Nevin Manimala

Pain Ther. 2021 Oct 2. doi: 10.1007/s40122-021-00323-3. Online ahead of print.

ABSTRACT

BACKGROUND: Multidimensional patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The PROMIS-29 assessment tool is utilized as a component of assessing multidimensional pain scales. It includes patient-reported measures of pain, mood, sleep, social participation, and function. Currently, there are no data on whether a patient’s immediate environment (remote versus in person) influences the reported patient outcomes measurement of a multidimensional tool represented as PROMIS-29 data.

METHODS: Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into a chronic pain or spine center in the United States. The PROMIS-29 v2.1 was recorded. Statistical differences were assessed among age groups and across the seven domains of the assessment.

RESULTS: A total of 25,187 distinct patients were enrolled in the study from August 2018 to December 2020 with a presenting baseline measurement of PROMIS-29. The PROMIS-29 v2.1 was evaluated across the seven domains, and subgroup age analysis was performed for patients completing surveys in the clinical setting (non-remote group) and those completing the survey in the remote setting (remote group) during entry into spine and pain practices across the United States. For mental health scores, those less than 40 years of age and those over 80 years of age showed significant differences in ratings of anxiety and depression in the remote versus non-remote setting. Regarding physical health scores, those aged 60-79 showed a significant difference in the remote versus non-remote ratings for pain interference (p = 0.005; 63.9 vs. 64.4), physical function (p = 0.000; 36.4 vs. 35.7), and fatigue (p = 0.020; 57.2 vs. 57.7), while subjects over 80 years of age showed a statistical difference between the remote versus non-remote setting only in rating physical function (p = 0.025; 33.0 vs. 34). Notably, the rating of sleep disturbance in the remote versus non-remote setting was the only significant variable in the 40-59 age category (p = 0.000; 60.0 vs. 59.1). Those less than 40 years of age also reported a significant difference in the remote versus non-remote setting when rating sleep disturbance (p = 0.000; 60.5 vs. 58.9). With regard to social function, only those older than 80 years showed a significant difference in rating of ability in the remote compared to the non-remote setting (p = 0.031; 39.6 vs. 40.7).

CONCLUSIONS: This data set is the first published data describing the influence of environment (remote versus in person) on PROMIS-29 outcome measurements in the chronic pain population.

PMID:34599754 | DOI:10.1007/s40122-021-00323-3

Psychiatr Q. 2021 Oct 2. doi: 10.1007/s11126-021-09954-3. Online ahead of print.

ABSTRACT

Microglial activation has long been posited to be involved in the neurobiology of schizophrenia. However, recent studies indicate that schizophrenia is associated with astrocytic activation, rather than microglia activation. Moreover, elevated levels of peripheral inflammatory cytokines associated with schizophrenia could induce or reflect brain inflammation. Therefore, based on: 1) findings of a periphery-to-brain communication pathway involving the cell adhesion molecule, P-selectin, in animal models; 2) dysregulated interleukin-6 (IL-6) and elevated levels of the astrocytic marker, S100B protein, in patients with schizophrenia, we sought to determine correlations between plasma soluble P-selectin (sP-selectin), S100B and IL-6 respectively. We recruited 106 patients with schizophrenia (mean age 33 years, 71.60% male) from the inpatient. sP-selectin, S100B and IL-6 were measured in fasting plasma. We calculated Pearson’s and partial correlations between sP-selectin, S100B and IL-6. After controlling for potential confounders, sP-selectin positively correlated with S100B (r=0.31, p=0.004) and IL-6 (r=0.28, P=0.046). The correlation between IL-6 and S100B (r=0.28, p=0.066) did not reach statistical significance. We propose that in some patients with schizophrenia, immune activation in the periphery is associated with P-selectin-mediated trafficking of inflammation into the brain (most likely via leukocytes), which might be associated with astrocytic activation. Future studies should include healthy controls and first episode/early-onset psychosis patients. Importantly, in vivo imaging of neuroinflammation should be correlated with sP-selectin, IL-6 and S100B in the periphery and the CSF. Finally, the utility of combining sP-selectin, IL-6 and S100B as biomarkers for subtyping patients with schizophrenia, treatment selection and prognosis, should be evaluated in longitudinal studies.

PMID:34599734 | DOI:10.1007/s11126-021-09954-3

Int J Clin Oncol. 2021 Oct 2. doi: 10.1007/s10147-021-02030-7. Online ahead of print.

ABSTRACT

BACKGROUND: TOURMALINE-MM1 was a global study that demonstrated a significant improvement in progression-free survival with ixazomib plus lenalidomide and dexamethasone compared with placebo plus lenalidomide and dexamethasone, in patients with relapsed and/or refractory multiple myeloma. The current study was conducted to evaluate further the efficacy and safety of ixazomib plus lenalidomide and dexamethasone in Japanese patients.

METHODS: This phase 2, open-label, single-arm, multicenter study enrolled patients aged ≥ 20 years with relapsed and/or refractory multiple myeloma at 16 sites in Japan. Patients refractory to lenalidomide or proteasome inhibitor-based therapy at any line were excluded. The primary endpoint was the rate of very good partial response or better in the response-evaluable analysis set. Secondary endpoints were progression-free survival, overall response rate, duration of response, time to progression, overall survival and safety.

RESULTS: In total, 34 patients were enrolled. The rate of very good partial response or better was 50.0% (95% confidence interval 31.9-68.1) and the overall response rate was 84.4% (95% confidence interval 67.2-94.7). Median progression-free survival was 22.0 months (95% confidence interval 17.3-not evaluable) and median overall survival was not estimable. The safety profile of ixazomib plus lenalidomide and dexamethasone in this study was similar to that in the TOURMALINE-MM1 study.

CONCLUSIONS: The efficacy and safety of ixazomib plus lenalidomide and dexamethasone in Japanese patients with relapsed and/or refractory multiple myeloma are comparable with reported TOURMALINE-MM1 study results. CLINICALTRIALS.

GOV IDENTIFIER: NCT02917941; date of registration September 28, 2016.

PMID:34599726 | DOI:10.1007/s10147-021-02030-7

Hernia. 2021 Oct 2. doi: 10.1007/s10029-021-02506-5. Online ahead of print.

ABSTRACT

PURPOSE: The laparoscopic ventral hernia repair (LVHR) may have a limit of effectiveness, especially in defects greater than 80 cm², with a higher recurrence rate which contraindicates this technique. The purpose of this study is to analyze the indication of LVHR determining and comparing the recurrence rate according to defect size in two series.

METHODS: We analyzed all patients who underwent LVHR between 2007 and 2017. Patients were divided according to the ring size: < o ≥ 80 cm² into group one (G1) and group two (G2) respectively. In both groups, all three techniques were used: intraperitoneal onlay mesh (IPOM), IPOM with closure of the defect (IPOM plus), and IPOM plus + anterior videoscopic component separation (AVCS).

RESULTS: A total of 258 patients underwent LVHR. Mean recurrence rate was 13% in G1 and 24% in G2. A statistically significant difference was found when comparing the IPOM technique among both groups, with a higher recurrence rate when ring size was ≥ 80 cm² (p < 0.5). However, when comparing recurrence rate in IPOM plus and IPOM plus + AVCS between both groups, no significant differences were observed, yielding a p of 0.51 and 0.63, respectively.

CONCLUSION: The IPOM technique has shown a limit of effectiveness in large ventral hernia defects. The combination of techniques (ring closure and AVCS) may be useful to expand the indication for this surgery to larger defects and to reduce the recurrence rate. Prospective randomized studies are required to confirm this trend.

PMID:34599719 | DOI:10.1007/s10029-021-02506-5

Int Urogynecol J. 2021 Oct 2. doi: 10.1007/s00192-021-04976-8. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: To assess the long-term satisfaction, cure rate and safety of a new titanium-covered transobturator tape compared to polypropylene tape for the treatment of stress urinary incontinence (SUI).

METHODS: A prospective study was conducted with 151 patients. Seventy patients underwent transobturator sling surgery with titanium tape from 2011 to 2019, and a historical control group (CG) of 81 patients was treated with a noncoated tape and underwent incontinence surgery from 1999 to 2009. We compared patient-reported outcome measures (PROMs) with the incontinence outcome questionnaire (IOQ).

RESULTS: The median follow-up was 2½ years in both groups. Based on responses to the IOQ, a statistically significantly shorter time of recovery (IOQ 15: 21.3 ± 26.4 [TG], 40.2 ± 38.5 [CG], p = 0.02), improvement of sex life (IOQ 13: 34.1 ± 29.4 [TG] vs. 65.3 ± 35.6 [CG], p = 0.01) and less voiding dysfunction (IOQ 19: 30.9 ± 28.1 [CG], 9.3 ± 18.6 [TG], p = 0.01) were observed in the TG. Objectively, no postoperative urinary retention was observed in the TG, but four cases were described in the CG. Ten patients needed a reoperation for SUI in the CG compared to three in the TG (p = 0.03).

CONCLUSION: The titanium-covered transobturator sling had superior recovery time, improved sexual function and reduced reoperation rate compared to a historical polypropylene group.

PMID:34599671 | DOI:10.1007/s00192-021-04976-8

Heart Vessels. 2021 Oct 2. doi: 10.1007/s00380-021-01950-8. Online ahead of print.

ABSTRACT

Tpeak-Tend/QT ratio (Tp-e/QT) in patients with ST-segment elevation myocardial infarction (STEMI) is reportedly associated with major adverse cardiac events (MACEs). However, Tp-e/QT measurement methods are controversial, and few studies have clarified the effect of different Tp-e/QT measures on prognosis. Our study is the first to investigate the advantages of the Tp-e/QT measured by infarct-related-lead method in predicting MACEs during hospitalization and long-term mortality in patients with STEMI. A total of 427 STEMI patients undergoing primary percutaneous coronary intervention (PCI) were included in this study. The Tp-e/QT before PCI was measured by traditional 12-lead method and infarct-related-lead method. Outcomes were tested using comparative statistics, logistic regression, receiver operating characteristic (ROC) curve and Kaplan-Meier survival analysis. There were 62 (14.5%) patients who had MACEs in-hospital. Logistic regression showed that the Tp-e/QT in infarct-related-lead was an independent predictor (p < 0.001). The area under the ROC curve (AUC) of the Tp-e/QT in infarct-related-lead was larger than that in the Tp-e/QT in traditional 12-lead (0.889 vs 0.741), and the optimal cutoff value was 0.32. The three-year survival rate of patients in the infarct-related-lead Tp-e/QT < 0.32 group was better than Tp-e/QT ≥ 0.32 group in Kaplan-Meier survival analysis (93.9 vs 87.0%). When stratified according to infarct-related arteries, the results showed that the common odds ratio of patients in Tp-e/QT ≥ 0.32 group occurred MACEs was 1.562, P = 0.038. The infarct-related-lead Tp-e/QT performed better than the traditional 12-lead Tp-e/QT in predicting poor prognosis.

PMID:34599658 | DOI:10.1007/s00380-021-01950-8

J Occup Health. 2021 Jan;63(1):e12283. doi: 10.1002/1348-9585.12283.

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has led to a major shift in workspace from office to home. This report examined how telecommuting is related to smoking behavior of wage and salary workers.

METHODS: Self-reported smoking behavior of 1,390 U.S. wage and salary workers aged 16-64 years from the Tobacco Use Supplement of the Current Population Survey 2018/19 were linked to the 2018 American Time Use Survey. Weighted multivariate logistic regression predicting smoking probability and generalized linear regression predicting smoking intensity were used for analysis.

RESULTS: Almost a fifth (19%) of wage and salary workers reported working from home and over a half (52%) reported working in telecommuting amenable occupations. Nearly 12% were current smokers, smoking 14.7 cigarettes daily on average. Compared to their counterparts, smoking prevalence (percentage points) was lower among those employed in telecommuting amenable occupations (-0.52, p < .001 for all; 0.01, p = .862 for men; -2.40, p < .001 for women) and who worked more frequently from home (-0.21, p < .001 for all; -0.76, p < .001 for men; -0.03, p = .045 for women). Smoking intensity (cigarettes per day) was lower among those employed in telecommuting amenable occupations (-3.39, p = .03 for all; -0.36, p = .90 for men; -4.30, p = .21 for women). We found no statistically significant association between smoking intensity and telecommuting frequency.

CONCLUSIONS: The lower likelihood of smoking and lower level of smoking intensity among telecommuting wage and salary workers suggests the need for proactive efforts to address the potential exacerbation in occupation-related smoking disparities between occupations that are and are not amenable to telecommuting.

PMID:34599638 | DOI:10.1002/1348-9585.12283

J Cosmet Dermatol. 2021 Oct 2. doi: 10.1111/jocd.14484. Online ahead of print.

ABSTRACT

INTRODUCTION: Chronic spontaneous urticaria (CSU) is defined as recurrent attacks of urticaria present for more than six weeks. The monoclonal anti-immunoglobulin E antibody, omalizumab, was approved for the treatment of CSU in patients who remain refractory to H1-antihistamines. Biologic agents are shown not to increase the risk of COVID-19 infection in different studies.

OBJECTIVE: In the present study, we aimed to determine the prevalance of COVID-19 infection in relation to the age, gender, presence of other comorbidities, and treatment given for CSU.

METHODS: We conducted a descriptive cross-sectional study of 233 patients diagnosed with CSU in a tertiary referral hospital. Demographical data, treatment given for CSU, the presence of COVID-19-related symptoms, history of close contact to a person with COVID-19 and COVID-19 real-time polymerase chain reaction (RT-PCR) results were determined via a telephone survey and checked from medical data records.

RESULTS: One hundred sixty patients were female; whereas 73 were male. The mean age was 44.76. Out of 233 patients with chronic urticaria, 125 had symptoms related to COVID-19 infection. RT-PCR testing for COVID-19 was performed in 156 patients. Of 156 patients with COVID-19 RT-PCR test, RT-PCR result was positive in 15 cases.

CONCLUSIONS: No statistically significant relationship was found between COVID-19 RT-PCR positivity and the type of treatment administered for chronic urticaria when the patients are divided into omalizumab ± oral antihistamines and only oral antihistamines treatment groups (p = 0.150). Omalizumab seems to be safe in the era of COVID-19.

PMID:34599630 | DOI:10.1111/jocd.14484

Laryngoscope. 2021 Oct 2. doi: 10.1002/lary.29887. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate histologic changes in middle ear and eustachian tube (ET) mucosa of mice after exposure to tobacco or electronic cigarette (e-cigarette) smoke. To determine whether there were any mitigating effects of middle ear application of anti-IL-13 or the epidermal growth factor receptor antagonist AG1478 on noted changes within ET mucosa.

STUDY DESIGN: Controlled animal study.

METHODS: Fifty BALB/cJ mice were randomly assigned to one of five groups: A control group with no smoke exposure, two groups exposed to tobacco smoke, and two groups exposed to e-cigarette vapor. Within the exposed groups after 4 weeks of exposure, one ear was infiltrated with a saline hydrogel and the other ear with hydrogel of either Anti-IL-13 or AG1478. After four more weeks of exposure, the animals were euthanized and the ETs were evaluated for mucosal changes.

RESULTS: Compared to control animals with no smoke exposure, there were significant decreases in the numbers of goblet cells within the ET mucosa of mice exposed to tobacco smoke and e-cigarette vapor. No significant differences in cilia, mucin, or squamous metaplasia were noted. Neither anti-IL-13 nor AG178 significantly altered goblet cell count in the ET mucosa of mice exposed to tobacco smoke; however, both agents significantly increased goblet cells within the ET mucosa of mice exposed to e-cigarette vapor.

CONCLUSION: Short-term tobacco smoke and e-cigarette vapor significantly decrease goblet cell count in mouse ET mucosa. Middle ear application of both anti-IL-13 and AG1478 resulted in an increase in goblet cell count among mice exposed to e-cigarette vapor, but not to tobacco smoke.

LEVEL OF EVIDENCE: NA Laryngoscope, 2021.

PMID:34599608 | DOI:10.1002/lary.29887

Allergy. 2021 Oct 2. doi: 10.1111/all.15117. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical trials of allergen immunotherapy (AIT) may require up to five years to complete. These lengthy trials may be complicated by high and potentially differential dropouts, especially among participants who perceive that they are receiving placebo. We propose a three-stage design in which the placebo group in Stage 1 crosses over to receive active treatment in Stage 2. In Stage 3, AIT is discontinued to determine whether benefit is maintained post-treatment. We apply inferential statistics to support the three-stage design for clinical trials to determine clinical efficacy, treatment response over time, and sustained response to AIT.

METHODS: The proposed framework constitutes a series of hypothesis tests for comparing treatment responses at the end of each stage. A simulation study was performed to illustrate the statistical properties under varying statistical missing mechanisms and effect sizes.

RESULTS: The statistical properties in terms of bias and statistical power were consistent with what are expected from conventional analyses. Specifically, the extent of bias depended on the missing mechanism and magnitude. The statistical powers were largely driven by effect and sample sizes as well as pre-specified success margins. As an illustration, assuming relative treatment differences of 25% and stagewise dropout rate of 15%, a sample size of 200 per group may achieve 93% power to demonstrate a treatment effect and 60% power to demonstrate a maintained response post-treatment.

CONCLUSIONS: Inferential statistics support our proposed study design for evaluating benefits of AIT over time and inform clinical understanding and decisions.

PMID:34599605 | DOI:10.1111/all.15117