The REQueST tool was developed to evaluate patient registries for their suitability for health technology assessment. It contains sections on methodological information, essential standards, and additional requirements. While many aspects of registries are considered, the tool focuses on those most relevant to outcomes assessment. Key items include ensuring objectives define proper data collection and address HTA questions, outcomes are clearly defined and aligned with data standards, and analysis considers confounding factors and data cleaning. The tool allows assessment agencies to consistently evaluate registries and supports registry holders in designing robust outcomes data collection.
Call Girls Kukatpally 7001305949 all area service COD available Any Time
Evaluating Patient Registries for HTA Outcomes
1. ISPOR Europe 2018 Annual Meeting, 10-14 November. Barcelona
THE REGISTRY EVALUATION AND QUALITY STANDARDS TOOL (REQueST) FOR
HEALTH TECHNOLOGY ASSESSMENT FROM AN OUTCOMES ASSESSMENT PERSPECTIVE
Gimenez E1, Valentic M2, Espallargues M1, Rodrigues J3, Varela L4, Guzina I5, Patrick H6, Long J6
Agency for Health Quality and Assessment of Catalonia (AQuAS)1, Croatian Institute of Public Health (HZJZ)2, National Authority of Medicines and Health Products (INFARMED)3
Galician Agency for Health Technology Assessment (AVALIA-T)4, Haute Autorité de Santé (HAS)5 , National Institute for Health and Care Excellence (NICE)6
contact: emmanuel.gimenez@gencat.cat
The PARENT Framework, which provided "Methodological guidelines and recommendations for efficient and rational governance of patient registries", is a useful
reference to support an assessment of patient registries . Afterwards, in order to improve the utility to HTA and regulatory agencies, in the context of EUnetHTA
JA3 Work Package 5B2, a registry evaluation and quality standard tool (REQueST) that can be used to evaluate the suitability of registries for HTA was developed.
The draft tool items (which has a vision paper describing options for the corresponding long-term delivery, use and sustainability) were analysed considering
those having a specific focus related with outcomes assessment perspective.
The current version of the tool has:
• 8 ‘methodological’ items relating to suitability of the register for a specific purpose (section A);
• 13 ‘essential’ standards relevant to any register for regulatory and HTA purposes (section B) and
• 3 additional requirements for specific purposes (section C).
Many aspects are considered in the tool but are not focused on outcomes assessment e.g. governance, data security, dataset standards or ethical aspects.
Several items relate to outcomes assessment (in grey in the item list) and the corresponding relations are:
(1) outcomes should be related with a clinical consensus and clear objectives that define proper data collection and address specific HTA questions,
(2) outcomes must be clearly defined in a formal protocol,
(3) outcomes must be aligned with an existing data dictionary,
(4) outcomes analysis should include the consideration and identification of confounding factors and a related strategy for their management
(5) outcomes analysis should we robust with regard to the existence of a cleaning plan for missings and inconsistencies
A- METHODOLOGICAL INFORMATION CHECKLIST B- ESSENTIAL STANDARDS
C- ADDITIONAL REQUIREMENTS
Data access and sharing procedures are available, time of approval/rejection of data access is clear, registry data is shared with interested
parties from other countries or international organizations, internationally agreed minimum data set is collected and information on existence
of fees for providing access is available.
Sources of data (paper questionnaires, electronic health records, directly from
clinical examinations, paper based, paper based health records…) are identified
The ethical committee is involved in the control of data
and ethical aspects
Tools like REQueST, allow assessment agencies or notified bodies to provide and hold consistent data requirements. The tool can
also support other stakeholders like registry-holders to design robust outcomes data collection. Federated or other type of registry
holders are empowered to generate and share excellent evidence with HTA and regulatory bodies.
1: Type of registry The registry focuses clearly on a disease, condition,
medication, medical technology or procedure.
2: Objectives and research
questions
3: Geographical and
organizational setting
4: Duration
5: Data providers
6: Size
7: Inclusion and exclusion
criteria
8: Follow-up
Clear objectives are essential to define the structure
and process of data collection and to ensure that the
registry effectively addresses the important questions
through the appropriate outcomes analyses
The local, national or international level of the registry
is clearly stated, as is its setting (hospital, pharmacy,
doctor's office, patient’s home ...).
The start and end of the data collection are clearly
presented.
The main data provider is identified. The main data
included are: clinical units, laboratories, discharge
records, patients and families, groups of patients,
disability records, specialist centres, birth and death
records.
The number of subjects or persons-years needed to
assess a clinical effect is available and clearly stated.
The conditions that patients must meet to be eligible
for inclusion, and the criteria that disqualify them, are
clearly presented and justified.
Information on follow-up, duration, recruitment
rates and the possible impact on costs during follow-
up is clearly presented
The registry protocol establishes if the Study (part of
the PICOS question) is a cohort or a case-control study,
which should be justified. E.g. cohort designs follow
over time people who possess a characteristic to see if
they develop a particular endpoint or outcome.
GOVERNANCE
1: Registry protocol
2: Governance
structure
3: Quality assurance
plan
4: Financial plan
DATA AND INFORMATION
5. Data collection
6-10. Data quality
11-12: Protection,
security and safety
LEGAL AND ETHICAL ISSUES
13: Ethics
The registry should have a study protocol that includes the
objectives, target population, exposure, results and sources,
and also sections on the management of bias and the
expected analysis
Minimum requirements are a steering committee or similar
governing body, as well as a data quality team or a body with
equivalent responsibilities (not including employees of the
manufacturers).
There must be a quality assessment plan that includes criteria,
indicators and control mechanisms.
Summary of the last 2 years expenses and income, financial
security until the end of the compilation of the evidence
must be demonstrated through a financial plan. Funding
sources must be identified.
There must be a data collection procedure description (reporting
dynamics, data needed to be collected and how, means of data
transmission, established controls for acquired data, access rights).
Identifying attributes and essential variables should be included and
enable to answer the evidential gap.
These items address security controls: controls of
administrative information policy, human resources, access,
data protection and physical and environmental security.
The informed consent document must explain to the
potential participants: the nature and purpose of the registry,
why they may be eligible to participate in the registry, the
risks, benefits of participation and alternatives, and their
rights as participants.
The suitability of the items in each
section is evaluated using a set of
corresponding categories.
Introduction
Methods
Results
Conclusions
Minimum dataset
Data dictionary
Data standards
Potential confounders
Data cleaning
Items directly related with adequate
outcomes assessment
2. Data sources
1. Data sharing
3. Ethics
Data elements are well defined and documented with an inventory for a
clear outcomes analysis..
Data specifications are consistent with national and international data
standards facilitating consistency, comparability, data exchange and reuse.
Variables influencing exposure and outcome in the analyses are defined.
Cleaning plan for missings and inconsistencies including an explanation
of whether the ommission of missing data may potentially bias
outcomes analysis results has to be provided.
Main clinical outcomes (part of the PICOS question)
should be reported in accordance with scientific
consensuses.
Yes meets the HTA study
Does not meed HTA study need
Needs development
Relevant but not directly usable
Meets the standard
Does not meed the standard
The suitability of the items in each
section is evaluated using a set of
corresponding categories.
Satisfactory
Fail, unusable
Needs further information or
development
The suitability of the
items in each
section is evaluated
using a set of
corresponding
categories.
Poster_REQueST_Tool_ISPORv2018 1200 x 675.indd 1 09/11/2018 18:29:19