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Nevin Manimala Statistics

Evaluating Performance of Circular Staplers Using Comparative Test Methods for Evidence-Based Surgery

Surg Innov. 2023 Apr 8:15533506231166447. doi: 10.1177/15533506231166447. Online ahead of print.

ABSTRACT

BACKGROUND: Circular stapler anastomosis is a common surgical procedure. Despite technological advancements, anastomotic leak remains a postoperative concern. Assessment of new technologies is impeded by variations in test methods and analysis, precluding outcome reproducibility and direct comparisons of results across studies. The development of robust and reproducible preclinical test methods is critical to accelerating stapling technology advancements.

METHODOLOGY: Leak pressure, staple line perfusion and security, and device removal force were quantified for triple-row (Tri-staple EEA, TriEEA) and double-row staplers (Echelon Circular Powered, ECP). Leak and perfusion testing were performed in vivo. Device removal force and staple line security testing were performed with synthetic medium using an Instron. Data were analyzed using unpaired student’s t-test or Kruskal-Wallis test, with statistical significance defined as P < .05.

RESULTS: Leak pressure was 73% higher in TriEEA vs ECP (P = .016). TriEEA staple line failure force was lower than ECP at 40 and 50 mmHg (P = .001 and P = .023, respectively). Perfusion to the staple line was higher (148%) for TriEEA than for ECP (P = .003) and the force required to remove the device from its stapled anastomosis was 78% lower for TriEEA than for ECP (P < .001).

DISCUSSION/CONCLUSIONS: This report addresses a primary limitation in stapling research by presenting novel methodologies which enhance clinical relevance and provide sufficient detail for reproduction by independent investigators. These methods are applied to a comparison between triple-row and double-row staplers to demonstrate utility of new test methods in assessing key technology design features.

PMID:37029908 | DOI:10.1177/15533506231166447

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Nevin Manimala Statistics

Cardiac Related Psychosocial Distress and Traumatic Distress in Individuals with Advanced Heart Failure

J Soc Work End Life Palliat Care. 2023 Apr 8:1-15. doi: 10.1080/15524256.2023.2198158. Online ahead of print.

ABSTRACT

Guided by the Transactional Model of Stress and Coping, this study explored relationships between cardiac related psychosocial distress, traumatic distress, and the number of lifetime traumas in people with advanced heart failure. Utilizing a cross-sectional survey design, a convenience sample of participants with advanced heart failure who received treatment in Washington, DC, completed standardized measures. Bivariate analysis showed a statistically significant difference in mean number of exposures and distress associated with advanced heart failure therapies and linear relationships between exposures and traumatic distress, distress and traumatic distress, and exposures and distress, as well as between the number of exposures and distress and traumatic distress and between the distress and traumatic distress. Multivariate analysis suggested that the higher the number of reported traumatic events, the higher the distress, and the higher the distress, the higher the traumatic distress. Social workers and allied team members should consider how a patient’s distress relates to traumatic distress in the advanced stage heart failure population.

PMID:37029906 | DOI:10.1080/15524256.2023.2198158

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Nevin Manimala Statistics

Health Reporting from Different Data Sources: Does it Matter for Mental Health?

J Ment Health Policy Econ. 2023 Mar 1;26(1):33-57.

ABSTRACT

BACKGROUND: Bipolar disorder is among the top 10 causes of disability worldwide. The Short-Form Six-Dimension (SF-6D) is a frequently BACKGROUND: Mental disorders are typically stigmatized conditions associated with negative stereotypes, which may lead individuals to underreport them. Thus, survey data may be subject to biases. Although administrative data has some limitations, it is an alternative data source that may be considered more objective.

AIMS OF THE STUDY: This study aimed to identify the degree of agreement between survey and administrative health care data for mental health conditions, factors affecting underreporting, and whether underreporting also occurs for physical health conditions.

METHODS: We used Ontario data from the Canadian Community Health Survey linked to health records to examine the presence of mental health conditions (i.e., schizophrenia and mood disorders) and select physical health conditions (i.e., diabetes and cancer). Using administrative data as the reference standard, we created four categories for each health condition based on the level of agreement between the two data sources: consistent cases and non-cases (i.e. individuals with concordant data based on their reported health condition), and people who were found to underreport and overreport a condition (i.e. where the condition was present in the administrative data, but not in the survey data and vice-versa, respectively). The overall level of agreement was assessed using Cohen’s kappa statistic. Probit regressions were estimated to determine the factors affecting underreporting.

RESULTS: The Kappa statistics for mood disorder was fair (k= 0.26) and moderate for schizophrenia (k = 0.49). Physical health conditions had higher kappa values (diabetes, k = 0.81; ever having cancer, k = 0.68), with the exception of currently having cancer (k = 0.24). Underreporting was highest for the most stigmatizing condition, schizophrenia (63%), followed by mood disorders (39%) and cancer (39%), and lowest for diabetes (25%). Older age, being born in Africa and Asia, and being employed all increased the probability of underreporting among individuals identified in the administrative data; the opposite held for social assistance.

DISCUSSION: We extended previous work on mental health reporting by combining survey data with administrative data to examine the level of agreement between respondents’ self-reported mental health and administrative records. The data include some mental disorders not studied previously. We examined the entire adult population; this is important because prevalence of schizophrenia may be less common among older population groups due to higher mortality among this patient population. Additionally, there may be potential age-related differences in stigma and mental health conditions. The administrative health data captured only health services covered by the public provincial health insurance plan and thus did not capture medical care provided by psychologists, social workers, and nurses. While this would affect Kappa statistic values, it does not directly affect the underreporting analyses.

IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Our results suggest that disclosure of mental health conditions may differ by the level of stigma, which has implications for obtaining accurate estimates of mental health prevalence from self-reported data sources. IMPLICATIONS FOR HEALTH POLICIES AND IMPLICATIONS FOR FURTHER RESEARCH: It may be useful to use a combination of both survey and administrative data when estimating the prevalence of mental disorders. Future research should seek to examine overreporting and its determinants.

PMID:37029904

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Nevin Manimala Statistics

Changes in Racial and Ethnic Disparities in Use of Mental Health Services under the Affordable Care Act: Evidence from California

J Ment Health Policy Econ. 2023 Mar 1;26(1):19-32.

ABSTRACT

BACKGROUND: The Affordable Care Act (ACA) aimed to expand mental health service use in the US, by expanding access to health insurance. However, the gap in mental health utilization by race and ethnicity is pronounced: members of racial and ethnic minoritized groups remain less likely to use mental health services than non-Hispanic White individuals even after the ACA.

AIMS OF THE STUDY: This study assessed the effect of the Affordable Care Act (ACA) on mental health services use in one large state (California), and whether that effect differed among racial and ethnic groups. Also, it tested for change in racial and ethnic disparities after the implementation of the ACA, using four measures of mental health care.

METHODS: Using pooled California Health Interview Survey (CHIS) data from 2011-2018, logistic regression and Generalized Linear Models (GLM) were estimated. Disparities were defined using the Institute of Medicine (IOM) definition. Primary outcomes were any mental health care in primary settings; in specialty settings, any prescription medication for mental health problems, and number of annual visits to mental health services.

RESULTS: Findings suggested that the change in Hispanic-non-Hispanic White disparities in prescription medication use under the ACA was statistically significant, narrowing the gap by 7.23 percentage points (p<.05). However, the disparity in other measures was not significantly reduced.

DISCUSSION: These findings suggest that the magnitude of the increase in primary and specialty mental health services among racial and ethnic minorities was not large enough to significantly reduce racial and ethnic disparities. One possible explanation is that non-financial factors played a role, such as language barriers, attitudinal barriers from home culture norms, and systemic barriers due to mental health professional shortages and a limited number of mental health care providers of color.

IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Integrated approaches that coordinate specialty and primary care mental health services may be needed to promote mental healthcare access for members of racial and ethnic minoritized groups.

IMPLICATIONS FOR HEALTH POLICIES: Federal and state policies aiming to improve mental health services use have historically given more weight to financial determinants, but this has not been enough to significantly reduce racial/ethnic disparities. Thus, policies should pay more attention to non-financial determinants.

IMPLICATIONS FOR FURTHER RESEARCH: Assessing underlying mechanisms of non-financial factors that moderate the effectiveness of the ACA is a worthwhile goal for future research. Future studies should examine the extent to which non-financial factors intervene in the relationship between the implementation of the ACA and mental health services use.

PMID:37029903

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Nevin Manimala Statistics

Mechanical evaluation of the effect of the rod to rod distance on the stiffness of uniplanar external fixator frames

Musculoskelet Surg. 2023 Apr 8. doi: 10.1007/s12306-023-00782-1. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the effect of the rod-to-rod distance on the mechanical stability of single-rod and double-rod external fixator frames.

METHODS: Four different constructs, one single-rod and three double-rod constructs with different rod-rod distances, were subjected to the axial, bending, and torsional forces. The stiffness of different configurations was calculated.

RESULTS: Single-rod configuration had statistically the lowest stiffness when subjected to the axial, bending, and torsional forces. Maximum stiffness against the axial and anterior-posterior bending forces was achieved when the rod-rod distance was adjusted to 50 mm (halfway between the first rod and the end of the Schanz pins). There was no statistically significant difference in lateral bending stiffness among different double-rod configurations (p value: 0.435). The maximum stiffness against torsional forces was achieved when the rod-rod distance was adjusted to 100 mm (the second rod at the end of the Schanz pins).

CONCLUSION: Double-rod uniplanar external fixator frames are significantly stiffer than the single-rod constructs, and however, the rod-rod distance can significantly affect the construct stiffness. We found that a frame with 50 mm rod-rod distance was the optimum fixator among tested configurations that allowed a balance between axial, bending, and torsional stiffness of the construct.

PMID:37029888 | DOI:10.1007/s12306-023-00782-1

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Nevin Manimala Statistics

Retrospective comparison of clinical outcomes of ultrasound-guided percutaneous cholecystostomy in patients with and without coagulopathy: a single center’s experience

Jpn J Radiol. 2023 Apr 8. doi: 10.1007/s11604-023-01422-1. Online ahead of print.

ABSTRACT

PURPOSE: To compare the complication rate and clinical outcomes for percutaneous cholecystostomy (PC) in patients with or without coagulopathy.

MATERIALS AND METHODS: We retrospectively reviewed electronic medical chart of patients who underwent ultrasound-guided PC with a 8.5-F drainage tube for acute cholecystitis between November 2003 and March 2017. We divided the patients into two groups: patients with coagulopathy (international normalized ratio > 1.5 or platelet count < 50 × 109/L or with a history of anticoagulant medication in preceding 5 days) and patients without coagulopathy. Duration of drainage, duration of hospital stay, 30-day mortality and complication rates were compared between these two groups. Student’s t test, Chi-square test or Fisher’s exact test was used for bivariate analyses. Age, age-adjusted Charlson Comorbidity Index (ACCI) and sepsis-adjusted complication rates were also compared.

RESULTS: In total, 141 patients had PC (mean age was 73.3 years [SD 13.3]; range 33-96 years; 94 men and 47 women). Fifty-two patients (36.9%) had coagulopathy and 89 patients (63.1%) were without any history of coagulopathy. Hemorrhagic complication rate was 3.5% (5 out of 141 patients, including 4 with coagulopathy and 1 without). One patient with coagulopathy died due to the hemorrhage. Duration of drainage was longer in patients with coagulopathy than patients without coagulopathy (20.0 days vs. 14.8 days; P = 0.033). No significant difference was observed with regard to duration of hospital stay (32.3 days vs. 25.6 days; P = 0.103) and 30-day mortality (7.7% vs. 1.1%; P = 0.062). The overall complication rate did not significantly differ (9.6% and 11.2%; P = 0.763), nor did age, ACCI or sepsis-adjusted complications.

CONCLUSION: Clinical outcomes and complications rates after PC did not statistically differ between patients with and without coagulopathy, but there was a tendency of higher risk of hemorrhage in coagulopathy patients. Therefore, the indication of this procedure should be carefully determined.

PMID:37029879 | DOI:10.1007/s11604-023-01422-1

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Nevin Manimala Statistics

Epidemiology and prognostic factors of 114 patients with mycosis fungoides in a Moroccan cohort: a 29-year review

Clin Exp Med. 2023 Apr 8. doi: 10.1007/s10238-023-01056-7. Online ahead of print.

ABSTRACT

Limited data regarding survival of Moroccan patients with mycosis fungoides (MF). To evaluate the clinical profile and long-term outcomes of these patients. A retrospective review of 114 MF cases diagnosed from 1993 to 2022 who were followed up for more than 6 months of diagnosis was performed. Of 114 patients, 71.9% were male and the median age at diagnosis was 56 years. Approximately 64 and 36% of the patients had an early stage and advanced stage, respectively. Median follow-up duration was 56 months, and median duration of symptoms before diagnosis was 31 months. Various subtypes were observed, including mycosis fungoides folliculotropic (12.3%), poikilodermatous (11.4%), and palmaris et plantaris MF (5.3%). The 10-year overall survival was 89% in early-stage patients and 48.8% in advanced-stage patients. Complete response to treatment occurred in 45.6%, stable disease in 16.7% and disease progression in 7.9% of patients. Older age of > 60 years, higher T-stage (T3/T4) and advanced-stage MF were statistically significant in predicting poorer outcomes in MF. Despite delay in diagnosis, most cases of MF in Morocco were diagnosed in early stages. We observed a high proportion of classic MF and favorable prognosis.

PMID:37029872 | DOI:10.1007/s10238-023-01056-7

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Nevin Manimala Statistics

Effectiveness and Tolerability of Bisoprolol/Perindopril Single-Pill Combination in Patients with Arterial Hypertension and a History of Myocardial Infarction: The PRIDE Observational Study

Adv Ther. 2023 Apr 8. doi: 10.1007/s12325-023-02462-9. Online ahead of print.

ABSTRACT

INTRODUCTION: This study assessed the real-life effectiveness of a single-pill combination (SPC) of bisoprolol/perindopril for controlling blood pressure (BP) and symptoms of angina in patients with hypertension and a history of myocardial infarction (MI).

METHODS: Eligible patients with arterial hypertension and a history of MI were aged 18-79 years and had initiated bisoprolol/perindopril SPC within 3 months of study enrollment as part of routine Russian clinical practice. The primary endpoint was mean change in systolic and diastolic BP (SBP/DBP) at week 12 compared with baseline (data collected retrospectively). Secondary endpoints were assessed at weeks 4 and 12 and included mean change in resting heart rate (HR), proportion of patients reaching target level of resting HR, antianginal effectiveness of the SPC, and proportion of patients reaching target BP levels.

RESULTS: A total of 504 patients were enrolled, of whom 481 comprised the full analysis set (mean age 61.4 ± 8.9 years, 68% men). Mean baseline SBP/DBP and HR values were 148.9 ± 16.8/87.7 ± 11.0 mmHg and 77.4 ± 10.5 bpm, respectively. Mean durations of hypertension and CAD were 12.8 ± 8.4 and 6.1 ± 6.3 years, respectively, and time since MI was 3.8 ± 5.3 years. At week 12, SBP/DBP had decreased by 24.9/12.2 mmHg (P < 0.001 vs baseline). Target BP (< 140/90 mmHg) was achieved by 69.8% and 95.9% of patients at weeks 4 and 12, respectively, and target HR (55-60 bpm) by 17.3% and 34.5% at weeks 4 and 12 versus 3.1% at baseline (P < 0.001). Reductions in angina attacks, nitrate consumption, and improvements in HR were statistically significant. Treatment was well tolerated.

CONCLUSION: Treatment of symptomatic patients with CAD, hypertension, and a history of MI with a bisoprolol/perindopril SPC was associated with significant decreases in SBP/DBP and a high proportion of patients achieving BP treatment goals. This was accompanied by improvements in angina symptoms and reductions in HR in a broad patient population representative of those seen in everyday clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04656847.

PMID:37029871 | DOI:10.1007/s12325-023-02462-9

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Correlation of Mammographic Microcalcifications with Final Surgical Pathology After Neoadjuvant Chemotherapy for Breast Cancer

Ann Surg Oncol. 2023 Apr 8. doi: 10.1245/s10434-023-13367-w. Online ahead of print.

ABSTRACT

INTRODUCTION: Imaging guidelines for post-neoadjuvant chemotherapy (NAC) breast cancer patients lack specificity on appropriateness and utility of individual modalities for surgical planning. Microcalcifications confound mammographic interpretation. We examined the correlation between the mammographic extent of microcalcifications present post-NAC, corresponding magnetic resonance imaging (MRI) lesions, and definitive surgical pathology.

METHODS: In this retrospective cohort study, patients with calcifications on mammography were collected from a database of consecutive breast cancer patients receiving NAC. The primary objective was to determine the correlation between maximum dimension of post-NAC calcifications with surgical pathology (invasive disease, tumor bed, and ductal carcinoma in situ [DCIS]), stratified by tumor receptor subgroup. Secondarily, we examined the correlation of residual disease with MRI mass enhancement (ME) and non-ME (NME). Pearson’s correlation coefficient was used to evaluate statistical significance (strong: R2 ≥70%; moderate: R2=25-70%; weak: R2 ≤25%).

RESULTS: Overall, 186 patients met the inclusion criteria. Mammographic calcifications correlated poorly with invasive disease (R2 = 10.8%), overestimating by 57%. In patients with calcifications on mammography, MRI ME and NME correlated weakly with the maximum dimension of invasive disease and DCIS. In triple-negative breast cancer (TNBC) patients, invasive disease correlated strongly with the maximum dimension of calcifications (R2 = 83%) and moderately with ME (R2 = 37.7%) and NME (R2 = 28.4%).

CONCLUSION: Overall, current imaging techniques correlate poorly and overestimate final surgical pathology. This poor correlation may lead to uncertainty in the extent of required surgical excision and the exclusion of potential candidates for non-surgical management in ongoing trials. TNBCs would be good candidates for these trials given the stronger observed correlations between pathology and imaging.

PMID:37029866 | DOI:10.1245/s10434-023-13367-w

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Proposal of multimodal computed tomography-based scoring system in prediction of hemorrhagic transformation in acute ischemic stroke

Acta Neurol Belg. 2023 Apr 8. doi: 10.1007/s13760-023-02239-5. Online ahead of print.

ABSTRACT

INTRODUCTION: The routinely used computed tomography (CT)-based workup in the setting of acute ischemic stroke (AIS) includes non-contrast brain CT, CT angiography (CTA), and CT perfusion. Several CT, CTA, CTP-based radiological biomarkers of hemorrhagic transformation (HT) were reported.

AIM OF THE STUDY: To assess the predictive value of the combined multimodal CT parameters for HT after AIS and proposal of predictive scoring scale.

METHODS: The source images of the NCCT, CTA and CTP of 282 AIS patients involving the anterior circulation (HT = 91, non-HT = 191) were retrospectively reviewed and the following biomarkers were recorded and analyzed: Early subtle ischemic signs, hyperdense middle cerebral artery sign (HMCAS) and Alberta Stroke Program Early CT Score (ASPECTS) < 7 in NCCT, large-vessel occlusion (LVO), clot burden score (CBS) < 6, large-vessel occlusion, poor collateral score (CS) and Tmax > 6 s ≥ 56.5 ml. A scoring system to predict HT based on these biomarkers was developed. Each biomarker counts for a single point with the total score ranging from 0 to 7.

RESULTS: All the aforementioned multimodal CT biomarkers and the selected cut offs were significantly associated with higher HT risk. The calculated scores were statistically significant different between the HT and the non-HT groups with AUC 0.761 (95% CI 0.703-0.819, P < 0.0000001). Rates of HT were approximately five times higher in patients with score ≥ 3.

CONCLUSION: Multimodal CT-based scoring system may provide highly reliable predictive model of hemorrhagic transformation in acute ischemic stroke.

PMID:37029844 | DOI:10.1007/s13760-023-02239-5