Risk Difference Research Articles

Buddy taping after reduction of displaced extra-articular phalangeal finger fractures in children: a randomized controlled trial.

In this randomized controlled trial, we assessed the non-inferiority of buddy taping to splinting after reduction of displaced extra-articular proximal and middle phalangeal finger fractures in children. The primary outcome was the rate of secondary fracture displacements; the secondary outcomes were patient comfort, analgesic efficacy and total range of active motion 6 months after injury. Eighty-one patients participated: 43 with taping and 38 with splinting. Secondary displacement occurred in eight patients: five in the splinting group and three in the taping group. Risk difference was below the predefined non-inferiority of 10%. Patient comfort was significantly higher in the taping group, with no group differences for other parameters. Our previous study recommended taping for undisplaced finger fractures in children. With the current data, we recommend taping these finger fractures irrespective of displacement or need for reduction. We are encouraged to propose taping as an alternative to splinting for increased patient comfort, lower cost, and shorter application time.Level of evidence: I.

Taxane/anthracycline combinations reduced incidence of breast cancer recurrence in young women across molecular subtypes: a real-world evidence of Taiwan from 2011 to 2019.

Adolescent and young adult (AYA) patients with breast cancer generally have poor prognoses and a higher risk of secondary cancers compared to those at the same cancer stage. Notably, AYA patients in Asia exhibit a higher incidence rate of breast cancer, with Luminal A as the predominant molecular subtype, which contrasts with the trends observed in Western countries. This study aims to compare the efficacy of Taxane/Anthracycline combination-based regimens (TACB) versus Anthracycline-based regimens (AB) in AYA patients with stage I-II breast cancer, focusing on different molecular subtypes. This study utilized data from the Taiwan National Health Insurance Research Database (NHIRD) and the Taiwan Cancer Registry (TCR) from 2011 to 2019. The study cohort included patients aged 15 to 39years who were diagnosed with stage I-II breast cancer and received either TACB or AB regimens. Propensity score matching and Cox proportional hazards regression models were used to calculate the hazard ratios (HR) for recurrence. The results showed that TACB regimens significantly reduced the risk of recurrence compared to AB regimens across all patients (aHR 0.73, 95% CI 0.55-0.97). Specifically, for low/middle-recurrence risk groups, the aHR was 0.68 (95% CI 0.49-0.96), and for high-recurrence risk groups, it was 0.43 (95% CI 0.21-0.87). The analysis further indicated no significant differences in recurrence risk between AYA and non-AYA patients using TACB regimens. The TACB regimens showed a more favorable prognosis than AB regimens across all molecular subtypes. Furthermore, TACB regimens not only outperformed AB treatments but also closed the gap in prognostic outcomes between AYA and non-AYA patients. We believe the findings of this study are highly reliable and can provide valuable guidance for physicians in choosing the most appropriate treatment strategies for AYA patients with stage I-II breast cancer.

Frame-based stereotactic biopsies of brainstem lesions – Monocentric comparison of the transfrontal and the suboccipital-transcerebellar approach over a 16-year period

Both the transfrontal and the suboccipital-transcerebellar approach are frequently used trajectories for frame-based stereotactic biopsies of brainstem lesions. Nevertheless, it remains unclear which approach is more favorable in terms of complications, diagnostic success and outcome, especially considering the location of the lesion within the brainstem. This study compared the safety and diagnostic yield of these two approaches. Furthermore, a brainstem zone model was created to answer the question, whether there is a favorable approach depending on the location of the lesion in the brainstem. A retrospective analysis of 84 consecutive cases of frame-based stereotactic biopsies for brainstem lesions via either transfrontal or suboccipital-transcerebellar approaches over a 16-year period was performed. Clinical and surgical data regarding trajectories, histopathology, complications and outcome was collected. The brainstem was divided in anatomical zones to compare the use of the two approaches depending on the location of the lesions. A total of n = 84 cases of stereotactic biopsies for brainstem lesions were performed. In 36 cases the suboccipital-transcerebellar approach was used, while in 48 cases surgery was performed via the transfrontal approach. The patient’s demographic data were comparable between the two approaches. Overall diagnostic yield was 90.5% (93.8% transfrontal vs. 86.1% suboccipital, p = 0.21, Risk Difference (RD) 0.077, CI [-0.0550, 0.2090]). Complications occurred in 11 cases (total complication rate: 13.1%; 12.5% transfrontal vs. 13.9% suboccipital, p = 0.55, RD 0.014, CI [-0.1607, 0.1327]). The brainstem model showed a more frequent use of the suboccipital approach in lesions of the dorsal pons. The transfrontal approach was used more frequently in mesencephalic targets. No significant differences in terms of complications and diagnostic yield were observed, even though complications in medullary lesions appeared higher using the transfrontal approach. This study showed, that if the approaches are used for their intended target locations there are no significant differences between the transfrontal and the suboccipital-transcerebellar approach for frame-based stereotactic biopsies of brainstem lesions in terms of diagnostic yield and safety. Therefore, our data suggests that both approaches should be considered for stereotactic biopsy of brainstem lesions.

Disparities in Survival Outcomes Among Patients With Metastatic Melanoma in Texas: Implications for Policy and Interventions in the Era of Immune Checkpoint Inhibitors.

Disparities exist in the length and quality of survival from melanoma. This study evaluated, in a Texas cohort, patient factors associated with melanoma survival and examined if newer immune-oncologic agents extend survival compared with conventional therapies. A retrospective analysis of patients diagnosed with metastatic melanoma from 2011 to 2018 in the Texas Cancer Registry database. Multivariable Cox proportional hazard regression was used to evaluate patient characteristics associated with cancer-specific survival (CSS) and overall survival (OS). The patient cohort was then grouped based on receipt of first-line immunotherapy or other therapies. The association between receipt of immunotherapy and survival was assessed with Kaplan-Meier analysis and inverse probability treatment weighted Cox regression. There were 1372 patients with metastatic melanoma. Factors associated with increased melanoma mortality risk (CSS) included being male (HR: 1.13, 95% CI: 1.02-1.26), non-Hispanic black (HR: 1.28, 95% CI: 1.13-1.45), living in poorer counties (HR: 1.40, 95%CI: 1.20-1.64), and having multimorbidity (HR: 1.35, 95% CI: 1.05-1.74). All minority races and Hispanics had poorer OS compared with non-Hispanic Whites. Patients who received first-line immunotherapy had significantly longer median (interquartile range) survival (CSS: 27.00 [21.00 to 42.00] mo vs. 16.00 [14.00 to 19.00] mo; OS: 22.00 [17.00 to 27.00] mo vs. 12.00 [11.00 to 14.00] mo). They also had reduced mortality risk (HR for CSS: 0.80; 95% CI: 0.73-0.88; P <0.0001; HR for OS: 0.76; 95% CI: 0.69-0.83; P <0.0001) compared with the nonimmunotherapy cohort. This study showed differences in risks from melanoma survival based on patient demographic and clinical characteristics. Low socioeconomic status increased mortality risk, and first-line immunotherapy use favored survival. Health policies and tailored interventions that will promote equity in patient survival and survivorship are essential for managing metastatic melanoma.

Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial.

Persistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population. INFINITY-SWEDEHEART is a single-blind, non-inferiority, registry-based, randomised controlled study conducted in 20 hospitals in Sweden. Patients aged 18-85 years, with chronic or acute coronary syndrome ischaemic heart disease, with an indication for PCI, with up to three de novo lesions suitable for implantation with one single device per lesion, and successful pre-dilatation were identified via the Swedish Coronary Angiography and Angioplasty Registry and eligible for enrolment. Participants were randomly assigned (1:1), using block randomisation with random variation in block size and stratified by site, to either the DynamX bioadaptor (Elixir Medical, Milpitas, CA, USA) or a zotarolimus-eluting DES (Resolute Onyx and Onyx Trustar, Medtronic, Minneapolis, MN, USA). The primary endpoint was the device-oriented clinical endpoint of target lesion failure at 12 months (a composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment, regardless of treatment received) who had either experienced an event up to 12 months or completed the trial up to 12 months. Non-inferiority was established if the upper limit of the two-sided 95% CI for the absolute risk difference was less than 4·2%. Powered secondary endpoints were landmark analyses from 6 months onwards for target lesion failure, target vessel failure (composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target vessel revascularisation), and target lesion failure for patients with acute coronary syndrome assessed in the ITT population). This study is registered with ClinicalTrials.gov, NCT04562805, and follow-up to 5 years is ongoing. Between Sept 30, 2020, and July 11, 2023, 2399 patients were randomly assigned to receive the bioadaptor (n=1201) or DES (n=1198; ITT population). Median age was 69·5 years (IQR 61·2-75·6), 575 (24·0%) of 2399 patients were female, and 1824 (76·0%) were male (data on race and ethnicity were not collected), and 1838 (76·6%) patients presented with acute coronary syndrome. The primary endpoint of 12-month target lesion failure occurred in 28 (2·4%) of 1189 assessable patients in the bioadaptor group versus 33 (2·8%) of 1192 assessable patients in the DES group, with a risk difference of -0·41% (95% CI -1·94 to 1·11; pnon-inferiority<0·0001). In the prespecified landmark analysis from 6 months to 12 months, the Kaplan-Meier estimates of target lesion failure were 0·3% (with events in three of 1170 patients) in the bioadaptor group versus 1·7% (with events in 16 of 1176 patients) in the DES group (hazard ratio 0·19 [95% CI 0·06 to 0·65]; p=0·0079), of target vessel failure were 0·8% (events in eight of 1167) versus 2·5% (events in 23 of 1174; 0·35 [0·16 to 0·79]; p=0·011), and of target lesion failure in patients with acute coronary syndrome were 0·3% (events in two of 906) versus 1·8% (events in 12 of 895; 0·17 [0·04 to 0·74]; p=0·018). The rate of definite or probable device thrombosis, which was recorded as a safety outcome, was low and did not differ between groups (eight [0·7%] of 1201 in the bioadaptor group vs six [0·5%] of 1198 in the DES group; difference in event rates of 0·16% [95% CI -0·50 to 0·83]). Among patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI. The additional planned follow-up will help to reinforce the clinical significance of the 1-year findings. Elixir Medical.

Comparison of the Efficacy of Cephalosporins and Non-cephalosporins in Preventing Surgical Site Infections in Colorectal Surgery Patients: An Updated Systematic Review and Meta-Analysis.

This study aims to compare the efficacy of cephalosporin and non-cephalosporin antibiotics in preventing surgical site infections (SSIs) in patients undergoing colorectal surgery, providing a scientific basis for the selection of perioperative antibiotics through systematic review and meta-analysis. Adhering to the PRISMA guidelines, this research employed an extensive literature search strategy across multiple databases to identify relevant studies, including randomized controlled trials (RCTs) and observational studies. Inclusion criteria were studies on adults undergoing colorectal surgery who received preoperative prophylaxis with either cephalosporin or non-cephalosporin antibiotics. Exclusion criteria included preoperative diagnosis of infectious diseases and preoperative use of antimicrobial agents. Meta-analysis was conducted using RevMan 5.3 software to assess the effectiveness of both antibiotic classes in preventing SSIs, including subgroup analyses. Eight studies met the inclusion criteria, comprising 872 patients. Meta-analysis revealed that the incidence of SSI in the cephalosporin group was lower than in the non-cephalosporin group (14.8% vs 25.1%), with statistical significance (OR = 1.94, 95% CI: 1.38-2.74, PP = =0.0001). However, no significant difference in SSI risk was observed between the groups within 30days (OR = =1.92, 95% CI: 1.08-3.42). Subgroup analysis indicated that higher-quality studies were associated with larger effect sizes. This study suggests that cephalosporin antibiotics may be superior to non-cephalosporins in preventing SSIs following colorectal surgery, especially in the short term. However, their long-term efficacy in SSI prevention may be similar. The selection of perioperative antibiotics should consider factors such as the antimicrobial spectrum, pharmacokinetic properties, and bacterial resistance.

Association of Oral Microbiome Diversity and All-Cause Mortality in the General US Population and in Individuals With Chronic Diseases: A Prospective Cohort Study.

To investigate whether oral microbiome diversity is associated with all-cause mortality in the general US population and in individuals with chronic diseases. We included 8224 individuals with oral microbiome diversity data from the National Health and Nutrition Examination Survey (2009-2012), representing 164,000,205 US adults, using a survey-weighted analysis method. Cox regression analyses were performed to identify the association between oral microbiome diversity and all-cause mortality. During a survey-weighted mean follow-up period of 8.86 years, 429 all-cause deaths (survey-weighted number: 7,124,920) occurred in 8224 participants. Cox regression analysis revealed that higher oral microbiome diversity was significantly associated with a lower all-cause mortality risk. Significant differences in all-cause mortality risk were observed among the different clusters based on oral microbiome β-diversity (log-rank p < 0.001). Subgroup analyses revealed that the oral microbiome diversity was independently associated with all-cause mortality in individuals with diabetes mellitus and hypertension. A multivariate logistic regression model showed that current smoking and antibiotic use were significantly associated with lower oral microbiome α diversity. Higher oral microbiome diversity was significantly associated with a lower all-cause mortality risk in the general US population and in individuals with diabetes mellitus and hypertension.

Radiolucent lines and revision risk in total knee arthroplasty using the conventional versus the Attune S+ tibial baseplate.

This multicentre retrospective observational study's aims were to investigate whether there are differences in the occurrence of radiolucent lines (RLLs) following total knee arthroplasty (TKA) between the conventional Attune baseplate and its successor, the novel Attune S+, independent from other potentially influencing factors; and whether tibial baseplate design and presence of RLLs are associated with differing risk of revision. A total of 780 patients (39% male; median age 70.7 years (IQR 62.0 to 77.2)) underwent cemented TKA using the Attune Knee System) at five centres, and with the latest radiograph available for the evaluation of RLL at between six and 36 months from surgery. Univariate and multivariate logistic regression models were performed to assess associations between patient and implant-associated factors on the presence of tibial and femoral RLLs. Differences in revision risk depending on RLLs and tibial baseplate design were investigated with the log-rank test. The conventional and novel Attune baseplates were used in 349 (45%) and 431 (55%) patients, respectively. At a median follow-up of 14 months (IQR 11 to 25), RLLs were present in 29% (n = 228/777) and 15% (n = 116/776) of the tibial and femoral components, respectively, and were more common in the conventional compared to the novel baseplate. The novel baseplate was independently associated with a lower incidence of tibial and femoral RLLs (both regardless of age, sex, BMI, and time to radiograph). One- and three-year revision risk was 1% (95% CI 0.4% to 1.9%)and 6% (95% CI 2.6% to 13.2%), respectively. There was no difference between baseplate design and the presence of RLLs on the the risk of revision at short-term follow-up. The overall incidence of RLLs, as well as the incidence of tibial and femoral RLLs, was lower with the novel compared to the conventional tibial Attune baseplate design, but higher than in the predecessor design and other commonly used TKA systems.

Social risk assessment of the transition from internal combustion engine vehicles to electric vehicles: Material supply chains in China, Japan, and South Korea

In order to reduce carbon emissions, the production of internal combustion engine vehicles (ICEVs) is being transitioned to the production of electric vehicles (EVs). However, the social unsustainability of this process needs further testing. This study explored the social risk characteristics of the transition from ICEVs to EVs based on the Social Hotspots Database (SHDB), combining with the Social Life Cycle Assessment (SLCA) and the Marginal Analysis Method (MAM). Here, we revealed the differences in social risks in the material supply chains between China, Japan, and South Korea, which may create incentives for 100 % supply concentration in a hypothetical game. In terms of social risk, common substitution trends in the iron‑aluminum sector and synergy patterns in the copper-rubber sector were observed in the three countries. As a key factor influencing social risks, cost factor may change, and cost changes due to transition were mainly influenced by production adjustments and sourcing differences, reflecting differences in production capacity trends. This study makes it possible to consider ICEVs and EVs as two endpoints for transition activity in a SLCA exercise and provides valuable insights focusing on transition, aiding in material selection for future product design and underscoring the importance of proactive consideration of social sustainability indices.

Prevalence and relevance of H558R in the efficacy and toxicity of flecainide in patients with atrial fibrillation: a cohort study.

The SCN5A gene polymorphism histidine-558-to-arginine (H558R) has been associated with atrial fibrillation (AF) and may affect the therapeutic effects of flecainide. This study aimed to assess the prevalence of the H558R polymorphism in a European cohort of patients with AF and examine its association with flecainide's effects on AF recurrence and toxicity. This cohort study included patients diagnosed with AF and prescribed flecainide between 2017 and 2021 in a regional health area. Patients without the polymorphism (H558R-/-) were compared with heterozygous patients (H558R+/-) for a primary outcome of combined 6-month AF recurrence or toxicity. Secondary analyses evaluated the long-term outcomes and compared the prevalence of H558R in the AF cohort to a general population sample (n=3401). A total of 104 patients were enrolled, with 57% H558R-/-, 37% H558R+/- and 6% H558R+/+. The prevalence of the H558R polymorphism was significantly higher in the AF cohort than in the general population (43.27% vs 24.37%, prevalence ratio 1.78, 95% CI 1.41 to 2.23, p<0.01). H558R+/- patients had a significantly lower risk of 6-month AF recurrence or toxicity (p=0.023, risk ratio 0.423, 95% CI 0.189 to 0.947), corresponding to an absolute risk difference of 21.5%. These findings were similar in the multivariable analysis. In long-term follow-up, H558R+/- patients continued to demonstrate a lower risk of AF recurrence or toxicity (p=0.039, HR 0.53, 95% CI 0.276 to 0.999). The H558R polymorphism is more prevalent in patients with AF compared with the general population and its presence is associated with a more favourable response to flecainide treatment.

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.

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.