Category: Nevin Manimala

Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):404-415. doi: 10.1097/MEG.0000000000002728. Epub 2024 Feb 21.

ABSTRACT

BACKGROUND: Vedolizumab is an anti-α4β7 integrin antibody used to treat moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). This post hoc analysis of patient-reported outcomes (PROs) from the VISIBLE 1 (NCT02611830) and 2 (NCT02611817) phase 3 studies evaluated onset of treatment effect on patient-reported symptoms during 6-week vedolizumab induction.

METHODS: Patient-reported stool frequency (SF) and rectal bleeding (RB) (UC Mayo score), and SF and abdominal pain (AP) in CD were collected via electronic diary from VISIBLE patients receiving one or more open-label intravenous (IV) vedolizumab induction doses (weeks 0 and 2). PRO data were analyzed using descriptive statistics.

RESULTS: Data from 994 patients (UC 383, CD 611) showed mean ratings for all PROs declined consistently week-on-week from baseline through week 6, with early onset of improvement. By week 2, 22% of patients with UC reported RB improvement (≥1-point reduction in RB subscore, 7-day mean), rising to 45% by week 6. By week 6, 18% of patients with UC achieved SF improvement (SF subscore 0; 21% antitumor necrosis factor alpha [anti-TNFα] naive, 13% anti-TNFα experienced). SF improvement in patients with CD (reduction of ≥3 stools, 7-day mean) was achieved by 32% at week 6 (34% anti-TNFα naive, 30% anti-TNFα experienced). Fewer patients with CD reported severe/moderate AP at week 6 (5.1%/28.5%) than baseline (14.6%/61.5%). SF decline appeared greater and faster for anti-TNFα-naive vs. anti-TNFα-experienced patients (UC and CD).

CONCLUSION: Results indicate early onset of patient-reported UC and CD symptom improvement during vedolizumab IV induction in VISIBLE 1 and 2.

PMID:38417060 | DOI:10.1097/MEG.0000000000002728

Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):394-403. doi: 10.1097/MEG.0000000000002734. Epub 2024 Feb 28.

ABSTRACT

OBJECTIVE: We measured the fecal levels of short-chain fatty acids (SCFAs) in subjects with slow transit constipation (STC) and assessed the correlation between SCFA levels and disease severity as well as quality of life.

METHODS: We isolated the supernatant from fecal samples of healthy and STC subjects and measured the SCFA levels. To assess the correlation between fecal SCFA levels and disease severity as well as quality of life, we used the Constipation Scoring System, Patient Assessment of Constipation Symptoms, and Patient Assessment of Constipation Quality of Life questionnaires.

RESULTS: 16 STC subjects and 16 healthy controls were enrolled. STC subjects had lower SCFA levels, but the difference was not statistically significant (475.85 ± 251.68 vs. 639.77 ± 213.97 µg/ml, P = 0.056). Additionally, STC subjects had lower acetic and propionic acid levels (149.06 ± 88.54 vs. 261.33 ± 109.75 µg/ml and 100.60 ± 60.62 vs. 157.34 ± 66.37 µg/ml, respectively, P < 0.05) and higher isobutyric and isovaleric acid levels (27.21 ± 15.06 vs. 18.16 ± 8.65 µg/ml and 31.78 ± 18.81 vs. 16.90 ± 10.05 µg/ml, respectively, P < 0.05). At 252.21 µg/ml acetic acid, the specificity and sensitivity to distinguish healthy from STC subjects were 93.7% and 56.3%, respectively. In STC subjects, there were significant negative correlations between acetic and propionic acid levels and Constipation Scoring System scores.

CONCLUSION: Fecal SCFA, acetic acid, and propionic acid levels decreased in STC subjects. There were significant negative correlations between the levels of the two acids and constipation severity.

PMID:38417059 | DOI:10.1097/MEG.0000000000002734

Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):382-386. doi: 10.1097/MEG.0000000000002717. Epub 2024 Feb 28.

ABSTRACT

The size, number and distribution of diverticula vary greatly in patients with diverticulosis. We aimed to study the association between the morphology of diverticulosis assessed on colonoscopy and the risk of diverticulitis. We performed a retrospective, case-control study of cases with a history of diverticulitis and controls with diverticulosis without diverticulitis matched on sex, age (within 5 years) and year of colonoscopy. Diverticulosis characteristics were obtained from endoscopy reports and were categorized according to severity, extent, number and size. We used conditional logistic regression on matched pairs to calculate the odds of diverticulitis among patients with diverticulosis according to differing morphologic characteristics. We identified 85 cases with computed tomography-documented diverticulitis and 85 matched controls with diverticulosis without a diagnosis of diverticulitis. In cases, 60% had left-sided only diverticulosis, 2% had right-sided only and 38% had both right and left-sided diverticulosis; whereas in controls, the distribution was 53%, 18% and 29%, respectively. Cases were more likely to have large diverticula [odds ratio (OR), 3.33; 95% confidence interval (CI), 1.30-8.56 for left colon only and 1.89, 95% CI, 0.78-4.57 for both right and left]. Similarly, when the severity of diverticulosis was compared between the groups, cases were more likely to have moderate or severe diverticulosis (OR, 3.44; 95% CI, 1.51-7.84 for moderate and OR, 8.87; 95% CI, 2.98-26.37 for severe). Diverticulitis cases were more likely to have large diverticula and severe diverticulosis when compared to controls suggesting that size and severity are novel risk factors for diverticulitis.

PMID:38417057 | DOI:10.1097/MEG.0000000000002717

Lab Med. 2024 Feb 28:lmae003. doi: 10.1093/labmed/lmae003. Online ahead of print.

ABSTRACT

BACKGROUND: Despite stewardship efforts, laboratory testing overuse persists across medicine.

OBJECTIVES: To understand laboratory stewardship perceptions and testing patterns at a tertiary care pediatric hospital so that we could identify potential improvement opportunities.

METHODS: An electronic survey exploring laboratory stewardship was sent to all pediatric medicine resident and staff physicians. Laboratory testing data were also assessed for patterns of testing and overuse.

RESULTS: The survey response rate was 54% (43/80). The results indicated good familiarity with stewardship but poor familiarity with testing specifics (eg, cost). A mobile reference application was the most preferred quality improvement intervention, and online modules were the least desired. Overuse was apparent, with as many as 53% of laboratory tests being repeated within 7 days and only half of repeated tests subsequently yielding abnormal results.

CONCLUSIONS: Altogether, the data we collated demonstrated poor understanding of laboratory stewardship and substantial repeat testing with few abnormal results. These study findings suggest that laboratory stewardship is lacking at our center, and that multiple improvement opportunities exist.

PMID:38417046 | DOI:10.1093/labmed/lmae003

Photobiomodul Photomed Laser Surg. 2024 Feb 28. doi: 10.1089/photob.2023.0105. Online ahead of print.

ABSTRACT

Objective: To evaluate the therapeutic effect of a novel air-cooled Nd:YAG laser in the venous lakes of the lips (VLL). Background: The thermal injury is one of the most important issues during laser therapy for venous lakes. Methods: Six pieces of fresh pork livers were used to provide 30 regions with a diameter of 6 mm for experiment in vitro, among which 15 regions were treated by Nd:YAG laser with air cooling until the tissue turned gray-white, whereas the rest were treated without air cooling as control. The operation time of laser irradiation, the degree of temperature increase, and the depth of coagulation tissue were compared between two groups. Then, 60 VLL patients were selected for Nd:YAG laser treatment with or without air cooling. The operation time of laser irradiation, the degree of temperature increase, the postoperative pain visual analog scale (VAS) score, and the percentage of lesions removed within 1 month were compared. Results: In tissue studies, the treated group showed a longer operation time of laser irradiation (p < 0.01), a lower degree of temperature increase (p < 0.01), and there was no significant statistical difference in the depth of coagulation tissue (p = 0.624). In clinical studies, the treated group showed a longer operation time of laser irradiation (p < 0.01), a lower degree of temperature increase (p < 0.01), and a lower VAS score on the 1st and 2nd day, compared with the control group (p < 0.01). Conclusions: Air cooling during Nd:YAG laser for the treatment of VLL can prolong the surgical time, but lowered tissue temperature and reduced patient pain within 2 days under the premise of ensuring the treatment effect.

PMID:38417045 | DOI:10.1089/photob.2023.0105

J Womens Health (Larchmt). 2024 Feb 28. doi: 10.1089/jwh.2023.1021. Online ahead of print.

ABSTRACT

Background: Alcohol intake is associated with breast cancer (BC) risk, but estimates of greatest public health relevance have not been quantified in large studies with long duration. Materials and Methods: In this prospective cohort study of 39,811 women (median 25 years follow-up), we examined the association between alcohol consumption and BC incidence and mortality with adjusted hazard ratios (HRs), cubic splines, absolute risks, number needed to harm (NNH), and population-attributable fractions. Results: We documented 2,830 cases of BC, including 237 BC deaths. Each additional alcoholic drink/day was associated with a 10% higher rate (HR = 1.10, 95% confidence intervals [CIs]: 1.04-1.16) of total BC in a linear manner (p = 0.0004). The higher rate was apparent for estrogen receptor (ER)⁺ (HR = 1.12, 95% CI: 1.06-1.18) but not ER^– tumors (HR = 0.95, 95% CI: 0.82-1.10), with a statistically significant difference between these associations (p = 0.03). We constructed models comparing BC incidence among 100,000 women followed for 10 years. Compared to a scenario where all women rarely or never consumed alcohol, we expect 63.79 (95% CI: 58.35-69.24) more cases (NNH = 1,567) had all women consumed alcohol at least monthly and 278.66 (95% CI: 268.70-288.62) more cases (NNH = 358) had all women consumed >1 drink/day. Approximately 4.1% of BC cases were attributable to consumption exceeding one drink/month. Conclusion: Alcohol consumption is associated with a linear dose-response increase in BC incidence even within recommended limits of up to one alcoholic drink/day, at least for ER⁺ tumors. Our estimates of risk differences, attributable fraction, and NNH quantify the burden that alcohol consumption imposes on women in the general population. ClinicalTrials.gov Identifier: NCT00000479.

PMID:38417039 | DOI:10.1089/jwh.2023.1021

J Cardiovasc Pharmacol. 2024 Feb 27. doi: 10.1097/FJC.0000000000001547. Online ahead of print.

ABSTRACT

The influence of IL-17 inhibition on blood pressure in autoimmune disease patients remains inconclusive. Our objective is to examine the risk of hypertension in patients with autoimmune diseases undergoing IL-17 inhibition therapies via meta-analysis of randomized, placebo-controlled trials (RCTs). We obtained integrated data from PubMed, Embase, and ClinicalTrials.gov. Incident hypertension rates were calculated, and hazard ratios (HRs) with 95% confidence intervals (CIs) were analyzed, along with Ι^2 statistics to assess heterogeneity. Sequential analysis ensured conclusion reliability. In 30 RCTs involving 9,909 patients with diverse autoimmune diseases treated with anti-IL-17 agents, our meta-analysis revealed a significant increase in hypertension risk (RR 1.69, CI 1.24-2.31, p=0.001), robustly supported by trial sequential analysis. Among the four agents (secukinumab, ixekizumab, bimekizumab, and brodalumab), only secukinumab exhibited a notable association with hypertension. Patients with various primary autoimmune diseases, particularly those with psoriatic arthritis, had a higher likelihood of developing hypertension; in rheumatic arthritis patient cohorts, anti-IL-17 agents did not elevate hypertension risk. Prolonged treatment duration correlated with an increased hypertension risk. Stratifying by gender, studies with a female predominance demonstrated a higher risk ratio for hypertension compared to male-predominant studies. This highlights that anti-IL-17 treatment escalates hypertension risk, emphasizing the need for extra caution when managing autoimmune disease patients. (Registered by PROSPERO, CRD42016053112).

PMID:38417026 | DOI:10.1097/FJC.0000000000001547

J Breast Imaging. 2022 Dec 11;4(6):582-589. doi: 10.1093/jbi/wbac063.

ABSTRACT

OBJECTIVE: Establish a radiologist-run consultation clinic to review breast density and supplemental screening exams (SSEs) directly with patients in response to breast density reporting laws.

METHODS: Breast radiologists opened and staffed a clinic for formal patient consultations regarding breast density and SSEs. An IRB-approved questionnaire assessed patient knowledge of breast density, SSEs, and encounter satisfaction. Comparative statistical analyses were performed on knowledge-based questions.

RESULTS: From February 2019 to February 2021, 294 reimbursable consultations were performed with 215 patients completing pre- and post-consultation questionnaires (survey response rate, 73%). Median patient age was 58 years (range, 34-86 years) and 9% (19/210) had a personal history of breast cancer. An increase in patient knowledge of breast density and SSEs was observed as follows: breast density categories (9% correct pre-consultation (20/215), 86% correct post-consultation (185/215), P < 0.001), dense breast effects on cancer risk (39% correct pre-consultation (83/215), 84% post-consultation (180/215)), mammogram sensitivity (90% correct pre-consultation (193/215), 94% post-consultation (201/215)), and increased cancer detection with SSEs (82% correct pre-consultation (177/215), 95% post-consultation (205/215)) (P < 0.001). Post-consultation, 96% (200/209) were satisfied with the usefulness of information, 89% (186/209) strongly agreed they had sufficient knowledge of SSEs, and 81% (167/205) agreed they would like future opportunities to meet with a breast radiologist.

CONCLUSION: A consultation clinic staffed by breast radiologists focused on breast density and supplemental breast cancer screening can provide personalized patient counseling, engage patients in shared decision making, assist referring clinicians, and support high quality patient-centered care.

PMID:38416998 | DOI:10.1093/jbi/wbac063

J Breast Imaging. 2022 Dec 11;4(6):612-617. doi: 10.1093/jbi/wbac064.

ABSTRACT

OBJECTIVE: To evaluate intervention of structured reporting after wrong-site surgery that occurred after localization of an incorrect breast biopsy marker.

METHODS: An IRB-exempt retrospective database review identified patients who underwent core-needle biopsy of a breast lesion from July 1, 2014 to July 1, 2020. They were divided into three cohorts: 2014 pre-intervention/pre-sentinel, 2017 pre-intervention/post-sentinel, and 2019 post-intervention of structured reports. One hundred reports per cohort were reviewed for documentation of marker and shape. Statistical analysis was performed with mixed-effects logistic regression model and chi-squared test with P < 0.05 considered significant.

RESULTS: The 2014 cohort consisted of 100 patients with 122 biopsies. Twenty-seven (22.1%) were excluded: 5/122 (4.1%) lesion resolution, 22/122 (18.0%) no documentation whether marker was/was not placed. Of the 95 biopsies remaining, 4/95 (4.2%) had no marker placed, 62/95 (65.3%) reported marker only, and 29/95 (30.5%) reported marker and shape. In the 2017 cohort, 100 patients underwent 108 biopsies. Four/108 (3.7%) were excluded: lesion resolution. Of the 104, 10/104 (9.6%) had no marker placed, 22/104 (21.2%) reported marker only, and 72/104 (69.2%) reported marker and shape. In the 2019 cohort, 100 patients underwent 114 biopsies. Two/114 (1.8%) were excluded: lesion resolution. Of the 112, 3/112 (2.7%) had no marker placed, 3/112 (2.7%) reported marker only, and 106/112 (94.6%) reported marker and shape. The predicted probability of both marker placement and shape described were statistically greater for 2019 compared to the other cohorts (P < 0.05).

CONCLUSION: Using structured reports facilitates and improves documentation of breast biopsy markers and may potentially reduce the risk of medical errors.

PMID:38416997 | DOI:10.1093/jbi/wbac064

J Breast Imaging. 2022 Jul 29;4(4):392-399. doi: 10.1093/jbi/wbac036.

ABSTRACT

OBJECTIVE: To assess the frequency, management, and early outcomes of COVID-19 vaccine-related adenopathy on breast MRI.

METHODS: This IRB-exempt retrospective study reviewed patients who underwent breast MRI following COVID-19 vaccine approval in the U.S. from December 14, 2020, to April 11, 2021 (N = 1912) and compared patients who underwent breast MRI the year prior to the pandemic, March 13, 2019, to March 12, 2020 (N = 5342). Study indication, patient age, date of study, date and type of vaccination(s), time difference between study and vaccinations, lymph node-specific and overall management recommendations, and outcomes of additional examinations were recorded. Differences in the final assessment categories between the subjects scanned pre-pandemic and post-vaccine were compared using the Fisher exact test.

RESULTS: Vaccine-related adenopathy was mentioned in 67 breast MRI reports; only 1 in the pre-pandemic group. There were no clinically relevant differences in patient demographics between groups. There was a statistically significant increase in BI-RADS 0 assessments between the pre-pandemic and post-vaccine approval groups-0.8% (45/5342) versus 1.8% (34/1912) (P = 0.001) and BI-RADS 3 assessments-6.5% (348/5342) versus 9.2% (176/1912) (P < 0.0001). Of the 29 patients who underwent additional imaging (range, 2-94 days following MRI) and the 2 patients who underwent biopsy, 47% (31/66), none were found to have malignant adenopathy.

CONCLUSION: COVID-19 vaccination is associated with transient axillary adenopathy of variable duration. This leads to additional imaging in women undergoing breast MRI, so far with benign outcomes, and this may affect audits of outcomes of MRI.

PMID:38416988 | DOI:10.1093/jbi/wbac036