Cohort Design Research Articles

Prevalence of Persistent Post-Concussion Syndrome in Adults After Mild Traumatic Brain Injury

Background: The incidence of post-concussion syndrome (PCS) in post-traumatic brain injury patients continues to increase every year. Although mild Traumatic Brain Injury (mTBI) is one of the primary causes of death and disability worldwide, research on the prevalence of PCS after mTBI is still extremely limited. Previous studies have shown that approximately 10-15% of mTBI patients experience PCS, but these studies often have different methodologies and sample sizes.Purpose: This study aimed to determine and compare the prevalence of persistent post-concussion syndrome (PCS; >1 month post-injury) in patients with mTBI and those without PCS.Methods: This study employed a retrospective cohort design and analyzed patient data from hospital records between July and December 2022, yielding a sample of 112 participants with persistent post-concussion syndrome (PCS) following mTBI and 204 participants without PCS. Patients with complete medical record data and active health checks for one month after being treated were taken as research subjects. PCS measurement was conducted using the Rivermead Post Concussion Symptoms Questionnaire (RPQ).Results: The total number of mTBI patients was 112 patients with PCS (35.4%) with p<0.000. The occurrence of PCS was found to be most prevalent in the second month, with 49 patients (43.7%). Problems concentrating (37.5%), headache (30.3%), and memory problems (16.9%).Conclusions: The study found that 35.4% of patients with mTBI experienced persistent post-concussion syndrome (PCS) after one month. The occurrence of PCS was most prevalent in the second month, with 43.7% of patients experiencing it. The symptoms most commonly indicating PCS were problems concentrating, headache, and memory problems. These findings warrant better screening guidelines, and practices that patients adopt after mTBI.

Comparative effectiveness of bivalent BA.4–5 or BA.1 mRNA booster vaccines among immunocompromised individuals across three Nordic countries: A nationwide cohort study

ObjectivesTo estimate the effectiveness and waning of the bivalent BA.4-5 or BA.1 mRNA booster vaccine against Covid-19-related hospitalization and death in immunocompromised individuals. MethodsNationwide analyses across Nordic countries from 1 September 2022 to 31 October 2023 using a matched cohort design. Individuals boosted with a BA.4-5 or BA.1 vaccine were matched 1:1 with unboosted individuals. The outcomes of interest were country-combined vaccine effectiveness (VE) estimates against Covid-19-related hospitalization and death at day 270 of follow-up. Waning was assessed in 45-day intervals. ResultsA total of 352,762 BA.4-5 and 191,070 BA.1 booster vaccine doses were included. At day 270, the comparative VE against Covid-19-related hospitalization was 34.2% (95% CI, 7.1% to 61.3%) for the bivalent BA.4-5 vaccine and 42.6% (95% CI, 31.3% to 53.9%) for the BA.1 vaccine compared with matched unboosted. The comparative VE against Covid-19-related death was 53.9% (95% CI, 38.6% to 69.3%) for the bivalent BA.4-5 vaccine and 57.9% (95% CI, 48.5% to 67.4%) for the BA.1 vaccine. ConclusionsIn immunocompromised individuals, vaccination with bivalent BA.4-5 or BA.1 booster lowered the risk of Covid-19-related hospitalization and death over a follow-up period of 9 months. The effectiveness was highest during the first months since vaccination with subsequent gradual waning.

Rehospitalisation risk by hypnotics class in older patients with heart failure: a cohort study utilizing administrative claims data in Japan

BackgroundStudies comparing the safety of orexin receptor antagonists and other hypnotic types for older patients with heart failure (HF) remain lacking. This study aimed to compare orexin receptor antagonists (suvorexant)...

Effectiveness of a Customized Peritoneal Dialysis Training Program in Reducing Infection and Dropout Rates: Insights From a Singapore Hospital.

Introduction Peritoneal dialysis (PD) is an essential home-based treatment for end-stage kidney disease, known for enhancing patients' quality of life and being more cost-effective compared to hemodialysis. However, in Singapore, PD education lacks of standardization, with each unit adopting varied methods based on their own experiences and resources. To address this, our hospital developed a tailored four-day PD training program guided by the International Society for Peritoneal Dialysis guidelines, adapted to meet local needs and resource availability. Methodology This study employed a retrospective cohort design, including all incident adult patients aged 18 years and above who initiated PD at our hospital from September 2018 to July 2023. Data on PD dropout rates and PD-related infection rates, such as PD peritonitis and exit site infection rates, were obtained from electronic medical records. Results This study comprised 99 patients who began PD and completed their PD training program at our hospital between September 2018 and July 2023. Our tailored PD training program successfully reduced dropout rates and maintained infection rates within the International Society for Peritoneal Dialysis guidelines. Specifically, exit site infection rates fluctuated between 0.18 and 0.29 episodes per year, PD peritonitis rates ranged from 0.2 to 0.26 episodes per patient-year, and dropout rates significantly improved from 40% in 2019 to 7% in 2023 (OR = 0.45, 95% CI = 0.49 to 0.84, p = 0.010). Conclusions The tailored PD training program at our hospital effectively reduced PD-related infections and dropout rates among end-stage kidney disease patients. These findings suggest that structured, locally adapted training programs can substantially improve patient outcomes in PD.

The impact of metformin on mortality in patients with type 2 diabetes mellitus: a prospective cohort study.

Metformin, a widely used antihyperglycemic drug, has shown efficacy in treating type 2 diabetes mellitus (T2DM) and is associated with potential benefits beyond glycemic control. This study investigates the impact of metformin on mortality in T2DM patients using a prospective cohort design utilizing data from the National Health and Nutrition Examination Survey (NHANES). In NHANES 1999-2014, a total of 5813 representative participants aged 20 and above with T2DM were included in the analysis. We utilized Kaplan-Meier survival curves and multivariate Cox regression analysis to investigate the impact of metformin on both all-cause mortality and cause-specific mortality among patients with T2DM. Kaplan-Meier analysis showed a significant reduction in all-cause and cause-specific mortality in metformin users compared to non-users (p < 0.05). Multivariate Cox regression confirmed these findings, indicating that metformin use was associated with a 18% reduction in all-cause mortality (HR = 0.82, 95% CI = 0.73-0.92, p < 0.001) and 25% reduction in cardiovascular mortality (HR = 0.75, 95% CI = 0.60-0.94, p = 0.01). Our results suggest that metformin significantly reduces all-cause and cardiovascular mortality in T2DM patients, highlighting its potential benefits beyond glycemic control. These results contribute to the existing literature by providing robust evidence from a large prospective cohort study. However, further research is needed to validate these findings and elucidate the underlying mechanisms controlling the effects of metformin on mortality outcomes in individuals with T2DM.

The Clinical Severity of COVID-19 Variants of Concern: Retrospective Population-Based Analysis.

SARS-CoV-2 variants of concern (VOCs) emerged and rapidly replaced the original strain worldwide. The increased transmissibility of these new variants led to increases in infections, hospitalizations, and mortality. However, there is a scarcity of retrospective investigations examining the severity of all the main VOCs in presence of key public health measures and within various social determinants of health (SDOHs). This study aims to provide a retrospective assessment of the clinical severity of COVID-19 VOCs in the context of heterogenous SDOHs and vaccination rollout. We used a population-based retrospective cohort design with data from the British Columbia COVID-19 Cohort, a linked provincial surveillance platform. To assess the relative severity (hospitalizations, intensive care unit [ICU] admissions, and deaths) of Gamma, Delta, and Omicron infections during 2021 relative to Alpha, we used inverse probability treatment weighted Cox proportional hazard modeling. We also conducted a subanalysis among unvaccinated individuals, as assessed severity differed across VOCs and SDOHs. We included 91,964 individuals infected with a SARS-CoV-2 VOC (Alpha: n=20,487, 22.28%; Gamma: n=15,223, 16.55%; Delta: n=49,161, 53.46%; and Omicron: n=7093, 7.71%). Delta was associated with the most severe disease in terms of hospitalization, ICU admissions, and deaths (hospitalization: adjusted hazard ratio [aHR] 2.00, 95% CI 1.92-2.08; ICU: aHR 2.05, 95% CI 1.91-2.20; death: aHR 3.70, 95% CI 3.23-4.25 relative to Alpha), followed generally by Gamma and then Omicron and Alpha. The relative severity by VOC remained similar in the unvaccinated individual subanalysis, although the proportion of individuals infected with Delta and Omicron who were hospitalized was 2 times higher in those unvaccinated than in those fully vaccinated. Regarding SDOHs, the proportion of hospitalized individuals was higher in areas with lower income across all VOCs, whereas among Alpha and Gamma infections, 2 VOCs that cocirculated, differential distributions of hospitalizations were found among racially minoritized groups. Our study provides robust severity estimates for all VOCs during the COVID-19 pandemic in British Columbia, Canada. Relative to Alpha, we found Delta to be the most severe, followed by Gamma and Omicron. This study highlights the importance of targeted testing and sequencing to ensure timely detection and accurate estimation of severity in emerging variants. It further sheds light on the importance of vaccination coverage and SDOHs in the context of pandemic preparedness to support the prioritization of allocation for resource-constrained or minoritized groups.

Cohort profile: study design and baseline characteristics of an observational longitudinal weight loss cohort and biorepository of patients undergoing sleeve gastrectomy in the USA

PurposeWe developed a comprehensive sleeve gastrectomy (SG) weight loss study cohort and biorepository to uncover mechanisms, biomarkers and predictive factors of weight loss, weight maintenance and amelioration of obesity-related comorbidities....

Moderating effects of self-construal on the associations of workload and role ambiguity with psychological distress: A cross-sectional and prospective study in a Japanese workplace

The self-construal of employees is a potential moderating factor in the challenge–hindrance model that may enhance our understanding of the varying effects of challenge and hindrance stressors on psychological health. The present study examined the moderating effect of self-construal on the association of workload and role ambiguity with psychological distress among employees in a Japanese workplace. A baseline survey (October 2020) and a follow-up survey (January 2022) were administered to employees of a manufacturing corporate group in Japan, which obtained 948 and 733 complete responses, respectively. Multiple linear regression analyses were conducted using a cross-sectional and a prospective cohort design. The cross-sectional analyses demonstrated the protective effects of independent and interdependent self-construal on the associations between workload and psychological distress; this moderating effect of self-construal diminished in the prospective analyses. By contrast, there were no moderating effects of self-construal on the association between role ambiguity and psychological distress. These findings suggest that self-construal may possibly provide a psychosocial context under which specific challenge and/or hindrance stressors become particularly harmful to employees’ psychological health, thus guiding selective and indicated interventions based on the self-construal.

Associations Between Readmission and Length of Stay in the Acute Admission Unit for Patients with Alcohol-Related Diagnoses-A Cohort Study.

Patients with alcohol-related diagnosis in emergency departments (ED) are at high risk of readmission. Evidence shows an association between alcohol related admissions and a wide range of diseases and disorders. Understanding the risk factors for readmission and the asso-ciation with length of stay in the ED may help identify those who would benefit from targeted interventions. Thus, the hypothesis of this study is that patients with alcohol-related diagnoses and a short length of stay in the ED have a higher risk for readmission. Therefore, this study aimed to investigate the association between length of stay in the ED and 30-day readmission for patients with alcohol-related acute admissions as well as to uncover possible risk factors for 30-day read-mission. The study used a retrospective cohort design and was carried out from March 1, 2019, to January 31, 2020. The inclusion criteria were ≥ 18 years, admitted to an ED, and having an alcohol-related primary or secondary diagnosis (based on ICD-10 codes). Patients were fol-lowed for 30 days after discharge from initial hospitalization to identify associations between length of stay and 30-day readmission. We included 1,174 patients and found that 17% (95% CI: 15-20) of the patients admitted with an alcohol-related primary or secondary diagnosis were readmitted within 30 days. The hazard ratio (HR) for readmission increased with length of stay when compared to admission ≤ 24 hr; admission > 24-48 hr HR 1.50 (95% CI: 1.08-2.08), admission > 48 hr HR 2.08 (95% CI: 1.23-3.52). The study revealed that patients with alcohol-related diagnoses were at a higher risk of ED readmission the longer they stayed in the ED. Furthermore, the risk of readmis-sion increased if patients had a medical or psychiatric diagnosis prior to admission or lived alone.

The Urban Factor: Meta-analysis of Air Pollution and Cancer Incidence

Background: Urban air pollution is a significant environmental health concern associated with various adverse health outcomes, including cancer. Understanding the relationship between urban air pollution exposure and cancer incidence is crucial for informing public health interventions and policy decisions. Methods: A systematic review and meta-analysis will be conducted to investigate the association between urban air pollution exposure and cancer incidence. Eligible studies will be identified through comprehensive searches of electronic databases. Inclusion criteria encompassed studies reporting quantitative data on air pollution exposure and cancer outcomes. Data extraction and quality assessment will be performed according to predefined criteria. Results: The systematic search will be yielded X studies meeting the inclusion criteria for the meta-analysis. These studies, representing diverse geographic regions, employed various exposure assessment methods and included cohort, case-control, and cross-sectional designs. The meta-analysis will reveal a statistically significant association between urban air pollution exposure and overall cancer incidence (p &lt; 0.05). The pooled effect will estimate indicated a X% increased risk of cancer per unit increase in air pollution exposure. Conclusion: Our meta-analysis provides robust evidence of a significant association between urban air pollution exposure and cancer incidence. These findings underscore the urgent need for targeted interventions to reduce air pollution levels in urban areas and mitigate cancer risks. Public health policies focusing on environmental quality improvements are crucial for promoting population health and well-being.

The effectiveness of driving simulator training on driving skills and safety in young novice drivers: A systematic review of interventions

Introduction: This systematic review evaluated the effectiveness of driving simulator training on simulated/on-road driving skills and safety in young novice drivers. Method: Searches were performed in Embase, Global Health, Medline, Scopus, and Web of Science databases, and on Google advanced, Google Scholar, and the Transport Research International Documentation websites. A total of 1,630 unique sources (titles and abstracts) were screened by two reviewers independently with 99 full-text articles reviewed for inclusion. Studies were included if they were a primary driving simulator intervention study that consisted of a randomized controlled trial, quasi-experimental, prospective cohort, and case-control design, published in English between January 1, 2010 and January 26, 2024. Results: The review included 15 studies published in 2010–2022 (study sample size ranged from 30 to 183,197). Findings showed that driving simulator training (compared to control conditions) can immediately improve simulated driving skills (e.g., adjustment to stimuli, lane maintenance, and speed regulation), although it was unclear whether simulator training can improve on-road driving skills or safety, immediately or longitudinally. Studies showed low quality of evidence with increased risks of selection bias, confounding factors, and type I errors influencing findings. Practical Applications: Since it is not known whether driving simulator training has short-term or long-term benefits on drivers’ real-world driving skills or safety, it should not replace any training offered in driver education programs. However, driving simulator training can be included in driver education programs to supplement the in-class and on-road training. Conclusions: The quality of evidence in this review shows low confidence on whether findings accurately reflect true effects on driving skills or safety. Further research should enhance the quality of evidence and demonstrate the transfer effects of driving simulator training to valid measures of real-world driving before recommending any integration of simulator training into standard practice.

An Association of Framingham Risk Score with Patient Determined Disease Steps in a Cohort of Relapsing-Remitting Multiple Sclerosis Patients: An Italian Real-World Monocentric Experience.

The associations between Multiple Sclerosis (MS) and cardiovascular diseases, drawn from epidemiological studies, have attracted much attention in recent years. The present study employed a monocentric, observational, retrospective cohort design. The primary objective of the study was to describe the Framingham Risk Score (FRS) rate in a cross-sectional analysis of our cohort of relapsing-remitting MS patients who are regularly followed up and, if applicable, to identify any association with the patient's Patient Determined Disease Steps (PDDS). Cardiovascular risk was classified as follows: low if the FRS is less than 10%, moderate if it is 10% to 19%, and high if it is 20% or higher. A total cohort of 229 patients was enrolled. The sample consists of 163 women (71.2%). FRS categories were distributed as follows: 97 (42.3%) patients had low FRS, 84 (36.7%) patients had moderate FRS, and 48 (21%) patients had high FRS. In the univariable ordinal regression analysis, one one-point increase in the PDDS scale was associated with a 24% risk of high FRS (vs. low) (proportional odds ratio [OR] =2.426, 95% confidence interval [CI] 1.660-3.545; p <.0001). The results were also confirmed by the EDSS score, with a point increase in the EDSS score associated with a 19% risk of high FRS (vs. low) (proportional OR =1.953, 95% CI 1.429-2.669-1.04; p <.0001). The FRS demonstrated an association with the patient's "perception of the disease" as indicated by the PDDS. Further studies with larger cohorts are needed to adequately address cardiovascular risk in life-threatening conditions, such as MS.

Lost in transition: A protocol for a retrospective, longitudinal cohort study for addressing challenges in opioid treatment for transition-age adults.

In the United States, there has been a concerning rise in the prevalence of opioid use disorders (OUD) among transition-age (TA) adults, 18 to 25-years old, with a disproportionate impact on individuals and families covered by Medicaid. Of equal concern, the treatment system continues to underperform for many young people, emphasizing the need to address the treatment challenges faced by this vulnerable population at a pivotal juncture in their life course. Pharmacotherapy is the most effective treatment for OUD, yet notably, observational studies reveal gaps in the receipt of and retention in medications for opioid use disorder (MOUD), resulting in poor outcomes for many TA adults in treatment. Few current studies on OUD treatment quality explicitly consider the influence of individual, organizational, and contextual factors, especially for young people whose social roles and institutional ties remain in flux. We introduce a retrospective, longitudinal cohort design to study treatment quality practices and outcomes among approximately 65,000 TA adults entering treatment for OUD between 2012 and 2025 in New York. We propose to combine data from multiple sources, including Medicaid claims and encounter data and a state registry of substance use disorder (SUD) treatment episodes, to examine three aspects of OUD treatment quality: 1) MOUD use, including MOUD option (e.g., buprenorphine, methadone, or extended-release [XR] naltrexone); 2) adherence to pharmacotherapy and retention in treatment; and 3) adverse events (e.g., overdoses). Using rigorous analytical methods, we will provide insights into how variation in treatment practices and outcomes are structured more broadly by multilevel processes related to communities, treatment programs, and characteristics of the patient, as well as their complex interplay. Our findings will inform clinical decision making by patients and providers as well as public health responses to the rising number of young adults seeking treatment for OUD amidst the opioid and polysubstance overdose crisis in the U.S.

Cumulative incidence of chronic health conditions recorded in hospital inpatient admissions from birth to age 16 in England.

Monitoring the incidence of chronic health conditions (CHCs) in childhood in England, using administrative data to derive numerators and denominators, is challenged by unmeasured migration. We used open and closed birth cohort designs to estimate the cumulative incidence of CHCs to age 16 years. In closed cohorts, we identified all births in Hospital Episode Statistics (HES) from 2002/3 to 2011/12, followed to 2018/19 (maximum age 8 to 16 years), censoring on death, first non-England residence record or 16th birthday. Children must have linked to later HES records and/or the National Pupil Database, which provides information on all state school enrolments, to address unmeasured emigration. The cumulative incidence of CHCs was estimated to age 16 using diagnostic codes in HES inpatient records. We also explored temporal variation. Sensitivity analyses varied eligibility criteria. In open cohorts, we used HES data on all children from 2002/3 to 2018/19 and national statistics population denominators. In open and closed approaches, the cumulative incidence of ever having a CHC recorded before age 16 among children born in 2003/4 was 25% (21% to 32% in closed cohort sensitivity analyses). There was little temporal variation. At least 28% of children with any CHC had more than one body system affected by age 16. Multimorbidity rates rose with later cohorts. Approximately one-quarter of children are affected by CHCs, but estimates vary depending on how the denominator is defined. More accurate estimation of the incidence of CHCs requires a dynamic population estimate.

Anxiety and Depression Associated With Increased Cardiovascular Disease Risk Through Accelerated Development of Risk Factors

BackgroundPrior studies have incompletely assessed whether the development of cardiometabolic risk factors (CVDRF) (hypertension, hyperlipidemia, and diabetes mellitus) mediates the association between anxiety and depression (anxiety/depression) and cardiovascular disease (CVD). ObjectivesThe authors aimed to evaluate the following: 1) the association between anxiety/depression and incident CVDRFs and whether this association mediates the increased CVD risk; and 2) whether neuro-immune mechanisms and age and sex effects may be involved. MethodsUsing a retrospective cohort design, Mass General Brigham Biobank subjects were followed for 10 years. Presence and timing of anxiety/depression, CVDRFs, and CVD were determined using ICD codes. Stress-related neural activity, chronic inflammation, and autonomic function were measured by the assessment of amygdalar-to-cortical activity ratio, high-sensitivity CRP, and heart rate variability. Multivariable regression and mediation analyses were employed. ResultsAmong 71,214 subjects (median age 49.6 years; 55.3% female), 27,048 (38.0%) developed CVDRFs during follow-up. Pre-existing anxiety/depression associated with increased risk of incident CVDRF (OR: 1.71 [95% CI: 1.59-1.83], P < 0.001) and with a shorter time to their development (β = −0.486 [95% CI: −0.62 to −0.35], P < 0.001). The development of CVDRFs mediated the association between anxiety/depression and CVD events (log-odds: 0.044 [95% CI: 0.034-0.055], P < 0.05). Neuro-immune pathways contributed to the development of CVDRFs (P < 0.05 each) and significant age and sex effects were noted: younger women experienced the greatest acceleration in the development of CVDRFs after anxiety/depression. ConclusionsAnxiety/depression accelerate the development of CVDRFs. This association appears to be most notable among younger women and may be mediated by stress-related neuro-immune pathways. Evaluations of tailored preventive measures for individuals with anxiety/depression are needed to reduce CVD risk.

Diagnostic accuracy of GeneXpert in the diagnosis of spinal tuberculosis: A systematic review and meta-analysis.

Tuberculosis remains a significant global health issue, with spinal tuberculosis being a severe form of extrapulmonary tuberculosis. Despite the high morbidity associated with spinal tuberculosis, effective and rapid diagnostic methods are limited. The aim of this study was to evaluate the diagnostic accuracy of the GeneXpert compared to other microbiological methods in diagnosing spinal tuberculosis. A systematic review and meta-analysis were conducted following the PRISMA guidelines. Six databases (PubMed, Scopus, EBSCO, EMBASE, ScienceDirect, and Cochrane Central) were searched for relevant studies as of August 31, 2023. Studies were selected based on predefined inclusion criteria, focusing on patients diagnosed with spinal tuberculosis and comparing GeneXpert to microbiological culture, acid-fast bacilli (AFB) staining, and polymerase chain reaction (PCR). Two authors independently performed data extraction and quality assessment, and the meta-analysis was conducted using Meta-DiSc 2.0. Fourteen studies comprising retrospective cohort, prospective cohort, and cross-sectional designs were included. GeneXpert demonstrated a pooled sensitivity of 92% (85-96%) and specificity of 71% (51-86%) compared to culture. AFB smear had the highest specificity at 80% (70- 88%) but the lowest sensitivity at 27% (20-35%). The PCR had sensitivity and specificity of 83% (67-92%) and 58% (31-81%), respectively. Substantial heterogeneity was noted across the studies. This study highlighted that GeneXpert had high sensitivity and moderate specificity in diagnosing spinal tuberculosis, making it an alternative to conventional methods. However, further validation through larger, interventional studies is necessary to standardize its use in clinical practice.

Evaluation of an Italian Population-Based Programme for Risk Assessment and Genetic Counselling and Testing for BRCA1/2-Related Hereditary Breast and Ovarian Cancer after 10 Years of Operation: An Observational Study Protocol.

Hereditary breast/ovarian cancer (HBOC) syndrome is caused by the inheritance of monoallelic germline BRCA1/2 gene mutations. If BRCA1/2 mutation carriers are identified before the disease develops, effective actions against HBOC can be taken, including intensive screening, risk-reducing mastectomy and salpingo-oophorectomy, and risk-reducing medications. The Italian National Prevention Plan mandates the creation of regional BRCA genetic testing programmes. So far, however, only informal data have been reported on their implementation. We have designed a study aimed at evaluating the results of a population-based programme for risk assessment and genetic counselling and testing for BRCA1/2-related HBOC that is underway in the Emilia-Romagna region (northern Italy). The programme-which is entirely free-includes basic screening with an estimate of the likelihood of carrying a BRCA1/2 mutation using a familial risk assessment tool, a closer examination of women with suspected risk increase, an assessment of the need for further genetic counselling and, if needed, genetic testing and risk-reducing interventions. In this paper, the design of the programme and the protocol of the study are presented. The study has an observational, historical cohort design. Eligible are the women found to be at an increased risk of HBOC (profile 3 women). The main objectives are (i) to determine the precision of the programme in measuring the level of risk of HBOC for profile 3 women; (ii) to determine the characteristics of profile 3 women and their association with the risk management strategy chosen; (iii) to compare the age at onset, histologic type, tumour stage, molecular subtype, and prognosis of breast/ovarian cancers observed in the cohort of profile 3 women with the features of sporadic cancers observed in the general female population; (iv) to determine the level and the determinants of adherence to recommendations; and (v) to determine the appropriateness and timing of risk-reducing surgery and medications. Investigating the quality and results of the programme is necessary because the best practices in risk assessment and genetic counselling and testing for BRCA1/2-related cancer and the challenges they encounter should be identified and shared. The study has the potential to provide sound empirical evidence for the factors affecting the effectiveness of this type of service.

Using formative process evaluation to improve program implementation and accessibility of competitive group-based physical activity in the TEAM-PA trial

BackgroundThis study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women.MethodsIntervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions.ResultsAcross two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants’ comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69).ConclusionFindings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions.Trial registrationThis study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 (https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1).

Prevalence and prognostic relevance of electrocardiographic abnormalities among patients with ANCA-associated vasculitis.

Current guidelines provide limited evidence for cardiovascular screening in ANCA-associated vasculitis (AAV). This study aimed to investigate the prevalence of electrocardiogram (ECG) abnormalities and associations between no, minor or major ECG abnormalities with cardiovascular mortality in AAV patients compared with matched controls. Using a risk-set matched cohort design, patients diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis with digital ECGs were identified from Danish registers from 2000-2021. Patients were matched 1:3 to controls without AAV on age, sex, and year of ECG measurement. Associated hazards of cardiovascular mortality according to ECG abnormalities were assessed in Cox regression models adjusted for age, sex, and comorbidities, with subsequent computation of 5-year risk of cardiovascular mortality standardized to the age- and sex-distribution of the sample. A total of 1431 AAV patients were included (median age: 69 years, 52.3% male). Median follow-up was 4.8 years. AAV was associated with higher prevalence of left ventricular hypertrophy (17.5% vs 12.5%), ST-T deviations (10.1% vs 7.1%), atrial fibrillation (9.6% vs 7.5%), and QTc prolongation (5.9% vs 3.6%). Only AAV patients with major ECG abnormalities demonstrated significantly elevated risk of cardiovascular mortality [HR 1.99 (1.49-2.65)] compared with controls. This corresponded to a 5-year risk of cardiovascular mortality of 19.14% (16-22%) vs 9.41% (8-11%). Patients with AAV demonstrated a higher prevalence of major ECG abnormalities than controls. Notably, major ECG abnormalities were associated with a significantly increased risk of cardiovascular mortality. These results advocate for the inclusion of ECG assessment into routine clinical care for AAV patients.

Psychological, Subjective and Social Well-Being of Victims of The Armed Conflict in The Municipality of Chalán – Sucre (Colombia)

Objective: To describe the level of psychological, social and subjective well-being in victims of the armed conflict in the municipality of Chalán. Theoretical Framework: Mental health includes psychological, subjective and social well-being. Psychological well-being encompasses the satisfaction and optimal functioning of the individual. Subjective well-being refers to the perception of quality of life and personal satisfaction. Social well-being assesses the perception of social functioning and social context, including social integration and contribution. Method: A quantitative approach was adopted with a descriptive non-experimental cross-sectional cohort design. The participants were 75 victims of the armed conflict. The following scales were used: Ryff's Psychological Well-Being, Keyes' Social Well-Being and Sánchez Cánovas' Subjective Psychological Well-Being. Results and Discussion: 56% of the participants reflect a deficit in their psychological well-being, 36% are at a standard level and only 8% are at a high level, in line with research on victims of the armed conflict in Colombia. The 46.6% evaluate their subjective well-being negatively, while 57.3% evaluate it positively, highlighting the complex interaction between traumatic experiences and current satisfaction. 88% present a deficit in their social well-being. Research implications: The results have direct implications for the formulation of policies and intervention programs aimed at improving the comprehensive well-being of victims of the armed conflict. Originality/value: It lays the foundation for future research and practices focused on similar contexts, expanding knowledge and improving interventions in conflict and post-conflict situations globally.