Nevin Manimala

Postgrad Med J. 2021 Nov 23:postgradmedj-2021-140835. doi: 10.1136/postgradmedj-2021-140835. Online ahead of print.

ABSTRACT

BACKGROUND: To explore the potential risk factors predicting malignancy in patients with indeterminate incidental mammographic microcalcification and to evaluate the short-term risk of developing malignancy.

METHODS: Between January 2011 and December 2015, one hundred and fifty (150) consecutive patients with indeterminate mammographic microcalcifications who had undergone stereotactic biopsy were evaluated. Clinical and mammographic features were recorded and compared with histopathological biopsy results. In patients with malignancy, postsurgical findings and surgical upgrade, if any, were recorded. Linear regression analysis (SPSS V.25) was used to evaluate significant variables predicting malignancy. OR with 95% CIs was calculated for all variables. All patients were followed up for a maximum of 10 years. The mean age of the patients was 52 years (range 33-79 years).

RESULTS: There were a total of 55 (37%) malignant results in this study cohort. Age was an independent predictor of breast malignancy with an OR (95% CI) of 1.10 (1.03 to 1.16). Mammographic microcalcification size, pleomorphic morphology, multiple clusters and linear/segmental distribution were significantly associated with malignancy with OR (CI) of 1.03 (1.002 to 1.06), 6.06 (2.24 to 16.66), 6.35 (1.44 to 27.90) and 4.66 (1.07 to 20.19). The regional distribution of microcalcification had an OR of 3.09 (0.92 to 10.3), but this was not statistically significant. Patients with previous breast biopsies had a lower risk of breast malignancy than patients with no prior biopsy (p=0.034).

CONCLUSION: Multiple clusters, linear/segmental distribution, pleomorphic morphology, size of mammographic microcalcifications and increasing age were independent predictors of malignancy. Having a previous breast biopsy did not increase malignancy risk.

PMID:34815330 | DOI:10.1136/postgradmedj-2021-140835

Respir Care. 2021 Nov 23:respcare.09518. doi: 10.4187/respcare.09518. Online ahead of print.

ABSTRACT

BACKGROUND: Although quality control standards are recommended to ensure accurate test results, the coefficient of variation for the FVC and FEV₁ biologic quality control (BioQC) is not specified. The primary aim of this study was to evaluate variations in spirometry BioQCs in a large and diverse cohort of individuals to determine an acceptable standard for the coefficient of variation.

METHODS: The FVC and FEV₁ biologic control data were secondary analyses from an inhaled medication trial that was conducted over 3 y ending in 2018 that included 114 laboratories. Results were sent to a central repository for expert review. The FVC and FEV₁ coefficients of variation were based upon a minimum of 10 spirometry values annually separated by at least 5 d. A second method of computing the coefficient of variation used 10 values within 28 d. Descriptive statistics were computed. Wilcoxon signed-rank tests were conducted to compare whether the median coefficient of variation values between the 2 methods differed, tested at α = 0.05 using SPSS.

RESULTS: Of 249 biologic control participants, 170 met the first year’s inclusion criteria. The coefficient of variation for the 5-d separated method was < 5% for 94.1% of FVC and 93.5% of FEV₁ values in the first year. By year 3, 90% of FVC and FEV₁ coefficient of variation values were < 4%. The medians for the 5-d separated and the 28-d measure showed no difference for either FVC coefficient of variation or FEV₁ coefficient of variation, Z = -1.764, P = .78, and Z = -0.980, P = .33, respectively.

CONCLUSIONS: Interlab biologic control variation values of < 4% for FVC and FEV₁ are achievable; however, individual labs should strive to attain lower values. Acceptable coefficients of variation can be achieved within 28 d.

PMID:34815323 | DOI:10.4187/respcare.09518

Neurol Neuroimmunol Neuroinflamm. 2021 Nov 23;9(1):e1113. doi: 10.1212/NXI.0000000000001113. Print 2022 Jan.

ABSTRACT

BACKGROUND AND OBJECTIVES: The pathophysiology of chronic fatigue syndrome (CFS) and Q fever fatigue syndrome (QFS) remains elusive. Recent data suggest a role for neuroinflammation as defined by increased expression of translocator protein (TSPO). In the present study, we investigated whether there are signs of neuroinflammation in female patients with CFS and QFS compared with healthy women, using PET with the TSPO ligand ¹¹C-(R)-(2-chlorophenyl)-N-methyl-N-(1-methylpropyl)-3-isoquinoline-carbox-amide ([¹¹C]-PK11195).

METHODS: The study population consisted of patients with CFS (n = 9), patients with QFS (n = 10), and healthy subjects (HSs) (n = 9). All subjects were women, matched for age (±5 years) and neighborhood, aged between 18 and 59 years, who did not use any medication other than paracetamol or oral contraceptives, and were not vaccinated in the last 6 months. None of the subjects reported substance abuse in the past 3 months or reported signs of underlying psychiatric disease on the Mini-International Neuropsychiatric Interview. All subjects underwent a [¹¹C]-PK11195 PET scan, and the [¹¹C]-PK11195 binding potential (BP_ND) was calculated.

RESULTS: No statistically significant differences in BP_ND were found for patients with CFS or patients with QFS compared with HSs. BP_ND of [¹¹C]-PK11195 correlated with symptom severity scores in patients with QFS, but a negative correlation was found in patients with CFS.

DISCUSSION: In contrast to what was previously reported for CFS, we found no significant difference in BP_ND of [¹¹C]-PK11195 when comparing patients with CFS or QFS with healthy neighborhood controls. In this small series, we were unable to find signs of neuroinflammation in patients with CFS and QFS.

TRIAL REGISTRATION INFORMATION: EudraCT number 2014-004448-37.

PMID:34815320 | DOI:10.1212/NXI.0000000000001113

Genome Res. 2021 Nov 23. doi: 10.1101/gr.275373.121. Online ahead of print.

ABSTRACT

The process of recombination between variable (V), diversity (D), and joining (J) immunoglobulin (Ig) gene segments determines an individual’s naive Ig repertoire and, consequently, (auto)antigen recognition. VDJ recombination follows probabilistic rules that can be modeled statistically. So far, it remains unknown whether VDJ recombination rules differ between individuals. If these rules differed, identical (auto)antigen-specific Ig sequences would be generated with individual-specific probabilities, signifying that the available Ig sequence space is individual specific. We devised a sensitivity-tested distance measure that enables inter-individual comparison of VDJ recombination models. We discovered, accounting for several sources of noise as well as allelic variation in Ig sequencing data, that not only unrelated individuals but also human monozygotic twins and even inbred mice possess statistically distinguishable immunoglobulin recombination models. This suggests that, in addition to genetic, there is also nongenetic modulation of VDJ recombination. We demonstrate that population-wide individualized VDJ recombination can result in orders of magnitude of difference in the probability to generate (auto)antigen-specific Ig sequences. Our findings have implications for immune receptor-based individualized medicine approaches relevant to vaccination, infection, and autoimmunity.

PMID:34815307 | DOI:10.1101/gr.275373.121

BMJ Open. 2021 Nov 23;11(11):e055902. doi: 10.1136/bmjopen-2021-055902.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has resulted in a range of unprecedented disruptions to maternity care with documented impacts on perinatal outcomes such as stillbirth and preterm birth. Metropolitan Melbourne has endured one of the longest and most stringent lockdowns in globally. This paper presents the protocol for a multicentre study to monitor perinatal outcomes in Melbourne, Australia, during the COVID-19 pandemic.

METHODS: Multicentre observational study analysing monthly deidentified maternal and newborn outcomes from births >20 weeks at all 12 public maternity services in Melbourne. Data will be merged centrally to analyse outcomes and create run charts according to established methods for detecting non-random ‘signals’ in healthcare. Perinatal outcomes will include weekly rates of total births, stillbirths, preterm births, neonatal intensive care admissions, low Apgar scores and fetal growth restriction. Maternal outcomes will include weekly rates of: induced labour, caesarean section, births before arrival to hospital, postpartum haemorrhage, length of stay, general anaesthesia for caesarean birth, influenza and COVID-19 vaccination status, and gestation at first antenatal visit. A prepandemic median for all outcomes will be calculated for the period of January 2018 to March 2020. A significant shift is defined as ≥6 consecutive weeks, all above or below the prepandemic median. Additional statistical analyses such as regression, time series and survival analyses will be performed for an in-depth examination of maternal and perinatal outcomes of interests.

ETHICS AND DISSEMINATION: Ethics approval for the collaborative maternity and newborn dashboard project has been obtained from the Austin Health (HREC/64722/Austin-2020) and Mercy Health (ref. 2020-031).

TRIAL REGISTRATION NUMBER: ACTRN12620000878976; Pre-results.

PMID:34815291 | DOI:10.1136/bmjopen-2021-055902

BMJ Open. 2021 Nov 23;11(11):e054298. doi: 10.1136/bmjopen-2021-054298.

ABSTRACT

INTRODUCTION: Guidelines for hip fracture care state that patients with hip fracture should be mobilised on the day after surgery and at least once a day thereafter. However, compliance with these guidelines is poor. One approach that would assist physiotherapists to meet mobility guidelines after hip fracture is to delegate the provision of daily mobilisation to allied health assistants under their supervision. Therefore, we plan to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient rehabilitation to patients with hip fracture.

METHODS AND ANALYSIS: Using a parallel group randomised controlled design with one-to-one allocation, participants will be randomly allocated to an experimental group (allied health assistant management) or a comparison group (physiotherapist management). Inclusion criteria are: adult with diagnosis of hip fracture; inpatient in acute hospital; walked independently pre-hip fracture and able to communicate in conversational English. The experimental group will receive routine physiotherapy rehabilitation, including daily mobilisation, from an allied health assistant following initial physiotherapist assessment. The comparison group will receive routine rehabilitation from a physiotherapist. The primary outcome will be the feasibility of allied health assistant management of patients with hip fracture. Feasibility will be determined using the following areas of focus in Bowen’s feasibility framework: acceptability (patient satisfaction), demand (proportion of patients who participate), implementation (time allied health assistant/physiotherapist spends with participant, occasions of service) and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant care will be interviewed to explore their perspectives on feasibility. Secondary outcomes include compliance with daily mobilisation guidelines, discharge destination, hospital readmission, falls, functional activity and length of stay. We aim to recruit 50 participants. Descriptive statistics will be used to describe feasibility and mobilisation rates will be calculated using Cox proportional hazards regression to compare compliance with mobilisation guidelines.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peninsula Health human research ethics committee (HREC/63 005/PH-2020). The findings will be disseminated in peer-reviewed journals and conference presentations.

TRAIL REGISTRATION NUMBER: Australian and New Zealand Clinical Trial Registry; ACTRN12620000877987; Pre-results.

PMID:34815289 | DOI:10.1136/bmjopen-2021-054298

BMJ Open. 2021 Nov 23;11(11):e050656. doi: 10.1136/bmjopen-2021-050656.

ABSTRACT

OBJECTIVES: To estimate occupation risk from COVID-19 among teachers and others working in schools using publicly available data on mortality in England and Wales.

DESIGN: Analysis of national death registration data from the Office for National Statistics.

SETTING: England and Wales, 8 March-28 December 2020, during the COVID-19 pandemic.

PARTICIPANTS: The total working age population in England and Wales plus those still working aged over 65 years.

PRIMARY AND SECONDARY OUTCOMES: Death with COVID-19 as a primary outcome and death from all causes as a secondary outcome.

RESULTS: Across occupational groups, there was a strong correlation between COVID-19 mortality and both non-COVID-19 and all-cause mortality. The absolute mortality rates for deaths with COVID-19 were low among those working in schools (from 10 per 100 000 in female primary school teachers to 39 per 100 000 male secondary school teachers) relative to many other occupations (range: 9-50 per 100 000 in women; 10-143 per 100 000 in men). There was weak evidence that secondary school teachers had slightly higher risks of dying with COVID-19 compared with the average for all working-aged people, but stronger evidence of a higher risk compared with the average for all professionals; primary school teachers had a lower risk. All-cause mortality was also higher among all teachers compared with all professionals. Teaching and lunchtime assistants were not at higher risk of death from COVID-19 compared with all working-aged people.

CONCLUSION: There was weak evidence that COVID-19 mortality risk for secondary school teachers was above expectation, but in general school staff had COVID-19 mortality risks which were proportionate to their non-COVID-19 mortality risk.

PMID:34815280 | DOI:10.1136/bmjopen-2021-050656

BMJ Open. 2021 Nov 23;11(11):e048782. doi: 10.1136/bmjopen-2021-048782.

ABSTRACT

INTRODUCTION: The quality of healthcare in childhood and adolescence is of key importance, in order to foster a healthy development and to avoid chronic health problems. Yet, data for Germany regarding the quality of healthcare for this patient group are lacking. The QualiPäd research project aims to estimate the quality of outpatient healthcare for children and adolescents in Germany, focusing on common psychiatric and physical disorders.

METHODS AND ANALYSIS: Quality indicators for seven common physical and mental childhood and adolescent clinical conditions (attention deficit/hyperactivity disorder, asthma, atopic dermatitis, depression, otitis media, conduct disorder/oppositional defiant disorder, tonsillitis) will be developed and ratified by experts, using the RAND/UCLA Appropriateness Method.Initially, 1400 medical records of children and adolescents with one of the aforementioned clinical conditions will then be randomly drawn from 40 outpatient practices in the German federal state of Hessen. The records will then be assessed regarding their adherence to the respective quality indicators. Based on this, the percentage of appropriate and inappropriate (eg, wasteful) healthcare of all clinical conditions (primary endpoint) will be estimated. Additionally, possible factors influencing the quality of care (eg, patient characteristics, type of condition, type of practice) will be identified using generalised estimation equation models.

ETHICS AND DISSEMINATION: This study will show for which of the studied clinical conditions and/or patients improvement of quality of care is necessary within the German health system. Also, the quality indicators designed for the study can afterwards be implemented in regular care and thus enable regular reporting of the outpatient care of this target group. The authors plan to disseminate their findings through international, peer-reviewed scientific publications, and through presentations at national and international paediatric and child psychiatric conferences.

TRIAL REGISTRATION NUMBER: DRKS00022408.

PMID:34815275 | DOI:10.1136/bmjopen-2021-048782

BMJ Open Respir Res. 2021 Nov;8(1):e001064. doi: 10.1136/bmjresp-2021-001064.

ABSTRACT

BACKGROUND: Multidrug-resistant tuberculosis (MDR-TB) drugs have never been associated with erythrocytosis. In Eritrea, however, several cases of incident erythrocytosis had been observed in the MDR-TB hospital. This study was aimed at exploring the association between MDR-TB drugs and secondary erythrocytosis, characterising the cases, and identifying other possible risk factors.

METHODS: A retrospective cohort study was conducted in Merhano National Referral MDR-TB hospital. Data were extracted from physically available clinical cards and laboratory results collected longitudinally between 23 June 2011 and 17 January 2021. Initially, univariate descriptive statistics (frequency, mean (SD), median (IQR) and range) were used as appropriate. Then, χ² or Fisher χ² test, and bivariate and/or multivariate Cox proportional hazard model were used to identify the predictors of incident erythrocytosis. All statistical analyses were conducted using R, and a two-sided alpha 0.05 was used to determine the statistical significance.

RESULTS: A total of 257 patients’ medical cards were screened, and 219 were eligible for further analysis. The median age of the patients was 38 years (range: 13-90 years) and 54.8% were males. During the follow-up time, 31 (14.2%) patients developed secondary erythrocytosis yielding an incidence rate of 7.8 cases per 1000 person-months. On average, the median time to onset of the event was found to be 5-months (range: 1-24 months). Males were more likely to develop the event than females (adjusted HR=7.13, 95% CI=1.66 to 30.53), and as body weight increases by 1 kg, the likelihood of developing secondary erythrocytosis was found to increase by 7% (adjusted HR=1.07, 95% CI=1.03 to 1.10). Moreover, all cases of secondary erythrocytosis were found to be possibly associated with the MDR-TB drugs.

CONCLUSION: The authors hypothesised that the incident erythrocytosis is possibly be associated with MDR-TB drugs, and further studies are required to substantiate this finding.

PMID:34815231 | DOI:10.1136/bmjresp-2021-001064

Am J Pharm Educ. 2021 Nov 23:8801. doi: 10.5688/ajpe8801. Online ahead of print.

ABSTRACT

Objective. Student pharmacists must cultivate self-awareness to ensure that they can assess their skill development and abilities, including affective domain skills such as empathy. External feedback can augment development, but validated assessments are needed for accuracy. Thus, the objectives of this study were to: establish validity evidence of the KCES-R (Kiersma-Chen Empathy Scale-Revised), compare student self-perceptions and standardized patient (SP) perceptions of student empathy using a parallel patient scale (KCES-PV), and evaluate student reflections on the encounter.Methods. Student pharmacists completed an assessment of their self-perceptions of empathy (KCES-R) pre-/post-patient encounter. SPs completed the KCES-PV regarding student pharmacist empathy immediately post-encounter. Student pharmacists also watched their encounter videos and completed a self-reflection on their use of empathy. Descriptive statistics, Spearman’s rank-order correlations, exploratory factor analysis, Cronbach’s alpha, and Wilcoxon Signed-Rank test were computed. Reflections were explored using thematic analysis.Results. The KCES-R contains 2 factors with high internal consistency and shows the ability to detect changes in empathy. Student pharmacist self-perceptions of empathy ability appeared higher than the SP evaluation. Student pharmacists had a stronger belief in the importance of expressing empathy during patient encounters and indicated a need for further development.Conclusion. This study provides validity evidence for the use of the KCES-R and presents a parallel scale that may be used by SPs. Validated parallel scales along with reflective practice could be a potential avenue to grow self-awareness and empathy by allowing students to receive feedback and then reflect on their perceived vs actual demonstration of the skill.

PMID:34815215 | DOI:10.5688/ajpe8801