Inpatient-level care at home delivered by virtual wards and hospital at home: a systematic review and meta-analysis of complex interventions and their components.

BACKGROUND: Technology-enabled inpatient-level care at home services, such as virtual wards and hospital at home, are being rapidly implemented. This is the first systematic review to link the components of these service delivery innovations to evidence of effectiveness to explore implications for practice and research. METHODS: For this review (registered here https://osf.io/je39y ), we searched Cochrane-recommended multiple databases up to 30 November 2022 and additional resources for randomised and non-randomised studies that compared technology-enabled inpatient-level care at home with hospital-based inpatient care. We classified interventions into care model groups using three key components: clinical activities, workforce, and technology. We synthesised evidence by these groups quantitatively or narratively for mortality, hospital readmissions, cost-effectiveness and length of stay. RESULTS: We include 69 studies: 38 randomised studies (6413 participants; largely judged as low or unclear risk of bias) and 31 non-randomised studies (31,950 participants; largely judged at serious or critical risk of bias). The 69 studies described 63 interventions which formed eight model groups. Most models, regardless of using low- or high-intensity technology, may have similar or reduced hospital readmission risk compared with hospital-based inpatient care (low-certainty evidence from randomised trials). For mortality, most models had uncertain or unavailable evidence. Two exceptions were low technology-enabled models that involve hospital- and community-based professionals, they may have similar mortality risk compared with hospital-based inpatient care (low- or moderate-certainty evidence from randomised trials). Cost-effectiveness evidence is unavailable for high technology-enabled models, but sparse evidence suggests the low technology-enabled multidisciplinary care delivered by hospital-based teams appears more cost-effective than hospital-based care for those with chronic obstructive pulmonary disease (COPD) exacerbations. CONCLUSIONS: Low-certainty evidence suggests that none of technology-enabled care at home models we explored put people at higher risk of readmission compared with hospital-based care. Where limited evidence on mortality is available, there appears to be no additional risk of mortality due to use of technology-enabled at home models. It is unclear whether inpatient-level care at home using higher levels of technology confers additional benefits. Further research should focus on clearly defined interventions in high-priority populations and include comparative cost-effectiveness evaluation. TRIAL REGISTRATION: https://osf.io/je39y .

Estimated health effects from domestic use of gaseous fuels for cooking and heating in high-income, middle-income, and low-income countries: a systematic review and meta-analyses.

BACKGROUND: Exposure to household air pollution from polluting domestic fuel (solid fuel and kerosene) represents a substantial global public health burden and there is an urgent need for rapid transition to clean domestic fuels. Gas for cooking and heating might possibly affect child asthma, wheezing, and respiratory health. The aim of this review was to synthesise the evidence on the health effects of gaseous fuels to inform policies for scalable clean household energy. METHODS: In this systematic review and meta-analysis, we summarised the health effects from cooking or heating with gas compared with polluting fuels (eg, wood or charcoal) and clean energy (eg, electricity and solar energy). We searched PubMed, Scopus, Web of Science, MEDLINE, Cochrane Library (CENTRAL), Environment Complete, GreenFile, Google Scholar, Wanfang DATA, and CNKI for articles published between Dec 16, 2020, and Feb 6, 2021. Studies eligible for inclusion had to compare gas for cooking or heating with polluting fuels (eg, wood or charcoal) or clean energy (eg, electricity or solar energy) and present data for health outcomes in general populations. Studies that reported health outcomes that were exacerbations of existing underlying conditions were excluded. Several of our reviewers were involved in screening studies, data extraction, and quality assessment (including risk of bias) of included studies; 20% of studies were independently screened, extracted and quality assessed by another reviewer. Disagreements were reconciled through discussion with the wider review team. Included studies were appraised for quality using the Liverpool Quality Assessment Tools. Key health outcomes were grouped for meta-analysis and analysed using Cochrane's RevMan software. Primary outcomes were health effects (eg, acute lower respiratory infections) and secondary outcomes were health symptoms (eg, respiratory symptoms such as wheeze, cough, or breathlessness). This study is registered with PROSPERO, CRD42021227092. FINDINGS: 116 studies were included in the meta-analysis (two [2%] randomised controlled trials, 13 [11%] case-control studies, 23 [20%] cohort studies, and 78 [67%] cross-sectional studies), contributing 215 effect estimates for five grouped health outcomes. Compared with polluting fuels, use of gas significantly lowered the risk of pneumonia (OR 0·54, 95% CI 0·38-0·77; p=0·00080), wheeze (OR 0·42, 0·30-0·59; p<0·0001), cough (OR 0·44, 0·32-0·62; p<0·0001), breathlessness (OR 0·40, 0·21-0·76; p=0·0052), chronic obstructive pulmonary disease (OR 0·37, 0·23-0·60; p<0·0001), bronchitis (OR 0·60, 0·43-0·82; p=0·0015), pulmonary function deficit (OR 0·27, 0·17-0·44; p<0·0001), severe respiratory illness or death (OR 0·27, 0·11-0·63; p=0·0024), preterm birth (OR 0·66, 0·45-0·97; p=0·033), and low birth weight (OR 0·70, 0·53-0·93; p=0·015). Non-statistically significant effects were observed for asthma in children (OR 1·04, 0·70-1·55; p=0·84), asthma in adults (OR 0·65, 0·43-1·00; p=0·052), and small for gestational age (OR 1·04, 0·89-1·21; p=0·62). Compared with electricity, use of gas significantly increased risk of pneumonia (OR 1·26, 1·03-1·53; p=0·025) and chronic obstructive pulmonary disease (OR 1·15, 1·06-1·25; p=0·0011), although smaller non-significant effects were observed for higher-quality studies. In addition, a small increased risk of asthma in children was not significant (OR 1·09, 0·99-1·19; p=0·071) and no significant associations were found for adult asthma, wheeze, cough, and breathlessness (p>0·05). A significant decreased risk of bronchitis was observed (OR 0·87, 0·81-0·93; p<0·0001). INTERPRETATION: Switching from polluting fuels to gaseous household fuels could lower health risk and associated morbidity and mortality in resource-poor countries where reliance on polluting fuels is greatest. Although gas fuel use was associated with a slightly higher risk for some health outcomes compared with electricity, gas is an important transitional option for health in countries where access to reliable electricity supply for cooking or heating is not feasible in the near term. FUNDING: WHO.

Clinical impact of gender and age at onset on disease trajectory in primary progressive multiple sclerosis patients.

BACKGROUND AND OBJECTIVES: Primary-progressive multiple sclerosis (PPMS) is characterized by gradual neurological deterioration without relapses. This study aimed to investigate the clinical impact of gender and age at disease onset on disease progression and disability accumulation in patients with this disease phenotype. METHODS: Secondary data from the RelevarEM registry, a longitudinal database in Argentina, were analyzed. The cohort comprised patients with PPMS who met inclusion criteria. Statistical analysis with multilevel Bayesian robust regression modeling was conducted to assess the associations between gender, age at onset, and Expanded Disability Status Scale (EDSS) score trajectories. RESULTS: We identified 125 patients with a confirmed diagnosis of PPMS encompassing a total of 464 observations. We found no significant differences in EDSS scores after 10 years of disease progression between genders (-0.08; credible interval (CI): -0.60, 0.42). A 20-year difference in age at onset did not show significant differences in EDSS score after 10 years of disease progression (0.281; CI: -0.251, 0.814). Finally, we also did not find any clinically relevant difference between gender EDSS score with a difference of 20 years in age at onset (-0.021; CI: -0.371, 0.319). CONCLUSION: Biological plausibility of gender and age effects does not correlate with clinical impact measured by EDSS score.

Conditional Cash Transfer to Improve TB Outcomes: Necessary but Not Sufficient Comment on "Does Direct Benefit Transfer Improve Outcomes Among People With Tuberculosis? - A Mixed-Methods Study on the Need for a Review of the Cash Transfer Policy in India".

Tuberculosis (TB) still represents a major public health problem in many regions of the world. TB control can only be achieved through a comprehensive and inclusive response which takes into account both upstream and downstream coordinated interventions related to structural determinants such as poverty, nutrition, sanitation, housing and access to healthcare as well as timely diagnosis and support throughout the course of treatment. Several social and financial support strategies have been proposed to improve TB treatment adherence, including conditional cash transfers (CCTs). In this context, demonstrating that social protection directly improves a specific health outcome using routinely collected data, incomplete registries or surveillance reports brings about many methodological challenges. We briefly discuss this paper and some limitations, describe main findings from our own research in this area and make a call to expand social protection interventions to address structural conditions of those most affected.

Prevalencia de infección tuberculosa latente e incidencia de viraje tuberculínico en contactos escolares mayores de 5 años en la Ciudad Autónoma de Buenos Aires / Prevalence of latent tuberculosis infection and incidence of tuberculin conversion among school contacts older than 5 years in the City of Buenos Aires

Introducción. La tuberculosis continúa siendo un problema frecuente en contextos de vulnerabilidad socioeconómica. El objetivo principal fue establecer la prevalencia de infección latente y viraje tuberculínico en contactos escolares de casos de tuberculosis. Población y métodos. En un área programática del sur de la ciudad, se evaluó la prevalencia de infección y viraje tuberculínico de 691 niñas, niños y adolescentes utilizando la prueba cutánea de tuberculina. Se investigó la asociación entre pérdida de seguimiento por parte del equipo de salud y características demográficas, escolares y asistencia inicial, y se describió el grado de adherencia cuando la quimioprofilaxis con isoniacida fue indicada. Resultados. Según las definiciones consideradas, la prevalencia de infección latente fue entre el 3,4 % (IC95 %: 2,3-5,2) y el 11,6 % (IC95 %: 9,3-14,4) de los 610 contactos con al menos una prueba cutánea aplicada. La incidencia de viraje tuberculínico se encontró entre el 0,3 % y el 6,8 % de los 294 evaluados. La edad mayor de 18 años, la mayor prevalencia de necesidades básicas insatisfechas en la comuna escolar, la pertenencia al turno escolar vespertino, la negatividad en la baciloscopia del caso índice y la ausencia de aplicación de la prueba cutánea inicial se asociaron con pérdida de seguimiento del contacto. Conclusiones. La incidencia de viraje tuberculínico en contactos escolares fue baja. La adherencia a isoniacida continúa siendo limitada. Se identificaron factores asociados con la pérdida de seguimiento de contactos que podrían orientar estrategias necesarias para mejorar este proceso.

Introduction. Tuberculosis continues to be a common problem in settings of socioeconomic vulnerability. Our primary objective was to establish the prevalence of latent infection and tuberculin conversion among school contacts of tuberculosis cases. Population and methods. In a programmatic area in the south of the City of Buenos Aires, the prevalence of latent infection and tuberculin conversion was assessed in 691 children and adolescents using the tuberculin skin test. The association between loss to follow-up by the health care team and the demographic, school, and baseline care characteristics was studied, and the level of adherence when isoniazid chemoprophylaxis was indicated was described. Results. According to established definitions, the prevalence of latent infection was between 3.4% (95% confidence interval [CI]: 2.3­5.2) and 11.6% (95% CI: 9.3­14.4) in the 610 contacts with at least one skin test. The incidence of tuberculin conversion was between 0.3% and 6.8% in the 294 assessed participants. Age older than 18 years, a higher prevalence of unmet basic needs in the school district, attending the afternoon school shift, negative sputum smear results in the index case, and absence of baseline skin test were associated with contact lost to follow-up. Conclusions. The incidence of tuberculin conversion among school contacts was low. Adherence to isoniazid treatment remains limited. Factors associated with loss of contact tracing were identified, which may guide strategies necessary to improve this process.

Effectiveness of a diabetes program based on digital health on capacity building and quality of care in type 2 diabetes: a pragmatic quasi-experimental study.

Health systems in Latin America face many challenges in controlling the increasing burden of diabetes. Digital health interventions are a promise for the provision of care, especially in developing countries where mobile technology has a high penetration. This study evaluated the effectiveness of the implementation of a Diabetes Program (DP) that included digital health interventions to improve the quality of care of persons with type 2 Diabetes (T2DM) in a vulnerable population attending the public primary care network. MATERIALS AND METHODS: A quasi-experimental pre-post uncontrolled study was conducted in 19 primary care centers and hospitals in the province of Corrientes, Argentina. We included persons with T2DM, age > = 18 years with access to a mobile phone. The multicomponent intervention included a mobile app with a diabetes registry, a clinical decision support tool for providers and a text messaging intervention for patients. RESULTS AND DISCUSSION: One thousand sixty-five participants were included, 72.8% had less than 12 years of formal education and 53.5% lacked health coverage. Comorbidities were hypertension (60.8%) and overweight/obesity (88.2%). During follow-up there was a significant increase in the proportion of participants who underwent laboratory check-ups (HbA1c 20.3%-64.4%; p < 0.01) and foot exams (62.1%-87.2%; p < 0.01). No changes were observed at 12 and 24 months in the proportion of participants with poor metabolic control. The proportion of participants with uncontrolled blood pressure (≥ 140/90 mmHg) decreased from 47.2% at baseline to 30.8% at 24 months in those with a follow-up visit. CONCLUSION: The DP was innovative by integrating digital health interventions in the public primary care level. The study showed improvements in quality indicators related with diabetes care processes and in blood pressure control.

Prevalence of latent tuberculosis infection and incidence of tuberculin conversion among school contacts older than 5 years in the City of Buenos Aires. / Prevalencia de infección tuberculosa latente e incidencia de viraje tuberculínico en contactos escolares mayores de 5 años en la Ciudad Autónoma de Buenos Aires.

Introduction. Tuberculosis continues to be a common problem in settings of socioeconomic vulnerability. Our primary objective was to establish the prevalence of latent infection and tuberculin conversion among school contacts of tuberculosis cases. Population and methods. In a programmatic area in the south of the City of Buenos Aires, the prevalence of latent infection and tuberculin conversion was assessed in 691 children and adolescents using the tuberculin skin test. The association between loss to follow-up by the health care team and the demographic, school, and baseline care characteristics was studied, and the level of adherence when isoniazid chemoprophylaxis was indicated was described. Results. According to established definitions, the prevalence of latent infection was between 3.4% (95% confidence interval [CI]: 2.3-5.2) and 11.6% (95% CI: 9.3-14.4) in the 610 contacts with at least one skin test. The incidence of tuberculin conversion was between 0.3% and 6.8% in the 294 assessed participants. Age older than 18 years, a higher prevalence of unmet basic needs in the school district, attending the afternoon school shift, negative sputum smear results in the index case, and absence of baseline skin test were associated with contact lost to follow-up. Conclusions. The incidence of tuberculin conversion among school contacts was low. Adherence to isoniazid treatment remains limited. Factors associated with loss of contact tracing were identified, which may guide strategies necessary to improve this process.

Introducción. La tuberculosis continúa siendo un problema frecuente en contextos de vulnerabilidad socioeconómica. El objetivo principal fue establecer la prevalencia de infección latente y viraje tuberculínico en contactos escolares de casos de tuberculosis. Población y métodos. En un área programática del sur de la ciudad, se evaluó la prevalencia de infección y viraje tuberculínico de 691 niñas, niños y adolescentes utilizando la prueba cutánea de tuberculina. Se investigó la asociación entre pérdida de seguimiento por parte del equipo de salud y características demográficas, escolares y asistencia inicial, y se describió el grado de adherencia cuando la quimioprofilaxis con isoniacida fue indicada. Resultados. Según las definiciones consideradas, la prevalencia de infección latente fue entre el 3,4 % (IC95 %: 2,3-5,2) y el 11,6 % (IC95 %: 9,3-14,4) de los 610 contactos con al menos una prueba cutánea aplicada. La incidencia de viraje tuberculínico se encontró entre el 0,3 % y el 6,8 % de los 294 evaluados. La edad mayor de 18 años, la mayor prevalencia de necesidades básicas insatisfechas en la comuna escolar, la pertenencia al turno escolar vespertino, la negatividad en la baciloscopia del caso índice y la ausencia de aplicación de la prueba cutánea inicial se asociaron con pérdida de seguimiento del contacto. Conclusiones. La incidencia de viraje tuberculínico en contactos escolares fue baja. La adherencia a isoniacida continúa siendo limitada. Se identificaron factores asociados con la pérdida de seguimiento de contactos que podrían orientar estrategias necesarias para mejorar este proceso.

AFP score and metroticket 2.0 perform similarly and could be used in a "within-ALL" clinical decision tool.

Background & Aims: Two recently developed composite models, the alpha-fetoprotein (AFP) score and Metroticket 2.0, could be used to select patients with hepatocellular carcinoma (HCC) who are candidates for liver transplantation (LT). The aim of this study was to compare the predictive performance of both models and to evaluate the net risk reclassification of post-LT recurrence between them using each model's original thresholds. Methods: This multicenter cohort study included 2,444 adult patients who underwent LT for HCC in 47 centers from Europe and Latin America. A competing risk regression analysis estimating sub-distribution hazard ratios (SHRs) and 95% CIs for recurrence was used (Fine and Gray method). Harrell's adapted c-statistics were estimated. The net reclassification index for recurrence was compared based on each model's original thresholds. Results: During a median follow-up of 3.8 years, there were 310 recurrences and 496 competing events (20.3%). Both models predicted recurrence, HCC survival and survival better than Milan criteria (p <0.0001). At last tumor reassessment before LT, c-statistics did not significantly differ between the two composite models, either as original or threshold versions, for recurrence (0.72 vs. 0.68; p = 0.06), HCC survival, and overall survival after LT. We observed predictive gaps and overlaps between the model's thresholds, and no significant gain on reclassification. Patients meeting both models ("within-ALL") at last tumor reassessment presented the lowest 5-year cumulative incidence of HCC recurrence (7.7%; 95% CI 5.1-11.5) and higher 5-year post-LT survival (70.0%; 95% CI 64.9-74.6). Conclusions: In this multicenter cohort, Metroticket 2.0 and the AFP score demonstrated a similar ability to predict HCC recurrence post-LT. The combination of these composite models might be a promising clinical approach. Impact and implications: Composite models were recently proposed for the selection of liver transplant (LT) candidates among individuals with hepatocellular carcinoma (HCC). We found that both the AFP score and Metroticket 2.0 predicted post-LT HCC recurrence and survival better than Milan criteria; the Metroticket 2.0 did not result in better reclassification for transplant selection compared to the AFP score, with predictive gaps and overlaps between the two models; patients who met low-risk thresholds for both models had the lowest 5-year recurrence rate. We propose prospectively testing the combination of both models, to further optimize the LT selection process for candidates with HCC.

Patient-centered mobile tuberculosis treatment support tools (TB-TSTs) to improve treatment adherence: A pilot randomized controlled trial exploring feasibility, acceptability and refinement needs.

Background: Digital adherence technologies hold promise to improve patient-centered tuberculosis (TB) monitoring, yet few studies have incorporated direct adherence monitoring or assessed patients' experiences with these technologies. We explored acceptability, feasibility, and refinement needs of the TB Treatment Support Tools (TB-TSTs) intervention linking a mobile app, a urine drug metabolite test, and interactive communication with a treatment supporter. Methods: This pilot study was a parallel-designed single-center randomized controlled trial with exit interviews. Newly diagnosed TB patients were randomized 1:1 using a treatment allocation button in the REDCap software preloaded with a random allocation sequence to usual care or usual care plus the TB-TSTs intervention from a respiratory medicine hospital in the province of Buenos Aires, Argentina and followed for 6-months. Due to the nature of the intervention, blinding to the group allocation could not be achieved for the recruiter or patients. The treatment outcome data extractor was blinded to the group allocation of the participants. Intervention participants used the app to report self-administering medication, potential side effects, submit photos of the urine test, and interact with a treatment supporter. Outcomes were feasibility, acceptability, and treatment outcomes. Findings: Forty-two patients were enrolled and evenly assigned to each group. Intervention participants submitted 147·2±58 (mean, SD) medication self-administration and 144·5±55 side effect reports out of 180 and 47.5±38·4 photos of the urine test out of 77. Treatment success for usual care was 81% [17/21] and 95% [20/21] for the TB-TSTs intervention. Thirty-three themes were identified within the main categories of motivation, what worked, issues experienced, and recommendations. Participants (n=12) rated it as 'easy to use' (4.57/5), 'would highly recommend to others' (4·43/5) and reported that access to the treatment support was a critical component. Recommendations included adding an alarm, appointment reminders, and off-line functionality. Interpretation: Findings suggest that the TB-TSTs intervention was feasible and acceptable and further refinement and testing is warranted. Funding: National Institute of Health K23NR017210.

[Hand-assisted Laparoscopic Surgery: experience with an original technique]. / Cirugía colorrectal laparoscópica mano asistida: experiencia con una técnica original.

Introduction: Hand-assisted laparoscopic colorectal surgery (HALS) is an alternative to straight laparoscopic approach (SL) that requires the use of a specific device to maintain the pneumoperitoneum. Our group has described an original double glove technique to replace it. Our purpose was to compare perioperative outcomes of patients undergoing HALS using this original technique vs SL. Methods: Retrospective review of a prospective database including patients who underwent elective laparoscopic colorectal resections between 2004 to 2020 at the Hospital Italiano, Argentina. Logistic regression analysis, propensity score matching, and inverse probability weighting were used to estimate adjusted treatment effects for perioperative outcomes. Results: HALS (n=458) and SL (n=1692) cases were demographically similar. HALS was associated with a shorter operative time (170.3 vs 206.9 minutes, p<0.001). Such difference was even more pronounced in obese (44.1 min), large patients (37.5 min), complex procedures (33.8 min) and surgeries carried out by non-trained surgeons (57,6 vs 31,6 minutes, p<0.001). Hand-assisted was associated with a lower conversion rate (5% vs 9.9%, p<0.001) with an adjusted odds ratio of 0.45 (95%CI 0.28-0.73). No difference in hospital stay, morbidity, and readmission rates was found. Conclusions: HALS with double-glove technique is comparable to SL in terms of postoperative outcomes keeping reduced operative time and conversion rates, especially in obese patients undergoing complex procedures.

Introducción: La cirugía colorrectal laparoscópica mano asistida (CLMA) es un abordaje alternativo a la laparoscopia directa (LD) que requiere de un dispositivo específico para mantener el neumoperitoneo. Nuestro grupo describió una técnica original de doble guante como alternativa a este dispositivo. El objetivo del presente trabajo fue analizar los resultados de esta técnica comparándola con la técnica de LD. Métodos: Se analizó una serie consecutiva de pacientes sometidos a cirugías colorrectales laparoscópicas entre 2004 y 2020 en el Hospital Italiano de Bs, As, Argentina. Se realizó un modelo de regresión múltiple de selección progresiva y apareamiento por puntaje de propensión para analizar los resultados perioperatorios. Resultados: Los casos de CLMA (n=458) y LD (n=1692) fueron demográficamente similares. CLMA se asoció a un menor tiempo operatorio (170,3 vs 206,9 minutos, p<0.001). Dicha reducción fue más marcada en obesos (44.1 min), pacientes grandes (37.5 min), cirugías complejas (33.8 min) y en procedimientos realizados por cirujanos no entrenados (57,6 vs 31,6 minutos, p<0.001). CLMA resultó tener menor índice de conversión (5% vs 9.9%, p<0.001) con una razón de probabilidades ajustada de 0,45. No se hallaron diferencias en cuanto a estadía hospitalaria, morbimortalidad y readmisión. Conclusión: CLMA con doble guante es comparable a la LD manteniendo un tiempo operatorio reducido y bajo índice de conversión, particularmente en pacientes obesos sometidos a procedimientos complejos.

R3-AFP score is a new composite tool to refine prediction of hepatocellular carcinoma recurrence after liver transplantation.

Background & Aims: Patients with hepatocellular carcinoma (HCC) are selected for liver transplantation (LT) based on pre-LT imaging ± alpha-foetoprotein (AFP) level, but discrepancies between pre-LT tumour assessment and explant are frequent. Our aim was to design an explant-based recurrence risk reassessment score to refine prediction of recurrence after LT and provide a framework to guide post-LT management. Methods: Adult patients who underwent transplantation between 2000 and 2018 for HCC in 47 centres were included. A prediction model for recurrence was developed using competing-risk regression analysis in a European training cohort (TC; n = 1,359) and tested in a Latin American validation cohort (VC; n=1,085). Results: In the TC, 76.4% of patients with HCC met the Milan criteria, and 89.9% had an AFP score of ≤2 points. The recurrence risk reassessment (R3)-AFP model was designed based on variables independently associated with recurrence in the TC (with associated weights): ≥4 nodules (sub-distribution of hazard ratio [SHR] = 1.88, 1 point), size of largest nodule (3-6 cm: SHR = 1.83, 1 point; >6 cm: SHR = 5.82, 5 points), presence of microvascular invasion (MVI; SHR = 2.69, 2 points), nuclear grade >II (SHR = 1.20, 1 point), and last pre-LT AFP value (101-1,000 ng/ml: SHR = 1.57, 1 point; >1,000 ng/ml: SHR = 2.83, 2 points). Wolber's c-index was 0.76 (95% CI 0.72-0.80), significantly superior to an R3 model without AFP (0.75; 95% CI 0.72-0.79; p = 0.01). Four 5-year recurrence risk categories were identified: very low (score = 0; 5.5%), low (1-2 points; 15.1%), high (3-6 points; 39.1%), and very high (>6 points; 73.9%). The R3-AFP score performed well in the VC (Wolber's c-index of 0.78; 95% CI 0.73-0.83). Conclusions: The R3 score including the last pre-LT AFP value (R3-AFP score) provides a user-friendly, standardised framework to design post-LT surveillance strategies, protocols, or adjuvant therapy trials for HCC not limited to the Milan criteria. Clinical Trials Registration: NCT03775863. Lay summary: Considering discrepancies between pre-LT tumour assessment and explant are frequent, reassessing the risk of recurrence after LT is critical to further refine the management of patients with HCC. In a large and international cohort of patients who underwent transplantation for HCC, we designed and validated the R3-AFP model based on variables independently associated with recurrence post-LT (number of nodules, size of largest nodule, presence of MVI, nuclear grade, and last pre-LT AFP value). The R3-AFP model including last available pre-LT AFP value outperformed the original R3 model only based on explant features. The final R3-AFP scoring system provides a robust framework to design post-LT surveillance strategies, protocols, or adjuvant therapy trials, irrespective of criteria used to select patients with HCC for LT.

Tasa de filtración glomerular conservada en personas mayores. Un estudio de base poblacional en el Cono Sur de América Latina

Introduction: Kidneys are affected by the aging process, usually suffering a progressive glomerular filtration rate (GFR) reduction of around 1 ml/year as of 30 years of age. Nevertheless, few older subjects show a stable GFR over time. This phenomenon has not been exhaustively studied, and even less in the Southern Cone. Aim: The aim was to estimate the prevalence of preserved GFR in a representative sample of older adults and explore the association between cardiovascular risk factors and preserved GFR in older individuals. Methods: We used data from a cross-sectional survey of a random sample of 1571 participants aged 65-74 years from 4 cities of the Southern Cone. We describe the prevalence of eGFR ≥80 ml/min/1.73 m2 and sociodemographic, biological, behavioral risk factors and medication use. Backward stepwise logistic regression analysis was used to study the effect of cardiovascular risk factors on eGFR ≥80 ml/min. Results: In this study, 962 had an eGFR >80 ml/min/1.73 m2 and 154 were healthy adults (Prevalence= 17.01% (95%CI 14.5%; 19.9%)). The median eGFR in the full sample was 85.53 ml/min/1.73 m² (IQR: 73.12-91.26). The prevalence of eGFR >80 ml/min/1.73 m2 was higher among men. Overall, older adults with no cardiovascular risk factors and eGFR >80 ml/min/1.73 m2 were predominantly men and showed a lower prevalence of dyslipidemia. Conclusion: The present study documented that 17% of healthy older individuals have preserved glomerular filtration rate (eGFR>80 ml/min/1.73 m2) despite their advanced age.

Introducción: Los riñones se ven afectados por el proceso de envejecimiento, sufriendo habitualmente una reducción progresiva de la tasa de filtración glomerular (TFG) de alrededor de 1 ml/año a partir de los 30 años de edad. Sin embargo, son pocos los sujetos de edad avanzada que muestran una TFG estable a lo largo del tiempo. Este fenómeno no ha sido estudiado exhaustivamente, y menos aún en el Cono Sur. Objetivo: El objetivo fue estimar la prevalencia de la TFG conservada en una muestra representativa de adultos mayores y explorar la asociación entre los factores de riesgo cardiovascular y la TFG conservada en individuos de edad avanzada. Métodos: Utilizamos datos de una encuesta transversal de una muestra aleatoria de 1571 participantes de 65-74 años de edad de 4 ciudades del Cono Sur. Describimos la prevalencia de FGe ≥80 ml/min/1,73 m2 y los factores de riesgo sociodemográficos, biológicos y conductuales y el uso de medicamentos. Se utilizó un análisis de regresión logística por pasos hacia atrás para estudiar el efecto de los factores de riesgo cardiovascular sobre la TFGe ≥80 ml/min. Resultados: En este estudio, 962 tenían una TFGe >80 ml/min/1,73 m2 y 154 eran adultos sanos (Prevalencia= 17,01% (IC 95% 14,5%; 19,9%)). La mediana de la TFGe en la muestra completa fue de 85,53 ml/min/1,73 m² (IQR: 73,12-91,26). La prevalencia de la TFGe >80 ml/min/1,73 m2 fue mayor entre los hombres. En general, los adultos mayores sin factores de riesgo cardiovascular y con una TFGe >80 ml/min/1,73 m2 eran predominantemente hombres y mostraban una menor prevalencia de dislipidemia. Conclusiones: El presente estudio documentó que el 17% de los individuos mayores sanos tienen una tasa de filtración glomerular preservada (TFGe>80 ml/min/1,73 m2) a pesar de su avanzada edad.

International study on the outcome of locoregional therapy for liver transplant in hepatocellular carcinoma beyond Milan criteria.

BACKGROUND & AIMS: Good outcomes after liver transplantation (LT) have been reported after successfully downstaging to Milan criteria in more advanced hepatocellular carcinoma (HCC). We aimed to compare post-LT outcomes in patients receiving locoregional therapies (LRT) before LT according to Milan criteria and University of California San Francisco downstaging (UCSF-DS) protocol and 'all-comers'. METHODS: This multicentre cohort study included patients who received any LRT before LT from Europe and Latin America (2000-2018). We excluded patients with alpha-foetoprotein (AFP) above 1,000 ng/ml. Competing risk regression analysis for HCC recurrence was conducted, estimating subdistribution hazard ratios (SHRs) and corresponding 95% CIs. RESULTS: From 2,441 LT patients, 70.1% received LRT before LT (n = 1,711). Of these, 80.6% were within Milan, 12.0% within UCSF-DS, and 7.4% all-comers. Successful downstaging was achieved in 45.2% (CI 34.8-55.8) and 38.2% (CI 25.4-52.3) of the UCSF-DS group and all-comers, respectively. The risk of recurrence was higher for all-comers (SHR 6.01 [p <0.0001]) and not significantly higher for the UCSF-DS group (SHR 1.60 [p = 0.32]), compared with patients remaining within Milan. The all-comers presented more frequent features of aggressive HCC and higher tumour burden at explant. Among the UCSF-DS group, an AFP value of ≤20 ng/ml at listing was associated with lower recurrence (SHR 2.01 [p = 0.006]) and better survival. However, recurrence was still significantly high irrespective of AFP ≤20 ng/ml in all-comers. CONCLUSIONS: Patients within the UCSF-DS protocol at listing have similar post-transplant outcomes compared with those within Milan when successfully downstaged. Meanwhile, all-comers have a higher recurrence and inferior survival irrespective of response to LRT. Additionally, in the UCSF-DS group, an ALP of ≤20 ng/ml might be a novel tool to optimise selection of candidates for LT. CLINICAL TRIAL NUMBER: This study was registered as part of an open public registry (NCT03775863). LAY SUMMARY: Patients with more extended HCC (within the UCSF-DS protocol) successfully downstaged to the conventional Milan criteria do not have a higher recurrence rate after LT compared with the group remaining in the Milan criteria from listing to transplantation. Moreover, in the UCSF-DS patient group, an ALP value equal to or below 20 ng/ml at listing might be a novel tool to further optimise selection of candidates for LT.

Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial.

BACKGROUND: Tuberculosis (TB) is an urgent global health threat and the world's deadliest infectious disease despite being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of the disease and development of drug-resistant disease. Mobile health interventions hold promise to provide the required adherence support to improve TB treatment outcomes. OBJECTIVE: This study aims to evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success and default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TSTs implementation. METHODS: The TB-TSTs study is an open-label, randomized controlled trial with 2 parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Participants will be recruited on a rolling basis from 4 clinical sites in Argentina. The intervention consists of a smartphone progressive web app, a treatment supporter (eg, TB nurse, physician, or social worker), and a direct adherence test strip engineered for home use. Intervention group participants will report treatment progress and interact with a treatment supporter using the app and metabolite urine test strip. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patients' and providers' perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share the results with stakeholders and policy makers. RESULTS: Enrollment began in November 2020, with a delayed start due to the COVID-19 pandemic, and complete enrollment is expected by approximately July 2022. Data collection and follow-up are expected to be completed 6 months after the last patient is enrolled. Results from the analyses based on the primary end points are expected to be submitted for publication within a year of data collection completion. CONCLUSIONS: To our knowledge, this randomized controlled trial will be the first study to evaluate a patient-centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on the effectiveness, implementation, and adoption of mobile health tools. The findings have broader implications not only for TB adherence but also more generally for chronic disease management and will improve our understanding of how to support patients facing challenging treatment regimens. TRIAL REGISTRATION: ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28094.

Comparison of different prognostic scores for patients with cirrhosis hospitalized with SARS-CoV-2 infection.

INTRODUCTION AND OBJECTIVES: Viral infections have been described to increase the risk of decompensation in patients with cirrhosis. We aimed to determine the effect of SARS-CoV-2 infection on outcome of hospitalized patients with cirrhosis and to compare the performance of different prognostic models for predicting mortality. PATIENTS: We performed a prospective cohort study including 2211 hospitalized patients with confirmed SARS-CoV-2 infection from April 15, 2020 through October 1, 2020 in 38 Hospitals from 11 Latin American countries. We registered clinical and laboratory parameters of patients with and without cirrhosis. All patients were followed until discharge or death. We evaluated the prognostic performance of different scoring systems to predict mortality in patients with cirrhosis using ROC curves. RESULTS: Overall, 4.6% (CI 3.7-5.6) subjects had cirrhosis (n = 96). Baseline Child-Turcotte-Pugh (CTP) class was assessed: CTP-A (23%), CTP-B (45%) and CTP-C (32%); median MELD-Na score was 19 (IQR 14-25). Mortality was 47% in patients with cirrhosis and 16% in patients without cirrhosis (P < .0001). Cirrhosis was independently associated with death [OR 3.1 (CI 1.9-4.8); P < .0001], adjusted by age, gender, and body mass index >30. The areas under the ROC curves for performance evaluation in predicting 28-days mortality for Chronic Liver Failure Consortium (CLIF-C), North American Consortium for the Study of End-Stage Liver Disease (NACSELD), CTP score and MELD-Na were 0.85, 0.75, 0.69, 0.67; respectively (P < .0001). CONCLUSIONS: SARS-CoV-2 infection is associated with elevated mortality in patients with cirrhosis. CLIF-C had better performance in predicting mortality than NACSELD, CTP and MELD-Na in patients with cirrhosis and SARS-CoV-2 infection. Clinicaltrials.gov:NCT04358380.

Validación de un instrumento para evaluar condicionantes de género y anticoncepción en adolescentes en Argentinas / Validation of an instrument to evaluate gender conditioners and contraception in Argentine adolescents

INTRODUCCIÓN: A pesar de las políticas y programas puestos en marcha, las estadísticas argentinas registran un alto número de nacimientos provenientes de embarazos en la población adolescente. Para explorar la relación entre los condicionantes de género, la conducta y la salud sexual adolescente, el presente estudio buscó validar un cuestionario de condicionantes de género y anticoncepción (Cogant) desarrollado en España. MÉTODOS: Se realizó un estudio observacional de corte transversal para evaluar la validez y las propiedades psicométricas del Cogant en adolescentes argentinas. RESULTADOS: Se incluyó a 657 mujeres menores de 20 años, que participaron de talleres educativos en el ámbito público de las provincias de Chaco, Corrientes y Buenos Aires. La consistencia interna global del instrumento mostró una alta confiabilidad (alfa de Cronbach 0,857). El análisis de factores sugirió la retención de 7 factores subyacentes, que explican un 61,6% de la varianza del cuestionario. DISCUSIÓN: La evaluación de las medidas psicométricas del Cogant en Argentina mostró resultados similares a los encontrados en las adolescentes españolas, aunque se retuvieron menor cantidad de factores que en el estudio original. El Cogant podría ayudar a identificar las características de los comportamientos vinculados a la sexualidad, al embarazo no planificado y a la maternidad, a fin de que el personal de salud priorice las estrategias de educación y de cuidados para las adolescentes argentinas.

Liver transplantation for hepatocellular carcinoma: impact of expansion criteria in a multicenter cohort study from a high waitlist mortality region.

This study aimed to compare liver transplantation (LT) outcomes and evaluate the potential rise in numbers of LT candidates with hepatocellular carcinoma (HCC) of different allocation policies in a high waitlist mortality region. Three policies were applied in two Latin American cohorts (1085 HCC transplanted patients and 917 listed patients for HCC): (i) Milan criteria with expansion according to UCSF downstaging (UCSF-DS), (ii) the AFP score, and (iii) restrictive policy or Double Eligibility Criteria (DEC; within Milan + AFP score ≤2). Increase in HCC patient numbers was evaluated in an Argentinian prospective validation set (INCUCAI; NCT03775863). Expansion criteria in policy A showed that UCSF-DS [28.4% (CI 12.8-56.2)] or "all-comers" [32.9% (CI 11.9-71.3)] had higher 5-year recurrence rates compared to Milan, with 10.9% increase in HCC patients for LT. The policy B showed lower recurrence rates for AFP scores ≤2 points, even expanding beyond Milan criteria, with a 3.3% increase. Patients within DEC had lower 5-year recurrence rates compared with those beyond DEC [13.3% (CI 10.1-17.3) vs 24.2% (CI 17.4-33.1; P = 0.0006], without significant HCC expansion. In conclusion, although the application of a stricter policy may optimize the selection process, this restrictive policy may lead to ethical concerns in organ allocation (NCT03775863).

Prospective Latin American cohort evaluating outcomes of patients with COVID-19 and abnormal liver tests on admission.

INTRODUCTION & OBJECTIVES: The independent effect of liver biochemistries as a prognostic factor in patients with COVID-19 has not been completely addressed. We aimed to evaluate the prognostic value of abnormal liver tests on admission of hospitalized patients with COVID-19. MATERIALS & METHODS: We performed a prospective cohort study including 1611 hospitalized patients with confirmed SARS-CoV-2 infection from April 15, 2020 through July 31, 2020 in 38 different Hospitals from 11 Latin American countries. We registered clinical and laboratory parameters, including liver function tests, on admission and during hospitalization. All patients were followed until discharge or death. We fit multivariable logistic regression models, further post-estimation effect through margins and inverse probability weighting. RESULTS: Overall, 57.8% of the patients were male with a mean age of 52.3 years, 8.5% had chronic liver disease and 3.4% had cirrhosis. Abnormal liver tests on admission were present on 45.2% (CI 42.7-47.7) of the cohort (n = 726). Overall, 15.1% (CI 13.4-16.9) of patients died (n = 244). Patients with abnormal liver tests on admission presented higher mortality 18.7% (CI 15.9-21.7), compared to those with normal liver biochemistries 12.2% (CI 10.1-14.6); P < .0001). After excluding patients with history of chronic liver disease, abnormal liver tests on admission were independently associated with death [OR 1.5 (CI 1.1-2.0); P = 0.01], and severe COVID-19 (2.6 [2.0-3.3], P < .0001), both adjusted by age, gender, diabetes, pneumonia and body mass index >30. CONCLUSIONS: The presence of abnormal liver tests on admission is independently associated with mortality and severe COVID-19 in hospitalized patients with COVID-19 infection and may be used as surrogate marker of inflammation. CLINICALTRIALS.GOV: NCT04358380.

Pilot study using the ECHO model to enhance linkage to care for patients with hepatitis C in the custodial setting.

Prisoners in most countries have a higher prevalence of HCV than the general population, but their access to treatment is very limited. Our aim was to evaluate a pilot programme using the ECHO model to enhance linkage to care in patients with HCV in 3 Argentinean prisons between October 2018 and January 2020. All inmates were invited to participate, and data were collected through a personal interview. We then estimated HCV prevalence with dried blood spot and performed a logistic regression analysis to identify risk behaviours associated with HCV infection. Finally, HCV management was assessed and monitored through ECHO. Overall, 1141 inmates agreed to participate, representing 39.7% of the total prison population. Anti-HCV prevalence was estimated at 1.58% (CI 0.93; 2.48), being significantly higher in women 2.98% (CI 1.4;5.6) than in men 1.07% (CI 0.5; 2.0); P = .03. Patients with anti-HCV were significantly older than those who tested negative, 42.3 years (CI 37.6;47.1) vs 30.1 years (CI 30.6;31.2), P < .001, respectively. Multiple logistic regression analysis, identified age OR 1.07 (CI 1.03;1.12, P = .001), history of sexually transmitted disease OR 3.08 (CI 0.97;9.82, P = .057) and intravenous drug use OR 12.6 (CI 3.31;48.53, P < .001) as risk factors associated with anti-HCV. Treatment was initiated in all the patients with specialist physician support utilizing ECHO model. In conclusion, our pilot study reported a low prevalence of anti-HCV in the studied population. Incarceration provides an ideal opportunity for testing and treating HCV. ECHO model arises as a useful tool to support assessment and treatment for inmates with chronic HCV.