The data that SKEZI can collect

Real-life data are data obtained in everyday practice, outside a strict experimental framework. These data reflect the effect of a procedure or a health product in real life, freeing us from the highly categorized populations of clinical trials. They can be a major leverage for improving practices, for continuous progress in collective knowledge, and for regulation through the quality and relevance of care°.
The SKEZI solution enables the collection of different types of real-life data, including (but not limited too), PROMs, PREMs, and satisfaction.

What are PROMs ?

PROMs (Patient-Reported Outcome Measures) are "any measure of a patient's health status that is reported directly by the patient, without interpretation by the physician or a third party" °. These measures are most often collected through validated standardized questionnaires°, and have been the subject of recommendations aimed at promoting their proper use, notably by drug registration agencies° °. These questionnaires explore important issues for patients: they can be general and therefore concern all patients, whatever their health problem, or more specific to a given pathology. They are particularly interested in topics concerning the impact on their quality of life (QoL or Health related QoL - HRQoL) or in more specific dimensions such as physical capacities. They can also measure parameters related to a specific pathology.

For instance:

- Quality of life by EQ-5D° or AQoL°
- Symptoms such as pain (NPRS)° or tiredness (FSS)°
- Disease severity, e.g. depression (K10°, PHQ2°) or anxiety (GAD°)
- Functional capacity by WHODAS 2.0° or ODI°
- Self-efficacy assessment by GSE°

Références
Icône flèche pour descendre sur la page
  1. 1.Patrick DL, Burke LB, Powers JH, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007;10(Suppl. 2):S125–37
  2. 2.Porter ME et al, Standardizing Patient Outcomes Measurement, NEJM, 2016
  3. 3.U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006

There are two types of PROMs :

1. Generic PROMs
can be administered to all patient populations. The most commonly used are for health-related quality of life such as the SF-36 and the EQ-5D.
2. Specific PROMs focus on either a disease (e.g., depression, asthma, etc.), a patient group (e.g., children, cancer patients, etc.), or an outcome dimension (e.g., pain, mobility, etc.). For example:

- Disease severity, such as depression (K10, PHQ2) or anxiety (GAD7)
- Functional capacity by WHODAS 2.0 or ODI

Why measure PROMS?

During clinical practice

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

PROMs can help make care more patient-include and improve communication between clinician and patient. PROMs have a major impact when they are integrated into patient follow-up. In clinical consultations, they allow to:

On the patient's side:
· Help them share their concerns with their clinician
· Help identify symptoms that may require further investigation and management.
· Become a true actor of their health.

On the caregiver's side:
· Facilitate tracking of health outcomes over time.
· Enable comparison of a patient's results to those of other patients with the same health conditions.
· Promote shared decision making on treatments.
· Improve patient-perceived health outcomes.

In quality improvement and research

PROMs are used in research, clinical registries and quality improvement activities. They can provide information about on:

· Comparative effectiveness of non-drug treatments or interventions
· The effectiveness of quality improvement practices
· Variations in care practices, costs and outcomes among health care providers.

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

In health policy

The collection of PROMs at the national health system level is growing (link to Areas of Expertise / VBHC). These PROMs can be used by:

· Patients to inform their choice of health care providers (when PROMs information is made public).
· Regulatory agencies and manufacturers to refine the risk benefit balance of medical devices, surgical proceduresmpm or pharmaceutical products.
· Policy makers to move the health care system towards a system based on the quality of care provided ("Value Based Healthcare")

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

In clinical practice

In quality improvement and research

In health policy

References :

Icône flèche pour descendre sur la page

Dans la pratique clinique

Les PROMs peuvent contribuer à centrer les soins sur le patient et à améliorer la communication entre le clinicien et le patient. Les PROMs ont un impact majeur lorsqu'ils sont intégrés dans le suivi des patients. Dans les consultations cliniques, ils permettent de :

Du côté du patient :
· Aider à partager ses préoccupations avec son clinicien.
· Contribuer à l'identification de symptômes qui pourraient nécessiter des examens et une prise en charge plus poussés.
· Devenir un véritable acteur de sa santé

Du côté du soignant :
· Faciliter le suivi des résultats de santé dans le temps.
· Permettre de comparer les résultats d'un patient à ceux d'autres patients souffrant des mêmes problèmes de santé.
· Favoriser la prise de décision partagée sur des traitements alternatifs.
· Améliorer les résultats de santé perçus par les patients.

Dans la pratique clinique

Les PROMs sont utilisés dans la recherche, dans les registres cliniques et dans les activités d'amélioration de la qualité. Ils peuvent apporter des informations sur :

· L'efficacité comparative de traitements ou d’interventions non-médicamenteuses
· L'efficacité des pratiques d'amélioration de la qualité
· Les variations des pratiques de soins, de coûts et de résultats entre les prestataires de soins de santé.

Dans la pratique clinique

La collecte de PROMs au niveau du système de santé national tend à s’accroitre (lien vers Domaines de compétences / VBHC). Ces PROMs peuvent être utilisés par :

· Les patients pour éclairer leur choix de prestataires de soins de santé (lorsque les informations PROMs sont rendues publiques).
· Les organismes de réglementation et les fabricants pour affiner la balance bénéfice-risque des dispositifs médicaux, des techniques chirurgicales ou des produits pharmaceutiques.
· Les décideurs pour orienter le système de santé vers un système basé sur la qualité des soins fournis (« Value Based Healthcare »)

Examples of PROMs collection initiatives in France

Recherche

· La plateforme de recherche publique ComPaRe (https://compare.aphp.fr/) de l’AP-HP permet à des patients atteints de maladies chroniques de participer de façon volontaire à des questions de recherche en répondant à des questionnaires en ligne PROMs.

Associations de patients

· Des associations de patients comme Renaloo et sa plateforme Moi Patient (https://www.moipatient.fr/) proposent des questionnaires types PROMs.

Soins courants

· En France, dans le cadre des forfaits alloués pour la prise en charge des patients atteints de maladie rénale chronique, le questionnaire PROMIS-29 est administré.
· Des expérimentations nationales innovantes pour certaines chirurgies promeuvent l’utilisation systématique de PROMs.

https://www.has-sante.fr/upload/docs/application/pdf/2019-10/iqss_2019_aide_utilisation_proms_eds.pdf

Research

· The public research platform ComPaRe of the AP-HP allows patients with chronic diseases to voluntarily participate in research questions by answering online PROMs questionnaires.

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

Patient Associations

· Patient associations such as Renaloo offer PROMs-type questionnaires.

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

Routine care

· In France, the PROMIS-29 questionnaire is administered within the framework of the packages allocated for the management of patients with chronic kidney disease.
· Innovative national experiments for certain surgeries are promoting the systematic use of PROMs.

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

Research

Patient Associations

Routine care

What are PREMs?

1.https://doi.org/10.1016/j.healthpol.2016.02.008.
2.https://doi.org/10.1371/journal.pone.0202911.
3.https://doi.org/10.1136/bmjqs-2020-011219.
4.Epstein RM, Franks P, Fiscella K, Shields CG, Meldrum SC, Kravitz RL, et al. Measuring patient-centeredcommunication in patient-physician consultations: theoretical

PREMs (Patient-Reported Experience measures) are objective measures of patient's experience. Unlike PROMs, PREMs are focus in how the patient perceives their care, in the description of the events that took place: PREMs make it possible to understand the whole patient's interaction with the care system.

There are two types of PREMs:

1. Generic PREMs
are design for all patients. For example:
· Time spent waiting for a consultation°
· Access to care (distance from health facilities, difficulty finding the right doctor, etc.)°.
· Patient involvement in medical decisions°.
· The quality of communication°

2. Specific PREMs focus on the patient experience for particular diseases. For example:
· Knowledge of the diabetes treatment plan and care pathway
· Support to manage long-term patient follow-up

1.https://doi.org/10.1016/j.healthpol.2016.02.008.
2.https://doi.org/10.1371/journal.pone.0202911.
3.https://doi.org/10.1136/bmjqs-2020-011219.
4.Epstein RM, Franks P, Fiscella K, Shields CG, Meldrum SC, Kravitz RL, et al. Measuring patient-centeredcommunication in patient-physician consultations: theoretical

Why measure PREMS?

PREMs are used to measure the quality of care. They allow to:

For the health care system

· Identify areas for improvement in the organization of care

· Better quantitation evaluation of health professionals' practices

· Measure resource allocation needs for public health decision makers

For customers

· Emphasize the dimensions that really matter to them

· Get the feed back from previous customers when they face the same need

For the health care system

- Identify areas for improvement in the organization of care

·Better quantitative evaluation of health professionals' practices

- Measure the needs in terms of resource allocations fore santé publique

For users

· Emphasize the dimensions that really matter to them

- Know the experience of other users before them for the same need

Examples of PREMs collection initiatives in France

In France, the e-Satis system allows for the collection of patient-perceived quality (PREMs). It has been implemented since 2016 by the French National Authority for Health on a national scale, in patients who have been hospitalized. The e-Satis indicators mainly measure the satisfaction and experience of hospitalized patients. They do not measure clinical outcomes or the health status felt by the patient.

Satisfaction

What is satisfaction?

Patient satisfaction reflects the degree of agreement between the patient's expectations of care and the perception of the quality of care provided. It depends on the patient's preferences, level of health, characteristics and culture, in addition to the quality and outcome of care. Patient satisfaction is different from experience in that satisfaction is considered more subjective. For example, despite negative experiences, patients may be satisfied with their care; the opposite is also possible. 

Why collect it?

The study of satisfaction is an important step in the adaptation of a service offer such as care. Satisfaction surveys ask individuals about various important points to improve the quality of the service provided. Patient satisfaction is measured by instruments such as self-administered questionnaires. Difficult to apprehend on an individual basis because it is very subjective, it provides a comprehensive view of the quality of care when combined with PROMs and PREMs.

What is satisfaction?

Patient satisfaction reflects the degree of agreement between the patient's expectations of care and the perception of the quality of care provided. It depends on the patient's preferences, level of health, characteristics and culture, in addition to the quality and outcome of care. Patient satisfaction is different from experience because satisfaction is considered more subjective. For example, despite negative experiences, patients may be satisfied with their care; the reverse is also possible. 

Why collect it?

The study of satisfaction is an important step in the adaptation of a service offer such as care. Satisfaction surveys ask individuals about various important points to improve the quality of the service provided. Patient satisfaction is measured by instruments such as self-administered questionnaires. Difficult to apprehend on an individual basis because it is very subjective, it provides a complete view of the quality of care when combined with PROMs and PREMs.

Other real-life data

What other data can be collected?

Patients can add medical reports (consultation, complementary examination, prescription...). This allows a comprehensive approach of his environment and context. Data from IOT (watch, smartphone...) or biosensors can also be collected. These newly generate health data can be useful, especially when evaluating physical activity.

Real-life data

What are they and where do they come from?

Real-life data are data that are not collected in a strict experimental setting (link to clinical research page), but are generated in the course of routine practice, including routine care. They can come from a number of sources, for example: administrative databases, medical records, product and disease registries, patient-generated data, including home use, data collected from other sources that can provide information on health status, such as mobile devices.°

Why collect them?

To generate real-life evidence: this is clinical evidence about the use and potential benefits or risks of a medical product derived from the analysis of real-life data. Real-life evidence can be generated by different types of studies or analyses, including, but not limited to, randomized trials, pragmatic trials, or observational studies (prospective and/or retrospective).°This makes it possible, for example:
- to observe the extent to which the conditions of the trials are verified in real life
- to highlight effects that cannot be identified in clinical trials (due to the limited number of participants and time horizons)
- to confirm or invalidate the results in terms of efficacy in populations that have actually been exposed to the treatment

To improve the quality of care: the challenge of real
-life data, and in particular data collected directly from patients, goes beyond simply demonstrating the efficacy or tolerance of a product:
they can constitute a major lever for improving practices, for continuous progress in collective knowledge, and for regulation through the quality and relevance of care.°

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

In France, a rich and dynamic ecosystem: the SNDS

The National Health Data System (SNDS) was created in 2016 to expand the use of health data. It's a significant step forward in analyzing and improving population health. It includes:
- Health insurance data (the national health insurance information system - SNIIRAM)
- Hospital data (the medicalization of information systems program - PMSI) historically matched to SNIIRAM
- Databases on medical causes of death (database of the Epidemiology Center on Medical Causes of Death of the National Institute of Health and Medical Research- Inserm's CépiDC)
- Data on disability (from the Departmental Houses for the Disabled - MDPH - data from the National Solidarity Fund for Autonomy - CNSA).

Les données de vie réelle sont des données qui ne sont pas collectées dans un cadre expérimental strict (lien page recherche clinique), mais qui sont générées dans la pratique courante, notamment à l’occasion des soins réalisés en routine. Elles peuvent provenir d'un certain nombre de sources, par exemple :Des bases de données administrativesDes dossiers médicauxDe registres de produits et de maladiesDe données générées par les patients, y compris dans le cadre de l'utilisation à domicileDe données recueillies à partir d'autres sources pouvant fournir des informations sur l'état de santé, comme les dispositifs mobiles.

(source : https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)

What are they and where do they come from?

Why collect them?

In France, a rich and dynamic ecosystem: the SNDS

Real-life data are data that are not collected in a strict experimental setting (link to clinical research page), but are generated in everyday practice, particularly during routine care. They can come from a number of sources, for example:
- Administrative databases
· Medical records
·Product and disease registries
· Patient-generated data, including in-home use
· Data collected from other sources that can provide information on health status, such as mobile devices.°

The National Health Data System (NHDS) was created in 2016 to expand the use of health data and is a significant step forward in analyzing and improving population health.

It includes:
- Health insurance data (database of the national health insurance interregime information system - SNIIRAM)
- Hospital data (information systems medicalization program - PMSI) historically matched to Sniiram
·Databases on medical causes of death (database of the Centre for Epidemiology of Medical Causes of Death of the National Institute of Health and Medical Research - CépiDC of Inserm)
·Data on disability (from the departmental houses for the disabled - MDPH - data from the national solidarity fund for autonomy - CNSA).

What is done at the international level

International initiatives such as ICHOM (International Consortium for Health Outcome Measurements) or PROMIS (Patient-Reported Outcomes Measurement Information System) standardize the collection of PROMsPREMs promote their global use.

HAS has compared 13 selected systems (England, Wales, the United States of America, Canada, Australia, New Zealand, Sweden, Netherlands, Norway, Germany, Denmark, Belgium, and France).°