A Consensual Paradigm for Defining and Evaluating NPI, the NPIS Model

All definitions

Given the complexity of the NPI topic and the divergent understanding of concepts depending on specialty, experience, and culture, the expert committee deemed it useful to create an open-access glossary defining the concepts used.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Acceptability

Acceptability refers to whether the individuals delivering or receiving a Non-Pharmacological Intervention (NPI) consider it appropriate for achieving its health objective.

Adherence

The extent to which study participants follow the instructions given to them for their participation in the clinical trial.

Adoption

Adoption encompasses the absolute number, proportion, and representativeness of the settings and professionals that will adopt the Non-Pharmacological Intervention (NPI). It is an organizational measure. To assess the impact of an NPI, it is crucial to understand how different settings vary based on available resources, the level of expertise, and commitment to the intervention. If there are differences between the sites participating in the implementation study, the NPI is adopted differentially. Adoption is typically evaluated through interviews, structured surveys, or direct observation.

Adverse Effects

Any unfavorable medical event in a person participating in a study, including any abnormal sign (for example, an abnormal physical examination or laboratory test), symptom, or disease, associated with and occurring consecutively to the person's participation in the study, regardless of whether it is considered related to the participation in the study or not.

Adverse Events

Any unfavorable medical event in a person participating in a study, including any abnormal sign (for example, an abnormal physical examination or laboratory test), symptom, or disease, associated with and occurring consecutively to the person's participation in the study, whether or not it is considered related to the participation in the study.

Adherence

The extent to which participants in the study follow the instructions provided to them for their participation in the clinical trial.

Alpha Risk

This is the risk of rejecting the null hypothesis (H0) when it is true; in other words, it is the risk of detecting an effect that does not exist. A 5% risk is commonly used, although it should be noted that this threshold is entirely arbitrary and has no theoretical foundation. However, it is reasonable to estimate that at a 5% risk, the probability that the observed difference is due to sampling fluctuations is sufficiently low to accept H0. Reducing this risk, for example to 1% or 0.1%, will make the study more robust. In the case of multiple testing, it is important to anticipate the inflation of the alpha risk.

B

Blinding

Blinding is a procedure in which one or more parties involved in a clinical trial are unaware of the treatment groups to which participants have been assigned, in other words, which treatment they have received. Blinding is an important aspect of a trial, as it helps to avoid and prevent both conscious and unconscious biases during the design and execution of the clinical trial. However, it is recommended to specifically describe which stakeholders have been blinded for greater transparency (Monaghan, 2021).

Bias

Any element (point of view, preference, etc.) that prevents an impartial judgment in how a measurement, evaluation, procedure, or analysis is performed or reported. Bias can be seen both as a measurement error, especially when it can be avoided, or as information about the intervention or population studied, particularly when it helps to better understand certain processes (of measurement, adaptation, etc.) or characteristics of the sample.

Blinding

Blinding is a procedure in which one or more parties in a clinical trial are unaware of which treatment groups participants have been assigned to, in other words, which treatment they received. Blinding is an important aspect of a trial, as it helps to avoid and prevent both conscious and unconscious biases during the design and execution of the clinical trial. However, it is recommended to specifically describe which stakeholders were blinded for greater transparency (Monaghan, 2021).

Blinding

Beta Risk

This is the probability of not rejecting the null hypothesis (H0) when it is false; in other words, it is the risk of failing to conclude the presence of an effect. Several reasons can explain this beta risk: a sample that is too small relative to the magnitude of the observed effect, sampling issues, etc. The beta risk is often exacerbated by the misinterpretation of the non-rejection of H0: not rejecting H0 does not mean that the alternative hypothesis has been shown to be false, but simply that we have failed to demonstrate that it is true (which is fundamentally different).

C

Causality

Causality is the influence by which one event causes another, which is therefore its consequence. A cause can be sufficient, meaning it can independently produce the consequence, or it can be insufficient, requiring combination with other elements to produce the consequence. To differentiate a simple correlation from a cause, Bradford Hill proposed in 1965 a series of minimum criteria to suspect causality, including:

Strength of association (the greater the magnitude of effects related to the association, the more likely a causal link is, although a weak effect does not imply an absence of causal link);
Consistency of association (its repetition over time and space);
Coherence (the same observations are made in different populations);
Specificity (a cause produces a particular effect in a specific population in the absence of other explanations);
Temporal relationship (causes must precede consequences);
Plausibility (biological plausibility, the possibility of explaining the mechanisms involved);
Experimental evidence (in animals or humans).

Coordinating Center

A team that coordinates the planning and operational aspects of a multicenter study.

CNIL

In the digital realm, the National Commission on Informatics and Liberty (CNIL) is the French regulatory authority for personal data. It assists private and public entities in implementing their compliance with personal data protection. CNIL receives and processes complaints from individuals and has the authority to conduct on-site or online inspections. It can require an entity to rectify its processing (formal notice) or impose sanctions (fines, etc.).

Cohort

A cohort is a scientific research tool that involves following a population with common characteristics over time in order to identify the occurrence of health-related events of interest (disease or dysfunction of the body).

Committee for the Protection of Persons

The Committees for the Protection of Persons (CPP) are responsible for providing a prior opinion on the ethics and validity conditions of any research involving human subjects, according to the criteria defined by Article L 1123-7 of the Public Health Code (CSP).

If the opinion is unfavorable, it prohibits the initiation of the research.

The CPP evaluates:

The conditions under which the research sponsor ensures the protection of individuals, particularly participants,
The justification and relevance of the research project,
Its methodological quality.

Comorbidity

It is defined as the simultaneous presence of multiple diseases in the same person, each of which requires medical care.

Correlation

Statistical correlation refers to the relationship between two or more factors, implying the absence of independence between them. Correlation can also be coincidental between two elements, where chance may cause independent elements to change together, or these elements could each be causal to a third element. Identifying a correlation is not sufficient to demonstrate causality, although causality necessarily implies a correlation.

CPP

The conditions under which the research sponsor ensures the protection of individuals, particularly participants,
The justification and relevance of the research project,
Its methodological quality.

CRF

A printed, optical, or electronic document (eCRF) designed to capture all the information required by the protocol for a study.

Controlled Clinical Study

A clinical trial in which at least one group of participants receives a test intervention (intended for evaluation), while at least one other group simultaneously receives a control intervention (placebo intervention, standard care, or another intervention).

Case Report Form

A printed, optical, or electronic document (eCRF) designed to capture all the information required by the protocol for a study.

Control Group

In the context of a clinical trial, this refers to the group of individuals receiving an intervention that is different from the one being evaluated, which serves as a comparison intervention. This control can take the form of a sham intervention (sham, placebo), standard care, or another intervention.

Control Group

In the context of a clinical trial, this refers to the group of individuals receiving an intervention different from the one being evaluated, which serves as a comparison intervention. This control can take the form of a sham intervention (placebo), standard care, or another intervention.

Confidence Interval

The X% confidence interval represents the range of expected values if the protocol were replicated across X different samples. (For example, a 95% confidence interval indicates where the studied value would fall in 95 out of 100 samples of participants.)

Conflicts of Interest

A conflict of interest exists when individuals involved in conducting, reporting, monitoring, or reviewing research have financial, personal, or other interests related to their beliefs or careers that they could benefit from, depending on the outcomes of the study.

Chronic Disease

A chronic disease is a long-lasting condition that evolves and impacts daily life. It can lead to disabilities or even serious complications. Examples include long-term illnesses (LTI).

Concomitant Treatment

A concomitant treatment refers to any prescribed or over-the-counter medication and complementary care that a study participant takes or receives simultaneously with the intervention being evaluated in the study. This information can be collected at the time of inclusion and during the study. Some studies may exclude an individual from participation for this reason.

D

Data Safety Monitoring Board (DSMB)

A Data Safety Monitoring Board (DSMB) is a group of independent experts responsible for ensuring patient safety during a clinical trial. This board regularly reviews clinical trial data (and its members have access to unblinded data in the case of blinded studies) and produces reports on any unexpected events and the performance of clinical studies.

Data Management

The process of handling the data collected during a clinical trial, from the development of study forms/CRFs to the locking of the database and its transfer to the statistician for final analysis.

Data Management Process

A strategy that documents the processes involved in data flow, from collection to analysis. It describes the software and hardware systems, as well as quality control and validation of these systems, where applicable.

Data and Safety Monitoring Process

A strategy included in the study grant application that establishes the overall framework for data and safety monitoring, how adverse events will be reported, and, where applicable, how national guidelines and supranational regulations will be adhered to.

E

Eligibility Criteria

Inclusion and exclusion criteria define the characteristics of individuals who should be included in a study. The exclusion criteria are not redundant with the inclusion criteria. Specifically, the inclusion criteria define the population intended to be included in the study. The exclusion criteria aim to prevent participants who would otherwise meet the inclusion criteria from being included. (For example, an inclusion criterion might be the required age of study participants between 65 and 85 years. An exclusion criterion could be the use of a non-pharmacological intervention within 3 months prior to the study).

Exclusion Criteria

Effectiveness

An indication that the clinical trial intervention produces the desired therapeutic effect on the disease, condition, or symptom being studied, based on real-world health data.

Efficacy

An indication that the intervention in the clinical trial produces a desired therapeutic effect that is of sufficient magnitude on the disease, condition, or symptom being studied.

Efficacy in Real Life

An indication that the intervention in the clinical trial produces a desired therapeutic effect on the disease, condition, or symptom being studied based on real-world health data.

Efficacy

An indication that the intervention in the clinical trial produces a desired therapeutic effect of sufficient magnitude on the disease, condition, or symptom being studied.

Evidence Based Medicine

The concept of Evidence Based Medicine (EBM) was developed by epidemiologists at McMaster University in Canada in the early 1980s. It aims to base medical decisions on theoretical knowledge, judgment, experience, and scientific evidence. The notion of evidence corresponds to knowledge derived from clinical research conducted in the field of disease treatment, which is based on valid and applicable results in current medical practice.

Evaluation Model

In epistemology, a paradigm is a way of seeing things, a coherent model of the world based on a defined foundation. It serves as a standardized framework.

F

Free Consent

Before giving consent to participate in a study, the patient or participant must receive honest, clear information that is appropriate to their level of understanding from the healthcare and medical or research teams, while being free from any pressure or coercion.

Formatted Data for Publication

Data derived from measurements taken during the study that have been modified during analysis for various reasons: readability, comprehension, anonymization or pseudonymization, aggregation, etc.

Feasibility

It refers to the practicality and achievability of a study or an intervention.

FDA

The agency of the U.S. Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and products that emit radiation. Its European equivalent is the European Medicines Agency (EMA).

Fidelity

Reliability and validity of the intervention in comparison to that planned in the implementation study, ensuring that the intervention assessed in the study is sufficiently close to that conducted in real life.

Food and Drug Administration

An agency of the U.S. Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and products that emit radiation. Its European equivalent is the European Medicines Agency (EMA).

G

Good Clinical Practice

These are ethical, deontological, and scientific quality standards in research (in health). They are standards that apply to the design and conduct of studies involving human participants, as well as to the recording and presentation of data related to these studies. Adhering to these standards ensures that the rights, safety, and well-being of individuals participating in the study are protected, in accordance with the principles derived from the Declaration of Helsinki, and that the data on clinical trials are reliable.

General Data Protection Regulation (GDPR)

The GDPR regulates the processing of personal data within the territory of the European Union. The legal context adapts to keep pace with the evolution of technologies and our societies. This new European regulation builds on the French Data Protection Act of 1978 and strengthens citizens' control over the use of their personal data. It harmonizes rules across Europe by providing a unique legal framework for professionals. It enables them to develop their digital activities within the EU based on user trust.

GDPR

H

Health Economic Analysis

The purpose of this analysis is to inform the choice between one or more care options. It involves comparing the medical benefits of a procedure, practice, medication, innovative organization, or screening program, etc., with the costs they incur. This provides public authorities and healthcare professionals with information about the economic consequences of diagnostic or therapeutic practices, as well as screening programs. Through simulation and modeling, this evaluation can have a predictive nature and serve as a decision-making tool before a new treatment becomes available to the population and relevant professionals.

Health Behavior

Any behavior or activity that is part of daily life but influences a person's health status. These are social behaviors related to health, in the sense that these behaviors are not necessarily consciously directed towards improving health, but they have an impact on health. Almost all behaviors or activities can influence health, and in this context, it may be helpful to consider health-related behaviors as an integral part of the lifestyles of an individual or a group (e.g., diet, physical activity, tobacco and alcohol consumption, etc.).

HAL

HAL is an online platform developed in 2001 by the Centre for Direct Scientific Communication of CNRS, designed for the deposit and dissemination of research articles, whether published or not, as well as theses from educational and research institutions in France and abroad, and from public or private laboratories. Access to the data is free, but their use or reuse is not necessarily so.

HAS

As an independent public authority with a scientific character, the HAS aims to promote quality in the health, social, and medico-social fields for the benefit of users.

High Authority of Health

As an independent public authority with a scientific character, the HAS aims to promote quality in the health, social, and medico-social sectors for the benefit of users.

Health Products

The National Agency for the Safety of Medicines and Health Products (ANSM) encompasses the following categories under the term health products:

Medications
Blood-derived medications
Narcotics and psychotropics
Vaccines
Cellular products for therapeutic purposes
Gene therapy medications
Labile blood products
Ancillary therapeutic products
Tissues or organs of human or animal origin
Medical devices
In vitro diagnostic medical devices
Cosmetic products
Tattoo products
Other products and substances.

Health Promotion

The aim of health promotion is to empower individuals to have greater control over their own health and to enhance their capacity to improve it. To achieve a state of complete physical, mental, and social well-being, individuals or groups must be able to identify and realize their aspirations, meet their needs, and evolve with or adapt to their environment. Health is thus seen as a resource for everyday life rather than as an end goal; it is a positive concept that emphasizes social and personal resources, as well as physical capabilities. Health promotion is not limited to the health sector; it does not merely advocate for lifestyle changes that promote good health; its ambition is the complete well-being of individuals (Ottawa Charter, 1986). It involves coordinated actions leading to health, financial, and social policies that foster greater equity. Collaborative action enables the provision of safer and healthier goods and services, public services that further promote health, and cleaner, more pleasant environments.

Health

"Health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity." This definition by the WHO dates back to 1946 and has not been modified since. It emphasizes the subjective, holistic, contextual, and multidimensional aspects of the concept of health. In other words, a person in a wheelchair may be healthier than someone who has lost their job. Two people with the same illness can have completely different health statuses.

I

Informed Consent

Inclusion Criteria

Interventional or Clinical Study

A study aimed at investigating the effectiveness of the intervention in groups of individuals by comparing the intervention to other standard or experimental interventions, as well as monitoring adverse effects and collecting information that will allow for the safe use of the intervention.

Integrity

Scientific integrity refers to the set of rules and values that must govern research activities to ensure they are honest and scientifically rigorous. Adhering to these rules is an essential condition for maintaining the trust that society places in research actors.

Intention to Treat

An intention-to-treat (ITT) analysis involves evaluating the results of patients based on their initial randomization group, regardless of the treatment they actually received or their progression in relation to the study. The ITT analysis allows for measuring the benefits of a treatment under conditions that are closer to its use in everyday practice.

Intervention

A procedure or treatment, such as a medication, a nutritional supplement, a gene transfer, a vaccine, a behavior modification, a non-drug intervention, or a device used for therapeutic purposes.

Invariants of a Non-Drug Intervention

The invariants of a non-drug intervention (NDI) in an implementation study are the essential and indispensable elements of the intervention. They should be adhered to as closely as possible, as they support the external validity and fidelity of the intervention.

Investigator

The investigator of a clinical trial is a healthcare professional who leads and monitors its execution, and must have appropriate experience in conducting clinical trials. When the trial is conducted at multiple sites in France, a coordinating investigator is designated by the sponsor. If the research is conducted by a team at a site, the lead investigator of that team is referred to as the principal investigator. The investigator does not necessarily have to be a physician.

Individual Threshold for Clinical Change

The minimal clinically important difference (MCID) is a predefined value of the expected change in the outcome measure, intended to represent the smallest benefit that is meaningful for the patient, regardless of statistical significance. Thus, an intervention may have a statistically significant effect but not be clinically relevant, which limits its usefulness in practice. It is recommended to always define and communicate this threshold alongside the results.

Implementation Strategy

The study of the implementability of the intervention involves prospectively assessing the acceptability, fidelity, and feasibility of the future implementation study, considering that the main stakeholders may differ.

Implementability Strategy

The study of the implementability of the intervention involves prospectively evaluating the acceptability, fidelity, and feasibility of the future implementation study, given that the main stakeholders are likely to differ.

L

Level of Adherence to the NPI

The totality of barriers and motivations that influence adherence to the non-pharmacological intervention (NPI)

Lost to Follow-Up

This refers to individuals participating in a clinical trial for whom the investigator no longer has any news. The greater the number of lost to follow-up participants in a trial, the larger the uncertainty regarding the trial results. The data already collected on these participants will be analyzed in the absence of withdrawal of consent.

M

Modular Components of a Non-Pharmacological Intervention (NPI)

In an implementation study, the modular components of an NPI refer to the adaptable elements, structures, and systems related to the NPI itself and the organization in which it is implemented. If they are appropriately adapted, they will not reduce the validity or reliability of the NPI.

Minimal Clinically Important Difference

The minimal clinically important difference is a predetermined value of the expected change in the outcome measure, considered to be the smallest benefit that makes sense for the patient, regardless of statistical significance. Thus, an intervention may have a statistically significant effect but not be clinically relevant, which limits its applicability in everyday practice. It is recommended to always define and communicate this threshold in addition to the results.

Medical Device

A medical device is a health product that achieves its medical purpose through a physical means. Many different products meet this definition, including instruments, apparatuses, equipment, or software intended by the manufacturer to be used on humans for purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of a disease or injury.
(Examples: a bandage that covers a wound, a prosthesis that replaces a damaged joint, a scanner that takes a "picture" of the body to allow a doctor to make a diagnosis, an external defibrillator that delivers an electrical shock to restore a normal heart rhythm...)

Macro-Environmental Factors

Meso-environmental factors refer to elements specific to the intervention environment (such as professionals, family members, care pathways, intervention locations, and their accessibility) that benefit the individual. In contrast, macro-environmental factors refer to the cultural, legislative, media, political contexts, and the healthcare system in which the non-drug intervention (NDI) operates.

Medication

Article L.5111-1 of the Public Health Code, amended by Law No. 2007-248 of February 26, 2007, concerning various provisions for adaptation to community law, defines a medication as follows: “any substance or composition presented as having curative or preventive properties with respect to human or animal diseases, as well as any substance or composition that may be used in humans or animals or that may be administered to them, for the purpose of establishing a medical diagnosis or restoring, correcting, or modifying their physiological functions by exerting a pharmacological, immunological, or metabolic action.”

Meso-Environmental Factors

Meso-environmental factors refer to elements specific to the intervention environment (such as professionals, family members, care pathways, intervention locations, and their accessibility) that benefit the individual. In contrast, macro-environmental factors refer to the cultural, legislative, media, and political contexts, as well as the healthcare system in which the non-drug intervention (NDI) operates.

Meta-Analysis

Meta-analysis is a method that combines the results of multiple studies to create an objective synthesis according to a specific and reproducible protocol. It also allows for quantifying the overall result for all the studies considered.

N

National Commission on Informatics and Liberty

In the digital realm, the National Commission on Informatics and Liberty (CNIL) is the French regulatory authority for personal data. It assists private and public entities in implementing their compliance with personal data protection. The CNIL receives and processes complaints from individuals and has the authority to conduct on-site or online inspections. It can require an entity to rectify its data processing (formal notice) or impose sanctions (fines, etc.).

Nocebo effect

Mirroring the placebo effect, the nocebo effect is defined as negative psychological and/or physiological effects related to the administration of a substance that has no known pharmacological action.

NPI sheet

Standardized content describing an NPI, supported by studies compliant with the NPIS Model evaluation framework, approved by an independent expert committee coordinated by NPIS, and integrated into the NPI Registry (White Paper on NPI, 2024, Ovadia Editions)

NPI

Effective, personalized, non-invasive health prevention or care protocol, referenced and supervised by a qualified professional (White Paper on NPI, 2024, Ovadia Editions).

Non-Drug Intervention

A referenced health method that is effective, non-invasive, personalized, and supervised by a qualified professional.

NPIS Model

Consensus-based scientific framework for evaluating NPI, featuring 77 methodological and ethical recommendations. This framework results from a transdisciplinary, intersectoral, and cross-party effort, serving personalized and precision medicine as well as promoting active and sustainable health (White Paper on NPI, 2024, Ovadia Editions)

NPI Registry

International digital registry of descriptive sheets for NPIS©-labeled NPI, intended for the general public, professionals, and healthcare operators. Each sheet, validated through an independent collective expertise process, is interoperable with the systems of healthcare, insurance, and social assistance actors, and can evolve based on feedback analysis (White Paper on NPI, 2024, Ovadia Editions)

O

Open-Label Study

A clinical trial in which both the investigators and the participants know which intervention is being administered. The lack of blinding, however, introduces many biases that can affect the robustness of the conclusions.

Open Researcher and Contributor

ORCID is a non-profit organization established in 2010, financially supported by a range of research institutions, publishers, funders, and other research stakeholders (https://orcid.org). It provides a permanent digital identifier (an ORCID ID) that distinguishes one researcher from another, similar to a “SIRET number” for researchers, enabling their identification. It allows for tracking research activities (from grant applications to manuscript submissions) and thus ensures that each individual contribution is recognized.

ORCID

P

Prospective Assignment

A predefined process of the interventional study or clinical trial specified in an approved protocol (for example, randomization) that dictates the assignment of individuals participating in the study (individually or in blocks, meaning small numbers of people) to one or more groups. For example: intervention, placebo, or another control.

Protocol Amendment

A written description of one or more changes or a formal clarification of the study protocol.

Protocol Deviation

Within the framework of Good Clinical Practices (GCP), a protocol deviation refers to a situation where an investigator does not comply with the requirements of the protocol, the procedures of the Ethics Committee, or the applicable legal framework governing research protection. This breach can be accidental or due to negligence, and in all cases, the protocol deviation must be documented. The distinction between a deviation and a violation lies in the failure to notify the sponsor of the non-compliance, either due to ignorance on the part of the principal investigator or a member of their team, or with the intent to deliberately disregard the protocol for fraudulent purposes.

Placebo effect

The placebo effect is defined as positive psychological and/or physiological effects related to the administration of a substance that has no known pharmacological action.

Placebo-Controlled Study

An investigative method in which an inactive substance or treatment (the placebo) is administered to one group of participants, while the experimental treatment being tested is administered to another group. The results obtained in both groups are then compared to determine if the experimental treatment is more effective in treating the disease.

Protective Factor

A risk factor is any attribute, characteristic, or exposure of an individual that increases the likelihood of developing a disease or suffering an injury. Conversely, a protective factor is an element that reduces this probability.
For example, an individual's exposure to a risk factor such as tobacco increases the risk of developing lung cancer, while quitting smoking decreases this risk. Therefore, not smoking is a protective factor against lung cancer.

p-value

The p-value is the probability of observing, under the null hypothesis—meaning in the absence of a difference—differences that are at least as significant as those observed.

For example, a p-value of 0.06 means that in 6% of cases, this effect would still be observed if the non-drug intervention (NDI) had no effectiveness. However, the quantitative interpretation of a statistic from which the p-value is calculated should be avoided, as significance should always be contextualized with other indicators (clinically relevant minimal difference, confidence intervals, data quality, etc.).

Paradigm

In epistemology, a paradigm is a way of seeing things, a coherent model of the world based on a defined foundation. It serves as a standardized framework.

Placebo

A placebo is an intervention used as a comparator to evaluate the specific effect of a treatment.

Prevention

Prevention encompasses all measures aimed at reducing the incidence, number, or severity of diseases, accidents, or disabilities. It includes all actions, attitudes, and behaviors that seek to avoid the onset of a disease or health issue and to maintain or improve health. Prevention can be categorized into primary, secondary, and tertiary prevention.

Primary Prevention

"Primary prevention is defined as all actions aimed at reducing the incidence of a disease, thereby decreasing the occurrence of new cases or delaying the age of onset." It involves actions designed to reduce the frequency of a disease or health issue in a healthy population by addressing the causes and risk factors. At the general population level, this type of prevention takes into account individual risk behaviors as well as environmental and societal risks. By acting upstream, this prevention prevents or delays the onset of a disease or health disorder. It primarily utilizes public information, health education, nutrition, and environmental improvements. This prevention requires initially identifying, with an acceptable level of certainty, the factors likely to influence the incidence of diseases. Research distinguishes between risk factors and protective factors.

For example: prevention campaigns in schools (noise, nutrition respecting environmental standards, air quality, and physical activity); training employees on environmental risks.

Protocol Deviation Report

Deviations must be reported to the sponsor by the principal investigator. This report is created as part of the ongoing quality control process, summarizing adherence to the protocol and listing deviations and/or violations of the protocol. By definition, a protocol violation report is prepared by someone other than the principal investigator. The confidentiality of the reporter is ensured.

Protocol Violation Report

Protocol Violation

In the context of Good Clinical Practice (GCP), this refers to an investigator's failure to comply with the requirements of the protocol, the procedures of the Ethics Committee, or the applicable legal framework governing research protection. This breach may be accidental or due to negligence, and in all cases, the deviation from the protocol must be documented. The distinction between deviation and violation lies in the failure to notify the sponsor of the non-compliance, either due to the ignorance of the principal investigator or a member of their team, or a willful intent to disregard the protocol for fraudulent purposes.

Q

Quality Assurance

A systematic approach aimed at ensuring that data are produced, documented (recorded), and communicated in accordance with the protocol and good research practice standards.

Quality Control

Internal techniques and operational activities carried out within the quality assurance system to verify that the quality requirements of activities related to the trial have been met (e.g., data and form verification, monitoring by study personnel, routine reporting, corrective actions, etc.).

Quaternary Prevention

Actions taken to identify a patient or population at risk of over-medicalization and to protect them from invasive or abusive medical interventions while offering ethically acceptable care procedures. For example: limiting the risk of overdose or medication dependence.

Quality of Life

Quality of life is a multifactorial concept. In its broadest sense, the WHO defines it as "the perception an individual has of their place in existence, in the context of the culture and value system in which they live, in relation to their goals, expectations, norms, and concerns." This definition encompasses somatic health, physical autonomy, psychological state, psychological functioning, well-being, social interactions, professional activities, and economic resources. The narrower concept related to health, termed health-related quality of life, corresponds to an "aggregate of representations based on health status, physiological condition, well-being, and life satisfaction." It excludes professional and spiritual domains. It aligns with the notion of health defined by the World Health Organization in 1947, giving it full perceptual, contextual, intimate, subjective, and singular value. It reflects the perspective of the patient or individual facing a health issue, taking into account physical, psychological, and relational aspects. It is correlated with notions of well-being, happiness, and wholeness. In summary, it is a blend of general life satisfaction and personal well-being.

R

Representativeness Bias

This refers to the tendency to base one's judgment or make a decision based on a limited number of elements that are considered representative of a much larger population.

REC

Research Ethics Committees (RECs) are responsible for providing prior advisory ethical opinions to researchers and faculty researchers regarding their research when they are not legally required to submit to a French ethics committee (CPP).

Research Ethics Committee

Raw Data

Data that comes directly from measurements taken during the study without any specific modifications made through analysis (such as aggregation, recoding, transformation, etc.).

Risk Factor

A risk factor is any attribute, characteristic, or exposure of an individual that increases the likelihood of developing a disease or suffering an injury. Conversely, a protective factor is an element that will reduce this probability.
For example, an individual's exposure to a risk factor like tobacco increases the risk of developing lung cancer, while quitting smoking decreases this risk. Therefore, not smoking is a protective factor against lung cancer.

Recruitment Process

A strategy that outlines how individuals will be recruited for the study and how the study will achieve its recruitment objectives.

Reasons for Withdrawal

This refers to individuals participating in a clinical trial who have withdrawn from the study or decided not to participate any longer. Participants are free to withdraw from the study at any time. The data already collected can be analyzed if the individual does not object. Collecting reasons for withdrawal can be relevant.

Randomization

A process that uses a random element to assign participants in a clinical trial to groups (treatment or control) in order to reduce bias, particularly by promoting comparability between groups at the time of inclusion.

Resampling

In statistics, resampling refers to the creation of new samples from an observed sample. Among the resampling methods, the bootstrap involves creating a new sample from the observations of the observed sample with replacement. Therefore, the new sample may contain the same observation multiple times. These techniques allow, among other things, the empirical calculation of statistical values: mean, measures of dispersion (variance, standard deviation...), confidence intervals...

S

Study Protocol

A set of procedures describing the conduct of the study. A protocol document is developed to facilitate consistency in the implementation of the protocol and data collection among study participants and clinical sites.

Study Coordinator

Reporting to the clinical study manager, the study coordinator is responsible for coordinating and supervising the conduct of clinical studies in compliance with regulations and timelines.

Source Document

Refers to any original document or object that serves to prove the existence or accuracy of a piece of data or a fact recorded during a clinical trial, or the reality of a person's or patient's inclusion in a study. (For example, the original of a laboratory test result allows verification that the test was performed and that its result has been accurately recorded in the trial's observation notebook.)

Sustainability

A measure of the likelihood that the effects of the health intervention (social and economic) will persist for individuals and/or organizations after the implementation study has concluded, with or without adaptation, and after a defined period of time.

SAE

Any unexpected event considering the health status and pathology of the individual, resulting in death, a threat to life, the likely occurrence of permanent functional impairment, including an anomaly or congenital malformation.

Serious Adverse Event

Any unexpected event regarding the individual's health and pathology, the consequences of which are death, a threat to life, the probable occurrence of permanent functional impairment, including an anomaly or congenital malformation.

Safety

The word "safety" comes from the Latin "innocuus," meaning not harmful. It refers to a preventive or therapeutic action that does not harm health or quality of life. It is a characteristic of a medical or non-medical intervention that does not cause any physiological, psychological, or social harm.

Screening Log

An essential document that records all individuals who participated in the screening process. The selection log demonstrates that the investigator attempted to recruit a representative sample of participants.

Scope

Scope is an individual measure of participation that encompasses the absolute number, meaning the proportion and representativeness of individuals who wish to participate in the non-drug intervention (NDI). Representativeness is defined as the similarities or differences between those who participate and those who are eligible but do not participate in the study. If there are differences, a given intervention may have a relative impact on the target population.

Secondary Prevention

Secondary prevention is "the set of measures aimed at preventing or reducing the number and severity of diseases, accidents, and disabilities." This stage includes actions intended to intervene at the very onset of a disorder or pathology to prevent its progression or to eliminate risk factors. It encompasses all actions, attitudes, and behaviors that aim to prevent the onset of a disease or health issue and to maintain or improve health in a at-risk population. For example: Mother-Child Health Programs, Child-Environment Consultations.

Standard Operating Procedure

Detailed written instructions aimed at ensuring the uniform execution of a specific intervention or evaluation across studies involving multiple sites. The standardization of the intervention allows for better identification of what was performed during the trial, comparison to real-world interventions, and improved reproducibility between studies. (For example, through the use of tools like the TIDieR checklist.)

Safety Monitoring Process

A strategy that describes the monitoring of the study.

Sponsor

The sponsor is the individual, company, or institution that initiates a clinical trial and assumes responsibility for it, including funding.

Study Protocol

A document that outlines the justification (why), objectives, methods (how), analyses, and organization of the study in the field of health.

Satisfaction

Participant satisfaction in studies is increasingly used as a measure. It relates to the feeling of achievement and/or physical or emotional well-being that results from accomplishing what an individual considers desirable.

SCImago

SCImago Journal Rank (SJR) is a measure of the scientific influence of academic journals, taking into account both the number of citations received by a journal and the significance of the journals from which these citations originate.

Sham

An inactive procedure designed to closely mimic the active procedure being studied in a clinical trial.
(For example, sham acupuncture uses needles that resemble acupuncture needles, but do not actually penetrate the skin.)

Stratification

Stratification involves dividing a study population into subgroups or strata based on specific characteristics, such as age or sex, to account for factors that may affect the study results. In the context of randomization, it refers to randomly assigning participants while ensuring an equitable distribution of one or more factors across the groups.

T

Tertiary Prevention

Tertiary prevention refers to all actions taken within a sick population aimed at reducing the risk of developing complications, comorbidities, and relapse. For example: therapeutic education for patients.

Type II Error

It is the probability of not rejecting the null hypothesis (H0) when it is false; in other words, it is the risk of failing to conclude the presence of an effect. This risk can be attributed to several factors, such as a sample size that is too small relative to the magnitude of the observed effect or sampling issues. The Type II error (beta) is often amplified by the misinterpretation of not rejecting H0: failing to reject H0 does not mean that the alternative hypothesis is false, but simply that we have not succeeded in proving that it is true, which is fundamentally different.

Type I Error

It is the risk of rejecting the null hypothesis (H0) when it is true; in other words, it is the risk of detecting an effect that does not exist. A 5% risk is commonly used, although it should be noted that this is a completely arbitrary threshold without any theoretical foundation. However, it is reasonable to estimate that at a 5% risk, the probability that the observed difference is due to sampling fluctuations is low enough to accept H0. Reducing this risk, for example to 1% or 0.1%, will make the study more robust. In the case of multiple testing, it is important to anticipate the inflation of the alpha risk.

Transferability

The ability or ease with which an intervention whose effectiveness has been demonstrated can be extended to other contexts or populations.

U

Unblinding

Unblinding is the disclosure to the participant and/or the study team of the treatment received by the participant during the trial. The unblinding process is planned and included in the study protocol. Unblinding a study may be a necessary process to protect participants if medical or safety reasons require it.

Unexpected Beneficial Events

A study may reveal unanticipated health benefits.

Unexpected Beneficial Events

A study may reveal unexpected health benefits.

Unblinding

Unblinding is the disclosure to the participant and/or the study team of the treatment received by the participant during the trial. The unblinding process is planned and included in the study protocol. Unblinding in a study may be a necessary process to protect participants if medical or safety reasons require it.

Unblinding

Unblinding is the disclosure to the participant and/or the study team of the treatment received by the participant during the trial. The unblinding process is planned and included in the study protocol. Unblinding in a study may be a necessary process to protect participants if medical or safety reasons require it.

Unforeseen Issues

Unforeseen issues involve risks to individuals participating in the study or to others, which meet all of the following criteria: unexpected in terms of nature, severity, or frequency; related or potentially related to participation in the research; and suggesting that the study exposes participants to a risk of harm (physical, psychological, economic, or social) that is higher than previously known or acknowledged.

W

Withdrawal

This refers to individuals participating in a clinical trial who have withdrawn from the study or decided to no longer participate. Participants are free to leave the study at any time. Data already collected may be analyzed unless the participant objects. Gathering the reasons for withdrawal may be relevant.