Nevin Manimala

Circulation. 2023 Jan 25. doi: 10.1161/CIR.0000000000001123. Online ahead of print.

ABSTRACT

BACKGROUND: The American Heart Association, in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure, and glucose control) that contribute to cardiovascular health. The Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs).

METHODS: The American Heart Association, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2023 Statistical Update is the product of a full year’s worth of effort in 2022 by dedicated volunteer clinicians and scientists, committed government professionals, and American Heart Association staff members. The American Heart Association strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year’s edition includes additional COVID-19 (coronavirus disease 2019) publications, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains.

RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics.

CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

PMID:36695182 | DOI:10.1161/CIR.0000000000001123

Phys Sportsmed. 2023 Jan 25. doi: 10.1080/00913847.2023.2170684. Online ahead of print.

ABSTRACT

OBJECTIVES: : Hamstring injuries are the most common muscle injuries in team sports. The aims of this study were to describe the epidemiology of hamstring muscle injuries in the professional and amateur sport sections of a multi-sport club (blinded for reviewers) and to determine any potential correlation between return-to-play (RTP) and injury location, severity of connective tissue damage, age, sex, and athlete’s level of competition.

METHODS: : This descriptive epidemiological study with data collected from September 2007 to September 2017 stored in the (blinded for reviewers) database. The study included non-contact hamstring injuries sustained during training or competition.

RESULTS: : A total of 538 hamstring injuries were reported in the club’s database, of which 240 were structurally verified by imaging as hamstring injuries. The overall incidence for the 17 sports studied was 1.29 structurally verified hamstring injuries per 100 athletes per year. The muscle most commonly involved in hamstring injuries was the biceps femoris, and the connective tissue most frequently involved was the myofascial. There was no evidence of a statistically significant association between age and RTP after injury, and no statistically significant difference between sex and RTP. However, the time loss by professionals was shorter than for amateurs, and proximal hamstring injuries took longer RTP than distal ones.

CONCLUSION: In the 17 sports practiced at multi-sport club, the incidence of hamstring injury was 1.29 per 100 athletes per year. Players from sports in which high speed sprinting and kicking are necessary, and amateurs, were at higher risk of suffering a hamstring injury. In addition, proximally located hamstring injuries involving tendinous connective tissue showed the longest RTP time. Age did not seem to have any influence on RTP. Documenting location and the exact tissue involved in hamstring injuries may be beneficial for determining the prognosis and RTP.

PMID:36695100 | DOI:10.1080/00913847.2023.2170684

Glob Health Action. 2023 Dec 31;16(1):2160543. doi: 10.1080/16549716.2022.2160543.

ABSTRACT

BACKGROUND: Peer-led education interventions are assumed to be an effective means of increasing contraceptive utilization and demand in adolescents. However evidence is lacking on whether peer-led education is effective in promoting the demand for and use of contraceptives in adolescent girls, especially in resource-limited settings.

OBJECTIVE: The present study evaluated the effectiveness of peer-led education interventions in improving contraceptive use, unmet needs, and demand among sexually active secondary school adolescent girls in Gedeo Zone, South Ethiopia.

METHODS: A single-blinded cluster randomised controlled trial study was performed in six randomly selected secondary schools in the Gedeo Zone, southern Ethiopia. A total of 224 participants were recruited and randomly assigned to the intervention and control groups. The intervention group received peer-led education intervention for six months. A pre-tested and validated questionnaire was used to measure contraceptive use, unmet need, and contraceptive demand. A generalised estimating equation (GEE) model was used to examine the effectiveness of the intervention.

RESULT: After six months of intervention, the Differences-in-difference in contraceptive use, unmet need, and contraceptive demand between the intervention and control groups were 25.1%, 7.4%, and 17.7%, respectively. There was a statistically significant difference in contraceptive use [AOR = 8.7, 95% CI: (3.66, 20.83), unmet need for contraceptives [AOR = 6.2, 95% CI: (1.61, 24.36)] and contraceptive demand [AOR = 6.1, 95% CI: (2.43, 15.11)] between the intervention and control groups.

CONCLUSIONS: School-based peer education intervention effectively improved contraceptive use and unmet needs in a low-resource setting and created demand in sexually active adolescent girls. These results support the potential utility of this approach in similar settings for the promotion of contraception use and demand.

PMID:36695098 | DOI:10.1080/16549716.2022.2160543

Subst Use Misuse. 2023 Jan 25:1-5. doi: 10.1080/10826084.2023.2170184. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic drove significant disruptions in access to substance use disorder (SUD) treatment and harm reduction services. Healthcare delivery via telemedicine has increasingly become the norm, rendering access to a phone essential for engagement in care.

METHODS: Adult patients with SUD who lacked phones (n = 181) received a free, pre-paid phone during encounters with inpatient and outpatient SUD programs. We evaluated changes in healthcare engagement including completed in-person and telemedicine outpatient visits and telephone encounters 30 days before and after phone receipt. We used descriptive statistics, where appropriate, and paired t-tests to assess the change in healthcare engagement measures.

RESULTS: Patients were predominantly male (64%) and white (62%) with high rates of homelessness (81%) and opioid use disorder (89%). When comparing 30 days before to 30 days after phone receipt, there was a significant increased change in number of telemedicine visits by 0.3 (95% CL [0.1,0.4], p < 0.001) and telephone encounters by 0.2 (95% CL [0.1,0.3], p = 0.004). There was no statistically significant change in in-person outpatient visits observed.

CONCLUSIONS: Pre-paid phone distribution to patients with SUD was associated with an increased healthcare engagement including telemedicine visits and encounters.

PMID:36695079 | DOI:10.1080/10826084.2023.2170184

J Eur Acad Dermatol Venereol. 2023 Jan 25. doi: 10.1111/jdv.18921. Online ahead of print.

ABSTRACT

BACKGROUND: Research suggests that Alopecia areata (AA) and Major Depressive Disorder (MDD) show substantial comorbidity. To date, no study has investigated the hypothesis that this is attributable to shared genetic etiology.

OBJECTIVES: To investigate AA-MDD comorbidity on both the epidemiological and the molecular genetic levels.

METHODS: First, epidemiological analyses were performed using data from a cohort of adult German health insurance beneficiaries (n=1.855 million) to determine the population-based prevalence of AA-MDD comorbidity. Second, analyses were performed to determine the prevalence of MDD in a clinical AA case-control sample with data on psychiatric phenotypes, stratifying for demographic factors to identify possible contributing factors to AA-MDD comorbidity. Third, the genetic overlap between AA and MDD was investigated using a polygenic risk score (PRS) approach and linkage disequilibrium score (LDSC) regression. For PRS, summary statistics from a large MDD GWAS meta-analysis (PGC-MD2) were used as the training sample, while a Central European AA cohort, including the above-mentioned AA patients, and an independent replication US-AA cohort were used as target samples. LDSC was performed using the summary statistics of the PGC-MD2 and the largest AA meta-analysis to date.

RESULTS: High levels of AA-MDD comorbidity were reported in the population-based (MDD in 24% of AA patients), and clinical samples (MDD in 44% of AA patients). MDD-PRS explained a modest proportion of the variance in AA case-control status (R² =1%). This signal was limited to the major histocompatibility complex (MHC) region on chromosome 6. LDSC regression (excluding MHC) revealed no significant genetic correlation between AA and MDD.

CONCLUSIONS: As in previous research, AA patients showed an increased prevalence of MDD. The present analyses suggest that genetic overlap may be confined to the MHC region, which is implicated in immune function. More detailed investigation is required to refine understanding of how the MHC is involved in the development of AA and MDD comorbidity.

PMID:36695075 | DOI:10.1111/jdv.18921

J Eur Acad Dermatol Venereol. 2023 Jan 25. doi: 10.1111/jdv.18914. Online ahead of print.

ABSTRACT

BACKGROUND: Etrasimod is an oral, selective, sphingosine 1-phosphate (S1P) receptor_1,4,5 modulator in development for immune-mediated inflammatory disorders. Efficacy and safety of orally administered S1P receptor modulation in atopic dermatitis (AD) has not yet been examined.

OBJECTIVE: To assess the efficacy and safety of etrasimod monotherapy in adults with moderate-to-severe AD.

METHODS: In this phase 2, randomized, double-blind, placebo-controlled trial, participants (≥18 years) with moderate-to-severe AD defined as baseline validated Investigator’s Global Assessment (vIGA-AD) score ≥3, Eczema Area and Severity Index (EASI) score ≥16, and body surface area involvement ≥10% were randomized 1:1:1 to once-daily oral etrasimod 1 mg, 2 mg, or placebo for 12 weeks. The primary outcome was percent change in EASI score from baseline at week 12, assessed in the Full Analysis Set (all randomized participants). Key secondary outcomes were achievement of a vIGA-AD score of 0 or 1 with a ≥2-point improvement from baseline and EASI-75 response at week 12. Safety was assessed during the double-blind period.

RESULTS: 140 participants were randomized to etrasimod 2 mg (n=47), 1 mg (n=47), or placebo (n=46). At week 12, percent change in EASI score was -57.2% in the etrasimod 2-mg group vs -48.4% in the placebo group (P=.18). A significantly greater proportion of participants receiving etrasimod 2 mg achieved vIGA-AD scores of 0 or 1 with a ≥2-point improvement at week 12 vs placebo (29.8% vs 13.0%; P=.045); however, EASI-75 response was not statistically significant vs placebo. Treatment-emergent adverse events occurred in 59.6%, 40.4%, and 47.8% of participants receiving etrasimod 2 mg, 1 mg, and placebo, respectively. There were no serious AEs or deaths.

CONCLUSIONS: The primary outcome was not met, though efficacy was observed for etrasimod 2 mg on several clinician- and patient-assessed measures, and both 1-mg and 2-mg doses were well tolerated, warranting further clinical investigation in AD.

PMID:36695074 | DOI:10.1111/jdv.18914

Pediatrics. 2023 Jan 25:e2022057860. doi: 10.1542/peds.2022-057860. Online ahead of print.

ABSTRACT

CONTEXT: Discovering new interventions to improve neurodevelopmental outcomes is a priority; however, clinical trials are challenging and methodological issues may impact the interpretation of intervention efficacy.

OBJECTIVES: Characterize the proportion of infant neurodevelopment trials reporting a null finding and identify features that may contribute to a null result.

DATA SOURCES: The Cochrane library, Medline, Embase, and CINAHL databases.

STUDY SELECTION: Randomized controlled trials recruiting infants aged <6 months comparing any “infant-directed” intervention against standard care, placebo, or another intervention. Neurodevelopment assessed as the primary outcome between 12 months and 10 years of age using a defined list of tools.

DATA EXTRACTION: Two reviewers independently extracted data and assessed quality of included studies.

RESULTS: Of n = 1283 records screened, 21 studies (from 20 reports) were included. Of 18 superiority studies, >70% reported a null finding. Features were identified that may have contributed to the high proportion of null findings, including selection and timing of the primary outcome measure, anticipated effect size, sample size and power, and statistical analysis methodology and rigor.

LIMITATIONS: Publication bias against null studies means the proportion of null findings is likely underestimated. Studies assessing neurodevelopment as a secondary or within a composite outcome were excluded.

CONCLUSIONS: This review identified a high proportion of infant neurodevelopmental trials that produced a null finding and detected several methodological and design considerations which may have contributed. We make several recommendations for future trials, including more sophisticated approaches to trial design, outcome assessment, and analysis.

PMID:36695068 | DOI:10.1542/peds.2022-057860

Stat Med. 2023 Jan 25. doi: 10.1002/sim.9658. Online ahead of print.

ABSTRACT

One of the main challenges when using observational data for causal inference is the presence of confounding. A classic approach to account for confounding is the use of propensity score techniques that provide consistent estimators of the causal treatment effect under four common identifiability assumptions for causal effects, including that of no unmeasured confounding. Propensity score matching is a very popular approach which, in its simplest form, involves matching each treated patient to an untreated patient with a similar estimated propensity score, that is, probability of receiving the treatment. The treatment effect can then be estimated by comparing treated and untreated patients within the matched dataset. When missing data arises, a popular approach is to apply multiple imputation to handle the missingness. The combination of propensity score matching and multiple imputation is increasingly applied in practice. However, in this article we demonstrate that combining multiple imputation and propensity score matching can lead to over-coverage of the confidence interval for the treatment effect estimate. We explore the cause of this over-coverage and we evaluate, in this context, the performance of a correction to Rubin’s rules for multiple imputation proposed by finding that this correction removes the over-coverage.

PMID:36695043 | DOI:10.1002/sim.9658

Trials. 2023 Jan 24;24(1):53. doi: 10.1186/s13063-022-06981-8.

ABSTRACT

BACKGROUND: External randomised pilot trials aim to determine whether a future definitive randomised controlled trial (RCT) should be conducted, and if so, how. However, not every pilot trial that suggests that a definitive trial will be feasible will progress to a definitive study. In this study, we surveyed corresponding authors of external randomised pilot trial publications to assess pilot trial outcomes in terms of feasibility and progression.

METHODS: Web-based surveys were sent to corresponding authors of external randomised pilot trial publications, open for four weeks between January and February 2022. Four surveys were produced depending on whether the corresponding author had published a trial protocol or results publication, and whether progression criteria were reported. Surveys asked whether a future RCT was considered feasible, whether progression criteria were met (if applicable), what other factors informed the assessment of pilot trial feasibility, and whether the pilot trial has progressed to further research. Data was analysed using descriptive statistics and conventional content analysis.

RESULTS: 98 of 276 corresponding authors completed the survey (average response rate of 36% across all surveys). Of these, 89 respondents indicated that their trial had completed. Ninety per cent of respondents who were corresponding authors of completed pilot trials stated that their pilot trial was either feasible (42/89, 47%) or feasible with changes to the trial design (38/89, 43%), yet only 66% (59/89) reported the intention to conduct a future definitive trial. Availability of funding for a future definitive trial and changing priorities of the Chief Investigator were the most common barriers to progression identified. Qualitative research findings was the most frequent factor considered both by corresponding authors who reported and who did not report progression criteria when determining trial feasibility.

CONCLUSIONS: Just under one quarter (21/89, 24%) of respondents who considered their external randomised pilot trial to be feasible, or feasible with changes, did not intend to conduct a definitive trial highlighting research inefficiency and waste.

TRIAL REGISTRATION: Open Science Framework osf.io/d28hr [20 December 2021].

PMID:36694266 | DOI:10.1186/s13063-022-06981-8

BMC Med Educ. 2023 Jan 24;23(1):56. doi: 10.1186/s12909-023-04032-7.

ABSTRACT

INTRODUCTION: Imperial College Teddy Bear Hospital (ICSM-TBH) is a student-led volunteering group, which uses interactive, play-based teaching to educate school pupils aged 5-7 years about healthy lifestyles and healthcare. During the COVID-19 pandemic, volunteering sessions shifted online. The aim of this study was to compare the value of online and in-person ICSM-TBH volunteering for volunteers and school pupils.

METHODS: Undergraduate university students at Imperial College London (medicine can be taken as a first degree in the UK) who volunteered with ICSM-TBH between 2019 and 22 were invited to complete an anonymous online questionnaire evaluating their experiences of volunteering online and in-person through Likert-scale questions. Those who completed the questionnaire were also invited to an interview. Teachers who hosted online ICSM-TBH sessions were also invited to an in-person interview, exploring their view of their pupils’ experiences with these sessions. Questionnaire results were analysed through descriptive statistics. Interviews were analysed through inductive thematic analysis.

RESULTS: Thirty-two university students completed the questionnaire. Of these, 9 experienced both in-person and online volunteering, all of whom preferred in-person volunteering. For those who only volunteered in-person, 92% reported that ICSM-TBH sessions were a positive experience, compared to 100% who volunteered online; 92% in person volunteers agreed or strongly agreed that ICSM-TBH volunteering in person improved their mood, compared to 89% online; and 100% agreed or strongly agreed that ICSM-TBH volunteering in person helped them feel part of a community, compared to 84% online. A total of 12 volunteers and 4 teachers were interviewed, from whom five themes emerged: interaction and engagement (interaction and engagement between pupils and volunteers was more readily achieved in-person); personal and professional development (both online and in-person sessions enabled volunteers to gain valuable skills); community and social (greater sense of community was established in-person); emotional wellbeing and enjoyment (both modalities were enjoyed by volunteers and pupils); and workload (online sessions were more convenient for volunteers but with risk of screen fatigue).

CONCLUSION: Overall, both in-person and online volunteering were of substantial benefit to volunteers and school pupils. However, most teachers and volunteers preferred in-person volunteering.

PMID:36694256 | DOI:10.1186/s12909-023-04032-7