Psychol Med. 2023 Aug 23:1-3. doi: 10.1017/S0033291723002490. Online ahead of print.
NO ABSTRACT
PMID:37609792 | DOI:10.1017/S0033291723002490
Psychol Med. 2023 Aug 23:1-3. doi: 10.1017/S0033291723002490. Online ahead of print.
NO ABSTRACT
PMID:37609792 | DOI:10.1017/S0033291723002490
Histopathology. 2023 Aug 23. doi: 10.1111/his.15032. Online ahead of print.
ABSTRACT
AIMS: The LUMINA trial demonstrated a very low local recurrence rate in women ≥55 years with low-risk luminal A breast cancer (defined as grade I-II, T1N0, hormone receptor positive, HER2 negative and Ki67 index ≤13.25%) treated with breast-conserving surgery and endocrine therapy (but no other systemic therapy), supporting the safe omission of radiation in these women. Here we describe the protocol for Ki67 assessment, the companion diagnostic used to guide omission of adjuvant radiotherapy.
METHODS: Ki67 immunohistochemistry was performed on full-face sections at one of three regional labs. Pathologists trained in the International Ki67 in Breast Cancer Working Group (IKWG) method demarcated tumour areas on scanned slides and scored 100 nuclei from each of at least five randomly selected 1-mm fields. For cases with high Ki67 heterogeneity, further virtual cores were selected and scored in order to confidently assign a case as luminal A (≤13.25%) or B (>13.25%). Interlaboratory variability was assessed through an annual quality assurance programme during the study period.
RESULTS: From the quality assurance programme, the mean Ki67 index across all cases/labs was 13%. The observed intraclass correlation coefficient (ICC) and kappa statistics were ≥0.9 and ≥0.7, respectively, indicating a substantial level of agreement. Median scoring time was 4 min per case. The IKWG-recommended scoring method, performed directly from slides, requiring up to four scored fields, is concordant with the LUMINA scoring method (ICC ≥ 0.9).
CONCLUSION: Ki67 is a practical, reproducible, and inexpensive biomarker that can identify low-risk luminal A breast cancers as potential candidates for radiation de-escalation.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT01791829.
PMID:37609778 | DOI:10.1111/his.15032
J Acupunct Meridian Stud. 2023 Aug 31;16(4):139-151. doi: 10.51507/j.jams.2023.16.4.139.
ABSTRACT
BACKGROUND: Fibromyalgia is a syndrome of chronic, generalized muscular pain, accompanied by sleep disturbances, fatigue and cardic autonomic dysfunction that will affect the quality of life. There is currently no gold standard treatment. There are limitations of studies with electroacupuncture in auricular acupuncture.
OBJECTIVES: We evaluate the effects of systemic electroacupuncture (EA) with frequencies of 2/100 Hz associated of auricular acupuncture with a Nogier frequency (2.28, 4.56 and 9.12 Hz) for pain intensity, heart rate variability (HRV), and quality of life in fibromyalgia.
METHODS: Randomized clinical trial, a pilot study. Eighteen volunteers were randomized into a control group (CG, n = 9) and an experimental group (EG, n = 9). Six systemic EA sessions systemic and auricular were applied in the EG for 20 min, twice a week, for six weeks consecutive. The Numerical Pain Assessment Scale (NPRS), 2010 diagnostic criteria of the American College of Rheumatology (FDC 2010), Fibromyalgia Impact Questionnaire (FIQ) and analysis of HRV were the instruments used. The independent t-test compared to the groups was applied.
RESULTS: There was no statistically significant difference for the primary outcome for NPRS (p > 0.05). In the secondary outcome there was a significant difference in the total score and in some FIQ domains (p = 0.008) and some variables such as pain (p = 0.02) and anxiety (p = 0.006). There was no significant difference for the FDC 2010 and HRV variables (p > 0.05).
CONCLUSION: 2/100 Hz systemic EA associated with the Nogier frequency positively influenced some quality of life variables; however, pain intensity, diagnostic criteria, and HRV variables did not change.
PMID:37609769 | DOI:10.51507/j.jams.2023.16.4.139
Asian Cardiovasc Thorac Ann. 2023 Aug 23:2184923231197022. doi: 10.1177/02184923231197022. Online ahead of print.
ABSTRACT
BACKGROUND: Aortic valve diseases are life-threatening conditions with increasing prevalence worldwide. Risk factors include gender, age, hypertension, dyslipidemia, and type 2 diabetes. Obesity is closely related to these risk factors and has been linked to a higher risk of developing aortic valve diseases. However, there is no specific guideline for managing aortic valve disease in patients with obesity, and the choice of valve type remains uncertain.
METHODS: A total of 130 patients with obesity who met the inclusion criteria underwent surgical aortic valve replacement. The patients were divided into two groups based on the type of prosthesis used. Among the study cohort, 50 patients received a bioprosthetic valve, while 80 patients received a mechanical valve. We compared these groups in terms of perioperative characteristics and follow-up results. Statistical significance was determined using a p-value threshold of 0.05.
RESULTS: There were no significant differences in age, gender, body mass index, or cardiac comorbidities between the two groups. Preoperative blood results and echo findings also showed no significant differences. Intraoperative characteristics and postoperative outcomes, including mortality and acute kidney injury, did not differ significantly between the groups. In addition, BHVG patients had shorter ICU stays compared to MHVG patients without significance.
CONCLUSION: Deliberate consideration is crucial when selecting valves for obese patients, particularly those with class II obesity. This is due to the potential influence of obesity on valve types, as well as the need to account for the possibility of bariatric surgery and its potential effects.
PMID:37609760 | DOI:10.1177/02184923231197022
Indian J Dermatol Venereol Leprol. 2023 Jul 21:1-10. doi: 10.25259/IJDVL_854_2022. Online ahead of print.
ABSTRACT
Background The effect of NDYag on normal skin flora and pathogenic microbes has not been studied. Objectives Evaluation of immediate (before versus after each session) and delayed (pre-first session versus pre-fourth session) antimicrobial effect of Nd:YAG laser-assisted hair removal. Methods Thirty females scheduled for axillary Nd:YAG laser hair removal were included. Skin swabs were collected from the vault of the dominant axilla before and after each of the four sessions. Bacteriological cultures were performed to record the counts of total aerobes, total anaerobes, lipophilic bacteria, total staphylococci, Staphylococcus epidermidis (S. epidermidis), S. saprophyticus, S. hominis, and S. aureus. Reported changes in sweat odour and folliculitis (if present) were recorded. Results S.hominis was the predominant species in all subjects before and after all sessions. Counts of total aerobes, total anaerobes, lipophilic bacteria, total staphylococci, and S.hominis significantly decreased after all 4 sessions. A significant reduction was noted in the median colony counts before the fourth session as compared to the baseline count before the first session in total aerobes (278.9 versus 126.3 × 105 CFU/cm2, p = 0.003), total anaerobes (338.7 versus 103.7 × 105 CFU/cm2, p = 0.002) and total staphylococci (248.5 versus 105.0 × 105 CFU/cm2, p = 0.004). Most subjects reported worsened or unchanged axillary sweat odour. There was a statistically significant positive correlation between sweat odour and the counts of total aerobes (r = 0.433, p = 0.017), total anaerobes (r = 0.377, p = 0.040), total staphylococci (r = 0.383, p = 0.036) and S.hominis (r = 0.497, p = 0.005) ; lower counts were associated with a worsened odour. Limitations Small sample size; few laser sessions; short follow-up; subjective assessment of sweat odor and quantity. Conclusions Laser caused an immediate and delayed reduction in axillary aerobes, anaerobes, lipophilic bacteria, and staphylococci. This form of dysbiosis might lead to sweat odour changes.
PMID:37609732 | DOI:10.25259/IJDVL_854_2022
Indian J Dermatol Venereol Leprol. 2023 Aug 10:1-6. doi: 10.25259/IJDVL_20_2023. Online ahead of print.
ABSTRACT
Background Direct immunofluorescence (DIF) is essential for the diagnosis of sub-epidermal immunobullous diseases (SIBD). Bullous pemphigoid (BP), a sub-epidermal immunobullous disease, shows linear IgG and C3 deposition along the dermo-epidermal junction by DIF. However, similar histological and DIF findings are also seen in epidermolysis bullosa acquisita (EBA). High-power examination of antibody deposition by DIF in a “u” or “n” serrated pattern can help differentiate these two entities. Aims/Objectives The aim of this study was to determine the diagnostic accuracy of serration patterns in IgG-mediated sub-epidermal immunobullous disease. Methods All cases of IgG-mediated sub-epidermal immunobullous disease diagnosed over the past 2 years and 9 months period and confirmed serologically, were included. Examination of the serration pattern in DIF was assessed on oil emersion. Salt split skin indirect immunofluorescence (SSS IIF), BP180 enzyme-linked immunosorbent assay (ELISA), profile ELISA and BIOCHIP mosaic were performed, wherever available. Results This study included 74 cases of bullous pemphigoid, eight cases of mucus membrane pemphigoid (MMP) and one case of epidermolysis bullosa acquisita. The characteristic zigzag “n” pattern was visualised in 66 out of 82 cases (80.5%) of the pemphigoid group (BP + MMP); the single epidermolysis bullosa acquisita case showed the “u” serrated pattern. No statistical correlation was seen between serration pattern and BP180 positivity by ELISA (P = 0.05). Limitations The study is limited by the single case of epidermolysis bullosa acquisita (which could be due to rarity of this disease in north Indian population due to genetic variation), lack of detailed serological investigations and immunoblot in all cases. Conclusion Serration pattern analysis is an easy-to-interpret and highly useful technique for characterisation of sub-epidermal immunobullous diseases.
PMID:37609723 | DOI:10.25259/IJDVL_20_2023
Child Care Health Dev. 2023 Aug 23. doi: 10.1111/cch.13165. Online ahead of print.
ABSTRACT
BACKGROUND: The aim of this study was to investigate the associations between screen time from ages 2 to 4 years and child neurodevelopment at age 4.
METHODS: The participants were from the 2004 (N = 3787) and 2015 (N = 3604) Pelotas (Brazil) birth cohort studies. Childhood neurodevelopment was assessed at age 4 using the Battelle Development Inventory. The time children spent on screen devices was reported by their guardians at ages 2 and 4 years. Linear regression models were used to investigate the association of: (i) time spent on television at ages 2 and 4 years; (ii) time spent on other screens at age 4; and (iii) total screen time at age 4 (television + other screens) with childhood neurodevelopment at age 4.
RESULTS: Average daily screen time among children born in 2004 and those born in 2005 aged 4 years were 3.4 (SD: 2.4) and 4.4 h (SD: 2.9), respectively. Overall, few associations of very small magnitude between screen time and child neurodevelopment were observed. Television time at 2 years of age was statistically associated with lower neurodevelopment at 4 years of age in the 2015 cohort (β = -0.30, 95%CI = -0.55; -0.05). Conversely, television time (β = 0.17, 95%CI = 0.07, 0.26) and total screen time (β = 0.22, 95%CI = 0.13, 0.31) at age 4 were associated with higher neurodevelopment at age 4 in the 2004 cohort.
CONCLUSIONS: The findings of this study suggest that the amount of time spent on screen devices might not be associated with neurodevelopment of children under 5 years of age. The small magnitude and inconsistencies in the direction of associations did not find evidence to support the current guidelines for screen time at this age. Therefore, more studies, especially those with longitudinal data, are important to comprehend the true effect of screen time on neurodevelopment and other health outcomes.
PMID:37609715 | DOI:10.1111/cch.13165
J Biol Rhythms. 2023 Aug 23:7487304231194663. doi: 10.1177/07487304231194663. Online ahead of print.
NO ABSTRACT
PMID:37609713 | DOI:10.1177/07487304231194663
Ophthalmic Physiol Opt. 2023 Aug 23. doi: 10.1111/opo.13216. Online ahead of print.
ABSTRACT
PURPOSE: To validate Pediatric Refractive Error Profile 2 (PREP2) subscales that can be used to evaluate contact lens wearers and compare vision-specific quality of life measurements between children wearing multifocal and single vision contact lenses for 2 weeks.
METHODS: Two hundred and ninety-four myopic children aged 7-11 years (inclusive) were enrolled in the 3-year, double-masked Bifocal Lenses In Nearsighted Kids (BLINK) Study. Participants completed the PREP2 survey after having worn contact lenses for 2 weeks. The Vision, Symptoms, Activities and Overall PREP2 subscales were used to compare participants’ subjective assessment while wearing +1.50 or +2.50 D add multifocal or single vision contact lenses. Rasch analysis was used to validate each subscale and to compare participants’ subjective assessment of contact lens wear.
RESULTS: Item fit to the Rasch model was good for all scales, with no individual items having infit mean square statistics outside the recommended range (0.7-1.3). Response category function was acceptable for all subscales, with ordered category thresholds. Measurement precision, assessed by the Rasch person reliability statistic, was less than ideal (≥0.8) for three of the subscales, but met the minimum acceptable standard of 0.5. Scores for the Vision subscale differed by treatment assignment (p = 0.03), indicating that participants with the highest add power reported statistically worse quality of vision, although the difference was only 3.9 units on a scale of 1-100. Girls reported fewer symptoms than boys (p = 0.006), but there were no other differences between boys and girls.
CONCLUSIONS: Rasch analysis demonstrates that the PREP2 survey is a valid instrument for assessing refractive error-specific quality of life. These results suggest that vision-related quality of life is not meaningfully affected by 2 weeks of soft multifocal contact lens wear for myopia control.
PMID:37609711 | DOI:10.1111/opo.13216
Pharmacoepidemiol Drug Saf. 2023 Aug 23. doi: 10.1002/pds.5681. Online ahead of print.
ABSTRACT
BACKGROUND: Adverse drug reactions (ADRs) are common and a leading cause of injury. However, information on ADR risks of individual medicines is often limited. The aim of this hypothesis-generating study was to assess the relative importance of ADR-related and emergency hospital admission for large group of medication classes.
METHODS: This study was a propensity-matched case-control study in English primary care. Data sources were Clinical Practice Research Databank and Aurum with longitudinal, anonymized, patient level electronic health records (EHRs) from English general practices linked to hospital records. Cases aged 65-100 with ADR-related or emergency hospital admission were matched to up to six controls by age, sex, morbidity and propensity scores for hospital admission risk. Medication groups with systemic administration as listed in the British National Formulary (used by prescribers for medication advice). Prescribing in the 84 days before the index date was assessed. Only medication groups with 50+ cases exposed were analysed. The outcomes of interest were ADR-related and emergency hospital admissions. Conditional logistic regression estimated odds ratios (ORs) and 95% confidence intervals (CI).
RESULTS: The overall population included 121 546 cases with an ADR-related and 849 769 cases with emergency hospital admission. The percentage of hospitalizations with an ADR-related code for admission diagnosis was 1.83% and 6.58% with an ADR-related code at any time during hospitalization. A total of 137 medication groups was included in the main ADR analyses. Of these, 13 (9.5%) had statistically non-significant adjusted ORs, 58 (42.3%) statistically significant ORs between 1.0 and 1.5, 37 (27.0%) between 1.5-2.0, 18 (13.1%) between 2.0-3.0 and 11 (8.0%) 3.0 or higher. Several classes of antibiotics (including penicillins) were among medicines with largest ORs. Evaluating the 14 medications most often associated with ADRs, a strong association was found between the number of these medicines and the risk of ADR-related hospital admission (adjusted OR of 7.53 (95% CI 7.15-7.93) for those exposed to 6+ of these medicines).
CONCLUSIONS AND RELEVANCE: There is a need for a regular systematic assessment of the harm-benefit ratio of medicines, harvesting the information in large healthcare databases and combining it with causality assessment of individual case histories.
PMID:37609702 | DOI:10.1002/pds.5681