Tag: statistics

JMIR Public Health Surveill. 2023 Mar 27;9:e43114. doi: 10.2196/43114.

ABSTRACT

BACKGROUND: Globally, men who have sex with men (MSM) continue to bear a disproportionately high burden of HIV infection. Rwanda experiences a mixed HIV epidemic, which is generalized in the adult population, with aspects of a concentrated epidemic among certain key populations at higher risk of HIV infection, including MSM. Limited data exist to estimate the population size of MSM at a national scale; hence, an important piece is missing in determining the denominators to use in estimates for policy makers, program managers, and planners to effectively monitor HIV epidemic control.

OBJECTIVE: The aims of this study were to provide the first national population size estimate (PSE) and geographic distribution of MSM in Rwanda.

METHODS: Between October and December 2021, a three-source capture-recapture method was used to estimate the MSM population size in Rwanda. Unique objects were distributed to MSM through their networks (first capture), who were then tagged according to MSM-friendly service provision (second capture), and a respondent-driven sampling survey was used as the third capture. Capture histories were aggregated in a 2k-1 contingency table, where k indicates the number of capture occasions and “1” and “0” indicate captured and not captured, respectively. Statistical analysis was performed in R (version 4.0.5) and the Bayesian nonparametric latent-class capture-recapture package was used to produce the final PSE with 95% credibility sets (CS).

RESULTS: We sampled 2465, 1314, and 2211 MSM in capture one, two, and three, respectively. There were 721 recaptures between captures one and two, 415 recaptures between captures two and three, and 422 recaptures between captures one and three. There were 210 MSM captured in all three captures. The total estimated population size of MSM above 18 years old in Rwanda was 18,100 (95% CS 11,300-29,700), corresponding to 0.70% (95% CI 0.4%-1.1%) of total adult males. Most MSM reside in the city of Kigali (7842, 95% CS 4587-13,153), followed by the Western province (2469, 95% CS 1994-3518), Northern province (2375, 95% CS 842-4239), Eastern province (2287, 95% CS 1927-3014), and Southern province (2109, 95% CS 1681-3418).

CONCLUSIONS: Our study provides, for the first time, a PSE of MSM aged 18 years or older in Rwanda. MSM are concentrated in the city of Kigali and are almost evenly distributed across the other 4 provinces. The national proportion estimate bounds of MSM out of the total adult males includes the World Health Organization’s minimum recommended proportion (at least 1.0%) based on 2012 census population projections for 2021. These results will inform denominators to be used for estimating service coverage and fill existing information gaps to enable policy makers and planners to monitor the HIV epidemic among MSM nationally. There is an opportunity for conducting small-area MSM PSEs for subnational-level HIV treatment and prevention interventions.

PMID:36972131 | DOI:10.2196/43114

Ophthalmic Plast Reconstr Surg. 2023 Mar 27. doi: 10.1097/IOP.0000000000002377. Online ahead of print.

ABSTRACT

PURPOSE: Determining the hemodynamic characteristics of an orbital vascular malformation is a critical step in management. The purpose of this study is to assess the relationship between enophthalmos and clinically apparent distensibility of orbital vascular malformations, to optimize imaging and treatment.

METHODS: In this cross-sectional cohort study consecutive patients at a single institution were screened for study entry. Data extracted included age, sex, Hertel measurements, presence or absence of distensibility during the Valsalva maneuver, whether lesions were primarily venous or lymphatic based on imaging, and location of the lesion relative to the globe. Enophthalmos was defined as ≥ 2 mm difference from the opposite side. Parametric and nonparametric statistics were used, and linear regression was performed to examine factors predictive of Hertel measurement.

RESULTS: Twenty-nine patients met the inclusion criteria. Relative enophthalmos ≥2 mm was significantly associated with distensibility (p = 0.03; odds ratio = 5.33). Distensibility and venous dominant morphology were the 2 most important factors associated with enophthalmos on regression analysis. The relative position of the lesion anterior or posterior to the globe did not have a significant bearing on baseline enophthalmos.

CONCLUSIONS: The presence of enophthalmos increases the likelihood that an orbital vascular malformation is distensible. This group of patients was also more likely to be characterized by venous dominant malformations. Baseline clinical enophthalmos may serve as a useful surrogate marker for distensibility and venous dominance, which may be useful in guiding the selection of appropriate imaging.

PMID:36972118 | DOI:10.1097/IOP.0000000000002377

JMIR Res Protoc. 2023 Mar 27;12:e39834. doi: 10.2196/39834.

ABSTRACT

BACKGROUND: Endometriosis-associated deep dyspareunia is associated with reduced sexual quality of life, lower self-esteem, and impaired sexual function.

OBJECTIVE: The primary objective is to assess the acceptability of a phallus length reducer (brand name: Ohnut [OhnutCo]), which is a buffer worn over the penis or a penetrating object to reduce endometriosis-associated deep dyspareunia, and the feasibility of a definitive randomized controlled trial (RCT). The secondary objective is to obtain estimates of the effectiveness of the buffer. An embedded substudy will explore the acceptability and the preliminary validity and reliability of a vaginal insert for the self-assessment of deep dyspareunia.

METHODS: Ours is an investigator-initiated, 2-arm RCT. We will recruit 40 patient participants with diagnosed endometriosis between the ages of 19 and 49 years, as well as their sexual partners. The participating couples will be randomized in a 1:1 ratio into the experimental arm or the waitlist control arm. The length of the study period will be 10 weeks, during which time all participants will record deep dyspareunia severity following each episode of sexual intercourse. In weeks 1 to 4, all patient participants will record deep dyspareunia severity at each sexual encounter. In weeks 5 to 10, participants in the experimental arm will use the buffer during vaginal penetration; participants in the waitlist control arm will continue engaging in vaginal penetration as usual. Participants will complete questionnaires for assessing measures of anxiety, depression, and sexual function at baseline, at 4 weeks, and at 10 weeks. In the substudy, patient participants will self-assess dyspareunia by using a vaginal insert on 2 occasions, at least 1 week apart. The primary outcomes-the acceptability and feasibility of the buffer-will be assessed with descriptive statistics, and the secondary outcome-phallus length reducer effectiveness-will be assessed by using an analysis of covariance-based approach. For the vaginal insert, we will assess acceptability, test-retest reliability, and convergent validity via correlation analyses comparing the use of the insert to clinical examination in terms of dyspareunia assessment outcomes.

RESULTS: Our pilot will provide initial data on the acceptability and effectiveness of the buffer and the feasibility of the study methodology. The results from our study are expected to be submitted for publication by the spring of 2023. As of September 2021, we have consented 31 couples into the study.

CONCLUSIONS: Our study will provide preliminary evidence for the self-assessment and management of endometriosis-associated deep dyspareunia. The findings will inform the decision to proceed to a definitive RCT.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04370444; https://clinicaltrials.gov/ct2/show/NCT04370444.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39834.

PMID:36972117 | DOI:10.2196/39834

J Psychopathol Clin Sci. 2023 Mar 27. doi: 10.1037/abn0000805. Online ahead of print.

ABSTRACT

Large-scale mental health surveys screen participants for the presence of the core diagnostic criteria of a mental disorder such as major depressive disorder (MDD). Only participants who screen positive are administered the full diagnostic module; the remainder “skip-out.” Although this procedure adheres faithfully to the psychiatric classification of mental disorders, it limits the use of the resulting survey data for conducting high-quality research of importance to scientists, clinicians, and policymakers. Here, we conduct a series of exploratory analyses using the Virginia Adult Twin Study of Psychiatric and Substance Use Disorders (VATSPSUD) data, a unique survey which suspended the skip-out procedure for assessing past-year MDD. Adult twins (N = 8,980) born between 1930 and 1974 were recruited from a multiple-birth record database established in 1980 and interviewed in mid-adulthood between 1987 and 1996. We compared the: (a) prevalence and levels of impairment of the diagnostic criteria (and disaggregated symptom items) of adults screening positive/negative and (b) patterns of associations between MDD diagnostic criteria (and disaggregated symptom items) under three conditions: (a) full data; (b) “skip-out” data substituted with zeros; and (c) “skip-out” data treated via listwise deletion. Important differences in the patterns of associations between diagnostic criteria and disaggregated symptom sets emerged which changed the statistical evidence regarding the dimensionality of the criteria/symptom items (i.e., Condition C). An ill-defined correlation matrix which was unsuitable for statistical analysis was produced (i.e., Condition B). Given the problems with these widely used approaches, we offer researchers and data analysts practical alternatives to using the skip-out procedure in future surveys. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:36972115 | DOI:10.1037/abn0000805

Psychol Methods. 2023 Mar 27. doi: 10.1037/met0000576. Online ahead of print.

ABSTRACT

Relations between variables can take different forms like linearity, piecewise linearity, or nonlinearity. Segmented regression analyses (SRA) are specialized statistical methods that detect breaks in the relationship between variables. They are commonly used in the social sciences for exploratory analyses. However, many relations may not be best described by a breakpoint and a resulting piecewise linear relation, but rather by a nonlinearity. In the present simulation study, we examined the application of SRA-specifically the Davies test-in the presence of various forms of nonlinearity. We found that moderate and strong degrees of nonlinearity led to a frequent identification of statistically significant breakpoints and that the identified breakpoints were widely distributed. The results clearly indicate that SRA cannot be used for exploratory analyses. We propose alternative statistical methods for exploratory analyses and outline the conditions for the legitimate use of SRA in the social sciences. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:36972079 | DOI:10.1037/met0000576

Psychol Methods. 2023 Mar 27. doi: 10.1037/met0000568. Online ahead of print.

ABSTRACT

A data matrix, where rows represent persons and columns represent measured subtests, can be viewed as a stack of person profiles, as rows are actually person profiles of observed responses on column subtests. Profile analysis seeks to identify a small number of latent profiles from a large number of person response profiles to identify central response patterns, which are useful for assessing the strengths and weaknesses of individuals across multiple dimensions in domains of interest. Moreover, the latent profiles are mathematically proven to be summative profiles that linearly combine all person response profiles. Since person response profiles are confounded with profile level and response pattern, the level effect must be controlled when they are factorized to identify a latent (or summative) profile that carries the response pattern effect. However, when the level effect is dominant but uncontrolled, only a summative profile carrying the level effect would be considered statistically meaningful according to a traditional metric (e.g., eigenvalue ≥ 1) or parallel analysis results. Nevertheless, the response pattern effect among individuals can provide assessment-relevant insights that are overlooked by conventional analysis; to achieve this, the level effect must be controlled. Consequently, the purpose of this study is to demonstrate how to correctly identify summative profiles containing central response patterns regardless of the centering techniques used on data sets. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:36972078 | DOI:10.1037/met0000568

JAMA Netw Open. 2023 Mar 1;6(3):e234723. doi: 10.1001/jamanetworkopen.2023.4723.

ABSTRACT

IMPORTANCE: For older adults with frailty syndrome, reducing polypharmacy may have utility as a safety-promoting treatment option.

OBJECTIVE: To investigate the effects of family conferences on medication and clinical outcomes in community-dwelling older adults with frailty receiving polypharmacy.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized clinical trial was conducted from April 30, 2019, to June 30, 221, at 110 primary care practices in Germany. The study included community-dwelling adults aged 70 years or older with frailty syndrome, daily use of at least 5 different medications, a life expectancy of at least 6 months, and no moderate or severe dementia.

INTERVENTIONS: General practitioners (GPs) in the intervention group received 3 training sessions on family conferences, a deprescribing guideline, and a toolkit with relevant nonpharmacologic interventions. Three GP-led family conferences for shared decision-making involving the participants and family caregivers and/or nursing services were subsequently held per patient at home over a period of 9 months. Patients in the control group received care as usual.

MAIN OUTCOMES AND MEASURES: The primary outcome was the number of hospitalizations within 12 months, as assessed by nurses during home visits or telephone interviews. Secondary outcomes included the number of medications, the number of European Union list of the number of potentially inappropriate medication (EU[7]-PIM) for older people, and geriatric assessment parameters. Both per-protocol and intention-to-treat analyses were conducted.

RESULTS: The baseline assessment included 521 individuals (356 women [68.3%]; mean [SD] age, 83.5 [6.17] years). The intention-to-treat analysis with 510 patients showed no significant difference in the adjusted mean (SD) number of hospitalizations between the intervention group (0.98 [1.72]) and the control group (0.99 [1.53]). In the per-protocol analysis including 385 individuals, the mean (SD) number of medications decreased from 8.98 (3.56) to 8.11 (3.21) at 6 months and to 8.49 (3.63) at 12 months in the intervention group and from 9.24 (3.44) to 9.32 (3.59) at 6 months and to 9.16 (3.42) at 12 months in the control group, with a statistically significant difference at 6 months in the mixed-effect Poisson regression model (P = .001). After 6 months, the mean (SD) number of EU(7)-PIMs was significantly lower in the intervention group (1.30 [1.05]) than in the control group (1.71 [1.25]; P = .04). There was no significant difference in the mean number of EU(7)-PIMs after 12 months.

CONCLUSIONS AND RELEVANCE: In this cluster randomized clinical trial with older adults taking 5 or more medications, the intervention consisting of GP-led family conferences did not achieve sustainable effects in reducing the number of hospitalizations or the number of medications and EU(7)-PIMs after 12 months.

TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015055.

PMID:36972052 | DOI:10.1001/jamanetworkopen.2023.4723

JAMA Netw Open. 2023 Mar 1;6(3):e234885. doi: 10.1001/jamanetworkopen.2023.4885.

ABSTRACT

IMPORTANCE: Many studies have reported a positive association of youth electronic cigarette (e-cigarette) use with subsequent cigarette smoking initiation, but it remains unclear whether e-cigarette use is associated with continued cigarette smoking after initiation.

OBJECTIVE: To assess the association of youth baseline e-cigarette use with their continued cigarette smoking 2 years after initiation.

DESIGN, SETTING, AND PARTICIPANTS: The Population Assessment of Tobacco and Health (PATH) Study is a national longitudinal cohort study. This sample consisted of youth who participated in waves 3, 4, and 5 of the study (wave 3 was from October 2015 to October 2016, wave 4 was from December 2016 to January 2018, and wave 5 was from December 2018 to November 2019) and had never used cigarettes (cigarette-naive) by wave 3. The current analysis used multivariable logistic regressions in August 2022 to assess the association between e-cigarette use among cigarette-naive adolescents aged 12 to 17 years in 2015 and 2016 and subsequent continued cigarette smoking. PATH uses audio computer-assisted self-interviewing and computer-assisted personal interviewing to collect data.

EXPOSURES: Ever and current (past 30-day) use of e-cigarettes in wave 3.

MAIN OUTCOMES AND MEASURES: Continued cigarette smoking in wave 5 after initiating smoking in wave 4.

RESULTS: The current sample included 8671 adolescents who were cigarette naive in wave 3 and also participated in waves 4 and 5; 4823 of the participants (55.4%) were aged 12 to 14 years, 4454 (51.1%) were male, and 3763 (51.0%) were non-Hispanic White. Overall, regardless of e-cigarette use, few adolescents (362 adolescents [4.1%]) initiated cigarette smoking at wave 4, and even fewer (218 participants [2.5%]) continued smoking at wave 5. Controlling for multiple covariates, the adjusted odds ratio of baseline ever e-cigarette use, compared with never e-cigarette use, was 1.81 (95% CI, 1.03 to 3.18) for continued smoking measured as past 30-day smoking at wave 5. However, the adjusted risk difference (aRD) was small and not significant. The aRD was 0.88 percentage point (95% CI, -0.13 to 1.89 percentage points) for continued smoking, with the absolute risk being 1.19% (95% CI, 0.79% to 1.59%) for never e-cigarette users and 2.07% (95% CI, 1.01% to 3.13%) for ever e-cigarette users. Similar results were found using an alternative measure of continued smoking (lifetime ≥100 cigarettes and current smoking at wave 5) and using baseline current e-cigarette use as the exposure measure.

CONCLUSIONS AND RELEVANCE: In this cohort study, absolute and relative measures of risks yielded findings suggesting very different interpretations of the association. Although there were statistically significant odds ratios of continued smoking comparing baseline e-cigarette users with nonusers, the minor risk differences between them, along with the small absolute risks, suggest that few adolescents are likely to continue smoking after initiation regardless of baseline e-cigarette use.

PMID:36972048 | DOI:10.1001/jamanetworkopen.2023.4885

JAMA Intern Med. 2023 Mar 27. doi: 10.1001/jamainternmed.2023.0265. Online ahead of print.

ABSTRACT

IMPORTANCE: Patients receiving maintenance dialysis experience intensive patterns of end-of-life care that might not be consistent with their values.

OBJECTIVE: To evaluate the association of patients’ health care values with engagement in advance care planning and end-of-life care.

DESIGN, SETTING, AND PARTICIPANTS: Survey study of patients who received maintenance dialysis between 2015 and 2018 at dialysis centers in the greater metropolitan areas of Seattle, Washington, and Nashville, Tennessee, with longitudinal follow-up of decedents. Logistic regression models were used to estimate probabilities. Data analysis was conducted between May and October 2022.

EXPOSURES: A survey question about the value that the participant would place on longevity-focused vs comfort-focused care if they were to become seriously ill.

MAIN OUTCOMES AND MEASURES: Self-reported engagement in advance care planning and care received near the end of life through 2020 using linked kidney registry data and Medicare claims.

RESULTS: Of 933 patients (mean [SD] age, 62.6 [14.0] years; 525 male patients [56.3%]; 254 [27.2%] identified as Black) who responded to the question about values and could be linked to registry data (65.2% response rate [933 of 1431 eligible patients]), 452 (48.4%) indicated that they would value comfort-focused care, 179 (19.2%) that they would value longevity-focused care, and 302 (32.4%) that they were unsure about the intensity of care they would value. Many had not completed an advance directive (estimated probability, 47.5% [95% CI, 42.9%-52.1%] of those who would value comfort-focused care vs 28.1% [95% CI, 24.0%-32.3%] of those who would value longevity-focused care or were unsure; P < .001), had not discussed hospice (estimated probability, 28.6% [95% CI, 24.6%-32.9%] comfort focused vs 18.2% [95% CI, 14.7%-21.7%] longevity focused or unsure; P < .001), or had not discussed stopping dialysis (estimated probability, 33.3% [95% CI, 29.0%-37.7%] comfort focused vs 21.9% [95% CI, 18.2%-25.8%] longevity focused or unsure; P < .001). Most respondents wanted to receive cardiopulmonary resuscitation (estimated probability, 78.0% [95% CI, 74.2%-81.7%] comfort focused vs 93.9% [95% CI, 91.4%-96.1%] longevity focused or unsure; P < .001) and mechanical ventilation (estimated probability, 52.0% [95% CI, 47.4%-56.6%] comfort focused vs 77.9% [95% CI, 74.0%-81.7%] longevity focused or unsure; P < .001). Among decedents, the percentages of participants who received an intensive procedure during the final month of life (estimated probability, 23.5% [95% CI, 16.5%-31.0%] comfort focused vs 26.1% [95% CI, 18.0%-34.5%] longevity focused or unsure; P = .64), discontinued dialysis (estimated probability, 38.3% [95% CI, 32.0%-44.8%] comfort focused vs 30.2% [95% CI, 23.0%-37.8%] longevity focused or unsure; P = .09), and enrolled in hospice (estimated probability, 32.2% [95% CI, 25.7%-38.7%] comfort focused vs 23.3% [95% CI, 16.4%-30.5%] longevity focused or unsure; P = .07) were not statistically different.

CONCLUSIONS AND RELEVANCE: This survey study found that there appeared to be a disconnect between patients’ expressed values, which were largely comfort focused, and their engagement in advance care planning and end-of-life care, which reflected a focus on longevity. These findings suggest important opportunities to improve the quality of care for patients receiving dialysis.

PMID:36972031 | DOI:10.1001/jamainternmed.2023.0265

Ther Innov Regul Sci. 2023 Mar 27. doi: 10.1007/s43441-023-00504-6. Online ahead of print.

ABSTRACT

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies. While these efforts have contributed positively to developing a common understanding of QTLs, some uncertainty remains regarding implementable approaches. In this article, we review the approaches taken by some leading biopharmaceutical companies, offering recommendations for how to make QTLs most effective, what makes them ineffective, and several case studies to illustrate these concepts. This includes how best to choose QTL parameters and thresholds for a given study, how to differentiate QTLs from key risk indicators, and how QTLs relate to critical-to-quality factors and the statistical design of the trials.

PMID:36972010 | DOI:10.1007/s43441-023-00504-6