GATE PROJECT (WHO)

Concept note  WHO Model List of Priority Assistive Products

Terminology:
Assistive Technology (AT) is a subset of health technologies and can be defined as the application of organized knowledge and skills, procedures and systems related to the provision of assistive products. AT is also considered as an umbrella term that covers both assistive products and their service provision, including their scientific application.
An Assistive product (AP) is one of a subset of health products, which includes any product (including devices, equipment, instruments and software) especially designed and produced or generally available, whose primary purpose is to maintain or improve an individual’s functioning and independence, to facilitate participation and to promote well-being. The most common examples of assistive products include wheelchairs, canes, prosthetic and orthotic devices, spectacles, low vision aids, hearing aids, supportive robots, and communication board.

Rationale:
Today, the world has more than a billion people with disabilities. The number of older people worldwide is increasing – from 841 million in 2013 to more than 2 billion by 2050 (1). The majority of this population will need AT to remain healthy, active, and productive – some will need more than one product. The need to access AT is becoming as important as access to any other medical/health products. However, today only 5–15% (approximately 1 in 10 persons) of the population in need has access to assistive technology (2).
Gradual functional decline is an unavoidable and integral part of the ageing process, whether one has a disease or not. The 21st century will see populations that live longer and thus need to remain independent, healthy and productive. Common medical products alone cannot solve this new emerging challenge: there will be a greater need for assistive technology (AT). Considering this, health interventions need to embrace the concept of “assistive” in addition to promotive, preventive, curative, rehabilitative and palliative health services. Gradual functional decline can neither be prevented, nor cured/rehabilitated – there is a need for assistive health intervention
including provision of assistive products. Recent years have also witnessed a dramatic rise in injuries, birth defects, noncommunicable diseases and musculoskeletal conditions, all of which make huge demands on the AT sector.
Access to AT is a fundamental right of every person in need. This basic or fundamental right was further reinforced by recent global acceptance of the United Nations Convention on the Rights of Persons with Disabilities (CRPD). The CRPD identifies access to mobility aids, assistive devices and technologies as a human rights obligation that every Member State must fulfil and highlights the importance of international cooperation to improve access (5). Therefore, the countries that have ratified the CRPD need to ensure the availability of AT at an affordable cost. The CRPD entitles people with disabilities of all ages to have affordable AT as a right, a first step or precondition to equal rights and opportunities, and ensuring this right is not only a matter of national responsibility, but a matter of international responsibility.
Unawareness, unavailability, high-cost and apathy are among the key reasons for poor access to AT. As a result, nearly 90% of the population in need are often confined to their homes, living a dependent-life in poor health – excluded from participating in society, and locked into poverty. The scenario is quite similar to the poor access to medicines in the 1960s or 70s, when there were few companies, over-priced products and most medicines were only accessible to the middle/high-income population.
To change the prevailing situation and improve access to medicines for all, WHO introduced the concept of essential medicines and introduced the first WHO Model List of Essential Drugs in 1977 (3). It identified 208 individual medicines, which together could provide safe, effective treatment for the majority of communicable and non-communicable diseases. Over the years, the list emerged as the WHO Model List of Essential Medicines and since its introduction it has been through seventeen revisions – almost one every two years.
The Essential Medicines List (EML) has been described as a “peaceful revolution” for its positive repercussions in international public health (4). Defining an essential medicine is an evidence-based process and includes criteria such as public health relevance, efficacy, safety and cost-effectiveness. The concept of essential medicines has been an incentive to rally public opinion, mobilize resources and create more competition. It has provided a stimulus/framework for Member States to develop their own national list and promote access to the essential medicines for their population.

Like common medical products, some assistive products are more important/needed than others and the ranges of AT products are very wide – costing less than a dollar a product to thousands of dollars a product. To make the full range available and ensure its provision for everyone in need, especially in low- and middle-income countries (LMIC) is an arduous job – hence, the identification of priority assistive products is crucial. Although there are many similarities to the issues involved in priority and access of essential medicines and medical products, accessing appropriate assistive products has its own set of unique problems and challenges that urgently need solutions.
Based on the learnings of the EML, WHO plans to develop and introduce a Model List of Priority Assistive Products (APL) to assist Member States to plan policies and programmes related to the provision of AT. Like the EML, the main goal of this initiative is to improve access to high-quality affordable assistive products. This initiative will also contribute to the fulfilment of WHO’s General Programme of Work for 2014–2019, WHO’s six leadership priorities, the Universal Health Coverage (UHC) and WHO’s Global Disability Action Plan 2014–2021 (7). This will also support the aims of the Sustainable Development Goals (SDG) – Goal 3 in particular: Ensure healthy lives and promote well-being for all at all ages (8).
Proposed definition of Priority Assistive Products: Priority Assistive Products (APP) may be defined as: those products, which are appropriate, highly needed, a must/absolutely necessary to maintain or improve an individual’s functioning and health; available at a price the individual and the community/state can afford.
The “priority” criteria will be selected based on need and efficacy, especially in terms of functional gain and safety. WHO will also take into account the principles of appropriate technology (5As & Q) — Acceptability, Accessibility, Adaptability, Affordability, Availability, and Quality (9).

The WHO Model List of Priority Assistive Products (APL) will serve as a guide for the development of National Priority Assistive Products List. It is not being designed as a global standard. The proposed list is not a restrictive list – it should be considered as a start-up list. This priority list does not include all kind of assistive products, which potential users are eligible under the CRPD. The proposed list also does not imply that only priority assistive products should be provided through the public system or reimbursed by the state or insurance. The APL will include the 50 minimum assistive products needed for a basic health-care/social welfare system. The proposed list can be and should be adapted to meet National needs, based on priorities and availability of resources. Its philosophy, principles and approaches will be equally relevant to high-, middle-, and low-income countries.
WHO will develop this model list based on best available evidence and a systematic process. The Global Burden of Disease data, WHO Study on global AGEing and adult health (SAGE) data, World Report on Disability, ISO 9999, the WHO International Classification of Functioning, Disability and Health (ICF), and other WHO initiatives such as EML and Priority Medical Devices (PMD) will guide the whole process and the outcome (10, 11, 12, 13). Based on this data, the 50 products on the APL will be divided into six categories: mobility, vision, hearing, communication, cognition and environment.

Identification Process of the APP
To develop 50 APL, a five-stage strategy has been designed:
1. Scoping review including disability, Global Burden Disease (GBD) and WHO Study on global AGEing and adult health (SAGE) data
2. Pilot survey
3. Delphi exercise
4. Global survey
5. Global consultation
Environment
Mobility
Vision
Hearing
Copmmunication
Cognition

Every stage of the process will be an inclusive one ─ involving all the key stakeholders; especially ensuring user participation at every step. WHO will use the decision-making framework, as outlined in the WHO Handbook for Guideline Development, to develop the first APL (14). WHO has also carried out an in-depth reviewed of the process of other similar successful initiatives such as the EML and PMD.
1. Scoping Review
WHO has already conducted a scoping review to identify important assistive products, with the following key objectives:
1. To gather evidence on specific assistive products, and their impact on quality of life or well-being.
2. To gather evidence on which specific assistive products are most essential or used in each of the functional domains of mobility, cognition, communication, hearing, vision and also for the environment.
3. To develop an initial list of 155 Assistive Products for the Delphi exercise.
Based on the result of the Scoping Review, a preliminary list of 140 assistive products has been identified to carry out the Delphi exercise. To ensure clarity and universal understanding, ICF and ISO 9999 terminology and taxonomy has been used in developing the initial list (12).
2. Pilot Survey
WHO has conducted a pilot survey to test the 150 assistive products list and identify 50 priority assistive products following a rapid mini-Delphi exercise. It also provided a snapshot on whether this type of survey is effective in fulfilling the purpose of the study and to determine whether conducting a large-scale survey is worth the effort. Based on the pilot survey and feedback received from the reviewers, the initial list has been updated and expanded to 155 assistive products for the next step, the full Delphi exercise.
50 APL
Quality of evidence
Values and preferences
Balance of benefits and harms
Resource implication
Priority of the problem
Equity and human rights
Acceptability
Feasibility

3. Delphi Exercise
The Delphi exercise/method is a common structured tool for forecasting, and can be characterized as a method for structuring a group communication process that is effective in allowing a group of individuals, as a whole, to deal with a complex problem. WHO will use the members from the GATE community and other experts, including leaders of user organizations, to carry out the Delphi exercise. An email-based Delphi exercise will be carried out in four steps:
Step 1. WHO will write to the relevant stakeholders to identify participants. WHO will use the GATE community as primary target group.
Step 2. Willing participants then will be provided with the draft list of 155 assistive products and they will be invited to suggest further additions to ensure no key assistive product has been missed out. However, participants need to justify any inclusion based on criteria mentioned above.
Step 3. Participants will receive the extended list of 150–200 assistive products. They will be asked to edit the list to 100 assistive products, based on need, supply (availability), evidence, practice, experience and cost-effectiveness.
Based on the best available GBD, disability/impairment and SAGE data and also considering global disability trend, the proposed break down of the 100 important assistive products could be as follows:
1. 30-34 products for mobility
2. 16–20 products for vision
3. 12-16 products for hearing
4. 6-10 products for communication
5. 16-20 products for cognition
6. 8-12 products for environment
Step 4. Participants will be provided with the list of 100 assistive products, which achieved maximum scoring and then they will be asked to carefully scrutinize the list and identify the 50 Priority Assistive Products; again based on the definition of , based on need, supply (availability), evidence, practice, experience and cost-effectiveness.
1. 14–18 products for mobility

2. 7–11 products for vision
3. 5–9 products for hearing
4. 2–6 products for communication
5. 7–11 products for cognition
6. 3–7 products for environment
3. Global survey
Once WHO has a list of 100 important assistive products (after completion of the third step of the Delphi exercise), WHO will carry out a Global survey to identify 50 Priority Assistive Products. An online and email-based survey will be conducted using WHO’s Lime survey tool. To ensure the best possible outcome, WHO will target two key stakeholder groups to take part in the survey: 1) service providers and 2) service receivers (users or potential users). The results of both the surveys will be analysed and compared.
4. Global Consultation (meeting of experts)
After the completion of the Delphi exercise and the global survey, WHO will organize a global consultation inviting 30 experts, representing different AT stakeholder groups (including users), to work towards developing the first WHO Model List of Priority Assistive Products (APL). The results of the Delphi exercise and the global survey will be presented at the meeting and a structured, consensus methodology will be used to develop the first WHO Model List of Priority Assistive Products (APL). The factors that determine the strength of a recommendation, as outlined in the WHO handbook for Guideline Development, will be the basis for the final recommendations.
To assist Member States to implement APL and to ensure its benefit reaches to all, especially people living in rural areas, experts will be further requested to divide the final 50 APL into two groups: 20–30 APP for Community Level (APPc) and 20–30 APP for Referral Level (APPr). Criteria for the two groups will be:
 Priority Assistive Products for Community Level (APPc) may be defined as: those priority assistive products, which can be provided at the community level by health workers/nurses/community-based rehabilitation (CBR) workers and others (non-specialists), following a short, comprehensive training programme.

 Priority Assistive Products for Referral Level (APPr) may be defined as: those priority assistive products, which can be provided at the referral level by specialist professionals within the related field.
Besides the principles of the priority concept, APP for community level will also be selected based on the nature of the assistive product, its purpose, and possible delivery method. To assist Member States to implement APL, it is very important to distinguish between APP that need the intervention of a specialist, either for fitting or training (for example, trans-tibial prosthesis; spectacles for myopia), and those products for which a specialist’s intervention is not necessary (for example, walking frame, crutches, magnifying glass).
Primary health centres and referral facilities will be interconnected to ensure primary health centres refer users when a higher level of intervention is required, and that referral facilities make use of primary health centre facilities for on-site training, maintenance, repairs and follow-up. Referral facilities are usually part of the District/Regional/National Health/Social Welfare system set-up.

Conclusion:
WHO Model List of Priority Assistive Products (APL) is a baseline or start-up list of assistive products, which must be available for every country. It is not a restrictive list ─ it is a guide and concept, based on which every country can develop their own National Priority Assistive Products List (APL). Individual health and functional needs, goals, and environments vary widely. This list outlines only the products, which then need to be provided by trained personnel, with necessary alterations and adaptations to match every individual user’s need and as per his/her choice. In addition, such a list can provide specific ideas to potential users, their families, therapists and support networks as to what might help them to perform their desired activities. Then, if funds are not available for purchase, these same people may be able to design and build equivalent devices using best available local resources.
Developing APL is the first step to improve access to assistive products. The next step for WHO will be to develop the related training package and single-window comprehensive service delivery model, to support Member States to implement National APL provision. The ultimate goal is to realize the aim of WHO’s Global Disability Action Plan 2014–2021, CRPD, SDG, UHC ─ to ensure all users have access to assistive products of as per their need and choice, as close as possible to their own communities or home.
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References
1. United Nations, Department of Economic and Social Affairs, Population Division. 2013. World Population Ageing 2013. ST/ESA/SER.A/348.
2. WHO. 2014. Concept note on Global Cooperation on Health technology. Geneva, World Health Organization.
3. WHO. 2014. WHO model list of Essential Medicines. Geneva, World Health Organization. http://www.who.int/medicines/publications/essentialmedicines/en/
4. Kar SS, Pradhan HS, Mohanta GP. Concept of Essential Medicines and Rational Use in Public Health. Indian Journal of Community Medicine : Official Publication of Indian Association of Preventive & Social Medicine. 2010;35(1):10-13.
5. United Nations. Convention on the Rights of Persons with Disabilities, G.A. Res. 61/106 (2007) http://www.un.org/esa/socdev/enable/rights/convtexte.htm.
6. Johan Borg, Stig Larsson and per-Olof Ostergen. The right to assistive technology: for whom, for what and by whom? Disability and Society. Vol.26, No. 2, March 2011, 151-167.
7. WHO. 2014. Disability and rehabilitation. WHO Global Action Plan 2014-2021. Geneva, World Health Organization (http://www.who.int/disabilities/actionplan/en/).
8. Open Working Group proposal for Sustainable Development Goals; United Nations Sustainable Development Knowledge Platform; Retrieved 29 May 2014 (https://sustainabledevelopment.un.org/sdgsproposal)
9. WHO. 2011. Joint position paper on the provision of mobility devices in less resourced settings. Geneva, World Health Organization, Page: 19. http://whqlibdoc.who.int/publications/2011/9789241502887_eng.pdf?ua=1&ua=1
10. International Organization for Standardization. 2007. Assistive products for persons with disability – Classification and terminology. Geneva: International Organization for Standardization.
11. WHO. 2001. International Classification of Functioning, Disability and Health. Geneva: WHO.
12. Stephen M. Bauer, Linda-Jeanne Elsaesser, Sajay Arthanat. Assistive technology device classification based upon the World Health Organization’s, International Classification of Functioning, Disability and Health (ICF). Disability and Rehabilitation: Assistive Technology, 2011, Vol. 6, No. 3 : Pages 243-259
13. WHO. 2010. Medical devices: managing the mismatch. Geneva, World Health Organization. http://www.who.int/medical_devices/access/en/
14. WHO. 2014. WHO Handbook for Guidelines Development. Geneva, World Health Organization, Page: 124.

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