Digital tools in the informed consent process: a systematic review.

BACKGROUND: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients' autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process. METHODS: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. RESULTS: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. CONCLUSIONS: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

Efficacy and safety of sofosbuvir/simeprevir plus flat dose ribavirin in genotype 1 elderly cirrhotic patients: A real-life study.

BACKGROUND & AIMS: The proportion of HCV-infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real-world efficacy and safety of the combination of sofosbuvir (SOF) and simeprevir (SMV) plus a flat dose of 800 mg/d ribavirin (RBV) in elderly patients with cirrhosis compared to younger patients. METHODS: Retrospective observational multicentre real-life investigation study of SOF/SMV/RBV for a duration of 12 weeks in HCV genotype 1-infected patients with cirrhosis. RESULTS: Of the 270 patients enrolled in this study, with compensated cirrhosis, 133 (49.2%) were ≥65 years of age. Sustained virological response at 12 weeks (SVR12) was achieved by 94.2% (129/137) of those aged <65 years and 97.7% (130/133) of those ≥65 years. Diabetes was the most common comorbidity in patients ≥65 years compared to younger patients (26.3% vs 12.4% P<.003). The most common adverse event (AE) in elderly patients was a grade 2 anaemia (35.3% vs 19.9% P<.004). CONCLUSIONS: Sofosbuvir/simeprevir plus a daily flat dose of RBV 800 mg for 12 weeks was highly effective and safe in genotype 1 elderly patients with compensated cirrhosis.

Long term nucleotide and nucleoside analogs treatment in chronic hepatitis B HBeAg negative genotype D patients and risk for hepatocellular carcinoma.

UNLABELLED: BACKGROUND AND RATIONALE OF THE STUDY: Effect of Long-term nucleoside/nucleotide (NUC) on hepatocellular carcinoma (HCC) incidence in a population of HBeAg-negative genotype D patients has not been adequately studied in real-life cohorts. Our aim was to evaluate the impact of liver fibrosis and other variables on HCC incidence in this population of patients. Of 745 patients with chronic hepatitis B (CHB), 306 HBeAg-negative genotype D were selected and included in this study. All patients received treatment with NUC for at least 18 months. Patients with CHB or compensated cirrhosis were included. Patients with HCC diagnosed before or during the first 18 months of NUC therapy were excluded. RESULTS: HCC was diagnosed in 2 CHB patients (1.0%) and 23 cirrhosis patients (20%) (OR = 24.41, 95% CI 5.40 < OR < 153.2; p < 0.0001). Multivariate analysis revealed that HCC risk was independently associated with age ≥ 60 years (OR = 6.45, 95% CI 1.22 to 34.0; p = 0.02) and liver cirrhosis (OR = 12.1, 95% CI 1.39 to 106.2; p = 0.02), but not with virological response (VR), and previous resistance to NUC, or rescue therapy. Multivariate analysis in cirrhosis patients revealed that only age ≥ 60 years was an independent risk factor associated with HCC (p = 0.003). CONCLUSIONS: Liver cirrhosis and age ≥ 60 years are the stronger risk factors for HCC in genotype D HBeA-gnegative patients. Previous resistance to NUC in patients that achieved a VR after rescue therapy was not a predictive factor regarding HCC. VR does not appear to significantly reduce the overall incidence of HCC when a patient has already progressed to liver cirrhosis.

HCV genotype 1a shows a better virological response to antiviral therapy than HCV genotype 1b.

BACKGROUND: The impact of viral subtype on the rate of sustained virological response (SVR) to antiviral therapy in patients chronically infected with hepatitis C genotype 1 subtype 1a and 1b has not been extensively investigated. The aim of this study is to determine whether the HCV genotype 1 subtypes 1a and 1b respond differently to treatment with PEGylated interferon (PEG-IFN) plus ribavirin. METHODS: For 48 weeks, 388 "naïve"genotype 1 patients were treated weekly with PEG-IFN α-2a or PEG-INF α-2b combined with daily ribavirin (1000-1200 mg/day). The numbers of patients in whom HCV-RNA was undetectable were compared after 4 (rapid virological response, RVR), 12 (early virological response, EVR), and 48 (end treatment virological response, ETR) weeks of treatment as well as 24 weeks after the last treatment (sustained virological response, SVR). RESULTS: The rate of SVR was higher in subtype 1a patients than subtype 1b patients (55% vs. 43%; p < 0.02). Multiple logistic regression analysis showed that infection with genotype 1a (odds ratio(OR) : 1.8; 95% confidence interval (CI): 1.4 to 4.1), age < 50 years (OR:7.0; 95% CI 1.1 to 21.2), alanine aminotransferase level (ALT)<100 IU/ml (OR:2.1; 95% CI: 1.3 to3.5), HCV-RNA < 5.6 log10 IU/ml (OR: 3.2; 95% CI: 2.7 to 6.9) and fibrosis score < S3 (OR: 3.8; 95% CI:3.2 to 7.4), were all independent predictors of SVR. CONCLUSION: Dual antiviral therapy is more effective against HCV subtype 1a than against subtype 1b and this difference is independent of other factors that may favour viral clearance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01342003.

Return to driving after severe traumatic brain injury: increased risk of traffic accidents and personal responsibility.

OBJECTIVE: To determine the frequency of road traffic accidents among individuals who start or resume driving after severe traumatic brain injury (TBI) and to investigate their responsibility for these accidents. DESIGN: Observational/retrospective study. PARTICIPANTS: Sixty adults with severe TBI and their caregivers. MEASURES: Return to Driving Questionnaire and Glasgow Outcome Scale. RESULTS: Thirty of the 60 participants started to drive or resumed driving after TBI. Nineteen (63%) of them were involved in traffic accidents, with personal responsibility in 26 of 36 after return to driving. Participants caused a significantly higher number of accidents after TBI than before. CONCLUSIONS: The ability to drive is frequently compromised after severe TBI. Specific rehabilitation of this complex activity should be a main goal of social reintegration programs in this population.

Epidemiology of skin disorders in Ethiopian children and adolescents: an analysis of records from the Italian Dermatological Centre, Mekelle, Tigray, Ethiopia, 2005 to 2009.

Skin disorders are an important problem in children living in developing countries, but only a few epidemiologic investigations on pediatric dermatoses are available in the literature. Our study is an analysis of the range and frequency of skin diseases presenting to the Italian Dermatological Center in a pediatric Ethiopian population. A retrospective analysis was performed on 17,967 medical records of children aged 0 to 18 years attending the Italian Dermatological Centre in Mekele (Ethiopia) from January 2005 to December 2009. Infections and infestations accounted for 47% of the disorders seen; fungal infections were the most common (44.1%), followed by bacterial and parasitic diseases. Dermatitis constituted the second most common diagnostic category (24.7%) of the disorders seen, and contact dermatitis was the most common diagnosis (48.8%). Pigmentary disorders and disorders of skin appendages were more common in girls, whereas fungal and parasitic infections were more common in boys. Bacterial and parasitic infections were more common in children younger than 1 year old, fungal infections in those aged 1 to 5.9, and disorders of skin appendages and pigmentary disorders in those aged 15 to 18. These findings demonstrate that most of the disorders seen could be easily managed in clinical practice with appropriate skill development. It is crucial to ensure that training of medical students and pediatricians focuses on accurate recognition, diagnosis, and management of these common skin diseases and that families, teachers, health workers, and nurses be educated about the most common signs of prevalent skin diseases to help facilitate appropriate care.

Dynamic anal endosonography and MRI defecography in diagnosis of pelvic floor disorders: comparison with conventional defecography.

BACKGROUND: Pelvic floor disorders are frequent, especially in women. Surgeons need more information on the accuracy of available diagnostic techniques to make therapeutic decisions. OBJECTIVE: This study aimed to compare the accuracy of dynamic anorectal endosonography and dynamic MRI defecography with conventional defecography as the criterion standard in the diagnosis of pelvic floor disorders. DESIGN: We used a prospective crossover design in which patients underwent each procedure in random order within the same month. SETTING: Investigations were conducted at a regional referral center in Marseille, France. PATIENTS: Women with dyschezia who were undergoing diagnostic evaluation were eligible. INTERVENTION: Dynamic anorectal endosonography, dynamic MRI, and conventional defecography were performed in all patients by 3 blinded operators. MAIN OUTCOME MEASURE: The accuracy of dynamic anorectal endosonography and dynamic MRI in the diagnosis of pelvic floor disorders was assessed by calculating sensitivity, specificity, positive and negative predictive values, correlation coefficients, concordance rates, and the Cohen κ statistic, with conventional defecography used as the criterion standard. RESULTS: The study comprised 56 women with a mean age of 50.7 (SD, 12.5) years. No significant differences were observed between dynamic anorectal endosonography and dynamic MRI in the number of patients with rectocele (P = .49), perineal descent (P = .11 when dynamic anorectal endosonography measured descent of the puborectalis muscle; P = .27 for bladder descent), or enterocele (P = .78); no differences were found between these techniques in sensitivity, specificity, or positive and negative predictive values. Diagnostic concordance with conventional defecography as the standard did not differ significantly between dynamic MRI and dynamic anorectal endosonography: Concordance rates for dynamic anorectal endosonography were 75% for rectocele, 64% for perineal descent, and 91% for enterocele (no rectal intussusception was found with dynamic anorectal endosonography); concordance rates for dynamic MRI were 82% for rectocele, 57% for perineal descent, 93% for enterocele, and 55% for rectal intussusception. Significantly more internal anal sphincter defects were found with dynamic anorectal endosonography than with dynamic MRI defecography: 21 patients (37.5%) vs 12 patients (21.4%); P = .02. Patient tolerance was significantly better for dynamic anorectal endosonography than for dynamic MRI (P = .002) or conventional defecography (P = .005). Most patients said they would choose dynamic anorectal endosonography (72.1%) rather than dynamic MRI (25.6%) or conventional defecography (2.3%) if follow-up were necessary (P < .001). CONCLUSION: Dynamic anorectal endosonography and dynamic MRI defecography show equivalent diagnostic performance in assessing pelvic floor disorders. However, because of its better tolerance and availability, dynamic anorectal endosonography may be preferable as the initial imaging procedure after clinical examination in the evaluation of pelvic floor disorders.

ED patients: how nonurgent are they? Systematic review of the emergency medicine literature.

Nonurgent visits to emergency departments (ED) are a controversial issue; they have been negatively associated with crowding and costs. We have conducted a critical review of the literature regarding methods for categorizing ED visits into urgent or nonurgent and analyzed the proportions of nonurgent ED visits. We found 51 methods of categorization. Seventeen categorizations conducted prospectively in triage areas were based on somatic complaint and/or vital sign collection. Categorizations conducted retrospectively (n = 34) were based on the diagnosis, the results of tests obtained during the ED visit, and hospital admission. The proportions of nonurgent ED visits varied considerably: 4.8% to 90%, with a median of 32%. Comparisons of methods of categorization in the same population showed variability in levels of agreement. Our review has highlighted the lack of reliability and reproducibility.

Nonurgent patients in the emergency department? A French formula to prevent misuse.

BACKGROUND: Overcrowding in emergency department (EDs) is partly due to the use of EDs by nonurgent patients. In France, the authorities responded to the problem by creating primary care units (PCUs): alternative structures located near hospitals. The aims of the study were to assess the willingness of nonurgent patients to be reoriented to a PCU and to collect the reasons that prompted them to accept or refuse. METHODS: We carried out a cross sectional survey on patients' use of EDs. The study was conducted in a French hospital ED. Patients were interviewed about their use of health services, ED visits, referrals, activities of daily living, and insurance coverage status. Patients' medical data were also collected. RESULTS: 85 patients considered nonurgent by a triage nurse were asked to respond to a questionnaire. Sex ratio was 1.4; mean age was 36.3 +/- 11.7 years.Most patients went to the ED autonomously (76%); one third (31.8%) had consulted a physician. The main reasons for using the ED were difficulty to get an appointment with a general practitioner (22.3%), feelings of pain (68.5%), and the availability of medical services in the ED, like imaging, laboratory tests, and drug prescriptions (37.6%). Traumatisms and wounds were the main medical reasons for going to the ED (43.5%).More than two-thirds of responders (68%) were willing to be reoriented towards PCUs. In the multivariate analysis, only employment and the level of urgency perceived by the patient were associated with the willingness to accept reorientation. Employed persons were 4.5 times more likely to accept reorientation (OR = 4.5 CI (1.6-12.9)). Inversely, persons who perceived a high level of urgency were the least likely to accept reorientation (OR = 0.9 CI (0.8-0.9). CONCLUSIONS: Our study provides information on the willingness of ED patients to accept reorientation and shows the limits of its feasibility. Alternative structures such as PCUs near the ED seem to respond appropriately to the growing demands of nonurgent patients. Reorientation, however, will be successful only if the new structures adapt their opening hours to the needs of nonurgent patients and if their physicians can perform specific technical skills.

The prevalence of musculoskeletal disorders and low back pain among Italian nurses: An observational study.

BACKGROUND AND AIM OF THE WORK: Musculoskeletal disorders and low back pain have negative impact amongst Italian nurses who work in hospital. Nursing staff are known to be at risk of developing back disorders, where low back pain has a prevalence from 16% to 60% in the world. This study aims to determine the prevalence of musculoskeletal disorders and low back pain among nurses who working in a Roman hospital. METHODS: Cross sectional study was carried out in an Italian hospital and the Nordic Musculoskeletal Questionnaire-IRSST was administered to 256 registered nurses. Logistic regression analyses were performed to understand risk factors associated with pain. RESULTS: Nurses reported different locations of pain related to musculoskeletal disorders. The prevalence of low back pain was 90.2% during life, 80% during the last year and 44.5% during the last week. Female sex increases the risk of being affected by low back pain (OR = 2.07, 95% CI= 1.00-4.32). CONCLUSIONS: Musculoskeletal disorders and low back pain are reported by the majority of nurses interviewed, and a higher prevalence is observed in women. Pain does not depend on the amount of years of work, nor on age or body mass index. In order to assess the prevalence of low back pain carefully, it is recommended to study a greater number of Italian nurses in different hospitals.

High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients.

Background/Aims: Patients with genotype 3 hepatitis C virus (G3-HCV) cirrhosis are very difficult to treat compared to patients with other HCV genotypes. The optimal treatment duration and drug regimen associated with ribavirin (RBV) remain unclear. To evaluate the efficacy and safety of daclatasvir (DCV)/sofosbuvir (SOF) plus a flat dose of 800 mg RBV (flat dose) compared to DCV/SOF without RBV or DCV/SOF plus an RBV dose based on body weight (weight-based) in G3-HCV patients with compensated or decompensated cirrhosis. Methods: We analyzed data for 233 G3 cirrhotic patients. Of these, 70 (30%), 87(37%) and 76 (33%) received SOF/DCV, SOF/DCV/RBV flat dose, and SOF/DCV/RBV weight-based dose, respectively. Treatment duration was 24 weeks. Sustained virological response (SVR) was evaluated at week 12 posttreatment (SVR12). Results: Overall, SVR12 was achieved in 220 out of 233 patients (94.4%). The SVR12 rate was lower in the DCV/SOF group than in the DCV/SOF/RBV flat-dose group and the DCV/SOF/RBV weight-based group (87.1% vs 97.7% and 97.4%, respectively, p=0.007). A higher incidence of anemia occurred in the DCV/SOF/RBV weight-based group compared to those in the other two groups (p<0.007). Conclusions: We found that the DCV/SOF/RBV flat-dose regimen is an effective treatment in terms of efficacy and safety in patients with G3-HCV compensated or decompensated cirrhosis. Therefore, antiviral regimens without RBV should be restricted only to naïve patients with G3-HCV compensated cirrhosis who have a clear contraindication for RBV.

Clinical guidelines: involvement of peers increases physician adherence.

The literature illustrates the important issue of physician adherence to guidelines in their daily practice. In a quantitative study, we asked a random sample of 100 hospital gastroenterologists to evaluate their knowledge of guidelines and awareness of promoters. The degree to which guidelines were considered reliable was not related to the scientific evidence but was significantly associated with the promoter. The French Society of Gastroenterology was considered to be a more reliable promoter than national health agencies and pharmaceutical industries. Gastroenterologists become aware of guidelines mainly through their specialty society (62%). Specialty societies appear to be a more important source of information on guidelines for physicians. National health agencies should involve the specialty societies in the guideline development process to achieve changes in clinical practice.

Pertinence of a pre-colonoscopy consultation for routine information delivery.

AIM OF THE STUDY: The purpose of this study was to determine whether patients have a better level of information about colonoscopy and are more satisfied with medical care when they attend a dedicated consultation with a gastroenterologist prior to the procedure. METHODS: We conducted a prospective study which compared "exposed" (E) and "non exposed" (NE) patients. In group E, information about colonoscopy was delivered by a gastroenterologist during a special consultation at least 24 hours before the procedure. In group NE, information was delivered in the usual manner. The patients' level of information was measured after colonoscopy and 3 months later. RESULTS: Thirteen patients were included in group E and 18 in group NE. The level of information was better in group E, 5.2 +/- 2.1 versus 3.3 +/- 2.1 (P<0.04), as was satisfaction with medical care, 24.9 +/- 4.6 versus 23.0 +/- 5.1 (P<0.03). The differences in information levels remained at 3 months. CONCLUSION: The information delivered during a dedicated precolonoscopy consultation increases assimilation of knowledge concerning the procedure and the patient's satisfaction with medical care.

[Evaluation of medical professional practices: historical perspective of the French situation]. / Evaluation des pratiques professionnelles du médecin: historique de la démarche en France.

The evaluation of the professional practices (EPP) is central to the new orientations of French health policies. This evaluation is an essential component of the evaluation process. It aims at increasing the effectiveness and the quality of the health system. Its objective is to help doctors to reflect on their practice, notably in order to engage a continuous improvement process. Contrary to the previous measures taken on this subject, the EPP is common to the whole medical profession (legal obligation). Its method is laid down by decree but the text leaves a free choice as for the method employed. The goal is to accompany doctors in the improvement of their practice by the means of a specific (five years) and continuous evaluation process.

The diagnostic challenge of mapping elephantiasis in the Tigray region of northern Ethiopia.

BACKGROUND: In Ethiopia, lymphatic filariasis and podoconiosis are the two neglected tropical diseases planned to be mapped together within the recently launched Ethiopian neglected tropical diseases master plan (2013-2015). However, other disorders cause tropical lymphedema, and this report aims to identify clinical epidemiological aspects of limb swelling in northern Ethiopia and to provide an algorithm orienting the clinical diagnosis. METHODS: Medical records of patients with lower limb elephantiasis attending the Italian Dermatological Centre of Mekele, Tigray capital city, over a 4-year period (2005-2009) were retrospectively analyzed. Nine variables were collected from the charts comprising demographic data, job, origin, literacy, clinical, histopathologic, microscopic, and cultural findings. RESULTS: Over a total of 511 patients, lymphedema resulted from trauma (40.7%), chronic venous insufficiency (12.5%), deep mycoses (10.8%), lymphatic filariasis (9.2%), elephantiasis nostras verrucosa (7.0%), tropical ulcer (6.3%), leprosy (4.9%), recurrent infections (3.1%), podoconiosis (1.8%), tuberculosis (1.0%), malignancy (1.3%), Kaposi's sarcoma (1.0%), leishmaniasis (0.2%), and neurofibromatosis (0.2%). CONCLUSIONS: Advanced-stage elephantiasis, chronic osteomyelitis, and podoconiosis not previously reported in Tigray were observed. Further epidemiological investigation and training programs addressed to healthcare providers at the peripheral level are needed to detect elephantiasis early, prevent disabilities, and improve patients' quality of life.