The term non-pharmacological intervention (NPI) was not chosen by the scientific society NPIS but has become necessary. It has been used by scientists since 1975. Various authorities and agencies have adopted it, including the World Health Organization since 2003, the French National Authority for Health since 2011, the National Solidarity Fund for Autonomy since 2014, the Ministry of Health since 2018, the High Council for Public Health since 2019, the European Centre for Disease Prevention and Control since 2020, the General Inspectorate of Social Affairs since 2022, the Economic, Social and Environmental Council since 2023, and Health Insurance since 2024. Many national and supranational scientific societies use the term NPI in their recommendations. These health solutions are often "squeezed" between health products and public health measures, despite efforts by professionals to raise awareness and recognition of them. They represent an underestimated area of intangible services situated between goods (e.g., medications, medical devices) and general public health recommendations (e.g., dietary rules, hygiene measures, environmental actions).

They can be lost in compilations of health solutions that mix health promotion actions with targeted programs or confuse methods for identifying a health problem with methods for resolving it. The challenge is to improve the traceability of practices for continuous enhancement of their quality, safety, implementation, and training. These practices can be easily shared from one country to another. The term NPI does not imply "anti-medication" or "alternative medicine" (parallel medicine). Instead, it draws from the rigor of the globally standardized drug validation process to establish good scientific and clinical practices. Over time, we believe that the abbreviation NPI will come to be more widely recognized than its full title, similar to WHO, IBM, SEAT, and many others.

Registers of non-pharmacological practices with imprecise criteria and boundaries.
Catalogs compile various health practices among which NPI may be submerged. Some target the general population, while others are more specific. The selection criteria are heterogeneous, and objectives and practical modalities vary widely. Three examples include two from the United States (EBCCP and Mindtools) and one from France (Capitalisation Santé).

A scientific validation model for medications has existed since the 1960s, with specific regulations recognized worldwide (e.g., FDA, EMA, ANSM). A similar procedure has recently been implemented for medical devices in Europe. However, until now, no consensual model existed for nutritional, bodily, and psychosocial health services due to confusions between approach, protocol, and technique/ingredient. A participatory, pragmatic, and multidisciplinary consensus work followed international scientific health recommendations to address this for NPI (Ninot et al., 2023).

This work took into account the specificities of NPI, health risks, the balance between internal and external validity, the justification of explanatory mechanisms, ethical considerations in health, and respect for contexts of use. The NPIS Model accelerates research through the harmonization of methodological and ethical expectations in NPI. It also enhances the identification, referencing, transferability, and implementation of NPI for the benefit of user health and safety, improving the quality of training.

Ultimately, the NPIS Model distinguishes between individualized, science-based services aimed at addressing known health issues in Western medicine and occupational practices (lifestyle, art of living, work, sociocultural activity, personal development, pursuit of happiness, spiritual practice, etc.). In this sense, the model does not impede individuals' freedom to choose a particular lifestyle. It aims to address a specific health issue for an individual or a group of people within a limited timeframe and a framework regulated by the health sector. The NPIS Model encourages innovations across all other health sectors, particularly in health organizations and early identification actions for health problems.

As of April 2019, there were 46 evaluation models for NPI in the scientific literature (Carbonnel and Ninot, 2019). These models were constructed by researchers for researchers, often from a monodisciplinary perspective and rarely from a patient-centered approach. This led to significant heterogeneity in study protocols and the way NPI were conceived (approach, method, technique, or materials). The results were scattered, debatable, poorly transferable, and rarely reproducible. Consequently, these practices were not widely recognized outside the study context (dependent on the establishment and/or practitioner). This situation raised doubts about their effectiveness (e.g., efficacy, safety, relevance, utility, cost-effectiveness), their content (e.g., heterogeneity in doses, procedures, ingredients, techniques, contexts, target populations), their approval (e.g., ethics committees), their dissemination (e.g., conflicting reviewer opinions), their teaching (e.g., protocols, best practices), and their recognition (e.g., authorization, integration into official classifications, reimbursement). This lack of a consensual evaluation model for NPI suggested that each professional had to reinvent their program for every new patient, given the wide or contradictory recommendations from authorities, agencies, and scientific societies. It also implied that only the patient-provider relationship mattered in the health effects induced (Ninot, 2020). Moreover, it left the door open for pseudoscientific practices and, more broadly, parallel medicine, along with all the obscurantist, health-related, sectarian, political, and judicial issues that are known in France (Miviludes, 2022; CNOI, 2023; CNOM, 2023) and around the world (Ernst and Smith, 2018). This idea was also gaining traction in the United States in the field of oncology, aiming to juxtapose two medical offerings: one based on experimental science, primarily focused on surgery, medication, radiotherapy, and medical devices, and the other described as "complementary, integrative, or traditional," based on individual experience, opinions, and traditions (Mao et al., 2022). This second offering claimed exclusivity in the domains of prevention and care, emphasizing care for the person versus cure for the disease. Thus, the NPIS Model was co-constructed with the idea that experimental science could demonstrate the existence of effective, safe, and reproducible prevention and care protocols. This work was supported by seed funding for participatory research from INSERM and involved over 1,000 participants under the guidance of a committee of 22 multidisciplinary experts, including two user representatives. This transdisciplinary innovation is currently supported by 30 French scientific societies, the National Center for Palliative Care and End of Life, INCa, and the French Platform for Clinical Research Networks.

The term NPI has been used by scientists working in the health field since 1975. However, it is not the only term; other similar terms are used synonymously, especially in PubMed. There are ten English terms to describe non-pharmacological processes and twenty-eight to describe methods of operation. An exhaustive inventory of NPI on a scientific article search engine is currently impossible due to the variety of terms researchers use, each with distinct meanings: rehabilitation intervention, psychosocial intervention, mental intervention, cognitive intervention, psychological intervention, behavioral intervention, psychosomatic intervention, nutrition intervention, dietary intervention, food intervention, physical intervention, body intervention, exercise intervention, manual intervention, salutogenic intervention, natural intervention, self-help intervention, nursing intervention, therapy intervention, care intervention, disease management intervention, multimodal intervention...

A search on PubMed from August 15, 2024, indicates 55,689 articles citing the term "non-pharmacological" or its equivalent up to 2023. While these figures do not challenge the trend, they are likely underestimated due to the database's focus on health products rather than services, biological treatments over psychosocial ones, studies on North American populations, and journals published by North American organizations. This aligns with an official U.S. government site managed by the National Center for Biotechnology Information and hosted by the National Library of Medicine, part of the National Institutes of Health (NIH).

A search on PubMed from August 15, 2024, also reveals 11,642 articles citing the term "non-pharmacological intervention" or its equivalent up to 2023. Both curves demonstrate an increase since 2000, with a notable acceleration since 2010.

The French National Authority for Health has been encouraging the use of the term NPI in health since 2011.

Indeed, the NPI Registry contributes to the development of precision medicine. For example, how can we advance this field in the non-pharmacological treatment of pain without confusing patients when a prestigious medical school like Stanford publishes such a vague, incomplete, and unranked list on its website?

• Physical activity
• Acupressure
• Acupuncture
• Application of heat or cold
• Aquatherapy
• Art therapy
• Biofeedback
• Family coaching
• Individual coaching
• Psychological conditioning
• Desensitization
• Therapeutic education
• Occupational therapy
• Horticultural therapy
• Hypnosis
• Physiotherapy
• Massage lotions
• Meditation
• Music therapy
• Posturology
• Companion presence
• Psychosocial support
• Transcutaneous electrical nerve stimulation (TENS)
• Comfort therapy
• Theatre therapy
• Psychosocial therapy
• Tonification and strengthening
• Yoga

How many hopes dashed? How much time wasted? How many futile efforts? How much money squandered? How many unnecessary carbon emissions from transport? This subtly highlights pharmacological treatments and pain surgeries, which have precise contents and proven effects. The NPIS and its partners propose a solution to break this deadlock in favor of those affected by health issues. The goal is to provide reliable information on the most relevant NPI. It is also about no longer opposing pharmacological and non-pharmacological therapies, but rather associating them wisely and at the right time.

NPI are protocols to be implemented with a target population, but they are merely specifications. They must be contextualized and personalized. The NPI Registry offers best practices and tips for optimal implementation. Furthermore, the NPIS recommends interdisciplinary training in health ethics for their application. The scientific society works with its partners to develop and recognize this foundational training, which could be conducted particularly in higher education institutions in collaboration with the Ministry of Health. This ethical training includes all the prerequisites of knowledge, skills, and attitudes necessary for interprofessional practice in health. Health professionals with practical experience, such as doctors, will have equivalencies.

Accessible Protocols in Consultation

• Enhanced Quality and Safety: Strengthens the quality and safety of existing practices through formalization, harmonization, and securitization.
• Integration with Professional Software: Codified NPI can be integrated into healthcare management software.
• Digital Documentation: Access to documentation from computers, tablets, or smartphones for ease of use.
• Broad Validation: Extends validation to all relevant professionals in the region.
• Quick and Easy Access: Facilitates rapid access to information at critical decision-making moments for prevention and care.
• Simplicity in Tracking: Eases the follow-up and evolutionary process of best implementation practices (e.g., identifying barriers, professional leadership, availability of training and support).

Quality Control and Adherence to Protocols

• Traceability: Utilizes unique coded protocols for tracking.
• Strengthened Care Link: Enhances the relationship between care provision and patient support.
• Monitoring Relevant Indicators: Provides tools for tracking key performance indicators.
• Continuous Education Tool: Serves as a resource for ongoing professional development.
• Regular Updates: Incorporates regular updates based on user feedback.

Means of Valuation

• Response to Identified Multidisciplinary Issues: Addresses problems identified by healthcare teams in a specific territory.
• Extended Roles for Various Professionals: Expands the roles of many professionals, particularly non-physicians.
• Elimination of Ineffective Protocols: Phases out protocols that are ineffective, hazardous, or costly.
• Reduction in Meeting Time: Decreases the need for multiple meetings focused on intervention planning.
• Support for Innovation: Encourages professionals to experiment with new practices, boosting their confidence.
• Financial Valuation: Ensures appropriate financial and resource allocation for effective implementation.

Moving, eating, drinking, sleeping, talking, reading, writing, painting, listening to music, watching a movie, dancing, laughing, walking, singing, meditating, gardening, socializing, etc., are all activities of daily life. Some of these can generate joy, pleasure, personal growth, and well-being. In a democratic country, everyone is free to interpret and experience these activities in their own way. This relates to life philosophy, lifestyle, the art of living, and personal development. In other words, a daily activity is not an intervention, even if it can occasionally and randomly contribute to the health of certain individuals. Occupational activities and treatments for health problems identified by medicine are different.

The following products are not considered NPI:

• Hygiene and beauty products (shampoo, toothpaste, brush, body cream, etc.)
• Natural products (plants, food, mushrooms, essential oils, etc.)
• Health products (medications, implantable biological materials, dietary supplements, etc.)
• Medical devices (artificial organs, prosthetics, orthotics, digital applications, monitoring systems, etc.)

The following goods and services are not considered NPI:

• Cultural products or services (video games, books, podcasts, artistic practices, museum visits, theater, writing, etc.)
• Everyday consumer products or services (haircuts, aesthetic treatments, dining out, etc.)

The following actions are not considered NPI:

• Public health promotion activities (communication campaigns, videos, posters, booklets, websites, social media posts, etc.)
• Architectural adaptations (creating access ramps, etc.)
• Environmental adaptations (reforestation of a park, creation of a sports workshop, etc.)

The following approaches are not considered NPI:

• Professional disciplines (physiotherapy, psychology, dietetics, public health, etc.)
• Educational approaches (personal development, etc.)
• Esoteric practices (spiritual practices, religious worship, divination, witchcraft, etc.)

The following organizations are not considered NPI :

• Health organizations (networks, platforms, clinics, health centers, healthcare establishments, etc.)
• Health systems (digital platforms, etc.)

The following measures are not considered NPI :

• Health policies (strategies, plans, programs, etc.)
• Regulations (decrees, laws, etc.)
• Judicial decisions (warnings, convictions, etc.)

An evidence-based data point is a theoretical or practical knowledge acquired through rigorous and integrated scientific methods and reasoning. The NPIS Model follows this logic in the health field (see Figure 3). It provides specific methodological and ethical recommendations for NPI for studies focusing on their mechanisms and explanatory processes (mechanistic study), their content (prototypical study), their evolution over time (observational study), their benefits and risks (interventional study), and their application and personalization modalities (implementation study).

Immaterial practices of prevention and care have existed since ancient times. However, the diversification of practices, the multiplication of professions at the intersection of prevention, care, and social assistance, and the globalization of information systems have leveled these services and obscured them at a time when medicine has made significant advances in the early detection and diagnosis of health issues. The interdisciplinary and multisectoral approach of the NPIS generates a value chain, from the design of practices to their implementation, regulation, and financing.

Innovative economic model initiatives are emerging worldwide, including fee-for-service, bundled payments, social economy provisions, offers promoting sustainable development, e-health economy, human innovation bundles, and long-term economy (World Economic Forum, 2024). The NPIS Prospective Pole, led by Michel Noguès, documents these initiatives in books (Noguès, 2022; Noguès, 2024). The NPIS Forums invite all innovators to share their experiences.

Each NPI file in the NPI Registry has been submitted by a practitioner or researcher through the dedicated platform hosted by the NPIS. Each file undergoes review by an independent and integrated scientific committee. This committee invites relevant scientific societies and health authorities to validate the NPI files and/or to oversee the decisions made. Each validated file is then reviewed by a committee of users and professionals. Once labeled NPIS©, the file is translated into at least English and French and integrated into the NPI Registry.

The file contains standardized content supported by scientific studies that align with the NPIS definition of NPI, the expected specifications (Table 2), and the consensual evaluation framework for NPI, known as the NPIS Model. It includes a manual for professionals, an information notice for users, a section on funding options, and an area for anonymous user feedback. This ensures the file remains dynamic and part of a virtuous cycle of continuous improvement for the NPI.

A minimum of one prototypical study, one mechanistic study, two interventional studies, and one implementation study published in a peer-reviewed journal is required for an NPI proposal to be accepted by the expert committee tasked with validating the NPI file and awarding the NPIS© label. Specifically, experts must have evidence to anonymously vote on each criterion of the NPI file proposed to the NPIS by a submitter:

• Described (≥ 1 prototypical study)
• Explainable (≥ 1 mechanistic study)
• Effective (≥ 2 interventional studies)
• Safe (≥ 2 interventional studies)
• Implementable (≥ 1 implementation study in the country)

A professional must understand all the specifics of the NPI, the criteria justifying its use, how to implement its protocol, whom to contact, useful tips, required materials, and any prerequisite training needed.

NPI are a field in which many amalgamations occur between scientific knowledge and opinion, due to their objective—human health—and their operational mode, which involves immaterial protocols. However, it is essential to learn to distinguish science from research amidst the multiplication of tools and information channels (Klein, 2020), particularly on the subject of NPI. The same communication channels transmit both scientific knowledge and beliefs, opinions, comments... Information of different statuses becomes intertwined. Knowledge can turn into the belief of a particular community, and vice versa.

Research, on the other hand, pertains to questions for which we do not yet have answers. These well-defined questions still have no answer. A researcher works on the subject using various methods and strategies. Research fosters doubt. Scientific societies work to advance research within a specific territory and theme.

Given that NPI are universal health protocols centered on individuals and administered by humans, an international multidisciplinary scientific society needed to be created. This has been achieved since 2021. This society is called the Non-Pharmacological Intervention Society (NPIS).

An alliance for NPI is essential today in response to siloed proposals from various disciplines (biology, psychology, public health), professions (medical, paramedical, educational, social), sectors (prevention, care, support for autonomy, social services, education, end-of-life care, disability), and currents (traditional or scientific medicine) at both national and supranational levels. The NPIS brings together these scattered and sometimes divided stakeholders to foster better understanding, practice, and recognition of NPI. The scientific society contributes to developing an NPI ecosystem that is often overlooked. It mobilizes hundreds of professionals and users worldwide to address the public health challenges of the 21st century that are widely recognized.

It highlights essential NPI and best practices to be delivered to the right people at the right time in their journey without criticizing other health solutions. Specifically, the NPIS enables:

• Research stakeholders to develop, evaluate, and promote NPI.
• Care, prevention, and social support professionals to enhance their skills and access best practice recommendations and implementation tools for NPI.
• Health operators to choose, organize, track, consolidate, secure, and sustain investments in NPI.
• National and supranational health agencies to improve their knowledge for designing effective strategies regarding NPI.
• Governments, non-governmental organizations, user associations, and health actor federations to establish a common language within a defined scope to create just, equitable, and sustainable policies.

After establishing a standardized evaluation model, the NPIS contributes to an interprofessional, intersectoral, and bipartisan alliance in favor of NPI. Through an annual global summit, it gathers all stakeholders in the ecosystem during the third week of October, known as the NPIS Summit. This significant event discusses the economic and regulatory structuring of the ecosystem with all parties involved. The 2024 edition will take place in a highly symbolic venue, the Cité Universitaire in Paris, a quintessential humanist space open to the world, science, and peace, created between the two world wars last century. Everyone can participate and contribute to this international dynamic aimed solely at legitimizing NPI within health system offerings without disparaging other solutions. This coalition is called the NPIS Alliance.

The NPIS has outlined a roadmap from 2021 to 2030 aligned with the strategies of European and international health institutions. To this end, it has initiated discussions with the European Public Health Association (EUPHA), involved in health service innovation, the European Centre for Disease Prevention and Control (ECDC), which is planning to create a registry, the European Commission, which aims to promote "health, nutrition, mental health, and psychosocial support to communities," and WHO Europe, which intends to identify the "most effective health interventions" by 2030. The NPIS submitted several European projects in 2024.

The NPIS is also engaging with WHO, which has advocated for "self-care interventions" since 2022, included NPI in its Global Action Plan for Mental Health published in 2022, and identified "the most effective and feasible interventions in a national context" in a report published in 2021. Additionally, it is collaborating with other international organizations such as UNESCO, which has promoted "specific health and well-being education interventions" since 2016, UNICEF, which has advocated for sharing "effective health interventions" since 2016 and developing "primary healthcare" since 2018, the UN, which has called for "accelerating essential health services" since 2023, and the Coalition of Partnerships for Universal Health Coverage and Global Health, advocating for "people-centered, comprehensive, and integrated services" since 2021.

Thus, an ecosystem for NPI, from research to practice through training and delivery, is being constructed, with NPIS actively participating. It involves all stakeholders, both academic and non-academic, to create a true value chain benefiting personalized and precision medicine based on science, sustainable health, and equitable longevity. With over 2.1 billion people aged over 60 by 2050, multistakeholder collaborations will be the foundation of a sustainable and equitable longevity economy.

This is why forums on NPI have been organized since 2024 in France and Europe, called NPIS Forum. An international summit titled NPIS Summit takes place every year in October, and regional events called NPIS Satellite gather professionals and users around a health theme.

The connection between mechanistic, interventional, and implementation studies forms the backbone of the epistemological positioning of the NPIS Model regarding the evaluation of NPI. This does not mean that an interventional study, for example, cannot explore biological mechanisms or psychosocial processes. Instead, this backbone provides coherence to the studies and structures the validation process of NPI for integration into a standardized practice framework.

PSYCHOSOCIAL DOMINANCE

Psychotherapies:

• Cognitive Stimulation Therapy for memory strategies in Alzheimer’s disease in 14 sessions by a psychologist in a healthcare facility, health center, or private practice.
• Mindfulness Based Stress Reduction (MBSR-BC) program against anxiety during cancer treatments in 8 group sessions by a clinical psychologist, psychiatrist, or physician in an oncology department, a patient association, a private practice, a health center, or a healthcare facility.
• Acceptance and Commitment Therapy for chronic pain in 9 group sessions by a clinical psychologist or psychiatrist in a healthcare facility, health center, or private practice.
• Cognitive Behavioral Therapy for Insomnia (CBT-I) in 6-8 individual sessions, either remote or in-person, by a neuropsychologist, clinical psychologist, psychiatrist, or neurologist in a healthcare facility, health center, or private practice.
• Now I Can Do Heights program using virtual reality to treat acrophobia (fear of heights) by a clinical psychologist or psychiatrist in a private practice or health center.

Health Prevention Programs:

• Living Well with COPD therapeutic education program against symptoms and exacerbations of COPD over 2 months with 4 sessions, in-person or remote, by a nurse, physician, or pharmacist in a healthcare facility, health center, or private practice.
• CHESS Method (Chronic Headache Education and Self-management) for migraine self-management by a nurse or physician in a healthcare facility, health center, or private practice.
• MyFriend Youth Program for preventing anxiety and depression among students aged 12 to 15 years, 10 sessions by a school psychologist or school nurse in an educational institution.
• Spiegel Hypnotherapy Method specialized in smoking cessation in 3 sessions by a psychologist, nurse, physician, or hypnotherapist in a private practice, healthcare facility, health center, or private practice.
• Cognitive Behavioral Therapy for Depression (CBT-d) by a clinical psychologist or psychiatrist in a healthcare facility, health center, or private practice.

CORPOREAL DOMINANCE

Physiotherapy Protocols:

• McKenzie Method for back pain by a physiotherapist in a healthcare facility, health center, or private practice.
• Pelvic Floor Muscle Training (PFMT) program by a midwife or physiotherapist in a health center or private practice.
• Rehabilitation program following hip prosthesis in 6 to 10 sessions by a physiotherapist in a healthcare facility, health center, or private practice.

Adapted Physical Activity Programs:

• Dance Therapy for Parkinson’s Disease addressing psychological symptoms of Parkinson’s by a physical activity instructor in a healthcare facility, health center, or private practice.
• Re-exercise program at ventilatory threshold against dyspnea caused by COPD by a physical activity instructor or physiotherapist in a healthcare facility, health center, or private practice.
• Anti-fatigue APA program during treatments for breast, prostate, or colon cancer by a physical activity instructor in a healthcare facility, health center, or private practice.

Thermal Treatments:

• Specialized thermal cure for gonarthrosis by a physiotherapist or thermal agent in a thermal facility.

NUTRITIONAL DOMINANCE

• Gluten-free diet for celiac disease by a dietitian in a healthcare facility, health center, or private practice.
• FODMAP diet for gastrointestinal disorders by a dietitian in a healthcare facility, health center, or private practice.

The choice and implementation of an NPI at a given moment in a person's prevention and care journey do not depend on the NPI Registry, nor on the mission of the NPIS. These decisions are influenced by individual health situations, preferences, the availability of professionals, the qualifications of practitioners, accessibility in a given area, and socio-cultural contexts. The art of combining NPI with each other and with other health solutions at the right time lies with professionals, expert systems, interdisciplinary organizations, and the healthcare system in place in a specific country. The NPI Registry highlights essential practices that have proven effective and continue to evolve through research and feedback analysis. The NPIS has no authority to impose a choice of NPI. Each professional is free to follow them, to pursue others, or to create new ones. The same applies to each healthcare organization.

The NPIS compiles and organizes calls for proposals for studies on NPIs and shares this information monthly with its members in its “Members” newsletter. An internet search can help identify them, but often too late.

The NPIS does not fund the design or submission of an NPI Card. Otherwise, the learned society would have a clear conflict of interest that would discredit the NPI. Its mission is to promote, worldwide, NPIs that have proven their worth and have been certified through the validation of the card in the Registry.

The human and material resources required depend on the study’s objective and, consequently, on its design (prototype, observational, mechanistic, interventional, or implementation study). The NPIS Model now enables study sponsors to estimate the costs of a study (NPIS Guidelines, 2024). A public or private research laboratory, a healthcare organization (hospital, clinic, accredited multidisciplinary healthcare facility, etc.), a Contract Research Organization (CRO), or a healthcare network can conduct the study and obtain all necessary authorizations (ethics committee approval, study protocol, data collection system, insurance, etc.). The researcher has a duty to conduct a comprehensive literature review to identify gaps in prototypical, observational, mechanistic, interventional, or implementation studies for a given NPI. Starting at the end that is, with an implementation study when there are no studies describing the NPI, none explaining its effect on health, and none demonstrating its efficacy would make no sense. The study is part of a collective process of development and validation. This approach is certainly tedious, but it is reliable and irreversible.

A NPI Card is not a study, but a standardized, universal, and protected description of a NPI. The NPI Card requires, at a minimum, validation of the NPI through five publications in peer-reviewed scientific journals: one prototype study, one mechanistic study, two interventional (or clinical) studies, and one implementation study (NPIS Guidelines, 2024). Nevertheless, the production of five different studies (published in peer-reviewed journals) is encouraged but is not a prerequisite for submission. At a minimum, reference must be made to two clinical studies. It will then be up to the Expert Committee to assess their validity.

These references so-called “pivotal” studies are explicitly cited in the bibliography of the NPI Card. They provide evidence of its scientific validity and reproducibility regardless of who implements it. They also provide a comprehensive and understandable description for healthcare professionals and users and can be implemented in multiple countries. We recommend that you refer to the document “Guidance on writing a NPI Card,” particularly section 2.3.

A NPI Card is not a study. It serves as the NPI’s set of specifications, providing a comprehensive description of how to implement it and ensuring that most participants will experience the same health benefits as those in the original interventional/clinical studies. Every claim made in the protocol must be supported by a bibliographic reference. The characteristics of a NPI are described and justified by studies published in peer-reviewed medical and scientific journals that meet the standards of international health research (International Committee of Medical Journal Editors; Medical Writing). They comply with the NPIS Model (NPIS Guidelines, 2024).

A study that has been conducted but not published in a peer-reviewed scientific journal, even if it has undergone independent and rigorous peer review, cannot be accepted in a NPI Card.
The reference must be formatted according to PubMed standards:
Hrozanova M, Skarpsno ES, Follestad T, Kallestad H, Pallesen S, Nordstoga AL, Møllerløkken NE, Rønning AS, Meisingset I. Effectiveness of group-delivered cognitive behavioral therapy for insomnia in primary care: a pragmatic, multicenter randomized controlled trial. Sleep Med. 2025 Jul;131:106495. doi:10.1016/j.sleep.2025.106495.
Most studies are available on PubMed.

The NPIS Model is a standardized scientific validation process for NPI, similar to the phase model used for pharmaceuticals.

• The results of a prototype study provide a detailed description of the intervention, its primary health objective, its target audience, its content, its context of use, and the healthcare professional involved.
• The results of a mechanistic study identify at least one specific biological mechanism of action or psychological process explaining the effect of the NPI on the primary health outcome described in the latest WHO International Classification of Diseases.
• The results of the two interventional or clinical studies demonstrate the real-world effectiveness and reproducibility of the NPI’s effect on the primary health outcome of a target population, as well as its safety.
• The results of the implementation study identify the modalities for customizing and deploying the NPI in a given territory and cultural context in accordance with the recommendations of health authorities.

The NPIS Guidelines (2024), on pages 16 and 17, provide definitions of these methods, while the NPIS Model outlines the methodological and ethical expectations for NPIs.

The concept of “presence” means that these pivotal studies must be listed in PubMed format in the bibliographic references of the submitted application.

If a survey can answer a relevant research question, this methodology is not necessary for the justification, writing and submission of a INM card. If you have a question about the procedure to follow or the methodology of a study justifying a NPI Card, please contact the Science Pole of the NPIS in advance.

Yes, this is an option proposed by the NPIS Model (NPIS Guidelines, 2024). Care must be taken to ensure that the instrument has validity recognized by the scientific community and has been administered under conditions and in cultural contexts consistent with its expectations. It is recommended that the instrument include an individual threshold for clinical change in order to determine the effect of the NPI on this health marker.

Yes, that is possible. There are two scenarios, but in both cases, the NPI Card must include scientific justification of its relevance to health and safety. Examples can be found in the first cards published in the Registry.

In the first scenario, a NPI may be supervised by one professional or another, such as a physical therapist, an occupational therapist, or a physical activity instructor, depending on the severity of a patient’s health condition.

In the second case, a NPI is a multimodal program combining, for example, a session conducted by a nurse, one by a dietitian, one by a psychologist, and one by a social worker.

Any deviation from the standard protocol, i.e., when it is used, will be the responsibility of the supervisor, and, where applicable, the prescriber and the healthcare facility where the NPI is taking place.

A NPI Card is a NPI identification document. It guarantees quality to the user (e.g., protection against misleading advertising) and enables better oversight through the collection of user feedback. The certificate ensures:

• Transferability of NPI research to practice,
• Scalability of the NPI,
• Exportability of the NPI,
• Security of the NPI,
• Acceptability of the NPI.

A NPI is a program or a prevention or care protocol. It is a comprehensive entity and is used on its own for a specific health-related purpose. Its entry in the NPIS Registry details all relevant best practices, both tangible (e.g., necessary tools) and intangible (e.g., attitude, soft skills). Its combination with other NPI and treatments results from a shared and informed decision between the prescriber (a professional or a team) and the user. The card may mention relevant combinations, especially if these have been cited in interventional studies.

A NPI is an “effective, personalized, non-invasive health prevention or treatment protocol that is evidence-based and supervised by a qualified professional” (NPIS Guidelines, 2024). A NPI is a protocol designed to prevent, treat, cure, or manage a health issue recognized by evidence-based medicine. The issue may be an acute illness, a rare disease, a chronic condition, a symptom, or a modifiable risk factor (e.g., frailty in older adults, risky behavior such as smoking, or a high-risk environment such as a job involving significant hazards). The benefit on this primary health outcome and other secondary outcomes can have a leverage effect that sustainably changes health behavior (e.g., smoking cessation following a therapeutic education program on cardiovascular disease), or even a lifestyle (e.g., using a bicycle for daily travel following a physical therapy program for low back pain).
A NPI is a standardized protocol that a professional tailors to a user or group of users. Its implementation follows a set of specifications and takes into account the user’s preferences and health status, as well as current regulations, the regional healthcare organization (e.g., healthcare facility, multi-professional health center, care network), and the socio-cultural context. This healthcare solution is thus “protocolized.” It is offered for a limited duration. A NPI complements other treatments and general public health messages.
A NPI focuses primarily on physical, nutritional, or psychosocial aspects. The physical domain includes, for example, physical therapy protocols, manual therapies, adapted physical activity programs, occupational therapy methods, psychomotor programs, midwifery protocols, nursing care protocols, and speech therapy methods. The psychosocial domain includes, for example, psychotherapies, health risk prevention programs, patient therapeutic education programs, art therapy protocols, and animal-assisted therapies. The nutritional domain includes, for example, specific diets and intermittent fasting. To determine whether your protocol could be validated as a NPI Card, we recommend referring to the NPIS Guidelines (2024, page 6). For more personalized assistance, contact the Science Division.

The NPIS has developed all the necessary tools for this purpose. It offers:
a guide in three languages,
the NPIS Guidelines,
an open registry that draws inspiration from NPI Cards validated by the NPIS committee of independent and impartial experts,
a glossary defining relevant terminology,
a white paper published in 2024 detailing how the NPI Card validation process was established,
an annual conference bringing together the authors of NPI Cards and those who would like to write them, the NPIS Summit,
a training program dedicated to cards writing, called NPIS Open Badge Science,
and freely accessible webinars to assist with writing NPI Cards.

These tools can be found on the NPIS website.
In addition, NPIS members can participate in the NPIS Science Division’s working groups. Digital resources shared with NPIS members facilitate the writing of NPI Cards.

Yes. A clinical study demonstrates the efficacy of the NPI in a target population but does not address its reproducibility, an essential criterion in science. Obtaining similar results in a population similar to that of the first clinical study proves that the observed benefits are not due to chance but to the effect of the NPI. This gives all professionals confidence that they will obtain the same results under the same conditions of use. A clinical study says nothing about the mechanisms of action. Experts must agree on each criterion through an anonymous vote requiring at least 80% agreement.
A NPI Card that has been rejected for publication in the Registry does not necessarily constitute a categorical and definitive rejection.
Experts may make substantive recommendations to conduct studies in order to consolidate knowledge under one or more of the following conditions:

• Insufficient description of the NPI requiring a prototype study,
• Insufficient explanation of the mechanisms underlying the NPI’s effect on the primary health outcome requiring a mechanistic study,
• Insufficient evidence of the NPI’s efficacy, requiring one or more interventional/clinical studies,
• Insufficient evidence of the NPI’s safety, requiring one or more interventional/clinical studies,
• Insufficient evidence of the NPI’s implementability in a given region, requiring an implementation study.

Experts may provide recommendations on the format, asking the author to submit the NPI Card in a format that meets the NPIS requirements. A certain degree of consistency in both content and format is expected among the cards in the registry.
Finally, experts may issue a negative opinion if a NPI Card is too similar to another already published. A NPI Card is unique. It has a unique code that allows it to be recognized by all healthcare stakeholders and by healthcare systems and AI.
Any NPIS member has access to the names of NPI Cards that have not been validated.
A refusal is by no means a categorical rejection of the NPI. It simply means that further studies are needed to clarify its primary health objective, its content, its target audience, its context of use, and its professional audience.

The experts have no a priori on a NPI, they examine the factual data provided and the content of the proposed card. The refusal is always accompanied by recommendations. The refusal is not a failure. It translates an objective state of knowledge on a file. It points out the lack of study on the required criteria and thus encourages the realization of relevant studies.

A peer-reviewed and approved card is published in the NPI Registry. It is translated into English as a minimum. It receives the NPIS label. It is promoted through NPIS communication channels, to the national and international press, and to NPIS partners (authorities, learned societies, organizations issuing NPIs, and funders of prevention, care, and support for independence). A ceremony is held each year at the NPIS Summit to honor the authors of NPI Cards that have been validated and published in the Repository.

If subsequent additional studies and analyses of feedback collected by the NPI Registry were to modify the content of the NPI Card, the author should submit a request to the NPIS for an update.

The cards protects the author by encouraging them to undergo specific professional training related to the INPI Card. They may, of course, seek support from their professional organization.

Like any scientific journal, any NPI Card validated by experts in accordance with international standards becomes the property of the NPIS. The NPIS is responsible for translating it into multiple languages, promoting it, keeping it up to date, and collecting feedback.

Any submitted but unpublished card remains the property of its authors.

In every card, the authors and their institutions are always listed as the authors. They thus retain moral rights and the opportunity to serve as the primary NPI trainer. Efforts to promote the database at the national, European, and international levels are currently underway to achieve greater recognition of the upstream research work (required preliminary studies), the work involved in submitting the card (writing, submission, revision), and the downstream research work (updating).

A NPI Card must be submitted by an individual. That individual may represent a legal entity mentioned in the record. A record may have multiple authors. The author of the record does not need to be the creator of the NPI or a researcher involved in any of the studies.

Yes. The author of the INM sheet is not necessarily the inventor of the INM. It is preferable that the initial inventor be aware, but this is not essential. The NPI has a universal scope. It is essential that the name of the first designer of the NPI be mentioned in the card. The author of the card undertakes to contribute if possible to its updating.

These two topics are different. One points out the publication of a card in the Registry. The other is a foundation of competence in the research or multiprofessional practice of NPIs (NPIS Guidelines, pages 23-24 and 27-28). 
The Science open badge is an asset to become a trainer in NPI and expert for the NPI registry. 

Each expert in the NPI Registry attests to their knowledge and scientific and practical skills in a field of NPI (psychosocial interventions, nutritional interventions and/or physical interventions) by its diplomas, by its experience and by its publications in scientific journals, in professional journals, in the NPI Registry and in collective expertise (health authorities, learned societies). He or she declares his/her links of interest, signs the ethical charter and respects the values of the NPIS. He or she participates in the expertise of cards within a team composed of 3 to 5 people after signing a contract with the NPIS. He or she declares to have no connection of interest with the INM and the bidder(s) and their institutions. Any fraud will result in the exclusion of the expert and the deletion of the INM sheet. Each card includes the names and first names of the experts to attest to the rigor and integrity of the expertise process. 
All health authorities and learned societies partners of the NPIS can participate, follow up and control the expertise. Any suspicion of fraud will generate a control. 

Each expert is selected on the basis of volunteering, his/her qualifications and skills. An expertise includes at least 3 experts, including 1 user representative. He or she submits a CV and a cover letter to the NPIS. An expert cannot intervene on a file of which he is one of the authors or if he has a link of interest with one of them or with the NPI. An expert may be a researcher, practitioner or user representative attesting to their skills, knowledge of NPIs and integrity (see previous question). Obtaining an open Science and/or Practice badge is an added value as it attests to one’s mastery of the NPIS Model. Training also at the NPI is also an added value. 

NPIS members will soon have a tool for this purpose, a general numerical table to track the status of the validation of the card.

The NPIS Open Badge Science training indeed offers training for this purpose. NPIS Open badges 1 and 2 Science share all the necessary knowledge and tools. The NPIS Summit gathers every year in October the authors of validated NPI Cards. 

Training for a specific NPI is not the responsibility of the learned society NPIS. It does not train to implement a particular NPI. It is the responsibility of the author, the authors if applicable, the national, European or international professional federation if applicable, public and private training bodies to train the practitioner and the operator in professional practice.