Categories
Nevin Manimala Statistics

Inverse publication reporting bias favouring null, negative results

BMJ Evid Based Med. 2023 Jun 14:bmjebm-2023-112292. doi: 10.1136/bmjebm-2023-112292. Online ahead of print.

NO ABSTRACT

PMID:37315987 | DOI:10.1136/bmjebm-2023-112292

Categories
Nevin Manimala Statistics

Effectiveness of GRACE risk score in patients admitted to hospital with non-ST elevation acute coronary syndrome (UKGRIS): parallel group cluster randomised controlled trial

BMJ. 2023 Jun 14;381:e073843. doi: 10.1136/bmj-2022-073843.

ABSTRACT

OBJECTIVE: To determine the effectiveness of risk stratification using the Global Registry of Acute Coronary Events (GRACE) risk score (GRS) for patients presenting to hospital with suspected non-ST elevation acute coronary syndrome.

DESIGN: Parallel group cluster randomised controlled trial.

SETTING: Patients presenting with suspected non-ST elevation acute coronary syndrome to 42 hospitals in England between 9 March 2017 and 30 December 2019.

PARTICIPANTS: Patients aged ≥18 years with a minimum follow-up of 12 months.

INTERVENTION: Hospitals were randomised (1:1) to patient management by standard care or according to the GRS and associated guidelines.

MAIN OUTCOME MEASURES: Primary outcome measures were use of guideline recommended management and time to the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospital admission, and readmission for cardiovascular event. Secondary measures included the duration of hospital stay, EQ-5D-5L (five domain, five level version of the EuroQoL index), and the composite endpoint components.

RESULTS: 3050 participants (1440 GRS, 1610 standard care) were recruited in 38 UK clusters (20 GRS, 18 standard care). The mean age was 65.7 years (standard deviation 12), 69% were male, and the mean baseline GRACE scores were 119.5 (standard deviation 31.4) and 125.7 (34.4) for GRS and standard care, respectively. The uptake of guideline recommended processes was 77.3% for GRS and 75.3% for standard care (odds ratio 1.16, 95% confidence interval 0.70 to 1.92, P=0.56). The time to the first composite cardiac event was not significantly improved by the GRS (hazard ratio 0.89, 95% confidence interval 0.68 to 1.16, P=0.37). Baseline adjusted EQ-5D-5L utility at 12 months (difference -0.01, 95% confidence interval -0.06 to 0.04) and the duration of hospital admission within 12 months (mean 11.2 days, standard deviation 18 days v 11.8 days, 19 days) were similar for GRS and standard care.

CONCLUSIONS: In adults presenting to hospital with suspected non-ST elevation acute coronary syndrome, the GRS did not improve adherence to guideline recommended management or reduce cardiovascular events at 12 months.

TRIAL REGISTRATION: ISRCTN 29731761.

PMID:37315959 | DOI:10.1136/bmj-2022-073843

Categories
Nevin Manimala Statistics

Relative sparsity for medical decision problems

Stat Med. 2023 Jun 14. doi: 10.1002/sim.9755. Online ahead of print.

ABSTRACT

Existing statistical methods can estimate a policy, or a mapping from covariates to decisions, which can then instruct decision makers (eg, whether to administer hypotension treatment based on covariates blood pressure and heart rate). There is great interest in using such data-driven policies in healthcare. However, it is often important to explain to the healthcare provider, and to the patient, how a new policy differs from the current standard of care. This end is facilitated if one can pinpoint the aspects of the policy (ie, the parameters for blood pressure and heart rate) that change when moving from the standard of care to the new, suggested policy. To this end, we adapt ideas from Trust Region Policy Optimization (TRPO). In our work, however, unlike in TRPO, the difference between the suggested policy and standard of care is required to be sparse, aiding with interpretability. This yields “relative sparsity,” where, as a function of a tuning parameter, λ $$ lambda $$ , we can approximately control the number of parameters in our suggested policy that differ from their counterparts in the standard of care (eg, heart rate only). We propose a criterion for selecting λ $$ lambda $$ , perform simulations, and illustrate our method with a real, observational healthcare dataset, deriving a policy that is easy to explain in the context of the current standard of care. Our work promotes the adoption of data-driven decision aids, which have great potential to improve health outcomes.

PMID:37315949 | DOI:10.1002/sim.9755

Categories
Nevin Manimala Statistics

Healthcare center clustering for Cox’s proportional hazards model by fusion penalty

Stat Med. 2023 Jun 14. doi: 10.1002/sim.9825. Online ahead of print.

ABSTRACT

There has been growing research interest in developing methodology to evaluate healthcare centers’ performance with respect to patient outcomes. Conventional assessments can be conducted using fixed or random effects models, as seen in provider profiling. We propose a new method, using fusion penalty to cluster healthcare centers with respect to a survival outcome. Without any prior knowledge of the grouping information, the new method provides a desirable data-driven approach for automatically clustering healthcare centers into distinct groups based on their performance. An efficient alternating direction method of multipliers algorithm is developed to implement the proposed method. The validity of our approach is demonstrated through simulation studies, and its practical application is illustrated by analyzing data from the national kidney transplant registry.

PMID:37315935 | DOI:10.1002/sim.9825

Categories
Nevin Manimala Statistics

Impact of High-Fidelity Microvascular Surgery Simulation on Resident Training

J Reconstr Microsurg. 2023 Jun 14. doi: 10.1055/a-2110-0271. Online ahead of print.

ABSTRACT

Background Microsurgery requires a high level of skill achieved only through repeated practice. With duty-hour restrictions and supervision requirements, trainees require more opportunities for practice outside the operating room. Studies show simulation training improves knowledge and skills. While numerous microvascular simulation models exist, virtually all lack the combination of human tissue and pulsatile flow. Methods The authors utilized a novel simulation platform incorporating cryopreserved human vein and a pulsatile flow circuit for microsurgery training at two academic centers. Subjects performed a standardized simulated microvascular anastomosis and repeated this task at subsequent training sessions. Each session was evaluated using pre and post-simulation surveys, standardized assessment forms and the time required to complete each anastomosis. Outcomes of interest include change in self-reported confidence scores, skill assessment scores and time to complete the task. Results In total 36 simulation sessions were recorded including 21 first attempts and 15 second attempts. Pre and post-simulation survey data across multiple attempts demonstrated a statistically significant increase in self-reported confidence scores. Time to complete the simulation and skill assessment scores improved with multiple attempts, however, these findings were not statistically significant. Subjects unanimously reported on post-simulation surveys that the simulation was beneficial in improving their skills and confidence. Conclusion The combination of human tissue and pulsatile flow results in a simulation experience that approaches the level of realism achieved with live-animal models. This allows plastic surgery residents to improve microsurgical skills and increase confidence without the need for expensive animal labs or any undue risk to patients.

PMID:37315933 | DOI:10.1055/a-2110-0271

Categories
Nevin Manimala Statistics

Influence of pigment Solutions on color stability and surface properties in low-shrinkage and conventional composites

Acta Odontol Latinoam. 2023 Apr 29;36(1):58-65. doi: 10.54589/aol.36/1/58.

ABSTRACT

Color stability is among the most frequent causes of restoration failures, and influences surface properties.

AIM: The aim of this study was to investigate the influence of pigment solutions on low-shrinkage and conventional composites regarding changes in the physical properties of composite surfaces.

MATERIALS AND METHOD: Specimens of four composites (Filtek Z350 XT, Point 4, N’Durance and Venus Diamond) were randomly distributed into three groups to be submitted to each of three pigment solutions (red wine, tomato sauce and coffee) in fifteen-minute daily cycles, for twenty-eight days. There were 12 groups altogether (n = 10). Color, surface roughness and hardness tests were performed. Statistical analysis includedAnalysis of variance (ANOVA) and Tukey’s significance test (a = 0.05).

RESULTS: Color changes caused by the solutions did not differ significantly among Filtek Z350 XT, Venus Diamond and N’Durance. Hardness decreased significantly in Filtek Z350 XT and Venus Diamond after chemical challenge with each solution. For the composite independent factor, roughness was highest in Venus Diamond, followed by Filtek Z350 XT, Point 4 and N’Durance.

CONCLUSIONS: Treatment with different pigment solutions (red wine, tomato sauce or coffee) increased stainability and decreased hardness of both low-shrinkage and conventional composites, while roughness was unaffected.

PMID:37315327 | DOI:10.54589/aol.36/1/58

Categories
Nevin Manimala Statistics

Effect of photopolymerization time on the microhardness of resin cement beneath feldspathic ceramic

Acta Odontol Latinoam. 2023 Apr 29;36(1):40-46. doi: 10.54589/aol.36/1/40.

ABSTRACT

During ceramic veneer luting, resin cement polymerization is performed with interposition of the dental ceramic.

AIM: To evaluate how and how much the photoactivation time affects the Vickers hardness of resin-based cements with interposed ceramic.

MATERIALS AND METHOD: A total 24 specimens H mm in diameter and 1 mm thick were made from Paracore White Coltene (PC), Densell Resin Duo Cement (DC), 3MRelyX Veneer (RX) and Coltene Fill Up! (FU), interposing VitablockMarkII (Vita Zahnfabrik) feldspathic ceramic 0.6 mm thick during photoactivation. The materials were polymerized using 100% and 25% of the times indicated by the manufacturers with a Coltolux LED ((Coltene) light with intensity 1200 mW/cm2. Each polymerization time group consisted of three specimens of each material, which were stored dry in darkness at 37 °C for 7 days. Three Vickers microhardness measurements were made on the top and bottom surfaces of each specimen using a Vickers Future Tech FM300 microhardness tester (300 g, 5 s). The values were averaged, and the bottom/top ratios calculated. Results were analyzed by ANOVA. (p<0.05) complemented with multiple comparisons using Tukey’s test (p<0.05).

RESULTS: Different photoactivation times were found to have a significant effect on hardness values of the cements evaluated, with significant differences between some of the cements. No statistically significant difference was found for the effect of photoactivation time on bottom/top microhardness ratio in those materials.

CONCLUSIONS: Under the experimental conditions employed, it can be concluded that photopolymerization for shorter times and the interposition of restorative material significantly affectpolymerization quality as evaluated by microhardness, but the bottom/top ratio was unaffected by differences in polymerization time.

PMID:37315311 | DOI:10.54589/aol.36/1/40

Categories
Nevin Manimala Statistics

Effect of Brachytherapy With External Beam Radiation Therapy Versus Brachytherapy Alone for Intermediate-Risk Prostate Cancer: NRG Oncology RTOG 0232 Randomized Clinical Trial

J Clin Oncol. 2023 Jun 14:JCO2201856. doi: 10.1200/JCO.22.01856. Online ahead of print.

ABSTRACT

PURPOSE: To determine whether addition of external beam radiation therapy (EBRT) to brachytherapy (BT) (COMBO) compared with BT alone would improve 5-year freedom from progression (FFP) in intermediate-risk prostate cancer.

METHODS: Men with prostate cancer stage cT1c-T2bN0M0, Gleason Score (GS) 2-6 and prostate-specific antigen (PSA) 10-20 or GS 7, and PSA < 10 were eligible. The COMBO arm was EBRT (45 Gy in 25 fractions) to prostate and seminal vesicles followed by BT prostate boost (110 Gy if 125-Iodine, 100 Gy if 103-Pd). BT arm was delivered to prostate only (145 Gy if 125-Iodine, 125 Gy if 103-Pd). The primary end point was FFP: PSA failure (American Society for Therapeutic Radiology and Oncology [ASTRO] or Phoenix definitions), local failure, distant failure, or death.

RESULTS: Five hundred eighty-eight men were randomly assigned; 579 were eligible: 287 and 292 in COMBO and BT arms, respectively. The median age was 67 years; 89.1% had PSA < 10 ng/mL, 89.1% had GS 7, and 66.7% had T1 disease. There were no differences in FFP. The 5-year FFP-ASTRO (95% CI) was 85.6% (81.4 to 89.7) with COMBO compared with 82.7% (78.3 to 87.1) with BT (odds ratio [OR], 0.80; 95% CI, 0.51 to 1.26; Greenwood T P = .18). The 5-year FFP-Phoenix was 88.0% (84.2 to 91.9) with COMBO compared with 85.5% (81.3 to 89.6) with BT (OR, 0.80; 95% CI, 0.49 to 1.30; Greenwood T P = .19). There were no differences in the rates of genitourinary (GU) or GI acute toxicities. The 5-year cumulative incidence for late GU/GI grade 2+ toxicity is 42.8% (37.0 to 48.6) for COMBO compared with 25.8% (20.9 to 31.0) for BT (P < .0001). The 5-year cumulative incidence for late GU/GI grade 3+ toxicity is 8.2% (5.4 to 11.8) compared with 3.8% (2.0 to 6.5; P = .006).

CONCLUSION: Compared with BT, COMBO did not improve FFP for prostate cancer but caused greater toxicity. BT alone can be considered as a standard treatment for men with intermediate-risk prostate cancer.

PMID:37315297 | DOI:10.1200/JCO.22.01856

Categories
Nevin Manimala Statistics

Sex and Tumor-Site Differences in the Association of Alcohol Intake With the Risk of Early-Onset Colorectal Cancer

J Clin Oncol. 2023 Jun 14:JCO2201895. doi: 10.1200/JCO.22.01895. Online ahead of print.

ABSTRACT

PURPOSE: Given the increasing incidence of early-onset colorectal cancer (CRC; diagnosed before age 50 years) worldwide, it is important to identify modifiable risk factors. We investigated whether alcohol consumption in the young population correlated with an increased early-onset CRC risk that differed by tumor location and sex.

PATIENTS AND METHODS: We investigated the association between average daily alcohol consumption and the risk of early-onset CRC among 5,666,576 individuals age 20-49 years using data from the Korean National Health Insurance Service (2009-2019). Alcohol consumption levels of nondrinker, light (reference), moderate, and heavy drinker were defined as 0, <10, 10 to <30, and ≥30 g/d for men and 0, <10, 10 to <20, and ≥20 g/d for women, respectively. Multivariate Cox proportional hazards models were used to estimate adjusted hazard ratios (aHRs) with 95% CIs.

RESULTS: We identified 8,314 incident early-onset CRC cases during the follow-up period. Moderate and heavy drinkers showed an increased risk of early-onset CRC compared with light drinkers (aHR, 1.09; 95% CI, 1.02 to 1.16 and aHR, 1.20; 95% CI, 1.11 to 1.29, respectively). Subgroup analysis by tumor location showed positive dose-response significance for early-onset distal colon and rectal cancers, but not for proximal colon cancer. The dose-response association between drinking frequency and risk of early-onset CRC was significant, with a 7%, 14%, and 27% increased risk for 1-2, 3-4, and ≥5 d/wk compared with nondrinkers, respectively.

CONCLUSION: Excessive alcohol consumption increases the risk of CRC onset before age 50 years. Thus, effective interventions are required to discourage alcohol consumption among young people and to tailor CRC screening approaches for high-risk individuals.

PMID:37315287 | DOI:10.1200/JCO.22.01895

Categories
Nevin Manimala Statistics

Risk factors for the development of psychotic disorders associated with synthetic cathinones usage

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):153-159. doi: 10.17116/jnevro2023123051153.

ABSTRACT

OBJECTIVE: To identify risk factors and predictors of the development of psychotic disorders in patients who used synthetic cathinones (SKat).

MATERIAL AND METHODS: The study included 176 patients who used SKat, which was toxicologically confirmed. One hundred and eleven (63.1%) were male and 65 (36.9%) were female. The median age was 27 years (22-32 (Q1-Q3)). Patients were divided into main and control groups depending on the presence of a psychotic disorder. The main group (those who developed psychosis) consisted of 98 patients, the control groupincluded 78 participants. Clinical-psychopathological, parametric and statistical methods were performed to study predictors and risk factors for the development of psychotic disorders associated with the use of SKat.

RESULTS: The study established factors influencing the incidence of psychosis. Older patients were more likely to develop psychosis (p=0.002). Patients who used SKat for more than 21 consecutive days developed psychoses more often (p=0.048). The use of α-pvp (α-pyrrolidinovalerophenone, alpha-pvp) more often led to the development of psychosis (p<0.001). Patients undergoing rehabilitation were less likely to experience the development of psychosis (p=0.009). The resulting regression model is statistically significant (p<0.001). Based on the value of the Nigelkirk coefficient of determination, the model explains 30.9% of the observed group variance. It has been established that the combination of the following factors increases the chances of developing psychosis: female gender, age, duration of daily use, the presence of signs of mental infantilism, fear of the dark in childhood. In turn, the experience of undergoing rehabilitation and any pathology of the mother’s pregnancy reduces the risk of psychosis.

CONCLUSION: The results are consistent with other studies of substance-induced psychoses. The observed patterns demonstrate that this is a special group of disorders that requires the attention of specialists. The results allow us to outline the field for further study, and may also be useful in the development of therapeutic and preventive recommendations.

PMID:37315255 | DOI:10.17116/jnevro2023123051153