PROTOCOL: Effectiveness of interventions for people with disabilities in low‐ and middle‐income countries—an evidence and gap map

Disability is an umbrella term, covering impairments, activity limitations and participation restrictions. The Preamble to the United Nation Convention on the Rights of Persons with Disability (UNCRPD) acknowledges that disability is “an evolving concept,” but also stresses that “disability results from the interaction between persons with impairments and attitudinal and environmental barriers that hinder their full and effective participation in society on an equal basis with others.” An impairment becomes disabling when individuals are prevented from participating fully in society because of social, political, economic, environmental, or cultural factors. More than one billion persons in the world have some form of disability. This corresponds to about 15% of the world’s population (World Health Organisation [WHO, 2011]). The majority of people with disabilities (80%) live in low‐ and middle‐income countries (LMICs), and disability is believed to affect disproportionately the most disadvantaged sector of the population (Banks, Kuper, & Polack, 2017). People with disabilities are more likely to experience a range of exclusions, including from employment, education, health care access and social participation (WHO, 2011). As a consequence, people with disabilities are more likely to experience poverty because disability causes poverty, but also because people who are poor are more likely to become disabled (WHO, 2011). The impact of disability on poverty is also borne at a global level (Banks et al., 2017). In 2004, the World Bank estimated the global GDP loss due to disability to be between $1.71 trillion and $2.23 trillion annually (Metts & Mondiale, 2004); between 12% and 20% of the populations of developing countries were thought to be nonproductive due to disability (Mondiale, 2007). A key argument in attaining welfare for people with disabilities is to equalise social and economic opportunities from both humanitarian and economic perspectives. From a humanitarian perspective, it is to secure basic human rights for people with disabilities. From an economic perspective, it is expected to increase the human capital of people with disabilities, and thus enable them to reduce their dependence on income transfers and other forms of public support. This economic expectation addresses disability as a development issue. Research is now required to determine the most cost‐effective ways to overcome the above obstacles and develop disability policies and strategies that increase the economic contributions of people (Metts & Mondiale, 2004). In recognition of this point, disability is referenced in various parts of the sustainable development goals (SDGs) (United Nations— Disability Department of Economic and Social Affairs) related to education, growth and employment, inequality and accessibility of human settlements. Furthermore, SDG 17 stresses that in order to strengthen the means of implementation and revitalise the global partnership for sustainable development, the collection of data, monitoring and accountability of the SDGs are crucial. Significantly increasing the availability of high‐quality, timely and reliable data that is also disaggregated by disability is one of the key mandates. Evidence and gap maps (EGMs) can contribute to achieving SDG 17 by supporting the prioritisation of global evidence synthesis needs and primary data collection.

Disability is also a human rights issue, and this is highlighted in a range of international documents, including the World Programme of Action Concerning Disabled People (WPA, 1982), the Convention on the Rights of the Child (CRC, 1989), the Standard Rules on the Equalisation of Opportunities for People with Disabilities (1993), and most importantly the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD, 2006). The UNCRPD aims to "promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity." It reflects the major shift in global understanding and responses towards disability, and emphasises that people with disabilities have the right for full inclusion.
Inclusive development is that which includes and involves everyone, especially those who are marginalised and often discriminated against (United Nations Development Programme, 2010).
Unless people with disabilities are brought into mainstream it is impossible to cut the cycle of poverty and discrimination. Attention to disability issues is now increasingly being seen in the policies and programmes of bilateral agencies like Department of International Development (DFID, 2000) either as part of inclusive new policies or in disability-specific initiatives, many of which are linked either implicitly or explicitly to poverty alleviation efforts or public health initiatives as United States Agency for International Development . Although there is little data on the cost-effectiveness of disability-inclusive development, the Asian Development Bank (ADB) maintains that the costs associated with including people with disabilities are far outweighed by the long-term financial benefits to individuals, families and society (ADB, 2005).
To enable people with disabilities to contribute to creating opportunities, share in the benefits of development, and participate in decision-making, a twin-track approach may be required (DFID, 2000). The "Twin-Track approach" aims to break this cycle between disability, poverty and exclusion, by both empowerment of individuals/families/organisations and by breaking down barriers in society, and is advocated for by many international donors (e.g., the World Bank, DFID, the German Cooperation; the European Community [EC] and the Finnish Cooperation) and non-governmental organisations (NGOs). The Twin-track approach promotes integration of disability-sensitive measures into the design, implementation, monitoring and evaluation of all development policies and programmes, called as "mainstreaming disability," while simultaneously undertaking "targeted measures" such as disability-specific policies, programmes and initiatives to ensure the inclusion and full enjoyment of human rights by persons with disabilities (United Nations Development Programme, 2010).
The WHO community-based rehabilitation (CBR) guidelines is based on this approach. CBR is a multisectoral, bottom-up strategy which can ensure that the Convention on Rights of People with Disabilities (ILO/UNESCO/WHO, 2004) makes a difference at the community level. While the UNCRPD provides the philosophy and policy, CBR is a practical strategy for implementation of disabilityinclusive development (Helander, 1989). CBR activities are designed to meet the basic needs of people with disabilities, reduce poverty, and enable access to health, education, livelihood and social opportunities-all these activities fulfil the aims of the UNCRPD.
Guidelines to generate an inclusive and global dialogue, implementing the SDGs must be in line with and build upon existing international and national commitments and mechanisms. The WHO's CBR recognises CBR as a comprehensive and multisectoral strategy to equalise opportunities and include people with disabilities in all aspects of community life. Therefore, the CBR will serve as a guiding framework and the five pillars of CBR: health, education, livelihood, social and empowerment will form the intervention and outcome categories.

| Why is it important to do the EGM?
Over the past decade the academic literature on disability outcomes and effectiveness has grown substantially (Andresen, Lollar, & Meyers, 2000;Devon, Lydon, Healy, & McCoy, 2016;Iemmi et al., 2015 Knowledge production takes place across several sectors (health, social welfare and education), focuses on various populations (different ages, ethnicities, or with different needs), and involves rather diverse methodical approaches (e.g., systematic reviews, primary studies of different designs, etc.). A mapping of the existing knowledge base is therefore required to provide a comprehensive overview of existing knowledge in this area and enable the purposeful and targeted commissioning of future research, tailored to the most eminent needs for knowledge and guidance. This ambition could be fulfilled by proposed EGM.

| OBJECTIVES
The proposed EGM will present studies of the effectiveness of these interventions across a range of outcome domains. Specifically, the objectives of the map are to 1. Develop a clear framework of types of interventions and outcomes related to effectiveness of interventions for people with disabilities in LMICs.

2.
Map available systematic reviews and primary studies on the effectiveness of disability interventions in low-and middle-income countries in this framework, with an overview provided in a summary report.
3. Provide database entries of included studies which summarise the intervention, context, study design and main findings.

| METHODOLOGY
EGMs provide a visual overview of the availability of evidence for a particular sector-in this case will include "people with disabilities." The EGM will consolidate what we know and do not know about "what works" by mapping out existing and ongoing systematic reviews and impact evaluations in this field; and by providing a graphical display of areas with strong, weak or nonexistent evidence on the effect of interventions or initiatives.
The EGMs are presented in two dimensions: the rows list interventions and the column list outcome domains. Each cell shows studies which contain evidence on that combination of intervention and outcomes. This EGM will provide an overview of the existing systematic reviews and impact evaluations on the key outcome domains and interventions aimed to increase the welfare of people with disabilities in LMICs. This EGM will be populated based on the following criteria (Appendix A): • Criteria for including and excluding studies • Types of studies to be included • Quality ratings using Assessing Methodological Quality of Systematic Reviews (AMSTAR-2).

| Types of study designs
The EGM will include systematic reviews of effects of interventions and effectiveness studies that used either (a) randomised experimental design, (b) rigorous quasi-experimental design, (c) natural experiments, (d) regression discontinuity, (e) propensity score matching, (f) difference in difference, (g) instrumental variables, (h) other matching designs and (i) single-subject designs. Usually for such studies protocols might have been published.

| Population
The target populations are people with disabilities living in LMICs based on World Bank Classifications (2016). People with disabilities include those who have long-term physical, mental, intellectual, or sensory impairments, which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others (Iemmi et al., 2015).
In recent years, the inclusion of traditionally underrepresented groups in research has received increasing attention, including racial and ethnic minorities, women, elderly individuals and children (Glickman et al., 2008). Also, some of the population groups are more affected by the outcomes of disability. The 2010 MDG report is the first to mention disabilities, noting the limited opportunities facing children with disabilities, and the link between disability and marginalisation in education. Similarly, the disability prevalence among people 45 years and older in low-income countries is higher than in high-income countries, and higher among women than among men (Üstün, Murray, & Evans, 2003).
Hence, the population subgroups of interest for this EGM include: women, vulnerable children (particularly children in care), conflict (conflict and postconflict settings), migrants and ethnic minority groups.
Studies with multiple populations are included in the map as long as they have a LMIC focus. For reviews with global focus, we will include them as eligible if they did not have any search restriction.

| EGM framework outcomes
The five main outcome categories are as mentioned below and they are plotted against the WHO's CBR indicators (Table 1) 1. Health

| Types of interventions
As indicated in SDG guidelines to generate an inclusive and global dialogue, implementing the SDGs must be in line with and build upon existing international and national commitments and mechanisms.
The WHO's CBR recognises CBR as a comprehensive and multisectoral strategy to equalise opportunities and include people with disabilities in all aspects of community life. Therefore, the CBR will serve as a guiding framework for the intervention and outcome categories as listed below in order to realise the full inclusion and empowerment of persons with disabilities. We have added "Advocacy and Governance" as one of the components as strong advocacy may be required to prevent and/or address abuse, neglect and exploitation that people with intellectual and/or developmental disabilities may experience (CBM, 2012). People with disabilities may need the support of advocates to become effective self-advocates.
The included interventions cover all main strategies to reduce disability related outcome. The six main intervention categories are 1. Health

Health component
Mental health and cognitive development Men, women, boys and girls with disability equally access mental health services and engage in activities needed to achieve the highest attainable standard of mental health services Access to health services Men, women, boys and girls with disability equally access health services and engage in activities needed to achieve the highest attainable standard of health Percentage of people with disabilities and their families that have access to medical care Men, women, boys and girls with disability feel they are respected and treated with dignity when receiving health services

Immunisation
Percentage of people with disabilities who receive full immunisation as recommended for their country by WHO Health check-up Men, women, boys and girls with disability know how to achieve good levels of health and participate in activities contributing to their health Percentage of children with disability who receive the recommended health check-ups

Rehabilitation services
Men, women, boys and girls with disability engage in planning and carry out rehabilitation activities with the required services Access to assistive devices Men, women, boys and girls with disability have access to, use, and know how to maintain appropriate assistive products in their daily life

Nutrition
Morbidity and mortality Men, women, boys and girls with disability access and benefit from quality medical services appropriate to their life stage needs and priorities

Education
Enrolment to primary, secondary, and tertiary education Policies and resources are conducive to education for people with disabilities and ensure smooth transitions through different stages of learning Children with disability participate in and complete quality primary education in an enabling and supportive environment Men, women, boys and girls with disability have resources and support to enrol and complete quality secondary and higher education in an enabling and supportive environment Youth with disability experience post school options on an equal basis with their peers Attendance Men, women, boys and girls with disability have resources and support to enrol and complete quality secondary and higher education in an enabling and supportive environment

| Systematic reviews
The search will be conducted in three stages Search will be as comprehensive as possible, using (but not limited to) relevant systematic review database for first stage along with bibliographic databases (Appendix B), EGM databases, webbased search engines, websites of specialist organisations, bibliographies of relevant reviews, and targeted calls for evidence using professional networks or public calls for submission of articles.
Database for EGMs will also be searched to identify any map and

Outcome WHO's community-based rehabilitation (CBR) indicators
Poverty and out-of-pocket payment Percentage of people with disabilities who are covered by social protection programmes Access to social protection programmes Men and women with disability access formal and informal social protection measures they need Participation in development of inclusive policies Inclusive policies, practices and appropriate resources, defined with people with disabilities enable equal participation of women and men with disability in livelihood (training, finance, work opportunities, and social protection)

Stigma and discrimination
Communities have increased awareness about disability, with a reduction in stigma and discrimination towards people with disabilities Representation at community level PwD actively engage in and benefit from self-help groups in the local communities, if they choose (inclusive or specific) Self-help groups come together to form federations to harness collective energy and influence positive change Men and women with different kinds of disability living in different situations (rural or urban areas, poor or rich, refugees) feel they are adequately represented by DPO Advocacy Men, women, boys, and girls with disability effectively use communication skills and resources (including supportive decision-making) to facilitate interactions and influence change Men, women, boys, and girls with disability play a catalysering role in mobilising key community stakeholders to create an enabling environment To identify unpublished reviews studies, we will search the following databases: Dissertation Abstracts, Conference Proceedings and Open Grey.
To identify ongoing studies, we will search ClinicalTrials.gov and

WHO International Clinical Trials Registry Platform and CENTRAL Trials
Register within the Cochrane Library will be used for published trials.
We will assess the methodological quality of each included systematic review using AMSTAR-2 (Shea et al., 2007). The assessments will be carried out by two reviewers independently.

| DIMENSIONS
The EGM will have two primary dimensions: interventions (rows) and outcomes (columns). Additional dimensions will be In the hard copy of the EGM, multiple 2 × 2 representations of the EGM will be reported. A copy of the coding form will be included as an annex to the EGM report.
In the online version, the additional dimensions will be possible to use as a filter. The online version will include references to included studies and brief summaries of each study based on the abstract (for primary studies) or plain language summary (for systematic reviews) provided for it. Primary studies included in systematic reviews will be highlighted.
In the EGM report, we will • summarise the findings of the EGM • present areas of particular interest in depth (e.g., areas of strong evidence; substantial evidence gaps; the prevalence of evidence by geographical region; the prevalence of evidence by gender or service setting etc.) • present potential implications for policy, practice and research • provide a plain language statement of the EGM findings.

| CODING/CLASSIFICATION
We will code each included study using a piloted coding tool covering study characteristics, population, intervention and outcomes (Appendix D).

| STAKEHOLDER ENGAGEMENT
An advisory group consisting of international experts in disability will contribute to the preparation of the EGM by commenting on protocol drafts. Suggested members for this advisory panel are

| Systematic review method expertise
All authors are experienced systematic reviewers, which means they are proficient in carrying out the various processes in an EGM, such as eligibility screening, quality assessment and coding.
• EGM methods expertise:All team members have previous experience in systematic review methodology, including search, data collection, statistical analysis, theory-based synthesis, which mean they are proficient in carrying out the various processes in an EGM, such as search, eligibility screening, quality assessment and coding.
• Information retrieval expertise: All authors have previous experience in developing search strategies.
All authors have previous experience in developing search strategies.

CONFLICT OF INTERESTS
The authors declare that there are no conflict of interests.

PRELIMINARY TIMEFRAME
This EGM will be developed in two phases. Plans for updating the EGM The lead author will be responsible for yearly updates of the EGM but this is also subject to financing being available.
People with disabilities and/or their family, their caregivers, their community living in high-income countries Disability is defined as impairments, activity limitations, and participation restrictions denoting the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (environmental and personal factors) (WHO, 2011(WHO, , 2001 For primary studies we will include participants from low-and middle-income countries only, as this was the original commitment of CBR (Helander, 1989) Interventions A CBR programme is formed by one or more activities in one or more of the five components (health, education, livelihood, social, and empowerment). List of activities for each element of the five components are presented within the CBR Guidelines under the section "Suggested activities" (WHO, 2010 Systematic review key words − ((systematic* or synthes*) adj3 (research or evaluation* or finding* or thematic* or report or descriptive or explanatory or narrative or meta* or review* or data or literature or studies or evidence or map or quantitative or study or studies or paper or impact or impacts or effect* or compar*)).ti,ab,sh OR ("meta regression" or "meta synth*" or "meta-synth*" or "meta analy*" or "metaanaly*" or "meta-analy*" or "metanaly*" or "metaregression" or "metaregression" or "methodologic* overview" or "pool* analys*" (Continues) T A B L E C 1 (Continued) Search string/key words (for Ovid Medline platform) or "pool* data" or "quantitative* overview" or "research integration").ti,ab,sh OR (review adj3 (effectiveness or effects or systemat* or synth* or integrat* or map* or methodologic* or quantitative or evidence or literature)).ti,ab,sh

APPENDIX D
Coding tool