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Nevin Manimala Statistics

Exposure to duloxetine during pregnancy and risk of congenital malformations and stillbirth: A nationwide cohort study in Denmark and Sweden

PLoS Med. 2021 Nov 22;18(11):e1003851. doi: 10.1371/journal.pmed.1003851. Online ahead of print.

ABSTRACT

BACKGROUND: The prevalence of depression and the exposure to antidepressants are high among women of reproductive age and during pregnancy. Duloxetine is a selective serotonin-norepinephrine reuptake inhibitor (SNRI) approved in the United States and Europe in 2004 for the treatment of depression. Fetal safety of duloxetine is not well established. The present study evaluates the association of exposure to duloxetine during pregnancy and the risk of major and minor congenital malformations and the risk of stillbirths.

METHODS AND FINDINGS: A population-based observational study was conducted based on data from registers in Sweden and Denmark. All registered births and stillbirths in the medical birth registers between 2004 and 2016 were included. Malformation diagnoses were identified up to 1 year after birth. Logistic regression analyses were used. Potential confounding was addressed through multiple regression, propensity score (PS) matching, and sensitivity analyses. Confounder variables included sociodemographic information (income, education, age, year of birth, and country), comorbidity and comedication, previous psychiatric contacts, and birth-related information (smoking during pregnancy and previous spontaneous abortions and stillbirths). Duloxetine-exposed women were compared with 4 comparators: (1) duloxetine-nonexposed women; (2) selective serotonin reuptake inhibitor (SSRI)-exposed women; (3) venlafaxine-exposed women; and (4) women exposed to duloxetine prior to, but not during, pregnancy. Exposure was defined as redemption of a prescription during the first trimester and throughout pregnancy for the analyses of malformations and stillbirths, respectively. Outcomes were major and minor malformations and stillbirths gathered from the national patient registers. The cohorts consisted of more than 2 million births with 1,512 duloxetine-exposed pregnancies. No increased risk for major malformations, minor malformations, or stillbirth was found across comparison groups in adjusted and PS-matched analyses. Duloxetine-exposed versus duloxetine-nonexposed PS-matched analyses showed odds ratio (OR) 0.98 (95% confidence interval [CI] 0.74 to 1.30, p = 0.909) for major malformations, OR 1.09 (95% CI 0.82 to 1.45, p = 0.570) for minor malformation, and 1.18 (95% CI 0.43 to 3.19, p = 0.749) for stillbirths. For the individual malformation subtypes, some findings were statistically significant but were associated with large statistical uncertainty due to the extremely small number of events. The main limitations for the study were that the indication for duloxetine and a direct measurement of depression severity were not available to include as covariates.

CONCLUSIONS: Based on this observational register-based nationwide study with data from Sweden and Denmark, no increased risk of major or minor congenital malformations or stillbirth was associated with exposure to duloxetine during pregnancy.

PMID:34807906 | DOI:10.1371/journal.pmed.1003851

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Nevin Manimala Statistics

Hybrid dedicated and distributed coding in PMd/M1 provides separation and interaction of bilateral arm signals

PLoS Comput Biol. 2021 Nov 22;17(11):e1009615. doi: 10.1371/journal.pcbi.1009615. Online ahead of print.

ABSTRACT

Pronounced activity is observed in both hemispheres of the motor cortex during preparation and execution of unimanual movements. The organizational principles of bi-hemispheric signals and the functions they serve throughout motor planning remain unclear. Using an instructed-delay reaching task in monkeys, we identified two components in population responses spanning PMd and M1. A “dedicated” component, which segregated activity at the level of individual units, emerged in PMd during preparation. It was most prominent following movement when M1 became strongly engaged, and principally involved the contralateral hemisphere. In contrast to recent reports, these dedicated signals solely accounted for divergence of arm-specific neural subspaces. The other “distributed” component mixed signals for each arm within units, and the subspace containing it did not discriminate between arms at any stage. The statistics of the population response suggest two functional aspects of the cortical network: one that spans both hemispheres for supporting preparatory and ongoing processes, and another that is predominantly housed in the contralateral hemisphere and specifies unilateral output.

PMID:34807905 | DOI:10.1371/journal.pcbi.1009615

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Nevin Manimala Statistics

Factors Affecting the Quality of Life of Hospitalized Persons with Chronic Foot and Lower Leg Wounds

Adv Skin Wound Care. 2021 Dec 1;34(12):645-650. doi: 10.1097/01.ASW.0000797956.61055.87.

ABSTRACT

OBJECTIVE: To determine the factors affecting the quality of life of patients with chronic wounds.

METHODS: This descriptive cross-sectional study was conducted in a university hospital wound care unit in western Turkey with 134 patients. The data were collected via personal information form, Barthel Index for activities of daily living, visual analog scale, and Short Form-12 questionnaire. Descriptive statistics and Spearman correlation were used for data analysis.

RESULTS: The mean age of the participants was 60.4 ± 10.7 years; 79.9% of the research group had diabetic foot wounds, and 56.7% had wounds on their right/left big toe. The mean duration of wounds was 9.4 ± 11.4 months, and 68.7% had previously been hospitalized because of wounds. The average visual analog scale pain level was 3.5 ± 2.5, and 45.5% of the patients were PEDIS (perfusion, extent, depth, infection, and sensation) classification grade II. A positive correlation was detected between Short Form-12 physical summary score and activities of daily living score.

CONCLUSIONS: Patients with chronic wounds have a poor quality of life. Patient quality of life decreases as pain and PEDIS score increase and increases with their level of independence.

PMID:34807896 | DOI:10.1097/01.ASW.0000797956.61055.87

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Nevin Manimala Statistics

Statistical Fragility of Surgical Clinical Trials in Orthopaedic Trauma

J Am Acad Orthop Surg Glob Res Rev. 2021 Nov 19;5(11). doi: 10.5435/JAAOSGlobal-D-20-00197.

ABSTRACT

INTRODUCTION: The Fragility Index (FI) and the Fragility Quotient (FQ) are powerful statistical tools that can aid clinicians in assessing clinical trial results. The purpose of this study was to use the FI and FQ to evaluate the statistical robustness of widely cited surgical clinical trials in orthopaedic trauma.

METHODS: We performed a PubMed search for orthopaedic trauma clinical trials in high-impact orthopaedics-focused journals and calculated the FI and FQ for all identified dichotomous, categorical outcomes.

RESULTS: We identified 128 studies with 545 outcomes. The median FI was 5, and the median FQ was 0.0482. For statistically significant and not statistically significant outcomes, the median FIs were 3 and 5, and the mean FQs were 0.0323 and 0.0526, respectively. The FI was greater than the number of patients lost to follow-up in most outcomes.

CONCLUSIONS: The orthopaedic trauma literature is of equal or higher quality than research in other orthopaedic subspecialties, suggesting that other orthopaedic subspecialties may benefit from modeling their clinical trials after those in orthopaedic trauma.

PMID:34807889 | DOI:10.5435/JAAOSGlobal-D-20-00197

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Nevin Manimala Statistics

Effect of Enhanced Recovery Protocol on Opioid Use in Pelvic Organ Prolapse Surgery

Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):e705-e709. doi: 10.1097/SPV.0000000000001114.

ABSTRACT

OBJECTIVES: Our primary objective was to compare the total opioid use by patients undergoing apical pelvic organ prolapse surgery before and after implementation of an enhanced recovery protocol (ERP).

METHODS: Participants of this ambispective cohort study included a “pre-ERP” retrospective cohort and an “ERP” cohort of patients prospectively enrolled after the full implementation of the ERP in January 2019. Demographic and clinical data were collected from the electronic record. Descriptive statistics were used for demographic variables. Total opioid use was calculated for each participant using morphine milligram equivalents (MMEs) and compared between cohorts using the Student t test.

RESULTS: Study participants (n = 65) were similar between cohorts and had a mean (SD) age of 62.4 (9.7) years and body mass index of 28.9 (4.8), and had a median parity of 3 (interquartile range, 2-4). Comorbid conditions, assessed with the Charlson Comorbidity Index, were also similar, with a mean (SD) of 2 (2.9). Hysterectomy approach and apical procedures did not differ between groups. After ERP implementation, mean (SD) intraoperative and postoperative MMEs decreased significantly (59.4 [31.6] vs 36.9 [20.5], P < 0.01). Total MMEs prescribed at discharge also decreased (392.3 [88.4] vs 94.6 [61.3], P < 0.01). Total anesthesia time and surgical time were similar, whereas mean total admission time decreased (27.3 [10.8] vs 18 [8.6] hours, P < 0.01). Telephone calls within 30 days increased from mean 1 (1.0) to 2.2 (1.9) (P < 0.01), whereas clinic visits and 30-day readmissions did not differ.

CONCLUSIONS: Women undergoing apical pelvic organ prolapse surgery at an academic medical center received significantly fewer opioids after implementation of an ERP without a change in postoperative pain scores.

PMID:34807884 | DOI:10.1097/SPV.0000000000001114

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Nevin Manimala Statistics

Perception and Initial Adoption of Mobile Health Services of Older Adults in London: Mixed Methods Investigation

JMIR Aging. 2021 Nov 19;4(4):e30420. doi: 10.2196/30420.

ABSTRACT

BACKGROUND: Advances in mobile technology and public needs have resulted in the emergence of mobile health (mHealth) services. Despite the potential benefits of mHealth apps, older adults face challenges and barriers in adopting them.

OBJECTIVE: The aims of this study are to understand older adults’ perception of mHealth services and to discover the barriers that older adults face in the initial adoption of mHealth apps.

METHODS: This paper systematically analyzed main determinants related to mHealth services and investigated them through questionnaires, interviews, and a workshop. Two studies were carried out in London. In study 1, the questionnaires with follow-up interviews were conducted based on the literature review to uncover older adults’ perception (including perceived usefulness, perceived ease of use, and perceived behavioral control) of mHealth services. Study 2 was a workshop helping older adults to trial selected mHealth apps. The workshop was conducted by the first author (JP) with assistance from 5 research students. The barriers that older adults faced in the initial adoption period were observed. The interviews and workshop were audiotaped and transcribed. Descriptive statistics and the thematic analysis technique were used for data analysis.

RESULTS: In total, 30 older adults in London completed the questionnaires and interviews in study 1. The results of study 1 show that the lack of obvious advantage, low reliability, scary information, and the risk of privacy leakage would decrease older adults’ perceived usefulness of mHealth services; the design of app interface would directly affect the perceived ease of use; and aging factors, especially the generation gap, would create barriers for older users. In total, 12 participants took part in the workshop of study 2, including 8 who took part in study 1. The results of study 2 identified that access to technology, the way of interaction, the risk of money loss, heavy workload of using an mHealth app, and different lifestyle are influential factors to older adults’ adoption of mHealth services.

CONCLUSIONS: The perceptions of mHealth services of older adults were investigated; the barriers that older adults may face in the initial adoption stage were identified. On the basis of the synthesis of these results, design suggestions were proposed, including technical improvement, free trial, information clarification, and participatory design. They will help inform the design of mHealth services to benefit older adults.

PMID:34807836 | DOI:10.2196/30420

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Nevin Manimala Statistics

Screening of Alzheimer’s disease with multiwavelength Stokes polarimetry in a mouse model

IEEE Trans Med Imaging. 2021 Nov 22;PP. doi: 10.1109/TMI.2021.3129700. Online ahead of print.

ABSTRACT

The minimum histological criterion for the diagnostics of Alzheimer’s disease (AD) in tissue is the presence of senile plaques and neurofibrillary tangles in specific brain locations. The routine procedure of morphological analysis implies time-consuming and laborious steps including sectioning and staining of formalin-fixed paraffin-embedded (FFPE) tissue. We developed a multispectral Stokes polarimetric imaging approach that allows characterization of FFPE brain tissue samples to discern the stages of AD progression without sectioning and staining the tissue. The Stokes polarimetry approach is highly sensitive to structural alterations of brain tissue, particularly to the changes in light scattering and birefringence. We present the results of the label-free non-destructive screening of FFPE mouse brain tissue and show several polarization metrics that demonstrate statistically significant differences for tissues at different stages of AD.

PMID:34807820 | DOI:10.1109/TMI.2021.3129700

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Nevin Manimala Statistics

Improving Completeness of Surgical Inpatient Medical Records in Saint Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia

Hosp Top. 2021 Nov 22:1-7. doi: 10.1080/00185868.2021.2005500. Online ahead of print.

ABSTRACT

INTRODUCTION: One of the most essential steps in improving the quality of service delivery in the health service is the improvement of patients’ medical record completeness. The aim of this study is to assess patient medical record completeness in the Saint Paul hospital department of surgery and assess the pattern of improvement in record completeness after intervention.

METHODS: surgical Patient charts were randomly reviewed with a standard patient chart completeness evaluation checklist prepared by the Federal Ministry of Health. Baseline data was collected in June 2019 and post intervention data was collected in November 2019. The schedule for intervention was carried out between July and October 2019. Interventions include modification of formats, continuous monitoring, and inclusion of chart completeness in the monthly morbidity and mortality conference, and establishment of a recognition system for best performing wards.

RESULT: A total of 253 and 273 medical charts were evaluated during baseline and post intervention. The Post intervention assessment showed 206 (75.5%) of records had admission notes completed, 205 (75%), the order sheet was completed in 218 (79.7%) and the discharge summary was completed in 217 (79.5%) of medical records. From nursing parameters, the medication sheet was completed in 177 (64.8%) and the nursing care plan was completed in 155 (56.8%) of medical records. When all six indicators were seen in aggregate, total medical record completeness showed a statistically significant improvement from 41% during base line to 72% post intervention (p < 0.05).

CONCLUSION AND RECOMMENDATION: Study has shown that small and persistent quality improvement interventions that focus on continuous evaluation, leadership engagement, and innovative strategies bring significant improvement in record completeness.

PMID:34807810 | DOI:10.1080/00185868.2021.2005500

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Nevin Manimala Statistics

Impact of comorbidity on renal cell carcinoma prognosis: a nationwide cohort study

Acta Oncol. 2021 Nov 22:1-6. doi: 10.1080/0284186X.2021.2005255. Online ahead of print.

ABSTRACT

BACKGROUND: Presence of comorbid diseases at time of cancer diagnosis may affect prognosis. We evaluated the impact of comorbidity on survival of patients diagnosed with renal cell carcinoma (RCC), overall and among younger (<70 years) and older (≥70 years) patients.

METHODS: We established a nationwide register-based cohort of 7894 patients aged ≥18 years diagnosed with RCC in Denmark between 2006 and 2017. We computed 1- and 5-year overall survival and hazard ratios (HRs) for death according to the Charlson Comorbidity Index (CCI) score.

RESULTS: Survival decreased with increasing CCI score despite an overall increase in survival over time. The 5-year survival rate of patients with no comorbidity increased from 57% among those diagnosed in 2006-2008 to 69% among those diagnosed in 2012-2014. During the same periods, the survival rate increased from 46% to 62% among patients with a CCI score of 1-2 and from 39% to 44% for those with a CCI score of ≥3. Patients with CCI scores of 1-2 and ≥3 had higher mortality rates than patients with no registered comorbidity (HR 1.15, 95% CI 1.06-1.24 and HR 1.56, 95% CI 1.40-1.73). Patterns were similar for older and younger patients. Particularly, diagnoses of liver disease (HR 2.09, 95% CI 1.53-2.84 and HR 4.01, 95% CI 2.44-6.56) and dementia (HR 2.16, 95% CI 1.34-3.48) increased mortality.

CONCLUSION: Comorbidity decreased the survival of patients with RCC, irrespective of age, despite an overall increasing survival over time. These results highlight the importance of focusing on comorbidity in this group of patients.

PMID:34807805 | DOI:10.1080/0284186X.2021.2005255

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Nevin Manimala Statistics

Geographical and Temporal Distribution of Radiologists, Computed Tomography and Magnetic Resonance Scanners in Croatia

Inquiry. 2021 Jan-Dec;58:469580211060295. doi: 10.1177/00469580211060295.

ABSTRACT

The aim of the study was to analyse the temporal and geographic distribution of radiologists, computed tomography and magnetic resonance scanners in Croatia. In this observational study we estimated radiologists’ number per 100,000 population for 1997, 2006, and 2017 and compared private and public CT and MR scanners between 2011 and 2018. We analyzed the availability of radiologists and scanners, and the relationship between the radiological workforce and economic strength among counties. The workforce increased significantly from 1997 to 2017 and was associated with economic strength categories in 2017. In 2018, there were more CT scanners in the public sector, while MR scanners were distributed evenly. In 2011, there was similar distribution of CT and MR between sectors, while in 2018 there were significantly more public CT scanners. Counties with a medical school had significantly more radiologists and MR scanners. The high-to-low ratios per CT and MR were 11 and 8.2, suggesting inequality of health care. Croatia significantly increased its radiological workforce; however, cross-county inequality remained. Counties with higher economic strength and medical schools have better availability of radiologists and equipment. To ensure the sustainable activity of the health care system, a precise estimate of supply and demand of radiology services is needed.

PMID:34807799 | DOI:10.1177/00469580211060295