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Nevin Manimala Statistics

Ten years of implementation outcome research: a scoping review protocol

BMJ Open. 2021 Jun 18;11(6):e049339. doi: 10.1136/bmjopen-2021-049339.

ABSTRACT

INTRODUCTION: A 2011 paper proposed a working taxonomy of implementation outcomes, their conceptual distinctions and a two-pronged research agenda on their role in implementation success. Since then, over 1100 papers citing the manuscript have been published. Our goal is to compare the field’s progress to the originally proposed research agenda, and outline recommendations for the next 10 years. To accomplish this, we are conducting the proposed scoping review.

METHODS AND ANALYSIS: Our approach is informed by Arksey and O’Malley’s methodological framework for conducting scoping reviews. We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We first aim to assess the degree to which each implementation outcome has been investigated in the literature, including healthcare settings, clinical populations and innovations represented. We next aim to describe the relationship between implementation strategies and outcomes. Our last aim is to identify studies that empirically assess relationships among implementation and/or service and client outcomes. We will use a forward citation tracing approach to identify all literature that cited the 2011 paper in the Web of Science (WOS) and will supplement this with citation alerts sent to the second author for a 6-month period coinciding with the WOS citation search. Our review will focus on empirical studies that are designed to assess at least one of the identified implementation outcomes in the 2011 taxonomy and are published in peer-reviewed journals. We will generate descriptive statistics from extracted data and organise results by these research aims.

ETHICS AND DISSEMINATION: No human research participants will be involved in this review. We plan to share findings through a variety of means including peer-reviewed journal publications, national conference presentations, invited workshops and webinars, email listservs affiliated with our institutions and professional associations, and academic social media.

PMID:34145020 | DOI:10.1136/bmjopen-2021-049339

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Development and validation of the OUTCoV score to predict the risk of hospitalisation among patients with SARS-CoV-2 infection in ambulatory settings: a prospective cohort study

BMJ Open. 2021 Jun 18;11(6):e044242. doi: 10.1136/bmjopen-2020-044242.

ABSTRACT

OBJECTIVES: To develop and validate a rule-out prediction model for the risk of hospitalisation among patients with SARS-CoV-2 infection in the ambulatory setting to derive a simple score to determine outpatient follow-up.

DESIGN: Prospective cohort study.

SETTING: Swiss university hospital.

PARTICIPANTS: 1459 individuals with a positive result for SARS-CoV-2 infection between 2 March and 23 April 2020.

METHODS: We applied the rule of 10 events per variable to construct our multivariable model and included a maximum of eight covariates. We assessed the model performance in terms of discrimination and calibration and performed internal validation to estimate the statistical optimism of the final model. The final prediction model included age, fever, dyspnoea, hypertension and chronic respiratory disease. To develop the OUTCoV score, we assigned points for each predictor that were proportional to the coefficients of the regression equation. Sensitivity, specificity, positive and negative likelihood ratios were estimated, including positive and negative predictive values in different thresholds.

MAIN OUTCOME MEASURE: The primary outcome was COVID-19-related hospitalisation.

RESULTS: The OUTCoV score ranged from 0 to 7.5 points. The two threshold parameters with optimal rule-out and rule-in characteristics for the risk of hospitalisation were 3 and 5.5, respectively. Outpatients with a score <3 (997/1459; 68.3%) had no follow-up as at low risk of hospitalisation (1.8%; 95% CI 1.1 to 2.8). For a score ≥5.5 (20/1459; 1.4%), the hospitalisation risk was higher (30%; 95% CI 11.9 to 54.3).

CONCLUSIONS: The OUTCoV score allows to rule out two-thirds of outpatients with SARS-CoV-2 infection presenting a low hospitalisation risk and to identify those at high risk that require careful follow-up to assess the need for hospitalisation. The model provides a simple decision-making tool for an effective allocation of resources to maintain quality care for outpatient populations.

PMID:34145007 | DOI:10.1136/bmjopen-2020-044242

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Validation of the Workplace Integrated Safety and Health (WISH) assessment in a sample of nursing homes using Item Response Theory (IRT) methods

BMJ Open. 2021 Jun 18;11(6):e045656. doi: 10.1136/bmjopen-2020-045656.

ABSTRACT

OBJECTIVES: To validate and test the dimensionality of six constructs from the Workplace Integrated Safety and Health (WISH) assessment, an instrument that assesses the extent to which organisations implement integrated systems approaches for protecting and promoting worker health, safety and well-being, in a sample of nursing homes in the USA.

DESIGN: Validation of an assessment scale using data from a cross-sectional survey.

SETTING: Nursing homes certified by the Centers for Medicaid and Medicare services in three states of the USA: Ohio, California and Massachusetts.

PARTICIPANTS: 569 directors of nursing from nursing homes serving adults and with more than 30 beds participated in the study.

RESULTS: Graded response Item Response Theory (IRT) models showed that five out of six constructs were unidimensional based on balanced interpretation of model fit statistics-M2 or C2 with p value >0.05, Comparative Fit Index >0.95, lower bound of the root mean squared error of approximation 90% CI <0.06 and standardised root mean square residual <0.08. Overall measure and construct reliability ranged from acceptable to good. Category boundary location parameters indicated that items were most informative for respondents in lower range of latent scores (ie, β1, β2, β3 typically below 0). A few items were recommended to be dropped from future administrations of the instrument based on empirical and substantive interpretation.

CONCLUSIONS: The WISH instrument has utility to understand to what extent organisations integrate protection and promotion of worker health, safety and well-being; however, it is most informative in organisations that present lower scores.

PMID:34145013 | DOI:10.1136/bmjopen-2020-045656

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Effect of Human Development Index and other socioeconomic factors on mortality-to-incidence ratio of lips and oral cavity cancer in Mexican states: an ecological study

BMJ Open. 2021 Jun 18;11(6):e042376. doi: 10.1136/bmjopen-2020-042376.

ABSTRACT

OBJECTIVES: To assess the association between the Human Development Index (HDI) and covariates on the mortality-to-incidence ratio (MIR) of lips and oral cavity cancer (LOCC) in Mexico.

DESIGN: Ecological study.

SETTING: Data from 32 Mexican states for year 2019.

PARTICIPANTS: Data set of male and female populations from Mexico.

EXPOSURES: Socioeconomic conditions based on HDI and covariates related to healthcare system capacity (total health spending per capita, school dropout and ratio of medical personnel in direct contact with patients).

PRIMARY AND SECONDARY OUTCOME MEASURES: MIR of LOCC by state and sex was calculated from the Global Burden of Disease Study website for year 2019. Data for calculating HDI 2019 by state and covariates were obtained from the National Institute of Statistics and Geography. A multiple regression model was constructed to measure the effects of HDI and covariates on LOCC-MIR.

RESULTS: Among the states with the highest HDI (>0.780), Colima had the highest aged-standardised rates per 100.000 in men for incidence (5.026) and mortality (3.118). The greatest burden of the disease was found on men, with the highest Men:Women MIR in Colima (3.10) and Baja California Sur (2.73). The highest MIR (>0.65) was found among the states with the lowest HDI (Oaxaca and Chiapas). For each unit of increase of the HDI there was a decrease in the LOCC- MIR of -0.778, controlling for the covariates. The most suitable regression model explained the 57% (F (p): 0.000) of the variance.

CONCLUSIONS: Men were most affected by LOCC in Mexican states. The highest MIRs of LOCC were found in the states with the highest HDI. But a worse prognosis of the disease, expressed as a higher MIR, is expected in contexts with lower HDI in the country, even with lower MIRs.

PMID:34145006 | DOI:10.1136/bmjopen-2020-042376

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Anterior communicating artery aneurysms: Nonmodifiable morphological parameters associated with rupture risk

J Neuroimaging. 2021 Jun 18. doi: 10.1111/jon.12896. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: The aim of this study was to investigate the relationship between arterial morphological parameters and the rupture risk of anterior communicating artery (AComA) aneurysms.

METHODS: A hospital database was retrospectively reviewed to identify patients with AComA aneurysms. Morphologic parameters were evaluated on the 3-dimensional computed tomography angiograms. The patients were divided into two groups as ruptured and unruptured. Patient age, sex, morphological parameters such as aneurysm height and weight, neck diameter, aspect ratio (AR), size ratio (SR), bifurcation angle, aneurysm shape, and diameters of the artery were statistically compared between two groups.

RESULTS: Ninety-five AComA aneurysms were analyzed in this study (60 ruptured and 35 unruptured). The aneurysm neck size (p = .005) and the diameter of the A1 segment of the ipsilateral anterior cerebral artery (i-A1) were smaller in the ruptured group than in the unruptured group (p = .001), but AR (p = .001) was higher. The number of patients with irregular shape aneurysm were higher in the ruptured group (p = .006). There was no significant difference between the two groups in terms of age, sex, aneurysm height and weight, bifurcation angle, and SR. Univariate logistic regression analysis showed that i-A1 segment diameter (odds ratio [OR]: -2.070, confidence interval [CI]: 0.030-0.531, p = .005), aneurysm neck diameter (OR: -0.409, CI: 0.491-0.899, p = .008), irregular shape (OR: 1.197, CI: 1.382-7.929, p = .007), and AR (OR: 0.880, CI: 1.315-4.417, p = .004) were significantly correlated with ruptured status. Multivariate regression analysis demonstrated that aneurysm neck diameter (OR: -0.457, CI: 0.410-0.977, p = .039) was the only independent variable for rupture.

CONCLUSION: AComA aneurysm rupture is more likely to occur in aneurysms with smaller i-A1 segment diameter, smaller aneurysm neck diameter, irregular aneurysm shape, and higher AR. Aneurysm neck diameter may be a more important determinant for rupture prediction.

PMID:34143925 | DOI:10.1111/jon.12896

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Sperm donation: an alternative to improve post-ICSI live birth rates in advanced maternal age patients

Hum Reprod. 2021 Jun 18:deab148. doi: 10.1093/humrep/deab148. Online ahead of print.

ABSTRACT

STUDY QUESTION: Can sperm donation increase live birth rates following ICSI in advanced maternal age (AMA) patients?

SUMMARY ANSWER: Sperm donation increases the live birth rate in AMA ICSI cycles.

WHAT IS KNOWN ALREADY: In ICSI practice, sperm donation has been predominantly applied to overcome male infertility. The involvement of paternal age and lower sperm quality in the severe reduction in fertility observed in AMA patients remains to be clarified.

STUDY DESIGN, SIZE, DURATION: Retrospective multicenter cohort study including data generated between 2015 and 2019 from 755 ICSI cycles achieving a fresh embryo transfer, of which 337 were first homologous cycles (normozoospermic partner sperm and homologous oocytes) and 418 were first sperm donation cycles (donor sperm and homologous oocytes). The association of sperm origin (partner vs donor) with live birth was assessed by multivariate analysis in non-AMA (<37 years, n = 278) and AMA (≥37 years, n = 477) patients, separately, including in the model all variables previously found to be associated with live birth in a univariate analysis (number of MII oocytes recovered, number of embryos transferred, and maternal age). ICSI outcomes were compared between sperm donation and homologous cycles in overall, non-AMA and AMA patients.

PARTICIPANTS/MATERIALS, SETTING, METHODS: The study was conducted in three fertility clinics and included 755 Caucasian patients aged 24-42 years undergoing their first homologous or sperm donation ICSI cycle achieving a fresh embryo transfer.

MAIN RESULTS AND THE ROLE OF CHANCE: The multivariate analysis revealed that sperm donation was positively associated with the likelihood of a live birth independently of all other variables tested in AMA (P = 0.02), but not in non-AMA patients. Live birth, delivery, and miscarriage rates differed substantially between sperm donation and homologous AMA cycles; live birth and delivery rates were 70-75% higher (25.4% vs 14.5% and 22.5% vs 13.5%, respectively; P < 0.01), while miscarriage occurrence was less than half (18.0% vs 39.5%; P < 0.01) in sperm donation compared to homologous AMA cycles.

LIMITATIONS, REASONS FOR CAUTION: This study is limited by its retrospective nature, differences in patients profiles between sperm donation and homologous-control groups and varying proportion of donor cycles between fertility centers, although these variations have been controlled for in the statistical analysis.

WIDER IMPLICATIONS OF THE FINDINGS: The findings suggest that sperm donation increases live birth rates while reducing miscarriage occurrence in AMA patients, and thus may be a valid strategy to improve ICSI outcomes in this growing and challenging patient group.

STUDY FUNDING/COMPETING INTEREST(S): N/A.

TRIAL REGISTRATION NUMBER: N/A.

PMID:34143887 | DOI:10.1093/humrep/deab148

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Combination of mitotane and locoregional treatments in low-volume metastatic adrenocortical carcinoma

J Clin Endocrinol Metab. 2021 Jun 18:dgab449. doi: 10.1210/clinem/dgab449. Online ahead of print.

ABSTRACT

PURPOSE: European and French guidelines for ENSAT stage IV low tumor burden or indolent adrenocortical carcinoma (ACC) recommend combination of mitotane and locoregional treatments (LRT) in first-line. Nevertheless, the benefit of LRT combination with mitotane has never been evaluated in this selected group of patients.

METHODS: A retrospective chart review was performed from 2003-2018 of patients with stage IV ACC with ≤2 tumoral organs who received mitotane in our center. Primary endpoint was the delay between mitotane initiation and first systemic chemotherapy. Secondary endpoints were progression-free survival (PFS) and overall survival (OS) from mitotane initiation. Adjusted analyses were performed on the main prognostic factors.

RESULTS: Out of 79 included patients, 48 (61%) patients were female and median age at stage IVA diagnosis was 49.8 years (interquartile-range:38.8-60.0). Metastatic sites were mainly lungs (76%) and liver (48%). Fifty-eight (73%) patients received LRT including adrenal bed radiotherapy (14 patients, 18%), surgery (37 patients, 47%) and/or interventional radiology n(35,44%). Median time between mitotane initiation and first chemotherapy administration was 9 months (Interquartile-range:4-18). Median PFS1 (first tumor-progression) was 6.0 months (CI95%:4.5-8.6). Median OS was 46 months (CI95%:41-68). PFS1, PFS2 and OS were statistically longer in the mitotane plus LRT group compared to the mitotane-only group (Hazard ratio (HR)=0.39 (CI95%:0.22-0.68), HR=0.35 (CI95%:0.20-0.63) and HR=0.27 (CI95%:0.14-0.50) respectively). Ten (13%) patients achieved complete response, all from mitotane plus LRT group.

CONCLUSION: Our results endorse European and French guidelines for stage IV ACC with ≤2 tumor-organs and favor the combination of mitotane and LRT as first-line treatment. For the first time, a significant number of complete responses were observed. Prospective studies are expected to confirm these findings.

PMID:34143888 | DOI:10.1210/clinem/dgab449

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Precursors of self-reported subclinical hypomania in adolescence: A longitudinal general population study

PLoS One. 2021 Jun 18;16(6):e0253507. doi: 10.1371/journal.pone.0253507. eCollection 2021.

ABSTRACT

Symptoms of subclinical hypomania (SHM) are common in the general population of adolescents and young adults. SHM are most often transient yet might be risk markers of later bipolar disorder. The current study aimed to assess the clinical correlates of SHM at age 11 in the general population, examine the continuity of SHM from age 11-age 16 and explore the clinical precursors of age 16 SHM. As part of the Copenhagen Child Cohort 2000, 1,632 preadolescents participated in the examination of SHM and various clinical correlates at age 11, 893 were re-assessed for SHM at age 16 years. At age 11, SHM, psychotic experiences and depressive symptoms were assessed by semi-structured psychopathological interviews. Furthermore, the participants were diagnostically assessed by the Development and Well-Being Assessment and interviewed about sleep length. At age 16, SHM was assessed by self-report, using the Hypomania Checklist-32. Cannabis use occurring at age 15 or earlier was assessed at age 16. At age 11, SHM was associated with depressive disorders (Relative Risk [RR] = 2.96 [95% CI 1.26-6.96]), interview-based depressive symptoms (RR = 9.22 [5.93-14.34]), neurodevelopmental disorders (RR = 2.94 [1.66-5.20]), psychotic experiences (RR = 4.51 [2.90-7.01]) and insufficient sleep (RR = 2.10 [1.28-3.43]. In the longitudinal analyses, age 16 SHM was preceded by age 11 SHM (RR = 1.89 [1.02-3.49]), psychotic experiences (RR = 2.06, [1.28-3.33]), emotional disorders (RR = 1.77, [1.02-3.09]) and cannabis use (RR = 3.14, [1.93-5.10]), after mutual adjustment and adjustment for sex, and sociodemographic factors. In conclusion, age 11 SHM was statistically significantly associated with other types of psychopathology in cross-sectional analyses and showed some continuity with later self-reported SHM at age 16. Particularly early psychotic experiences and cannabis use stood out as independent precursors of self-reported SHM and might constitute important risk markers for the development of future SHM and bipolar disorder. An important potential caveat of the current study includes the self-report assessment of SHM.

PMID:34143836 | DOI:10.1371/journal.pone.0253507

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Respiratory virus surveillance in Canada during the COVID-19 pandemic: An epidemiological analysis of the effectiveness of pandemic-related public health measures in reducing seasonal respiratory viruses test positivity

PLoS One. 2021 Jun 18;16(6):e0253451. doi: 10.1371/journal.pone.0253451. eCollection 2021.

ABSTRACT

BACKGROUND: Various public health measures have been implemented globally to counter the coronavirus disease 2019 (COVID-19) pandemic. The purpose of this study was to evaluate respiratory virus surveillance data to determine the effectiveness of such interventions in reducing transmission of seasonal respiratory viruses.

METHOD: We retrospectively analysed data from the Respiratory Virus Detection Surveillance System in Canada, before and during the COVID-19 pandemic, by interrupted time series regression.

RESULTS: The national level of infection with seasonal respiratory viruses, which generally does not necessitate quarantine or contact screening, was greatly reduced after Canada imposed physical distancing and other quarantine measures. The 2019-2020 influenza season ended earlier than it did in the previous year. The influenza virus was replaced by rhinovirus/enterovirus or parainfluenza virus in the previous year, with the overall test positivity remaining at approximately 35%. However, during the 2019-2020 post-influenza period, the overall test positivity of respiratory viruses during the COVID-19 was still low (7.2%). Moreover, the 2020-2021 influenza season had not occurred by the end of February 2021.

CONCLUSION: Respiratory virus surveillance data may provide real-world evidence of the effectiveness of implemented public health interventions during the current and future pandemics.

PMID:34143839 | DOI:10.1371/journal.pone.0253451

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Predictive functional analysis reveals inferred features unique to cervicovaginal microbiota of African women with bacterial vaginosis and high-risk human papillomavirus infection

PLoS One. 2021 Jun 18;16(6):e0253218. doi: 10.1371/journal.pone.0253218. eCollection 2021.

ABSTRACT

Mounting evidence suggests that Lactobacillus species may not necessarily be the sine qua non of healthy cervicovaginal microbiota (CVM), especially among reproductive-age African women. A majority of African women have high-diversity non-Lactobacillus-dominated CVM whose bacterial functions remain poorly characterized. Functional profiling of the CVM is vital for investigating human host-microbiota interactions in health and disease. Here, we investigated the functional potential of L. iners-dominated and high-diversity non-Lactobacillus-dominated CVM of 75 African women with and without bacterial vaginosis (BV) and high-risk human papillomavirus (HR-HPV) infection. Functional contents were predicted using PICRUSt. Microbial taxonomic diversity, BV, and HR-HPV infection statuses were correlated with the inferred functional composition of the CVM. Differentially abundant inferred functional categories were identified using linear discriminant analysis (LDA) effect size (LEfSe) (p-value <0.05 and logarithmic LDA score >2.0). Of the 75 women, 56 (74.7%), 35 (46.7%), and 29 (38.7%) had high-diversity non-Lactobacillus-dominated CVM, BV, and HR-HPV infection, respectively. Alpha diversity of the inferred functional contents (as measured by Shannon diversity index) was significantly higher in women with high-diversity non-Lactobacillus-dominated CVM and BV than their respective counterparts (H statistic ≥11.5, q-value <0.001). Ordination of the predicted functional metagenome content (using Bray-Curtis distances) showed that the samples segregated according to the extent of microbial taxonomic diversity and BV (pseudo-F statistic ≥19.6, q-value = 0.001) but not HR-HPV status (pseudo-F statistic = 1.7, q-value = 0.159). LEfSe analysis of the inferred functional categories revealed that transport systems (including ABC transporters) and transcription factors were enriched in high-diversity CVM. Interestingly, transcription factors and sporulation functional categories were uniquely associated with high-diversity CVM, BV, and HR-HPV infection. Our predictive functional analysis reveals features unique to high-diversity CVM, BV and HR-HPV infections. Such features may represent important biomarkers of BV and HR-HPV infection. Our findings require proof-of-concept functional studies to examine the relevance of these potential biomarkers in women’s reproductive health and disease.

PMID:34143825 | DOI:10.1371/journal.pone.0253218