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Capturing and reporting topical treatment use in childhood eczema: lessons for data collection in eczema trials

Clin Exp Dermatol. 2024 Aug 17:llae328. doi: 10.1093/ced/llae328. Online ahead of print.

ABSTRACT

BACKGROUND: Emollients and topical corticosteroids (TCS) prevent and treat flares in eczema. However, topical treatment use is poorly recorded and reported in clinical trials. There is no clear consensus of how best to capture and summarise topical treatment use.

OBJECTIVES: To explore different ways of capturing and reporting topical treatment use in childhood eczema.

METHODS: Secondary data analysis using 450 participants from the Best Emollients for Eczema (BEE) trial. Participants were allocated to use one type of emollient (lotion, cream, gel, or ointment) ‘twice daily and when required’ for 16 weeks. Otherwise, clinical management remained unchanged. Parents completed weekly questions about topical therapy use and eczema symptoms. Two versions of topical treatment use questionnaires were used. The first (n=202, 44.9%) asked parents to report treatment use on days 1-7, starting completion on the day they were randomised. The second (n=248, 55.1%) reported use by day of the week (Monday to Sunday), starting completion the first Monday after randomisation. Both underwent Patient and Public Involvement (PPI) review, but the second version was tested more thoroughly using cognitive interviewing techniques, following parent feedback that questions on the first version were confusing. Descriptive statistics compared questionnaire completion and differences in emollient and TCS use.

RESULTS: Overall, questionnaire completion for both emollient and TCS use decreased with time: but at weeks 1 and 16 were 84.7% (381/450) and 58.9% (265/450) for emollient use, and 94.2% (424/450) and 80.4% (362/450) for TCS use, respectively. Fewer emollient use questionnaires were completed with first (33.5%) than the second (87.9%) version (p<0.001). TCS use questionnaire completion were similar for both (84.9% and 87.4%, p=0.002). We present different ways of summarising topical treatment use.

CONCLUSIONS: While questionnaire completion was similar for TCS use, emollient use data completeness was higher in the second version. When designing questionnaires, balancing the detail and complexity of questions is important, especially if being collected as a secondary outcome measure. Numerous ways of summarising the same data can provide different information. Future collection and reporting of treatment use should reflect specific trial aims.

PMID:39154354 | DOI:10.1093/ced/llae328

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Inpatient opioid prescribing patterns and their effect on rehospitalisations: a nested case-control study using data from a Swiss public acute hospital

Swiss Med Wkly. 2024 Aug 18;154:3391. doi: 10.57187/s.3391.

ABSTRACT

AIMS OF THE STUDY: Opioid prescriptions have increased in Switzerland, even though current guidelines warn of their harms. If opioids for postoperative analgesia are not tapered before hospital discharge, patients are at risk of adverse events such as constipation, drowsiness, dependence, tolerance and withdrawal. The aim of this study was to investigate and quantify the potential association between opioids prescribed at discharge from hospital and rehospitalisation.

METHODS: We conducted a nested case-control study using routinely collected electronic health records from a Swiss public acute hospital. Cases were patients aged 65 years or older admitted between November 2014 and December 2018, with documented opioid administration on the day of discharge and rehospitalisation within 18 or 30 days after discharge. Each case was matched to five controls for age, sex, year of hospitalisation and Charlson Comorbidity Index. We calculated odds ratios for 18-day and 30-day rehospitalisation based on exposure to opioids using a conditional logistic regression adjusted for potential confounders. Secondary analyses included stratifications into morphine-equivalent doses of <50 mg, 50-89 mg and ≥90 mg, and co-prescriptions of gabapentinoids and benzodiazepines.

RESULTS: Of 22,471 included patients, 3144 rehospitalisations were identified, of which 1698 were 18-day rehospitalisations and 1446 were 30-day rehospitalisations. Documented opioid administration on the day of discharge was associated with 30-day rehospitalisation after adjustment for confounders (adjusted odds ratio 1.48; 95% CI 1.25-1.75, p <0.001), while no difference was observed in the likelihood of 18-day rehospitalisation. The combined prescription of opioids with benzodiazepines or gabapentinoids and morphine-equivalent doses >50 mg were rare.

CONCLUSIONS: Patients receiving opioids on the day of discharge were 48% more likely to be readmitted to hospital within 30 days. Clinicians should aim to discontinue opioids started in hospital before discharge if possible. Patients receiving an opioid prescription should be educated and monitored as part of opioid stewardship programmes.

PMID:39154328 | DOI:10.57187/s.3391

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MRI-guided transrectal prostate laser ablation for benign prostatic hypertrophy: a retrospective cohort study

Radiol Med. 2024 Aug 18. doi: 10.1007/s11547-024-01855-2. Online ahead of print.

ABSTRACT

PURPOSE: To investigate whether MRI-guided transrectal laser ablation is safe and effective for the treatment of lower urinary tract symptoms caused by BPH.

MATERIALS AND METHODS: This single-center retrospective cohort study evaluated men who underwent MRI-guided transrectal laser ablation for BPH between February 2017 and July 2021. Age, prostate-specific antigen, prostate volume, prior surgical BPH treatments if any, International Prostate Symptom Score (IPSS) and Sexual Health Inventory of Men (SHIM) were collected. The primary outcome measures assessed were change in IPSS and SHIM 6, 12 and 24 months after laser ablation and adverse events.

RESULTS: Fifty-two patients were included, having completed at least one follow-up survey. The mean patient age was 62.9 ± 5.7 years, and mean prostate volume was 80.2 ± 39.2 cc. Eighteen patients (34.6%) had received a prior BPH treatment. The IPSS scores dropped an average of 16.7 ± 7.0 (p < 0.001), 16.9 ± 7.5 (p < 0.001) and 17.1 ± 7.2 (p < 0.001) points from baseline at 6, 12 and 24 months, respectively. There was no statistically significant difference in IPSS score drop between patients who had received a prior BPH procedure and those who had not (p = 0.628). The SHIM scores showed a statistically insignificant increase at all time points. Nineteen patients (36.5%) reported a complication. There were 12 grade II complications (23%) and seven grade I complications (13.5%). There were no grade III or higher complications.

CONCLUSION: Transrectal MRI-guided focal laser ablation is safe and effective for the treatment of lower urinary tract symptoms caused by BPH, with a significant improvement in symptom severity after 2 years.

PMID:39154318 | DOI:10.1007/s11547-024-01855-2

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Association of tumor-infiltrating lymphocytes with clinical outcomes in patients with triple-negative breast cancer receiving neoadjuvant chemotherapy: a systematic review and meta-analysis

Clin Transl Oncol. 2024 Aug 18. doi: 10.1007/s12094-024-03661-8. Online ahead of print.

ABSTRACT

OBJECTIVE: Triple-negative breast cancer (TNBC) presents a clinical challenge as an aggressive tumor, correlated with unfavorable prognosis. Tumor-infiltrating lymphocytes (TILs) have garnered interest as a potential prognostic biomarker. However, the disparity in outcomes between varying TILs rates remains inadequately explored.

METHODS: PubMed, Scopus, Web of Science, and Cochrane databases were searched for studies about the prognostic value of TILs in patients with TNBC receiving neoadjuvant chemotherapy. The hazard ratios (HRs) or odds ratios (ORs) were computed for binary endpoints, with 95% confidence intervals (CIs).

RESULTS: Twenty-nine studies were included, involving a population of six thousand one hundred sixty-one (80.41%) with TNBC. The cut-off TILs value ranged from 10 to 60%, with 50% being the most related value. Compared with the low-TIL expression group, the disease-free survival (DFS) (HR 0.71; 95% CI 0.61-0.82; p < 0.00001) and overall survival (OS) (HR 0.76; 95% CI 0.63-0.90; p = 0.002) rates showed significant improvement with higher TIL infiltrations. In the subgroup analyses of the lymphocyte subtypes CD4 + and CD8 + , there was statistical significance favoring higher TILs rates in both subtypes, each associated with improved DFS (HR 0.48; 95% CI 0.33-0.71; p = 0.0002) and OS (HR 0.53; 95% CI 0.36-0.78; p = 0.001), regardless of which cell subtype was predominantly infiltrated. The complete pathological response analysis showed better rates for the higher TIL group than the control for both the TIL (OR 1.29; 95% CI 1.13-1.48; p = 0.0003) and Ki-67 (OR 2.74; 95% CI 2.01-3.73; p < 0.00001) analyses.

CONCLUSION: Higher expressions of TILs in patients with TNBC were associated with improved significantly DFS, OS, and pCR outcomes.

PMID:39154313 | DOI:10.1007/s12094-024-03661-8

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Dispensed drugs during pregnancy in outpatient care between 2015 and 2021 in Switzerland: a retrospective analysis of Swiss healthcare claims data

Swiss Med Wkly. 2024 Aug 12;154:3616. doi: 10.57187/s.3616.

ABSTRACT

AIM OF THE STUDY: We aimed to evaluate the utilisation of all prescribed drugs during pregnancy dispensed in outpatient care in Switzerland between 2015 and 2021.

METHODS: We conducted a descriptive study using the Swiss Helsana claims database (2015-2021). We established a cohort of pregnancies by identifying deliveries and estimating the date of the last menstrual period. We analysed the drug burden during a 270-day pre-pregnancy period, during pregnancy (overall and by trimester), and during a 270-day postpartum period. Subsequently, we quantified 1) the median number of drug dispensations (total vs. unique drug claims); and 2) the prevalence of exposure to at least one dispensed drug and the number of dispensed drugs (0, 1, 2, 3, 4, and ≥5); and 3) the 15 most frequently dispensed drugs were identified during each period, overall and stratified by maternal age.

RESULTS: Among 34,584 pregnant women (5.6% of all successful pregnancies in Switzerland), 87.5% claimed at least one drug (not including vitamins, supplements, and vaccines), and 33.3% claimed at least five drugs during pregnancy. During trimester 1 alone, 8.2% of women claimed at least five distinct drugs. The proportion of women who claimed prescribed drugs was lower pre-pregnancy (69.1%) and similar postpartum (85.6%) when compared to during pregnancy (87.5%). The most frequently claimed drugs during pregnancy were meaningfully different during pregnancy than before and after.

CONCLUSIONS: This study suggests that 8 of 10 women in Switzerland are exposed to prescribed drugs during pregnancy. Most drugs dispensed during pregnancy are comparatively well investigated and are considered safe. However, the high drug burden in this vulnerable patient population underlines the importance of evidence on the benefit-risk profile of individual drugs taken during pregnancy.

PMID:39154296 | DOI:10.57187/s.3616

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Modern predictors and management of incidental prostate cancer at holmium enucleation of prostate

Prostate. 2024 Aug 18. doi: 10.1002/pros.24781. Online ahead of print.

ABSTRACT

BACKGROUND: To evaluate contemporary preoperative risk factors and subsequent postoperative management of incidental prostate cancer (iPCa) and incidental clinically significant prostate cancer (icsPCa, Grade Group [GG] ≥ 2 PCa).

METHODS: A retrospective cohort of 811 men undergoing Holmium enucleation of the prostate (HoLEP) (January 2021-July 2022) were identified. Advanced preoperative testing was defined as prostate health index (PHI), prostate MRI, and/or negative preoperative biopsy. Descriptive statistics (Whitney-Mann U test, Chi-squared test) and multivariable logistic regression were performed.

RESULTS: iPCa and icsPCa detection rates were 12.8% (104/811) and 4.4% (36/811), respectively. Advanced preoperative testing (406/811, 50%) was associated with younger age and higher (prostate specific antigen) PSA, prostate volume, and PSA density. On multivariable analysis, PHI ≥ 55 was associated with iPCa (OR 6.91, 95% CI 1.85-26.3, p = 0.004), and % free PSA (%fPSA) was associated with icsPCa (OR 0.83, 95% CI 0.67, 0.94, p = 0.01). GG1 disease comprised the majority of iPCa (65%, 68/104) with median 1% involvement. iPCa patients were followed with active surveillance (median follow up 9.3 months), with higher risk patients receiving prostate MRI and confirmatory biopsy. Three patients proceeded to radical prostatectomy or radiation.

CONCLUSIONS: In the era of MRI and advanced biomarkers, the majority of iPCa following HoLEP is low volume GG1 suitable for active surveillance. A tentative follow-up strategy is proposed. Patients with PHI ≥ 55 or low %fPSA, even with negative prostate MRI, can consider preoperative prostate biopsy before HoLEP.

PMID:39154284 | DOI:10.1002/pros.24781

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Study of electrocardiographic corrected QT interval and QT dispersion abnormalities, erythrocyte sedimentation rate, serum uric acid in patients with systemic lupus erythematosus

Lupus. 2024 Aug 18:9612033241274599. doi: 10.1177/09612033241274599. Online ahead of print.

ABSTRACT

INTRODUCTION: Systemic Lupus Erythematosus (SLE) is an autoimmune disease having a variety of clinical symptoms because of multiple organs being affected at once or progressively over time. Cardiovascular system (CVS) involvement is the third most frequent cause of death in SLE, among other factors. The prognosis can be determined by looking at QT interval measurements, which have shown an elevated risk of mortality from cardiovascular causes.

METHODS: A case-control study was conducted on 80 patients (40 SLE patients and 40 controls) for a duration of 16 months. SLE patients and controls were identified from the general medicine and rheumatology outpatient department (OPD) based on the inclusion criteria. A thorough clinical examination was performed after obtaining a detailed clinical history. Baseline blood tests were then performed on the SLE patients and ECG was taken from both cases and controls. The serum uric acid level was measured using an automated analyzer, and the ESR was computed using Westergren’s Method. The corrected QT interval (QTc) was estimated using Bazett’s method. All the collected data were compared and analyzed using IBM SPSS Statistics version 23.0.

RESULTS: The majority of age distribution among SLE patients and controls was 21-25 years (37.5%) (Mean – 15.7 ± 14.9 years). Duration of SLE was predominantly reported between 1 and 12 months (62.5%). Very high (40%) and high (40%) lupus disease activity was recorded in the majority as per the SELENA-SLEDAI score. There was a significant difference between QTc values among SLE patients and controls (t- 8.117) (p-.0005). Upon correlating SLEDAI with the QTc, QTd, ESR, and Uric acid parameters among the SLE patients, ESR parameters were found to be moderately correlated (r-0.460) with the SLEDAI which was statistically significant (p– .003).

CONCLUSION: QTc interval and ESR values can be a simple and potential method for early detection of cardiac involvement in SLE patients with active disease activity. This will not only facilitate early diagnosis of disease activity, but it will also provide an affordable and accessible avenue for low and middle-income countries to decrease the SLE burden.

PMID:39154283 | DOI:10.1177/09612033241274599

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Comparative analysis of natural resistance-associated macrophage protein 1 gene expression and anti-PGL-1 antibodies in multibacillary leprosy and household contacts

Trop Biomed. 2024 Jun 1;41(2):214-219. doi: 10.47665/tb.41.2.013.

ABSTRACT

Leprosy continues to pose a significant challenge to public health, particularly in certain global regions. Accurate diagnosis and understanding of the disease’s etiology are crucial for effective management and prevention. This study aimed to explore the contribution of Natural resistance-associated macrophage protein 1 (NRAMP1) and its genetic variations, as well as the levels of anti-PGL-1 antibodies, to the pathology of multibacillary leprosy in affected individuals and their household contacts. The study included 23 multibacillary leprosy patients and 28 household contacts. NRAMP1 protein expression and anti-PGL-1 IgG and IgM levels were measured using PCR and ELISA techniques, respectively. Genotypic variants of the NRAMP1 gene were also examined. Statistical analyses, including Mann-Whitney tests and univariate logistic regression, were employed to evaluate the data. Significant differences were observed in NRAMP1 protein expression and IgG and IgM levels between the patient and household contact groups. The study also highlighted the role of the NRAMP1 gene and its D543N and 3’UTR polymorphisms in leprosy susceptibility. No significant differences were observed in the genotype variants of INT4 between the two groups. These findings emphasize the potential of integrating PCR technology with serological tests to enhance diagnostic precision in leprosy. They also suggest the need for further research to clarify the role of NRAMP1 and its polymorphisms in leprosy susceptibility and resistance.

PMID:39154276 | DOI:10.47665/tb.41.2.013

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Localised 0.2% chlorhexidine irrigation delivery system versus oral antibiotics in reducing postoperative complications in the surgical extraction of impacted mandibular third molar (IMTM). – a randomised controlled trial

Med Oral Patol Oral Cir Bucal. 2024 Aug 18:26676. doi: 10.4317/medoral.26676. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of the study was to compare the efficacy of the use of 0.2% chlorhexidine irrigation and the oral antibiotics for the prevention of postoperative complication like pain, trismus, swelling and infection after the surgical extraction of IMTM.

MATERIAL AND METHODS: A randomised, double blinded clinical trial was planned with two equal groups. Patients were randomly divided into two groups using computer-generated codes with an allocation ratio of 1:1. Group I (Control): Standard preoperative and postoperative systemic oral antibiotics and Group II (Study): No systemic antibiotics and Chlorhexidine irrigation local delivery. The primary outcomes evaluated were postoperative pain, mouth opening, swelling and infection. The secondary outcome variables were the number of analgesics and antibiotics taken by the patient in the postoperative period, the satisfaction of the patient and adverse events, were followed up regulary for 7 days postoperatively.

RESULTS: A total of 84 patients, divided into two equal groups participated in the study. In intergroup comparison of swelling, the difference was non-significant on postoperative day (POD) 1 and 7, except for POD 3, where it showed significantly lower results in the antibiotic group (p = 0.012). However, there was no significant difference in pain found between both groups at any of the postoperative time points, and the study group had a lesser need for rescue analgesics than the control group. A statistically significant difference in incidence of dry socket was observed (p = 0.03) and gastrointestinal adverse symptoms, but it showed insignificant results for wound dehiscence and pus discharge. Also, patient satisfaction was higher in the study group.

CONCLUSIONS: both antibiotics and localised delivery demonstrated comparable results in terms of swelling, pain and trismus. However, with lesser adverse events, the localised chlorhexidine delivery with curved tips outperformed the antibiotic group.

PMID:39154253 | DOI:10.4317/medoral.26676

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Predictors of permanent pacemaker implantation for transcatheter self-expandable aortic valve implant in the cusp overlap era

Catheter Cardiovasc Interv. 2024 Aug 18. doi: 10.1002/ccd.31176. Online ahead of print.

ABSTRACT

BACKGROUND: Predictors of permanent pacemaker implantation (PPMI) after self-expanding transcatheter aortic valve implant (TAVI) were described. Is unknown if PPMI predictors remain in the era of high implants using the cusp overlap (COP).

METHODS: Single-center, prospective, consecutive case series of patients undergoing self-expanding TAVI with the COP approach. The status of PPMI and other clinical events were ascertained at 30 days.

RESULTS: A total of 261 patients were included (84% with Evolut, n = 219). Implant depth >4 mm was infrequent (13.8%). TAVI depth (OR 1.259; p = 0.005), first or second-degree auriculo-ventricular block (OR 3.406; p = 0.033), right-bundle (OR 15.477; p < 0.0001), and incomplete left-bundle branch block (OR 7.964; p = 0.036) were found to be independent predictors of PPMI. The risk of PPMI with deep implant and no electrical disturbances was 3%, and 0% with high implant and no prior electrical disturbances. Those who received PPMI had no statistically significant increased risk of death, myocardial infarction, stroke, bleeding events, or vascular complications at 30 days, but longer hospital stay (mean difference 1.43 days more, p = 0.003).

CONCLUSIONS: Implant depth and prior conduction abnormalities remain the main predictors of PPMI using self-expanding TAVI in the COP era. Patients with high implants and no prior conduction abnormalities may be candidates for early discharge after uneventful self-expanding TAVI, while the rest may need inpatient monitoring regardless of achieving a high implant. The need for PPMI was associated with longer hospital stays.

PMID:39154247 | DOI:10.1002/ccd.31176