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Nevin Manimala Statistics

Time Interval Between the End of Neoadjuvant Therapy and Elective Resection of Locally Advanced Rectal Cancer in the CRONOS Study

JAMA Surg. 2023 Jul 12. doi: 10.1001/jamasurg.2023.2521. Online ahead of print.

ABSTRACT

IMPORTANCE: The treatment for extraperitoneal locally advanced rectal cancer (LARC) is neoadjuvant therapy (NAT) followed by total mesorectal excision (TME). Robust evidence on the optimal time interval between NAT completion and surgery is lacking.

OBJECTIVE: To assess the association of time interval between NAT completion and TME with short- and long-term outcomes. It was hypothesized that longer intervals increase the pathologic complete response (pCR) rate without increasing perioperative morbidity.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included patients with LARC from 6 referral centers who completed NAT and underwent TME between January 2005 and December 2020. The cohort was divided into 3 groups depending on the time interval between NAT completion and surgery: short (≤8 weeks), intermediate (>8 and ≤12 weeks), and long (>12 weeks). The median follow-up duration was 33 months. Data analyses were conducted from May 1, 2021, to May 31, 2022. The inverse probability of treatment weighting method was used to homogenize the analysis groups.

EXPOSURE: Long-course chemoradiotherapy or short-course radiotherapy with delayed surgery.

MAIN OUTCOME AND MEASURES: The primary outcome was pCR. Other histopathologic results, perioperative events, and survival outcomes constituted the secondary outcomes.

RESULTS: Among the 1506 patients, 908 were male (60.3%), and the median (IQR) age was 68.8 (59.4-76.5) years. The short-, intermediate-, and long-interval groups included 511 patients (33.9%), 797 patients (52.9%), and 198 patients (13.1%), respectively. The overall pCR was 17.2% (259 of 1506 patients; 95% CI, 15.4%-19.2%). When compared with the intermediate-interval group, no association was observed between time intervals and pCR in short-interval (odds ratio [OR], 0.74; 95% CI, 0.55-1.01) and long-interval (OR, 1.07; 95% CI, 0.73-1.61) groups. The long-interval group was significantly associated with lower risk of bad response (tumor regression grade [TRG] 2-3; OR, 0.47; 95% CI, 0.24-0.91), systemic recurrence (hazard ratio, 0.59; 95% CI, 0.36-0.96), higher conversion risk (OR, 3.14; 95% CI, 1.62-6.07), minor postoperative complications (OR, 1.43; 95% CI, 1.04-1.97), and incomplete mesorectum (OR, 1.89; 95% CI, 1.02-3.50) when compared with the intermediate-interval group.

CONCLUSIONS AND RELEVANCE: Time intervals longer than 12 weeks were associated with improved TRG and systemic recurrence but may increase surgical complexity and minor morbidity.

PMID:37436726 | DOI:10.1001/jamasurg.2023.2521

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Nevin Manimala Statistics

Changes in Intraset Repetitions in Reserve Prediction Accuracy During Six Weeks of Bench Press Training in Trained Men

Percept Mot Skills. 2023 Jul 12:315125231189098. doi: 10.1177/00315125231189098. Online ahead of print.

ABSTRACT

In this study we investigated whether the accuracy of intraset repetitions in reserve (RIR) predictions changes over time. Nine trained men completed three bench press training sessions per week for 6 weeks (following a 1-week familiarization). The final set of each session was performed until momentary muscular failure, with participants verbally indicating their perceived 4RIR and 1RIR. RIR prediction errors were calculated as raw differences (RIRDIFF), with positive and negative values indicating directionality, and absolute RIRDIFF (absolute value of raw RIRDIFF) indicating error scores. We constructed mixed effect models with time (i.e., session) and proximity to failure as fixed effects, repetitions as a covariate, and random intercepts per participant to account for repeated measures, with statistical significance set at p ≤ .05. We observed a significant main effect for time on raw RIRDIFF (p < .001), with an estimated marginal slope of -.077 repetitions, indicating a slight decrease in raw RIRDIFF over time. Further, the estimated marginal slope of repetitions was -.404 repetitions, indicating a decrease in raw RIRDIFF as more repetitions were performed. There were no significant effects on absolute RIRDIFF. Thus, RIR rating accuracy did not significantly improve over time, though there was a greater tendency to underestimate RIR in later sessions and during higher repetition sets.

PMID:37436724 | DOI:10.1177/00315125231189098

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Nevin Manimala Statistics

A framework for assessing interactions for risk stratification models: the example of ovarian cancer

J Natl Cancer Inst. 2023 Jul 12:djad137. doi: 10.1093/jnci/djad137. Online ahead of print.

ABSTRACT

Generally, risk stratification models for cancer use effect estimates from risk/protective factor analyses that have not assessed potential interactions between these exposures. We have developed a four-criterion framework for assessing interactions which includes statistical, qualitative, biological, and practical approaches. Using ovarian cancer, we present the application of the framework as this is an important step in developing more accurate risk stratification models. Using data from nine case-control studies in the Ovarian Cancer Association Consortium, we conducted a comprehensive analysis of interactions between 15 unequivocal risk/protective factors for ovarian cancer (including 14 non-genetic factors and a 36-variant polygenic score) with age and menopausal status. Pairwise interactions between the risk/protective factors were also assessed. We found that menopausal status modifies the association between endometriosis, first degree family history of ovarian cancer, breastfeeding, and depot-medroxyprogesterone acetate use and disease risk, highlighting the importance of understanding multiplicative interactions when developing risk prediction models.

PMID:37436712 | DOI:10.1093/jnci/djad137

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Nevin Manimala Statistics

Probing pocket depth reduction after non-surgical periodontal therapy: tooth-related factors

J Periodontol. 2023 Jul 12. doi: 10.1002/JPER.23-0285. Online ahead of print.

ABSTRACT

BACKGROUND: To investigate tooth-related factors that influence the reduction of pocket probing depths (PPD) after non-surgical periodontal therapy (NST).

MATERIALS AND METHODS: 746 patients with a total of 16825 teeth were included and retrospectively analyzed. PPD reduction after NST was correlated with the tooth-related factors; tooth type, number of roots, furcation involvement, vitality, mobility and type of restoration; using logistic multilevel regression for statistical analysis.

RESULTS: NST was able to reduce probing depth overall stratified probing depths (1.20±1.51mm p = <0.001). The reduction was significantly higher at teeth with higher probing depths at baseline. At pockets with PPD ≥ 6mm PPD remains high after NST. Tooth type, number of roots, furcation involvement, vitality, mobility and type of restoration are significantly and independently associated with the rate of pocket closure.

CONCLUSION: The tooth-related factors: tooth type, number of roots, furcation involvement, vitality, mobility and type of restoration had a significant and clinically relevant influence on phase I and II therapy. Considering these factors in advance may enhance the prediction of sites not responding adequately and the potential need for additional treatment, such as re-instrumentation or periodontal surgery, to ultimately achieve the therapy endpoints. This article is protected by copyright. All rights reserved.

PMID:37436696 | DOI:10.1002/JPER.23-0285

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Nevin Manimala Statistics

Evaluation of the effect of sodium-glucose cotransporter 2 inhibition on fracture risk: evidence from Mendelian randomization and genetic association study

J Bone Miner Res. 2023 Jul 12. doi: 10.1002/jbmr.4880. Online ahead of print.

ABSTRACT

This study aims to evaluate the causal effect of sodium-glucose cotransporter 2 (SGLT2) inhibition on bone mineral density (BMD), osteoporosis, and fracture risk using genetics. Two-sample Mendelian randomization (MR) analyses were performed utilizing two sets of genetic variants as instruments (six and two single-nucleotide polymorphisms [SNPs]) associated with SLC5A2 gene expression and glycated hemoglobin A1c levels. Summary statistics of BMD from the Genetic Factors for Osteoporosis (GEFOS) consortium (BMD for total body, n = 66,628; femoral neck, n = 32,735; lumbar spine, n = 28,498; forearm, n = 8,143) and osteoporosis (6,303 cases, 325,717 controls) and 13 types of fracture (≤ 17,690 cases, ≤ 328,382 controls) data from the FinnGen study were obtained. One-sample MR and genetic association analyses were conducted in UK Biobank using the individual-level data of heel BMD (n = 256,286) and incident osteoporosis (13,677 cases, 430,262 controls) and fracture (25,806 cases, 407,081 controls). Using six SNPs as the instrument, genetically proxied SGLT2 inhibition showed little evidence of association with BMD of total body, femoral neck, lumbar spine, and forearm (all P ≥ 0.077). Similar results were observed using two SNPs as instruments. Little evidence was found for the SGLT2 inhibition effect on osteoporosis (all P ≥ 0.112) or any 11 major types of fracture (all P ≥ 0.094), except for a nominal significance for fracture of lower leg (P = 0.049) and shoulder and upper arm (P = 0.029). One-sample MR and genetic association analysis showed that both the weighted genetic risk scores constructed from the six and two SNPs were not causally associated with heel BMD, osteoporosis, and fracture (all P ≥ 0.387). Therefore, this study does not support an effect of genetically proxied SGLT2 inhibition on fracture risk. This article is protected by copyright. All rights reserved.

PMID:37436694 | DOI:10.1002/jbmr.4880

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Nevin Manimala Statistics

Analysis of risk factors for early crestal bone loss in osseointegrated, submerged implants prior to restoration

J Periodontol. 2023 Jul 12. doi: 10.1002/JPER.23-0161. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence regarding the etiology behind bone loss around submerged, prosthetically non-loaded implants is still limited. The long-term stability and success of implants with early crestal bone loss (ECBL) especially when placed as two-stage implants, is uncertain. Hence, the aim of this retrospective study is to analyze the potential patient-level, tooth and implant related factors for ECBL around osseointegrated, submerged implants, prior to restoration as compared with healthy implants with no bone loss.

METHODS: Retrospective data was collected from patient electronic health records between 2015 and 2022. Control sites included healthy implants with no bone loss and test sites included implants with ECBL, both of which were submerged. Patient, tooth and implant level data was collected. ECBL was assessed using peri-apical radiographs obtained during implant placement and second-stage surgeries. Generalized estimating equation logistic regression models were used to account for multiple implants within patients.

RESULTS: The total number of implants included in the study was 200 from 120 patients. Lack of supportive periodontal therapy (SPT) was shown to have nearly five-times higher risk of developing ECBL and was statistically significant (p < 0.05). Guided bone regeneration (GBR) procedures prior to implant placement had a protective effect with an odds ratio of 0.29 (p < 0.05).

CONCLUSIONS: Lack of SPT was significantly associated with ECBL, while sites that received GBR procedures prior to implant placement were less likely to exhibit ECBL. Our results underscore the importance periodontal treatment and SPT for peri-implant health, even when the implants are submerged and unrestored. This article is protected by copyright. All rights reserved.

PMID:37436693 | DOI:10.1002/JPER.23-0161

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Nevin Manimala Statistics

Significance of Anti-COVID-IgA antibody response in COVID-19 breakthrough infection in vaccinated patients – a single-centered study from Pakistan

Immunol Res. 2023 Jul 12. doi: 10.1007/s12026-023-09407-y. Online ahead of print.

ABSTRACT

An increasing number of breakthrough-COVID-19-vaccinated individuals are being reported across the world. Humoral immunity has a crucial role in combating infection. In this study, we aimed to assess the importance of anti-COVID-S1-IgA and anti-COVID-NP-IgA in confirmed COVID-19 after vaccination (breakthrough infection group). Blood samples were collected from the breakthrough infection group within one week of breakthrough infections (n = 34). A second sample was also collected after 4 to 8 weeks (n = 27). Blood samples of healthy individuals (n = 29) were collected 4-8 weeks after the completion of vaccination. Anti-COVID-S1-IgA and anti-COVID-NP-IgA were detected by ELISA. Statistical analysis was performed using IBM SPSS version 24. In this study, we found a higher positivity rate for anti-COVID-S1-IgA in the breakthrough infection group (70% vs. 28% in healthy individuals). Anti-COVID-NP-IgA was not found in the control group (11% in the breakthrough infection group vs. 0 in healthy individuals). In the breakthrough-infected group, the positivity rate of anti-COVID-NP-IgA decreased significantly (median titers 16.9 IU/ml decreased to 4.2 IU/ml) p = 0.001), while anti-COVID-S1-IgA increased over a period of 4-8 weeks (9.35-16.35 IU/ml). Importantly, IgA response to both COVID-19 NP and S1 antigens was not found in 13 patients at initial testing. The findings of this study show that serum IgA may have a role both in breakthrough infections and also in the prevention of severe infection. Sluggish anti-COVID-19-IgA antibody response may be responsible for the occurrence of COVID-19 infection in breakthrough infection. On the other hand, more sustained anti-COVID-19-S1-IgA over a longer period of time may have a role in preventing these patients from severe infections and hospitalization. However, a study on a larger sample size including patients with severe disease after vaccination is required to prove this hypothesis. To the best of our knowledge, this is the first study reporting the importance of serum IgA in breakthrough-infected patients from our region.

PMID:37436673 | DOI:10.1007/s12026-023-09407-y

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Nevin Manimala Statistics

Evaluation of Darbandikhan Lake and its tributaries’ water quality in the Sulaymaniyah Province in Iraqi Kurdistan, using the water quality index model and multivariate statistical analysis

Environ Monit Assess. 2023 Jul 12;195(8):937. doi: 10.1007/s10661-023-11543-9.

ABSTRACT

This study evaluated the characteristics of the water in Darbandikhan Lake and its rivers in the Kurdistan Region of Iraq. For this purpose, 25 samples were collected seasonally and analysed for 36 physiochemical parameters. The proportions of physiochemical parameters exceeding the WHO standards in the samples with their highest exceedances were 9894% for Al, 198% for Mn, 40% for Pb, 1.6% for pH, 3250% for PO4, 11.8% for Sr, 155% for T.Alk, 7813% for turbidity, 1188% for Ti, 1033% for Tl and 1293% for V in the river water and 120% for Co, 74% for Cr, 4485% for Fe and 9% for K in the lake water. The pollution sources were designated by multivariate statistical analysis as being related to industrial and domestic waste, solid waste disposal, fertilisers and organic contamination from agricultural and natural sources. The water quality index (WQI) results were 22.3 to 721.3 for drinking, 13.9 to 86.2 for irrigation, 1.4 to 299.5 for livestock, 71.5 to 1754.4 for the textile industry, 20.7 to 237.9 for recreation and 64.6 to 1867.4 for aquatic life. The irrigation water quality index (IWQI) results were excellent for sodium adsorption ratio (SAR), and for the US salinity scale, all water samples fell into the medium salinity-low sodium category (C2-S1) in all seasons, except for all Chaqan River samples. The Tanjaro River sample in spring fell in the relatively high salinity-low sodium category (C3-S1), excellent and good for sodium percentage (Na%), suitable to moderate for permeability index (PI%), suitable to unsuitable for magnesium hazard percentage (MH%), suitable for Kelly Index (KI) and safe to unsuitable for residual sodium carbonates (RSC). The Sirwan River, Tanjaro River and Zmkan River took first to third place in both the annual average pollution share ratio and the discharge. While the Zalm River ranked fourth in discharge and fifth in pollution share ratio, the Chaqan River was the reverse. The highest pollution share ratio was 64.3 for the Sirwan River in summer, and the lowest was 0.7 for the Zalm River in autumn.

PMID:37436670 | DOI:10.1007/s10661-023-11543-9

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Nevin Manimala Statistics

Religious Beliefs Shaping Health Care and Transforming Health Concepts: The Case of Shanghai

J Relig Health. 2023 Jul 12. doi: 10.1007/s10943-023-01864-x. Online ahead of print.

ABSTRACT

This study examines the connection between health and religious beliefs in modern Chinese society and builds a model reimagining the conception of health. The study draws on interviews with 108 patients (52 were women and 56 were men) at Huashan Hospital (Shanghai City, China). The survey ran between May 10 and May 14, 2021. More than 50% of female and male respondents reported having religious beliefs. Most acknowledged the crucial role of faith and religious beliefs in overcoming treatment challenges and alleviating patient suffering. The role of faith and religious beliefs in physical/mental treatment and health maintenance received the highest average percent positive score among female respondents. According to the multiple regression results of demographic parameters (age, ethnicity, gender, education, and urban or rural residence), only gender had a statistically significant effect on the impact of religious beliefs on health care attitudes. The proposed model builds on the Confucian concept of Ren (humanity), which refers to a harmonious relationship between people within a family or society bound by specific rules. The results of this study can help expand awareness about religion and its role in healthcare as a means to support patients’ spiritual and physical health.

PMID:37436667 | DOI:10.1007/s10943-023-01864-x

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Nevin Manimala Statistics

Fourteen-year Clinical Performance of a HEMA-free One-step Self-etch Adhesive in Non-carious Cervical Lesions

J Adhes Dent. 2023 Jul 12;25(1):147-158. doi: 10.3290/j.jad.b4208859.

ABSTRACT

PURPOSE: This randomized controlled trial aimed to evaluate the 14-year clinical performance of a HEMA-free 1-step self-etch adhesive (1SEa) compared with that of a 3-step etch-and-rinse adhesive (3E&Ra).

MATERIALS AND METHODS: 267 non-carious cervical lesions in 52 patients were restored with the microhybrid composite Gradia Direct (GC), bonded in random order either with the HEMA-free 1SEa G-Bond (GB; GC) or the 3E&Ra Optibond FL (OFL; Kerr), which is considered the gold-standard E&Ra (control). The restorations were followed over 14 years for retention, marginal adaptation and discoloration, and caries occurrence. Statistical analysis involved a logistic regression model with generalized estimating equations (2-way GEE model).

RESULTS: The patient recall rate at 14 years was 63%. In total, 79 restorations (39 GB, 40 OFL) failed because of retention loss (GB: 19.4%, OFL: 19.6%), severe marginal defects, discoloration and/or caries (GB: 21.7%; OFL: 22.5%). The overall clinical success rate was 58.9% and 57.9% for GB and OFL, respectively. The number of restorations with an unacceptable marginal defect (GB: 14.5%; OFL: 19.2%) and deep marginal discoloration (GB: 18.2%; OFL: 13.2%) increased during the last 5 years. No significant difference in overall clinical performance was recorded between the two adhesives (p > 0.05). Changes in the medical health of some patients and recurrence of abrasion/erosion/abfraction increased the failure rate and retention rate.

CONCLUSION: After 14 years, restorations bonded with the HEMA-free 1SEa performed as well as those bonded with the 3E&Ra gold standard. Unacceptable marginal deterioration was the main reason for failure, followed by loss of retention.

PMID:37435814 | DOI:10.3290/j.jad.b4208859