Risk Difference Research Articles

Hair-sparing approach versus traditional hair clipping for cerebral spinal fluid shunt procedures: a retrospective comparative study.

Cerebral spinal fluid (CSF) diversion methods, including ventriculoperitoneal (VP) shunts, are the standard treatment for hydrocephalus. Hair clipping (HC) has been a routine neurosurgical practice of the great majority of neurosurgeons, due to the perception that this will either decrease the risk of shunt infection or allow for a faster, unimpeded opening and closing of the skin. The benefits of not cutting or clipping hair in terms of normalizing appearance and self-esteem are obvious. The purpose of this study was to assess whether the rate of shunt infection would differ between pediatric patients receiving operation via the hair-sparing (HS) approach versus HC. A retrospective single-institution study comparing HS versus HC was conducted on pediatric patients undergoing long-term CSF shunt procedures at the Montreal Children's Hospital between August 2014 and April 2021. The primary outcome measure was shunt infection at 90 days and at long-term follow-up. Inclusion criteria were having at least 18 months of follow-up after long-term CSF shunt procedures, including insertions or revisions of VP shunts, ventriculoatrial shunts, cystoperitoneal shunts, subdural-peritoneal shunts, ventriculosubgaleal shunts, and ventriculosubgaleal reservoirs. Excluded procedures were those involving external ventricular drains, externalized shunts, Omaya reservoirs, endoscopic third ventriculostomies, and lumbar shunts. There were 434 CSF shunt procedures performed in 226 unique patients; 155 (35.71%) procedures were done using the HS approach versus 279 (64.29%) procedures via HC. At 90 days postoperatively, the infection rate was 1.29% in the HS group and 2.87% in the HC group, with an absolute risk difference of 1.58% (95% CI -1.07% to 4.23%, p = 0.24). At long-term follow-up (mean follow-up: 752 days and 716 days for the HS and HC groups, respectively), the rate of shunt infection remained at 1.29% for the HS group (no new infections) but rose to 4.66% for the HC group, with an absolute risk difference of 3.37% (95% CI 0.33%-6.41%, p = 0.03). Performing CSF shunt procedures without cutting or clipping any hair has a very low risk of shunt infection, and certainly does not appear to increase the risk of infection (or malfunction) versus the hair removal approach. It is a safe alternative and should be considered due to its esthetic and psychological benefits regarding normalization of appearance and ease of resuming a normal life following shunt surgery.

Breaking Down Cardiogenic Shock: An Analytical Reflection on the DanGer-SHOCK and ECLS-SHOCK Trials

Mechanical circulatory support (MCS) devices, particularly the microaxial flow pump (mAFP), have gained traction in managing cardiogenic shock (CS) in patients with acute myocardial infarction (AMI). However, trials like DanGer-Shock and ECLS-Shock have reported differing outcomes, making it challenging to draw definitive conclusions. To explore this further, we conducted a comparative analysis of the 30-day and 6-month mortality rates from the DanGer-Shock and ECLS-Shock trials, examining differences in patient populations and risk profiles. The goal was to determine whether these differences could explain the conflicting outcomes or if the benefits observed in the DanGer-Shock trial were directly attributable to the mAFP strategy. One key finding is that, despite similar control group mortality rates, the intervention group in DanGer-Shock demonstrated a notably lower mortality rate at both 30 days and 6 months compared to the ECLS trial, with an absolute difference of about 8%. This benefit is not due to inherent risk differences but is instead attributed to the Impella-based strategy. Compared to standard care, mAFP data revealed a 7% mortality reduction at 30 days, which grew to 12.7% at 180 days, highlighting the long-term effectiveness of the mAFP strategy in maintaining hemodynamic stability and improving survival. These results suggest that, in CS management, the DanGer unloading strategy, when combined with percutaneous coronary intervention (PCI), plays a significant role in improving long-term survival through early intervention and ventricular unloading, independent of control group factors. Further research is needed to confirm the broader applicability of this approach in different patient populations.

Relationship between training volume and overuse injuries in female volleyball players

Problems and Purpose. Overuse injuries are a result of repetitive stress without sufficient recovery, and female volleyball players are known to have high risk of overuse injuries due to the cumulative impact of these repetitive actions. Overuse injuries can occur due to high training volume, which is important for skill development. This raises the potential for overuse injuries. For this reason, the study was conducted to evaluate the correlation between training volume and the incidence of overuse injuries in female volleyball players. Materials and methods. This study used a cohort research design to evaluate the correlation between training volume and the incidence of overuse injuries in female volleyball players, using a questionnaire to collect demographic data such as age, weight, height, exercise history, and previous injury history and OSTRC to collect data regarding the incidence, severity, and impact of overuse injuries on sport participation and daily activities. The sample consisted of 48 female volleyball players of Yusso Yogyakarta club. Results. Out of 48 respondents, 42 athletes had experienced injuries. Based on the OSTRC measurement there were 22 athletes had no injuries on their knees, while 12 athletes had mild injuries to their knees, 8 athletes had moderate injuries to their knees, 6 people had severe injuries to their knees and none. For lower back injuries, 12 athletes did not suffer any, 30 experienced mild injuries, 6 experienced moderate injuries, 6 experienced severe injuries, and 2 experienced very severe injuries. And for the shoulder area, there were 18 athletes were not injuried, 12 athletes had mild injuries, 14 athletes had moderate injuries, 2 athletes had severe injuries, and 2 others had suffered very severe injuries. The correlation between training volume and the incidence of overuse injuries in female volleyball players was tested using the Spearman test. It was found that the amount of training per week influence knee overuse injury with a significant value of 0.001. The amount of exercise per week also correlates with the incidents of low back overuse injury (significance value of 0.043) and overuse injuries in the shoulder area (significance value of 0.034). Conclusion. This study found that high volume training increases the risk of injury excess in female volleyball players, such as shoulder, knee and wrist injuries. Therefore, It is important to develop a balanced excercise program that includes rest periods and recovery to prevent injury.

Differences in Risk for Sexual Violence Protocol (RSVP) risk factors among older and adult men who have sexually offended

ABSTRACT Ageing has a protective impact on recidivism risk, including for those who offend sexually (Ambroziak, G., Kahn, R. E., Mundt, J. C., Keiser, K. L., & Thornton, D. (2020). Are civilly detained and committed sexually violent persons released after age 60 low risk? Criminal Justice and Behavior, 48(7), 981–998; Doren, D. M. (2006). What do we know about the effect of aging on recidivism risk for sexual offenders? Sexual Abuse: A Journal of Research and Treatment, 18; Harris, G. T., & Rice, M. E. (2007). Adjusting actuarial violence risk assessments based on aging or the passage of time. Criminal Justice and Behavior, 34(3), 297–313). Recent research of the Risk for Sexual Violence Protocol (RSVP) suggests increased age may affect the validity of this guideline, with good predictive performance in samples of men mostly aged under 50 (Davis, M. R., Woods, M., Raymond, B., Ogloff, J. R. P., & McEwan, T. E. (in submission). Does it work? Convergent and predictive validity of the Risk for Sexual Violence Protocol (RSVP) in an Australian Community Forensic Mental Health Setting. Manuscript submitted for publication; Vargen, L. M., Jackson, K. J., & Hart, S. D. (2020). Interrater reliability, concurrent validity, and predictive validity of the Risk for Sexual Violence Protocol. Law and Human Behavior, 44(1), 37–50), but poor predictive performance in a sample aged over 50 (Raymond, B. C., Davis, M. R., Ogloff, J. R. P., & McEwan, T. E. (in submission). Convergent and predictive validity of the sexual violence risk-20 and risk for sexual violence protocol with older sexual offenders. Manuscript submitted for publication). This study investigated possible reasons for these contrasting results by investigating age-related differences in risk factor endorsement and the relationships between risk factors. RSVP risk factors in two samples of men with prior sexual offending, older adults aged between 50 and 78 (n = 95) and adults aged between 18 and 46 (n = 139). Few differences were identified in risk factor endorsement or the relationship between risk factors. The younger adult sample were observed to have more risk factors present. PRACTICE IMPACT STATEMENT This research adds to the literature regarding older men who offend sexually. It is anticipated that further research into factors that are associated with this age group, may encourage future research of gerontological literature in a forensic arena. Until more reliable evidence is available, the current risk assessment tools may require a level of caution when used with older men.

Chewing gum to treat postoperative nausea and vomiting in female patients: a multicenter randomized trial.

Postoperative nausea and vomiting (PONV) is common after general anesthesia, with consequences for patient outcomes, satisfaction with care and healthcare costs. Our aim was to compare a new treatment, chewing gum, with a widely-used intravenous agent, ondansetron, to treat PONV in female patients in the post anesthesia care unit (PACU). We conducted a multicenter, randomized, controlled non-inferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged ≥12 years undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized anti-emetic prophylaxis was administered. Patients who developed PONV in the PACU were randomized to either 15 min of chewing gum or 4 mg of intravenous ondansetron. The primary outcome was cessation of nausea, retching or vomiting, with no recurrence nor rescue medication for 2 h after administration of the randomized intervention (i.e., complete response). Of 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% confidence interval (CI)] -17.3 [-30.4 to -4.3] %), not reaching our prespecified non-inferiority limit. Time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI] 0.53 [0.34, 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI] 14.07 [1.65, 26.49]). Chewing gum cannot be recommended as an alternative to ondansetron for treatment of PONV in female patients administered antiemetic prophylaxis.

Addressing bias due to measurement error of an outcome with unknown sensitivity in database epidemiological studies.

In epidemiological database studies, the occurrence of an event is measured with error through an indicator whose specificity is often maximised, at the expense of sensitivity. However, if the indicator has low sensitivity, measures of occurrence are underestimated. In association studies, risk difference is biased, and risk ratio may be biased as well, in either direction, if the sensitivity is differential across exposure groups. In this work, we show that if an auxiliary screening indicator can be defined to complement the main indicator, estimates of the positive predictive value of both indicators provide tools to estimate the sensitivity of the primary indicator, or a lower bound thereof. This mitigates bias in estimating the number of cases, prevalence, cumulative incidence, rate (particularly when the event is rare), and in association studies, risk ratio and risk difference. They also allow testing for non-differential sensitivity. While direct estimation of sensitivity is often infeasible, this novel methodology improves evidence based on data obtained from re-use of existing databases, which may prove critical for regulatory and public health decisions.

Outpatient Antibiotic Use and Treatment Failure Among Children With Pneumonia

Although a viral etiology can be detected in most cases of pediatric pneumonia, antibiotic treatment is common. The effectiveness of antibiotics in the outpatient setting for children diagnosed with pneumonia is not known. To compare outcomes among children diagnosed with pneumonia who were and were not treated with oral antibiotics. This retrospective cohort study identified Medicaid-insured children and adolescents 17 years or younger diagnosed with pneumonia and discharged from ambulatory settings in a multistate claims database from January 1, 2017, to December 31, 2019. Propensity score matching was used to mitigate confounding. Data were analyzed from August 31, 2023, to August 16, 2024. Antibiotic receipt, defined as an oral antibiotic dispensed from a pharmacy on the day of the index visit or on the subsequent day. Children who did not receive antibiotics included those who were not prescribed antibiotics and those who were prescribed antibiotics but did not fill the prescription. Treatment failure and severe outcomes within 2 to 14 days after the index visit. Treatment failure included hospitalization or ambulatory revisits for pneumonia, new antibiotic dispensation with a same-day ambulatory visit, or complicated pneumonia. Severe outcomes included hospitalization for pneumonia or complicated pneumonia. Among the 103 854 children with pneumonia included in the analysis, the median age was 5 (IQR, 2-9) years, and 54 665 (52.6%) were male. Overall, 20 435 children (19.7%) did not receive an antibiotic within 1 day. The propensity score-matched analysis included 40 454 children (20 227 per group). Treatment failure occurred in 2167 children (10.7%) who did not receive antibiotics and 1766 (8.7%) who received antibiotics (risk difference, 1.98 [95% CI, 1.41-2.56] percentage points). Severe outcomes occurred in 234 of 20 435 children (1.1%) who did not receive antibiotics and in 133 of 83 419 (0.7%) who did (risk difference, 0.46 [95% CI, 0.28-0.64] percentage points). In this cohort study of children diagnosed with pneumonia in ambulatory settings, almost 20% did not receive antibiotics within a day of diagnosis. Although not receiving antibiotics was associated with a small increase in the risk of treatment failure, severe outcomes were uncommon regardless of whether antibiotics were received. These results suggest that some children diagnosed with pneumonia can likely be managed without antibiotics and highlight the need for prospective studies to identify these children.

Association of postoperative opioid type with mortality and readmission rates: multicentre retrospective cohort study.

Opioid treatment in postoperative pain management is crucial, but the impact of administration practices on outcomes is unclear. The hypothesis was that prescription trends remained stable over recent years, and that no difference in mortality and readmission risks is associated with prescription strategies. Electronic health records of surgical episodes in the Capital and Zealand Regions of Denmark from 2017 to 2021 were analysed. All opioids administered during postoperative admission were converted to oral morphine equivalents (OMEQs) and an average daily dose per patient was calculated. The opioid administered in the highest OMEQ dosages is considered the primary opioid strategy for the surgical case. Administration trends were analysed through linear regression, and Cox regression was used to calculate hazard ratios to assess dominant opioid strategies' association with 90-day mortality and readmission rates while controlling for confounders. A total of 183 317 patients met the inclusion criteria. Prescription trends remained steady during the study period. Multivariable analysis revealed increased readmission risk (HR 1.18, P < 0.001) of tramadol and tapentadol compared to morphine. They exhibited decreased 90-day mortality risk (HR 0.63, P < 0.001). Oxycodone had similar readmission risk (HR 1.009, P = 0.24) but lower 90-day mortality risk (HR 0.68, P < 0.001). Postoperative in-hospital opioid administration remained stable from 2017 to 2021. Tramadol/tapentadol had a higher risk of readmission but lower mortality risk. Oxycodone had comparable readmission but reduced mortality risk. This study provides a framework for future clinical trials assessing this potential impact of opioids in a targeted manner.

Surgical Site Infection and Periprosthetic Joint Infection in Nonelective versus Elective Total Hip Arthroplasty

Introduction: Total hip arthroplasty (THA) is a treatment used for both elective (eg, osteoarthritis) and nonelective (eg, fracture) indications. Patients undergoing nonelective THA may not be able to undergo the same preoperative optimization protocols as those undergoing elective THA. We aimed to determine differences in 30-day, 90-day, and 1-year surgical site infection (SSI) rates; 90-day and 1-year periprosthetic joint infection (PJI)–related revision; and 90-day and 1-year PJI-related surgery (ie, revision or irrigation and débridement) between nonelective and elective THA status. Method: This retrospective cohort study using the Medicare Limited Data Set included fee-for-service Medicare beneficiaries aged 65+ years who underwent inpatient primary THA in 2017 to 2020. Propensity score matching (1:5, nonelective: elective) was used. We assessed differences in surgical site infection (SSI), periprosthetic joint infection (PJI) outcomes by nonelective versus elective surgery status using mixed-effects logistic regression models, reporting adjusted odds ratios (OR) and 95% confidence intervals (CI). Results: From a total of 433,326 patients, 88,940 (19,094 nonelective; 69,846 elective) were successfully matched. Nonelective surgery status was associated with markedly higher odds of 30-day SSI (OR 1.55, 95% CI 1.25 to 1.92, P &lt; 0.001), 90-day SSI (OR 1.53, 95% CI 1.30 to 1.78, P &lt; 0.001), and 1-year SSI (OR 1.41, 95% CI 1.25 to 1.59, P &lt; 0.001). Nonelective status was also associated with higher odds of 1-year PJI-related revision (OR 1.33, 95% CI 1.08-1.63, P = 0.006) but not 90-day PJI-related revision. Similarly, nonelective status was associated with higher odds of 1-year PJI-related surgery (OR 1.33, 95% CI 1.09 to 1.62, P = 0.004) but not 90-day PJI-related surgery. Conclusion: Nonelective THA status was an independent risk factor for SSI throughout the first postoperative year and for 1-year PJI-related revision and PJI-related surgery. Additional research is necessary to elucidate the etiology of observed differences in infection risk between patients undergoing nonelective and elective THA and to define strategies to mitigate this difference in infection risk.

Effectiveness of an Impella versus intra-aortic balloon pump in patients who received extracorporeal membrane oxygenation: a nationwide inpatient database study

Abstract Background/Introduction Previous studies have suggested that left ventricular (LV) unloading with an intra-aortic balloon pump (IABP) or percutaneous ventricular assist device (Impella) in combination with extracorporeal membrane oxygenation (ECMO) is associated with lower mortality; however, it is unclear which is better. Purpose This study aimed to evaluate the effectiveness of LV unloading with an Impella versus IABP on in-hospital mortality and other clinical outcomes. Methods Using the Japanese Diagnosis Procedure Combination database from September 28, 2016, to March 31, 2022, we identified inpatients who received an Impella or IABP in combination with ECMO (ECPella or ECMO+IABP group, respectively). The primary outcome was in-hospital mortality and the secondary outcomes were the length of hospital stay, length of ECMO, total hospitalization cost, and complications including major bleeding, an ischemic stroke, vascular complications, and renal replacement therapy during hospitalization. Propensity score matching was performed to compare the outcomes between the groups. We performed sensitivity analyses excluding patients who received extracorporeal cardiopulmonary resuscitation. Results Of 14,525 eligible patients, 603 (4.2%) received ECPella and 13,922 (96%) received ECMO+IABP. After propensity score matching, there was no significant difference in in-hospital mortality between the two groups (58.9% versus 56.6%; risk difference, 2.3%; 95% confidence interval, -3.9% to 8.5%). A Kaplan–Meier analysis with the log-rank test showed no significant difference in the 60-day in-hospital mortality between the two groups (P value = 0.114) (Figure 1). The ECPella group had a longer hospital stay (mean 42.8 days versus 33.7 days; risk difference, 9.1 days; 95% confidence interval, 2.6 to 15.6 days), a higher total hospitalization cost (12,573,000 yen versus 6,857,000 yen; risk differences, 5,716,000 yen; 95% confidence interval, 4,439,000 yen to 6,993,000 yen), and more frequent major bleeding (8.1% versus 5.8%; risk difference, 2.0%; 95% confidence interval, 0.007% to 4.0%), vascular complications (4.1% versus 2.2%; risk difference, 2.0%; 95% confidence interval, 0.04% to 3.9%), and renal replacement therapy during hospitalization (50.6% versus 41.1%; risk difference, 9.5%; 95% confidence interval, 3.0% to 15.9%) than the ECMO+IABP group (Figure 2). The results of the sensitivity analyses, excluding 6,360 patients (44%) who received extracorporeal cardiopulmonary resuscitation, showed similar results to those for the main analyses. Conclusions This nationwide inpatient database study showed that ECPella was not associated with a survival benefit but was associated with a longer hospital stay, a higher total hospitalization cost, and more complications than ECMO+IABP.Figure 1Figure 2

Symptomatic patients without coronary artery disease do not have excess cardiovascular risk compared to the general population

Abstract Background Patients with stable angina with no coronary atherosclerosis by coronary computed tomography angiography (CCTA) have a lower cardiovascular risk compared to CCTA patients with greater atherosclerotic burden. However, it remains unknown whether these symptomatic patients have excess cardiovascular risk when compared to the general population and if any excess risk is sex or age dependent. Purpose To examine the 10-year cardiovascular risk and mortality in patients with no coronary atherosclerosis by CCTA compared to a matched general population comparison cohort. Methods We included every symptomatic CCTA patient with no coronary artery disease (CAD), defined as no coronary plaques and Agatston calcium score of 0, in Western Denmark from 2008-2021. Each patient was matched by age and sex with 5 individuals with no previous history of ischemic heart disease from the Western Danish general population. Maximum follow-up was 10 years. Outcomes were myocardial infarction, ischemic stroke, and all-cause death. We estimated 10-year risk difference (RD) and incidence rate ratios (IRR) using a conditional Poisson regression, comparing patients with no CAD to the general population cohort. Additionally, we performed age- (&amp;lt;45 year, 45-65 years, and ≥65 years) and sex stratified analyses. Results We included 39,223 patients with no CAD who were matched with 196,115 individuals from the general population. Median age was 54 and 60% were women. Baseline use of anti-thrombotic agents, statins, and anti-hypertensive drugs was higher in patients with no CAD than the general population. Median follow-up was 6.1 years. CCTA patients with no CAD had lower risk of myocardial infarction [RD -0.2%, IRR 0.75 (95% CI 0.65-0.85)] and death [RD -3.3%, IRR 0.51 (95% CI 0.48-0.55)], but similar risk of ischemic stroke [RD 0.0%, IRR 0.93 (95% CI 0.84-1.02)] compared to the general population (Figure 1). However, patients &amp;lt;45 years had higher 10-year risk of both myocardial infarction and ischemic stroke despite absence of CAD by CCTA compared the general population (Figure 2). Conclusions Symptomatic patients without CAD by CCTA do not have excess cardiovascular risk when compared to a general population cohort without known ischemic heart disease. Future cardiovascular risk management of these patients should therefore follow primary prevention guidelines. However, patients &amp;lt;45 years did exhibit higher risk of ischemic outcomes and may require intensified preventative treatment.Figure 1Figure 2

Cangrelor versus no cangrelor during percutaneous coronary intervention in hemodynamically unstable patients: a cohort study on benefits and risks

Abstract Background Cangrelor is an intravenous P2Y12 inhibitor which, according to the European guidelines, may be considered for administration in acute coronary syndrome during percutaneous coronary intervention (PCI). Little is known regarding benefits and risks of such administration in hemodynamically unstable patients. Purpose To investigate the effects of cangrelor versus no cangrelor during PCI regarding major adverse cardiac events (MACE), in-hospital bleeding, and all-cause mortality in patients with cardiogenic shock and/or cardiac arrest. Methods The study population was extracted from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and included patients with cardiogenic shock or cardiac arrest undergoing PCI during the years 2016-2022. Propensity score matching (PSM) was used to create comparable groups. After matching, all variables used for calculating propensity score were balanced (standardized mean difference&amp;lt;0.1). Outcomes were MACE within 30 days, in-hospital bleeding, and all-cause mortality within 30 days. Risk ratios (RR) with 95% confidence intervals (CI) were calculated. When RR deviated from the null, the risk difference (RD) was determined. Results In all, 2,100 (66%) out of 3,206 patients with cardiogenic shock and/or cardiac arrest were included in the PSM analyses (median age: 69 years; 76% male; 78% ST-elevation myocardial infarction (STEMI)). Comparing cangrelor versus no cangrelor in this matched set of patients, the RR was 0.93 (95% CI: 0.84; 1.04) for MACE; 1.51 (1.02; 2.25) for in-hospital bleeding, with an RD of 1.9 percentage points (0.10; 3.7); and 0.93 (0.82; 1.04) for all-cause mortality (Table). In the PSM analysis regarding patients with cardiogenic shock, 1,098 (60%) out of 1,815 patients were included (median age: 71 years; 68% male; 82% STEMI). For these patients, RR was 0.85 (95% CI: 0.74; 0.97) for MACE, with an RD of -7.5 percentage points (-1.6; -13); 1.31 (0.82; 2.09) for in-hospital bleeding; and 0.83 (0.72; 0.95) for all-cause mortality, with an RD of -8.0 percentage points (-2.2; -14). In the PSM analysis regarding patients with cardiac arrest, 1,388 (76%) out of 1,827 patients were included (median age: 67 years; 81% male; 75% STEMI). RR was 0.98 (95% CI: 0.86; 1.12) for MACE; 1.53 (0.95; 2.49) for in-hospital bleeding; and 0.98 (0.86; 1.13) for all-cause mortality. Conclusion For patients with cardiogenic shock, but not for patients with cardiac arrest, administration of cangrelor versus no cangrelor during PCI was associated with a reduction in both MACE and all-cause mortality, with numbers needed to treat of 14 and 13, respectively. Overall, for patients with cardiogenic shock or cardiac arrest, administration of cangrelor versus no cangrelor during PCI was associated with an increased risk of in-hospital bleeding with a number needed to harm of 53.

Intersectional inequalities in child social-emotional health: a case for proportionate universalism

Abstract Background Social-emotional difficulties in early childhood are associated with a range of outcomes across the life course and are related to socioeconomic factors. The aim of this study was to examine intersectional inequalities in social-emotional problems in preschool children relating to their parents’ income, education and country of birth in addition to investigating the public health implications. Methods This population-based study with a repeated cross-sectional design in the Västerbotten County of Sweden used the Ages and Stages Questionnaires: Social-Emotional (ASQ:SE) for children aged 3 in child health care services over the years of 2014-2018 and socio-economic information from national population registers. The effective sample of 8,823 individuals was analyzed using additive binomial regression in combination with an analysis of individual heterogeneity and discriminatory accuracy (AIHDA) approach to estimate risk differences for social-emotional problems across 27 intersectional groups and discriminatory accuracy. Results Average risk differences generally increased in the groups where multiple dimensions of social inequality intersected, with risk differences as high as 18% (95% CI 8 to 28%) and 25% (95% CI 14 to 37%) compared to the most advantaged category. The discriminatory accuracy of all three included regression models was estimated as moderate, but improved in a slight but statistically significant way with the addition of social inequalities. Conclusions This study increases our understanding of intersectional and social inequalities in social-emotional problems in preschool children. It supports the need for universal public health policies in addition to policies targeting more vulnerable groups when addressing this issue, consistent with the concept of proportionate universalism. An intersectional research perspective including discriminatory accuracy could increase our knowledge of health inequities and improve public health effectiveness. Key messages • Intersecting dimensions of social inequalities are associated with an increased risk of social-emotional problems in children aged 3. • Universal public health policies are needed in addition to policies targeting vulnerable population groups with regards to social-emotional problems in young children.

Modern epidemiology of heart failure with reduced and preserved ejection fraction in population-wide linked electronic health records: a study of 208815 heart failure patients in England

Abstract Background The modern epidemiology of heart failure (HF) with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) is yet to be studied on a population-wide scale in the United Kingdom, particularly in the post-COVID-19 era. Purpose To explore the post-pandemic epidemiology and outcomes of HFrEF and HFpEF in population-wide electronic health records (EHRs). Methods We accessed data in the National Health Service England’s Secure Data Environment for England via the British Heart Foundation Data Science Centre CVD-COVID-UK/COVID-IMPACT Consortium. We used EHRs for 57 million individuals to identify patients aged ≥18 years, of known sex, who were diagnosed with HF as the primary condition in any inpatient hospital stay from 01 Jan 2020 to 27 Feb 2023. By linking HF admissions with the National Heart Failure Audit, six other National Institute for Cardiovascular Outcomes Research audits, and the General Practice Extraction Service Data for Pandemic Planning and Research, we classified HF into HFrEF and HFpEF based on recorded left ventricular ejection fraction (LVEF; ≤40% and &amp;gt;40% respectively) or documented diagnosis. We compared characteristics of these groups and used Cox proportional hazards models, adjusted for key confounders, to examine differences in cause-specific mortality and hospitalisation outcomes. Results Over 3.2 years, we identified 208815 patients with a HF hospitalisation. 86110 (41%) patients had HFrEF, 65735 (31%) had HFpEF, and 56970 (27%) could not be categorised. Compared to patients with HFrEF, patients with HFpEF were older (mean [SD], 80.5 [10.9] vs 75.6 [13.6] years), more often female (n [%], 35990 [54.8] vs 30835 [35.8]), and less deprived (n [%] in the least-deprived Index of Multiple Deprivation 2019 quintile, 12275 [18.7] vs 15055 [17.5]; Table). Over a median follow-up of 11 months among patients with HFrEF and HFpEF, 99740 patients were re-hospitalised (66%) and 71075 (47%) died. Risks of all-cause, cardiovascular, non-cardiovascular, and heart-failure re-hospitalisations were all higher in patients with HFpEF compared with patients with HFrEF (Figure). The risk of all-cause mortality was modestly higher in patients with HFpEF (HR 1.04, 95% CI 1.02–1.06; Figure). Risks of death due to cardiovascular disease overall, fatal myocardial infarction, and fatal HF were higher among patients with HFrEF. In contrast, risks of death due to non-cardiovascular causes were higher in patients with HFpEF. There were no differences in risk of death due to COVID-19. Conclusions Unlike previous epidemiological surveys of HF, patients with HFpEF appear to face worse prognosis and risk-adjusted disease trajectories compared with those with HFrEF after hospitalisation in this population-wide study. Excess mortality in HFpEF appears driven by higher risk of non-cardiovascular mortality. However, post-discharge survival is poor regardless of LVEF and represents an ongoing target for quality improvement efforts.

Resumption of anticoagulation therapy among Non-Valvular Atrial Fibrillation (NVAF) patients with prior intracranial haemorrhage

Abstract Purpose Resumption of anticoagulation therapy (OAC) in patients with non-valvular atrial fibrillation (NVAF) suffering from intracranial haemorrhage (ICH) is challenging in clinical practice. The aim of this study was to evaluate impact of resumption of OAC on clinical outcomes in NVAF patients with history of ICH. Methods Consecutive patients with NVAF with or without OAC who survived from an index ICH between January 2018 and July 2022 in 16 public hospitals in Hong Kong were identified and analyzed retrospectively. Resumption of OAC was substantiated by new prescription obtained from electronic medical records. Patients were divided into 5 groups: (i) OAC naïve (as reference group); (ii) resume direct oral anticoagulant (DOAC); (iii) resume Vitamin K antagonist (VKA); (iv) discontinue DOAC; (v) discontinue VKA. Risks of ischemic stroke, recurrent ICH and all-cause mortality were estimated for all groups and compared with individuals without OAC, using adjusted sub-distribution hazard ratios (aSHR) derived from Fine and Gray regression models, accounting for death as competing risk, adjusting for components of CHA2DS2VASC and HASBLED scores. Sub-analysis was conducted to compare outcomes between different DOAC agents (i.e, apixaban, dabigatran, edoxaban, rivaroxaban), using VKA as reference among patients who resumed DOAC or VKA. Results Of 982 patients who met inclusion criteria (mean age 77.7±10.9, female 40.9%), 39.1% (n=384) were OAC naive, 32.2% (n=316) resumed DOAC, 12.6% (n=124) resumed VKA, 9.0% (n=88) discontinued DOAC and 7.1% (n=70) discontinued VKA. During a median follow-up period of 2.0 (IQR: 0.7-3.5) years, no statistically significant difference in risk of ischemic stroke was observed among 5 groups. Discontinuation of DOAC was associated with markedly higher risk of ischemic stroke (aSHR=8.32 (1.8-39.3)) only among AF patients with CHA2DS2VASC score ≥ 4, Risk of recurrent ICH was higher in patients who resumed VKA (aSHR=1.6(1.0-2.5)). Sub-analysis demonstrated resumption of apixaban was associated with lowest risk of recurrent ICH (aSHR=0.6(0.4-0.9)). Compared to OAC naïve patients, those who resumed DOAC (aSHR=0.5(0.4-0.7)) had lowest risk of all-cause mortality, whereas discontinuation DOAC (aSHR=1.9(0.4-2.5) and VKA (aSHR=1.6(0.2-2.2)) were both associated with increased mortality. Conclusion Our real-world data revealed among NVAF patients with prior ICH long term discontinuation of OAC was associated with increased risk of ischemic stroke. Recurrent ICH was highest among patients who resumed VKA and lowest with apixaban.

Risk of thromboembolic and haemorrhagic events associated with anticoagulation among 11,355 patients with non-valvular atrial fibrillation and thrombocytopenia

Abstract Background Oral anticoagulation (OAC) is the mainstay for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Management is challenging among patients with NVAF complicated with thrombocytopenia. Purpose We compared risk of thromboembolic and hemorrhagic events between vitamin-k antagonist (VKA) and direct oral anticoagulants (DOAC) users. Methods We retrospectively analyzed patients with thrombocytopenia and NVAF prescribed VKA (N=5,251, 46.2%) and DOAC (N=6,104, 53.8%) between January 2012 and July 2022 in 16 public hospitals in Hong Kong. Mild to moderate thrombocytopenia was defined as mean platelet count (PLT) 100-150 × 10^9/L and 50-100 × 10^9/L respectively, during the year of OAC initiation. Propensity-matched cohorts of VKA and DOAC were generated on the basis of age, sex, baseline co-morbidities (components of CHA2DS2VASC and HAS-BLED scores) and medications. Time to intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB) and ischemic stroke (IS) was analyzed using competing risk regression, accounting for death as competing risk. Subgroup analysis was performed to detect heterogeneity of effect across mild and moderate thrombocytopenia. Secondary outcome included (i) comparisons between 4 DOAC agents with full dose; (ii) Full-dose DOAC vs. reduced-dose DOAC. Results Of the whole cohort (N=11,355, mean age 75.8±10.5, female 38.6%), 10.3% (n=1,174) and 89.7% (n=10,181) had moderate and mild thrombocytopenia, respectively. After propensity-score matching, VKA and DOAC (n=4,302 each cohort) users were well balanced at baseline characteristics, with a median follow-up of 4.0 (IQR: 1.6-7.3) years. Overall, utilization of DOAC was associated with reduced risk of ICH [Hazards Ratio (HR) 0.56 (95% CI 0.45-0.70)] and GIB [HR 0.60 (95% CI 0.48-0.75)], compared with VKA. No difference in risk of IS was observed [HR 1.00 (95%CI 0.83-1.20)]. Dosing reduction of DOAC made no difference in all outcomes. Subgroup analysis demonstrated the benefit in decreasing GIB might be more marked in moderate thrombocytopenia [(HR 0.24 (95%CI 0.09-0.61)], than in mild thrombocytopenia [HR 0.64 (95%CI 0.51-0.81)]. Conclusion In patients with NVAF and thrombocytopenia, DOAC has similar efficacy but better safety profile than VKA. In terms of GIB, the superiority appeared to be more pronounced in patients with more significant thrombocytopenia.

Cardiopulmonary exercise testing predicts risk of progressive heart failure and long term mortality in ambulatory patients awaiting isolated heart transplant

Abstract Introduction Cardiopulmonary exercise testing (CPET) parameters such as peak VO2 ≤ 14ml/kg/min, percentage predicted peak VO2 (ppVO2) ≤ 50% and ventilation equivalent of carbon dioxide (Ve/VCO2) &amp;gt;35 l/min/l/min are recommended thresholds to list for isolated heart transplant. There is minimal data on clinical events after listing to guide clinical management or priority in organ allocation. Purpose To assess the effect of peak VO2, ppVO2, Ve/VCO2 on clinical events after listing for isolated heart transplant. Methods In a single centre retrospective study, we identified patients who were status 6 or status 2 prior to 2018 at time of listing for isolated heart transplant between 2007 and 2021. Clinical data were collected by chart review. Primary outcome of progressive heart failure was defined as death or upgrade in transplant priority status (new inotropes or mechanical circulatory support). Comparison was made between peak VO2 strata (&amp;gt; 14 vs ≤ 14 ml/kg/min), ppVO2 strata (&amp;gt; 50% vs 40-50% vs &amp;lt;40%) and Ve/VCO2 strata (&amp;lt;35 vs &amp;gt;35 l/min/l/min). Secondary outcome was time dependent survival after listing for heart transplant. Results We identified 141 patients of which 133 underwent CPET and follow up was available for 130 who were included in the analysis. Median age was 53 years (interquartile range 41-59 years), 29.1% of patients were female. Median peak VO2 was 14.0 ml/kg/min (11.2-15.7), ppVO2 was 44% (36-52), Ve/VCO2 slope was 34.0 (31.0-37.0) and RER was 1.1 (1.1-1.2). 87 patients had progressive heart failure consisting of 34 deaths and 83 patients having upgrade in priority status. There was a significant difference in risk of progressive heart failure comparing peak VO2 strata (Figure 1) (freedom from event at one year 71.4% with peak VO2 &amp;gt; 14 vs 46.5% with peak VO2 ≤ 14, p=0.00061) and ppVO2 strata (Figure 2) (freedom from event at one year 75.0% with ppVO2 &amp;gt;50% vs 61.2% with ppVO2 40-50% vs 42.6% with ppVO2 &amp;lt;40%, p=0.0015). There was no significant difference with Ve/VCO2 strata (freedom from event at one year 59.8% with Ve/VCO2 &amp;lt;34 vs 54.9% with Ve/VCO2 &amp;gt;34, p=0.52). There were 34 deaths before transplant and 23 deaths after transplant. 87 patients underwent transplant. In a time dependent survival analysis, age, gender and ppVO2&amp;lt;50% (HR 1.65 (0.87-3.12)) were not significant predictors of mortality. Both early transplant (defined as &amp;lt; 1 year after listing, HR 0.14 (0.06-0.34) and late transplant (defined as &amp;gt; 1 year after listing, HR 0.16 (0.08-0.32)) were significant predictors of lower mortality whilst Ve/VCO2&amp;gt;35 (HR 2.09 (1.19-3.68)) was a significant predictor of higher mortality. Conclusions Peak VO2 and ppVO2 stratify risk of progressive heart failure in ambulatory patients awaiting isolated heart transplant. However, Ve/VCO2 is a predictor of significantly higher mortality. These findings should affect clinical management and transplant priority status; and influence revision of future guidelines.Freedom from event by peak VO2 strataFreedom from event by ppVO2 strata

Generalizability of SELECT to a contemporary cohort of cardiac surgical patients: analysis of the TRICS III Randomized Trial

Abstract Background The SELECT trial reported a significant reduction in cardiovascular (CV) outcomes with semaglutide amongst patients without diabetes who had pre-existing CV disease and a body-mass index (BMI) of 27 or greater. Patients undergoing cardiac surgery represent a high-risk subset of those with established CV disease, and may benefit from treatment with semaglutide. Purpose This study evaluated the generalizability of SELECT to a contemporary international cohort of cardiac surgical patients, and assessed whether differences between SELECT-eligible and non-eligible patients translated to altered risks of CV outcomes. Methods Present data was gathered from the TRICS III trial, a multicentre, randomized trial of restrictive versus liberal red-cell transfusion thresholds amongst 5243 cardiac surgical patients with a EuroSCORE I of ≥6. The proportion of cardiac surgical patients eligible for SELECT was determined by applying its selection criteria to the TRICS III cohort. Finally, baseline characteristics and outcomes stratified by SELECT eligibility were compared. Results A total of 4887 patients from the TRICS III cohort had available data for analysis, of which 452 (9.2%) were deemed to have been eligible for the SELECT trial. A comparison of baseline characteristics between SELECT-eligible and non-eligible patients are presented in Table 1; while SELECT-eligible patients were more likely to have preserved left ventricular function (71.7% vs. 61.0%), EuroSCORE I values were comparable between the two groups (7.8±2.1 vs. 7.9±1.9). The rate of a 3-point MACCE of Death, MI or stroke in the present cohort of SELECT-eligible patients undergoing cardiac surgery (16.6%) was numerically higher than those enrolled in SELECT receiving semaglutide (8.1%) or placebo (10.0%), despite the shorter follow-up (6 months vs. 39.8 months). Six month outcomes following cardiac surgery were similar regardless of SELECT eligibility (Figure 1); no difference in risk of outcomes was documented for the 3-point MACCE [SELECT Eligible vs. Non-eligible – 16.6% vs. 14.5%; OR 1.17 (0.9-1.53); P=0.24] and the TRICS III primary composite of Death, MI, Stroke, or New-Onset Renal Failure with Dialysis [17.0% vs. 17.0%; OR 1.0 (0.77-1.29); P=0.98]. There was a trend towards higher rates of MI at 6 months amongst SELECT-eligible patients, but this difference failed to reach statistical significance [8.5% vs. 6.3%; OR 2.0 (0.96-1.39); P=0.08). Conclusions In this large international cohort of contemporary cardiac surgical patients, nearly 10% would have met eligibility for SELECT. SELECT-eligible patients undergoing cardiac surgery in TRICS III had a numerically higher rate of MACCE than those enrolled in SELECT, highlighting the high risk nature of this patient subgroup. However, amongst SELECT-eligible and non-eligible patients undergoing cardiac surgery, no significant difference in CV outcomes was uncovered.

Diagnoses of mental health disorders among Norwegian youth and young adults with immigrant parents

Abstract Introduction Adolescence and early adulthood are associated with an increase in mental health problems. Migration is also a risk factor for mental disorders. Yet, there is a notable gap in research concerning the mental well-being of descendants of immigrants. This study investigates the risk of a diagnosis of a mental health disorder among those aged 16-30 years, born in Norway with at least one immigrant parent. Methods Data were sourced from the Medical Birth Registry of Norway, the Norwegian Patient Register, and Statistics Norway. Cox proportional hazard regressions were used to estimate hazard ratios (HR) of being diagnosed with different mental disorders, in total and by parental region of origin, compared to individuals of Norwegian background. Analyses were adjusted for sex, year of birth, and parental education. Results Individuals with two immigrant parents had a lower risk of most mental disorder diagnoses, while those of one immigrant parent had a higher risk. With the exception of schizophrenia, individuals with two immigrant parents had a lower risk of most mental disorder diagnoses compared to those with Norwegian-born parents. The HR for the risk of a diagnosis of anxiety for those with two immigrant parents was: 0.79 [95% CI 0.76 - 0.81], with immigrant mother: 1.07 [95% CI 1.04-1.10], with immigrant father: 1.28 [95% CI 1.24 -1.30]. Similarly, for depression, two immigrant parents: 0.85 [95% CI 0.82-0.88], immigrant mother: 1.13 [95% CI 1.09 - 1.17], immigrant father: 1.31 (95% CI 1.28-1.37). Bipolar disorders, two immigrant parents: 0.67 [95% CI 0.60-0.76], immigrant mother: 1.19 [95% CI 1.07 - 1.31], immigrant father: 1.47 [95% CI 1.35-1.61]. The pattern was relatively consistent across parental regions of origin. Conclusions Those with one immigrant parent are more likely to use specialist mental health services, while those with two immigrant parents are not. These need special attention in adulthood. Key messages • Differences in risk of diagnosis for mental disorders could be due to differences in the utilization of mental health services. • Early prevention of mental health issues seems to be especially important among children and youth raised in families with one immigrant parent.

Patient and practice characteristics related to patient’s consent for health data exchange

Abstract Background Sharing patient health data electronically between healthcare providers can prevent medical errors and improve patient safety. In the Netherlands, exchange of health information is facilitated on a national level and is only allowed with patient consent. Consequently, it is important to know which factors are related to this patient consent. Methods Routine electronic health records data from up to 10% of Dutch general practices (sourced from the Nivel Primary Care Database) were utilized, covering the period from 2016 to 2020. We examined whether patient consent for health data exchange varied depending on patient and practice characteristics, which are expected to have a relationship with granting consent for health data exchange. Therefore, multilevel analysis was performed. Results The percentage of patients granting consent ranged between 40%-50% in the period 2016 to 2019, while this was 97% in 2020, due to the governmental corona opt-in regulation. Significant disparities were observed across several of the included patient and practice characteristics in relation to patient consent for all the years examined. In most years, patient consent provision varied by gender, age, socioeconomic position, location, and healthcare use. Practice characteristics showed notable differences in patient consent across information systems, patient volumes, and practice types over all years examined. Conclusions We observed significant variations in patient consent for health data exchange, both among the included patient (need) and practice characteristics. These differences may stem from unequal exposure to opportunities to grant consent, differences in risk of inadequate communication between healthcare providers, levels of health literacy, and practice resources. These factors should be taken into account by policymakers when further implementing and upscaling the national health data exchange system. Key messages • Variations in patient consent for health data exchange were observed among different patient groups and general practices. • Variations in patient consent for health data exchange may stem from unequal exposure to opportunities to grant consent, levels of health literacy, and practice resources, among other factors.