Tag: statistics

Ann Surg Oncol. 2021 Mar 28. doi: 10.1245/s10434-021-09863-6. Online ahead of print.

ABSTRACT

BACKGROUND: Intraoperative blood cell salvage and autotransfusion (IBSA) during liver transplantation (LT) for hepatocellular carcinoma (HCC) is controversial for concern regarding adversely impacting oncologic outcomes.

OBJECTIVE: We aimed to evaluate the long-term oncologic outcomes of patients who underwent LT with incidentally discovered HCC who received IBSA compared with those who did not receive IBSA.

METHODS: Patients undergoing LT (January 2001-October 2018) with incidental HCC on explant pathology were retrospectively identified. A 1:1 propensity score matching (PSM) was performed. HCC recurrence and patient survival were compared. Kaplan-Meier survival analyses were performed, and univariable Cox proportional hazard analyses were performed for risks of recurrence and death.

RESULTS: Overall, 110 patients were identified (IBSA, n = 76 [69.1%]; non-IBSA, n = 34 [30.9%]). Before matching, the groups were similar in terms of demographics, transplant, and tumor characteristics. Overall survival was similar for IBSA and non-IBSA at 1, 3, and 5 years (96.0%, 88.4%, 83.0% vs. 97.1%, 91.1%, 87.8%, respectively; p = 0.79). Similarly, the recurrence rate at 1, 3, and 5 years was not statistically different (IBSA 0%, 1.8%, 1.8% vs. non-IBSA 0%, 3.2%, 3.2%, respectively; p = 0.55). After 1:1 matching (26 IBSA, 26 non-IBSA), Cox proportional hazard analysis demonstrated similar risk of death and recurrence between the groups (IBSA hazard ratio [HR] of death 1.26, 95% confidence interval [CI] 0.52-3.05, p = 0.61; and HR of recurrence 2.64, 95% CI 0.28-25.30, p = 0.40).

CONCLUSIONS: IBSA does not appear to adversely impact oncologic outcomes in patients undergoing LT with incidental HCC. This evidence further supports the need for randomized trials evaluating the impact of IBSA use in LT for HCC.

PMID:33778907 | DOI:10.1245/s10434-021-09863-6

Alcohol Alcohol. 2021 Mar 29:agab016. doi: 10.1093/alcalc/agab016. Online ahead of print.

ABSTRACT

AIMS: This meta-analysis reviewed 15 clinical trials (18 study sites/arms), examining the efficacy of an integrated cognitive-behavioral intervention (CBI) delivered to individuals with an alcohol or other drug use disorder and a co-occurring mental health disorder (AOD/MHD). Outcomes were alcohol or other drug use and mental health symptoms at post-treatment through follow-up.

METHODS: The inverse-variance weighted effect size was calculated for each study and pooled under random effects assumptions.

RESULTS: Integrated CBI showed a small effect size for AOD (g = 0.188, P = 0.061; I2 = 86%, τ2 = 0.126, k = 18) and MHD (g = 0.169, P = 0.024; I2 = 58%, τ2 = 0.052, k = 18) outcomes, although only MHD outcomes were statistically significant. Analysis by subgroup suggested that effect magnitude varied by type of contrast condition (integrated CBI + usual care vs. usual care only; integrated CBI vs. a single-disorder intervention), follow-up time point (post-treatment vs. 3-6 months) and primary AOD/MHD diagnosis, although these sub-groups often contained significant residual heterogeneity. In a series of mixed effects, meta-regression models, demographic factors were non-significant predictors of between-study heterogeneity. For AOD outcomes, greater effects were observed in higher quality studies, but study quality was not related to effect size variability for MHD outcomes.

CONCLUSIONS: The current meta-analysis shows a small and variable effect for integrated CBI with the most promising effect sizes observed for integrated CBI compared with a single disorder intervention (typically an AOD-only intervention) for follow-up outcomes, and for interventions targeting alcohol use and/or post-traumatic stress disorder. Given the clinical and methodological variability within the sample, results should be considered a preliminary, but important step forward in our understanding of treatment for co-occurring AOD/MHD.

PMID:33778869 | DOI:10.1093/alcalc/agab016

J Appl Lab Med. 2021 Mar 29:jfab004. doi: 10.1093/jalm/jfab004. Online ahead of print.

ABSTRACT

BACKGROUND: Traumatic brain injury (TBI) is a significant public health issue affecting nearly 69 million patients worldwide per year. Reliable diagnostic biomarkers are urgently needed to aid in disease diagnosis and prognosis and to guide patient aftercare. Blood biomarkers represent an attractive modality to quickly, cheaply, and objectively evaluate clinical status. We hypothesize that deep and quantitative plasma proteomic profiling with a novel technology, proximity extension assay, may lead to the discovery of diagnostic and/or prognostic biomarkers of TBI.

METHODS: We used high-throughput proximity extension assays (PEA) to quantify the relative abundance of over 1000 unique proteins in plasma. PEA is a highly sensitive multiplex immunoassay capable of detecting very low-abundance proteins (down to fg/mL) in complex biological matrices. Our patient cohort consisted of severe TBI (sTBI) patients, matched healthy controls, and another non-TBI group that was included in the analysis to validate the specificity of the candidates during the selection process. The obtained protein quantification data was then filtered to identify candidate biomarkers through statistical analysis, literature searches, and comparison to our reference control groups.

RESULTS: Overall, we identified 6 novel candidate TBI biomarkers. Candidates exhibit a significant increase in plasma protein abundance in sTBI when comparing between healthy controls and sTBI patients. Candidates generally had low expression in our reference groups compared with the sTBI group.

CONCLUSIONS: Our preliminary findings represent a starting point for future validation. These biomarkers, either alone or in combination, may have significant clinical utility in aiding in TBI diagnosis, prognosis, and/or management.

PMID:33778875 | DOI:10.1093/jalm/jfab004

Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Mar 25:S2451-9022(21)00086-0. doi: 10.1016/j.bpsc.2021.03.009. Online ahead of print.

ABSTRACT

BACKGROUND: Stressful life events (SLEs) is an important causal factor in depression, the mechanism of which, however, remains unclear. Recent studies suggested that white matter (WM) micro-structures might be a potential mediator between SLEs and depression. Hence, we intended to investigate the concrete correspondence among them using the mediation effect models.

METHODS: WM micro-structures of 194 participants with SLEs experience prospectively recruited from 6 residential communities were detected with diffusion tensor imaging (DTI). The relationship with each other among SLEs, WM micro-structures and depression were respectively explored with multiple linear regression models and logistic regression models. Furthermore, the influence of WM micro-structures on the association between SLEs and depression was tested with the mediation effect models.

RESULTS: The successfully established mediation effect models showed the specific influence of fractional anisotropy (FA) of the corpus callosum and left uncinate fasciculus on the association between SLEs and depression onset (ab path = 0.032; ab path = 0.026) and depressive severity (ab path = 0.052; ab path = 0.067). The significantly total mediation effects on the association between SLEs and depression onset (ab path = 0.031) and severity (ab path = 0.075) through FA of the corpus callosum and left uncinate fasciculus also were found.

CONCLUSIONS: WM micro-structures alterations imposed a substantial mediation effect on the association between SLEs and depression, which suggested the changes in the WM micro-structures integrity might increase the risk of depression onset and unfavorable disease courses induced by the SLEs.

PMID:33775928 | DOI:10.1016/j.bpsc.2021.03.009

J Gynecol Obstet Hum Reprod. 2021 Mar 25:102126. doi: 10.1016/j.jogoh.2021.102126. Online ahead of print.

ABSTRACT

OBJECTIVE: Clarify the normal patterns of voiding after minimally invasive hysterectomy. We also aim to identify perioperative factors associated with delayed time to void immediately following hysterectomy.

DESIGN: Retrospective cohort study SELECTION: Women undergoing laparoscopic hysterectomy between September 2012 to October 2018 at a single academic university hospital.

RESULTS: 450 minimally invasive hysterectomies were included in the final analysis; 274 (60.9%) robotically-assisted, and 176 (39.1%) conventional laparoscopy. The overall median postoperative time-to-void following a retrograde bladder filling of 150 mL normal saline was 179 minutes. Based on the 50^th percentile of the distribution of the time-to-void, two groups were created. Demographic characteristics between the groups were similar, except those who were above the 50^th percentile were more likely to be older, have a reported history of previous myomectomy, and had a longer postoperative PACU stay compared to those below or equal to the 50^th percentile. The mean time-to-void following conventional laparoscopic hysterectomy was less than that of robotic surgery (187.3 vs 200.5 minutes) however the difference was not statistically significant (p=0.22). The use of hydromorphone intraoperatively and the combination of oxycodone-acetaminophen postoperatively were more likely to be associated with the group of patients above the 50^th percentile but there was no significant difference in perioperative utilization of median morphine milliequivalents (MME) between the two groups.

CONCLUSIONS: Following laparoscopic hysterectomy (either conventional or with robotic-assistance) with a retrograde bladder fill of 150 mL normal saline most patients will void within 4 hours after surgery. This is consistent with historic data on normal voiding patterns facilitating safe same day discharge without prolonged time in the PACU.

PMID:33775918 | DOI:10.1016/j.jogoh.2021.102126

Acad Pediatr. 2021 Mar 25:S1876-2859(21)00156-X. doi: 10.1016/j.acap.2021.03.018. Online ahead of print.

ABSTRACT

OBJECTIVE: Ride-share services are increasingly used for transportation, but little is known about ride-share use and passenger safety behaviors among parents of children for whom child restraint systems (CRS) are recommended. Our objectives were to characterize ride-share use with children and examine passenger restraint use in ride-share.

METHODS: A cross-sectional survey, distributed to the TurkPrime Parent Panel using Amazon Mechanical Turk (MTurk), was designed to assess ride-share and passenger safety behaviors. After screening, adult parents of minor children were invited to complete the full survey about transportation behaviors. Descriptive and chi-square statistics were calculated. Logistic regression was conducted to test for characteristics associated with suboptimal restraint use in ride-share.

RESULTS: Of 655 screened parents, 162 had no minor children, 43 had incomplete responses or failed an attention check question. Of 450 parents with minor children, 309 (68.7%) used ride-share in the past year and 73.1% of parents who use ride-share did so with their child(ren). Ride-share use with children was most common on vacation. Among parents of children age ≤ 8 years, 49% reported always using their child’s CRS when traveling in ride-share. Suboptimal restraint use in rideshare was associated with child age (3-8 years compared with <3 years), larger family size, and attitudes and behaviors that tolerate suboptimal CRS use.

CONCLUSION: This study identifies an opportunity to promote use of CRS in ride-share services. Child passenger safety messaging, education, policy, enforcement of legislation, and CRS design will need to be adapted as ride-share services become more widely adopted.

PMID:33775920 | DOI:10.1016/j.acap.2021.03.018

Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Mar 25:S2451-9022(21)00087-2. doi: 10.1016/j.bpsc.2021.03.010. Online ahead of print.

ABSTRACT

BACKGROUND: Obsessive-compulsive disorder (OCD) is a chronic, disabling mental health condition with limited treatment options available to date. Numerous randomised controlled trials (RCT) have explored the efficacy of repetitive transcranial magnetic stimulation (rTMS) in OCD. This meta-analysis synthesized data from selected RCTs and examined the impact of different treatment parameters to generate hypotheses that would direct future RCTs.

METHODS: A database search was performed to identify studies published in English up to October 2020. Randomised, sham-controlled studies that used rTMS to treat OCD were included. Effect sizes were calculated using Hedges’ g for pre- to post-treatment Yale-Brown Obsessive Compulsive Scale (YBOCS) scores. Subgroup analyses were conducted to assess the effects of variations in rTMS treatment parameters.

RESULTS: A total of 26 studies with 781 participants were included. Overall, rTMS demonstrated a modest effect on reduction of YBOCS scores (Hedges’ g=0.77, 95% CI=0.41, 1.14; p<0.0001). The largest significant effect size was obtained by targeting the bilateral dorsolateral prefrontal cortex (BL-DLPFC). High and low frequency rTMS showed comparable effects. Studies with follow-up data suggested that effects of active rTMS remain significantly superior to sham 4 weeks post-treatment.

CONCLUSIONS: The therapeutic effects of rTMS are superior to sham in the treatment of OCD. Targeting the BL-DLPFC was the most favourable approach in administering rTMS. Further research is required to determine the optimal frequency, total pulses per session and duration of treatment with rTMS for OCD.

PMID:33775927 | DOI:10.1016/j.bpsc.2021.03.010

Clin Gastroenterol Hepatol. 2021 Mar 25:S1542-3565(21)00337-2. doi: 10.1016/j.cgh.2021.03.027. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Patients with advanced colorectal adenomas (AA) are directed to undergo intensive surveillance. However, the benefit derived from surveillance may be outweighed by the risk of death from non-colorectal cancer (CRC) causes, leading to uncertainty on how best to individualize follow-up. The aim of this study was to derive a risk prediction model and risk index that estimates and stratifies the risk for non-colorectal cancer mortality (NCM) subsequent to diagnosis and removal of AA.

METHODS: We conducted a retrospective cohort study of Veterans > 40 years who had colonoscopy for diagnostic or screening indications at 13 VAMCs between 2002 and 2009, and had one or more AAs. The primary outcome was non-CRC mortality (NCM) using a fixed follow-up time period of 5 years. Logistic regression using the lasso technique was used to identify factors independently associated with non-CRC mortality (NCM), and an index based on points from regression coefficients was constructed to estimate risk of 5-year NCM.

RESULTS: We identified 2,943 Veterans with AA (mean age (SD) 63 (8.6) years, 98% male, 74% white), with an overall 5-year mortality of 16.7%, which was nearly all due to NCM (16.6%). Age, comorbidity burden, specific comorbid conditions, and hospitalization within the preceding year were independently associated with NCM. The risk prediction model had a goodness of fit (calibration) p-value of 0.41, and c-statistic (discrimination) of 0.74 (95% CI, 0.71-0.76). Based on comparable 5-year risks of NCM, the scores comprised 3 risk categories: low (score of 0-1), intermediate (score of 2-4) and high (score of ≥ 5), in which NCM occurred in 6.5%, 14.1%, and 33.2%, respectively.

CONCLUSIONS: We derived a risk prediction model that identifies Veterans at high risk of NCM within 5 years, and who are thus unlikely to benefit from further surveillance.

PMID:33775897 | DOI:10.1016/j.cgh.2021.03.027

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