Effectiveness of different booster vaccine combinations against SARS-CoV-2 during a six-month follow-up in Mexico and Argentina.

Introduction: Given the limited number of patients in Latin America who have received a booster dose against the COVID-19, it remains crucial to comprehend the effectiveness of different vaccine combinations as boosters in real-world scenarios. This study aimed to assess the real-life efficacy of seven different vaccine schemes against COVID-19, including BNT162b2, ChAdOx1-S, Gam-COVID-Vac, and CoronaVac as primary schemes with either BNT162b2 or ChAdOx1-S as booster vaccines. Methods: In this multicentric longitudinal observational study, participants from Mexico and Argentina were followed for infection and SARS-CoV-2 Spike 1-2 IgG antibodies during their primary vaccination course and for 185 days after the booster dose. Results: A total of 491 patients were included, and the booster dose led to an overall increase in the humoral response for all groups. Patients who received BNT162b2 exhibited the highest antibody levels after the third dose, while those with primary Gam-COVID-Vac maintained a higher level of antibodies after six months. Infection both before vaccination and after the booster dose, and Gam-COVIDVac + BNT162b2 combination correlated with higher antibody titers. Discussion: The sole predictor of infection in the six-month follow-up was a prior COVID-19 infection before the vaccination scheme, which decreased the risk of infection, and all booster vaccine combinations conveyed the same amount of protection.

Effect of the SARS-CoV-2 pandemic on metabolic control in patients with type 2 diabetes: a 5-year cohort follow-up managed by a dynamic multidisciplinary team in Northeastern Mexico.

BACKGROUND: The SARS-CoV-2 pandemic brought a radical shift in the healthcare system and suboptimal care for vulnerable patients, such as those with Type 2 Diabetes Mellitus (T2D). Therefore, we compared metabolic control and macro/microvascular complications of patients with T2D before and throughout the three-year SARS-CoV-2 pandemic. RESEARCH DESIGN AND METHODS: A retrospective observational cohort of subjects with T2D studied from 2018 to 2022 in Northern Mexico was treated by a dynamic multidisciplinary team. Levels of Glycated hemoglobin (HbA1c), fasting serum glucose (FG), LDL-Cholesterol (LDL-C), blood pressure (BP), albuminuria, triglycerides, Body Mass Index (BMI), and FIB-4 score, micro and macrovascular complications were evaluated. RESULTS: A total of 999 patients were studied, 51.7% males with a mean (SD) age of 60.1 (12.7) years. Adequate glycemic control based on HbA1c increased by 15.2% and 42.3% in FSG (p < 0.001) between the beginning 2018 and the end of 2022. LDL-C control decreased by 5.1% between 2018 and 2022 (p < 0.001). Systolic BP control decreased by 2.6% (p < 0.001), whereas diastolic BP control increased by 1.8% (p = 0.01) between 2018 and 2022. Albuminuria control increased by 8.5% (p = 0.002). When comparing the Area Under the Curve (AUC) of metabolic parameters between patients who developed SARS-CoV-2 vs. those who did not, AUC was statistically higher in those who developed SARS-CoV-2 (p < 0.05). Diabetic neuropathy was the most prevalent microvascular complication (n = 35; 3.6%); ischemic heart disease was the most frequent macrovascular complication (n = 11;1.1%). CONCLUSIONS: A multidisciplinary dynamic team that adapts to the pandemic SARS-CoV-2 maintains and increases metabolic control in subjects with type 2 diabetes in Mexico. This represents a low percentage of chronic complications. The AUC of metabolic parameters of subjects with SARS-CoV-2 infection is higher, reflecting more variability in metabolic control.

Neuromuscular monitoring during modified rapid sequence induction: A comparison of TOF-Cuff® and TOF-Scan®.

BACKGROUND: Acceleromyometry is the clinical standard for quantitative neuromuscular monitoring, mostly using the stimulation pattern train-of-four (TOF). TOF-Cuff®, a recently introduced neuromuscular monitor with stimulating electrodes integrated within a blood pressure cuff, assesses the muscular response in the upper arm. METHODS: The time from administration of a neuromuscular blocking agent to TOF-ratio 0% during modified rapid sequence induction was compared between TOF-Cuff® and acceleromyometry (TOF-Scan®). Included were 26 adults with body mass index <35 kg/m2. TOF-Scan® and TOF-Cuff® were simultaneously fitted on patients' opposite arms. The mean difference to TOF-ratio 0% was compared using the one sample t-test (p < 0.05) and Bland-Altman plots. RESULTS: After anesthesia induction, atracurium 0.9 mg/kg (±0.08) i.v. was administered. The mean time to TOF ratio 0% for TOF-Scan® was 140.4 s (±34.3), and 132.7 s (±32.5) for TOF-Cuff®, with a mean difference of 5.4 (95% CI: -9.9 to 20.7, p = 0.472). The maximum difference between the two modalities was 135 s when the TOF-Cuff® was faster and 60 s when the TOF-Scan® was faster. CONCLUSIONS: No statistically significant systematic difference was found between TOF-Scan® and TOF-Cuff®. However, there was high variability and wide limits of agreement. The two devices cannot be used interchangeably.

Efficacy of intraoperative epidural triamcinolone application in lumbar microdiscectomy: a matched-control study.

OBJECTIVE The purpose of this study was to investigate whether the intraoperative application of an epidural steroid (ES) on the decompressed nerve root improves short- and midterm subjective and objective clinical outcomes after lumbar microdiscectomy. METHODS This study was a retrospective analysis of a 2-center database including consecutive cases in which patients underwent lumbar microdiscectomy. All patients who received ES application (40 mg triamcinolone, ES group) were matched by age and sex to patients who had not received ES application (control group). Objective functional impairment (OFI) was determined using age- and sex-adjusted T-scores of the Timed Up and Go (TUG) test. Back and leg pain (visual analog scale), functional impairment (Oswestry Disability Index [ODI], Roland-Morris Disability Index [RMDI], and health-related quality of life (hrQoL; 12-Item Short Form Health Survey [SF-12] physical component summary [PSC] score and EuroQol [EQ-5D index]) were measured at baseline, on postoperative day 3, and at postoperative week 6. RESULTS Fifty-three patients who received ES application were matched with 101 controls. There were no baseline demographic or disease-specific differences between the study groups, and preoperative pain, functional impairment, and hrQoL were similar. On postoperative day 3, the ES group had less disability on the RMDI (mean 7.4 vs 10.3, p = 0.003) and higher hrQoL as determined by the SF-12 PCS (36.5 vs 32.7, p = 0.004). At week 6, the ES group had less disability on the RMDI (3.6 vs 5.7, p = 0.050) and on the ODI by trend (17.0 vs 24.4, p = 0.056); better hrQoL, determined by the SF-12 PCS (44.3 vs 39.9, p = 0.018); and lower OFI (TUG test T-score 100.5 vs 110.2, p = 0.005). The week 6 responder status based on the minimum clinically important difference (MCID) was similar in the ES and control groups for each metric. The rates and severity of complications were similar, with a 3.8% and 4.0% reoperation rate in the ES group and control group, respectively (p = 0.272). There was a tendency for shorter hospitalization in the ES group (5.0 vs 5.8 days, p = 0.066). CONCLUSIONS Intraoperative ES application on the decompressed nerve root is an effective adjunct treatment that may lower subjective and objective functional impairment and increase hrQoL in the short and intermediate term after lumbar microdiscectomy. However, group differences were lower than the commonly accepted MCIDs for each metric, indicating that the effect size of the benefit is limited. ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: retrospective cohort trial; evidence: Class II.

Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease.

BACKGROUND: The Timed Up and Go (TUG) test, as a measure of objective functional impairment in lumbar degenerative disk disease (DDD), complements patient-reported outcome measures (PROMs) of subjective functional impairment. METHODS: Prospective 2-center study on consecutive patients scheduled for surgical treatment for lumbar DDD who underwent an objective (TUG test) and subjective (PROMs) functional assessment before and 1 and 3 days after surgery. PROMs included the visual analog scale (VAS), Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), Euro-Qol (EQ-5D), and Short Form 12 (SF-12) questionnaires. On completion of each assessment, patients were asked whether they would prefer performing the TUG test or completing the PROMs questionnaires. RESULTS: A total of 109 of 125 patients (87.2%) completed the assessments. Preoperatively, patients were 2.18 times as likely to prefer the TUG test to the PROMs (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.27-3.75). On postoperative days 1 and 3, patients were 5.79 (OR, 5.79; 95% CI, 3.23-10.37) and 6.33 times as likely to prefer the TUG test to the PROMs, respectively (OR, 6.33; 95% CI, 3.51-11.41). There were no statistical differences in baseline characteristics, TUG t scores, VAS, RMDI, ODI, SF-12, and EQ-5D index between patients preferring either the TUG test or the PROMs questionnaires. CONCLUSIONS: The TUG test is preferred over a battery of PROMs by 60%-70% of patients with lumbar DDD not only in the preoperative, but also in the postoperative, setting. High functional disability does not result in avoidance of the TUG test, and repeated assessments lead to higher preference.

Effects of Smoking on Subjective and Objective Measures of Pain Intensity, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disk Disease.

BACKGROUND: Numerous studies assessed the effects of smoking on lumbar degenerative disk disease (DDD); they focused on patient-reported outcome measures (PROMs) and yielded conflicting results. METHODS: In this 2-center study on consecutive patients receiving surgical treatment for lumbar DDD, subjective functional impairment (SFI) in terms of PROMs including visual analog scale back and leg pain, Roland-Morris, Oswestry Disability Index, Euro-Qol-5D, and a Short-Form 12 physical component summary was determined at baseline, 3 days, 6 weeks, 6 months, and 1 year postoperatively. Age- and sex-adjusted T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go test up to 6 weeks postoperatively. The responder status was defined by the minimal clinically important difference. RESULTS: We analyzed 375 patients (n = 96 [25.6%] smokers and n = 279 [74.4%] nonsmokers). SFI on any of the PROMs before treatment was similar in smokers and nonsmokers. Smokers were more likely to have OFI in univariate logistic regression analysis (95% confidence interval 1.31-3.37, P = 0.002). In multivariate analysis, however, this relationship became insignificant (95% confidence interval 0.85-2.38, P = 0.184). The smoking status had no predictive capacity on the 6-week SFI or OFI responder status, and there were no differences in any of the PROMs until the 1-year follow-up. CONCLUSIONS: PROMs measuring SFI for pain intensity, functional impairment, and health-related quality of life were similar in smokers and nonsmokers before surgery for lumbar DDD, as well as postoperatively. The smoking status has negligible impact on the Timed Up and Go test, which appears to be a robust assessment tool for OFI.

Validity and Reliability of a Measurement of Objective Functional Impairment in Lumbar Degenerative Disc Disease: The Timed Up and Go (TUG) Test.

BACKGROUND: There are few objective measures of functional impairment to support clinical decision making in lumbar degenerative disc disease (DDD). OBJECTIVE: We present the validation (and reliability measures) of the Timed Up and Go (TUG) test. METHODS: In a prospective, 2-center study, 253 consecutive patients were assessed using the TUG test. A representative cohort of 110 volunteers served as control subjects. The TUG test values were assessed for validity and reliability. RESULTS: The TUG test had excellent intra- (intraclass correlation coefficient: 0.97) and interrater reliability (intraclass correlation coefficient: 0.99), with a standard error of measurement of 0.21 and 0.23 seconds, respectively. The validity of the TUG test was demonstrated by a good correlation with the Visual Analog Scale (VAS) back (Pearson's correlation coefficient [PCC]: 0.25) and VAS (PCC: 0.29) leg pain, functional impairment (Roland-Morris Disability Index [PCC: 0.38] and Oswestry Disability Index [PCC: 0.34]), as well as with health-related quality of life (Short Form-12 Mental Component Summary score [PCC: -0.25], Short Form-12 Physical Component Summary score [PCC: -0.32], and EQ-5D [PCC: -0.28]). The upper limit of "normal" was 11.52 seconds. Mild (lower than the 33rd percentile), moderate (33rd to 66th percentiles), and severe objective functional impairment (higher than the 66th percentile) as determined by the TUG test was <13.4 seconds, 13.4 to 18.4 seconds, and >18.4 seconds, respectively. CONCLUSION: The TUG test is a quick, easy-to-use, valid, and reliable tool to evaluate objective functional impairment in patients with lumbar degenerative disc disease. In the clinical setting, patients scoring a TUG test time of over 12 seconds can be considered to have functional impairment. ABBREVIATIONS: BMI, body mass indexDDD, degenerative disc diseaseHRQOL, health-related quality of lifeICC, intraclass correlationLDH, lumbar disc herniationLSS, lumbar spinal stenosisODI, Oswestry Disability IndexOFI, objective functional impairmentPCC, Pearson's correlation coefficientPCS, Physical Component SummaryRMDI, Roland-Morris Disability IndexSF, Short FormVAS, visual analog scale.

The timed up and go test for lumbar degenerative disc disease.

We report on the use and performance of an objective measure of functional impairment, the timed up and go (TUG) test, in clinical practice for patients with lumbar degenerative disc disease (DDD). We illustrate nine representative patients with lumbar DDD, who were selected from an ongoing prospective study, to report our clinical experience with the TUG test. In addition, a preliminary sample of 30 non-selected consecutive patients is presented. The following parameters were assessed preoperatively, and 3 days and 6 weeks postoperatively: back and leg pain using the visual analogue scale (VAS); functional impairment using the Oswestry disability index (ODI) and Roland-Morris disability index (RMDI); health-related quality of life using the EuroQol 5D (EQ5D) and Short-Form 12 (SF-12). The TUG test results improved by 2.6 and 5.4s after 3 days and 6 weeks compared to the baseline assessment. The mean VAS for back and leg pain decreased by 2.3 and 5.3, respectively, after 3 days, and by 2.7 and 4.6 after 6 weeks. The mean RMDI and ODI decreased by 3.4 and 23.3, respectively, after 3 days, and by 7.0 and 28.0 after 6 weeks. The mean EQ5D increased by 0.38 after 3 days and 0.358 after 6 weeks. The mean SF-12 mental component scale decreased by 0.2 after 3 days and increased by 5.6 after 6 weeks, whereas the mean SF-12 physical component scale increased by 6.4 after 3 days and by 9.8 after 6 weeks. The TUG test proved to be a useful, easy to use tool that could add a new, objective dimension to the armamentarium of clinical tests for the diagnosis and management of DDD. From our preliminary experience, we conclude that the TUG test accurately reflects a patient's objective functional impairment before and after surgery.