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BACKGROUND: Heart failure (HF) can coexist with atrial fibrillation in up to 60 % of cases, increasing rates of hospitalizations and death. This study analyzed the clinical characteristics, treatment, hospitalization, and mortality of patients with HF and atrial fibrillation based on left ventricular ejection fraction (LVEF). METHODS: A retrospective cohort study included patients from an outpatient HF clinic at Medellín (Colombia) between 2020-2022. Patients were classified into two groups according to LVEF: reduced (LVEF≤40 %) and mildly reduced or preserved ejection fraction (LVEF>40 %). The evaluated outcomes were hospitalization and mortality during follow-up. Values for B-type natriuretic peptide (BNP), LVEF and functional class according to the New York Heart Association (NYHA) were also analyzed at admission and during the last follow-up visit. RESULTS: The study included 185 patients, with 51.9% being male. The median age of the participants was 80 years (interquartile range [IQR] 74 - 86). There was an overall improvement in the NYHA functional class, BNP levels, and LVEF compared with the baseline values, irrespective of left systolic function. Atrial fibrillation ablation was performed in 3.2 % of patients, and cardiac device implantation with atrioventricular node ablation in 29 %. No statistically significant differences were found in terms of hospitalization and mortality regarding left systolic function. CONCLUSION: Compressive optimal treatment for patients with HF and atrial fibrillation requires pharmacological treatment, ablation strategies, cardiac devices, cardiovascular rehabilitation and close follow-up. In this cohort, hospitalization and mortality rates were similar according to LVEF categories and there was improvement in NYHA functional class and BNP level.
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OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is a common condition associated with age, multimorbidity and frequently involves the use of health care across levels. Understanding the factors associated with the initiation of long-term care is important when planning the future need for services. We describe healthcare use before and after the reception of any home care. We further studied the associations between healthcare use and first registered home care service and from first registered home care service to nursing home admission or death. DESIGN AND SUBJECTS: Patients residing in Oslo or Trondheim at the time of first contact with a COPD primary diagnosis, 2009-2018. Patient data were linked across national and municipal registries, covering healthcare and sociodemographics. The sample consisted of 16,738 individuals. RESULTS: There was a marked increase in inpatient and outpatient hospital contacts in the years prior to and after the reception of any home care. Adjusted for comorbidities and sociodemographics, high numbers of GP consultations, and inpatient and outpatient hospital contacts for respiratory diagnoses were associated with a significantly higher likelihood of receiving home care the next year (hazard odds ratios > 1.3). Following the reception of home care, the type of home care service received (e.g. home nursing or short-term rehabilitation/treatment) was more important than outpatient services in predicting next-year nursing home admission or death. CONCLUSION: Including data on prior outpatient care when predicting future need for home care is beneficial. A high frequency (top 10%) of yearly GP, in- or outpatient hospital contacts can imply that the patient may be in need of home care in the near future.
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BACKGROUND: Therapies are needed to address worsening congestion, without hospitalization, in patients with chronic heart failure (HF). OBJECTIVES: This pilot study assessed outcomes of a novel subcutaneous (SC) furosemide formulation compared to usual care in outpatients with worsening congestion. METHODS: Participants with chronic HF and worsening congestion were randomized open-label 2:1 to SC furosemide compared to usual care (UC). Decongestion was estimated by tracking body weight. The primary endpoint was a win ratio of a 30-day hierarchical composite of cardiovascular death, HF events, and change in N-terminal pro-B-type natriuretic peptide. Secondary endpoints included dyspnea severity, functional capacity, and quality of life. RESULTS: Thirty-four participants were randomized to SC furosemide and 17 to UC. SC furosemide caused greater reduction in body weight: between-group difference in least square mean change was -2.02 kg at day 3 (95% CI: -3.9 to -0.14; P = 0.035). SC furosemide-to-UC win ratio was 1.11 (95% CI: 0.48-2.50; P = 0.806). Significant between-group least square mean differences favoring SC furosemide occurred in 7-point dyspnea score (P = 0.017) and 6-minute walk test (P = 0.032), with trend in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 Overall Summary Score of 9.15 (95% CI: 1.95-20.3; P = 0.106). The most common related adverse event with SC furosemide was mild infusion site pain (11.8%). CONCLUSIONS: SC furosemide augmented weight loss in patients with HF and worsening congestion. The composite primary endpoint was not statistically significant in this pilot investigation. However, findings of improved dyspnea scores and functional capacity, with favorable trend in KCCQ-12 score, warrant additional investigation to further document the clinical value of SC furosemide as an alternative to hospitalization (AT HOME-HF [Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure-A Pilot Study]; NCT04593823).
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Outpatient surgery in the treatment of hernia is currently a major challenge for patients and treating physicians in Germany due to the new legal regulations (key term hybrid diagnosis-related groups, DRG). Despite large economic challenges and empty funds, the principle of medical treatment is still the patient-oriented scientifically founded medicine. Although outpatient treatment would be very desirable, clear medical knowledge should the basis for the justification of surgical strategies: outpatient short hospitalization (24h) or fully inpatient hospitalization (>24h). A completely outpatient treatment of hernias is not meaningful and the demarcation of outpatient, short inpatient and inpatient treatment should be demonstrated in a risk-adjusted manner. A classification is essential, particularly against the background of an intersectoral hybrid DRG.
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Percutaneous ultrasound-assisted carpal tunnel (CT) release is an emerging minimally invasive technique in hand surgery that could reduce complications, enhance patient satisfaction, and facilitate earlier return to daily activities. Among the various devices employed for this procedure, the Sono-Instrument allows pin-hole surgery. Its safety and effectiveness have been established. This study presents the technical nuances, pearls and pitfalls, advantages, and challenges of using the Sono-Instrument for percutaneous ultrasound-assisted CT release.
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Purpose: This study aimed to determine the combination of factors associated with continuity of care in outpatients with cancer-related edema six months after the initial visit. Patients and Methods: A total of 101 outpatients were divided into two groups: continuation (n=65) and non-continuation (n=36) groups. Details regarding age, body mass index, sex, affected extremities (upper or lower), site of edema (unilateral or bilateral), International Society of Lymphology (ISL) classification, presence of distant metastasis, and overall score on the lymphedema quality of life questionnaire (LYMQOL) were obtained before initial lymphedema care. In this study, we performed a decision tree analysis using a classification and regression tree (CART) to detect the combination of factors associated with the continuity of edema care for cancer-related edema. Results: Significant differences were observed in the site of edema (unilateral or bilateral) and distant metastasis between the two groups. In the decision tree using CART analysis, the factors selected to influence the possibility of continuation were the side of edema as the first layer, and body mass index of 23.0 and distant metastasis (with/without) as the second layer. Outpatients with unilateral edema and a body mass index higher than 23.0 were most likely to be able to continue care. In contrast, outpatients with bilateral edema and distant metastasis had greater difficulty in continuing care. Conclusion: In this study, factors that were suggested to influence the continuity of cancer-related edema care were the side with edema, body mass index higher than 23.0, and distant metastasis. This information may be helpful for developing care strategies and improving patient adherence.
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Objective: This study aimed to explore the relationship between climatic parameters and the daily cases of Bell's palsy (BP) among hospital outpatients, providing ecological evidence for understanding BP etiology and prevention. Methods: Retrospective analysis was conducted on data from 2187 BP patients who attended Kunshan First People's Hospital Outpatient Clinic from January 1, 2020, to December 31, 2022. Meteorological data, including temperature, relative humidity, precipitation, wind speed, sunshine duration, and atmospheric pressure, were collected and combined with daily BP case records. Additionally, air quality index was used as a covariate. Results: The number of new BP cases among outpatients showed a negative correlation with average daily temperature. A nonlinear relationship between daily average temperature and BP cases was observed through the generalized additive model (GAM). A significant negative correlation was identified between daily average temperature and BP cases, with inflection points at temperatures above 4.2°C, suggesting a potential decrease in BP risk with temperature rise beyond this threshold. Conclusion: This study provides ecological evidence of a link between climatic factors and BP occurrence. Temperature demonstrated a significant nonlinear negative correlation with daily BP incidence, highlighting temperature and cold exposure as key targets for BP prevention in Kunshan.
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During the COVID-19 pandemic period, many patients who required outpatient chemotherapy developed COVID-19, requiring chemotherapy interruption. However, there are no clear guidelines regarding the safe timing for restarting chemotherapy. We conducted a retrospective study to assess when such patients can safely recommence chemotherapy. Of the 40 patients included in this study, 34 restarted anticancer drug therapy after COVID-19 infection. Six patients, four with multiple myeloma, and one each with follicular lymphoma and glioma, remained SARS-CoV-2 antigen positive >20 days after COVID-19 onset. Multiple myeloma patients recorded significantly higher frequencies of SARS-CoV-2 antigen positivity >20 days after COVID-19 onset compared with solid tumor patients, with no significant differences in the frequency of SARS-CoV-2 positivity during 5-20 days from COVID-19 onset between them. According to our data, most solid tumor patients achieved SARS-CoV-2 antigen negativity after 20 days from COVID-19 onset. On the other hand, multiple myeloma patients might need serial antigen tests before restarting anticancer therapy in the outpatient chemotherapy setting.
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In order for patients to gain the benefit of innovation in cardiac CT, it is necessary for coding, coverage, and payment to adapt to the novelty of algorithm-based healthcare procedures and services (ABHS). Appendix S to the CPT Code Set, the "AI Taxonomy", enables creation of discrete and differentiable codes for reimbursement of ABHS which has been clinically validated and FDA-labeled. Payment policy in OPPS and PFS is evolving to take account of the unique opportunities and issues arising from the clinical adoption of ABHS.
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BACKGROUND: Individuals with psychotic disorders face an increased risk of physical health issues, leading to reduced life expectancy. Despite recommendations to integrate physical health promotion into mental healthcare, challenges persist, and mortality from somatic diseases continues to rise. Understanding healthcare providers' perspectives is crucial to overcoming these barriers. This study aims to explore the experiences of healthcare providers working in direct patient care and as unit heads regarding factors influencing health promotion in Swedish psychosis outpatient units. METHODS: A qualitative descriptive study was conducted in two specialized psychosis outpatient units. Thirteen healthcare providers, including clinical case managers and three heads of units, were individually interviewed. Thematic analysis was used to analyze the data. RESULTS: Three main themes were generated: (1) Health care providers' attitudes and competence. The health care provider's values and beliefs influenced the engagement in health promotion. (2) Patient-related aspects. Understanding how different patient life components shaped the physical health and need for measurements (3) Organizational prerequisites. Prioritizing resources and leadership impact the experience of health promotion. Clinical case management appeared as a promising approach to coordinate/integrate physical and mental health care, evident in themes 1 and 3. CONCLUSIONS: Beyond organizational factors, healthcare providers' skills, patient understanding, and ethical reflection influence their motivation to engage in physical health promotion. The study included only 13 participants, representing various professions, including managers who provided specific leadership perspectives. Clinical case managers appear well-suited to address physical health promotion due to their proficiency in shared decision-making and coordination.
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BACKGROUND: Due to the short duration of inpatient stays and increasing outpatient treatment it is assumed that the incidence of delirium in ophthalmology is underestimated. The overall aim of this study was to record the incidence of delirium in ophthalmology through long-term follow-up. METHOD: The study was divided into 2 groups. In group A delirium events were recorded retrospectively based on the discharge reports of all inpatients at the University Clinic Freiburg, Clinic for Ophthalmology from 1 January 2020 to 31 December 2022. In group B delirium events were recorded prospectively by the Augennetz Südbaden (Eye Network South Baden, ANSB) in the period 60-120 days after ophthalmological surgery. RESULTS: During the study period of the retrospective analysis a total of 16,384 patients were treated as inpatients. There was evidence of a total of 7 new delirium events. This corresponds to a proportion of 0.04%. A total of 12,381 patients were assessed by the ANSB, including 11,530 outpatient cataract operations. There were indications of 31 delirium events, which corresponds to a proportion of 0.25%. CONCLUSION: The long-term prospectively recorded delirium events suggest that the incidence of delirium in the inpatient setting is underdiagnosed; however, postoperative delirium appears to be rare in ophthalmology in relation to the high number of procedures.
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Background: It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Methods: Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Findings: Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53-0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Interpretation: Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. Funding: National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.
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BackgroundIn Europe and other high-income countries, antibiotics are mainly prescribed in the outpatient setting, which consists of primary, specialist and hospital-affiliated outpatient care. Established surveillance platforms report antimicrobial consumption (AMC) on aggregated levels and the contribution of the different prescriber groups is unknown.AimTo determine the contribution of different prescribers to the overall outpatient AMC in Switzerland.MethodsWe conducted a retrospective observational study using claims data from one large Swiss health insurance company, covering the period from 2015 to 2022. We analysed antibiotic prescriptions (ATC code J01) prescribed in the Swiss outpatient setting. Results were reported as defined daily doses per 1,000 inhabitants per day (DID) and weighted according to the total population of Switzerland based on census data.ResultsWe analysed 3,663,590 antibiotic prescriptions from 49 prescriber groups. Overall, AMC ranged from 9.12 DID (2015) to 7.99 DID (2022). General internal medicine (40.1% of all prescribed DID in 2022), hospital-affiliated outpatient care (20.6%), group practices (17.3%), paediatrics (5.4%) and gynaecology (3.7%) were the largest prescriber groups. Primary care accounted for two-thirds of the prescribed DID. Quantity and type of antibiotics prescribed varied between the prescriber groups. Broad-spectrum penicillins, tetracyclines and macrolides were the most prescribed antibiotic classes.ConclusionPrimary care contributed considerably less to AMC than anticipated, and hospital-affiliated outpatient care emerged as an important prescriber. Surveillance at the prescriber level enables the identification of prescribing patterns within all prescriber groups, offering unprecedented visibility and allowing a more targeted antibiotic stewardship according to prescriber groups.
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Antibacterianos , Programas de Optimización del Uso de los Antimicrobianos , Pacientes Ambulatorios , Pautas de la Práctica en Medicina , Humanos , Suiza , Estudios Retrospectivos , Antibacterianos/uso terapéutico , Pacientes Ambulatorios/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Prescripciones de Medicamentos/estadística & datos numéricos , Atención Ambulatoria/estadística & datos numéricos , Femenino , Masculino , Utilización de Medicamentos/estadística & datos numéricosRESUMEN
Background: Cancer remains a leading chronic disease in the United States with a high burden of disease and challenging treatment protocol. Nutrition is critically linked to long-term health outcomes and recovery rates among cancer patients, but there remains a persistent gap in clinician training regarding functional nutrition. This study interviews patients to understand their experiences of nutrition support they received while in cancer treatment. Objectives: Understand patient experiences and needs regarding cancer treatment (i.e., surgery, chemotherapy, radiation, and/or immunotherapy) and available nutrition counseling. Methods: This was a multi-phase study incorporating survey data (n = 50) and follow-up, semi-structured interviews (n = 20) of cancer patients in the Mid-Atlantic United States. Interview participants included those undergoing active cancer treatment (n = 7) and those in remission at the time of contact (n = 13). Participants shared their experiences receiving treatment and their perspectives regarding the quality of care they received in outpatient oncology clinics. Central to this study was a discussion regarding the quality of nutrition counseling they received while in treatment. Results: Five themes emerged through data collection and analysis: (1) patients need additional education regarding nutrition, (2) personalized resources are not readily available, (3) perceptions from patients that oncologists receive little formal nutrition training related to cancer, (4) oncologists' attitude toward nutrition may influence patient care, and (5) patients seek nutrition information through informal sources. Commonly, patients had little access to licensed dieticians or other professionals capable of providing lifestyle recommendations. Conclusions: The results of this study are being used to develop a clinician toolbox of resources, recommendations, and services that can be shared with patients seeking additional information regarding nutrition and diet change.
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Ubrogepant is the first medication that blocks calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, from binding to its receptors. Ubrogepant has shown positive safety, efficacy, and tolerability results for the treatment of acute migraine in phase 3 randomized trials. At this time, there are very few case reports on ubrogepant. Herein, we describe a complex patient with treatment-resistant migraine who showed substantial improvement in migraine severity, duration, and overall disability after using ubrogepant. A 46-year-old woman with a 25-year history of migraine presented with an improvement in headache severity, duration, and disability after using a new FDA-approved medication, ubrogepant, for less than five months. Before commencing ubrogepant,her headache duration hours ranged from 36 to 60 hours, headache severity was rated 7.5/10, and mean headache days ranged from 10 to 12 days. After taking ubrogepant, her headache duration was less than 12 hours, headache severity was 3/10, and mean headache days was five. Previously, she had been prescribed a combination of first-line medications with little improvement in headache severity. Her Migraine Disability Assessment (MIDAS) score showed moderate disability resulting in missed work and lower quality of life. To date, there have been no case reports showing the efficacy of the new FDA-approved medication, ubrogepant, showing a greater than 50% decrease in headache duration.
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BACKGROUND: With advancements in perioperative care, joint replacement (JR) surgery is undergoing a transition from opacified in-patient institutions to nimble out-patient Ambulatory Surgical Centers (ASC). The goal of JR in ASC setting is safe patient discharge with subsequent rehabilitation without readmission. Multi-modal preoperative rehabilitation (MMPR) is a novel field of perioperative care, encompassing comprehensive parameters to ensure smooth transition from fitness for surgery to JR in outpatient setting. At present, there are no open-access schemes for selecting patients qualified for JR in the ASC setting. In this article, we propose an evidence-based, 10-point systematic evaluation of patients with target endpoints for MMPR to qualify patients for JR as an outpatient procedure. This checklist is a non-proprietary scheme serving as an initial framework for surgeons exploring surgery in the ASC setting. BODY: We introduce factors for a prehabilitation scheme, called Checklist Outpatient-Joint Replacement (CO-JR) to qualify patients for outpatient JR surgery. These factors have been developed based on an extensive literature review and the significant experience of authors to incorporate variables that drive a successful outpatient JR procedure. The factors include patient education, psychiatric & cognitive ability, medical fitness, musculoskeletal capability, financial ability, transportation access, patient motivation, information technology (IT) capabilities, along with ability to recover independently at home postoperatively. The CO-JR scheme is under the process of validation at multiple institutions. We introduce this as a starting point for collaborative development of an open-access scheme for all surgeons to learn and adapt as needed for their respective global region. CONCLUSION: We established a non-proprietary 10-point CO-JR scheme, serving as a framework for surgeons to successfully select patients for JR surgery in the ASC setting. We encourage concomitant validation of this scheme globally. Our goal is to reach an international consensus on an open-access scheme, available for all surgeons to enrol patients for JR in the ASC setting, but modifiable to accommodate regional needs.
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Background: While several studies have noted a higher SII correlates with multiple diseases, research on the association between SII and atopic dermatitis remains limited. Our cross-sectional study seeks to examine the association between SII and atopic dermatitis among outpatient US adults. Methods: This compensatory cross-sectional study utilized NHANES data from 2001-2006 cycles, conducting sample-weighted multivariate logistic regression and stratified analysis of sub-groups. Results: Higher levels of SII were positively associated with an increased risk of atopic dermatitis in adults with BMI <30 (OR, 1.44; 95% CI, 1.10-1.90) (p = 0.010). Conclusion: Our findings suggested SII higher than 330 × 109/L was positively associated with a high risk of atopic dermatitis in US adults with BMI <30. To our knowledge, this is the first study focused on the risk of higher SII on atopic dermatitis in the outpatient US population. Currently, there are differences in the standards used to diagnose atopic dermatitis across countries, and our study may have implications.
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Acute respiratory infections (ARIs) are a serious public health concern across the world, causing considerable morbidity and mortality. Every year, around 13 million children under the age of five die. Approximately 95% of them are from developing nations, and ARIs are responsible for one-third of all deaths. Human Metapneumovirus (hMPV) is one of the causative agents associated with respiratory tract infections. There is lack of information about hMPV from the eastern region of Uttar Pradesh. At Indian Council of Medical Research- Regional Medical Research Centre, Gorakhpur (ICMR-RMRC, Gorakhpur) in Uttar Pradesh, India; we tested respiratory pathogens in under-five patients presenting with ARI and severe acute respiratory illness (SARI) through semi nested PCR. A total of 100 nasal and throat specimens were collected from the outdoor and indoor patient Departments (OPD) and (IPD) of Department of Paediatrics, BRD Medical College, Gorakhpur during February to April 2022. Out of 100 enrolled paediatric patients, 4(4%) were found to be hMPV positive. Among the patients who tested positive for hMPV, 25%(1/4) unfortunately died. The phylogenetic analysis of hMPV showed the close resemblance with the clade of Singapore and USA hMPV isolates. The study underlines the importance of hMPV as the cause of acute respiratory infections in children and the highlight the need for routine testing for this virus in laboratories. Further more comprehensive detailed study on various aspects of hMPV in this area is needed.
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BACKGROUND: A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). METHODS: SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. DISCUSSION: The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
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Procedimientos Quirúrgicos Ambulatorios , Apendicectomía , Apendicitis , Estudios Multicéntricos como Asunto , Humanos , Apendicectomía/efectos adversos , Apendicectomía/métodos , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/métodos , Estudios Prospectivos , Apendicitis/cirugía , Apendicitis/mortalidad , Persona de Mediana Edad , Adulto , Adolescente , Anciano , Adulto Joven , Francia , Resultado del Tratamiento , Femenino , Factores de Tiempo , Laparoscopía/efectos adversos , Laparoscopía/métodos , Tiempo de Internación , Masculino , Estudios de Equivalencia como Asunto , Calidad de Vida , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: Phenylketonuria (PKU) is an inherited metabolic disease. If left untreated, it can lead to severe irreversible intellectual disability and can cause seizures, behavior disturbance, and white matter disease. This study aimed at evaluating the health economic impact of patients with PKU in France. Methods: This retrospective observational study used health insurance claims data from the French SNDS (Système National des Données de Santé) database, which contains data from over 66 million French inhabitants. Patients with PKU were identified by ICD-10 diagnosis codes E70.0 (PKU) and E70.1 (Other hyperphenylalaninemia) documented as a chronic condition (affection de longue durée - ALD) or in the inpatient setting in the SNDS database between 2006 and 2018. Patients with PKU were matched to controls without PKU by age, sex, and region. Patients with early- and late-diagnosed PKU were defined as patients born after and before the implementation of nationwide newborn screening in France in 1972, respectively. Outcomes were analyzed for the year 2018. Results: Overall, 3549 patients with PKU were identified in the database on January 1st, 2018. Of those, 3158 patients versus 15,703 controls with at least one healthcare consumption in 2018 were available for outcome analyses. Patients with PKU had 7.7 times higher healthcare costs than non-PKU controls in 2018 (11,144 versus 1456 mean costs; p < 0.0001). Pharmaceutical costs including dietary amino acid supplements were the cost driver and contributed 80.0% of the overall mean difference (MD) between patients with PKU and matched non-PKU controls. More than half (52.4%) of the mean pharmaceutical costs per patient with PKU was attributable to medical foods including dietary amino acid supplements.Of the 3158 patients with PKU, 2548 (80.7%) were classified as early-diagnosed and 610 (19.7%) as late-diagnosed. Increased healthcare costs, in comparison to non-PKU controls, were more evident in early-diagnosed patients (11,263 versus 855 mean costs; 13.2-fold increase; p < 0.0001). For patients with late-diagnosed PKU, healthcare costs were 2.7-fold higher compared to matched non-PKU controls (10,644 versus 3951 mean costs; p < 0.0001). Outpatient pharmaceutical costs accounted for 89.1% of the MD between early-diagnosed patients and controls. Among late-diagnosed patients, 55.5% of the MD were attributable to costs for inpatient care, followed by costs for outpatient care (23.9%) and outpatient pharmaceutical costs (20.6%). Conclusion: The results indicate that PKU is associated with substantially increased health care costs compared to non-PKU controls in France. The health economic impact was most evident in patients with early-diagnosed PKU due to increased outpatient pharmaceutical costs, especially for medical foods including dietary amino acid supplements. For late-diagnosed and by definition older patients with PKU, the excess costs compared with matched controls were mostly driven by costs for inpatient care.