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Nevin Manimala Statistics

The Needle and the Damage Done: A retrospective review of the health impact of recreational intravenous drug use and the collateral consequences for Vascular Surgery

Ann Vasc Surg. 2021 Aug 30:S0890-5096(21)00560-4. doi: 10.1016/j.avsg.2021.06.018. Online ahead of print.

ABSTRACT

BACKGROUND: The UK has one of the highest rates of recreational drug use and consequent deaths in Europe. Scotland is the “Drugs death capital of Europe.” Intravenous drug use can result in limb- and life-threatening pathology. This study aimed to characterise limb-related admissions associated with intravenous drug use, outcomes and healthcare expenditure.

METHODS: Retrospective data collection between December 2011-August 2018. Patients were identified through discharge codes. Admission details were extracted from electronic records and a database compiled. Statistical analyses were performed using Statistical Package for the Social Science, p<0.05 denoted significance.

RESULTS: There were 558 admissions for 330 patients (1-9 admissions/patient), mean age 37 years (+/-7.6 SD) and 196 (59.2%; 319 admissions, 57.2%) were male. 348 (62.4%) admissions were to surgical specialties, predominantly Vascular Surgery (247). Including onward referrals, Vascular ultimately managed 54.8% of admissions. Patients presented with multiple pathologies: 249 groin abscesses; 38 other abscesses; 74 pseudoaneurysms; 102 necrotising soft tissue infections (NSTI); 85 cellulitis; 138 DVTs; 28 infected DVTs and 70 other diagnoses. 277 admissions (220 patients) required operations, with 361 procedures performed (1-7 operations/admission). There were 24 major limb amputations and 74 arterial ligations. 11 amputations were due to NSTI and 13 followed ligation (17.6% of ligations). During follow-up 50 (15.2%) patients died, of which six (12%) had amputations (OR 3.2, 95% CI 1.04-9.61, p=0.043). Cumulative cost of acute care was £4,783,241.

CONCLUSION: Limb-related sequalae of intravenous drug use represents a substantial surgical workload, especially for Vascular. These are complex, high-risk patients with poor outcomes and high healthcare costs.

PMID:34474130 | DOI:10.1016/j.avsg.2021.06.018

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Nevin Manimala Statistics

Preoperative opioid usage predicts markedly inferior outcomes two years after reverse total shoulder arthroplasty

J Shoulder Elbow Surg. 2021 Aug 30:S1058-2746(21)00643-1. doi: 10.1016/j.jse.2021.07.027. Online ahead of print.

ABSTRACT

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) has proven to be a highly effective treatment for rotator cuff deficient conditions and other end-stage shoulder pathologies. With value-based care emerging, identifying predictive factors of outcomes are of great interest. Although preoperative opioid use has been shown to predict inferior outcomes after anatomic total shoulder arthroplasty and rotator cuff repair, there is a paucity of data regarding its effect on outcomes after RTSA. We analyzed a series of RTSAs to determine the influence of preoperative opioid use on clinical and radiographic outcomes at a minimum of 2 years follow-up.

METHODS: A retrospective review of primary RTSA patient data revealed 264 patients with at least 2 years of clinical and radiographic follow-up. Patients were classified as preoperative opioid users (71 patients) if they had taken narcotic pain medication for a minimum of 3 months prior to surgery or opioid-naive (193 patients) at the time of surgery. Assessments included preoperative and postoperative visual analog pain scores (VAS), American Shoulder and Elbow Surgeons (ASES) scores, strength, range of motion (ROM), complications, and revisions. Radiographs were analyzed for signs of loosening or mechanical failure. Mann-Whitney U and Fisher exact tests were used for comparisons between groups. Statistical significance was set at p < 0.05.

RESULTS: The mean patient age was 69.9 years, and the mean follow-up time was 2.8 years. Opioid users were significantly younger (66.1 vs. 70.7 years, p < 0.001) at time of surgery and had significantly higher preoperative rates of mood disorders, chronic pain disorders, and disability status (all p < 0.05). Postoperatively, opioid users had inferior VAS (2.59 vs 1.25, p < 0.001), ASES scores (63.2 vs 75.2, p < 0.001), active forward elevation (p < 0.001), and internal and external rotational shoulder strength (all p < 0.05) than opioid-naïve patients. Periprosthetic radiolucency (8.45% vs 2.07%, p = 0.026) and subsequent revision arthroplasty (14.1% vs 4.66%, p = 0.014) occurred more frequently in opioid users than opioid-naïve patients. Both groups improved from baseline preoperatively to most recent follow-up in terms of functional outcomes and pain.

CONCLUSION: Preoperative opioid use portended markedly inferior clinical outcomes in patients undergoing RTSA. Additionally, opioid users had significantly increased rates of periprosthetic radiolucency and revisions. Preoperative opioid use appears to be a significant marker for adverse outcomes after RTSA.

PMID:34474138 | DOI:10.1016/j.jse.2021.07.027

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Nevin Manimala Statistics

Response to the comment on “SGLT-2 inhibitors reduce the risk of cerebrovascular/cardiovascular outcomes and mortality: a systematic review and meta-analysis of retrospective cohort studies”

Pharmacol Res. 2021 Aug 30:105863. doi: 10.1016/j.phrs.2021.105863. Online ahead of print.

NO ABSTRACT

PMID:34474101 | DOI:10.1016/j.phrs.2021.105863

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Nevin Manimala Statistics

An improved method for analysis of interrupted time series (ITS) data: accounting for patient heterogeneity using weighted analysis

Int J Biostat. 2021 Sep 2. doi: 10.1515/ijb-2020-0046. Online ahead of print.

ABSTRACT

Interrupted time series (ITS) design is commonly used to evaluate the impact of interventions in healthcare settings. Segmented regression (SR) is the most commonly used statistical method and has been shown to be useful in practical applications involving ITS designs. Nevertheless, SR is prone to aggregation bias, which leads to imprecision and loss of power to detect clinically meaningful differences. The objective of this article is to present a weighted SR method, where variability across patients within the healthcare facility and across time points is incorporated through weights. We present the methodological framework, provide optimal weights associated with data at each time point and discuss relevant statistical inference. We conduct extensive simulations to evaluate performance of our method and provide comparative analysis with the traditional SR using established performance criteria such as bias, mean square error and statistical power. Illustrations using real data is also provided. In most simulation scenarios considered, the weighted SR method produced estimators that are uniformly more precise and relatively less biased compared to the traditional SR. The weighted approach also associated with higher statistical power in the scenarios considered. The performance difference is much larger for data with high variability across patients within healthcare facilities. The weighted method proposed here allows us to account for the heterogeneity in the patient population, leading to increased accuracy and power across all scenarios. We recommend researchers to carefully design their studies and determine their sample size by incorporating heterogeneity in the patient population.

PMID:34473922 | DOI:10.1515/ijb-2020-0046

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Nevin Manimala Statistics

HbA1c combined with glycated albumin or 1,5-anhydroglucitol improves the efficiency of diabetes screening in a Chinese population

Diabet Med. 2021 Sep 2:e14685. doi: 10.1111/dme.14685. Online ahead of print.

ABSTRACT

AIMS: This study aimed to evaluate the ability of HbA1c combined with glycated albumin (GA) or 1,5-anhydroglucitol (1,5-AG) to detect diabetes in residents of Jiangsu, China.

METHODS: The oral glucose tolerance test (OGTT) was performed on 2,184 people in Jiangsu. HbA1c, GA, 1,5-AG, and other serum biochemical parameters were measured. Receiver operating characteristic curves were plotted to determine the optimal thresholds of HbA1c, GA, and 1,5-AG according to the Youden index.

RESULTS: (1) The optimal thresholds of HbA1c, GA, and 1,5-AG for the screening of diabetes were ≥ 45 mmol/mol (6.3%), ≥ 13.0%, and ≤ 23.0 μg/ml, respectively. (2) The sensitivities of HbA1c combined with GA and 1,5-AG were both 85%, higher than that of HbA1c (70%, P < 0.001).

CONCLUSIONS: This study is suitable for cases where plasma glucose is unavailable. Among the residents of Jiangsu, HbA1c combined with GA or 1,5-AG can improve the sensitivity of diabetes screening, reduce the miss rate, and save the use of OGTT. GA and 1,5-AG are superior in individuals with mild glucose metabolism disorder. GA enhances the detection of diabetes in the nonobese, and 1,5-AG enhances the detection in those with hyperuricemia.

PMID:34473869 | DOI:10.1111/dme.14685

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Nevin Manimala Statistics

Clinical characterization and diagnostic evaluation of non-immediate hypersensitivity reactions to iodinated contrast media

Int J Clin Pract. 2021 Sep 2:e14766. doi: 10.1111/ijcp.14766. Online ahead of print.

ABSTRACT

BACKGROUND: Iodinated contrast media (ICM) – frequently used compound in radiology. Non-immediate hypersensitivity reactions (HSR) appear when a patient leaves the department and usually are undocumented. True hypersensitivity in this group is rarely proved.

METHODS: Single-center 2014-2018 data was retrospectively analysed. HSR to ICM were classified and investigated according to the time of occurrence (immediate <1h, non-immediate >1h). ENDA questionnaire and skin tests (prick or intradermal test) were performed according to ENDA/EAACI recommendations.

RESULTS: 69 patients with a clinical history of HSR to ICM were identified, 72.46% were females (n=50). Average age was 56 (SD ± 13.16) years. Non-immediate HSR occurred in 28.99% (n=20) patients. The suspected culprit drugs were: iodixanol 20% (n=4), iopromide 5% (n=1), diatrizoate 10% (n=2), iohexol 10% (n=2). Among non-immediate HSR 96.00% (n=19) of patients had skin rashes. A statistically significant correlation was found between the clinical symptoms and the type of reaction (p-value < 0,05): isolated skin manifestations mostly occurred in non-immediate HSR 75.00% (n=15). Only 13.04% (n=9) of all the patients were proved to be allergic to a certain ICM after the proposed diagnostic workup.

CONCLUSIONS: One third of the hypersensitivity reactions investigated were classified as non-immediate type. Most of them manifested with isolated skin symptoms. The most frequent culprit drug encountered was iodixanol. The overall non-immediate hypersensitivity confirmation rate after diagnostic evaluation was only 15%.

PMID:34473887 | DOI:10.1111/ijcp.14766

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Nevin Manimala Statistics

Does transcutaneous auricular vagus nerve stimulation affect vagally mediated heart rate variability? A living and interactive Bayesian meta-analysis

Psychophysiology. 2021 Sep 2:e13933. doi: 10.1111/psyp.13933. Online ahead of print.

ABSTRACT

Non-invasive brain stimulation techniques, such as transcutaneous auricular vagus nerve stimulation (taVNS), have considerable potential for clinical use. Beneficial effects of taVNS have been demonstrated on symptoms in patients with mental or neurological disorders as well as transdiagnostic dimensions, including mood and motivation. However, since taVNS research is still an emerging field, the underlying neurophysiological processes are not yet fully understood, and the replicability of findings on biomarkers of taVNS effects has been questioned. The objective of this analysis was to synthesize the current evidence concerning the effects of taVNS on vagally mediated heart rate variability (vmHRV), a candidate biomarker that has, so far, received most attention in the field. We performed a living Bayesian random effects meta-analysis. To keep the synthesis of evidence transparent and up to date as new studies are being published, we developed a Shiny web app that regularly incorporates new results and enables users to modify study selection criteria to evaluate the robustness of the inference across potential confounds. Our analysis focuses on 16 single-blind studies comparing taVNS versus sham in healthy participants. The meta-analysis provides strong evidence for the null hypothesis (g = 0.014, CIshortest = [-0.103, 0.132], BF01 = 24.678), indicating that acute taVNS does not alter vmHRV compared to sham. To conclude, there is no support for the hypothesis that vmHRV is a robust biomarker for acute taVNS. By increasing transparency and timeliness, the concept of living meta-analyses can lead to transformational benefits in emerging fields such as non-invasive brain stimulation.

PMID:34473846 | DOI:10.1111/psyp.13933

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Nevin Manimala Statistics

The shaping ability of WaveOne Gold, TRUShape and XP-endo Shaper systems in oval-shaped distal canals of mandibular molars: a micro-computed tomographic analysis

Int Endod J. 2021 Sep 2. doi: 10.1111/iej.13625. Online ahead of print.

ABSTRACT

AIM: To compare the shaping ability of a heat-treated centric reciprocating file system (WaveOne Gold), a heat-treated eccentric rotary multi-file system (TRUShape 3D Conforming Files), and a heat-treated expandable one-file rotary system (XP-endo Shaper) extending its activation time, in preparing oval-shaped root canals in extracted mandibular molars by means of micro-computed tomography (micro-CT) analysis.

METHODOLOGY: Thirty moderately curved oval-shaped distal roots of mandibular molars were selected. The normality of canal length, curvature angle, volume, surface area, structure model index, and aspect ratio were confirmed. The samples were randomly divided into three groups (n = 10). Micro-CT scans were taken before and after canals were instrumented using WaveOne Gold (size 35, .06 taper), or TRUShape (size 30, .06v taper), both following the manufacturer’s instructions, or XP-endo Shaper following a new protocol with extended activation time. The mechanical preparation time for each sample was recorded. Pre- and postoperative images were analysed for the percentage of unprepared areas and the percentage of removed dentine. Data were compared between groups using the statistical analyses one-way ANOVA and Tukey tests (P < 0.05).

RESULTS: The percentage of unprepared canal areas was significantly higher with WaveOne Gold (% 11.5 ± 4.0) and TRUShape (% 12.4 ± 5.8) compared to XP-endo Shaper (% 5.2 ± 2.6) (P < 0.05). XP-endo Shaper removed significantly more dentine (3.3 ± 1.5 mm3) than WaveOne Gold (1.8 ± 0.8 mm3) and TRUShape (1.9 ± 0.8 mm3) (P < 0.05). No significant differences were seen for mechanical preparation time between WaveOne Gold (79 ± 31 s), TRUShape (104 ± 41 s) and XP-endo Shaper (71 ± 23 s) (P > 0.05).

CONCLUSIONS: The comparison of three recognized root canal filing systems has shown that, with similar preparation times, the XP-endo Shaper removed more dentine (mm3) leaving less unprepared area (%) than WaveOne Gold and TRUShape when preparing oval-shaped root canals of extracted mandibular molars.

PMID:34473842 | DOI:10.1111/iej.13625

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Nevin Manimala Statistics

Creation and validation of a polysocial score for mortality among community-dwelling older adults in the USA: the health and retirement study

Age Ageing. 2021 Aug 28:afab174. doi: 10.1093/ageing/afab174. Online ahead of print.

ABSTRACT

BACKGROUND: the interrelatedness between social determinants of health impedes researchers to identify important social factors for health investment. A new approach is needed to quantify the aggregate effect of social factors and develop person- centred social interventions.

METHODS: participants ([n = 7,383], 54.5% female) were aged 65 years or above who complete an additional psychosocial questionnaire in the health and retirement study in 2006 or 2008. Social determinants of health encompassed five social domains: economic stability, neighbourhood and physical environment, education, community and social context, and healthcare system. We used the forward stepwise logistic regression to derive a polysocial score model for 5-year mortality. Indices of goodness-of-fit, discrimination and reclassification were used to assess model performance. We used logistic regression to identify the association between polysocial score and mortality. Subgroup analyses were conducted to examine sex- and race-specific association.

RESULTS: polysocial score was created using 14 social determinants of health. In the training cohort, the C-statistic was 0.71 for the reference model (only age, sex and race/ethnicity) and increased to 0.75 for the continuous and categorical polysocial score. Compared with the reference model, the integrated discrimination index for adding the continuous or categorical polysocial score was both 0.03 (P values < 0.001). Participants with an intermediate (odds ratio [OR] = 0.69; 95% confidence interval [CI], 0.51-0.82) or high (OR = 0.48; 95% CI, 0.38-0.60) polysocial score had lower odds of death than those in the low category in the fully adjusted model, respectively.

CONCLUSIONS: the polysocial approach may offer possible solutions to monitor social environments and suggestions for older people to improve their social status for specific health outcomes.

PMID:34473824 | DOI:10.1093/ageing/afab174

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Nevin Manimala Statistics

Impact of SARS-CoV-2 infection (COVID-19) on cytochromes P450 activity assessed by the Geneva cocktail

Clin Pharmacol Ther. 2021 Sep 2. doi: 10.1002/cpt.2412. Online ahead of print.

ABSTRACT

Coronavirus Disease 2019 (COVID-19), caused by SARS-CoV-2 infection, is a severe acute respiratory syndrome with an underlying inflammatory state. We have previously demonstrated that acute inflammation modulates cytochromes P450 (CYP) activities in an isoform-specific manner. We therefore hypothesized that COVID-19 might also impact CYP activities, and thus aimed to evaluate the impact of acute inflammation in the context of SARS-CoV-2 infection on the six main human CYPs activity. This prospective observational study was conducted in 28 patients hospitalized at the Geneva University Hospitals (Switzerland) with a diagnosis of moderate to severe COVID-19. They received the Geneva phenotyping cocktail orally during the first 72h of hospitalization and after three months. Capillary blood samples were collected 2h after cocktail administration to assess the metabolic ratios (MRs) of CYP1A2, 2B6, 2C9, 2C19, 2D6 and 3A. CRP, IL-6 and TNF-α levels were also measured in blood. CYP1A2, CYP2C19, and CYP3A MRs decreased by 52.6% (p=0.0001), 74.7% (p=0.0006) and 22.8% (p=0.045), respectively, in COVID-19 patients. CYP2B6 and CYP2C9 MRs increased by 101.1% (p=0.009) and 55.8% (p=0.0006) respectively. CYP2D6 MRs variation did not reach statistical significance (p=0.072). As expected, COVID-19 was a good acute inflammation model as mean serum levels of CRP, IL-6 and TNF-α were significantly (p<0.001) higher during SARS-CoV-2 infection. CYP activities are modulated in an isoform-specific manner by SARS-CoV-2 infection. The pharmacokinetics of CYP substrates, whether used to treat the disease or as the usual treatment of patients, could be therefore clinically impacted.

PMID:34473836 | DOI:10.1002/cpt.2412