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Nevin Manimala Statistics

Comparison of coronary CT angiography-based and invasive coronary angiography-based quantitative flow ratio for functional assessment of coronary stenosis: A multicenter retrospective analysis

J Cardiovasc Comput Tomogr. 2022 Jun 30:S1934-5925(22)00100-9. doi: 10.1016/j.jcct.2022.06.002. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the diagnostic performance of coronary CT angiography (CTA)-based quantitative flow ratio (QFR), namely CT-QFR, and compare it with invasive coronary angiography (ICA)-based Murray law QFR (μQFR), using fractional flow reserve (FFR) as the reference standard.

METHODS: Patients who underwent coronary CTA, ICA and pressure wire-based FFR assessment within two months were retrospectively analyzed. CT-QFR and μQFR were computed in blinded fashion and compared with FFR, all applying the same cut-off value of ≤0.80 to identify hemodynamically significant stenosis.

RESULTS: Paired comparison between CT-QFR and μQFR was performed in 191 vessels from 167 patients. Average FFR was 0.81 ​± ​0.10 and 42.4% vessels had an FFR ≤0.80. CT-QFR had a slightly lower correlation with FFR compared with μQFR, although statistically non-significant (r ​= ​0.87 versus 0.90, p ​= ​0.110). The vessel-level diagnostic performance of CT-QFR was slightly lower but without statistical significance than μQFR (AUC ​= ​0.94 versus 0.97, difference: -0.03 [95%CI: -0.00-0.06], p ​= ​0.095), and substantially higher than diameter stenosis by CTA (AUC difference: 0.17 [95%CI: -0.10-0.23], p ​< ​0.001). The patient-level diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio for CT-QFR to identify FFR value ​≤ ​0.80 was 88%, 90%, 86%, 86%, 91%, 6.59 and 0.12, respectively. The diagnostic accuracy of CT-QFR was 84% in extensively calcified lesions, while in vessels with no or less calcification, CT-QFR showed a comparable diagnostic accuracy with μQFR (91% versus 92%, p ​= ​0.595). Intra- and inter-observer variability in CT-QFR analysis was -0.00 ​± ​0.04 and 0.00 ​± ​0.04, respectively.

CONCLUSIONS: Performance in diagnosis of hemodynamically significant coronary stenosis by CT-QFR was slightly lower but without statistical significance than μQFR, and substantially higher than CTA-derived diameter stenosis. Extensively calcified lesions reduced the diagnostic accuracy of CT-QFR.

PMID:35811245 | DOI:10.1016/j.jcct.2022.06.002

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Nevin Manimala Statistics

Comparative analysis of three vs. four cycles of neoadjuvant gemcitabine and cisplatin for muscle invasive bladder cancer

Urol Oncol. 2022 Jul 7:S1078-1439(22)00192-2. doi: 10.1016/j.urolonc.2022.05.023. Online ahead of print.

ABSTRACT

PURPOSE: Because the optimal number of cycles of neoadjuvant gemcitabine and cisplatin chemotherapy (GC) is unclear, we aimed to compare disease response and survival outcomes of patients receiving either 3 or 4 cycles of neoadjuvant GC for muscle-invasive bladder cancer (MIBC).

METHODS: A total of 166 patients who were treated with neoadjuvant GC and radical cystectomy for clinical stage T2-4N0M0 were identified. Response and effectiveness of different cycle counts were assessed using downstaging (complete pathologic and partial pathologic response), cancer-specific survival (CSS), and overall survival (OS). Response and survival outcomes were examined with adjusted logistic regression and Cox regression models. Statistical significance was defined as P < 0.05.

RESULTS: Of 166 patients who received neoadjuvant GC, 107 (64.5%) received 3 cycles and 59 (35.5%) received 4 cycles. Age, insurance, comorbidity, tumor histology (pure urothelial carcinoma, urothelial with divergent differentiation, variant histology), and tumor stage were similar between the 2 treatment groups. Rates of complete response or any downstaging were similar between groups (21.5% and 40.2% in the 3-cycle group and 20.3% and 44.1% in the 4-cycle group, respectively). While disease response was similar (OR 1.03, 95% CI 0.43-2.45), both cancer-specific survival (HR 1.69, 95% CI 0.87-3.26) and overall survival (HR:1.88, 95% CI:1.02-3.48) were more favorable among patients managed with 4 cycles of neoadjuvant chemotherapy compared to those who received 3 cycles in adjusted models.

CONCLUSIONS: Our analysis demonstrated that survival outcomes tended to be better among patients who received 4 cycle of neoadjuvant GC compared to those treated with 3 cycles. Although potential benefits of omission of fourth cycle may include expedited time to surgery, reduced chemotherapy-associated toxicity, and lower treatment costs, continuation of treatment with a fourth cycle of neoadjuvant GC chemotherapy may benefit patients with muscle-invasive bladder cancer and further improve disease outcomes.

PMID:35811208 | DOI:10.1016/j.urolonc.2022.05.023

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Nevin Manimala Statistics

The relationship between erythema nodosum and prognosis in systemic sarcoidosis: a retrospective cohort study

An Bras Dermatol. 2022 Jul 7:S0365-0596(22)00111-8. doi: 10.1016/j.abd.2021.09.011. Online ahead of print.

ABSTRACT

BACKGROUND: Erythema Nodosum (EN) is the most common skin manifestation in sarcoidosis and has often been associated with a good prognosis.

OBJECTIVES: To compare the clinical characteristics and treatment-related features in patients with sarcoidosis according to whether or not EN was seen as a presenting symptom at the time of diagnosis.

METHODS: A 20-year single-center retrospective study was performed. The following two groups were identified: one group with EN as one of the presenting symptoms at the time of diagnosis of sarcoidosis (EN group) and a second group without EN as a presenting symptom at diagnosis (non-EN group). The clinical characteristics and treatment modalities were collected from the medical records.

RESULTS: A total of 122 patients (31 in the EN group, 91 in the non-EN group) were included. Radiological stages of pulmonary disease were significantly lower in the EN group. Articular involvement was more common in the EN group (p = 0.001), whereas other systemic organ involvements (p = 0.025), especially neurological involvement (p = 0.036), were significantly more common in the non-EN group. In the EN group, a higher percentage of patients were managed without systemic therapy (71.0% vs. 54.9%) and spontaneous remission was more frequent (25.0% vs. 14.1%), however, this wasn’t statistically significant.

STUDY LIMITATIONS: Retrospective design.

CONCLUSIONS: The lower radiological stage of pulmonary sarcoidosis and lower frequency of systemic organ involvement in patients with EN augment the prognostic value of EN highlighted in the literature. However, this study couldn’t confirm that the patients with EN would need less systemic therapy in the course of their disease.

PMID:35811196 | DOI:10.1016/j.abd.2021.09.011

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Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: A randomized trial

J Hand Ther. 2022 Jul 7:S0894-1130(22)00040-0. doi: 10.1016/j.jht.2022.03.009. Online ahead of print.

ABSTRACT

STUDY DESIGN: Randomized, interventional trial with 1 year follow-up.

INTRODUCTION: Though recommended, evidence is lacking to support specific exercises to stabilize and strengthen the first carpometacarpal (CMC) joint for cases of osteoarthritis (OA).

PURPOSE OF THE STUDY: To determine in a naturalistic setting, whether standard treatment plus a home exercise program (ST+HEP) is more effective than standard treatment (ST) alone in improving Quick Disabilities of Arm, Shoulder and Hand (qDASH) scores, and secondarily, in other patient-centered (pain, function) and clinical outcomes (range of motion, strength).

METHODS: A total of 190 patients from a hand therapy practice in northwestern PA were enrolled by informed consent and randomized into ST or ST+HEP groups. Average age was 60 years, most were female (78%) with sedentary occupations most common (36%). ST group received orthotic interventions, modalities, joint protection education and adaptive equipment recommendations, while the ST+HEP group received a home exercise program in addition to ST for 6-12 months. Follow-up occurred at 3, 6, and 12 months. Outcomes included grip strength, pinch strength, range of motion (ROM), qDASH, Patient Specific Functional Scale (PSFS) and pain ratings. At the 6 month mark, all subjects could change groups if desired. Efficacy data analysis included both parametric and non-parametric tests. The threshold for statistical significance was 0.05 and adjusted for multiple comparisons.

RESULTS: Repeated measures ANOVA failed to show a statistically significant difference in strength and ROM assessments between treatment groups over the 12 month follow-up (P ≥ .398). Differences between groups did not exceed 13%. Both the ST and ST+HEP groups evidenced improvement over time in most patient-focused assessments (P ≤ .011), including improvements exceeding reported clinically important differences in pain with activity and PSFS scores. Scores for these measures were similar at each follow-up period (P ≥ .080) in each group. The presence of CTS exerted no effect on outcomes; longer treatment time was weakly related to poorer qDASH and PSFS scores initially. Of those enrolled, 48% of subjects completed the study.

CONCLUSIONS: The addition of a high-frequency home exercise program did not improve clinical or patient-centered outcomes more so than standard care in our sample however, study limitations are numerous. Both groups had decreased pain with activity and improved PSFS scores, meeting the established minimally clinically important difference (MCID) of each at 6 and 12 months. Adherence with the home program was poor and/or unknown.

PMID:35811182 | DOI:10.1016/j.jht.2022.03.009

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Nevin Manimala Statistics

Prognostic role of perineural invasion in vulvar squamous cell carcinoma: A systematic review and meta-analysis

Eur J Surg Oncol. 2022 Jun 25:S0748-7983(22)00536-4. doi: 10.1016/j.ejso.2022.06.031. Online ahead of print.

ABSTRACT

The prognostic role of perineural invasion (PNI) in vulvar squamous cell carcinoma (VSCC) has not been fully established since few studies on this topic are currently available in the literature. In the present study, we conducted a systematic review and metanalysis of literature data in order to determine if PNI could be an independent prognostic predictor of patient’s survival in VSCC. Four electronic databases (PubMed, ISI Web of Science, Scopus and Google Scholar) were searched from their inception to December 2021 for all studies assessing the prognostic value of PNI in VSCC. Multivariate hazard ratios (HRs) for overall survival (OS), disease-specific survival (DSS), and progression-free survival (PFS) were pooled. Six studies with 1048 patients were included. PNI was significantly associated with decreased OS (HR = 2.687; p < 0.001), DSS (HR = 2.375; p = 0.014) and PFS (HR = 1.757; p = 0.001), with no statistical heterogeneity among studies and no significant risk of bias across studies. The present meta-analysis highlights that PNI is independently associated with unfavorable prognosis in patients with VSCC. Therefore, PNI should be included in the pathological report of VSCC and considered in combination with other risk factors as a possible criteria for prognostic assessment adjuvant treatment planning inclusion.

PMID:35811178 | DOI:10.1016/j.ejso.2022.06.031

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Nevin Manimala Statistics

Application of power analysis to determine the optimal reporting time frame for use in statewide trauma system quality reporting

Surgery. 2022 Jul 7:S0039-6060(22)00414-7. doi: 10.1016/j.surg.2022.05.028. Online ahead of print.

ABSTRACT

BACKGROUND: Meaningful reporting of quality metrics relies on detecting a statistical difference when a true difference in performance exists. Larger cohorts and longer time frames can produce higher rates of statistical differences. However, older data are less relevant when attempting to enact change in the clinical setting. The selection of time frames must reflect a balance between being too small (type II errors) and too long (stale data). We explored the use of power analysis to optimize time frame selection for trauma quality reporting.

METHODS: Using data from 22 Level III trauma centers, we tested for differences in 4 outcomes within 4 cohorts of patients. With bootstrapping, we calculated the power for rejecting the null hypothesis that no difference exists amongst the centers for different time frames. From the entire sample for each site, we simulated randomly generated datasets. Each simulated dataset was tested for whether a difference was observed from the average. Power was calculated as the percentage of simulated datasets where a difference was observed. This process was repeated for each outcome.

RESULTS: The power calculations for the 4 cohorts revealed that the optimal time frame for Level III trauma centers to assess whether a single site’s outcomes are different from the overall average was 2 years based on an 80% cutoff.

CONCLUSION: Power analysis with simulated datasets allows testing of different time frames to assess outcome differences. This type of analysis allows selection of an optimal time frame for benchmarking of Level III trauma center data.

PMID:35811165 | DOI:10.1016/j.surg.2022.05.028

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Time of day-dependent deviations in dynamic and static occlusion: A prospective clinical study

J Prosthet Dent. 2022 Jul 7:S0022-3913(22)00353-5. doi: 10.1016/j.prosdent.2022.05.025. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The registration of dental occlusion is essential for prosthodontic treatment. However, studies on time-dependent changes of static and dynamic occlusion that may affect definitive restorations are lacking.

PURPOSE: The purpose of this prospective clinical study was to use conventional and digital occlusal registration techniques to evaluate time-dependent fluctuations in static and dynamic occlusion.

MATERIAL AND METHODS: The static and dynamic occlusion of 19 healthy individuals (14 women and 5 men with a mean ±standard deviation age of 30.8 ±4.8 years) was examined 3 times a day using occlusal foil (12-μm occlusion foil) and a digital sensor (T-Scan III). The procedure was repeated after 14 days. The statistical analysis covered all registrations referencing the first measurement point to assess occurring differences, and changes per tooth and arch were determined (α=.05). Potential influencing factors were calculated by using mixed logistic regression. Marginal probabilities were calculated considering the registration technique and the time of measurement.

RESULTS: Significant differences were found between registered occlusal patterns and the different registration techniques. Occlusal changes per maxillary dental arch were observed with static foil registration (P<.001; 98.8%), left laterotrusion foil registration (P=.001; 29.6%), right laterotrusion foil registration (P=.001; 29.6%), static sensor registration (P<.001; 20.3%), left laterotrusion sensor registration (P=.001; 71.7%), and right laterotrusion sensor registration (P=.005; 67.7%). None of the techniques showed higher probabilities of occlusal changes at a given time of day with respect to time-dependent changes.

CONCLUSIONS: The study revealed that occlusion cannot be considered constant and that the topography and intensity of the contact points vary. Circadian occlusion variance can be assumed without preferring a specific time of the day. This differentiated view of occlusion as a changing system helps to clarify the challenge of dental restorations for both the patient and the practitioner.

PMID:35811164 | DOI:10.1016/j.prosdent.2022.05.025

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Industry support for dental implant research: A metatrend study of industry partnership in the development of new technologies

J Prosthet Dent. 2022 Jul 7:S0022-3913(22)00355-9. doi: 10.1016/j.prosdent.2022.05.026. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Industry needs scientific knowledge to develop new products and services, and their financial support to dental implant researchers translates into commercial products. Therefore, identifying the relevant factors for a successful industry partnership is important.

PURPOSE: The purpose of this study was to provide a 20-year bibliometric overview of industry-sponsored studies in implant dentistry to identify possible factors involved in industry partnership motivations.

MATERIAL AND METHODS: A hand search of 6 of the most established journals in the implant dentistry field was performed for articles published in 1999, 2004, 2009, 2014, and 2019. Information regarding the continent of origin of the corresponding author, interinstitute collaboration, type and topic of research, and the h-index of the corresponding author was recorded for each included article. Bivariate and multivariate logistic regression was used to determine statistical relationship between industry support and exploratory factors (α=.05).

RESULTS: A 6% increase in the chance of industry investment was observed over the years (odds ratio [OD]=1.06; P<.001). Studies from North America (OD=4.87; P<.001) and Europe (OD=3.13; P<.001) were more likely to receive industry funding. Data also revealed a direct relationship between the increasing number of institutions involved in the study and the probability of industry funding (OD=1.21; P<.001). Animal studies (OD=2.26; P<.001) about surgical procedures and prosthodontic topics (OD=1.40; P=.044) stood out for having greater industry support. Researchers with an h-index between 31 and 40 were more likely to receive industry financial support (OD=2.46; P=.001).

CONCLUSIONS: Industry support for dental implant research was closely aligned with the continent of origin, interinstitute collaboration, type and topic of research, and the h-index of the corresponding author.

PMID:35811163 | DOI:10.1016/j.prosdent.2022.05.026

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Nevin Manimala Statistics

Special considerations in randomized trials investigating neonatal surgical treatments

Semin Perinatol. 2022 Jun 10:151640. doi: 10.1016/j.semperi.2022.151640. Online ahead of print.

ABSTRACT

Randomized controlled trials (RCTs) are challenging, but are the studies most likely to change practice and benefit patients. RCTs investigating neonatal surgical therapies are rare. The Necrotizing Enterocolitis Surgery Trial (NEST) was the first surgical RCT conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN), and multiple lessons were learned. NEST was conducted over a 7.25-year enrollment period and the primary outcome was death or neurodevelopmental impairment (NDI) at 18-22 months corrected age. Surgical investigators designing clinical trials involving neonatal surgical treatments have many considerations to include, including how to study eligible but non-randomized patients, heterogeneity of treatment effect, use of frequentist and Bayesian analyses, assessment of generalizability, and anticipating criticisms during peer review. Surgeons are encouraged to embrace these challenges and seek innovative methods to acquire evidence that will be used to improve patient outcomes.

PMID:35811154 | DOI:10.1016/j.semperi.2022.151640

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Nevin Manimala Statistics

Characteristics of kangaroo-related motor vehicle crashes

Injury. 2022 Jun 10:S0020-1383(22)00419-3. doi: 10.1016/j.injury.2022.06.007. Online ahead of print.

ABSTRACT

BACKGROUND: Kangaroo-related motor vehicle collisions are common but there is limited literature on this topic. Drivers confronted by kangaroos may choose to swerve or to directly collide with the kangaroo. The effect of these differing crash mechanisms, along with the effect of vehicle type or time of day, has not yet been reported.

METHODS: A retrospective cohort study was performed, examining patients admitted to our tertiary trauma centre for kangaroo-related motor vehicle collisions between 2000 and 2020. Data on patient demographics, crash characteristics, and hospital stay were collected and analysed.

RESULTS: A total of 366 patients were included and were predominantly male (76%) with an median age of 40. Swerve crashes were more common (59%) than direct impact and swerving was a statistically significant predictor of reduced injury severity score on multivariable analysis (other significant factors were female sex and no rollover). Motor vehicle crashes and motorbike crashes had differing crash characteristics. Motor vehicle crashes were more likely the result of swerving, and swerving was less likely to cause ejection or require extrication but more likely to cause rollover. Motorbike crashes however, were more likely the result of head on collision and riders were more likely to be ejected from the vehicle, require extrication, or be involved in a rollover. In terms of time of day, there were more crashes at dawn and there was a trend towards higher injury severity score and length of stay for night-time crashes.

CONCLUSION: For kangaroo-related motor vehicle crashes, predictors of increased injury severity score on multivariable analysis were male sex, direct impact, and rollover. Motorbikes and motor vehicles had differing crash mechanisms and characteristics, as did night-time crashes when compared to daytime or twilight crashes.

LEVEL OF EVIDENCE: IV, prognostic.

PMID:35811153 | DOI:10.1016/j.injury.2022.06.007