Tag: statistics

Contemp Clin Trials. 2021 Mar 25:106368. doi: 10.1016/j.cct.2021.106368. Online ahead of print.

ABSTRACT

OBJECTIVES: COVID-19 pandemic caused several alarming challenges for clinical trials. On-site source data verification (SDV) in the multicenter clinical trial became difficult due to travel ban and social distancing. For multicenter clinical trials, centralized data monitoring is an efficient and cost-effective method of data monitoring. Centralized data monitoring reduces the risk of COVID-19 infections and provides additional capabilities compared to on-site monitoring. The key steps for on-site monitoring include identifying key risk factors and thresholds for the risk factors, developing a monitoring plan, following up the risk factors, and providing a management plan to mitigate the risk.

METHODS: For analysis purposes, we simulated data similar to our clinical trial data. We classified the data monitoring process into two groups, such as the Supervised analysis process, to follow each patient remotely by creating a dashboard and an Unsupervised analysis process to identify data discrepancy, data error, or data fraud. We conducted several risk-based statistical analysis techniques to avoid on-site source data verification to reduce time and cost, followed up with each patient remotely to maintain social distancing, and created a centralized data monitoring dashboard to ensure patient safety and maintain the data quality.

CONCLUSION: Data monitoring in clinical trials is a mandatory process. A risk-based centralized data review process is cost-effective and helpful to ignore on-site data monitoring at the time of the pandemic. We summarized how different statistical methods could be implemented and explained in SAS to identify various data error or fabrication issues in multicenter clinical trials.

PMID:33775899 | DOI:10.1016/j.cct.2021.106368

J Sport Health Sci. 2021 Mar 25:S2095-2546(21)00044-2. doi: 10.1016/j.jshs.2021.03.009. Online ahead of print.

ABSTRACT

BACKGROUND: An extraordinary long-term running performance may benefit from low dynamic loads and a high load-bearing tolerance. An extraordinary runner (age = 55 years, height = 1.81 m, mass = 92 kg) scheduled a marathon a day for 100 consecutive days. His running biomechanics and bone density were investigated to better understand successful long-term running in the master athlete.

METHODS: Overground running gait analysis and bone densitometry were conducted before the marathon-a-day challenge and near its completion. The case’s running biomechanics were compared pre-challenge to 31 runners who were matched by a similar foot strike pattern.

RESULTS: The case’s peak vertical loading rate (Δx̄ = -61.9 BW/s or -57%), peak vertical ground reaction force (Δx̄ = -0.38 BW or -15%), and peak braking force (Δx̄ = -0.118 BW or -31%) were remarkably lower (p < 0.05) than the control group at ∼3.3 m/s. The relatively low loading-related magnitudes were attributed to a remarkably high duty factor (0.41) at the evaluated speed. The foot strike angle of the marathoner (29.5°) was greater than that of the control group, affecting the peak vertical loading rate. Muscle powers in the lower extremity were also remarkably low in the case vs. controls: peak power of knee absorption (Δx̄ = -9.16 W/kg or -48%) and ankle generation (Δx̄ = -3.17 W/kg or -30%). The bone mineral density increased to 1.245 g/cm² (+2.98%) near completion of the challenge, whereas the force characteristics showed no statistically significant change.

CONCLUSION: The remarkable pattern of the high-mileage runner may be useful in developing or evaluating load-shifting strategies in distance running.

PMID:33775883 | DOI:10.1016/j.jshs.2021.03.009

Hand Surg Rehabil. 2021 Mar 25:S2468-1229(21)00092-X. doi: 10.1016/j.hansur.2021.03.006. Online ahead of print.

ABSTRACT

We hypothesized that WALANT would provide similar perioperative analgesic comfort compared to local anesthesia with peripheral nerve blocks (LAPNV). We analyzed whether the patient’s active participation during surgery would improve its early functional results. We did a retrospective, single study in an outpatient surgery unit, comparing two types of surgery: trapeziometacarpal arthroplasty (TMCA) under LAPNV and TMCA under WALANT. Fifteen patients were included per group. Pain levels were determined during anesthesia induction, intraoperatively, postoperatively, at rest and during activity at the last follow-up visit. The overall satisfaction with the surgery and time to resume daily activities and work were documented. The statistical analysis was performed on SAS software with an ANOVA. The significance threshold was set at 0.05. The groups were comparable on age, sex, dominant side, and operated side. No patients were lost to follow-up. The mean follow-up was 4 months (2.3-11). The QuickDASH score was 4.93 for TMCA under WALANT vs. 13.47 for TMCA under LAPNV (p = 0.01). There was no loosening, dislocation, or major complication. Our study showed that TMCA performed with WALANT yields similar results to the same procedure with LAPNV for perioperative pain relief without additional complications. Functional scores seem to be slightly improved with WALANT compared to LAPNV, but these results should be confirmed with longer follow up.

PMID:33775887 | DOI:10.1016/j.hansur.2021.03.006

Clin Gastroenterol Hepatol. 2021 Mar 25:S1542-3565(21)00340-2. doi: 10.1016/j.cgh.2021.03.030. Online ahead of print.

ABSTRACT

BACKGROUND & AIM: Bowel Ultrasonography (BUS) is a non-invasive tool for evaluating bowel activity in Crohn’s disease (CD) patients. Aim of our multicenter study was to assess whether BUS helps to monitor intestinal activity improvement/resolution following different biological therapies.

METHODS: Adult CD patients were prospectively enrolled at 16 sites in Italy. Changes in BUS parameters [i.e. bowel wall thickening (BWT), lesion length, echopattern, blood flow changes and transmural healing (TH: normalization of all BUS parameters)] were analyzed at baseline and after 3, 6 and 12 months of different biological therapies.

RESULTS: One hundred and eighty-eight out of 201 CD patients were enrolled and analyzed (116 males [62%]; median age 36 years). Fifty-five percent of patients were treated with adalimumab, 16% with infliximab, 13% with vedolizumab and 16% with ustekinumab. TH rates at 12 months were 27.5% with an NNT of 3.6. TH at 12 months after adalimumab was 26.8%, 37% after infliximab, 27.2% after vedolizumab and 20% after ustekinumab. Mean BWT improvement from baseline was statistically significant at 3 and 12 months (p<0.0001). Median Harvey-Bradshaw index, C-reactive protein and fecal calprotectin decreased after 12 months from baseline (p<0.0001). Logistic regression analysis showed colonic lesion was associated with a higher risk of TH at 3 months and a greater BWT at baseline was associated with a lower risk of TH at 3 months [p=0.03 (OR 0.70, 95%CI 0.50-0.97)] and 12 months [p=0.01 (OR 0.58, 95%CI 0.38-0.89)]. At 3 months therapy optimization during the study was the only independent factor associated with a higher risk of no ultrasonographic response [p=0.02 (OR 3.34, 95%CI 1.18-9.47)] and at 12 months disease duration [p=0.02 (OR 3.03, 95%CI 1.15-7.94)].

CONCLUSION: Data indicate that BUS is useful to monitor biologics-induced bowel activity improvement/resolution in CD.

PMID:33775896 | DOI:10.1016/j.cgh.2021.03.030

Gene. 2021 Mar 25:145614. doi: 10.1016/j.gene.2021.145614. Online ahead of print.

ABSTRACT

Pfn3 is an intron-less gene, encoding actin binding protein that affects structure of cytoskeleton. Although, Pfn3 is mentioned in Allen Brain Atlas and in adult and prenatal Human Brain Tissue Gene Expression Profiles dataset, however, no report on brain and/or brain tumor associated Pfn3 nucleotide sequences are available in the databases. Moreover, pfn3 and pfn4 are always considered as testicular specific genes. The current study explored transcriptional expression profile and genetic architecture of pfn3 in a cohort of fifty formalin fixed paraffin embedded (FFPE) human glioma archive tissues. Results of designed study highlighted the significant dysregulated transcriptional pattern of pfn3. Molecular similarity index indicated 97% in nucleotide and 93 % homology in protein sequences (with clear differences in nine amino acid residues). Thus, molecular variations in the pfn3 may be corelated with the malignancy of brain tumors, as previously, pfn1 and pfn2 were reported as tumor suppressor genes in other types of cancer.

PMID:33775850 | DOI:10.1016/j.gene.2021.145614

Can J Cardiol. 2021 Mar 25:S0828-282X(21)00163-X. doi: 10.1016/j.cjca.2021.03.014. Online ahead of print.

ABSTRACT

The limitations of traditional statistical analyses of randomized clinical trials which follow the frequentist inference paradigm have been increasingly noted. This article discusses the Bayesian approach to statistical inference in randomized clinical trials, demonstrating its functioning, utility, and limitations through an examination of current cardiovascular examples. A simplified overview of the mechanics of Bayesian inference and a glossary of the Bayesian terminology is first provided. The duality of the Bayesian approach providing both an evidential calculus based on the likelihood ratio and a belief calculus that incorporates our prior beliefs with the current data is presented. Specific cardiovascular trials are re-analysed with Bayesian methods. It is claimed that the Bayesian approach by providing an enhanced ability to appreciate and model uncertainty leads to an enriched understanding of the strength and quantification of the evidence, of the distinction between statistical and clinical significance, of the within and between trial variability, of subgroup analyses, of the utility of informative priors and of our ability to synthesize and update our knowledge base. Ultimately, it is argued that the Bayesian approach is more intuitive, transparent, permits enhanced data analysis and interpretation, and may lead to improved decision making not only by trialists but also by practicing clinicians, guideline writers, and even expert regulatory advisory consultants.

PMID:33775879 | DOI:10.1016/j.cjca.2021.03.014

J Sport Health Sci. 2021 Mar 25:S2095-2546(21)00043-0. doi: 10.1016/j.jshs.2021.03.008. Online ahead of print.

ABSTRACT

PURPOSE: The study was to examine county-level associations of physical activity with COVID-19 cases and deaths, per 100,000 county residents.

METHODS: Data were collected from publicly available data sources for 3142 counties and equivalents, including the District of Columbia. Subjective health ratings, percentage uninsured, percentage unemployed, median household income, percentage female residents, percentage White residents, percentage of residents age 65 or older, and rural designation served as controls.

RESULTS: The two-level random intercept regression showed that physical activity rates at the county level were statistically and negatively associated with COVID-19 cases and deaths. Additional analyses showed that physical activity rates moderated the relationship between cases and deaths, such that the relationship was strongest when physical activity rates were low.

CONCLUSION: The results presented here offer empirical evidence of the benefits of county-level physical activity during a pandemic. Implications for public health and physical activity provision are discussed.

PMID:33775882 | DOI:10.1016/j.jshs.2021.03.008

Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 25:110308. doi: 10.1016/j.pnpbp.2021.110308. Online ahead of print.

ABSTRACT

This study examined the changes in the mental health state of college students with and without mental disorder background, during successive time cuts of the Argentina’s lengthy mandatory quarantine, while adjusting for quarantine duration, sex, age, suicidal behavior history, loneliness, and region of residence. We used a longitudinal design (N = 1615, 26% with mental disorder history). Successive samplings were performed from three days before quarantine start and across quarantine phases of up to 103-days duration. Follow-up was one month later. Sex (woman) and age (younger) were significant predictors of worse mental health only in college students without mental disorder background. Having any suicidal behavior background significantly predicted worse mental health in college students both with and without mental disorder history. Loneliness and region of residence were not statistically significant. In the between-groups comparisons, college students having mental disorder background had worse mental health than those without such a background. However, in the within-subject comparisons, no statistically significant changes occurred across time in the mental health of college students having mental disorder history. Conversely, significant changes occurred in those without such a background, but only when the interaction between time and quarantine duration was considered. Worsening mental health occurred during the most heavily restrictive quarantine phases, while some of the remissions occurred during the longest, but less restrictive ones.

PMID:33775744 | DOI:10.1016/j.pnpbp.2021.110308

J Clin Epidemiol. 2021 Mar 25:S0895-4356(21)00095-0. doi: 10.1016/j.jclinepi.2021.03.019. Online ahead of print.

ABSTRACT

OBJECTIVE: To conduct a bibliometric analysis using a large sample of overviews of systematic reviews (OoSRs) and reveal research trends and areas of interest about these studies.

STUDY DESIGN AND SETTING: We searched MEDLINE, Scopus and Cochrane Database of Systematic Reviews from 1/1/2000 to 15/10/2020. We used Scopus meta-data and two authors recorded supplementary information independently. We summarized the data using frequencies with percentages.

RESULTS: A total of 1558 studies were considered eligible for analysis. We found that the publications have been increasing yearly and their nomenclature was not uniform (the most frequent label in the title was “overview of systematic reviews”). The largest number of papers and the most cited ones were published by corresponding authors from the UK. The publications were distributed across 737 scholarly journals and many of them were published in the field of complementary/alternative medicine, psychiatry/psychology, nutrition/dietetics, and pediatrics. The co-authorship analysis revealed collaborations among countries. The most common clinical conditions were depression, diabetes, cancer, dementia, pain, cardiovascular disease, stroke, obesity, and schizophrenia.

CONCLUSION: OoSRs have recently become a popular approach of evidence synthesis. International collaborations between overview authors from countries with increased research productivity and countries with less research activity should be encouraged.

PMID:33775811 | DOI:10.1016/j.jclinepi.2021.03.019

J Vasc Interv Radiol. 2021 Mar 25:S1051-0443(21)00932-5. doi: 10.1016/j.jvir.2021.03.528. Online ahead of print.

ABSTRACT

PURPOSE: To assess safety and efficacy of CT-guided radio frequency ablation (RFA) and Magnetic Resonance guided Focused Ultrasounds (MRgFUS) in the treatment of osteoid osteoma with a long-term follow-up study (mean follow-up time longer than 2 years).

MATERIALS AND METHODS: Database research was carried out in two different centres with experience in musculoskeletal interventions. Both centres, one performing RFA, the other MRgFUS, identified 116 patients, who were submitted to either RFA or MRgFUS for the treatment of symptomatic osteoid osteoma and retrospectively evaluated data regarding pain scores (using a visual analogue scale). Complications were recorded according to the CIRSE classification system. Propensity score matching for multiple variables was performed. Pre- and post-therapy pain scores were compared.

RESULTS: Out of the 116 patients treated, 61 underwent RFA and 55 MRgFUS. The mean values of pre-treatment pain in the two groups were 9.1±0.88 (RFA) and 8.7±0.73 (MRgFUS) VAS units. Post- treatment statistically significant (p<0.00001) overall reduction in pain symptomatology was recorded. No statistically significant difference was observed between the post-treatment mean values of both groups (p=0.256). Four cases of relapse (1 RFA; 3 MRgFUS) and one complication (RFA) were observed. The analysis from propensity score matching that identified a matched cohort of 48 patients showed similar results.

CONCLUSIONS: Both techniques for the treatment of osteoid osteoma seem to ensure a similar pain relief. The presence of thick cortical bone over the nidus can of reduce the effectiveness of MRgFUS.

PMID:33775816 | DOI:10.1016/j.jvir.2021.03.528