Data quality assessment of the Dutch Breast Implant Registry by automated data verification using medical billing data.

BACKGROUND: The Dutch Breast Implant Registry (DBIR) provides real-time population-based data to monitor and improve the quality and safety of breast implants and to trace patients in the event of an (inter)national recall. To serve these main goals, the capture rate and percentage of implants that are actually registered should be known and data should be complete. This study aimed to describe an automated verification process for capture rates and data completeness using medical billing data as the external source. METHODS: DBIR-data on reconstructive permanent breast implants and tissue expanders (TEs) from 2019 were compared to medical billing data. At the hospital level, the capture rate of DBIR and accuracy of the selected data points were assessed. RESULTS: In total, 2389 implants (1420 patients) were included from 12 participating hospitals (11% of all healthcare institutions registering in DBIR). DBIR had capture rates of 99% to 114% for inserted permanent implants and TEs and 49% for explanted permanent implants and TEs. Among the 9015 data points analyzed in DBIR, 8861 (98%) matched the medical billing data. Mastopexy had the highest matching percentage (100%) and capsulectomy the lowest (86%). CONCLUSION: This study showed varying capture rates in DBIR depending on the intervention group, indicating that registration of DBIR-data and medical billing codes could be further optimized. Data accuracy was high as only 2% of data points did not correspond to medical billing data. For future data verification, other external data sources could be explored, including sources that enable verification of cosmetic implants.

Linkage of the CF Foundation Patient Registry with the Scientific Registry of Transplant Recipients database.

BACKGROUND: The Cystic Fibrosis Foundation Patient Registry (CFFPR) maintains clinical data, including history of solid organ transplant, on people with cystic fibrosis (CF) who obtain care at CF Foundation-accredited care centers. The Scientific Registry of Transplant Recipients (SRTR) database is a collection of national data related to organ transplantation that supports research to evaluate solid organ transplant candidate and recipient outcomes. METHODS: Individuals in the CFFPR were matched to SRTR records using an algorithm that compared names, last four digits of social security numbers, date of birth and date of death. We evaluated match quality by summarizing the extent to which transplant status agreed between the two data sources by organ and year of listing or transplant. We summarized CFFPR-reported characteristics for lung and liver transplants in the year prior to transplant. RESULTS: A total of 7,594 individuals who participated in the CFFPR matched SRTR records with approximately 75% having at least one transplant record in SRTR. Over 97% of the matched population had a CF diagnosis reported to SRTR. In total, 5,253 people were identified as lung transplant recipients and 499 as liver transplant recipients in SRTR. Clinical characteristics for lung and liver transplants were consistent with the epidemiology of transplantation for people with CF. CONCLUSIONS: Linkage of the two data sources was successful, with high agreement between them supporting the use of the matched population as a valid resource to study transplantation in CF, particularly leveraging pre-transplant characteristics (collected in CFFPR) with detailed transplant data (collected in SRTR).

Reliability of Variables of Consonant Production and Velopharyngeal Competence in 10-year-olds with Cleft Palate Using Multiple Raters.

OBJECTIVE: To assess the reliability of speech data and speech-related quality indicators in the Swedish quality registry for cleft lip and palate (CLP) at 10 years of age. DESIGN: Retrospective study. SETTING: University hospitals. PARTICIPANTS: One hundred twenty-one 10-year-olds with unilateral or bilateral CLP. MAIN OUTCOME MEASURES: Six independent raters reassessed audio recordings for comparison with registry data. For calculation of agreement, the single measures intraclass correlation coefficient (ICC) was used for percentage of consonants correct (PCC) and non-oral speech errors, quadratic weighted kappa for velopharyngeal competence (VPC), and percentage agreement and kappa for quality indicators. The results of the three to four raters with the highest intra-rater and inter-rater reliability were used for comparison with registry data. RESULTS: There was excellent agreement between registry data and reassessments for PCC (ICC, 0.93) and percentage of non-oral errors (ICC, 0.80). For VPC, one rater and registry data had good agreement (k, 0.704); the remaining cases had fair agreement (k, 0.476-0.554). The percentage agreement between registry data and reassessments for quality indicators ranged from fair to excellent. When calculated with kappa, agreement was good to excellent (mean of all k values, 0.67-0.70). CONCLUSIONS: The CLP registry variables PCC and percentage of non-oral errors and the quality indicators without non-oral speech errors and competent/marginally incompetent velopharyngeal function are reliable for use in clinical audits and research of 10-year-olds. The three-tier ratings of VPC have weaker reliability but can still be useful in more detailed analyses if interpreted with caution.

Anxiety and depression in cancer patients and survivors in the context of restrictions in contact and oncological care during the COVID-19 pandemic.

Treatment modifications and contact restrictions were common during the COVID-19 pandemic and can be stressors for mental health. There is a lack of studies assessing pandemic-related risk factors for anxiety and depression of cancer patients and survivors systematically in multifactorial models. A total of 2391 participants, mean age 65.5 years, ≤5 years post-diagnosis of either lung, prostate, breast, colorectal cancer, or leukemia/lymphoma, were recruited in 2021 via the Baden-Württemberg Cancer Registry, Germany. Sociodemographic information, pandemic-related treatment modifications, contact restrictions, and anxiety/depression (Hospital Anxiety and Depression Scale, HADS) were assessed via self-administered questionnaire. Clinical information (diagnosis, stage, and treatment information) was obtained from the cancer registry. Overall, 22% of participants reported oncological care modifications due to COVID-19, mostly in follow-up care and rehabilitation. Modifications of active cancer treatment were reported by 5.8%. Among those, 50.5% had subclinical anxiety and 55.4% subclinical depression (vs. 37.4% and 45.4%, respectively, for unchanged active treatment). Age <60 years, female sex, lung cancer, low income, and contact restrictions to peer support groups or physicians were identified as independent risk factors for anxiety. Risk factors for depression were lung cancer (both sexes), leukemia/lymphoma (females), recurrence or palliative treatment, living alone, low income, and contact restrictions to relatives, physicians, or caregivers. The study demonstrates that changes in active cancer treatment and contact restrictions are associated with impaired mental well-being. The psychological consequences of treatment changes and the importance for cancer patients to maintain regular contact with their physicians should be considered in future responses to threats to public health.

The Children's National Hospital Outcomes Registry: a plea for a benchmarking tool that provides longitudinal outcomes for patients and families.

Surgical advancements in paediatric cardiovascular surgery have led to improved survival rates for those patients with the most complex CHDs leading to greater numbers of patients who are living well into adulthood. Despite this new era of long-term survival, our current reporting systems continue to focus largely on using short-term postoperative outcomes as the criteria to both rate and rank hospitals. Using such limited criteria to rate and rank hospitals may mislead the intended audiences: patients and families. The goal of this article is to describe the creation of a local benchmarking report which aims to retrospectively review long-term outcomes from our single centre. This report is updated annually and published on our cardiac surgery webpage in an effort to be as transparent as possible for our patient and family communities.

Psoriasis localization patterns in the Swiss Psoriasis Registry (SDNTT) over 11 years: an analysis by sex and age.

Real-world data on anatomically localized psoriasis and its response to systemic therapy across different age-groups and sexes is limited. This study aimed to evaluate the severity and distribution of psoriasis over time in female and male patients receiving systemic therapies, categorized by age within the Swiss psoriasis registry (SDNTT). Patient-data was obtained over 11 years through the SDNTT. The localized Psoriasis Area and Severity Index (locPASI) of the head, trunk, upper and lower extremities was analyzed over two years following the start of systemic non-/biologic treatment. A total of 316 female and 517 male patients were analyzed. Male patients had a higher baseline locPASI for legs, trunk and arms (p < 0.001), but not for the head (p = 0.961). The locPASI for the head in younger female patients (18-40 years) had a higher score than those aged 55 + (p = 0.022) and after two years, middle aged (41-54) showed a lower score compared to younger patients (p = 0.045). Younger male patients revealed a lower score after two years of therapy in the leg- and arm-area compared to older (p = 0.018 and p = 0.048, respectively). Female patients on non-biologics had a fast initial response, converging with male patients' scores over 24 months. Over 75% locPASI reduction was observed for female head-area (81.4%), male trunk (82.7%) and legs (76.1%). Absolute locPASI ≤ 2 was achieved 3-6 months for all locations with interleukin (IL)-17, IL-12/23 and IL-23-inhibitors, except for the legs of male patients on anti-IL-17 and female patients on anti-IL-12/23 and -IL-23. After two years, male patients did not achieve a locPASI ≤ 2 for any biologic-treatment in the legs, nor for the arms on anti-TNF-α. Significant disparities in localized PASI were observed between female and male patients. The age, sex and severity of distinct localizations should be considered to optimize treatment goals.

Relationship between initial B-type natriuretic peptide levels and detection of atrial fibrillation with an insertable cardiac monitor in cryptogenic stroke: CRYPTON-ICM registry.

High B-type natriuretic peptide (BNP) levels are associated with new atrial fibrillation (AF). This study investigated the distribution of AF detection rates according to BNP levels in patients with cryptogenic stroke (CS) using an insertable cardiac monitor (ICM). We enrolled consecutive patients with CS who underwent ICM implantation between October 2016 and September 2020 at eight stroke centers in Japan. Those with BNP levels were divided into three groups by tertiles. We evaluated the association of BNP levels with AF detection. Youden's index was calculated to identify the optimal cutoff for BNP. Of 417 patients, we analyzed 266 patients with BNP data. The tertile range of BNP level was 19.0 to 48.5 pg/mL. AF detection rate was 13.3%/year, 12.8%/year, and 53.7%/year in the low-BNP (≤19.0), mid-BNP (19.1-48.4), and high-BNP (≥48.5) groups, respectively (log-rank trend p < 0.01). Compared with low-BNP group, the adjusted hazard ratios for AF detection in mid-and high-BNP groups were 0.91 [95% confidence interval (CI) 0.46-1.78] and 2.17 (95% CI 1.14-4.13), respectively. Receiver operating characteristic curve analysis showed the optimal cutoff value was 43.4 pg/mL. The area under curve using BNP to predict AF detection was 0.69. The BNP level was associated with AF detection in patients with CS. This relationship changed around the BNP levels of 40-50 pg/mL.

Comprehensive review of Korean Medicine registries 2015-2023.

Background: Despite the increasing popularity of Korean Medicine (KM), its scientific evidence faces scrutiny. Instead of randomized controlled trials, registries are favored to capture the real world of KM practice due to the difficulties associated with proper control and the holistic nature of the KM approach. This review aimed to examine the KM registries in detail, identify the scope and focus of studies within this field, and assess the research trends. Methods: We conducted a comprehensive analysis of KM registries listed in trial registration platforms, covering records from their inception until the end of 2023. The selection criteria aimed to include studies focusing on various interventions related to KM, with data extraction focusing on study characteristics and outcomes measured. The analysis utilized descriptive statistics to summarize the findings. Results: We identified a steady increase in registry studies (2015, one; 2023, seven). Musculoskeletal disorders were most studied (28%), aligning with patients' demand. The involvement of 112 primary clinics and Quality of Life (QOL) as the predominant outcome in 14 (66.7%) registries demonstrates the positive impact on patient well-being and the critical role that primary clinics play in KM practice. Conclusion: Our findings indicate a heightened interest and commitment to evidence-based KM practices. Future Registries should be implemented on a large scale, incorporating long-term follow-up encompassing primary clinics. This approach would enable a comprehensive evaluation of the effectiveness and safety of KM interventions, as well as offer valuable insights into the influence of KM on chronic conditions and QOL.

Study Protocol and Mission for the Tohoku Registry of Acute Aortic Dissection (TRAD).

Background: Acute aortic dissection (AAD) is a life-threatening condition that imposes a significant socioeconomic burden on society. The Tohoku Registry of Acute Aortic Dissection (TRAD) is a collaboration of 13 tertiary referral hospitals in the Tohoku region of Japan designed to investigate all aspects of AAD treatment in this district, and to address significant clinical questions to help understand its dynamic pathology and develop optimal strategies for treating AAD. Methods and Results: Comprehensive cases developing type A and type B AAD, including those with prehospital cardiopulmonary arrest transported to TRAD centers, over 5 years from 2017 to 2022 are registered. The TRAD dataset encompasses prehospital information, diagnostic imaging findings, treatment modalities, and outcomes for each case. After discharge, patients will be followed up for 10 years for survival, aortic events and inspection data. Conclusions: We believe that this multicenter registry of AAD analyses will clarify the current short-term outcomes of recent surgical, endovascular, and medical treatments in the Tohoku region, and provide insights into the long-term outcomes of different treatment modalities to achieve extended life expectancy in reasonably good health.

Conservative management of brain arteriovenous malformations: results of the prospective observation registry of a pragmatic trial.

OBJECTIVE: Many patients recruited in the Treatment of Brain Arteriovenous Malformations Study (TOBAS) are managed conservatively. The aim of this study was to monitor what happened to those patients. METHODS: TOBAS comprises two randomized controlled trials and multiple prospective registries. All patients with brain arteriovenous malformations (AVMs) can participate. This report concerns patients selected for conservative management. The primary trial outcome measure is related death or dependency (modified Rankin Scale [mRS] score > 2) at 10 years. Secondary outcomes include intracranial hemorrhages, nonhemorrhagic neurological events, and serious adverse events (SAEs). For this report, outcome results are presented using patient-years, Kaplan-Meier survival curves, and Cox log-rank tests. There was no blinding. RESULTS: From June 2014 to May 2021, 1010 patients were recruited, of whom 498 (49%) were proposed the prospective observation registry. After exclusions, 434 (87%) patients remained for analysis. The majority of patients had unruptured AVMs (378/434 [87%]), of which 195 (52%) were low grade (Spetzler-Martin grade I or II). During a mean follow-up period of 3.2 years (total 1368 patient-years), the primary outcome occurred in 23 of 434 (5%) patients, corresponding to an incidence of 1.7 (95% CI 1.1-2.5) per 100 patient-years. For unruptured AVMs the incidence was 1.1 (95% CI 0.7-1.9) per 100 patient-years, and for low-grade unruptured AVMs it was 0.6 (95% CI 0.2-1.7) per 100 patient-years. Poor outcomes were more frequent in patients with a history of rupture (HR 5.6 [95% CI 2.4-13.0], p < 0.001), infratentorial AVMs (HR 2.9 [95% CI 1.1-7.3], p = 0.027), and age ≥ 55 years (HR 3.2 [95% CI 1.4-7.6], p = 0.007). Major intracranial hemorrhage occurred in 35 of 434 (8%) patients (incidence of 2.6 [95% CI 1.9-3.6] per 100 patient-years; 2.0 [95% CI 1.3-2.9] per 100 patient-years for unruptured AVMs and 1.3 [95% CI 0.6-2.6] per 100 patient-years for low-grade unruptured AVMs). Major AVM hemorrhages were more frequent in ruptured (HR 4.4 [95% CI 2.1-8.9], p < 0.001), large (HR 2.6 [95% CI 1.1-6.6], p = 0.039), and high-grade (HR 2.5 [95% CI 1.2-5.3], p = 0.013) AVMs and those with deep venous drainage (HR 2.1 [95% CI 1.1-4.2], p = 0.032). SAEs occurred in 48 of 434 (11%) patients (incidence of 3.6 [95% CI 2.7-4.8] per 100 patient-years). For unruptured AVMs the incidence was 2.8 (95% CI 2.0-4.0) per 100 patient-years, and for low-grade unruptured AVMs it was 1.8 (95% CI 1.0-3.2) per 100 patient-years. CONCLUSIONS: Nearly half of TOBAS participants were observed. Rates of untoward neurological events were within expected boundaries.

The contemporary management and coronary angioplasty outcomes in young patients with ST-Elevation myocardial infarction (STEMI) age < 40 years old: the insight from nationwide Thai PCI registry.

BACKGROUND: Cardiovascular disease (CVD) remains one of the major causes of death around the world in which ST elevation MI (STEMI) is in the lead. Although the mortality rate from STEMI seems to decline, this result might not be demonstrated in young adults who basically have different baseline characteristics and outcomes compared with older patients. METHODS: Data of the STEMI patients aged 18 years or older who underwent PCI during May 2018 to August 2019 from Thai PCI Registry, a prospective, multi-center, nationwide study, was included and aimed to investigate the predisposing factors and short-term outcomes of patients aged < 40 years compared with age 41-60, and > 61 years. RESULTS: Data of 5,479 STEMI patients were collected. The patients' mean age was 62.6 (SD = 12.6) years, and 73.6% were males. There were 204, 2,154, and 3,121 patients in the youngest, middle, and oldest groups. The young patients were mainly male gender (89.2% vs. 82.4% and 66.6%; p < 0.001), were current smokers (70.6%, 57.7%, 34.1%; p < 0.001), had BMI ≥ 25 kg/m2 more frequently (60.8%, 44.1%, 26.1%; p < 0.001), and had greater family history of premature CAD (6.9%, 7.2%, 2.9%; p < 0.001). The diseased vessel in the young STEMI patients was more often single vessel disease with the highest percentage of proximal LAD stenosis involvement. Interestingly, there were trends of higher events of procedural failure (2.9%, 2.1%, 3.3%; p = 0.028) and procedural complications (8.8%, 5.8%, 9.4%; p < 0.001) in both youngest and oldest groups compared to the middle-aged group. In-hospital death was found in 3.4% in the youngest group compared to 3.3% in the middle-aged patients and 9.2% in the older patients (p < 0.001). CONCLUSIONS: Despite experiencing higher rates of procedural failure and complications during treatment compared to middle-aged and older patients, young STEMI individuals demonstrate a significantly lower risk of death during hospitalization and within one year of the event. Younger patients might have a more robust physiological reserve or benefit from more aggressive post-procedure management. However, the higher prevalence of modifiable risk factors like smoking and obesity in younger individuals underscores the need for preventative measures. Encouraging smoking cessation and weight control in this demographic is crucial not only to prevent STEMI but also to potentially improve their long-term survival prospects.

Comparison of the epidemiology of elderly trauma between major trauma centres in Riyadh, Saudi Arabia and Melbourne, Australia.

OBJECTIVES: To review the epidemiology of elderly trauma at the Kind Saud Medical City (KSMC), Riyadh, Saudi Arabia, and carry out risk-adjusted analyses to benchmark outcomes with the Alfred Hospital, Melbourne, Australia, the largest Australasian trauma service. METHODS: This retrospective study included records of injured patients (≥65 years) from the hospital trauma registries during 2022. Demographic and injury data were extracted. Risk-adjusted endpoints were: inpatient mortality and length of stay, analysed using logistic and median regression. RESULTS: A total of 193 elderly patients were registered on the KSMC registry and 1233 elderly patients were registered on the Alfred Hospital registry. Kind Saud Medical City saw proportionally less major trauma (injury severity score of >12, 24.4% vs. 44.2%, p<0.001) and less females (31.1% vs 44.4%, p<0.001). The modal injury group was low level falls in both centres (≈60%). Discharge destination was different, particularly for patients discharged home (86.5% vs. 56%) or to a rehabilitation facility (0.5% vs. 28.2%). The risk-adjusted length of stay was 4.5 days less at the Alfred Hospital (95% CI: [3.25-5.77] days, p<0.001). The odds of in-hospital death were not significantly different (OR=0.72, 95% CI: [0.36-1.47], p=0.37). CONCLUSION: Despite the different settings, low level falls were the major cause of injury in older patients. A longer length of stay in the acute hospital was identified for KSMC, however, this may be partly explained by discharge destination practices in the 2 countries.

Implementation research on registering cancer cases in primary health centres of Puducherry through community health workers.

Background & objectives Hospital-based cancer registry does not represent the true burden of cancer in the community. Initiating a Primary Health Centre (PHC)-based cancer registry may better estimate population-level data for cancer cases in an area. This study aimed to set up a system for facilitating a PHC-based cancer registry and to assess the registration status of cancer cases in various PHCs of Puducherry. The facilitating and limiting factors while setting up this registry were also assessed. Methods A quasi-experimental study with an embedded mixed-method design was conducted in 31 PHCs/Community Health Centres (CHCs) from March 2021 to November 2022. The interventions were implemented in all PHCs/CHCs of Puducherry with the involvement of the State Non-Communicable Diseases (NCD) cell. The line list of cancer cases from the Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) Hospital-based cancer registry was shared with all PHCs/CHCs. Sensitization sessions for all Community Health Workers (CHWs) were conducted, and feedback on cancer registration status was given to the State NCD cell. Focus group discussion (FGD)/Key informant interview (KII) was undertaken to understand strengths, challenges, and suggestions. The logic model was used to understand the various indicators while setting up this PHC-based cancer registry. Results Over a one-year intervention period, 1270 cancer cases were registered at Puducherry's PHCs/CHCs, 1203 (88%) from the shared list and 67(5%) from other facilities. However, only 53 per cent of the expected living cases were captured in the various PHCs. Major limitations for registration were the COVID-19 pandemic, stigma, inadequate manpower, infrastructure issues, and privacy concerns during screening. Interpretation & conclusions It was feasible to set up a PHC-based cancer registry in all PHCs of Puducherry. However, registration of cancer cases was suboptimal, as population-based screening of cancer cases, as recommended in the National Programme for Prevention & Control of Non-Communicable Diseases (NP-NCD) programme, was weak due to the COVID-19 pandemic. Once this is strengthened, the PHC-based cancer registry will better represent the population.

Disparities in overall and site-specific cancer mortality among immigrant generations in Sweden: A nationwide follow-up study over three decades.

We examined the overall and site-specific cancer mortality disparities among first-generation - separately in adults (G1) and children (G1.5) at immigration - and second-generation (G2) immigrants and their countries of origin using population-based registries in Sweden, encompassing over 8.5 million individuals aged 20 and above residing in Sweden since 1990, with follow-up until December 31, 2023. Cox proportional hazard models were fitted, stratified by gender, to estimate hazard ratios and 95% confidence intervals compared to natives. Mortality rates for most cancers transitioned from lower in G1 towards the rate of natives in G2. However, elevated mortality rates were sustained across generations for liver cancer in males and stomach cancer in females. Among G2, mortality from lymphohematopoietic cancers in males, and lung and cervix uteri cancers in females were elevated - by 10%, 9%, and 17% respectively compared to natives. Country of origin analyses revealed substantial disparities. For instance, G2 females with Nordic parental origin had a 13% higher risk of death from lung cancer, while those with non-Western parental origin had a 54% lower risk as compared to natives. These findings suggest a generational and arrival-age dynamics of cancer mortality and highlight target groups for cancer prevention and control among immigrants.

Evaluating the Association Between Social Vulnerability and Outcomes of Heart Transplantation in the United States.

INTRODUCTION: The Social Vulnerability Index (SVI) is a tool that was developed by the Centers for Disease Control and Prevention to help identify communities that are at risk of harm from social, economic, or environmental factors. This study evaluates the association between SVI and outcomes of adult heart transplantation (HT) in the United States. METHODS: The United Network for Organ Sharing registry was used to identify all isolated adult (≥18 y) HT recipients and their home address zip codes between 2010 and 2021. Recipients were classified into three SVI risk groups: low risk (SVI: <0.33), intermediate risk (SVI: 0.33-0.65), and high risk (SVI: ≥0.66). Kaplan-Meier analysis was used to estimate recipient survival probability based on SVI risk. Multivariable Cox proportional hazard models were built to evaluate the association of SVI with 1- and 5-y mortality. RESULTS: A total of 22,400 recipients distributed over 9753 zip codes were included. Unadjusted 1-y survival rates in the three risk groups were as follows: low risk: 90.5%, intermediate risk: 91.1%, high risk 90.9%, and Log-rank P = 0.550 and 5-y survival rates were as follows: low risk: 80.8%, intermediate risk: 78.6%, high risk: 76.1%, and Log-rank P < 0.001. Compared to low-risk recipients, risk-adjusted 1-y mortality hazard ratio was 1.02 (0.92-1.14, P = 0.657) for intermediate risk and 1.09 (0.95-1.24, P = 0.222) for high-risk recipients. Risk-adjusted 5-y mortality hazard ratio was 1.07 (0.99-1.16, P = 0.095) for intermediate-risk recipients and 1.17 (1.06-1.28, P = 0.002) for high-risk recipients. CONCLUSIONS: Social vulnerability is associated with HT outcomes. The Centers for Disease Control and Prevention SVI may be a useful tool in identifying at-risk geographic areas where targeted efforts may be prudent for reducing disparities in HT outcomes.

Short bowel syndrome related intestinal failure outcomes in Latin America: Insights from the RESTORE Registry.

BACKGROUND: Short bowel syndrome is considered a low prevalence disease. The scant information available about intestinal failure in Latin America was the driving force to expand this registry. METHODS: A prospective, multicenter observational registry was created for patients with chronic intestinal failure short bowel at specialized centers in Latin America. Demographics, clinical characteristics, nutrition assessment, parenteral nutrition management, intestinal rehabilitation, related complications, clinical outcome, and survival were analyzed. RESULTS: From May 2020 to July 2023, 167 patients (115 adults, 52 children) from 20 centers were enrolled. For the adults, the mean age was 37.2 ± 18 years, 48% were female, and the mean follow-up was 22.6 ± 18.3 months. The main etiology was surgical resections (postsurgical complications: 37%; ischemia: 25%); the mean intestinal length was 73 ± 55 cm. The complications were as follows: infections: 0.4/1000 catheter-days; thrombosis: 0.24/1000 catheter-days; liver disease: 2.6%. The outcomes were as follows: 28% were rehabilitated, 15% died, 9.6% were lost to follow-up, 0.9% underwent transplant, and 45.6% continued follow-up. For the children, the mean age 48 ± 52 months, 48% were female, 52% were premature. The mean follow-up was 17.2 ± 5.6 months; the mean remaining intestinal length was 38 ± 45 cm. The leading etiologies were atresia (25%), NEC (23%), and gastroschisis (21%). The complication were as follows: infections: 2/1000 catheter-days; thrombosis: 2.22/1000 catheter-day; 25% developed liver disease. The outcomes were as follows: 7.7% died, 3.8% were rehabilitated, and 88.5% continued follow-up. CONCLUSION: The RESTORE amendment served as a registry and educational tool for the participating teams. The aspiration is to objectively show current aspects of intestinal failure in the region and carry them to international standards. Including all Latin American countries and etiologies of chronic intestinal failure besides short gut would serve to complete this registry.

Infrarenal Aortic Treatment With AFX2 Endograft: Results From a Multicentric, International, Non-Randomized, Prospective Registry-the AFX2-LIVE Study.

INTRODUCTION: To confirm real-world clinical practice results reported with anatomically fixed bifurcated endograft, a physician-initiated study was designed-AFX2-LIVE registry. MATERIALS AND METHODS: From November 2019 to August 2021, investigators enrolled all consecutive patients treated with AFX2 (Endologix Inc., Irvine, CA, USA) endograft. Patients with abdominal aortic aneurysms (AAAs), penetrating aortic ulcers (PAU), and isolated infrarenal aortic dissections were included. Clinical and anatomical data, including baseline, intraoperative, and in-hospital details, as well as follow-up data, were collected in an anonymized prospectively compiled database. The primary endpoint of this study was to evaluate the technical and clinical success of endovascular aortic repair (EVAR) using AFX2 endograft. RESULTS: A total of 535 patients were enrolled from 43 Italian and Spanish centers and analyzed according to the protocol. Four hundred eighty-nine patients were male (91.4%), with a mean age of 75±8.92 years (range 52-94). Four hundred sixty-six patients (87.1%) were treated for AAA, 49 (9.3%) for PAU, and 20 (3.6%) for isolated abdominal aortic dissection. A proximal extension was needed in 48% of the cases. Assisted technical success was achieved in all but one patient (99.8%). At 30 days follow-up, no AAA-related deaths were recorded, and nine patients (1.6%) required reintervention. At a mean follow-up period of 15.22±13.65 (range 1-53) months, data were available for 479 patients (89.5%). Clinical success was achieved in 98.2% (95% confidence interval [CI]: 96.4-99.1) at 3 months, 93.9% (95% CI: 90.1-96.1) at 1 year, and 74.1% (95% CI: 62.8-82.4) at 4 years follow-up. The estimated freedom from all-cause mortality was 97.7%, 93.4%, 81.6%, 77.5%, and 70.9%, and freedom from AAA-related mortality was 100%, 99.6%, 99.6%, 99.6%, and 97.3% at 3, 12, 24, 36, and 48 months, respectively. Twenty reinterventions (3.7%) were required in 19 patients, of which 3 late open conversions (0.6%) were performed, and 2 AAA-related deaths were observed. CONCLUSION: This study demonstrated excellent clinical and technical success rates of EVAR with anatomically fixed endografts, providing valuable insights into real-world clinical outcomes. CLINICAL IMPACT: The AFX2-LIVE study could have a significant impact by providing robust evidence supporting the effectiveness and safety of EVAR using bifurcated endografts with anatomical fixation in real-world clinical practice, ultimately leading to improved outcomes and enhanced patient care in the management of abdominal aortic pathologies.

Unveiling Sex Differences in Pediatric Burns Through the World Health Organization (WHO) Global Burn Registry.

INTRODUCTION: Pediatric burns present a significant global health challenge, particularly in low- and middle-income countries (LMICs). Despite this burden, few studies have explored global sex-based differences in pediatric burns. This study aims to describe pediatric burn incidence, burn care facilities' capacities, and burn outcomes with a focus on sex, comparing LMICs to HICs. METHODS: This study utilizes the World Health Organization's (WHO) Global Burn Registry (GBR) to analyze pediatric burn cases from 2018 to 2022, examining patient demographics, causes of burns, burn care facilities' capacities, and burn outcomes in relation to sex. Statistical analysis was done by chi-square and logistic regression. RESULTS: It was found that female patients were less likely than males to undergo surgical treatment during their hospital stay in low-income countries (adjusted odd ratios = 0.86, 95% CI: 0.45-1.26; p = 0.168) and middle-income countries (adjusted odd ratios = 0.72, 95% Cl: 0.52-0.95; p = 0.002). Additionally, females in both low- (adjusted odd ratios = 2.23, 95% Cl: 1.12-3.53; p = 0.045) and middle-income countries (adjusted odd ratios = 1.72, 95% Cl: 1.12-2.95; p < 0.001) exhibited higher odds of discharging with disability compared to males. CONCLUSION: Sex-based differences persist in pediatric burn epidemiology and treatment outcomes. Addressing these differences involves sex-sensitive strategies to mitigate the burden of pediatric burns, particularly in vulnerable populations in low- and middle-income countries. TYPE OF STUDY: Retrospective observational study. LEVEL OF EVIDENCE: Level III evidence.

Influence of nationality on the trajectories of pain, disability and health related quality of life in neck and back patients - The Norwegian Neck and Back Registry.

PURPOSE: The aim of the current study was to examine differences in trajectories of pain, disability, and health related quality of life (HRQOL) between non-Norwegian and Norwegian patients with neck and back pain over 12 months. METHODS: The study is based on data from the Norwegian Neck and Back Registry (NNRR). The data include demographics and patient-reported outcome measures such as pain rating, the Oswestry Disability Index and HRQOL. Data were collected at baseline, 6 and 12 months after consultation for neck and back pain in specialist health care. RESULTS: A total of 5012 patients were included. We found a significant main effect of nationality. Non-Norwegian patients showed higher levels of pain and disability and lower HRQOL than Norwegian patients. Both patient groups exhibited an improvement in all three outcomes at 6- and 12-month follow-ups. The improvement was similar for pain with the greatest improvement taking place during the first 6 months and then slightly flattening out. For disability and HRQOL, we observed a differential effect over time as a function of nationality. Both groups reported an improvement the first 6 months, however, while the Norwegian patients continued their improvement to 12 months, non-Norwegian patients had increasing disability and lower HRQOL at 12 months. CONCLUSION: Both patient groups improved over the 12-month period. Non-Norwegian patients showed an overall higher level of pain, disability and lower HRQOL compared to Norwegian patients, with a differential effect over time as a function of nationality for disability and HRQOL. Suggesting that future studies should focus on potential systemic barriers that may affect the recovery of neck and back patients based on nationality.

[What is being investigated and who conducts clinical research related to medicines in Argentina?] / ¿Qué se investiga y quién realiza en Argentina la investigación clínica relacionada a medicamentos?

INTRODUCTION: Clinical trials that involve medicines are performed in order to determine their effectiveness and safety. In Argentina, these studies are presented either to National Administration of Drugs, Food and Medical Technology (ANMAT) to obtain drug registration, or to the National Ministry of Health (MSAL) (to obtain the official recognition). This work was carried out to increase the knowledge about the clinical trials performed in Argentina. MATERIALS AND METHODS: The MSAL/ANMAT databases were explored. The variables were: dates of request, institution, phase of the study, enrollment modality, product investigated, therapeutic group, comparator, pathology involved, and location of laboratory performance. RESULTS: A total of 201 protocols were detected in the period of study, all of them performed with registration purposes. Twenty pharmaceutical companies carried out 60% of the studies (17 with foreign capital). Seventy percent were phase III (90% multicenter protocols). Three out of 4 trials corresponded to the oncology / immunosuppressant therapeutical group. In 65% the comparator used was placebo. A 71% of the studies were carried out in health institutions of Buenos Aires City. Ninety-eight per cent of laboratory controls were carried out abroad. DISCUSSION: Foreign pharmaceutical companies are the only ones that carry out clinical trials on medicines in Argentina, all of them for registration purposes. The use of placebo as a comparator is inappropriate, since each drug is expected to be validated against another of recognized efficacy already available in the market. Oncological/immunological pathologies are the ones that arouse greater interest among local researchers due to their prevalence and their greater profitability in the pharmaceutical market.

Introducción: Los ensayos clínicos que involucran medicamentos, tienen como objetivo determinar su eficacia y seguridad. En Argentina, estos estudios se presentan ante la agencia reguladora Administración Nacional Medicamentos, Alimentos y Tecnología Médica (ANMAT), para registrarlos; o bien ante el Ministerio de Salud de la Nación (MSAL). El objetivo de este trabajo fue conocer cuáles son los medicamentos de interés y quiénes son los que llevan adelante este tipo investigación clínica en Argentina. Materiales y métodos: Se exploraron las bases de datos MSAL/ANMAT. Las variables fueron fechas de solicitud del trámite, institución solicitante, fase del estudio, modalidad de enrolamiento, producto investigado, grupo terapéutico, comparador, enfermedad involucraday lugar de realización de laboratorio. Resultados: Se detectaron en el periodo 201 protocolos, todos ellos con fines registrales. Veinte compañías farmacéuticas realizaron el 60% de los estudios (17 de capitales extranjeros). El 70% fueron fase III (90% multicéntricos). Tres de cada 4 ensayos correspondieron al grupo de oncológicos/ inmunosupresores. En el 65% el comparador fue placebo. El 71% de los estudios se realizaron en instituciones de la Ciudad Autónoma de Buenos Aires. El 98 % de controles de laboratorio se realizaron en el exterior. Discusión: Las compañías farmacéuticas extranjeras son quienes realizan con fines registrales el mayor número de ensayos clínicos sobre medicamentos en Argentina. El predominio del uso de placebo como comparador resulta inapropiado, ya que el verdadero valor del estudio es cuando un fármaco innovador demuestra superioridad contra otro ya existente de reconocida eficacia. Las enfermedades oncológicas/inmunológicas fueron aquellas que despertaron mayor interés entre los investigadores y patrocinantes por prevalencia y rentabilidad.