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Quali conseguenze derivano, sotto il profilo risarcitorio, dalla condotta inadempiente del medico, che non abbia illustrato al paziente i rischi connessi al trattamento terapeutico, così da ottenere il necessario consenso alla sua esecuzione? L'articolo Quali danni per il medico per non aver adempiuto all’obbligo informativo? sembra essere il primo su Sanità Informazione.

L'oncologo Sobrero; "Ema e Fda rivedano i parametri per dare l'ok a queste terapie"

Mayor Lori Lightfoot faces a wide field of challengers on Tuesday, including one front-runner who has portrayed Chicago as a city in disarray.

It’s not a presidential campaign (yet). It’s also not a book tour (though he has a new book to sell).

L'ultimo autorizzato a dicembre.Quando dieta e sport non bastano

(Adnkronos) - "La meningite non è una patologia comune, ma questa infezione in 24 ore, anche meno, nell'adolescente, passa rapidamente dai primi sintomi, che sono aspecifici e similinfluenzali, al ricovero con quadri clinici molto diversificati, fino al decesso, purtroppo". Lo spiega all'AdnKronos Salute Vincenzo Baldo, professore ordinario di Igiene all'Università di Padova, commentando il caso del 17enne di Bassano (Vicenza) ricoverato per meningite B sabato 25 febbraio, per il quale si sono perse le speranze ed è in corso la procedura per la dichiarazione della morte cerebrale.

(Adnkronos) - "Purtroppo i vari germi del meningococco circolano e sono albergati, in modo asintomatico, in una popolazione adulta e pediatrica che li tollera. In alcuni soggetti sono aggressivi, o lo diventano per condizioni di abbassamento delle difese immunitarie, come dopo l'influenza. La meningite ha un decorso molto veloce: quando ci sono i sintomi, gli organi sono già compromessi". Così Mattia Doria, segretario provinciale di Venezia della Federazione italiana medici pediatri (Fimp), presidente Centro studi veneto per la formazione e ricerca in pediatria territoriale (Cesper), commentando il caso del giovane 17enne vicentino, ricoverato sabato 25 febbraio a Bassano per meningite B, per il quale si sono perse le speranze ed è in corso la procedura per la dichiarazione della morte cerebrale.

Objectives Excessive opioid prescribing is a contributing factor to the opioid epidemic in the USA. We aimed to develop, implement and evaluate the usability of a clinical decision-making mobile application (app) for opioid prescription after surgery. Methods We developed two clinical decision trees, one for opioid prescription after adult laparoscopic cholecystectomy and one for posterior spinal fusion surgery in adolescents. We developed a mobile app incorporating the two algorithms with embedded clinical decision-making, which was tested by opioid prescribers. A survey collected prescription intention prior to app use and participants’ evaluation. Participants included opioid prescribers for patients undergoing (1) laparoscopic cholecystectomy in adults or (2) posterior spinal fusion in adolescents with idiopathic scoliosis. Results Eighteen healthcare providers were included in this study (General Surgery: 8, Paediatrics: 10). Intended opioid prescription before app use varied between departments (General Surgery: 0–10 pills (mean=5.9); Paediatrics: 6–30 pills (mean=20.8)). Intention to continue using the app after using the app multiple times varied between departments (General Surgery: N=3/8; Paediatrics: N=7/10). The most reported reason for not using the app is lack of time. Conclusions In this project evaluating the development and implementation of an app for opioid prescription after two common surgeries with different prescription patterns, the surgical procedure with higher intended and variable opioid prescription (adolescent posterior spinal fusion surgery) was associated with participants more willing to use the app. Future iterations of this opioid prescribing intervention should target surgical procedures with high variability in both patients’ opioid use and providers’ prescription patterns.

Objectives As highlighted by the COVID-19 pandemic, researchers are eager to make use of a wide variety of data sources, both government-sponsored and alternative, to characterise the epidemiology of infectious diseases. The objective of this study is to investigate the strengths and limitations of sources currently being used for research. Design Retrospective descriptive analysis. Primary and secondary outcome measures Yearly number of national-level and state-level disease-specific case counts and disease clusters for three diseases (measles, mumps and varicella) during a 5-year study period (2013–2017) across four different data sources: Optum (health insurance billing claims data), HealthMap (online news surveillance data), Morbidity and Mortality Weekly Reports (official government reports) and National Notifiable Disease Surveillance System (government case surveillance data). Results Our study demonstrated drastic differences in reported infectious disease incidence across data sources. When compared with the other three sources of interest, Optum data showed substantially higher, implausible standardised case counts for all three diseases. Although there was some concordance in identified state-level case counts and disease clusters, all four sources identified variations in state-level reporting. Conclusions Researchers should consider data source limitations when attempting to characterise the epidemiology of infectious diseases. Some data sources, such as billing claims data, may be unsuitable for epidemiological research within the infectious disease context.

Objective To estimate the prevalence of chronic kidney disease (CKD) among patients with type 2 diabetes mellitus (T2DM) and determine the sociodemographic and clinical risk factors associated with CKD. Design and settings Cross-sectional study among diabetic outpatients of a tertiary hospital in Nepal. Participants 201 patients with T2DM above 18 years of age. Intervention Participants completed a questionnaire regarding their socioeconomic information and underwent pertinent physical and haematological examinations. Primary and secondary outcomes measure The prevalence and risk factors of CKD among patients with T2DM. Results The prevalence of CKD in T2DM was 86.6%. In univariable analysis, the variables like age (p=0.026), hypertension status (p=0.002), duration of diabetes (p=0.009) and haemoglobin levels (p=0.027) were significantly associated with CKD among the participants with T2DM. Kruskal-Wallis H test showed that age was significantly different between various CKD stages. Multivariate analysis demonstrated a significant relationship between CKD with age (Adjusted odds ratio (AOR) 3, 95% CI 1.1 to 8.8) and literacy status (AOR 5.8, 95% CI 1.4 to 24.6) Conclusion Advancing age, concomitant hypertension, increasing duration of T2DM and presence of anaemia were found to be important risk factors of CKD. Age is the most important predictor of CKD showing increasing prevalence in the elderly population. Periodic screening tests are essential at an early age to identify kidney diseases at incipient stages, thereby preventing progression to end-stage renal disease.

Introduction Burn registers can provide high-quality clinical data that can be used for surveillance, research, planning service provision and clinical quality assessment. Many countrywide and intercountry burn registers now exist. The variables collected by burn registers are not standardised internationally. Few international burn register data comparisons are completed beyond basic morbidity and mortality statistics. Data comparisons across registers require analysis of homogenous variables. Little work has been done to understand whether burn registers have sufficiently similar variables to enable useful comparisons. The aim of this project is to compare the variables collected in countrywide and intercountry burn registers internationally to understand their similarities and differences. Methods and analysis Burn register custodians will be invited to participate in the study and to share their register data dictionaries. Study objectives are to compare patient inclusion and exclusion criteria of each participating burn register; determine which variables are collected by each register, and if variables are required or optional, identify common variable themes; and compare a sample of variables to understand how they are defined and measured. All variable names will be extracted from each register and common themes will be identified. Detailed information will be extracted for a sample of variables to give a deeper insight into similarities and differences between registers. Ethics and dissemination No patient data will be used in this project. Permission to use each register’s data dictionary will be sought from respective register custodians. Results will be presented at international meetings and published in open access journals. These results will be of interest to register custodians and researchers wishing to explore international data comparisons, and countries wishing to establish their own burn register.

Introduction Administration of large volumes of fluids is associated with poor outcome in septic shock. Recent data suggest that non-resuscitation fluids are the major source of fluids in the intensive care unit (ICU) patients suffering from septic shock. The present trial is designed to test the hypothesis that a protocol targeting this source of fluids can reduce fluid administration compared with usual care. Methods and analysis The design will be a multicentre, randomised, feasibility trial. Adult patients admitted to ICUs with septic shock will be randomised within 12 hours of admission to receive non-resuscitation fluids either according to a restrictive protocol or to receive usual care. The healthcare providers involved in the care of participants will not be blinded. The participants, outcome assessors at the 6-month follow-up and statisticians will be blinded. Primary outcome will be litres of fluids administered within 3 days of randomisation. Secondary outcomes will be proportion of randomised participants with outcome data on all-cause mortality; days alive and free of mechanical ventilation within 90 days of inclusion; any acute kidney injury and ischaemic events in the ICU (cerebral, cardiac, intestinal or limb ischaemia); proportion of surviving randomised patients who were assessed by European Quality of Life 5-Dimensions 5-Level questionnaire and Montreal Cognitive Assessment; proportion of all eligible patients who were randomised and proportion of participants experiencing at least one protocol violation. Ethics and dissemination Ethics approval has been obtained in Sweden. Results of the primary and secondary outcomes will be submitted for publication in a peer-reviewed journal. Trial registration number NCT05249088.

The aim of this scoping review is to provide an overview of the existing qualitative research concerning the lived experiences of children and young people currently in foster care. Introduction Lived experience of foster care is an area of limited research. Studies tend to focus on foster caregiver retention rates, education performance outcomes, evaluations and policy development. Although these studies are important, they provide little insight into the everyday lives of those currently in foster care, which is likely to influence these previous areas of research. Methods and analysis The scoping review will be guided by Arksey and O’Malley’s approach to scoping studies. A systematic database search of PubMed, CINAHL and PsycINFO will be conducted followed by a systematic chain search of referenced and referencing literature. English-language peer-reviewed qualitative studies of children and young people currently in foster care will be included. We will exclude studies linked to transitioning out of foster care and studies with samples mixed with other types of out-of-home care. Mixed-methods studies will be excluded in addition to programme, treatment or policy evaluations. Following removal of duplicates, titles and abstracts will be screened, followed by a full-text review. Two researchers will independently screen references against inclusion and exclusion criteria using Covidence software. The quality of the included studies will be assessed by two independent reviewers using the appropriate Critical Appraisal Skills Programme checklist. Ethics and dissemination Information gathered in this research will be published in peer-reviewed journals and presented at national and international conferences relevant to foster care services and quality improvement. Reports will be disseminated to relevant foster care agencies, where relevant. Ethical approval and informed consent are not required as this protocol is a review of existing literature. Findings from the included studies will be charted and summarised thematically in a separate manuscript.

Introduction Gallbladder cancer (GBC) is an aggressive type of digestive system cancer with a dismal outcome. Given the lack of effective treatment options, the disease rapidly reoccurs and 5-year survival rate is <5%. Our team previously found that a significant percentage of GBC tissues harboured mutations of the ErbB-related pathway. Afatinib is a chemically synthesised drug specifically targeting the ErbB pathway mutations. However, its efficacy in the treatment of patients with GBC remains unknown. Circulating tumour DNA (ctDNA) refers to a proportion of cell-free DNA in the blood which is released by apoptotic and necrotic cells from tumours in situ, metastatic foci or circulating tumour cells. ctDNA-based liquid biopsy is a non-invasive pathological detection method that offers additional value to evaluate the therapeutic efficacy of antitumour drugs. Methods and analysis We conduct a multicentre and randomised study on afatinib combined with gemcitabine and oxaliplatin (GEMOX) in patients with ErbB pathway mutated GBC. Clinical and biological evaluation involving ErbB pathway ctDNA detection will be made during the 3-year follow-up after participation. The primary objective of this clinical trial is to evaluate the clinical efficacy of afatinib. Disease-free survival is the primary end point and will be correlated with plasma ctDNA of patients in the treatment with afatinib. In addition, we will evaluate the sensitivity and specificity of plasma ctDNA for monitoring tumour recurrence and progression. Finally, we will assess the safety of afatinib by keeping an eye on the safety indicators. Ethics and dissemination The study was approved by the medical-ethical review committee of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The clinical trials results, even inconclusive, will be published in peer-reviewed journals. Trial registration number NCT04183712.

Objectives Knowledge on information needs in cardiac rehabilitation (CR) patients is scarce. This study investigates determinants of information needs in patients with coronary artery disease (CAD). Design Prospective observational study. Participants A total of 259 patients participated. Setting CR centre serving a general hospital in The Netherlands. Methods Patients with a coronary event and/or revascularisation referred for CR completed questionnaires assessing their level of information needs with respect to nutrition, physical activity, smoking, medication use and psychological well-being, and potential determinants of information needs (sociodemographic characteristics, health literacy, illness perceptions, anxiety, depression, Type D personality and quality of life). Results The majority (63%) of patients indicated a need for information on at least one of the four topics (nutrition, physical activity, medication use, psychological well-being), with considerable inter-individual variation. Female sex, being employed, higher socioeconomic status, higher levels of anxiety and higher illness perception were associated with higher information needs on specific topics. Conclusions The majority of CR patients with CAD have a need for information, with considerable inter-individual variability. Several demographic, socioeconomic and psychosocial characteristics were related to their preference for information topics. These results underline the need for personalised information strategies in patients undergoing CR.

Background Aerosol-generating procedures such as oesophagogastroduodenoscopy (OGD) result in infectious particles being exhaled by patients. This substantially increases the medical staff’s risk of occupational exposure to pathogenic particles via airway inhalation and facial mucosal deposition. Infectious particles are regarded as a key route of transmission of SARS-CoV-2 and, thus, represents a major risk factor for medical staff during the ongoing COVID-19 pandemic. There is a need for quantitative evidence on medical staff’s risk of multiroute exposure to infectious particles exhaled by patients during OGD to enable the development of practical, feasible and economical methods of risk-reduction for use in OGD and related procedures. This randomised controlled trial (RCT)—Personal protective EquiPment intervention TrIal for oesophagogastroDuodEnoscopy (PEPTIDE)—aims to establish a state-of-the-art protocol for quantifying the multiroute exposure of medical staff to infectious particles exhaled by patients during real OGD procedures. Method and analysis PEPTIDE will be a prospective, two-arm, RCT using quantitative methods and will be conducted at a tertiary hospital in China. It will enrol 130 participants (65 per group) aged over 18. The intervention will be an anthropomorphic model with realistic respiratory-related morphology and respiratory function that simulates a medical staff member. This model will be used either without or with a surgical mask, depending on the group allocation of a participant, and will be placed beside the participants as they undergo an OGD procedure. The primary outcome will be the anthropomorphic model’s airway dosage of the participants’ exhaled infectious particles with or without a surgical mask, and the secondary outcome will be the anthropomorphic model’s non-surgical mask-covered facial mucosa dosage of the participants’ exhaled infectious particles. Analyses will be performed in accordance with the type of data collected (categorical or quantitative data) using SPSS (V.26.0) and RStudio (V.1.3.959). Ethics and dissemination Ethical approval for this RCT was obtained from the Ethics Committee of Peking Union Medical College Hospital (ZS-3377). All of the potential participants who agree to participate will provide their written informed consent before they are enrolled. The results will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals. Trial registration number NCT05321056.

Objective To describe and synthesise studies of SARS-CoV-2 seroprevalence by occupation prior to the widespread vaccine roll-out. Methods We identified studies of occupational seroprevalence from a living systematic review (PROSPERO CRD42020183634). Electronic databases, grey literature and news media were searched for studies published during January–December 2020. Seroprevalence estimates and a free-text description of the occupation were extracted and classified according to the Standard Occupational Classification (SOC) 2010 system using a machine-learning algorithm. Due to heterogeneity, results were synthesised narratively. Results We identified 196 studies including 591 940 participants from 38 countries. Most studies (n=162; 83%) were conducted locally versus regionally or nationally. Sample sizes were generally small (median=220 participants per occupation) and 135 studies (69%) were at a high risk of bias. One or more estimates were available for 21/23 major SOC occupation groups, but over half of the estimates identified (n=359/600) were for healthcare-related occupations. ‘Personal Care and Service Occupations’ (median 22% (IQR 9–28%); n=14) had the highest median seroprevalence. Conclusions Many seroprevalence studies covering a broad range of occupations were published in the first year of the pandemic. Results suggest considerable differences in seroprevalence between occupations, although few large, high-quality studies were done. Well-designed studies are required to improve our understanding of the occupational risk of SARS-CoV-2 and should be considered as an element of pandemic preparedness for future respiratory pathogens.

Introduction Behavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index 40.0 kg/m2 or 35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients’ use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients’ weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being. Methods and analysis In the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively. Ethics and dissemination The study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications. Registration This study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de. Trial registration number DRKS00026018

Objectives To investigate the prevalence and risk factors of hypothyroidism after universal salt iodisation for 20 years in mainland China. Design Nationwide, cross-sectional survey. Setting and participants The Thyroid Disorders, Iodine Status and Diabetes epidemiological study included adults from 31 provinces of China. Data included demographic, physical characteristics, urine, serum thyroid-stimulating hormone (TSH), thyroid-peroxidase antibody (TPOAb), thyroglobulin antibody (TgAb) and thyroid ultrasonography. Subclinical hypothyroidism (SCH) was classified into severe SCH (TSH >10 mU/L) and mild SCH (TSH 4.2–9.9 mU/L). A total of 78 470 (38 182 men and 40 288 women) participants were included in the final analysis. Results The prevalence of hypothyroidism was 13.95%. The prevalence rates of overt hypothyroidism (OH) and SCH were 1.02% and 13.93%, which mild SCH was significantly higher than severe SCH (12.18% vs 0.75%). Prevalence was higher in women than in men, and this gender difference was noted among all age groups. The prevalence of mild SCH, severe SCH and OH increases by 1.16%, 1.40% and 1.29% for every 10 years older. TPOAb or/and TgAb positive were significantly associated with OH and severe SCH (OR 15.9, p<0.001). However, SCH was positively correlated with increased urine iodine concentration, but this correlation was only in antibody-negative female patients. In non-autoimmune and male populations, there was a U-shaped relationship between severe SCH and OH and urine iodine concentration. Conclusions Mild SCH is the most common form of hypothyroidism, which is related to iodine intake. Severe SCH is more similar to OH which autoimmune is the main cause. The various effects of iodine on hypothyroidism depend on thyroid autoimmune and gender.

Objective To derive and validate a tool that retrospectively identifies delayed diagnosis of appendicitis in administrative data with high accuracy. Design Cross-sectional study. Setting Five paediatric emergency departments (EDs). Participants 669 patients under 21 years old with possible delayed diagnosis of appendicitis, defined as two ED encounters within 7 days, the second with appendicitis. Outcome Delayed diagnosis was defined as appendicitis being present but not diagnosed at the first ED encounter based on standardised record review. The cohort was split into derivation (2/3) and validation (1/3) groups. We derived a prediction rule using logistic regression, with covariates including variables obtainable only from administrative data. The resulting trigger tool was applied to the validation group to determine area under the curve (AUC). Test characteristics were determined at two predicted probability thresholds. Results Delayed diagnosis occurred in 471 (70.4%) patients. The tool had an AUC of 0.892 (95% CI 0.858 to 0.925) in the derivation group and 0.859 (95% CI 0.806 to 0.912) in the validation group. The positive predictive value (PPV) for delay at a maximal accuracy threshold was 84.7% (95% CI 78.2% to 89.8%) and identified 87.3% of delayed cases. The PPV at a stricter threshold was 94.9% (95% CI 87.4% to 98.6%) and identified 46.8% of delayed cases. Conclusions This tool accurately identified delayed diagnosis of appendicitis. It may be used to screen for potential missed diagnoses or to specifically identify a cohort of children with delayed diagnosis.