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Defining Non-Pharmacological Intervention (NPI)

Defining Non-Pharmacological Intervention (NPI)

Blog in Health presents the most rigorous studies assessing the efficacy of Non-Pharmacological Interventions (NPIs) and their cost/benefit ratios. But what exactly are NPIs?

“Non Pharmacological Interventions (NPIs) are science-based and non invasive interventions on human health. They aim to prevent, treat, or cure health problems. They may consist in products, methods, programs or services whose contents are known by users. They are linked to biological and/or psychological processes identified in clinical studies. They have a measurable impact on health, quality of life, behavioral and socioeconomic markers. Their implementation requires relational, communicational and ethical skills.” (CEPS Platform,  2017).

Increasingly, NPIs are integrating digital health solutions (web-based interface, e-Health apps for mobile devices, electronic pill box, serious games, etc.) as well as technology solutions (motion sensors, e-cigarette, etc.). They do not include surgery, radiation therapy, gene therapy or drug treatments, which are also called conventional therapies in this Blog.

“NPIs are complementary to biological or surgical treatments” (Ninot, 2013). They often potentiate their action (for example, improving adherence). They rarely are alternatives to them. They involve the active participation of patients, who often adopt new health behaviors.

The effects of NPIs on people’s health and quality of life are direct (via identified mechanisms and processes) and occur in the midterm (1-6 months); they are observable (exceeding a single satisfaction instance), significant (greater than placebo effects) and verified (proven by randomized controlled trials). The demonstration of their efficacy relies on the principles of Evidence-Based Medicine and Evidence-Based Prevention, as implemented in Randomized Controlled Trials (RCT) and Meta-Analyses, the most rigorous and reliable research protocols available today.

Hence, NPIs should therefore not be confused with general health promotion programs within the broader contexts of home improvement, environmental or social reorganization or legislative regulation. They do not fall within the scope of cosmetics either, whose purpose is purely aesthetic. Lastly, they are designed to benefit patients directly, not their loved ones or their support networks, be they personal or professional.

The other names of NPIs

NPIs are known under several designations, which vary according to countries, healthcare, educational and social service specializations. Those appellations include:
– secondary or tertiary prevention actions,
– technical and technological support,
– medical devices,
– behavioral interventions,
– complementary medicine,
– behavioral medicine,
– alternative medicine,
– health products,
– health services,
– adjuvant treatments,
– supportive care,
– non-drug therapies,
– complementary medicine,
– complementary therapies,
– complementary treatments,
– non-pharmacological treatments.

Since NPI legislation and regulation (e.g., FDA, EMA) have not been finalized yet, and since neither the French Health Authority (Haute Autorité de Santé, HAS) and the World Health Organization (WHO) have issued specific vocabulary recommendations, the area of NPIs remains ill-defined. It ranges from therapy to prevention, from products to services, from medical prescriptions to recommendations by health professionals. Proving their efficacy in improving people’s health and quality of life may provide the foundation for their historical legitimacy.

“NPIs are not alternatives to conventional treatments; instead, they most often complement”.

The 3 types of NPIs (according to the French Health Authority, HAS)

According to the French Health Authority (Haute Autorité de Santé, HAS), NPIs fall into three categories: Nutrition, Physical Therapy and Behavioral Interventions. The French Health Authority has issued a searchable report on this subject in 2011 (see also Ninot, 2014).

Physical therapy and adapted physical activity

Kinesiology interventions fall into two sub-categories. The first one comprises all the procedures involving therapeutic gestures applied to the body (massage, physiotherapy, osteopathy, chiropractic, acupuncture, etc.). The other involves the individual or group practice of physical activity (yoga, tai chi, nordic walking, adapted physical activity, etc.).

Lifestyle and dietary programs

Nutrition interventions comprise two sub-categories: diets (diets, dietary advice, etc.) and dietary supplements (mushroom, vitamin, antioxidant food supplements).

Psychological treatments

Psycho-education Interventions are also divided into two sub-categories: educational therapy (patient monitoring programs, serious games, etc.) and psychotherapy (cognitive behavioral therapy, mindfulness, meditation, discussion groups, hypnosis, etc.).


The objectives of NPIs

NPIs seek to address, reduce or stabilize an individual’s health problem (symptom or disease) or to eliminate a modifiable risk factor (prodrome or high-risk disease-causing behavior). Thus, depending on context, the aim of NPIs is to have a preventive (primary, secondary or tertiary), therapeutic, curative or palliative effect. Professionals offer them to patients in order to:

– (1) Cure a disease,

– (2) Alleviate the symptoms of a disease,

– (3) Increase life expectancy,

– (4) Enhance the effects of conventional treatments,

– (5) Prevent the emergence of new diseases,

– (6) Improve quality of life,

– (7) Limit unplanned health expenses (treatments, hospitalization, etc.)

– (8) Reduce productivity losses (sick leave, welfare, etc.).

Offering NPIs: prescription or over-the-counter?

Both professionals and users wonder about the best way to distribute/procure NPIs.  Their questions include:

– What class? (i.e., what processes or action mechanisms? What method? Based on what technique or theory? What training for professionals?)

– What therapeutic indications?

– What contraindications?

– What precautions?

– What side effects?

– What “dosage”? (i.e., what should the nature, the dose, the length, the intensity, the frequency, the place of administration, the supervision mode of an NPI be?)


The Bottom Line

NPIs are currently associated with two fallacies.The first fallacy is that their efficacy  is “self-evident”, and therefore does not require scientific or clinical proof. It assumes that if their benefits are “obvious” and have been known “since the dawn of time”, “there is no need to prove the efficacy of non-pharmacological interventions, which are merely routine hygiene measures.” The second fallacy states that NPIs do not belong to the domain of healthcare products and services. Naysayers claim that NPIs belong instead to the wellness or the entertainment industry, where user satisfaction is paramount. Unfortunately, such biases slow the development of research aiming to provide evidence of the efficacy of NPIs, and are therefore detrimental to their credibility (Ninot, 2013).

A knowledge-based policy is the key to integrate Traditional an Complementary Medicine into national health systems. Research should be prioritized and supported in order to generate knowledge. While there is much to be learned from controlled clinical trials, other evaluation methods are also valuable. These include outcome and effectiveness studies, as well as comparative effectiveness research, patterns of use, and other qualitative methods. There is an opportunity to take advantage of, and sponsor such “real world experiments” where different research designs and methods are important, valuable and applicable. The importance of embracing various kinds of contributory research methods and designs in the effort to build a broad evidence base to inform national policy and decision making has been underlined by the National Institute for Health and Care Excellence (NICE), as well as others” (WHO, 2013, p.39).

The Blog invites to think that any NPI must go beyond the observation of the benefit of a few cases. It must go through the contribution of safety and effectiveness evidence on the health and quality of life from rigorous clinical studies.

“Non-pharmacological interventions must make the demonstration that they are beneficial to people’s health and quality of life.”


What it means for Health Professionals

NPIs are not substitutes for conventional treatments. Neither do they fall into the alternative medicine category. NPIs target modifiable factors. They often complement proven treatments. In several medical specializations, they are considered “adjuvant”(pejoratively understood as nonessential) or hygiene (pejoratively understood as harmless) treatments. In fact, NPIs are full-fledged treatments, whose interactions with other treatments should be known. They have been the subject of extensive clinical studies. Therefore, similar to drug treatments, non-pharmacological treatments should be prescribed by physicians. Indeed, physicians are trained and qualified to target specific health issues, selecting the best solutions from an arsenal of available interventions. They know the action mechanisms of non-pharmacological interventions, and can anticipate potential interactions with other treatments. They prioritize risks and benefits. They customize the “dose” to each patient, recommend procedures to follow, orient patients within local networks of skilled professionals, and order full check-ups when necessary.

What it means for Researchers

Checking the indications for a medication on the package insert is now a reflex for most users, who can readily identify a drug’s therapeutic category, therapeutic indications, contraindications, precautions and adverse/side effects. Dosage recommendations are also available (administration mode, dose, length, frequency). These criteria were standardized and regulated (Boutron et al., 2012). But few professionals are able to provide this level of detail on non-pharmacological interventions, because no standard is available at this time.  This leaves the door open to speculation and misconceptions (Ninot, 2013).

What it means for Policymakers

In the last ten years, pilot studies have shown the positive effects of NPIs on people’s health and their positive impact on social and economic markers. Observational studies have highlighted quality of life improvements and increases in survival without disability. However, these observations do not amount to scientific proof. To provide the evidence necessary for the generalization of NPIs, interventional research is now required (HAS, 2011).


References

Boutron I, Ravaud P, Moher D (2012). Randomized Clinical Trials of Non Pharmacological Treatments. Boca Raton: CRC Press Taylor and Francis.

Haute Autorité de Santé (2011). Développement de la Prescription de Thérapeutiques Non Médicamenteuses Validées. Paris: HAS.

Ninot G (2013). Démontrer l’Efficacité des Interventions Non Médicamenteuses: Question de Points de Vue. Montpellier: PUM.

Ninot G (2014). Defining the Concept of Non-Pharmacological Intervention. Blog en Sante, L16.

WHO (2013). World Traditional Medicine Strategy 2014-2023. Geneva: OMS.


To reference this Blog en Sante © article

Ninot G (2014). Defining the Concept of Non-Pharmacological Intervention. Blog en Sante, L16.

© Copyright 2014 Grégory Ninot. All rights reserved.