Nevin Manimala

Hum Reprod. 2023 Oct 25:dead219. doi: 10.1093/humrep/dead219. Online ahead of print.

ABSTRACT

STUDY QUESTION: Is embryo culture in a closed time-lapse system associated with any differences in perinatal and maternal outcomes in comparison to conventional culture and spontaneous conception?

SUMMARY ANSWER: There were no significant differences between time-lapse and conventional embryo culture in preterm birth (PTB, <37 weeks), low birth weight (LBW, >2500 g) and hypertensive disorders of pregnancy for singleton deliveries, the primary outcomes of this study.

WHAT IS KNOWN ALREADY: Evidence from prospective trials evaluating the safety of time-lapse incubation for clinical use show similar embryo development rates, implantation rates, and ongoing pregnancy and live birth rates when compared to conventional incubation. Few studies have investigated if uninterrupted culture can alter risks of adverse perinatal outcomes presently associated with IVF when compared to conventional culture and spontaneous conceptions.

STUDY DESIGN, SIZE, DURATION: This study is a Swedish population-based retrospective registry study, including 7379 singleton deliveries after fresh embryo transfer between 2013 and 2018 from selected IVF clinics. Perinatal outcomes of singletons born from time-lapse-cultured embryos were compared to singletons from embryos cultured in conventional incubators and 71 300 singletons from spontaneous conceptions. Main perinatal outcomes included PTB and LBW. Main maternal outcomes included hypertensive disorders of pregnancy (pregnancy hypertension and preeclampsia).

PARTICIPANTS/MATERIALS, SETTING, METHODS: From nine IVF clinics, 2683 singletons born after fresh embryo transfer in a time-lapse system were compared to 4696 singletons born after culture in a conventional incubator and 71 300 singletons born after spontaneous conception matched for year of birth, parity, and maternal age. Patient and treatment characteristics from IVF deliveries were cross-linked with the Swedish Medical Birth Register, Register of Birth Defects, National Patient Register and Statistics Sweden. Children born after sperm and oocyte donation cycles and after Preimplantation Genetic testing cycles were excluded. Odds ratio (OR) and adjusted OR were calculated, adjusting for relevant confounders.

MAIN RESULTS AND THE ROLE OF CHANCE: In the adjusted analyses, no significant differences were found for risk of PTB (adjusted OR 1.11, 95% CI 0.87-1.41) and LBW (adjusted OR 0.86, 95% CI 0.66-1.14) or hypertensive disorders of pregnancy; preeclampsia and hypertension (adjusted OR 0.99, 95% CI 0.67-1.45 and adjusted OR 0.98, 95% CI 0.62-1.53, respectively) between time-lapse and conventional incubation systems. A significantly increased risk of PTB (adjusted OR 1.31, 95% CI 1.08-1.60) and LBW (adjusted OR 1.36, 95% CI 1.08-1.72) was found for singletons born after time-lapse incubation compared to singletons born after spontaneous conceptions. In addition, a lower risk for pregnancy hypertension (adjusted OR 0.72 95% CI 0.53-0.99) but no significant difference for preeclampsia (adjusted OR 0.87, 95% CI 0.68-1.12) was found compared to spontaneous conceptions. Subgroup analyses showed that some risks were related to the day of embryo transfer, with more adverse outcomes after blastocyst transfer in comparison to cleavage stage transfer.

LIMITATIONS, REASONS FOR CAUTION: This study is retrospective in design and different clinical strategies may have been used to select specific patient groups for time-lapse versus conventional incubation. The number of patients is limited and larger datasets are required to obtain more precise estimates and adjust for possible effect of additional embryo culture variables.

WIDER IMPLICATIONS OF THE FINDINGS: Embryo culture in time-lapse systems is not associated with major differences in perinatal and maternal outcomes, compared to conventional embryo culture, suggesting that this technology is an acceptable alternative for embryo incubation.

STUDY FUNDING/COMPETING INTEREST(S): The study was financed by a research grant from Gedeon Richter. There are no conflicts of interest for all authors to declare.

TRIAL REGISTRATION NUMBER: N/A.

PMID:37879843 | DOI:10.1093/humrep/dead219

Rev Esp Patol. 2023 Oct-Dec;56(4):219-226. doi: 10.1016/j.patol.2023.05.002. Epub 2023 Sep 4.

ABSTRACT

INTRODUCTION AND OBJECTIVES: The histopathological identification of Helicobacter pylori using the routine method (haematoxylin-eosin) is not only very difficult but also has low sensitivity. Giemsa staining is often used in addition, but different protocols do not produce homogeneous results. Furthermore, the Gold Standard recommended by the European Helicobacter Pylori Study Group has been applied in very few studies, thus resulting in uncertain outcomes. Therefore, a new staining method is required to overcome these limitations. The aim of this study was to evaluate the diagnostic capacity and inter-observer agreement of “Gissell’s stain”.

MATERIAL AND METHODS: A cross-sectional study evaluated 99 gastric paraffin blocks from a private laboratory. Three sections were prepared from each block, and haematoxylin-eosin (HE), Giemsa and “Gissell’s stain” methods were applied. The kappa statistics, sensitivity, specificity, and predictive values were calculated.

RESULTS: “Gissell’s stain” obtained the highest inter-observer agreement (kappa=0.87) compared to the other two methods (HE, kappa=0.51; Giemsa, kappa=0.83). It also obtained the best sensitivity and negative predictive value (97.1% and 98.3%, respectively) compared with the other two methods (HE: 68.6% and 85.1%, respectively; Giemsa: 88.6% and 93.9%, respectively).

CONCLUSIONS: Given its unique characteristics (fast, cheap, accessible, and easy to use), in addition to its statistical reliability, “Gissell’s stain” has great potential for routine use in the identification of H. pylori.

PMID:37879818 | DOI:10.1016/j.patol.2023.05.002

JACC Cardiovasc Interv. 2023 Oct 23;16(20):2514-2524. doi: 10.1016/j.jcin.2023.08.019.

ABSTRACT

BACKGROUND: Nearly 20% of patients on ticagrelor experience dyspnea, which may lead to treatment discontinuation in up to one-third of cases.

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of dyspnea-related ticagrelor discontinuation after percutaneous coronary intervention (PCI).

METHODS: In the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial, after 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The occurrence of dyspnea associated with ticagrelor discontinuation was evaluated among all patients enrolled in the trial. A landmark analysis was performed at 3 months after PCI, that is, the time of randomization. Predictors of dyspnea-related ticagrelor discontinuation were obtained from multivariable Cox regression with stepwise selection of candidate variables.

RESULTS: The incidence of dyspnea-related ticagrelor discontinuation was 6.4% and 9.1% at 3 and 15 months after PCI, respectively. Independent predictors included Asian race (lower risk), smoking, prior PCI, hypercholesterolemia, prior coronary artery bypass, peripheral artery disease, obesity, and older age. Among 179 patients who discontinued ticagrelor because of dyspnea after randomization, ticagrelor monotherapy was not associated with a higher risk of subsequent ischemic events (composite of all-cause death, myocardial infarction, or stroke) compared with ticagrelor plus aspirin (5.0% vs 7.1%; P = 0.566).

CONCLUSIONS: In the TWILIGHT trial, dyspnea-related ticagrelor discontinuation occurred in almost 1 in 10 patients and tended to occur earlier rather than late after PCI. Several demographic and clinical conditions predicted its occurrence, and their assessment may help identify subjects at risk for therapy nonadherence.

PMID:37879803 | DOI:10.1016/j.jcin.2023.08.019

Lupus Sci Med. 2023 Oct;10(2):e000996. doi: 10.1136/lupus-2023-000996.

ABSTRACT

OBJECTIVE: Tissue damage in lupus nephritis (LN) is mediated by activation of the classical complement pathway. Complement-mediated upregulation of endothelial cell adhesion molecules is seen in dermal blood vessels of non-lesional skin of patients with active lupus. In diseases with systemic complement activation, extensive microvascular C5b-9 deposition is seen in non-lesional skin. In this study, we assess the presence of systemic complement pathway activation as determined by non-lesional skin microvascular C5b-9 deposition in patients with LN.

METHODS: Eight patients with active LN and eight patients without active LN underwent non-lesional skin biopsies. Using a diaminobenzidine technique, specimens were evaluated for microvascular C5b-9 consistent with systemic complement pathway activation.

RESULTS: Five of eight patients with active LN and one of eight patients without active LN demonstrated positive C5b-9 staining in non-lesional skin (p=0.04). Positive non-lesional C5b-9 staining has greater specificity, 87.5%, for active LN than pyuria, low complements, elevated double-stranded DNA (dsDNA) and proteinuria. Urine protein creatinine ratio was significantly higher in patients with positive non-lesional C5b-9 deposition (5.18 vs 1.20; p=0.04). C5b-9 deposition was not associated with a higher NIH Activity Index, interstitial fibrosis, dsDNA or lower complements.

CONCLUSION: This is the first study to demonstrate evidence in non-lesional skin of microvascular C5b-9 indicative of systemic complement pathway activation in LN. C5b-9 deposition is statistically more common and demonstrated greater specificity than most historical biomarkers for active LN. The findings support a potential role for microvascular C5b-9 assessment in non-lesional skin as a biomarker for LN activity.

PMID:37879755 | DOI:10.1136/lupus-2023-000996

BMJ Open. 2023 Oct 24;13(10):e077256. doi: 10.1136/bmjopen-2023-077256.

ABSTRACT

INTRODUCTION: A decade ago, the first national valuation study of the EQ-5D-Y-3L (Y-3L) involved a discrete choice experiment (DCE) that asked 4155 US adult respondents to complete 40 paired comparisons, choosing between two dying children. Instead of choosing between dying children, the respondents in this novel protocol are asked whether ‘being in a coma’ is better or worse than experiencing ‘health problems’ (ie, experience scale) and how they would relieve health problems (ie, kaizen tasks). Our aims are to compare the preference evidence of the paired comparison and kaizen tasks and to conduct a DCE for the valuation of Y-3L profiles on an experience scale.

METHODS AND ANALYSIS: Under this protocol, we will conduct an online survey that collects preference evidence from 600 US adult respondents on the health of a 10-year-old child for a week. Across all scenarios, each child will be described as either being ‘in a coma’ or having ‘health problems’, namely five three-level attributes (Y-3L). In this DCE, each respondent will be randomly assigned to one of four D-efficient blocks, including five coma comparisons (ie, Y-3L vs coma), 10 paired comparisons (Y-3L vs Y-3L) and 10 kaizen tasks (preference paths). In addition to comparing evidence by task (aim 2), the analysis plan includes the estimation of main-effects conditional logit models to create a Y-3L value set on an ‘experience scale’ where positive (negative) experiences have positive (negative) values (0 is ‘being in a coma’ and 1 is full health).

ETHICS AND DISSEMINATION: The institutional review board (IRB) (Advarra) determined that this project (Pro00072276) is exempt from IRB oversight based on DHHS 45 CFR 46.104(d)(2) and is not subject to requirements for continuing review. The results will be prepared for publication in peer-reviewed journals and presented at scientific meetings. The data and code will be made available on reasonable request.

PMID:37879694 | DOI:10.1136/bmjopen-2023-077256

BMJ Open. 2023 Oct 24;13(10):e072183. doi: 10.1136/bmjopen-2023-072183.

ABSTRACT

OBJECTIVE: The purpose of this study was to assess nurses caring behaviours and its associated factors among nurses working at public hospitals in the Gamo zone of southern Ethiopia in 2022.

DESIGN: Institutional based cross-sectional study was used.

SETTING: This study was conducted in five public hospitals in Gamo zone, southern Ethiopia.

PARTICIPANTS: A total of 360 nurses of different level of qualification were included in this study using a proportional allocation method from the five hospitals and final study participants were recruited from all wards using a simple random sampling method from 20 June to 20 July 2022.

OUTCOME MEASUREMENTS: Caring behaviour was assessed using 24 standardised Caring Behaviour Inventory (CBI) scales. Data were collected using a structured questionnaire and, analysed using the logistic regression method, and those variables with a p value of <0.05 in multivariable analysis were considered statistically significant.

RESULT: The overall percentage of nurse caring behaviour in this study was 53.3%. Most of the respondents practiced technical aspects of caring behaviour rather than psychosocial aspects of caring. Being married (adjusted OR (AOR)=0.027 (0.003-0.263), having work experience of (0-5 years) (AOR=5.547 (1.42-21.64)), (6-10 years) (AOR=8.693 (2.317-32.6), being satisfied with motivation and prospect (AOR=0.473 (0.290-0.770)) and being satisfied with the nursing profession (AOR=1.716 (1.065-2.765) were significantly associated with nurses caring behaviour.

CONCLUSION: The proportion of nurses with a good caring behaviour found in this study was relatively poor. Being married, having lower work experience, being satisfied with motivation and prospects, and nursing profession were associated with nurses caring behaviour. This study recommends the need to focus on including caring behaviour courses in the nursing curriculum and training nurses focusing on those with a few experiences on the meaning and importance of caring behaviour.

PMID:37879693 | DOI:10.1136/bmjopen-2023-072183

BMJ Open. 2023 Oct 24;13(10):e062582. doi: 10.1136/bmjopen-2022-062582.

ABSTRACT

OBJECTIVE: The aim of this study is to determine the prevalence of acute malnutrition and associated factors in South Wollo zone, East Amhara, Northeast Ethiopia.

DESIGN: A community-based cross-sectional study was conducted among 504 children aged 6-59 months who were selected by using a multistage sampling technique. The mid-upper-arm-circumference and Z-scores for weight-for-height were used to determine the nutritional status of the participants. A semi-structured interview questionnaire was used to collect the data. Then data was entered into EpiData V.3.1 and exported to SPSS software V.25 for analysis. Binary logistic regression was used to identify factors associated with acute malnutrition and variables with p value<0.05 were declared as statistically significant.

SETTING: The study was conducted in South Wollo zone, Northeast Ethiopia from 1 August 2020 to 30 September 2020.

PARTICIPANTS: Children aged 6-59 months with their mothers were the study subjects.

RESULTS: The prevalence of acute malnutrition among children aged 6-59 months was 31.0%. Child aged 6-11 months (adjusted OR (AOR)=3.92; 95% CI: 1.74 to 8.82), illiterate mothers (AOR=3.01; 95% CI: 1.92 to 7.01), single mother (AOR=3.06; 95% CI: 1.32 to 7.07), lack of latrine (AOR=2.39; 95% CI: 1.12 to 5.11), diarrhoea (AOR=4.18; 95% CI: 2.02 to 8.65), respiratory tract infection (AOR=2.31; 95% CI: 1.08 to 4.94), family size (≥5) (AOR=3.29; 95% CI: 1.53 to 7.09) and cessation of breast feeding before 2 years (AOR=3.79; 95% CI: 1.71 to 8.23) were the independent predictors of acute malnutrition.

CONCLUSION: Acute malnutrition is highly prevalent in the study area which is more than the national figure. Thus, improving maternal education, access to the latrine, improved breastfeeding practice, improved family planning usage and early detection and treatment of diarrhoea and respiratory tract infections will enhance children’s nutritional status. In addition, nutritional diversity education needs to be strengthened.

PMID:37879690 | DOI:10.1136/bmjopen-2022-062582

BMJ Open. 2023 Oct 24;13(10):e073228. doi: 10.1136/bmjopen-2023-073228.

ABSTRACT

BACKGROUND: Early initiation of antenatal care (ANC) is vital for the early detection and treatment of adverse pregnancy outcomes. Despite the widespread convenience of free ANC services, most women in Ethiopia attend their initial antenatal clinic late and fail to come back for follow-up care, which results in both maternal and fetal complications. Despite the fact that assessing the determinants of early ANC booking based on the local context is advised, it is not well studied in the study area.

OBJECTIVE: This study aimed to assess determinants of early ANC booking among pregnant women attending ANC at public health facilities in the Nole Kaba district, western Ethiopia.

METHODS: Facility-based unmatched case-control study design was conducted from April to June 2020. Systematic random sampling was used to select a total of 297 participants. A validated, pretested and structured instrument was used to interview the participants. The data were cleaned and coded before being entered into Epi-Info V.7.2.2.6 and exported to SPSS V.25 for analysis. The logistic regression analyses were done to assess the determinants of early ANC booking. Adjusted odds ratio (AOR) with 95% CI was estimated to measure the strength of the association. The level of statistical significance was set at a p value <0.05.

RESULT: A total of 297 pregnant women participated in the study (99 cases and 198 controls), with a 100% response rate. Place of residence (AOR=2.21, 95% CI 1.11, 2.72), level of education (AOR=3.42, 95% CI 1.01, 6.04), planned pregnancy (AOR=8.01, 95% CI 2.79, 23.03), history of abortion (AOR=5.96, 95% CI 2.07, 17.13), places of previous delivery (AOR=4.57, 95% CI 1.09, 19.12), presence of accompanied by husband during ANC visit (AOR=2.48, 95% CI 2.77, 7.98) and media exposure (AOR=6.95, 95 CI 2.68, 18.02) were found statistically significant.

CONCLUSION AND RECOMMENDATIONS: Places of residence, educational level, pregnancy, having a history of abortion, accompanied by the husband during ANC visit, place of previous delivery and media exposure were significantly associated with early initiation of ANC. Therefore, health extension programmes on early ANC initiation should be strengthened by giving priority to less educated women and living in rural areas.

PMID:37879687 | DOI:10.1136/bmjopen-2023-073228

BMJ Open. 2023 Oct 24;13(10):e075597. doi: 10.1136/bmjopen-2023-075597.

ABSTRACT

INTRODUCTION: Visceral leishmaniasis (VL) is a neglected tropical disease responsible for many thousands of preventable deaths each year. Symptomatic patients often struggle to access effective treatment, without which death is the norm. Risk prediction tools support clinical teams and policymakers in identifying high-risk patients who could benefit from more intensive management pathways. Investigators interested in using their clinical data for prognostic research should first identify currently available models that are candidates for validation and possible updating. Addressing these needs, we aim to identify, summarise and appraise the available models predicting clinical outcomes in VL patients.

METHODS AND ANALYSIS: We will include studies that have developed, validated or updated prognostic models predicting future clinical outcomes in patients diagnosed with VL. Systematic reviews and meta-analyses that include eligible studies are also considered for review. Conference abstracts and educational theses are excluded. Data extraction, appraisal and reporting will follow current methodological guidelines. Ovid Embase; Ovid MEDLINE; the Web of Science Core Collection, SciELO and LILACS are searched from database inception to 1 March 2023 using terms developed for the identification of prediction models, and with no language restriction. Screening, data extraction and risk of bias assessment will be performed in duplicate with discordance resolved by a third independent reviewer. Risk of bias will be assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). Tables and figures will compare and contrast key model information, including source data, participants, model development and performance measures, and risk of bias. We will consider the strengths, limitations and clinical applicability of the identified models.

ETHICS AND DISSEMINATION: Ethics approval is not required for this review. The systematic review and all accompanying data will be submitted to an open-access journal. Findings will also be disseminated through the research group’s website (www.iddo.org/research-themes/visceral-leishmaniasis) and social media channels.

PROSPERO REGISTRATION NUMBER: CRD42023417226.

PMID:37879686 | DOI:10.1136/bmjopen-2023-075597

BMJ Open. 2023 Oct 24;13(10):e075800. doi: 10.1136/bmjopen-2023-075800.

ABSTRACT

OBJECTIVE: Estimate the prevalence of diagnosed Alzheimer’s disease (AD) and early Alzheimer’s disease (eAD) overall and stratified by age, sex and deprivation and combinations thereof in England on 1 January 2020.

DESIGN: Cross-sectional.

SETTING: Primary care electronic health record data, the Clinical Practice Research database linked with secondary care data, Hospital Episode Statistics (HES) and patient-level deprivation data, Index of Multiple Deprivation (IMD).

OUTCOME MEASURES: The prevalence per 100 000 of the population and corresponding 95% CIs for both diagnosed AD and eAD overall and stratified by covariates. Sensitivity analyses were conducted to assess the sensitivity of the population definition and look-back period.

RESULTS: There were 448 797 patients identified in the Clinical Practice Research Datalink that satisfied the study inclusion criteria and were eligible for HES and IMD linkage. For the main analysis of AD and eAD, 379 763 patients are eligible for inclusion in the denominator. This resulted in an estimated prevalence of diagnosed AD of 378.39 (95% CI, 359.36 to 398.44) per 100 000 and eAD of 292.81 (95% CI, 276.12 to 310.52) per 100 000. Prevalence estimates across main and sensitivity analyses for the entire AD study population were found to vary widely with estimates ranging from 137.48 (95% CI, 127.05 to 148.76) to 796.55 (95% CI, 768.77 to 825.33). There was significant variation in prevalence of diagnosed eAD when assessing the sensitivity with the look-back periods, as low as 120.54 (95% CI, 110.80 to 131.14) per 100 000, and as high as 519.01 (95% CI, 496.64 to 542.37) per 100 000.

CONCLUSIONS: The study found relatively consistent patterns of prevalence across both AD and eAD populations. Generally, the prevalence of diagnosed AD increased with age and increased with deprivation for each age category. Women had a higher prevalence than men. More granular levels of stratification reduced patient numbers and increased the uncertainty of point prevalence estimates. Despite this, the study found a relationship between deprivation and prevalence of AD.

PMID:37879685 | DOI:10.1136/bmjopen-2023-075800