Category: Statistics

JMIR Res Protoc. 2023 Jan 6;12:e40496. doi: 10.2196/40496.

ABSTRACT

BACKGROUND: Veterans Affairs Farming and Recovery Mental Health Services (VA FARMS) is an innovative pilot program to provide supportive resources for veterans with interests in agricultural vocations. Implemented at 10 pilot sites, VA FARMS will provide mental health services and resources for veterans while supporting training in gardening and agriculture. As each pilot site project has unique goals, outreach strategies, and implementation efforts based on the local environment and veteran population, evaluating the pilot program provides a unique challenge for evaluators. This paper describes the protocol to evaluate VA FARMS, which was specifically designed to enable site variation by providing both site-specific and cross-site understanding of site implementation processes and outcomes.

OBJECTIVE: The objectives of this paper are to (1) describe the protocol used for evaluating VA FARMS, as an innovative Department of Veterans Affairs (VA) agriculturally based, mental health, and employment pilot program serving veterans at 10 pilot sites across the Veterans Health Administration enterprise; and (2) provide guidance to other evaluators assessing innovative programs.

METHODS: This evaluation uses the context, inputs, process, product (CIPP) model, which evaluates a program’s content and implementation to identify strengths and areas for improvement. Data collection will use a concurrent mixed methods approach. Quantitative data collection will involve quarterly program surveys, as well as three individual veteran participant surveys administered upon the veteran’s entrance and exit of the pilot program and 3 months postexit. Quantitative data will include baseline descriptive statistics and follow-up statistics on veteran health care utilization, health care status, and agriculture employment status. Qualitative data collection will include participant observation at each pilot site, and interviews with participants, staff, and community stakeholders. Qualitative data will provide insights about pilot program implementation processes, veterans’ experiences, and short-term participation outcomes.

RESULTS: Evaluation efforts began in December 2018 and are ongoing. Between October 2018 and September 2020, 494 veterans had enrolled in VA FARMS and 1326 veterans were reached through program activities such as demonstrations, informational presentations, and town-hall discussions. A total of 1623 community members and 655 VA employees were similarly reached by VA FARMS programming during that time. Data were collected between October 2018 and September 2020 in the form of 336 veteran surveys, 30 veteran interviews, 27 staff interviews, and 11 community partner interviews. Data analysis is expected to be completed by October 2022.

CONCLUSIONS: This evaluation protocol will provide guidance to other evaluators assessing innovative programs. In its application to the VA FARMS pilot, the evaluation aims to add to existing literature on nature-based therapies and the rehabilitation outcomes of agricultural training programs for veterans. Results will provide programmatic insights on the implementation of pilot programs, along with needed improvements and modifications for the future expansion of VA FARMS and other veteran-focused agricultural programs.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40496.

PMID:36607716 | DOI:10.2196/40496

J Med Internet Res. 2023 Jan 6;25:e41669. doi: 10.2196/41669.

ABSTRACT

BACKGROUND: While e-cigarettes usually contain nicotine, their addictive potential is not yet fully understood. We hypothesized that if e-cigarettes are addictive, users will experience typical symptoms of addiction.

OBJECTIVE: The aim of our study was to investigate whether and how e-cigarette users report signs of addiction.

METHODS: We identified 3 large German-language e-cigarette online forums via a systematic Google search. Based on a netnographic approach, we used deductive content analysis to investigate relevant posts in these forums. Netnography has the advantage of limiting the social desirability bias that prevails in face-to-face research, such as focus groups. The data were coded according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for tobacco use disorder, adapted for e-cigarettes. The DSM-5 criteria were used to portray a broad spectrum of possible experiences of addiction.

RESULTS: Overall, 5337 threads in 3 forums were screened, and 451 threads containing relevant information were included in the analysis. Users reported experiences consistent with the DSM-5 criteria, such as craving e-cigarettes, excessive time spent vaping, and health issues related to e-cigarette use. However, our analysis also showed that users reported the absence of typical tobacco use disorder criteria, such as successful attempts to reduce the nicotine dosage. For most themes, reports of their absence were more frequent than of their presence. The absence of perceived addiction was mostly reported in contrast to prior tobacco smoking.

CONCLUSIONS: This is the first study to use a netnographic approach to explore unfiltered self-reports of experiences of e-cigarette addiction by users in online forums. As hypothesized, some but not all users reported subjective experiences that corresponded to the criteria of tobacco use disorder as defined by the DSM-5. Nevertheless, subjective reports also indicated that many e-cigarette users felt in control of their behavior, especially in contrast to their prior use of tobacco cigarettes. The finding that some e-cigarette users subjectively experience addiction highlights the need for effective cessation programs to support users who experience their e-cigarette use as burdensome. This research can guide the refinement of instruments to assess e-cigarette addiction and guide cessation programs.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40359-021-00682-8.

PMID:36607713 | DOI:10.2196/41669

JAMA Netw Open. 2023 Jan 3;6(1):e2249785. doi: 10.1001/jamanetworkopen.2022.49785.

ABSTRACT

IMPORTANCE: Although incarcerated older adults experience higher rates of chronic disease and geriatric syndromes, it is unknown whether community-dwelling older adults with a history of incarceration are also at risk for worse health outcomes.

OBJECTIVE: To evaluate the association between a history of incarceration and health outcomes, including chronic health conditions and geriatric syndromes, in older age.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study using population-based data from the nationally representative Health and Retirement Study included US community-dwelling adults aged 50 years or older who completed the 2012 or 2014 survey waves assessing self-reported history of incarceration. Statistical analysis was completed from December 2021 to July 2022.

EXPOSURES: Self-reported history of incarceration.

MAIN OUTCOMES AND MEASURES: Geriatric health outcomes included cognitive impairment, mobility impairment, vision impairment, hearing impairment, urinary incontinence, and impairment of activities of daily living (ADLs). Chronic health outcomes included high blood pressure, diabetes, chronic lung disease, heart disease, stroke, mental health conditions, heavy alcohol use, and self-reported health. Survey weights were applied to adjust for the survey design.

RESULTS: Among 13 462 participants, 946 (7.6%) had experienced incarceration (mean [SD] age, 62.4 [7.8] years); compared with 12 516 people with no prior incarceration (mean [SD] age, 66.7 [10.0] years), previously incarcerated adults were more likely to be male (83.0% vs 42.8%; P < .001) and in the lowest quartile of wealth (44.1% vs 21.4%; overall P < .001). After adjusting for age, sex, race and ethnicity, wealth, educational attainment, and uninsured status, a history of incarceration was associated with a 20% to 80% increased risk of all geriatric syndromes evaluated, including impairment of ADLs (relative risk [RR], 1.62; 95% CI, 1.40-1.88) and hearing impairment (RR, 1.22; 95% CI, 1.04-1.44). Incarceration was also associated with increased risk of some chronic diseases, including chronic lung disease (RR, 1.56; 95% CI, 1.27-1.91), mental health conditions (RR, 1.80; 95% CI, 1.55-2.08), and heavy alcohol use (RR, 2.13; 95% CI, 1.59-2.84). Prior incarceration was not associated with diabetes or cardiovascular conditions.

CONCLUSIONS AND RELEVANCE: In this study, at least 1 in 15 older US adults reported a history of incarceration in their lifetime. Past incarceration was associated with many chronic diseases and geriatric syndromes even after accounting for socioeconomic status. These findings suggest that attention to incarceration history may be an important consideration in understanding and mitigating health risks in older age.

PMID:36607638 | DOI:10.1001/jamanetworkopen.2022.49785

J Cardiovasc Pharmacol. 2022 Nov 18. doi: 10.1097/FJC.0000000000001382. Online ahead of print.

ABSTRACT

Dual pathway inhibition (DPI) with low dose rivaroxaban and aspirin in patients with coronary artery (CAD) and/or peripheral artery disease (PAD) reduces the occurrence of cardiovascular (CV) events; however, the underlying mechanisms explaining these latter CV benefits are not clearly understood. Our explorative observational study aimed to evaluate the effect of DPI on plasma inflammation and coagulation markers among real-world patients with CAD and/or PAD. We prospectively included all consecutive patients with an established diagnosis of CAD and/or PAD treated with aspirin (ASA) 100 mg once daily (OD) and rivaroxaban 2.5 mg twice daily (TD). Clinical evaluation and laboratory analyses, including haemoglobin, renal function (creatinine, urea, cystatin-C); coagulation markers (INR, aPTT); inflammation markers (IL-6, CRP, lipoprotein-associated phospholipase A2, copeptin), growth differentiation factor-15 (GDF-15), were carried-out at baseline, before starting treatment, and at 4 and 24 weeks after study drugs administration. 54 consecutive patients (mean age 66 ± 7 years; male 83%) who completed the six-months follow-up were included. At 24 weeks follow-up, a statistically significant reduction in IL-6 serum levels (4.6 [3.5- 6.5] vs 3.4 [2.4- 4.3] pg/ml; p=0.0001) and fibrinogen (336 [290- 390] vs 310 [275- 364] mg/dl; P=0.04) was shown; moreover, a significant increase in GDF-15 serum level (1309 [974- 1961] vs 1538 [1286- 2913] pg/ml; p=0.002) was observed. Haemoglobin, renal function and cardiovascular homeostasis biomarkers remain stable over the time. The anti-Xa activity at both (0.005 [0-0.02] vs 0.2 [0.1-0.34]; p<0.0001) significantly increased. The dual pathway inhibitions with low-dose rivaroxaban and aspirin in patients with CAD and/or PAD were associated with the reduction of inflammation biomarkers.

PMID:36607629 | DOI:10.1097/FJC.0000000000001382

Spine (Phila Pa 1976). 2023 Feb 1;48(3):164-171. doi: 10.1097/BRS.0000000000004510. Epub 2022 Oct 13.

ABSTRACT

STUDY DESIGN: Multicenter retrospective analysis of routinely collected data.

OBJECTIVE: The underlying aim of this study was to identify potential treatment-related risk factors for odontoid fracture nonunion while accounting for known patient- and injury-related risk factors.

SUMMARY OF BACKGROUND DATA: Type II and III odontoid fractures represent the most common cervical spine fracture in elderly patients and are associated with a relatively high nonunion rate. The management of odontoid fractures is controversial and treatment strategies range from conservative treatment to extensive surgical stabilization and fusion.

METHODS: A total of 415 individuals who sustained odontoid fracture and were treated in either of four tertiary referral centers in Austria and Germany were included in the study. We included the following potential contributing factors for fracture nonunion in cross-validated extreme gradient boosted (XGBoost) and binary logistic regression models: age, gender, fracture displacement, mechanism of injury (high vs. low energy), fracture classification (Anderson II vs. III), presence of comorbidities (Charlson comorbidity index), and treatment (conservative, anterior screw fixation with one or two screws, posterior C1/C2 spondylodesis, cervico-occipital C0-C4 fusion).

RESULTS: In our cohort, 187 (45%) had radiologically confirmed odontoid nonunion six months postinjury. The odds for nonunion increase significantly with age, and are lower in type III compared to type II fractures. Also, odds for nonunion are significantly lower in posterior C1/C2 spondylodesis, and C0-C4 fusion compared to conservative treatment. Importantly, odds are not statistically significantly lower in the group treated with anterior screw fixation compared to conservative treatment. The factors gender, fracture displacement, mechanism of injury, and the presence of comorbidities did not produce significant odds.

CONCLUSION: Higher age, type II fractures, and conservative treatment are the main risk factors for odontoid nonunion. Anterior screw fixation did not differ significantly from conservative treatment in terms of fracture union.

LEVEL OF EVIDENCE: 3.

PMID:36607627 | DOI:10.1097/BRS.0000000000004510

Transl Vis Sci Technol. 2023 Jan 3;12(1):11. doi: 10.1167/tvst.12.1.11.

ABSTRACT

OBJECTIVE: This study aims to compare a new prototype for a portable anterior eye segment imaging system with the standard method for ophthalmology examination.

METHODS: The new imaging system consisted of two IMX219 Arducam autofocus sensors (Arducam, China, Nanjing) for Raspberry Pi V2 camera module connected to a Raspberry Pi Zero W (Raspberry Pi Foundation, UK, Cambridge) that clips to a wearable headset. The 2D videos of the anterior eye segment were recorded with the new system and a 720p FaceTime HD camera (Apple, Cupertino, CA). Afterward, ophthalmologists evaluated the videos using a standard clinical eye examination form. These evaluations were compared with the standard slit-lamp clinical assessment performed during the patient’s visit.

RESULTS: Thirty-five eyes were evaluated. The sensitivity and specificity percentages were statistically significant between the two imaging modalities (P ≤ 0.001). The evaluations performed from videos obtained with the new imaging system had better sensitivity and specificity percentages overall. However, statistically significant differences were only observed in cornea, anterior chamber, iris, and lens.

CONCLUSIONS: Specificity percentages were higher than sensitivity percentages in both imaging modalities, indicating that video evaluations are less accurate for pathological screening. Nevertheless, the new system evaluations were significantly better than the webcam evaluations.

TRANSLATIONAL RELEVANCE: This study presented an alternative system to assess eye conditions for telemedicine, one that provides more details than the current standard and uses new wearable headsets technologies.

PMID:36607624 | DOI:10.1167/tvst.12.1.11

Genes Genomics. 2023 Jan 6. doi: 10.1007/s13258-022-01363-5. Online ahead of print.

ABSTRACT

BACKGROUND: Jeju Island is the largest island of South Korea, located southwest far from the mainland of Korea, and has a unique history and its own cultures that are distinguished from those of the other regions of the Korean mainland. However, the Jeju population has not been deeply investigated to date to understand their genetic structure, which may reflect their historical and geographical background.

OBJECTIVE: To identify the genetic characteristics and biogeographic origin of people of Jeju Island based on the statistical analysis of genetic data using lineage markers.

METHODS: 17 Y-STRs data for 615 unrelated males and mitochondrial DNA haplogroup data for 799 unrelated individuals residing on Jeju Island were generated, and analyzed to investigate genetic diversity and genetic characteristics using statistical methods including pairwise Fst or Rst, Analysis of molecular variance (AMOVA) and Multidimensional scaling (MDS).

RESULTS: For male individuals of Jeju Island, unique genetic characteristics were observed in the analysis of Y-STRs, including low haplotype diversity, strong association with surnames, genetic difference from other regions of Korea, and common genetic variation of the Y-STR loci known to be predominant in Northern populations, such as Mongolians. Statistical analysis of the mitochondrial DNA haplogroups also revealed similar results that showed low haplogroup diversity and high frequency of haplogroup Y prevalent mostly in ethnic populations around the Sea of Okhotsk in Northeastern Asia. All these results suggest that Jeju Island is genetically distinct from other regions of Korea, possibly being a subpopulation in Korea, and related closely to Northern Asian populations.

CONCLUSION: The findings in the genetic approach could support understanding of the historical background of Jeju Island that is consistent with evidence from other multidisciplinary studies.

PMID:36607592 | DOI:10.1007/s13258-022-01363-5

Drugs. 2023 Jan 6. doi: 10.1007/s40265-022-01819-8. Online ahead of print.

ABSTRACT

BACKGROUND: Posaconazole is widely used for the prophylaxis and treatment of invasive fungal diseases. Because of the limited and variable absorption of the initially available oral suspension, a delayed-release tablet and intravenous formulation were developed.

OBJECTIVE: This study aimed to characterize the pharmacokinetics, including the absolute oral bioavailability, of all posaconazole formulations in healthy volunteers.

METHODS: Data from 182 healthy volunteers with 3898 densely sampled posaconazole concentrations were pooled from eight phase I clinical studies on the three formulations of various single and multiple dosage regimens between 50 and 400 mg. Analysis and simulations were performed using NONMEM 7.5.0. In the covariate analysis, the influence of food (fed vs fasted), nonlinearity, and for the delayed-release tablet, comedication (antacid, ranitidine, esomeprazole, and metoclopramide) were tested.

RESULTS: A two-compartment model with respectively, four and eight absorption transit compartments, best described the profiles of the oral suspension and delayed-release tablet. For the suspension, both a food effect and a dose-dependent nonlinear bioavailability were quantified, resulting in lower bioavailability when fasted or at a higher dose. The typical bioavailability of the suspension at 100 mg and 400 mg was derived to be respectively, 17.1% and 10.1% under fasted conditions and 59.1% and 49.2% under fed conditions. The absolute bioavailability of the delayed-release tablet was 58.8% (95% confidence interval 33.2-80.4) under fasted conditions and approached complete absorption under fed conditions for dosages up to 300 mg. Food intake reduced the absorption rate constant of the suspension by 52.2% (confidence interval 45.2-59.2). The impact of comedication on the absorption of the delayed-release tablet was not statistically significant. Model-based simulations indicate that under fed conditions, the licensed dosages of the three formulations yield a steady-state trough concentration ≥ 0.7 mg/L in over 90% of healthy volunteers. About 35% of healthy volunteers who receive the licensed 300-mg delayed-release tablet under fasted conditions do not achieve this target, while for the suspension this percentage varies between 55 and 85%, depending on the dose.

CONCLUSIONS: For both oral posaconazole formulations, we quantified bioavailability and absorption rate, including food effects, in healthy volunteers. The pharmacokinetic superiority of the delayed-release tablet was demonstrated under both fed and fasted conditions, compared with the oral suspension. The impact of food on the bioavailability of the delayed-release tablet was larger than anticipated, suggesting that administering the delayed-release tablet with food enhances absorption.

PMID:36607589 | DOI:10.1007/s40265-022-01819-8

Chin J Integr Med. 2023 Jan 6. doi: 10.1007/s11655-022-3682-9. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the efficacy of integrated Chinese and Western medicine extending the progression-free survival (PFS) and overall survival (OS) of limited-stage small cell lung cancer (LS-SCLC) patients after the first-line chemoradiotherapy.

METHODS: The data of 67 LS-SCLC patients who received combined treatment of CM and Western medicine (WM) between January 2013 and May 2020 at the outpatient clinic of Guang’anmen Hospital were retrospectively analyzed. Thirty-six LS-SCLC patients who received only WM treatment was used as the WM control group. The medical data of the two groups were statistically analyzed. Survival analysis was performed using the product-limit method (Kaplan-Meier analysis). The median OS and PFS were calculated, and survival curves were compared by the Log rank test. The cumulative survival rates at 1, 2, and 5 years were estimated by the life table analysis. Stratified survival analysis was performed between patients with different CM administration time.

RESULTS: The median PFS in the CM and WM combination treatment group and the WM group were 19 months (95% CI: 12.357-25.643) vs. 9 months (95% CI: 5.957-12.043), HR=0.43 (95% CI: 0.27-0.69, P<0.001), respectively. The median OS in the CM and WM combination group and the WM group were 34 months (95% CI could not be calculated) vs. 18.63 months (95% CI: 16.425-20.835), HR=0.40 (95% CI: 0.24-0.66, P<0.001), respectively. Similar results were obtained in the further stratified analysis of whether the duration of CM administration exceeded 18 and 24 months (P<0.001).

CONCLUSION: The combination treatment of CM and WM with continuing oral administration of CM treatment after the first-line chemoradiotherapy for LS-SCLC patients produced better prognosis, lower risks of progression, and longer survival than the WM treatment alone. (Registration No. ChiCTR2200056616).

PMID:36607585 | DOI:10.1007/s11655-022-3682-9

J Racial Ethn Health Disparities. 2023 Jan 6. doi: 10.1007/s40615-022-01490-5. Online ahead of print.

ABSTRACT

Disproportionate exposure to adverse neighborhood conditions and greater discrimination may contribute to health disparities among African Americans (AAs). We examined whether adverse neighborhood conditions, alone or in conjunction with discrimination, associate with shorter leukocyte telomere length among a predominantly AA cohort. The sample included 200 residents from two low-income neighborhoods (96% AA; mean age = 67 years). Perceived neighborhood conditions and discrimination were surveyed in 2018, and objective neighborhood conditions (total crime rate, neighborhood walkability, ambient air pollution (PM_2.5, black carbon)) were collected in 2017/2018. Relative telomere length (T/S; ratio of telomeric DNA to a single-gene copy) was assessed from blood samples. Linear regression models estimated the main effects of each neighborhood condition and discrimination and their interactions on the T/S ratio. Less walkable neighborhoods were associated with shorter telomeres. Higher air pollution (PM_2.5) was associated with shorter telomeres among those experiencing greater discrimination. Findings highlight the importance of understanding the intersecting influences of historic and contemporary sources of systemic racism and how they contribute to accelerated aging among adults.

PMID:36607563 | DOI:10.1007/s40615-022-01490-5