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Nevin Manimala Statistics

Rates Of Patient Safety Indicators In Belgian Hospitals Were Low But Generally Higher Than In US Hospitals, 2016-18

Health Aff (Millwood). 2024 Sep;43(9):1274-1283. doi: 10.1377/hlthaff.2023.01120.

ABSTRACT

More than two decades ago, the Agency for Healthcare Research and Quality developed its Patient Safety Indicators (PSIs) to monitor potentially preventable and severe adverse events within hospitals. Application of PSIs outside the US was explored more than a decade ago, but it is uncertain whether they remain relevant within Europe, as no up-to-date assessments of overall PSI-associated adverse event rates or interhospital variability can be found in the literature. This article assesses the nationwide occurrence and variability of thirteen adverse events for a case study of Belgium. We studied 4,765,850 patient stays across all 101 hospitals for 2016-18. We established that although adverse event rates were generally low, with an adverse event observed in 0.1 percent of medical hospital stays and in 1.2 percent of surgical hospital stays, they were higher than equivalent US rates and were prone to considerable between-hospital variability. Failure-to-rescue rates, for example, equaled 23 percent, whereas some hospitals exceeded nationwide central line-associated bloodstream infection rates by a factor of 8. Policy makers and hospital managers can prioritize PSIs that have high adverse event rates or large variability, such as failure to rescue or central line-associated bloodstream infections, to improve the quality of care in Belgian hospitals.

PMID:39226493 | DOI:10.1377/hlthaff.2023.01120

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Nevin Manimala Statistics

The effects of acupressure, laughter yoga, and a mindfulness-based stress reduction program applied to postmenopausal women for menopause symptoms and quality of life

Menopause. 2024 Sep 3. doi: 10.1097/GME.0000000000002402. Online ahead of print.

ABSTRACT

OBJECTIVE: This research was conducted to determine the effects of acupressure, laughter yoga, and a mindfulness-based stress reduction program applied to postmenopausal women for menopause symptoms and quality of life.

METHODS: A randomized controlled design was used. The study was conducted with a total of 146 women, including 41 acupressure, 31 laughter yoga, 37 mindfulness-based stress reduction, and 37 control group women. The women in the acupressure group were administered acupressure twice a week, which accounted for 16 sessions in total. Women in the laughter yoga and mindfulness-based stress reduction groups received a total of eight sessions of the related intervention, which was performed once a week. Study data were collected using a participant information form, the Menopause Rating Scale (MRS), and the Menopause-Specific Quality of Life Scale (MENQOL). Descriptive statistics, paired-samples t test, χ2 test, analysis of variance test, and intention to treat analysis were used to analyze the data. Before the intention to treat analysis was performed, the multiple imputation method was employed to deal with missing data.

RESULTS: In the study, it was found that there was a decrease in the MRS total score after the intervention in women in all three intervention groups compared to the control group (P < 0.05). In the laughter yoga group, total MRS scores decreased by 3.16 points (P < 0.05). In the acupressure group, total MRS scores decreased by 5.46 points (P < 0.05). In the mindfulness-based stress reduction (MBSR) program group, total MRS scores decreased by 4.65 points (P < 0.05). It was determined that the mean scores of women in the laughter yoga and acupressure groups on all subscales of the MENQOL decreased after the intervention compared to the control group (P < 0.05). The comparison of the MBSR group and the control group showed that there was a decrease only in the psychosocial domain subdimension of the MENQOL (P < 0.05).

CONCLUSIONS: In conclusion, it was determined that laughter yoga, acupressure, and MBSR could be effective in reducing menopause symptoms and improving quality of life, although findings require further testing in a rigorously controlled study and in a study with only a single prespecified outcome.

PMID:39226408 | DOI:10.1097/GME.0000000000002402

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Nevin Manimala Statistics

Establishing an Evaluation Indicator System for User Satisfaction With Hypertension Management Apps: Combining User-Generated Content and Analytic Hierarchy Process

J Med Internet Res. 2024 Sep 3;26:e60773. doi: 10.2196/60773.

ABSTRACT

BACKGROUND: Hypertension management apps (HMAs) can be effective in controlling blood pressure, but their actual impact is often suboptimal. Establishing a user satisfaction evaluation indicator system for HMAs can assist app developers in enhancing app design and functionality, while also helping users identify apps that best meet their needs. This approach aims to improve the overall effectiveness of app usage.

OBJECTIVE: This study aims to systematically collect data on HMAs and their user reviews in the United States and China. It analyzes app usage patterns and functional characteristics, identifies factors influencing user satisfaction from existing research, and develops a satisfaction evaluation indicator system to provide more accurate recommendations for improving user satisfaction.

METHODS: We conducted a descriptive statistical analysis to assess the development status of HMAs in both countries and applied the task-technology fit model to evaluate whether the app functionalities align with business needs. We separately summarized the factors influencing user satisfaction in both countries from previous research, utilized the analytic hierarchy process to develop an evaluation indicator system for HMA user satisfaction, and calculated satisfaction levels. Based on these findings, we propose improvements to enhance app functionality and user satisfaction.

RESULTS: In terms of current development status, there were fewer HMAs and user reviews in China compared with the United States. Regarding app functional availability, fewer than 5% (4/91) of the apps achieved a demand fulfillment rate exceeding 80% (8/10). Overall, user satisfaction in both countries was low.

CONCLUSIONS: In the United States, user satisfaction was lowest for advertising distribution, data synchronization, and reliability. By contrast, Chinese apps need improvements in cost efficiency and compatibility.

PMID:39226103 | DOI:10.2196/60773

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Nevin Manimala Statistics

Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials

JAMA Intern Med. 2024 Sep 3. doi: 10.1001/jamainternmed.2024.4346. Online ahead of print.

ABSTRACT

IMPORTANCE: Obesity is associated with numerous psychosocial complications, making psychiatric safety a consideration for treating people with obesity. Few studies have investigated the psychiatric safety of newly available antiobesity medications.

OBJECTIVE: To evaluate the psychiatric safety of subcutaneous semaglutide, 2.4 mg, once weekly in people without known major psychopathology.

DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes. Trial designs have been published previously.

INTERVENTIONS: Semaglutide, 2.4 mg, vs placebo.

MAIN OUTCOMES AND MEASURES: Depressive symptoms and suicidal ideation/behavior were assessed using the Patient Health Questionnaire (PHQ-9) and Columbia-Suicide Severity Rating Scale, respectively. Psychiatric and nervous system disorder adverse events were investigated.

RESULTS: This analysis included 3377 participants in the STEP 1, 2, and 3 trials (2360 women [69.6%]; mean [SD] age, 49 [13] years) and 304 participants in STEP 5 (236 women [77.6%]; mean [SD] age, 47 [11] years). In the STEP 1, 2, and 3 trials, mean (SD) baseline PHQ-9 scores for the semaglutide, 2.4 mg, and placebo groups were 2.0 (2.3) and 1.8 (2.3), respectively, indicating no/minimal symptoms of depression. PHQ-9 scores at week 68 were 2.0 (2.9) and 2.4 (3.3), respectively; the estimated treatment difference (95% CI) between groups was -0.56 (-0.81 to -0.32) (P < .001). Participants treated with semaglutide vs placebo were less likely to shift (from baseline to week 68) to a more severe category of PHQ-9 depression (odds ratio, 0.63; 95% CI, 0.50-0.79; P < .001). Based on the Columbia-Suicide Severity Rating Scale, 1% or fewer of participants reported suicidal ideation/behavior during treatment, with no differences between semaglutide, 2.4 mg, and placebo. Psychiatric disorder adverse events were generally balanced between groups. Similar results were observed in STEP 5.

CONCLUSIONS AND RELEVANCE: The results of this post hoc analysis suggest that treatment with semaglutide, 2.4 mg, did not increase the risk of developing symptoms of depression or suicidal ideation/behavior vs placebo and was associated with a small but statistically significant reduction in depressive symptoms (not considered clinically meaningful). People with obesity should be monitored for mental health concerns so they can receive appropriate support and care.

TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: STEP 1 (NCT03548935), 2 (NCT03552757), 3 (NCT03611582), and 5 (NCT03693430).

PMID:39226070 | DOI:10.1001/jamainternmed.2024.4346

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Nevin Manimala Statistics

Surgery and Suicide Deaths Among Patients With Cancer

JAMA Netw Open. 2024 Sep 3;7(9):e2431414. doi: 10.1001/jamanetworkopen.2024.31414.

NO ABSTRACT

PMID:39226059 | DOI:10.1001/jamanetworkopen.2024.31414

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Nevin Manimala Statistics

Case Definition for Diagnosed Alzheimer Disease and Related Dementias in Medicare

JAMA Netw Open. 2024 Sep 3;7(9):e2427610. doi: 10.1001/jamanetworkopen.2024.27610.

ABSTRACT

IMPORTANCE: Lack of a US dementia surveillance system hinders efforts to support and address disparities among persons living with Alzheimer disease and related dementias (ADRD).

OBJECTIVE: To review diagnosis and prescription drug code ADRD identification algorithms to develop and implement case definitions for national surveillance.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, a systematic literature review was conducted to identify unique International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and prescription drug codes used by researchers to identify ADRD in administrative records. Code frequency of use, characteristics of beneficiaries identified by codes, and expert and author consensus around code definitions informed code placement into categories indicating highly likely, likely, and possible ADRD. These definitions were applied cross-sectionally to 2017 to 2019 Medicare fee-for-service (FFS) claims and Medicare Advantage (MA) encounter data to classify January 2019 Medicare enrollees. Data analysis was conducted from September 2022 to March 2024.

EXPOSURES: ICD-10-CM and national drug codes in FFS claims or MA encounters.

MAIN OUTCOMES AND MEASURES: The primary outcome was counts and rates of beneficiaries meeting each case definition. Category-specific age, sex, race and ethnicity, MA enrollment, dual-eligibility, long-term care utilization, mortality, and rural residence distributions, as well as frailty scores and FFS monthly expenditures were also analyzed. Beneficiary characteristics were compared across categories, and age-standardized to minimize confounding by age.

RESULTS: Of the 60 000 869 beneficiaries included (50 853 806 aged 65 years or older [84.8%]; 32 567 891 female [54.3%]; 5 555 571 Hispanic [9.3%]; 6 318 194 non-Hispanic Black [10.5%]; 44 384 980 non-Hispanic White [74.0%]), there were 4 312 496 (7.2%) with highly likely ADRD, 1 124 080 (1.9%) with likely ADRD, and 2 572 176 (4.3%) with possible ADRD, totaling more than 8.0 million with diagnostic evidence of at least possible ADRD. These beneficiaries were older, more frail, more likely to be female, more likely to be dual-eligible, more likely to use long-term care, and more likely to die in 2019 compared with beneficiaries with no evidence of ADRD. These differences became larger when moving from the possible ADRD group to the highly likely ADRD group. Mean (SD) FFS monthly spending was $2966 ($4921) among beneficiaries with highly likely ADRD compared with $936 ($2952) for beneficiaries with no evidence of ADRD. Differences persisted after age standardization.

CONCLUSIONS AND RELEVANCE: This cross-sectional study of 2019 Medicare beneficiaries identified more than 5.4 million Medicare beneficiaries with evidence of at least likely ADRD in 2019 using the diagnostic case definition. Pending validation against clinical and other methods of ascertainment, this approach can be adopted provisionally for national surveillance.

PMID:39226058 | DOI:10.1001/jamanetworkopen.2024.27610

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Nevin Manimala Statistics

Error Rates in Race and Ethnicity Designation Across Large Pediatric Health Systems

JAMA Netw Open. 2024 Sep 3;7(9):e2431073. doi: 10.1001/jamanetworkopen.2024.31073.

ABSTRACT

IMPORTANCE: Without knowledge of the degree of misattribution in racial and ethnic designations in data, studies run the risk of missing existing inequities and disparities and identifying others that do not exist. Further, accuracy of racial and ethnic designations is important to clinical care improvement efforts and health outcomes.

OBJECTIVE: To determine the error rate of racial and ethnic attribution in the electronic medical records (EMRs) across the 3 largest pediatric health systems in Michigan.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study collected race and ethnicity data from parents in outpatient clinics, emergency departments, and inpatient units at the 3 largest pediatric health systems in Michigan. A total of 1594 parents or guardians participated at health system A, 1537 at health system B, and 1202 at health system C from September 1, 2023, to January 31, 2024. Parent or guardian report of race and ethnicity for a child was used as the gold standard for comparison with the designation in the EMR.

EXPOSURE: Race and ethnicity designations in the EMR. Options for race designation across the health systems ranged from 6 to 49; options for ethnicity, from 2 to 10.

MAIN OUTCOMES AND MEASURES: Matching occurred in 3 stages. First, the exact racial and ethnic designations made by parents for their child were compared with what was found in the EMR. Second, for any child whose parent selected more than 1 racial category or for whom more than 1 appeared in the EMR, the designation of a minoritized racial group was used for matching purposes. Third, starting with the product of stage 2, racial designations were combined or collapsed into 6 (health systems A and C) or 5 (health system B) designations.

RESULTS: A total of 4333 survey responses were included in the analysis. The greatest error rate across the health systems occurred with the exact match of parental report of racial designation with the EMR, which ranged from 41% to 78% across the health systems. Improvement in the matching rate for each health system occurred with consolidation of race options provided. Differences between the health systems narrowed at the final consolidation to varying from 79% to 88% matching. Ethnicity matching between the EMR and the parental report ranged from 65% to 95% across the health systems. Missing race or ethnicity data in the EMR was counted as a nonmatch. Rates of missing racial data varied across the health systems from 2% to 10%. The health system with the greatest number of options for race and ethnicity had the highest error rates.

CONCLUSIONS AND RELEVANCE: Although there will always be some misattribution of race and ethnicity in the EMR, the results of this cross-sectional study suggest that significant error in these data may undermine strategies to improve care. It is unclear whether those in an organization who determine the number of potential categories are the same persons who use those data to investigate potential disparities and inequities.

PMID:39226057 | DOI:10.1001/jamanetworkopen.2024.31073

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Nevin Manimala Statistics

Derivation of Indices of Cognitive Change Among Hispanic Adults and Elders

JAMA Netw Open. 2024 Sep 3;7(9):e2431180. doi: 10.1001/jamanetworkopen.2024.31180.

ABSTRACT

IMPORTANCE: Determining the influence of race and ethnicity on change in cognitive test performance has significant implications for clinical practice and research in populations at risk for Alzheimer disease.

OBJECTIVE: To evaluate the significance of race and ethnicity in predicting longitudinal cognitive test performance and to develop models to support evidence-based practice.

DESIGN, SETTING, AND PARTICIPANTS: This prognostic study included baseline and 24-month follow-up data that were obtained from the Health and Aging Brain Study-Health Disparities (HABS-HD) study, an ongoing longitudinal observational study of aging and dementia in a multiracial, multiethnic cohort. Participants included community-dwelling adults and elders living in the Dallas and Fort Worth metropolitan area who were Hispanic and non-Hispanic adults older than the age of 50 years and were cognitively unimpaired.

EXPOSURE: The primary exposure of interest was time, measured in months.

MAIN OUTCOMES AND MEASURES: Demographic variables included age, sex, education, and race and ethnicity. Cognitive domains included attention and working memory, processing speed, language, memory, and executive functioning. Linear regression models predicted follow-up performance from baseline performance and demographic variables for 13 commonly used neuropsychological tests. Follow-up testing was the primary outcome for all domains. Raw scores from 13 standardized tests were used for analyses.

RESULTS: This study included 799 adults who were cognitively unimpaired (352 Hispanic individuals [44.1%]; 447 non-Hispanic individuals [55.9%]; 524 female [65.6%]; mean [SD] age, 65.4 [8.1] years). In the regression models, all 13 follow-up scores were significantly predicted from their respective baseline scores and demographic variables. Baseline performance and education were the most consistent predictors of follow-up scores, contributing to all 13 models. Age was significantly associated with follow-up in 11 models, and sex was significant in 5 models. Race and ethnicity contributed to 10 of 13 models, with Hispanic participants predicted to have poorer follow-up scores than their non-Hispanic White counterparts on each test.

CONCLUSIONS AND RELEVANCE: In this longitudinal study of cognitive change in Hispanic and non-Hispanic older adults who were cognitively unimpaired, standardized regression-based models were influenced by multiple demographic variables, including race and ethnicity. These findings highlight the importance of including race and ethnicity in such cognitive change models. This ability to accurately predict cognitive change is expected to become increasingly important as clinical practice and clinical trials need to become more diverse and culturally appropriate in this burgeoning global medical and societal crisis.

PMID:39226056 | DOI:10.1001/jamanetworkopen.2024.31180

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Emergency Department Process Times and Door-In-Door-Out Times in Interhospital Transfers After Acute Ischemic Stroke

JAMA Netw Open. 2024 Sep 3;7(9):e2431183. doi: 10.1001/jamanetworkopen.2024.31183.

ABSTRACT

IMPORTANCE: Stroke treatment is exquisitely time sensitive. The door-in-door-out (DIDO) time, defined as the total time spent in the emergency department (ED) at a transferring hospital, is an important quality metric for the care of acute stroke. However, little is known about the contributions of specific process steps to delays and disparities in DIDO time.

OBJECTIVE: To quantify process steps and their association with DIDO times at transferring hospitals among patients with acute ischemic stroke (AIS).

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study analyzed patients in the American Heart Association Get With the Guidelines-Stroke registry with AIS presenting between January 1, 2019, to December 31, 2021, and transferred from the presenting hospital ED to another acute care hospital for evaluation of thrombolytics, endovascular therapy, or postthrombolytic care. Data were analyzed from July 8 to October 13, 2023.

EXPOSURES: Intervals of ED care of ischemic stroke: door-to-imaging and imaging-to-door times.

MAIN OUTCOMES AND MEASURES: The primary outcome was DIDO time. Multivariate generalized estimating equations regression models were performed to compare contributions of interval process times to explain variation in DIDO time, controlling for patient- and hospital-level characteristics.

RESULTS: Among 28 887 patients (50.5% male; mean [SD] age, 68.3 [14.8] years; 5.5% Hispanic, 14.7% non-Hispanic Black, and 73.2% non-Hispanic White), mean (SD) DIDO time was 171.4 (149.5) minutes, mean (SD) door-to-imaging time was 18.3 (34.1) minutes, and mean (SD) imaging-to-door time was 153.1 (141.5) minutes. In the model adjusting for door-to-imaging time, the following were associated with longer DIDO time: age 80 years or older (compared with 18-59 years; 5.97 [95% CI, 1.02-10.92] minutes), female sex (5.21 [95% CI, 1.55-8.87] minutes), and non-Hispanic Black race (compared with non-Hispanic White 10.09 [95% CI, 4.21-15.96] minutes). In the model including imaging-to-door time as a covariate, disparities in DIDO by age and female sex became nonsignificant, and the disparity by Black race was attenuated (2.32 [95% CI, 1.09-3.56] minutes).

CONCLUSIONS AND RELEVANCE: In this national cohort study of interhospital transfer of patients with AIS, delays in DIDO time by Black race, older age (≥80 years), and female sex were largely explained by the imaging-to-door period, suggesting that future systems interventions should target this interval to reduce these disparities. While existing guidelines and care resources heavily focus on reducing door-to-imaging times, further attention is warranted to reduce imaging-to-door times in the management of patients with AIS who require interhospital transfer.

PMID:39226055 | DOI:10.1001/jamanetworkopen.2024.31183

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Nevin Manimala Statistics

Universal Genetic Testing for Newly Diagnosed Invasive Breast Cancer

JAMA Netw Open. 2024 Sep 3;7(9):e2431427. doi: 10.1001/jamanetworkopen.2024.31427.

ABSTRACT

IMPORTANCE: Between 5% and 10% of breast cancer cases are associated with an inherited germline pathogenic or likely pathogenic variant (GPV) in a breast cancer susceptibility gene (BCSG), which could alter local and systemic therapy recommendations. Traditional genetic testing criteria misses a proportion of these cases.

OBJECTIVE: To evaluate the prevalence and clinicopathological associations of GPVs in 2 groups of BCSGs among an ethnically diverse cohort of women with newly diagnosed breast cancer.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study, conducted at 3 Montreal hospitals between September 2019 and April 2022, offered universal genetic counseling and testing to all women with a first diagnosis of invasive breast cancer. Women were offered an obligatory primary panel of BRCA1, BRCA2, and PALB2 (B1B2P2) and an optional secondary panel of 14 additional BCSGs. Eligible participants were women 18 years of age or older who received a diagnosis of a first primary invasive breast cancer not more than 6 months before the time of referral to the study. Data were analyzed from November 2023 to June 2024.

RESULTS: Of 1017 referred patients, 805 were eligible and offered genetic counseling and testing, and 729 of those 805 (90.6%) consented to be tested. The median age at breast cancer diagnosis was 53 years (range, 23-91 years), and 65.4% were White and of European ancestry. Fifty-four GPVs were identified in 53 patients (7.3%), including 39 patients (5.3%) with B1B2P2 and 15 patients (2.1%) with 6 of the 14 secondary panel BCSGs (ATM, BARD1, BRIP1, CHEK2, RAD51D, and STK11). On multivariable analysis, clinical factors independently associated with B1B2P2-positive status included being younger than 40 years of age at diagnosis (odds ratio [OR], 6.83; 95% CI, 2.22-20.90), triple-negative breast cancer (OR, 3.19; 95% CI, 1.20-8.43), high grade disease (OR, 1.68; 95% CI, 1.05-2.70), and family history of ovarian cancer (OR, 9.75; 95% CI, 2.65-35.85). Of 39 B1B2P2-positive patients, 13 (33.3%) were eligible for poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors.

CONCLUSIONS AND RELEVANCE: In this cross-sectional universal genetic testing study of women with newly diagnosed invasive breast cancer, the prevalence of GPVs was 7.3%, with 5.3% of patients testing positive for B1B2P2. Among B1B2P2-women women, one-third were eligible for PARP inhibitors.

PMID:39226054 | DOI:10.1001/jamanetworkopen.2024.31427