Nevin Manimala Statistics

Evaluation of a Pilot Program to Prevent the Misuse of Prescribed Opioids Among Health Care Workers: Repeated Measures Survey Study

JMIR Form Res. 2024 Apr 12;8:e53665. doi: 10.2196/53665.


BACKGROUND: Overprescription of opioids has led to increased misuse of opioids, resulting in higher rates of overdose. The workplace can play a vital role in an individual’s intentions to misuse prescription opioids with injured workers being prescribed opioids, at a rate 3 times the national average. For example, health care workers are at risk for injuries, opioid dispensing, and diversion. Intervening within a context that may contribute to risks for opioid misuse while targeting individual psychosocial factors may be a useful complement to interventions at policy and prescribing levels.

OBJECTIVE: This pilot study assessed the effects of a mobile-friendly opioid misuse intervention prototype tailored for health care workers using the preparation phase of a multiphase optimization strategy design.

METHODS: A total of 33 health care practitioners participated in the pilot intervention, which included 10 brief web-based lessons aimed at impacting psychosocial measures that underlie opioid misuse. The lesson topics included: addiction beliefs, addiction control, Centers for Disease Control and Prevention guidelines and recommendations, beliefs about patient-provider relationships and communication, control in communicating with providers, beliefs about self-monitoring pain and side effects, control in self-monitoring pain and side effects, diversion and disposal beliefs, diversion and disposal control, and a conclusion lesson. Using a treatment-only design, pretest and posttest surveys were collected. A general linear repeated measures ANOVA was used to assess mean differences from pretest to posttest. Descriptive statistics were used to assess participant feedback about the intervention.

RESULTS: After completing the intervention, participants showed significant mean changes with increases in knowledge of opioids (+0.459; P<.001), less favorable attitudes toward opioids (-1.081; P=.001), more positive beliefs about communication with providers (+0.205; P=.01), more positive beliefs about pain management control (+0.969; P<.001), and increased intentions to avoid opioid use (+0.212; P=.03). Of the 33 practitioners who completed the program, most felt positive about the information presented, and almost 70% (23/33) agreed or strongly agreed that other workers in the industry should complete a program like this.

CONCLUSIONS: While attempts to address the opioid crisis have been made through public health policies and prescribing initiatives, opioid misuse continues to rise. Certain industries place workers at greater risk for injury and opioid dispensing, making interventions that target workers in these industries of particular importance. Results from this pilot study show positive impacts on knowledge, attitudes, and beliefs about communicating with providers and pain management control, as well as intentions to avoid opioid misuse. However, the dropout rate and small sample size are severe limitations, and the results lack generalizability. Results will be used to inform program revisions and future optimization trials, with the intention of providing insight for future intervention development and evaluation of mobile-friendly eHealth interventions for employees.

PMID:38607664 | DOI:10.2196/53665

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High-Acuity Alcohol-Related Complications During the COVID-19 Pandemic

JAMA Health Forum. 2024 Apr 5;5(4):e240501. doi: 10.1001/jamahealthforum.2024.0501.


IMPORTANCE: Research has demonstrated an association between the COVID-19 pandemic and increased alcohol-related liver disease hospitalizations and deaths. However, trends in alcohol-related complications more broadly are unclear, especially among subgroups disproportionately affected by alcohol use.

OBJECTIVE: To assess trends in people with high-acuity alcohol-related complications admitted to the emergency department, observation unit, or hospital during the COVID-19 pandemic, focusing on demographic differences.

DESIGN, SETTING, AND PARTICIPANTS: This longitudinal interrupted time series cohort study analyzed US national insurance claims data using Optum’s deidentified Clinformatics Data Mart database from March 2017 to September 2021, before and after the March 2020 COVID-19 pandemic onset. A rolling cohort of people 15 years and older who had at least 6 months of continuous commercial or Medicare Advantage coverage were included. Subgroups of interest included males and females stratified by age group. Data were analyzed from April 2023 to January 2024.

EXPOSURE: COVID-19 pandemic environment from March 2020 to September 2021.

MAIN OUTCOMES AND MEASURES: Differences between monthly rates vs predicted rates of high-acuity alcohol-related complication episodes, determined using claims-based algorithms and alcohol-specific diagnosis codes. The secondary outcome was the subset of complication episodes due to alcohol-related liver disease.

RESULTS: Rates of high-acuity alcohol-related complications were statistically higher than expected in 4 of 18 pandemic months after March 2020 (range of absolute and relative increases: 0.4-0.8 episodes per 100 000 people and 8.3%-19.4%, respectively). Women aged 40 to 64 years experienced statistically significant increases in 10 of 18 pandemic months (range of absolute and relative increases: 1.3-2.1 episodes per 100 000 people and 33.3%-56.0%, respectively). In this same population, rates of complication episodes due to alcohol-related liver disease increased above expected in 16 of 18 pandemic months (range of absolute and relative increases: 0.8-2.1 episodes per 100 000 people and 34.1%-94.7%, respectively).

CONCLUSIONS AND RELEVANCE: In this cohort study of a national, commercially insured population, high-acuity alcohol-related complication episodes increased beyond what was expected in 4 of 18 COVID-19 pandemic months. Women aged 40 to 64 years experienced 33.3% to 56.0% increases in complication episodes in 10 of 18 pandemic months, a pattern associated with large and sustained increases in high-acuity alcohol-related liver disease complications. Findings underscore the need for increased attention to alcohol use disorder risk factors, alcohol use patterns, alcohol-related health effects, and alcohol regulations and policies, especially among women aged 40 to 64 years.

PMID:38607643 | DOI:10.1001/jamahealthforum.2024.0501

Nevin Manimala Statistics

Prediction Models and Clinical Outcomes-A Call for Papers

JAMA Netw Open. 2024 Apr 1;7(4):e249640. doi: 10.1001/jamanetworkopen.2024.9640.


PMID:38607631 | DOI:10.1001/jamanetworkopen.2024.9640

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Depression Onset After a Spouse’s Cardiovascular Event

JAMA Netw Open. 2024 Apr 1;7(4):e244602. doi: 10.1001/jamanetworkopen.2024.4602.


IMPORTANCE: Although cardiovascular disease (CVD) is a known risk factor for depression, evidence is lacking regarding whether and to what extent a spouse’s CVD is associated with the subsequent mental health of individuals.

OBJECTIVE: To examine the association between CVD onset in spouses and subsequent depression.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study examined 277 142 matched married couples enrolled in the Japan Health Insurance Association health insurance program between April 2015 and March 2022, covering approximately 40% of the working-age population in Japan. Index individuals (primary insured) whose spouses (dependent) experienced incident CVD between April 2016 and March 2022 were 1:1 matched to controls whose spouses did not experience CVD. Matching was based on age, sex, income, or the onset date of the spouses’ CVD. Data analysis was conducted from April 2016 to March 2022.

EXPOSURE: Spousal onset of CVD between fiscal years 2016 and 2021. The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes were used to identify the composite CVD outcomes (stroke, heart failure, and myocardial infarction).

MAIN OUTCOMES AND MEASURES: Multivariate Cox proportional hazards models were used to investigate the association between spouses’ new-onset CVD and individuals’ depression, adjusting for sociodemographic characteristics and comorbidities of index individuals (diabetes, hypertension, and CVD) and spouses (diabetes, hypertension, and depression). Subgroup analyses were conducted according to sex, age, income levels, and history of CVD.

RESULTS: Among 277 142 matched pairs of married couples, 263 610 (95.1%) had a male index individual; the mean (SD) age of index individuals was 58.2 (10.2) years. A new onset of depression was observed in 4876 individuals (1.8%). In multivariable Cox models, there was an association between the spouse’s CVD and the individuals’ depression (hazard ratio, 1.13 [95% CI, 1.07-1.20]). The subgroup analysis found no evidence of heterogeneity in sex, age, income level, or CVD history. The results were consistent when additionally adjusted for health behaviors (smoking, alcohol consumption, physical activity, and use of antihypertensive drugs) and objectively measured physical health conditions (body mass index, blood pressure, cholesterol levels, glucose levels, and estimated glomerular filtration rate) (hazard ratio, 1.16 [95% CI, 1.06-1.28]).

CONCLUSIONS AND RELEVANCE: In this nationwide cohort study of matched couples, a spouse’s onset of CVD was associated with an increased risk of an individual’s depression. These findings highlight the importance of preventive care for mental health disorders in individuals whose spouses experience incident CVD.

PMID:38607629 | DOI:10.1001/jamanetworkopen.2024.4602

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Physician Coaching by Professionally Trained Peers for Burnout and Well-Being: A Randomized Clinical Trial

JAMA Netw Open. 2024 Apr 1;7(4):e245645. doi: 10.1001/jamanetworkopen.2024.5645.


IMPORTANCE: Physician burnout is problematic despite existing interventions. More evidence-based approaches are needed.

OBJECTIVE: To explore the effect of individualized coaching by professionally trained peers on burnout and well-being in physicians.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial involved Mass General Physician Organization physicians who volunteered for coaching from August 5 through December 1, 2021. The data analysis was performed from February through October 2022.

INTERVENTIONS: Participants were randomized to 6 coaching sessions facilitated by a peer coach over 3 months or a control condition using standard institutional resources for burnout and wellness.

MAIN OUTCOMES AND MEASURES: The primary outcome was burnout as measured by the Stanford Professional Fulfillment Index. Secondary outcomes included professional fulfillment, effect of work on personal relationships, quality of life, work engagement, and self-valuation. Analysis was performed on a modified intention-to-treat basis.

RESULTS: Of 138 physicians enrolled, 67 were randomly allocated to the coaching intervention and 71 to the control group. Most participants were aged 31 to 60 years (128 [93.0%]), women (109 [79.0%]), married (108 [78.3%]), and in their early to mid career (mean [SD], 12.0 [9.7] years in practice); 39 (28.3%) were Asian, 3 (<0.1%) were Black, 9 (<0.1%) were Hispanic, 93 were (67.4%) White, and 6 (<0.1%) were of other race or ethnicity. In the intervention group, 52 participants underwent coaching and were included in the analysis. Statistically significant improvements in burnout, interpersonal disengagement, professional fulfillment, and work engagement were observed after 3 months of coaching compared with no intervention. Mean scores for interpersonal disengagement decreased by 30.1% in the intervention group and increased by 4.1% in the control group (absolute difference, -0.94 poimys [95% CI, -1.48 to -0.41 points; P = .001), while mean scores for overall burnout decreased by 21.6% in the intervention group and increased by 2.5% in the control group (absolute difference, -0.79 points; 95% CI, -1.27 to -0.32 points; P = .001). Professional fulfillment increased by 10.7% in the intervention group compared with no change in the control group (absolute difference, 0.59 points; 95% CI, 0.01-1.16 points; P = .046). Work engagement increased by 6.3% in the intervention group and decreased by 2.2% in the control group (absolute difference, 0.33 points; 95% CI, 0.02-0.65 points; P = .04). Self-valuation increased in both groups, but not significantly.

CONCLUSIONS AND RELEVANCE: The findings of this hospital-sponsored program show that individualized coaching by professionally trained peers is an effective strategy for reducing physician burnout and interpersonal disengagement while improving their professional fulfillment and work engagement.

TRIAL REGISTRATION: Identifier: NCT05036993.

PMID:38607628 | DOI:10.1001/jamanetworkopen.2024.5645

Nevin Manimala Statistics

Remote Monitoring and Data Collection for Decentralized Clinical Trials

JAMA Netw Open. 2024 Apr 1;7(4):e246228. doi: 10.1001/jamanetworkopen.2024.6228.


IMPORTANCE: Less than 5% of patients with cancer enroll in a clinical trial, partly due to financial and logistic burdens, especially among underserved populations. The COVID-19 pandemic marked a substantial shift in the adoption of decentralized trial operations by pharmaceutical companies.

OBJECTIVE: To assess the current global state of adoption of decentralized trial technologies, understand factors that may be driving or preventing adoption, and highlight aspirations and direction for industry to enable more patient-centric trials.

DESIGN, SETTING, AND PARTICIPANTS: The Bloomberg New Economy International Cancer Coalition, composed of patient advocacy, industry, government regulator, and academic medical center representatives, developed a survey directed to global biopharmaceutical companies of the coalition from October 1 through December 31, 2022, with a focus on registrational clinical trials. The data for this survey study were analyzed between January 1 and 31, 2023.

EXPOSURE: Adoption of decentralized clinical trial technologies.

MAIN OUTCOMES AND MEASURES: The survey measured (1) outcomes of different remote monitoring and data collection technologies on patient centricity, (2) adoption of these technologies in oncology and all therapeutic areas, and (3) barriers and facilitators to adoption using descriptive statistics.

RESULTS: All 8 invited coalition companies completed the survey, representing 33% of the oncology market by revenues in 2021. Across nearly all technologies, adoption in oncology trials lags that of all trials. In the current state, electronic diaries and electronic clinical outcome assessments are the most used technology, with a mean (SD) of 56% (19%) and 51% (29%) adoption for all trials and oncology trials, respectively, whereas visits within local physician networks is the least adopted at a mean (SD) of 12% (18%) and 7% (9%), respectively. Looking forward, the difference between the current and aspired adoption rate in 5 years for oncology is large, with respondents expecting a 40% or greater absolute adoption increase in 8 of the 11 technologies surveyed. Furthermore, digitally enabled recruitment, local imaging capabilities, and local physician networks were identified as technologies that could be most effective for improving patient centricity in the long term.

CONCLUSIONS AND RELEVANCE: These findings may help to galvanize momentum toward greater adoption of enabling technologies to support a new paradigm of trials that are more accessible, less burdensome, and more inclusive.

PMID:38607626 | DOI:10.1001/jamanetworkopen.2024.6228

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Incidence and Presenting Characteristics of Angiosarcoma in the US, 2001-2020

JAMA Netw Open. 2024 Apr 1;7(4):e246235. doi: 10.1001/jamanetworkopen.2024.6235.


IMPORTANCE: Angiosarcoma is an aggressive vascular malignant neoplasm presenting either as a primary or secondary cancer, often arising after radiotherapy or in the context of preexisting lymphedema. Comprehensive data describing its incidence and presentation patterns are needed.

OBJECTIVE: To describe the incidence, presenting characteristics, and change over time of angiosarcoma in the US.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study used data from the US Cancer Statistics (USCS) National Program of Cancer Registries-Surveillance, Epidemiology, and End Results Combined Database, which captures more than 99% of newly diagnosed cancers in the US. The study included all 19 289 patients in the US with a new diagnosis of angiosarcoma between 2001 and 2020 captured in the USCS database. Statistical analysis was performed from June to September 2023.

MAIN OUTCOMES AND MEASURES: Incidence of angiosarcoma, demographics of patients with angiosarcoma, and extent of disease at presentation.

RESULTS: The study included 19 289 patients (median age, 71 years [IQR, 59-80 years]; 10 506 women [54.5%]) with a new diagnosis of angiosarcoma. The US incidence of angiosarcoma doubled between 2001 (657 cases) and 2019 (1312 cases), reflecting both an increase in the adjusted incidence rate of 1.6% per year (P = .001), to 3.3 cases per 1 000 000 person-years (95% CI, 3.1-3.5 cases per 1 000 000 person-years), and an increase in the population at risk. In 2020, the reported incidence rate (3.0 cases per 1 000 000 person-years) and cases of angiosarcoma (n = 1159) were modestly lower than in 2019. Overall, 72.3% of cases of angiosarcoma (n = 13 955) were cutaneous, subcutaneous, or breast angiosarcomas; 24.4% were visceral (n = 4701); and 3.3% were located in unknown or rare primary sites (n = 633). Secondary breast and chest wall angiosarcomas among women represented the largest contribution to increasing incidence. Among breast angiosarcomas, 99.2% (2684 of 2705) were in women and 71.9% (1944 of 2705) were secondary. A total of 80.4% of chest wall or thorax cases among women (1861 of 2316) were secondary vs 26.5% among men (112 of 422), and 63.9% of upper extremity cases among women (205 of 321) were secondary vs 26.8% (56 of 209) among men (P = .001). Rates of secondary angiosarcoma in the abdomen and lower extremities were similar between men and women. The incidence rate of visceral angiosarcoma was also found to be increasing (1.5% per year; P = .001).

CONCLUSIONS AND RELEVANCE: This cross-sectional study describes angiosarcoma presentation patterns and incidence rates in the US over a 20-year period and shows that the number of cases in men and women increased, with the greatest increase among women with secondary angiosarcoma of the chest, breast, and upper extremity. These data increase awareness of a rare but highly morbid disease and highlight the need for improved early detection of angiosarcoma among patients at high risk, such as women with a history of breast cancer.

PMID:38607625 | DOI:10.1001/jamanetworkopen.2024.6235

Nevin Manimala Statistics

Childhood Adversity and Adolescent Smartphone Use Across Sexual Orientation and Gender Expression

JAMA Netw Open. 2024 Apr 1;7(4):e246448. doi: 10.1001/jamanetworkopen.2024.6448.


IMPORTANCE: Nonheterosexual and gender-nonconforming (GNC) individuals tend to report adverse childhood experiences (ACEs) more frequently compared with heterosexual and gender-conforming individuals, and individuals who have experienced ACEs, identify as nonheterosexual, or exhibit moderate to high levels of GNC are more prone to engaging in problematic smartphone use (PSU). However, there is limited school-based data among adolescents regarding this matter.

OBJECTIVES: To explore the associations between ACEs and PSU among adolescents across different sexual orientation and gender expression groups.

DESIGN, SETTING, AND PARTICIPANTS: Using data from the 2021 School-Based Chinese Adolescents Health Survey, this cross-sectional study includes participants from 288 public high schools across 8 provinces in China. Statistical analysis was performed from October 2023 to February 2024.

EXPOSURES: Data on ACEs, sexual orientations, and gender expressions (high, moderate, and low GNC) were collected.

MAIN OUTCOMES AND MEASURES: PSU was assessed using the 10-item Smartphone Addiction Scale-Short Version (SAS-SV). Weighted linear, logistic, or Poisson regression models were used.

RESULTS: Among the 85 064 adolescents included (mean [SD] age, 14.92 [1.77] years), 42 632 (50.1%) were female, 70 157 (83.2%) identified as Han Chinese, and 14 208 (16.8) identified as other ethnicities (Miao, Hui, Yi, Dai, and other ethnic groups). The prevalence of PSU among participants was 35.4%. Weighted Poisson regression models indicated that the interaction between GNC and ACE was significant (adjusted prevalence ratio [APR], 0.98; 95% CI, 0.97-0.99). Further stratified analysis demonstrated homosexual adolescents who experienced 4 or more ACEs showed a significantly increased prevalence of PSU (APR, 1.79; 95% CI, 1.64-1.96). Similarly, a markedly higher prevalence of PSU was observed among bisexual individuals with 4 or more ACEs (APR, 1.60; 95% CI, 1.41-1.80). Regarding gender expression categories, a significantly higher prevalence of PSU was noted among high GNC adolescents with 4 or more ACEs (APR, 1.78; 95% CI, 1.60-1.98) compared with low GNC adolescents without ACEs. Furthermore, experiencing any 3 ACE categories (abuse, neglect, and household dysfunction) was associated with an increased prevalence of PSU across different sexual orientation and gender expression subgroups.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, the amalgamation of elevated ACE scores with nonheterosexual orientations or GNC identities was significantly associated with increased PSU prevalence. These findings underscore that preventing ACEs may be beneficial in mitigating PSU among adolescents, particularly for nonheterosexual adolescents and those with high levels of GNC.

PMID:38607622 | DOI:10.1001/jamanetworkopen.2024.6448

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Smartphone-based imaging colorimetric assay for monitoring the quality of curcumin in turmeric powder

Anal Sci. 2024 Apr 12. doi: 10.1007/s44211-024-00562-2. Online ahead of print.


This research developed a colorimetric assay for semi-quantitative curcumin detection. The screening test was performed using a ferric chloride to form a brownish color which was further used to evaluate the amount of curcumin in the turmeric powder samples. The quantitative assay was performed based on the color intensity of the curcumin target using a smartphone digital image colorimetry with a developed lightbox constructed with a white light-emitting diodes (LED) light source as the measurement device. Images in red, green, and blue (RGB) color were processed to obtain relevant colors from the image and the color values were used to analyze curcumin concentrations. The intensity of the ΔB was correlated to the concentration of curcumin with high sensitivity. The method showed a linear range between 0.25 and 5 mg L-1 with the LOD and LOQ of 0.12 and 0.41 mg L-1, respectively. Sample analysis was carried out in turmeric powders. Curcumin in turmeric powder samples was simply extracted using acetonitrile followed by dilution 100 times for sample preparation. The accuracy was tested by spiking 0.25, 1.00, and 4.00 mg L-1 of standard curcumin into the turmeric sample solution. The average percentage recoveries were acceptable in all samples (90-104%). The method was validated by comparing the results obtained from the proposed method and high-performance liquid chromatography (HPLC). There was no statistically significant difference between the two methods (P = 0.05).

PMID:38607598 | DOI:10.1007/s44211-024-00562-2

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Diagnostic value of circulating tumor cells in patients with thyroid cancer: a retrospective study of 1478 patients

Discov Oncol. 2024 Apr 12;15(1):114. doi: 10.1007/s12672-024-00976-4.


BACKGROUND: Circulating tumor cell (CTC) detection is one form of liquid biopsy. It is a novel technique that is beginning to be applied in the field of thyroid cancer. The present study was designed to evaluate the diagnostic value of CTCs in patients with thyroid cancer.

METHODS: A total of 1478 patients were retrospectively analyzed and divided into malignant group (n = 747) and benign group (n = 731). Peripheral blood was collected, and CTCs were enriched and quantified before surgery. The baseline data of the two groups were matched by Propensity Score Matching (PSM). Receiver operating characteristic (ROC) curves were used to evaluate the diagnostic efficiency of different indicators for thyroid cancer. The malignant group before PSM was further divided into subgroups according to the BRAF V600E mutation and lymphatic metastasis (N stage), and the number of CTCs in different subgroups was compared.

RESULTS: After 1:1 PSM, baseline characteristics of the malignant group and benign group were matched and assigned 315 cases in each group. The number of CTCs and the TPOAb values were comparable in the two groups (p > 0.05). The TgAb values [1.890 (1.110 – 16.010) vs 1.645 (1.030 – 7.073) IU/mL, p = 0.049] were significantly higher in the malignant group than in the benign group. After PSM, ROC analyses showed that the areas under the curve (AUCs) of CTC, TgAb and ultrasound were 0.537 (sensitivity 65.6%, specificity 45.8%), 0.546 (sensitivity 40.0%, specificity 70.8%) and 0.705 (sensitivity 77.1%, specificity 63.2%), respectively. The AUCs of the combined detection of ‘CTC + ultrasound’ (combine 1) and the combined detection of ‘CTC + TgAb + ultrasound’ (combine 2) were 0.718 (sensitivity 79.3%, specificity 61.7%) and 0.724 (sensitivity 78.0%, specificity 63.3%), respectively. The AUC of ultrasound was significantly higher than CTC (p < 0.001). There was no statistically significant difference in AUC between combination 1 and ultrasound, and between combination 2 and ultrasound (p > 0.05). The number of CTCs between the N0 and N1 subgroups, and between the BRAF mutant and BRAF wild subgroups was comparable (p > 0.05).

CONCLUSIONS: As an emerging and noninvasive testing tool, the efficacy of CTCs in diagnosing thyroid cancer is limited.

PMID:38607590 | DOI:10.1007/s12672-024-00976-4