 scenarios were designed involving a single platform trial (scenario 1), 1 multigroup followed by 5 2-group trials (scenario 2), and a series of 10 2-group trials (scenario 3). All scenarios started with 5 interventions, then 5 more interventions were either added to the platform or evaluated independently. Simulations with the survey results as inputs were used to compare the platform vs conventional trial designs. Data were analyzed from July to September 2021.

EXPOSURE: Platform trial design.

MAIN OUTCOMES AND MEASURES: Total trial setup and conduct cost and cumulative duration.

RESULTS: Although setup time and cost requirements of a single trial were highest for the platform trial, cumulative requirements of setting up a series of multiple trials in scenarios 2 and 3 were larger. Compared with the platform trial, there was a median (IQR) increase of 216.7% (202.2%-242.5%) in cumulative setup costs for scenario 2 and 391.1% (365.3%-437.9%) for scenario 3. In terms of total cost, there was a median (IQR) increase of 17.4% (12.1%-22.5%) for scenario 2 and 57.5% (43.1%-69.9%) for scenario 3. There was a median (IQR) increase in cumulative trial duration of 171.1% (158.3%-184.3%) for scenario 2 and 311.9% (282.0%-349.1%) for scenario 3. Cost and time reductions in the platform trial were observed in both the initial and subsequently evaluated interventions.

CONCLUSIONS AND RELEVANCE: Although setting up platform trials can take longer and be costly, the findings of this study suggest that having a single infrastructure can improve efficiencies with respect to costs and efforts.

PMID:35819785 | DOI:10.1001/jamanetworkopen.2022.21140

Ir J Med Sci. 2022 Jul 11. doi: 10.1007/s11845-022-03075-x. Online ahead of print.

ABSTRACT

BACKGROUND: Apatinib, a small molecule targeting VEGFR2, is commonly used for advanced gastric cancer treatment. This prospective cohort study further investigated the efficacy and safety of neoadjuvant apatinib plus chemotherapy in locally advanced gastric carcinoma patients.

METHODS: Ninety-six locally advanced gastric carcinoma patients were divided into the apatinib plus chemotherapy group (N = 45) and chemotherapy group (N = 51) according to their chosen treatment. Apatinib was administered (375 mg/day), and S-1 plus oxaliplatin (SOX) or oxaliplatin plus capecitabine (CapOx) was given as chemotherapy, for 3 cycles with 3 weeks a cycle before surgery.

RESULTS: The objective response rate (62.2% vs. 37.3%, P = 0.015) and pathological response grade (P = 0.011) were better; meanwhile, the tumor-resection rate (95.6% vs. 84.3%, P = 0.143) and pathological complete response rate (23.3% vs. 9.3%, P = 0.080) exhibited increasing trends (without statistical significance) in the apatinib plus chemotherapy group compared with the chemotherapy group. Additionally, the apatinib plus chemotherapy group achieved prolonged disease-free survival (DFS) (P = 0.019) and overall survival (OS) (P = 0.047) compared with the chemotherapy group. After adjusted by multivariate Cox’s regression analysis, neoadjuvant apatinib plus chemotherapy was still superior to chemotherapy regarding DFS (hazard ratio (HR): 0.277, P = 0.014) and OS (HR: 0.316, P = 0.038). Notably, the incidences of adverse events between the two groups were not different (P > 0.050). Moreover, the most common adverse events of neoadjuvant apatinib plus chemotherapy were leukopenia (42.2%), fatigue (37.8%), hypertension (37.8%), and anemia (31.1%).

CONCLUSION: Neoadjuvant apatinib plus chemotherapy realizes better clinical response, pathological response, survival profile, and non-inferior safety profile compared to chemotherapy in locally advanced gastric carcinoma.

PMID:35819743 | DOI:10.1007/s11845-022-03075-x

Oral Radiol. 2022 Jul 11. doi: 10.1007/s11282-022-00637-8. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare the crown and root metric properties of two- and single-rooted/multi-canal mandibular canines (MnCn) with single-rooted/single-canal MnCn.

METHODS: Cone-beam computed tomography images of 1000 patients (500 women and 500 men) with both right and left MnCn were analyzed. First, the root and canal morphologies of all teeth were examined. Then, the teeth were divided into three groups; (a) 2-rooted, (b) 1-rooted and multi-canals, (c) 1-rooted and single-canal. Crown lengths/sizes and tooth lengths were compared between the three groups. Statistical analyses were performed using Chi-square, one-way ANOVA, Welch, post hoc pairwise comparison, and independent sample t-tests. The significance level was set at 5%.

RESULTS: Of all the teeth, 2.35% were 2-rooted, and 6.3% were 1-rooted/multi-canal. The frequency of double roots was higher in women (p < 0.05). Double-rooted teeth had longer crown lengths but shorter tooth lengths than single-rooted teeth (p < 0.05). In 2-rooted teeth, buccal and lingual root lengths were similar, root bifurcation levels were mostly at the mid-root, and the mean distance of the bifurcation points of the canals to the cemento-enamel junction was 4.09 mm. Double-rooted teeth were mostly observed unilaterally.

CONCLUSIONS: Since 2-rooted MnCn do not differ significantly from other teeth in terms of crown sizes, it is not possible to differentiate between single- vs. double-rooted MnCn based on clinical examination.

PMID:35819742 | DOI:10.1007/s11282-022-00637-8

Int Ophthalmol. 2022 Jul 12. doi: 10.1007/s10792-022-02402-6. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the effect of intranasal mometasone furoate (INMF) on short-term intraocular pressure (IOP) alterations in children with allergic rhinitis (AR).

METHODS: Children diagnosed with AR and to whom INMF nasal spray had been firstly prescribed were enrolled. Cases with any ocular diseases except for refractive errors were excluded. Complete ophthalmologic examinations including IOP measurements using Tonopen XL were performed before the treatment as well as at the first and sixth weeks of follow-up. Demographics and ophthalmologic findings were noted and statistically analyzed.

RESULTS: Study population consisted of 62 right eyes of 62 children with a mean age of 8.55 ± 3.14 years. Of them, 29 were female (46.8%) and 33 were male (53.2%). Dilated fundoscopy revealed an enlarged Cup/Disc ratio in 12 eyes (19.4%). Family history of glaucoma was positive in 13 cases (21.0%). Mean best corrected visual acuity was found as 0.05 ± 0.08 logMAR. Initial IOP was 17.1 ± 2.3 mmHg; whereas it was measured as 18.2 ± 2.0 mmHg and 17.3 ± 2.1 mmHg at the first and sixth weeks of follow-up, respectively (p < 0.001). Both at the first and sixth weeks of follow-up, significant IOP rise was present in children with a positive family history of glaucoma (p < 0.001 and p = 0.003, respectively). Besides, increased IOP was found in participants with cupping revealed on fundoscopy at the first week of follow-up (p = 0.044).

CONCLUSION: Since children have greater risk for steroid-induced ocular hypertensive response than adults, ophthalmologic evaluation must be recommended in children receiving intranasal steroids.

PMID:35819739 | DOI:10.1007/s10792-022-02402-6

Neurosurg Rev. 2022 Jul 12. doi: 10.1007/s10143-022-01834-z. Online ahead of print.

ABSTRACT

Vestibular schwannoma (VS) is a benign tumor which develops in the internal auditory canal and the cerebellopontine angle, potentially diminishing hearing or balance. Most VS tumors arise from one of two vestibular branches: the superior or inferior vestibular nerve. Determining the specific nerve of origin could improve patient management in terms of preoperative counseling, treatment selection, and surgical decision-making and planning. The aim of this study was to introduce a preoperative testing protocol with high accuracy to determine the nerve branch of origin. The nerve of origin was predicted on the basis of preoperative vestibular evoked myogenic potentials (VEMPs), caloric stimulation test, and pure tone audiometry on 26 recipients. The acquired data were entered into a statistic scoring system developed to allocate the tumor origin. Finally, the nerve of origin was definitively determined intraoperatively. Receiver operating characteristic (ROC) curves analysis of preoperative testing data showed the possibility of predicting the branch of origin. In particular, ROC curve of combined VEMPs absence, nystagmus detectable at caloric stimulation, and PTA < 75 dB HL allowed to obtain high accuracy for inferior vestibular nerve implant of the tumor (area under the curve-AUC = 0.8788, p = 0.012). In 24 of 26 cases, the preoperatively predicted tumor origin was the same as the origin determined during surgery. Preoperative audiological and vestibular evaluation can predict the vestibular tumor branch of origin with high accuracy. Despite the necessity of larger prospective cohort studies, these findings may change preoperative approach, possible functional aspects, and counseling with the patients.

PMID:35819734 | DOI:10.1007/s10143-022-01834-z

J Exp Orthop. 2022 Jul 10;9(1):67. doi: 10.1186/s40634-022-00503-w.

ABSTRACT

PURPOSE: Intraoperative wound irrigation prior to closure during total joint arthroplasty (TJA) is an essential component of preventing infections and limiting health care system costs. While studies have shown the efficacy of dilute betadine in reducing infection risk, there remains concerns over its safety profile and theoretical inactivation by blood and serum. This study aims to compare infection and wound complications between chlorhexidine gluconate (CHG) and betadine lavage during TJA.

METHODS: All primary TJA between 2019-2021 were analyzed at a single institution, and periprosthetic joint infection (PJI), wound drainage, 30 and 90-day emergency room (ER) readmission due to wound complications, aseptic loosening, and revision surgery rate were compared between patients undergoing intraoperative CHG versus betadine lavage prior to closure. Baseline demographics were controlled, and multivariate logistic regression was performed to compare complication rates.

RESULTS: A total of 410 TJA, including 160 hip and 250 knee arthroplasties were included. Compared to the dilute betadine cohort, all TJA patients undergoing CHG lavage had a statistically significant lower 30 and 90-day emergency room readmission rate due to wound complications. Both hip and knee arthroplasty patients with CHG had a statistically significant lower rate of postoperative superficial drainage and dressing saturation at clinic follow-up, but only knee arthroplasty patients had significant decreased readmission rate for incisional wound vacuum placement and close inpatient monitoring of wound healing. Among all TJA, there was no significant association in the rate of PJI requiring return to the OR between groups.

CONCLUSIONS: Although betadine is cost-effective and has been shown to reduce PJI rates, there remains concerns in the literature over soft tissue toxicity and wound healing. This study suggests CHG may be as efficacious as dilute betadine in preventing PJI while also decreasing the risk of superficial drainage and wound complications needing unplanned ER visits during the acute postoperative period.

PMID:35819733 | DOI:10.1186/s40634-022-00503-w

Neurotherapeutics. 2022 Jul 11. doi: 10.1007/s13311-022-01271-2. Online ahead of print.

ABSTRACT

Thoughtful clinical trial design is critical for efficient therapeutic development, particularly in the field of amyotrophic lateral sclerosis (ALS), where trials often aim to detect modest treatment effects among a population with heterogeneous disease progression. Appropriate outcome measure selection is necessary for trials to provide decisive and informative results. Investigators must consider the outcome measure’s reliability, responsiveness to detect change when change has actually occurred, clinical relevance, and psychometric performance. ALS clinical trials can also be performed more efficiently by utilizing statistical enrichment techniques. Innovations in ALS prediction models allow for selection of participants with less heterogeneity in disease progression rates without requiring a lead-in period, or participants can be stratified according to predicted progression. Statistical enrichment can reduce the needed sample size and improve study power, but investigators must find a balance between optimizing statistical efficiency and retaining generalizability of study findings to the broader ALS population. Additional progress is still needed for biomarker development and validation to confirm target engagement in ALS treatment trials. Selection of an appropriate biofluid biomarker depends on the treatment mechanism of interest, and biomarker studies should be incorporated into early phase trials. Inclusion of patients with ALS as advisors and advocates can strengthen clinical trial design and study retention, but more engagement efforts are needed to improve diversity and equity in ALS research studies. Another challenge for ALS therapeutic development is identifying ways to respect patient autonomy and improve access to experimental treatment, something that is strongly desired by many patients with ALS and ALS advocacy organizations. Expanded access programs that run concurrently to well-designed and adequately powered randomized controlled trials may provide an opportunity to broaden access to promising therapeutics without compromising scientific integrity or rushing regulatory approval of therapies without adequate proof of efficacy.

PMID:35819713 | DOI:10.1007/s13311-022-01271-2

Int J Behav Med. 2022 Jul 11. doi: 10.1007/s12529-022-10113-6. Online ahead of print.

ABSTRACT

BACKGROUND: High sedentary time (ST) and low physical activity may increase cardiovascular risk, potentially though cardiac-autonomic dysregulation. This study investigated associations of statistically exchanging device-measured ST and physical activity with measures of cardiac-autonomic regulation in previously pregnant women.

METHOD: This cross-sectional, secondary analysis included 286 women (age = 32.6 ± 5.7 years; 68% white) measured 7-15 years after delivery. ST and light (LPA), moderate (MPA), vigorous (VPA), and moderate-to-vigorous (MVPA) intensity physical activity were measured by ActiGraph GT3X. ST was further partitioned into long (≥ 30 min) and short (< 30 min) bouts. MVPA was also partitioned into long (≥ 10 min) and short (< 10 min) bouts. Cardiac-autonomic regulation was assessed by heart rate variability (HRV) (resting heart rate, natural log transformed standard deviation of normal R-R intervals [lnSDNN], natural log-transformed root mean square of successive differences [lnRMSSD]) from a 5-min seated ECG. Progressive isotemporal substitution models adjusted for confounders. Sensitivity analyses removed women with related underlying medical conditions and who did not meet respiration rate criteria.

RESULTS: Initial analyses found no significant associations with HRV when exchanging 30 min of ST and physical activity (p > 0.05). Yet, replacing long- and short-bout ST with 30 min of long-bout MVPA yielded significantly higher (healthier) lnRMSSD (B = 0.063 ± 0.030 and B = 0.056 ± 0.027, respectively; both p < 0.05). Sensitivity analyses strengthened these associations and yielded further associations of higher lnSDNN and lnRMSSD when replacing 30 min of short-bout MVPA with equivalent amounts of long-bout MVPA (B = 0.074 ± 0.037 and B = 0.091 ± 0.046, respectively).

CONCLUSION: Replacing ST with long-bout MVPA is a potential strategy to improve cardiac-autonomic function in previously pregnant women.

PMID:35819720 | DOI:10.1007/s12529-022-10113-6

Indian J Pediatr. 2022 Jul 12. doi: 10.1007/s12098-022-04285-y. Online ahead of print.

NO ABSTRACT

PMID:35819703 | DOI:10.1007/s12098-022-04285-y