Management of Dyslipidaemia in Real-world Clinical Practice: Rationale and Design of the VIPFARMA ISCP Project.
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SUBMITTER: Santi RL
PROVIDER: S-EPMC8117136 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe Alzheimer's biomarkers in daily practice (ABIDE) project is designed to translate knowledge on diagnostic tests (magnetic resonance imaging [MRI], cerebrospinal fluid [CSF], and amyloid positron emission tomography [PET]) to daily clinical practice with a focus on mild cognitive impairment (MCI).MethodsABIDE is a 3-year project with a multifaceted design and is structured into interconnected substudies using both quantitative and qualitative research methods.ResultsBased on retrospective data, we develop personalized risk estimates for MCI patients. Prospectively, we collect MRI and CSF data from 200 patients from local memory clinics and amyloid PET from 500 patients in a tertiary setting, to optimize application of these tests in daily practice. Furthermore, ABIDE will develop strategies for optimal patient-clinician conversations.DiscussionUltimately, this will result in a set of practical tools for clinicians to support the choice of diagnostic tests and facilitate the interpretation and communication of their results.
| S-EPMC5318541 | biostudies-literature
Project description:Our objective was to describe real-world patterns of care and outcomes in pancreatic cancer. 912 patients diagnosed with pancreatic cancer from 2014 to 2017 were registered by the population-based cancer registry of Burgundy (France). Progression-free and net survival were estimated. at diagnosis, 52% of tumors were associated with metastases. Among the 20% of patients fulfilling resectability criteria, half of those aged 75-84 years and none of those ≥85 years actually underwent resection. Age was not associated with 3-year observed survival in patients who underwent resection. Overall, 77% of patients aged <75 years, 55% of those aged 75-84 years and 8% of those ≥85 years received chemotherapy. Among patients who were offered chemotherapy, 73% of those aged ≥85 years refused. Chemotherapy toxicity was higher with Gemcitabine_Oxaliplatin/Gemcitabine_Abraxane and FOLFIRINOX than with Gemcitabine alone. Patients resected after induction FOLFIRINOX and those treated with adjuvant Gemcitabine presented the lowest risk of progression. Three-year net survival was 35% in patients with non-metastatic resectable tumors and under 10% for other patients. Only half of patients aged 75-84 years with a resectable tumor actually underwent resection. Two thirds of patients aged ≥85 years refused chemotherapy, thus underlining the need to expand geriatric assessments.
| S-EPMC8996902 | biostudies-literature
Project description:BackgroundMobile health (mHealth) is an emerging field of scientific interest worldwide. Potential benefits include increased patient engagement, improved clinical outcomes, and reduced health care costs. However, mHealth is often studied in projects or trials, and structural implantation in clinical practice is less common.ObjectiveThe purpose of this paper is to outline the design of the Box and its implementation and use in an outpatient clinic setting. The impact on logistical outcomes and patient and provider satisfaction is discussed.MethodsIn 2016, an mHealth care track including smartphone-compatible devices, named the Box, was implemented in the cardiology department of a tertiary medical center in the Netherlands. Patients with myocardial infarction, rhythm disorders, cardiac surgery, heart failure, and congenital heart disease received devices to measure daily weight, blood pressure, heart rate, temperature, and oxygen saturation. In addition, professional and patient user comments on the experience with the care track were obtained via structured interviews.ResultsFrom 2016 to April 2020, a total of 1140 patients were connected to the mHealth care track. On average, a Box cost €350 (US $375), not including extra staff costs. The median patient age was 60.8 (IQR 52.9-69.3) years, and 73.59% (839/1140) were male. A median of 260 (IQR 105-641) measurements was taken on a median of 189 (IQR 98-372) days. Patients praised the ease of use of the devices and felt more involved with their illness and care. Professionals reported more productive outpatient consultations as well as improved insight into health parameters such as blood pressure and weight. A feedback loop from the hospital to patient to focus on measurements was commented as an important improvement by both patients and professionals.ConclusionsIn this study, the design and implementation of an mHealth care track for outpatient follow-up of patients with various cardiovascular diseases is described. Data from these 4 years indicate that mHealth is feasible to incorporate in outpatient management and is generally well-accepted by patients and providers. Limitations include the need for manual measurement data checks and the risk of data overload. Moreover, the tertiary care setting in which the Box was introduced may limit the external validity of logistical and financial end points to other medical centers. More evidence is needed to show the effects of mHealth on clinical outcomes and on cost-effectiveness.
| S-EPMC8726018 | biostudies-literature
Project description:Background & aimsDespite availability of diagnostic and management reference guidelines outlining standard of care for patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), national and regional guidelines are lacking, resulting in variations in patient management between regions. We retrospectively analyzed patient characteristics and management data from the Adelphi Real World NASH Disease Specific Programme™ for patients with NASH in the EU5, Canada, and the Middle East to identify gaps between real-world practice and that advocated by reference guidelines, irrespective of clinician awareness or consultation of guidelines.MethodsWe performed an analysis of physicians (hepatologists, gastroenterologists, diabetologists) and their patients diagnosed with NASH. Physicians completed patient record forms for the next 5 consulting patients, collecting information on patient care, including diagnosis and disease management.ResultsA total of 429 physicians provided data for 2,267 patients with NASH (EU5, n = 1,844; Canada, n = 130; Middle East, n = 293). Patient age, physician-defined fibrosis stage, comorbidities and symptoms, and diagnostic testing practices highlighted statistically significant differences across regions. Substantial disconnects between reference guidelines and real-world practice were observed. Use of liver function tests, non-invasive tests (e.g. ultrasound and transient elastography), and tests to exclude other conditions was suboptimal. Although lifestyle advice was widely provided, patients were less commonly referred to diet, exercise, and lifestyle specialists. Two-thirds of patients were receiving off-label treatment for NASH or associated underlying conditions with the aim of improving NASH, most commonly statins, metformin, and vitamin E.ConclusionReal-world NASH management approaches differ across regions and from proposed standard of care represented by reference multidisciplinary guidelines. Establishment and awareness of, and adherence to regional and national guidelines may improve identification and management of patients with NASH and potentially improve outcomes in this population.Lay summaryAlthough reference guidelines are available to guide the management of patients with NASH, these are not widely used and there is a lack of national guidelines. Our study shows how clinical practice in the EU, Canada, and Middle East differs from proposed standard of care, particularly relating to how patients are diagnosed and treated. Wider establishment of, awareness of, and reference to guidelines may improve how physicians identify and manage patients with NASH.
| S-EPMC8686034 | biostudies-literature
Project description:Fingolimod is a multiple sclerosis treatment licensed in Europe since 2011. Its efficacy has been demonstrated in three large phase III trials, used in the regulatory submissions throughout the world. As usual, in these trials the inclusion and exclusion criteria were designed to obtain a homogeneous population, with interchangeable characteristics in the different treatment arms. Although this is the best strategy to achieve a robust answer to the investigation question, it does not guaranty the treatment efficacy in the clinical practice, since in the real world there are concomitant treatments, comorbidities, adherence, and persistence challenges. But, to make informed treatment decision for a real life patient, we need to have evidence of the treatment efficacy, what has been called treatment effectiveness. This work aims to review fingolimod effectiveness, using, as source of information, abstracts, posters, and manuscripts. This unorthodox strategy was developed because more than half of the published experience with fingolimod is still on abstracts and posters. Only a small part of the studies reviewed are already published in peer reviewed journals. Fingolimod seems to be, at least, as effective and safe as it was on clinical trials, and with its long-term experience no new safety signals were observed.
| S-EPMC4674597 | biostudies-literature
Project description:ObjectivesAccording to the 10th revision of the International Classification of Diseases, the main categories of tic disorders (F95.0, F95.1, and F95.2) follow a diagnostic hierarchy based on the duration and diversity of tic symptoms. The present study investigated the use of this diagnostic hierarchy in real-world clinical practice.MethodsBased on the National Health Insurance Service-National Health Information Database, the diagnosis of transient tic disorder (F95.0) made after a diagnosis of chronic motor or vocal tic disorder (F95.1) or Tourette's syndrome (F95.2) and diagnosis of chronic motor or vocal tic disorder (F95.1) made after a diagnosis of Tourette's syndrome (F95.2) were referred to as type A errors. The diagnosis of transient tic disorder (F95.0) repeated after a period of >12 months was referred to as type B error. Demographic and clinical differences according to the diagnostic error types were analyzed using analysis of variance, Student's t-tests, and chi-squared tests.ResultsMost participants (96.5%) were without errors in the diagnosis of tic disorders. Higher proportions of males (p=0.005) and antipsychotic prescriptions (p<0.001) were observed in patients with type A or B diagnostic errors. A higher proportion of health insurance holders was observed among those with type A errors (p=0.027).ConclusionErrors were absent in majority of the tic diagnoses in real-world clinical practice in terms of the diagnostic hierarchy.
| S-EPMC10568186 | biostudies-literature
Project description:BackgroundThere has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation.ObjectiveTo evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy.MethodsData were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line.ResultsFinally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases.ConclusionsSingle-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.
| S-EPMC8259339 | biostudies-literature
Project description:BACKGROUND:The safety of pirfenidone on pulmonary fibrosis patients with other kinds of interstitial lung diseases (ILDs) in addition to idiopathic pulmonary fibrosis (IPF) is unknown. Furthermore, its effectiveness-related factors on IPF patients are not quite explored. METHODS:A retrospective study, on patients prescribed pirfenidone for pulmonary fibrosis, was conducted to assess effectiveness on IPF patients and tolerability of all patients with lung fibrosis. The effectiveness of pirfenidone was tested on 110 IPF subjects receiving treatment for ≥3 months by high-resolution computed tomography (HRCT). Response-linked factors and progression-free survival (PFS) were also analyzed. The data about safety outcomes and drug dose adjustments were collected from all included subjects. RESULTS:A total of 176 subjects were included: 117 were IPF, 19 connective tissue disease-associated interstitial lung disease (CTD-ILD), and 40 unclassifiable ILD. Out of the 110 IPF subjects, 89 subjects were assessed as stable and 21 as progressive, out of which 10 died of acute exacerbation and 11 progressed. The effectiveness was significantly related to their baseline body mass index (BMI). IPF subjects with BMI>25kg/m2 or diffusion capacity of carbon monoxide (DLco)>30% had higher PFS rate. The most common adverse events were skin-related and gastrointestinal-related. Drug discontinuation owing to adverse events occurred similarly in these three groups. CONCLUSION:Pirfenidone was well tolerated in most of the lung fibrosis patients besides IPF, with a similar pattern of adverse events. Nearly 80% of IPF subjects were assessed as stable. More benefits were seen in IPF patients with higher BMI or mild-to-moderate disease.
| S-EPMC6992179 | biostudies-literature
Project description:BackgroundHypertension is the main risk factor for most cardiovascular diseases. A coordinated and organized system from the Brazilian Ministry of Healthy involving Family Health Strategy (FHS), a program for the prevention of chronic disease, and the Popular Pharmacy Program (PPP), which subsidizes medications for the population, could allow an earlier identification and better blood pressure (BP) control. Matão Controlling Hypertension (MatCH) is a community-based population project that aims to apply an organized, integrated and coordinated program in the city of Matão, Brazil, involving FHS and PPP in order to actively search, treat and follow-up hypertensive subjects.MethodThis is a population community-based, interventional, follow-up study where all subjects aged ≥ 40 years assisted by the FHS program in Matão will have BP assessed monthly by trained Community Health Agents (CHA) during a domiciliary visit. Identified hypertensive subjects will be referred to FHS physicians for nonpharmacological and pharmacological treatment. Most of the hypertensive drugs used will be available through the PPP. Prevalence of hypertension, awareness, demographics and risk factors will be correlated with BP control. The population study is expected to involve approximately 18.600 subjects. The study period will be four years.DiscussionConsidering that hypertension is asymptomatic in most cases, to reduce the population burden of BP-related deaths and diseases it is essential to detect and treat early all hypertensive patients. If we achieve our large-scale BP control, this program can be applied to other populations from developing countries.
| S-EPMC5898479 | biostudies-literature
Project description:This study describes the design of the TARGET-hepatocellular carcinoma (HCC) cohort and descriptive characteristics of the patient population at diagnosis among those who were enrolled in the cohort across academic and community clinical centers. TARGET-HCC is a 5-year, longitudinal, observational cohort of patients with HCC receiving care in usual clinical practice. Redacted clinical information, obtained from medical records, captures the natural history and management of the disease, including the safety and efficacy of treatment interventions used in usual clinical practice. Patients can complete patient-reported outcome measures and provide biological specimens for future translational studies. The TARGET-HCC study includes adults with histologic, cytologic, or radiologic diagnosis of HCC from academic and community centers in both the United States and Europe. A total of 1,841 participants were enrolled between January 9, 2017, and July 23, 2019, at 67 sites in the United States and Europe. To date, the most common liver disease etiology in the cohort continues to be hepatitis C, although nearly half had a nonviral etiology, including alcohol-related liver disease or nonalcoholic steatohepatitis. Most included patients were diagnosed at an early stage (Barcelona Clinic Liver Cancer Stage [BCLC] 0/A), but only approximately one third underwent curative treatment. Systemic therapy has been used in 7.3% of enrolled patients, including 45.7% of those with BCLC stage C tumors. Conclusion: Overall, the TARGET-HCC cohort allows for the assessment of patient characteristics and investigation of new treatment paradigms and sequencing with existing agents as well as novel regimens for HCC.
| S-EPMC7917285 | biostudies-literature