Nevin Manimala

Biom J. 2023 Aug 23:e2200370. doi: 10.1002/bimj.202200370. Online ahead of print.

ABSTRACT

Decentralized clinical trials (DCTs), that is, studies integrating elements of telemedicine and mobile/local healthcare providers allowing for home-based assessments, are an important concept to make studies more resilient and more patient-centric by taking into consideration participant’s views and shifting trial activities to better meet the needs of trial participants. There are however, not only advantages but also challenges associated with DCTs. An area to be addressed by appropriate statistical methodology is the integration of data resulting from a possible mix of home and clinic assessments at different visits for the same variable, especially in adjusting for sources of possible systematic differences. One source of systematic bias may be how a participant perceives their disease and treatment in their home versus in a clinical setting. In this paper, we will discuss these issues with a focus on Neuroscience when participants have the choice between home and clinic assessments to illustrate how to identify systematic biases and describe appropriate approaches to maintain clinical trial scientific rigor. We will describe the benefits and challenges of DCTs in Neuroscience and then describe the relevance of home versus clinic assessments using the estimand framework. We outline several options to enable home assessments in a study. Results of simulations will be presented to help deciding between design and analysis options in a simple scenario where there might be differences in response between clinic and home assessments.

PMID:37609878 | DOI:10.1002/bimj.202200370

Disaster Med Public Health Prep. 2023 Aug 23;17:e459. doi: 10.1017/dmp.2023.110.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the occurrence of the disease and research risk factors through sociodemographic data of children aged 0 to 15 years, with symptoms suggestive of COVID-19 in 3 Brazilian municipalities in an international border region.

METHODS: Epidemiological and RT-PCR test results were collected from the COVID-19 notification records in suspected children and adolescents from March 1 to August 31, 2020, in municipalities (Assis Chateaubriand, Tupãssi, and Formosa do Oeste) located in an international border region. The results obtained and the variables associated were subjected to statistical analysis using the Chi-Square Test (x²) or Fisher’s Exact Test, using the statistical program SPSS v. 21.0 (IBM Corp., Armonk, New York, USA) at the 5% significance level.

RESULTS: Among the 147 children from the 3 municipalities, 20 (13.60%) were diagnosed as positive. The predominance of cases was in male children (60.00%) and in children living in urban areas (80%). The most frequent symptoms observed in children were fever (65.00% of the cases), followed by headache (60.00%), cough (55.00%), and nasal congestion, as well as sore throat, both found in 35.00% of the cases.

CONCLUSION: All these data highlight the importance and the need for more epidemiological studies, especially in children and adolescents, as COVID-19 becomes part of the child health panorama worldwide, with serious direct and indirect impacts for humans, animals, and the environment.

PMID:37609851 | DOI:10.1017/dmp.2023.110

J Perinat Med. 2023 Aug 23. doi: 10.1515/jpm-2023-0234. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the impact of an Enhanced Recovery After Cesarean (ERAC) protocol on the post-cesarean recovery experience using a validated ten-item questionnaire (ERAC-Q).

METHODS: This is a prospective cohort study of patients completing ERAC quality-of-life questionnaires (ERAC-Q) during inpatient recovery after cesarean delivery (CD) between October 2019 and September 2020, before and after the implementation of our ERAC protocol. Patients with non-Pfannenstiel incision, ICU admission, massive transfusion, bowel injury, existing chronic pain disorders, acute postpartum depression, or neonatal demise were excluded. The ERAC-Q was administered on postoperative day one and day of discharge to the pre- and post-ERAC implementation cohorts, rating aspects of their recovery experience on a scale of 0 (best) to 10 (worst). The primary outcome was ERAC-Q scores. Statistical analysis was performed with SAS software.

RESULTS: There were 196 and 112 patients in the pre- and post-ERAC cohorts, respectively. The post-ERAC group reported significantly lower total ERAC-Q scores compared to the pre-ERAC group, reflecting fewer adverse symptoms and greater perceived recovery on postoperative day one (1.6 [0.7, 2.8] vs. 2.7 [1.6, 4.3]) and day of discharge (0.8 [0.3, 1.5] vs. 1.4 [0.7, 2.2]) (p<0.001). ERAC-Q responses did not predict the time to achieve objective postoperative milestones. However, worse ERAC-Q pain and total scores were associated with higher inpatient opiate use.

CONCLUSIONS: ERAC implementation positively impacts patient recovery experience. The administration of ERAC-Q can provide real-time feedback on patient-perceived recovery quality and how healthcare protocol changes may impact their experience.

PMID:37609844 | DOI:10.1515/jpm-2023-0234

Infect Control Hosp Epidemiol. 2023 Aug 23:1-6. doi: 10.1017/ice.2023.130. Online ahead of print.

ABSTRACT

BACKGROUND: Patients diagnosed with coronavirus disease 2019 (COVID-19) aerosolize severe acute respiratory coronavirus virus 2 (SARS-CoV-2) via respiratory efforts, expose, and possibly infect healthcare personnel (HCP). To prevent transmission of SARS-CoV-2 HCP have been required to wear personal protective equipment (PPE) during patient care. Early in the COVID-19 pandemic, face shields were used as an approach to control HCP exposure to SARS-CoV-2, including eye protection.

METHODS: An MS2 bacteriophage was used as a surrogate for SARS-CoV-2 and was aerosolized using a coughing machine. A simulated HCP wearing a disposable plastic face shield was placed 0.41 m (16 inches) away from the coughing machine. The aerosolized virus was sampled using SKC biosamplers on the inside (near the mouth of the simulated HCP) and the outside of the face shield. The aerosolized virus collected by the SKC Biosampler was analyzed using a viability assay. Optical particle counters (OPCs) were placed next to the biosamplers to measure the particle concentration.

RESULTS: There was a statistically significant reduction (P < .0006) in viable virus concentration on the inside of the face shield compared to the outside of the face shield. The particle concentration was significantly lower on the inside of the face shield compared to the outside of the face shield for 12 of the 16 particle sizes measured (P < .05).

CONCLUSIONS: Reductions in virus and particle concentrations were observed on the inside of the face shield; however, viable virus was measured on the inside of the face shield, in the breathing zone of the HCP. Therefore, other exposure control methods need to be used to prevent transmission from virus aerosol.

PMID:37609833 | DOI:10.1017/ice.2023.130

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