Category: Statistics

BJGP Open. 2023 Oct 25:BJGPO.2023.0077. doi: 10.3399/BJGPO.2023.0077. Online ahead of print.

ABSTRACT

BACKGROUND: Burnout is common among general practitioners (GPs). Previous studies have indicated an association between high workload and burnout among doctors.

AIM: To assess the risk of burnout among single-handed GPs in Denmark in relation to self-reported and register-based workload.

DESIGN & SETTING: Questionnaire data from 312 Danish single-handed GPs and register data on their patients and provided services.

METHOD: Burnout was measured using the Maslach Burnout Inventory (MBI). A composite burnout score of quartile points was calculated. The questionnaire provided information on working hours. Register data included number of services and patient list size. Association between composite burnout score and workload was estimated with binomial regression analyses adjusting for the GPs’ age and gender, and social deprivation score of their patient lists.

RESULTS: Working more than five days a week in practice increased the risk of a high burnout score (RR_adjusted =2.34, 95% CI [1.62-3.37]). Spending more than 7.5 hours a day on patient-related tasks increased the risk of a high burnout score, highest among GPs spending 8.5-9.5 hours a day on patient-related tasks (RR_adjusted =2.01, 95% CI [0.90-4.51]), although not statistically significant. There was no association between number of services and risk of burnout.

CONCLUSION: Working more than five days a week in practice significantly increased the risk of burnout in Danish single-handed GPs. Spending more than 7.5 hours a day on patient-related tasks tended to increase the risk. We found no association between a high number of services and increased risk of burnout.

PMID:37879851 | DOI:10.3399/BJGPO.2023.0077

Hum Reprod. 2023 Oct 25:dead220. doi: 10.1093/humrep/dead220. Online ahead of print.

ABSTRACT

STUDY QUESTION: Do women have worse pregnancy and neonatal outcomes of IVF/ICSI-fresh embryo transfer (ET) after conservative treatment of atypical hyperplasia (AH)?

SUMMARY ANSWER: AH has no impact on live birth but is associated with increased risks of pregnancy loss and preterm delivery (PTD).

WHAT IS KNOWN ALREADY: AH is a precancerous lesion of endometrial cancer. Several recognized AH risk factors include nulliparity, increased body mass index, ovulation disorders, diabetes mellitus, and others. As such, patients are suggested to attempt conception upon achieving AH regression. Recently, successful pregnancies with IVF/ICSI have been increasingly reported.

STUDY DESIGN, SIZE, DURATION: Forty-two patients with AH regression and 18 700 women with no evidence of endometrial abnormality, who underwent their first autologous oocytes’ retrieval and fresh ET cycles of IVF/ICSI in the Center for Reproductive Medicine, Shandong University, from May 2008 to July 2021, were retrospectively enrolled.

PARTICIPANTS/MATERIALS, SETTING, METHODS: First, 42 AH patients were propensity score matched with control women (n = 168) at a 1:4 ratio. Reproductive outcomes and maternal/neonatal complications were compared between the matched pairs. Binary logistic regression analyses were conducted to assess odds ratios (ORs) of AH for live birth, pregnancy loss, and PTD from AH women and all 18 700 eligible controls.

MAIN RESULT AND THE ROLE OF CHANCE: Patients with AH achieved a numerically lower live birth rate (LBR) as compared to the matched controls, but without significant difference (26% versus 37%, P = 0.192). However, compared with the matched controls, AH patients showed significantly higher rates of pregnancy loss (52% versus 21%, P = 0.003) and PTD (45% versus 16%, P = 0.041). Further analyses revealed a statistically significantly increased rate of late pregnancy loss (17% versus 3%, P = 0.023), but not early miscarriage (35% versus 18%, P = 0.086), in the AH group. Furthermore, after correcting for potential confounders, the likelihood of a live birth in AH patients narrowly failed to be statistically significantly different from controls (adjusted OR [aOR]: 0.51, 95% CI: 0.25-1.04, P = 0.064). Nonetheless, the logistic regression reconfirmed that AH was an independent risk factor for pregnancy loss (aOR: 3.62, 95% CI: 1.55-8.46, P = 0.003), late pregnancy loss (aOR: 9.33, 95% CI: 3.00-29.02, P < 0.001), and PTD (aOR: 5.70, 95% CI: 1.45-22.38, P = 0.013).

LIMITATIONS, REASONS FOR CAUTION: Selection bias was an inherent drawback of this study. First, because of the low AH prevalence among women receiving IVF/ICSI treatment, and consequently, limited sample size, the relationship between AH with LBR and adverse complications might be concealed and underestimated. Hence, the results should be interpreted cautiously. Similarly, the impacts of diverse clinical features of AH patients on the pregnancy outcomes need further studies in a larger population. Second, although most data used in this study were obtained by reviewing the medical records, missing data did exist and so did the recall bias. Third, although the propensity score matching and multivariable logistic models were performed collectively in order to minimize potential confounders between AH and controls, the intrinsic disadvantages of the retrospective nature of this study could not be avoided completely, and additional confirmation bias might be induced with reduplication of statistical analyses.

WIDER IMPLICATION OF THE FINDINGS: Our results highlight the necessity of adequate counseling and intensive pregnancy monitoring for AH individuals and their families.

STUDY FUNDING/COMPETING INTEREST(S): This work was supported by grants from the National Key Research & Developmental Program of China (2022YFC2703800), the Natural Science Foundation of Shandong Province (ZR2022MH009), and Projects of Medical and Health Technology Development Program in Shandong Province (202005010520, 202005010523). There are no conflicts of interest to declare.

TRIAL REGISTRATION NUMBER: N/A.

PMID:37879850 | DOI:10.1093/humrep/dead220

Int J Spine Surg. 2023 Oct 25:8550. doi: 10.14444/8550. Online ahead of print.

ABSTRACT

BACKGROUND: Intraoperative (IO) image guidance surgery using 3-dimensional fluoroscopic navigation methods, such as the O-arm system, has improved the accuracy of pedicle screw placement in instrumented spine surgery. IO and postoperative (PO) validation of the implant’s correct position from radiological images is a decisive step to ensure patient safety and avoidance of complications related to implant misplacement. In this prospective single-center study, the authors investigated the accuracy and agreement of assessment of pedicle screws from IO O-arm images in comparison to PO computed tomography images. This study aimed to determine whether final evaluation of pedicle screws can safely be conducted from IO images that supersedes the PO computed tomography control.

METHODS: A prospective single-center study was carried out at the Spine Unit in the Department of Orthopedics at Umeå University Hospital between 2019 and 2021. All patients enrolled in the study underwent instrumented thoracolumbar spine surgery using navigation. Imaging data were obtained from IO and PO examinations. Four reviewers-2 attending senior spine surgeons, 1 final year resident in orthopedics, and 1 attending neuroradiologist-classified pedicle screws using the Gertzbein and Robbins classification system. Agreement and accuracy of the reviewers were studied to evaluate the assessment of pedicle screws from IO and PO images.

RESULTS: A total of 70 patients (422 screws) were included in the study. There was high accuracy among surgeons both on IO and PO images (0.96-0.97, 95% CI [0.94-0.99] and 0.97, 95% CI [0.94-0.99], respectively), and the overall agreement between all raters was 92% to 98% (95% CI [0.90, 1.00]). The discrepancy in assessment between optimal (Group 1) and suboptimal (Group 2) screws between IO and PO images was as low as 1% to 1.7%, which indicates that very few suboptimal screws are missed in the assessment of IO images.

CONCLUSIONS: The assessment of navigated pedicle screws using IO images is safe and reliable and may replace the need for further assessment using PO imaging.

PMID:37879846 | DOI:10.14444/8550

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