Report written by Duska Glavas (Split, Croatia)
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J.N. TROCHU (Nantes, FR):ADVANTAGES AND DISADVANTAGES WITH A REGISTRY IN HEART FAILURE
Definition: registry is a organized programme for the collection, storage and dissemination of data collected on identifiable individuals for a specific purpose. Different types of registries prospectively and systematically collected data for a group of patients with a common disease or therapeutic intervention. "Good" registry should function as a clinical support system and provide data as freedback to physicians.
Advantages of HF registries:
1) Focus on management and the use of treatment guidelines, rapidly collect data in large numbers of patients, the views of multiple clinical and demographic aspects.
2) Improve quality of care: information on the physician's adherence to guidelines, patients outcomes, compare population with that of other clinicians.
3) Useful for population healthcare improvement by hypothesis generation or retrospective studies: estimation of mortality, morbidity, resource utilization in every day practice, compare disease management in different countries, provide insights for clinical studies and lead to clinical trials.
Participating to a registry have an important impact on continuous medical education.
RARE DISEASE REGISTRIES-cardiomyopathies
Registry is a early step in the understanding of the natural history of disease, identification of biomarkers and treatment, building a cause for future research and genetic studies. Registry contain important results for government departments, research centers, and networks for rare disease to support public health functions.
DESCRIPTIVE REGISTRIES
One of the descriptive registries are VALIANT registry. Registry is an international project on heart failure and left ventricular systolic dysfunction complicating myocardial infarction.
QUALITY IMPROVEMENT REGISTRIES
ADHERE is a large, national database in the United States describing the clinical characteristics, treatment and outcomes of patients hospitalized with acute HF (>50 publications). Specific objectives:
1) describe the demographic and clinical characteristics of HF patients
2) to characterize the initial emergency department evaluation and management
3) to identify medical care practices associated with health outcomes
4) to characterize trends over time in the management of acute HF
5) to assist hospitals in evaluating and improving quality of care for HF patients.
Some announcement results from ADHERE Registry: Renal dysfunction is a hallmark of HF population (30% of patients have a history of renal insufficiency).
OPTIMIZE-HF is a program to initiate lifesaving treatment in hospitalized patients with HF (>25 publications):
1) design to improve care and education of hospitalized HF patients, accelerate the initiation of evidence-based (EB) HF guideline therapies by administering them before hospital discharge, and to amalioration the standard of HF care in the hospital and outpatients
2) a significant proportion of HF patients are not receiving guideline-recommended treatment (initiation of beta-blockers (BB) is often delayed)
3) recent studies suggest: BB can be safely and effectively initiated in patients with HF before hospital discharge,
clinical outcomes are improved, with lower mortality and hospitalization, with no increase in hospital lenght of stay or worsening of HF.
QUALITY IMPROVEMENT REGISTRIES in the outpatient domain
IMPROVE HF-is a program for improving the use of EB HF therapies in the outpatient setting. IMPROVE HF is designed to characterize the current outpatient management of systolic HF (>15 publications).
Findings: Use of ACE inhibitors/sartans (ACEI/ARB) and BB in the outpatient cardiology practice is higher than previously reported. Baseline use of EB therapy in the outpatient cardiology practice is still below optimal, particulary for: aldosterone antagonist, ICD/CRT device therapy and HF education.
The Swedish Heart Failure Registry (S-HFR; RiksSvikt; 2003): 30254 patients from 62 hospitals and 60 outpatients clinics. Some of the tested possibilities: assocation of candesartan vs. losartan with all-cause mortality in patients with HF (30254 patients from 62 hospitals and 60 outpatients clinics).
OFICA-France/ Groupe "Insuffisance Cardiaque et Cardiomyopathies";170 hospitals and 1818 selected patients
Objectives: epidemiological data and treatment on acute HF illustrating the "real life" (all patients, different types of hospitals and departments; before, during, and after hospitalization).
Intention is to continue the survey into a permanent registry.
Possibly disadventages: Before considering a registry we should have: motivations and commitment. Multinational registries can employ houndreds of people with lot of expense. Data collection and documentation have to be conducted for many years before a registry becomes productive for epidemiological purpose. Small pilot investigations can help determine the data source to meet purpose of the registry.
More efficient and cheaper alternatives to registries should be considered (cross sectional surveys?).
EURObservational Research Programme: The Heart Failue Pilot Survey (ESC-HF Pilot)
This programme improve our knowledge on the epidemiology and outcomes of real-word HF patients and capture all clinical information of patients with chronic HF, including acute episodes. The primary objective is to describe the epidemiology and management of outpatients and inpatients with HF from 12 European countries (136 centers with 5118 patients: 37% in-hospital and 63% outpatients).
Randomized clinical trials-RCT vs. registries
Registry will provide answere to the questions asked, and will never complete replace the RCT. For any comparison of treatment effectiveness RCT remain the ideal circumstance. Strict inclusion/exclusion criteria in RCT limits applicability to many patient groups (as elderly).
In registries, treatment may change over time. Some variables that may affect choice of medications and strategies: hypertension, diabetes, duration of HF, renal function. Despite covariate and propensity adjustment, residual confounding cannot be excluded and documentation may be incomplete. Nevertheless, registry have advantages compared with RCT and provides information useful for everyday clinical practice for unselected population. Registry reflect actual clinical practice and avoid the selection bias that characterises RCT.
U.G. DAHLSTRÖM (Linkoping, SE):POTENTIAL VALUES OF REGISTRY IN HEART FAILURE
Dahlmström discussed about advantages of registry and randomized controlled clinical trial (RCT).
Advantages of RCT in heart failure (HF) patients: good way of studying treatment effects and differences.
Disadvantages of RCT: inclusion and exclusion criteria, limited generalizability due to selected patients, treatment effects beyond the study period are not evaluated, and large differences due to regional distinction.
Characteristics of the HF registry: no inclusion or exclusion criteria (include all patients), no assignment to a special treatment, individual characteristics of the patients decide the treatment.
Evaluation of data from HF registries: to adjust for pre-treatment differences, compensate for different confounding factors (by using covariance regression analysis), and propensity score analysis (the score is calculated by using logistic regression methods). The goal is to resemble the situation in a RCT.
Some differences between HF patients enrolled in RCTs and those of clinical practice
Mean age in RCT is 60-65 year (y), in community >75 y. Renal dysfunction is usually exclusion criteria in RCT, but in community 20-30% patients have renal dysfunction. Drug prescription in RCT is optimized, and in community is suboptimal. Treatment duration in RCT is 1-3 years, and in community is life long. One year mortality in RCT is 9-19%, and in community 25-30%.
Data from Sweden Registry: mean age 75 y (women 78 y, men 73 y); men 61%, women 39%; 22% >85 y; 85% have performed an echocardiography (22% have an EF >50%). Anaemia as well as renal dysfunction increase the one-year mortality.
Data from HF registries have important functions: the analysis how guidelines are followed in the units, and to collect data on large numbers of patients in a particular moment. This data enable clinicians to compare their results with other physicians. Failure to give guidelines treatment without good reasons is a medical error.
The adventage of a HF registry is the creation of a database that includes information about the parameters from a large number of HF patients, making it possible to initiate new hypothesis, projects and trials. For example, in Swedish HF Registry it was found that the use of candesartan compared with losartan was associated with a lower mortality risk (JAMA 2011). Information from HF registres have important functions by collecting follow-up data on mortality, morbitidy, medication, and quality of life in different subgroups of patients. The media, general public, and politicians are often interested in various aspect of registry data.
In Sweden there are more than 70 registries partly financially supported by the government-most of them are internet-based. Sweden is an ideal country for establishing health care registries since it is permitted to link registry data to other official statistics on mortality, morbidity and drug prescription. Money is not paid for registration, but for running the registries and maintaining the computer-system used.
Quality control in Registry: central bord (for guidance of the registries) and regional centres (with epidemiologists, statisticians, computer experts). They invest more money in the registries based on results. Centers are focused on quality control, development, and research (goal is 4-7 published papers/year).
Targets for the Swedish HF registry:
1) Quality control: >85% HF patients in the registry, data should be automatically retrieved from the computerized documentation system, regularly random monitoring the data.
2) Quality development: improve the management of HF patients, project directed to primary health care.
3) Research: stimulate to research based on the data base, connect more units to the registry biobank, publish scientific papers, perform education (in epidemiology and statistics).
The majority of Swedish HF patients have a correct diagnosis and an optimal treatment.
Conclusions: There is a value of having a HF Registry. Registry increase our knowledge about HF and we can retrieve information about the extend to which clinicians follow recommended guidelines. Representativity of collected data is very important. It enables comparisons of differences between hospitals and primary care.
The adventage of a HF registry: for the patient-increased survival and quality of life, less hospitalization; for the society-reduced costs for the treatment of HF patients.
J. DROZDZ (Lodz, PL):SHOULD WE COLLECT PATIENT FOCUSED VARIABLES?
Aims of international registry:
1) to compare the data between countries (european and "the rest of the world"), and with the current recommendations.
2) to analyse the reasons for differences (one country has better healthcare, doctors, or doctors participating in the registry?). The recommendations clearly indicate the rules of treating patients with HF. Nevertheless, the treatment depends on personal experiences, too.
What is the rate of adherence to EB treatments of patients with HF in Europe and Poland? Analysed treatments: beta-blockers-BB, ACE inhibitors-ACE-i, sartans-ARB, aldosteron antagonists-AA, ICD, CRT.
Data about chronic HF and BB
EUROPE: 4702/4949=95% to be prescribed according to guidelines and personal experience; 86% actually prescribed.
POLAND: 1101/1159=95% to be prescribed according to guidelines and personal experience; 96% actually prescribed.
Data about chronic HF and ACE-i
EUROPE: 85% to prescribed according to guidelines and personal experiences; 72% actually prescribed.
POLAND: 85% to prescribed according to guidelines and personal expiriences; 92% actually prescribed.
Data about chronic HF and AA
EUROPE: 50% to be prescribed according to guidelines and personal experiences; 87% actually prescribed.
POLAND: 50% to be prescribed according to guidelines and personal experiences; 135% actually prescribed.
Data about chronic HF and ICD
EUROPE: 37.4%, to be prescribed according to guidelines and personal experiences; 33% actually implanted.
POLAND: 27% to be prescribed according to guidelines and personal experiences; 25% actually implanted.
Data about chronic CHF and CRT
EUROPE: 6.2% to be prescribed according to guidelines and personal experiences; 23% actually implanted.
POLAND: 10% to be prescribed according to guidelines and personal expiriences; 9% actually implanted.
Conclusions: Adherence to the current recommendation in Poland is excellent regarding the pharmacological treatments, over-optimal regarding the aldosteron antagonist, and not optimal regarding the device therapy. Results of registry is important for identifications of differences between theory and practice and could be the basis in creating conference session topic and educational material.
A.P. MAGGIONI (Florence, IT):PRESENTATION OF A CONCEPT FOR A EUROPEAN HEART FAILURE REGISTRY (Aldo P Maggioni is chairman of the Pilot and Long-Term HF registry of the ESC EurObservational research Programme)
Why an European registry on HF?
General argumetations: increased surveillance of CV disease, facilitate interoperability of health data within and across countries, monitor standards of care and assess trends, enable comparison of data on a national and an international level, promote best practices, and optimize health care resources.
Specific argumentations: HF patients have a high burden of mortality and hospitalizations, reduced quality of life and increasing healthcare costs.
Registries and surveys conducted in patients with acute and chronic HF, single centre or in a single country. Purpose of the registry is to capture all relevant clinical information, answer questions generally not addressed by trials and identify unmet clinical needs.
General concerns regarding observational studies: consecutiveness, representativeness, completeness of follow-up, not only descriptive features, but credible answers to questions and independency from fund sources.
Characteristics of the new ESC EurObservational research Programme
Part of the ESC duty to provide a better understanding of medical practice in Europe. Centralized at EORP Department and conducted in collaboration with ESC Constituent Bodies (National Societies, Associations and Working Groups). In cooperation with (but independent from) Industry (database ownership, publication policy).
Models of Registries:
1) General: to assess the management of disease of major epidemiological impact on public health
2) Sentinel: to assess the impact of intervantional procedures, imaging techniques and therapeutic tools
3) Specific topics: to assess epidemiology and management of rare and complex conditions.
Provisional Programme:
2009: Pregnancy in cardiac diseases
2010: HF long-term, Pregnancy in cardiac diseases, Atrial fibrillation ablation pilot, Percutaneous valve pilot
2011: HF long-term, Pregnancy in cardiac diseases long-term, Atrial fibrillation ablation medium-term, Percutaneous valve pilot, Angina/IHD pilot, Cardiomyopathies long-term
2012: HF long-term, Pregnancy in cardiac disease long-term, Atrial fibrillation ablation medium-term,
Percutaneous valve long-term, Angina/IHD long-term, Cardiomyopathies long-term, Atrial fibrillation pilot, EUROASPIRE IV (if fully supported).
Enrolment period of HF Pilot study: October 2009 to May 2010.
Representativeness of 12 European countries in HF Pilot study:
1) countries: 4 Western (Austria, France, Germany, the Netherlands), 2 Eastern (Romania, Poland), 3 Southern (Greece, Italy, Spain), and 4 Northern (Denmark, Norwey, Sweden);
2) characteristics of the centers: defined number (1 center/2 million people), ratio for centers (1 with cardac surgery, 2 with intervantional cardiology (PCI, CRT, ICD), and 3 with no surgery or intervantional cardiology)
HF Pilot study inluded 136 centers with 5118 patients: 1892 (37%) in-hospital patients (AHF), and 3226 (63%) out-patients (CHF). One-year follow-up is still ongoing (collection of follow-up data till the end of May 2011; data base locked by the end of June 2011-06-08; statistical analysis in July-August; final results presented in Paris at the ESC Congress 2011).
From the Pilot to the Long-term registry (data collection started on April 14, 2011)
Aim of the HF Long-term registry: to describe the demographic, clinical and biological characteristics and the use of resources in outpatients and inpatients with HF followed by a representative setting of ESC cardiology centers.
Specific attention will be focused on: preserved EF, co-morbidities (such as COPD and diabetes mellitus), better definition of profiles patients with HF, cardiogenic shock, prognostic models, reasons for non utilization or under dosage of EB treatments with respect to the recommendations of guidelines.
Prescribed pharmacological treatments in HF Pilot Registry (3226 pts)(%): ACE-i 64.9, ARBs 27.0, ACE-i/ARBs 88.5, BB 86.7, Digitalis 20.6, Diuretics 82.8, AA 43.7, Nitrates 15.6, Antiplatelets 47.9, Oral antikoagulant. 42.6.
Realisable dosages of some prescribed drugs: ramipril 38.2%, losartan 19.7, valsartan 16.7.
Results from HF Pilot about ICD implantations:
2965 total population of out-patients with chronic HF; 37.4% (1109) patients (NYHA II-III, EF <35%, at least 2 neurohormonal blockers) have indications for ICD according to guidelines; only 32.7% (363) actually implanted.
In HF long-term Registry, up to May 19, 2011, participating 28 countries.
The concept for an ESC Heart Failure registry: independent source of data that allows to assess and monitor standards of care, comparisons on an international level, optimize best practices, address unanswered clinical questions, and identify unmet needs to focus future research.
HF Registry enable representativeness and completeness of follow-up data, quality of data comparable to that of the trials, and information of the HF clinical presentations.