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. 2020 Sep 11;15(9):e0238851. doi: 10.1371/journal.pone.0238851

Preliminary steps of the development of a Minimum Uniform Dataset applicable to the international wheelchair sector

María Luisa Toro-Hernández 1,#, Nancy Augustine 1,2,#, Padmaja Kankipati 3,4, Patricia Karg 1,2, Karen Rispin 4,5,¤, Richard M Schein 2,4, Krithika Kandavel 1,2, Megan E D’Innocenzo 1,2, Mary Goldberg 1,2, Jonathan Pearlman 1,2,*
Editor: Sara Rubinelli6
PMCID: PMC7485892  PMID: 32915874

Abstract

Assistive products outcomes are needed globally to inform policy, practice, and drive investment. The International Society of Wheelchair Professionals developed a Minimum Uniform Dataset (MUD) for wheelchair services worldwide with the intent to gather data that is comparable globally. The MUD was developed with the participation of members from around the globe and its feasibility piloted at 3 sites. Three versions of the MUD are now available—a short form with 29 data points (available in English, Spanish, and French) and a standard version with 38 data points in English. Future work is to validate and complete the translation cycles followed by promoting the use of the MUD globally so that the data can be leveraged to inform policy, practice and direct investments.

Introduction

The World Health Organization (WHO) defines rehabilitation as a strategy to optimize an individual’s functioning [1]. WHO has also recognized that rehabilitation is a prerequisite to achieve health and well-being for all [1]. There is a vast gap of evidence and outcomes in rehabilitation, including rehabilitation needs of the population, cost-benefit analysis, and measures of impact through standardized measures of rehabilitation [13]. Absence of reliable data and information poses significant barriers to the development and monitoring of effective rehabilitation policies, programs, and the realization of the right to the highest attainable health [2, 4, 5]. Therefore, reliable data and statistics are needed to achieve the United Nations Sustainable Development Goals (SDGs) and to support the scale up of rehabilitation in health systems, especially in low- and middle-income countries (LMICs) [1, 6]. For many people, access to assistive products (AP), and learning how to use them, is needed to realize the right to fully participate in their communities [1, 79]. Access to AP across the life span is key to reducing inequalities within and among nations [1013]. Context-specific evidence is needed to inform the development of policies and programs that warrant appropriate access to AP [10, 14]. Specific to wheelchairs, there is a need for comparable wheelchair provision data, mostly in LMICs, to strengthen the evidence on different interventions [15, 16].

One strategy to measure rehabilitation outcomes through time is large datasets; that is, multiple rehabilitation service sites using the same outcome measures in order to compare rehabilitation outcomes among type of services (i.e., specialized rehabilitation unit vs. non-specialized), health condition, sex, age, and with the potential to assess the interplay of different determinants [5, 1721]. These large datasets pose an opportunity to generate practice-based evidence to develop benchmarks for the sector [17, 18]. Most large rehabilitation data sets are in high-resourced settings and collect demographic, hospitalization, diagnostic, functional status data, but do not measure AP use at discharge [17, 18, 20, 22]. The use of AP has been identified globally as an overlooked outcome in people who have sustained a spinal cord injury [23]. An exception is the US National Spinal Cord Injury Database which collects data to study the course of spinal cord injury, health service delivery (including AP), and outcomes [24]. Outcomes comparable among different settings [2, 25, 26] with a special emphasis on LMIC [15] are needed to strengthen the evidence on AP. For instance, there is a need to measure the met and unmet need and to monitor and evaluate initiatives longitudinally, including measuring cost-effectiveness to be able to prioritize and promote investment [10, 14, 2730]. An example is the Assistive Technology Needs Assessment proposed by the World Health Organization (WHO) to measure at a population base the proportion of people who self-identify a need for AP and current AP product satisfaction [28]. This tool, however, is not meant to be used to measure outcomes at multiple time intervals [28]. There is little research to support current wheelchair service delivery recommendations (e.g. WHO guidelines, professional organizations guidelines), and the evidence that exists commonly involves small sample sizes, inconsistent definitions, and different outcome measurements [16, 31]. Most research has been exploratory, including single subject designs in high-income settings, which provide weak evidence [3133]. Efforts targeted at LMICs to measure wheelchair provision outcomes longitudinally have used different measurements, and a significant group of people were lost to follow-up, making it impossible to aggregate the data [3437]. Outcomes that are important for users and families is also lacking [33], and instead, outcomes focus on the interface between the user and the wheeled mobility device [38], the working condition of the wheelchair [39, 40], or outcomes related to specific mobility skills interventions [41]. There are two recent large dataset examples specific to wheelchair service in high-income settings. First, in the US, the Functional Mobility Assessment and Uniform Dataset (FMA/UDS) is a Wheeled Mobility and Seating registry responding to the country’s context of wheelchair service provision which has been created for quality assurance and to understand what type of mobility devices promote best health and participation according to health condition and other circumstances [42]. The data collected is based on the Functional Mobility Assessment [22, 43] and a uniform dataset [42]. Data is collected at the time of assessment for a new device and periodically afterwards as a follow-up measure [42]. Second, in the UK, the National Wheelchair Data Collection initiative started in 2015 to improve transparency and benchmarking by collecting, in a centralized manner, expenditure, access, volume, and wheelchair user experience [44]. For LMICs, and based on consensus wheelchair provision guidelines, the World Health Organization proposed general intake and follow-up forms for wheelchair services that may be useful to gather global data uniformly [4547].

A scoping report on global access to AP stated that “the needs of a comprehensive wheelchair service are not widely understood in any country” [27], which may result in low quality of rehabilitation services both in quantity and quality [4]. A full picture of the need for appropriate wheelchair products and services, including the policies and personnel that support them, is necessary for strategic planning and capacity building to realize the human right to personal mobility [7, 48]. In fact, a global wheelchair sector stakeholders (e.g., users, WHO, aid agencies, academia, international and local NGOs, humanitarian organizations, professional organizations, service providers, governments) meeting in 2018 held to reflect on past achievements, challenges, current initiatives, and to strategize a future of better access to wheelchairs, identified one of the global priorities to be: “Conduct research and collect data … Create a repository of data related to: unmet need; product and service quality; impact of appropriate wheelchair provision on health, quality of life, participation, reintegration into daily living and economic benefit analysis; and promote the use of the data to drive evidence-based practice” [49]. To help bridge the gap in wheelchair provision data gathered and comparable in LMICs, the International Society of Wheelchair Professionals (ISWP) [50] developed a Minimum Uniform Dataset with the objective to promote the global use of a common language to strengthen the evidence [15] and to foster comparison among interventions [16]. The purpose of this manuscript is to present the development process and final composition of ISWP’s Minimum Uniform Dataset (MUD).

Methods and results

The Minimum Uniform Dataset (MUD) was developed through an iterative process by stakeholders composed from ISWP’s global membership, including the members of the Evidence-based Practice Working Group Data Collection Subcommittee. The iterative process included initial question development, pilots, revisions based on pilots’ results, and launch (Fig 1) [51, 52]. Information on the development process was presented at the RESNA conference in 2018 [53].

Fig 1. ISWP Minimum Uniform Dataset iterative process.

Fig 1

ISWP member survey

On May 5, 2015, ISWP sent an e-mail to 353 ISWP wheelchair sector stakeholders who are ISWP members with a survey (S1 File) link to request input on: data they currently collect in their practices; methods of collecting the information; willingness to share de-identified data to help develop common data fields and to use a standardized data management system; methods for using de-identified, aggregated data; and suggested data to be collected. Forty-one individuals (41) responded (11.6%) representing all stakeholder groups and 18 countries, providing a representative sample for this first step of identifying the types and extend of data collection. De-identified data is available in S1 Dataset.

Among 39 respondents who selected the occupation that best described them, 28% (n = 11) were clinicians; 15% (n = 6) worked for non-government organizations; 15% (n = 6) were researchers; and 10% (n = 4) were manufacturers. Thirty percent (n = 12) were grouped in the Other category, which was comprised of suppliers (n = 3), academicians (n = 3), as well as individuals who reported to be in private practice, product manager, or technician. Respondents represented 18 countries: Albania, Argentina, Brazil, Canada, Colombia, Germany, Hong Kong, India, Japan, Kenya, Mexico, Portugal, South Africa, South Korea, Spain, Sri Lanka, United Kingdom, and United States. The survey was distributed only in English; this may have prevented stakeholders whose first language is not English from responding.

Slightly less than half of respondents—47.4% (n = 18)—indicated they collected data on wheelchair skills and abilities of their clients; 52.6% (n = 20) did not, 3 respondents skipped the question.

Overall, the 13 questions had a response rate of 76% or higher. Two questions were responded by 76% of the respondents, one by 88%, and 10 questions were responded by 90% or higher. Among the methods used and reported by 36 respondents (multiple responses accepted): 77.7% (n = 28) kept records on paper; 72.2% (n = 26) conducted user interviews at time of delivery or follow-up (data collection method not specified); and 58.3% (n = 21) conducted user satisfaction, feedback, or impact surveys.

Respondents were shown a list of 25 data points that could be included in a uniform/minimum dataset and asked to select those which should be included; multiple answers were accepted. Eighty percent or more of respondents (n = 33) indicated 21 measures should be included as part of a uniform minimum dataset (Fig 2). No criteria were set a-priori to delete items based on missing responses.

Fig 2. 2015 ISWP wheelchair sector survey results indicating for each data point the percentage of respondents (n = 33) who thought it should be included in a Uniform Minimum Dataset.

Fig 2

Survey results were presented to the ISWP Advisory Board and Evidence-based Practice Working Group. In November 2015, the group established a subcommittee devoted to the Minimum Uniform Dataset (MUD).

Questionnaire development

The ISWP MUD subcommittee, comprised of a cross-section of wheelchair sector stakeholders, used the 21 data points from the 2015 survey as the basis for the first draft of the MUD. The subcommittee also reviewed the WHO wheelchair service provision forms in the WSTP-Basic Wheelchair Service Training Package [45], data fields that World Vision was collecting as part of its ACCESS project [54], WHO Quality of Life [55] and WHO Disability Assessment Schedule 2.0 [56] measures, among other data points they felt service providers should know to inform wheelchair service and provision in international settings. As the number of data points to be collected grew, the subcommittee identified what minimum information should be collected so that a variety of organizations could share the same data points with ISWP.

In late 2015 and early 2016, the subcommittee iteratively refined the questionnaire in preparation for a May 2016 pilot at Bethany Kids Relief and Rehabilitation and Joy Town School for Students with Disabilities in Kenya. Multiple conference calls and response to input resulted in a 21-item questionnaire (Table 1):

Table 1. ISWP Minimum Uniform Dataset questionnaire data points, 2016.

Year of Birth Primary mobility aid used*
Height Mobility aid manufacturer name
Weight Mobility aid model/make
Gender Mobility aid serial number
Diagnosis* How long using primary mobility aid*
Year of diagnosis Hours/Day Mobility Aid Used*
Highest grade in school completed* Who Provided Mobility Aid*
Current occupational status* (If wheelchair) Type of Cushion Used*
Date of interaction (If wheelchair) Type of Backrest Used*
Purpose of visit* Settings where mobility aid is used*
Physical function ability**

*Close-ended question.

**Included yes/no statements for client to answer related to ability to walk 25 feet without support; whether unilateral or bilateral support is needed; whether support is needed only when traveling; and if upper body is impacted and affects ability to self-propel a wheelchair.

2016 Kenya pilot

A pilot was conducted in May 2016 by one of the co-authors (KR). The purpose of the pilot was to determine: a) how long it took to administer the questionnaire; b) background of the individual administering it; c) setting/location where it was administered; and c) whether the wording was at a suitable level for comprehension. Students from two schools who used a wheelchair were invited to participate in the pilot. A total of 45 primary school students (average age 11.5 years) and 60 secondary school students (average age 17 years) who all used wheelchairs as their primary mobility device participated. Ethics approval was given by LeTourneau University and LeTourneau’s partner organizations in Kenya (LETU IRB: Feb 23, 2017). Participants 18 years or older signed the informed consent and participants younger than 18 provided assent and their guardian signed the written consent. Participants completed paper versions of the 21-item questionnaire. At the primary school, a single data collector administered the ISWP MUD individually to all 45 wheelchair users. An occupational therapist working with the students reviewed the completed documents to identify if there were inaccuracies, specifically with regard to diagnosis. At the secondary school, 60 wheelchair users completed the form in a group session. The research team circled the room to try to clarify questions while students completed the MUD. Those administering the questionnaire recorded comments on an Excel spreadsheet about difficulties with specific questions (e.g., very few respondents knew their height and weight or the year of diagnosis; most countries use meters to measure distance, not feet). S2 Dataset presents the aggregated feedback provided by the data collector.

The 2016 pilot feedback and additional working group and subcommittee review and input resulted in a standard version of the MUD with 40 data points and a short form with 28 data points (Table 2). The subcommittee decided to offer a standard and short form version to provide flexibility while promoting consistency in the implementation as time constraints in services may vary across LMICs. The standard version includes additional questions about wheelchair and cushion manufacturer, make, and model; training received; assistance using a wheelchair indoors and outside; distance traveled in the wheelchair; whether the client takes public transportation; and which transportation methods are used. ISWP also created Excel workbooks for each version which included drop-down boxes for questions with close-ended responses to facilitate data entry.

Table 2. ISWP MUD questionnaires, 2017 (bold X indicates data point in standard version only).

Data Point Short Form Standard Version
Client and wheelchair clinic information
 Client ID X X
 Client town X X
 Client country X X
 Service provider name X X
 Service provider location X X
Date completed X X
Primary purpose of visit* X X
Demographics
 Age/approximate age X X
 Gender* X X
 Education* X X
 Employment* X X
 Living situation* X X
Reasons for assistance
 How long needed mobility aid X X
 Why mobility aid is needed* X X
 Year diagnosis received* X X
Mobility aids used (list of 30 mobility aids grouped by category: Manual wheelchair; electrically powered wheelchair; crank system [cycle]; walking products; braces and artificial limbs; and other mobility aids. Presented as one question with five parts.)
 Rank top 4 currently used most often X X
 Where used (indoors/outdoors) X X
 Use more than one year X X
 Number of hours/days used (grouped) X X
 Number of days/week used (grouped) X X
Mobility aid details
Manufacturer name, model/make and serial number for each aid used X
Difficulty walking long distance in past 30 days* X X
Assistance
 Help indoors X
 Help outside X
Questions for current wheelchair users
 Degree of difficulty pushing* X X
 How client pushes wheelchair* X X
 If not pushing with arms or legs, reasons why* X X
 Places where wheelchair is used currently* X X
 How person received wheelchair* X X
 Agreement statements regarding wheelchair (7) X X
 Overall level of satisfaction with wheelchair X X
 Distance traveled in wheelchair each day X
 Whether public/private transportation is used X
 If public/private transportation used, what kind X
 Whether client has ever fallen out of wheelchair X
 Cushion type*, manufacturer, make/model name or number X
 Training received about how to use wheelchair X
Whether survey was completed by client or someone else X
Name of referral, if applicable X
Cushion details
 Manufacturer name, model/make for cushion X

*Close-ended question.

2017 Indonesia and Kenya pilots

A second pilot of the short form questionnaire was conducted by LeTourneau University in Kenya in May 2017 with 31 primary school students and 64 secondary school students who all use wheelchair as their primary means of mobility. Ethical approval and recruitment and consent processes were as described above. A volunteer used the Excel workbook to administer the questionnaire with the primary students. Secondary school students completed the paper questionnaire with help from volunteers who clarified questions, but did not help with responses, and noted when students said they had difficulty completing a question. Secondary school students took, on average, 11 minutes to complete the questionnaire and had difficulty answering 7 of the 28 data points. S2 Dataset presents the aggregated feedback provided by the data collector.

In February 2017, UCP Wheels for Humanity partnered with the Comprehensive Initiative on Technology Evaluation at the Massachusetts Institute of Technology (CITE-MIT) and Puspadi Bali Foundation to pilot a standard version of the survey (40 data points) with 150 respondents in Bali, Indonesia as part of the Wheelchair User’s Voice Project [57]. Ethics approval was given by the University of Pittsburgh (ID: 679—CITE Evaluation of Wheelchair Usage and Rider Experience in Indonesia). The questionnaire was forward translated and administered in Bahasa, and written consent was obtained from all research participants (S2 File presents the MUD in Bahasa Indonesia). Guardians signed the informed consent on behalf of participants younger than 18 years old. MIT and the University of Washington provided feedback to ISWP by e-mail in December 2017. Overall, the MIT team felt the questions were useful but noted several items which were difficult for respondents to answer. For example, it was not easy for users to remember when they received their chair, but they could give a date range; users could not easily remember when they received their diagnosis but could estimate the number of years; and some questions were double-barreled (i.e., an item that asks two or more questions at the same time, and each one can be answered differently [52]). They also revised some questions to better meet their study objectives.

Finalizing the questionnaires and launch

Feedback from the 2017 pilots was incorporated along with input from domain experts in instrument development at the University of Washington and University of Pittsburgh [51, 52]. The Evidence-based Practice Working Group provided additional feedback, resulting in final versions of the questionnaires prepared in March 2018 and presented to the ISWP Evidence-based Practice Working Group on April 5, 2018 [51, 52]. The Excel workbooks and interviewer guides also were updated.

Table 3 presents a description of the launched MUD short form with 29 data points and standard version with 38 data points. The forms, fillable Excel workbooks, and questionnaire guides are available free of charge on ISWP’s site: https://wheelchairnetwork.org/resource-library/mud/.

Table 3. ISWP MUD questionnaires (bold X indicates data point in standard version only).

This table has been reproduced from the RESNA Conference Abstract [53].

Data Point Short Form Standard Version
Client and wheelchair clinic information
 Client ID X X
 Client country X X
 Wheelchair clinic ID X X
 Wheelchair clinic country X X
Date completed X X
Purpose of Visit* X X
Name of individual/organization referring client X
Demographics
 Age/approximate age X X
 Gender* X X
 Education* X X
 Employment* X X
 Living situation* X X
Reasons for Assistance X X
 How long need something to help walk/move X X
 Diagnosis* X X
 Year diagnosis received X X
 Difficulty walking long distance (100 meters) X X
Assistance when outdoors/inside* X
Items used to help walk/move (list of 10 mobility aids. Presented as one question with 6 parts)
Own item X X
 Use indoors X X
Use outside X X
 Use for more than one year X X
 Number of days per week used X X
 Number of hours per day used X X
Questions for current wheelchair users
 Degree of difficulty pushing* X X
 How client typically pushes wheelchair* X X
 If not pushing with arms reasons why* X X
 Places where wheelchair is used* X X
Distance traveled each day in wheelchair* X
 Whether public/private transportation is used* X
 If public/private transportation used, what kind* X
 Whether client has ever fallen out of wheelchair* X
 How person received wheelchair* X X
 Agreement statements regarding wheelchair* X X
 Level of satisfaction with wheelchair* X X
 Wheelchair training received* X
Manufacturer name, model, serial number of item used to help person walk/move* X
Manufacturer name, make, model name of cushion and/or postural support device(s) used* X

*Close-ended question.

ISWP Minimum Uniform Dataset preliminary translation

Forward translation of the MUD into French and Spanish was conducted. These translations were done in response to the request of two initiatives that were looking for a tool that they could quickly implement. First, a 2017 version of the short form is available in French. The translation was provided by Université de Montréal, CHU Sainte-Justine Centre de réadaptation Marie Enfant. It has not been forward-backward-forward translated, and there have been several changes to questions which are reflected in the 2018 short form. Second, UCP Wheels for Humanity continued to use the 2017 standard version (40 data points) in the full-study phase of its Wheelchair User’s Voice Project. The questions were translated into Spanish and incorporated into a larger dataset which was administered in El Salvador in 2019. The short version of the questionnaire was translated into Spanish in 2019. Fig 3 presents the MUD’s development, validation, and translation steps that were accomplished and the future work steps to be completed.

Fig 3. ISWP’s Minimum Uniform database accomplished and future development, validation, and translation steps.

Fig 3

Green shaded boxes indicate the completed steps. Adapted from [58].

The English, Spanish, and French MUD versions are open-access resources that may be used by other groups for validation and/or to complete or conduct a full translation cycle [58].

Discussion, limitations and future work

The International Society of Wheelchair Professionals developed a Minimum Uniform Dataset (MUD) for Wheelchair Service in English, Spanish, and French. This is the first measurement tool of its kind intended to promote global wheelchair service data collection and developed iteratively with input from global stakeholders (e.g., service providers in LMICs, researchers, service managers, users, NGOs, manufacturers). We believe that this collaboration will be key for a successful implementation; previous outcome measures research has identified the engagement of clinicians, as well as wheelchair users, managers, and providers, in the development of this type of clinical dataset as key for the success [18, 59]. The MUD may be used by ISWP members and allies to gather the short- and long-term evidence that is needed to provide guidance for policy and inform allocation of scarce resources into appropriate wheelchair provision, especially in LMICs [4, 12, 14]. The MUD has the potential to contribute to closing the Policy Implementation Monitoring Gap which has been defined as a lack of explicit disability disaggregated indicators for monitoring and evaluation at the national, regional, and global-levels [5, 14, 27, 49, 60]. The information could be used to accredit wheelchair services in a similar manner as how the Joint Commission and Commission on Accreditation of Rehabilitation Facilities International use the Uniform Dataset for Medical Rehabilitation in the US in their service accreditation processes [60]. Aggregated data also may be used to prove the conceptual framework that was developed to illustrate the factors that affect the cost effectiveness of wheelchair provision [61]. Last, the MUD may contribute to understanding at a system’s level the demand and supply of wheelchair products and services that can inform procurement, innovation, and drive investment [29, 62]. As demonstrated in the UK, national and uniform wheelchair service data allow decisions to better align supply and demand with appropriate resource allocation [59].

The pilots conducted with the MUD in Kenya and Indonesia indicate that its use appears to be feasible. In addition, preliminary data from the registry in the US has demonstrated that administering the Wheeled Mobility Questionnaire is feasible in the clinical setting and does not add burden to the clinical routine [42]. The dataset being used in the US has 31 questions as compared to 29 questions in the short version MUD and 38 questions in the standard version MUD [42]. They differ in that the US dataset has context-specific questions [42], and the MUD is intended to be context-neutral. As expressed by ISWP members, there is an opportunity to develop the data collection and sharing system [53].

Experiences from large multicenter datasets have reported the need for sustained efforts to oversee the data collection quality to improve its reliability [17, 21, 63]. Currently, ISWP’s MUD has accompanying written instructions on how to use it. Future work in data collector training, periodical centralizing of the global data, and frequent auditing is needed to maximize data quality. Specifically, pending resource allocation, ISWP could conduct training for personnel who will administer the data collection tool [18] so it is used as intended [42]. The MUD presents organizations such as ISWP with the opportunity of a global data collection centralized repository. Instead of offering the opportunity to provide information when they want, ISWP could contact all MUD users quarterly or every 6 months to gather the data collected [59]. In addition, ISWP dedicated personnel could check for errors and missing data to request service providers/MUD users to correct as needed [18].

A potential limitation that this MUD presents is that it is a self-report measure, which is expected to be mitigated by having a large sample size [42] that will only result from a large uptake. However, future measurements are needed to ensure the reliability and validity of the MUD before it can serve as a reference on a global scale. The MUD’s reliability is unknown, and the French and Spanish translations were done only forward (i.e. English to Spanish and French) [53]. Future work should include evaluating the psychometric properties of the MUD [53] and a complete forward-backward-forward translation process into other languages. As English is not the local language in most LMIC settings, translation of the MUD is important. By using a common MUD centralized at ISWP, the organization has the potential of gathering, analyzing, and reporting on non-English evidence. This is especially important as non-English evidence is commonly excluded from publications and analysis [13, 15].

Currently, ISWP members are encouraged to contribute to the MUD’s psychometrics properties assessment and/or complete translation process. These steps must precede the use of the questionnaires in their practices. The tool is recommended for use at the assessment for a new device and regularly during follow-up and maintenance visits. The tool should be integrated into research protocols evaluating or comparing seating and mobility interventions.

ISWP could explore collaborations to complete the validation and translation steps in settings that have taken steady steps towards improving their wheelchair sector. For instance, Tajikistan, the Philippines, and Romania have conducted wheelchair sector situational analyses and indicated their need for reliable data [48, 64]. Last, ISWP could explore the feasibility of offering a service, in different languages, where member organizations could pay a nominal fee to conduct the follow-ups [42]. Future work should involve local service providers and grassroots organizations to ensure that the data collected is responding to the needs of local wheelchair providers and users [14, 25].

Conclusion

A Minimum Uniform Dataset was developed and piloted by global ISWP stakeholders, and it is available in a short version with 29 data points and a standard form with 38 data points in English, Spanish, and French from www.wheelchairnetwork.org. Upon the validation and complete translation process of the MUD, and with appropriate resources, ISWP has the potential to manage the MUD as a global resource to bridge the gap in wheelchair service evidence that is needed to drive investment and foster the change that is needed so wheelchair users can exercise their human right to personal mobility in LMICs.

Supporting information

S1 File. ISWP member survey.

(DOCX)

S2 File. Minimum Uniform Dataset questionnaire in Bahasa.

(DOCX)

S3 File

(DOCX)

S1 Dataset

(XLSX)

S2 Dataset

(DOCX)

Acknowledgments

The authors thank the ISWP Evidence-based Practice Working Group, Data Collection, and Comparative Effectiveness Research Subcommittee members for helping to develop the questionnaires: Kavi Bhalla, Johns Hopkins University; Johan Borg, Lund University; Nathan Bray, Centre for Health Economics and Medicine Evaluation; Molly Broderson, Free Wheelchair Mission; Mark Harniss, University of Washington; Kristi Haycock, Latter-day Saint Charities; Astrid Jenkinson, Motivation UK; Sara Múnera, Whee; Karen Reyes, World Health Organization; Chandra Whetstine, World Vision; and Eric Wunderlich, Latter-day Saint Charities. We thank LeTourneau University staff led by Karen Rispin, BethanyKids Relief and Rehabilitation, Joy Town School for Students with Disabilities, and the Wheelchair User’s Voice Project, led by UCP Wheels for Humanity and implemented by CITE-MIT and the University of Pittsburgh, for piloting the questionnaires. We also thank University of Montreal representatives Paula Rushton and Geneviève Daoust for the French translation of the short form; Sara Munera, Whee, for the translation of the short form into Spanish; Dagmar Amtmann, University of Washington research professor experienced in developing patient-reported outcome measures, for reviewing the questionnaire; and University of Pittsburgh faculty and staff Deepan Kamaraj and Christina Zigler.

Data Availability

All relevant data are within the manuscript and its Supporting Information files.

Funding Statement

This research was made possible by the generous support of the International Society of Wheelchair Professionals (ISWP) and the University of Pittsburgh. University of Pittsburgh scientists are working with the U.S. Agency for International Development (USAID) under sub-awards to develop the International Society of Wheelchair Professionals, a global network to ensure a level of standardization, certification and oversight, to teach and professionalize wheelchair services, and to build affiliations to put better equipment in the right hands. Since 2002, USAID has granted more than $45 million to improve wheelchairs and wheelchair services worldwide. The sub-awards are: Agreement No. APC-GM-0068 and Agreement No. APC-GM-0107, presented by Advancing Partners & Communities, a cooperative agreement funded through USAID under Agreement No. AIDOAA-A-12-00047, beginning Oct. 1, 2012; and FY19-A01-6024, presented through University Research Co. LLC Health Evaluation and Applied Research Development (HEARD) Project. HEARD is funded by United States Agency for International Development (USAID) under cooperative agreement number AID-OAA-A-17-00002. The project team includes prime recipient, University Research Co., LLC (URC) and sub-recipient organizations. The contents of the findings of this study are the sole responsibility of Advancing Partners & Communities, University Research Co., LLC and the University of Pittsburgh and do not necessarily reflect the view of USAID or the United States Government. Jonathan Pearlman (JP) is the recipient of the above-mentioned awards. The funder provided support in the form of salaries for authors NA, JP, MG, KK, MLTH, RS, MD, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. PK participated as a volunteer and not as part of her role with SMOI.

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Decision Letter 0

Sara Rubinelli

30 Apr 2020

PONE-D-20-02442

Development of a Minimum Uniform Dataset applicable to the international wheelchair sector

PLOS ONE

Dear Dr Pearlman,

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Reviewer #1: Yes

Reviewer #2: Partly

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: N/A

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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I am unfamiliar with statistical analysis on development of questionnaires and related restrictions on including datasets. Citations/literature on this would be helpful.

General comments:

The text contains a lot of jargon that people outside this area would be unfamiliar with – wheelchair sector, wheelchair stakeholders, etc. – that should be defined in the introduction. I am in the SCI field and I’ve never heard the term “wheelchair sector” and I’m unclear as to who a stakeholder is. Also, if “wheelchair sector” refers to individuals what use wheelchairs for mobility, it should be replaced with people-first language (“individuals that use wheelchairs” etc.).

The introduction could benefit from restructuring/reorganization: it’s long and there’s a lot of (necessary) information presented, but it’s hard to keep track of the aims of the paper and some of the ideas are repeated in each paragraph. For example, you talk about datasets in paragraphs 1 and 3, use of AP is introduced in paragraphs 1, 2, and 3, LMICs are discussed in paragraphs 2 and 3, and that there is no comparable research for clinicians to use is discussed in paragraphs 1 and 3. It would be easier to follow/understand if the structure were first paragraph – unmet need/significance; second paragraph: current datasets/evidence available; third paragraph: what is missing from datasets and why is it necessary.

Methods – there should be a sentence that summarizes this methodology in the beginning (needs assessment, rounds of pilot testing, refinement, etc.) with citations so the reader can know this methodology is standard for development and application of questionnaires/surveys.

Regarding the discussion – there was a lot of emphasis in the introduction on AP but no mention of it in the discussion. If it’s necessary and now included in the dataset, how is that going to improve the lives of individuals with SCI? How is that going to change rehabilitative outcomes?

Specific comments

31 Rehabilitation is a strategy to promote functioning and a prerequisite to achieve health and well

32 being for all (1)

“functioning” is awkward, and the tense doesn’t agree with the rest of the sentence – maybe “functional gains” or something similar is better

41 outcome measures which are useful to compare rehabilitation outcomes among type of services

“which are useful” should be replaced with “in order to”

46 hospitalization, diagnostic, functional status data, but do not measure assistive technology use

47 at discharge (7, 8, 10, 12). The use of assistive products (AP) has been identified globally as an

The abstract and line 46 have “assistive technology” but the abbreviation is for assistive products – should be consistent throughout

52 For many people, acc

ess to AP, and learning how to use them, is needed to improve functioning

Change “functioning”

67 rehabilitation services both in quantity and quality (4). A full picture of the wheelchair sector is

68 necessary for strategic planning and the capacity building to realize the right to personal mobility

“a full picture” of what? AP use/needs?

69 (15, 30). In fact, a global wheelchair sector stakeholders meeting in 2018 identified as one of the

70 sector’s 10 priorities to:

Who is in the sector and who is a stakeholder? What was the meeting?

74 to support current recommendations on wheelchair service delivery models, and the evidence

Recommendations by whom? What is a wheelchair service delivery model?

79 measurements and had high attrition rates, making it impossible to aggregate the data (36-39).

I don’t think I’ve ever seen attrition used in this manner and I’m unclear – turnover is high among individuals administering the assessment? Or are individuals that participate lost to follow-up?

97 To help bridge the gap in wheelchair provision data gathered and comparable in LMIC, the

98 International Society of Wheelchair Professionals (50) developed a Minimum Uniform Dataset

99 with the objective to promote the global use of a common language to strengthen the evidence

100 (29) and to foster comparison among interventions (33).

Something similar to this statement should be moved earlier in the introduction, there’s a lot of background presented and it’s very easy to lose sight of the message

101 present the development process and final composition of ISWP’s

I’m assuming this is an abbreviation for International Society of Wheelchair Professionals but it wasn’t defined on line 98

117 On May 5, 2015, ISWP sent an e-mail to 353 ISWP wheelchair sector stakeholders who are ISWP […]

121 identified, aggregated data; and suggested data to be collected. Forty-one individuals (41)

122 responded, for an 11.6% response rate.

Is this typical survey method and a typical response rate for this type of analysis? It seems low and maybe would have benefitted from multiple emails/methodologies/etc. How can we be sure this is a representative sample of clinicians/professionals necessary to make the standards valid?

137 satisfaction, feedback or impact surveys

Need comma after “feedback”

197 The 2016 pilot feedback and additional working group and subcommittee review and input

198 resulted in a standard version of the MUD with 40 data points and a short form with 28 data point

It’s unclear why a short form and standard form were considered necessary

233 and some questions were double barreled.

What is “double barreled”?

238 Feedback from the 2017 pilots was incorporated, along with input from domain experts in

239 instrument development at the University of Washington and University of Pittsburgh.

A citation of some sort would be useful here, to demonstrate this is the standard method for modifying survey questionnaires based on pilot data

271 tool of its kind intended to promote global wheelchair service data collection and developed

272 iteratively with input from global stakeholders

Again – it’s unclear who the stakeholders are, and what “wheelchair service” refers to

274 has been identified as key for the success (8, 56).

Are you saying it’s already been successful? Or the collaboration will make it successful?

279 disaggregated by disability (5, 22). In addition, as the global wheelchair sector strives to set

280 service standards (31) […]

287 to illustrate the factors that affect the cost effectiveness of wheelchair provision (58).

These lines are all related to the same idea (standards/development of best practices), it can be decreased to one sentence. It’s speculation

294 feasible. In addition, preliminary data from the registry in the US has shown that administering

“shown” should be replaced with a more quantitative word

296 the clinical routine (44). The dataset being used in the US has 31 questions as compared to 29

297 questions in the short version MUD and 38 questions in the standard version MUD (44).

Why is the dataset different?

303 has accompanying written instructions on how to use it. Future work is needed to maximize data

304 quality.

What specifically needs to be improved and why?

312 A potential limitation that this MUD presents is that it is a self-report measure, which is expected

It seems a limitation is also the small response during creation of the questionnaire by stakeholders, and the fact that implementation is mostly limited to ISWP stakeholders. How do the authors propose to get this dataset used by a wider audience?

332 grass roots organizations of people with disabilities who can contribute to gathering, monitoring

333 and evaluating data points in addition to providing users’ perspective (22, 27).

Is improving their own care and health outcomes really an appropriate burden to give individuals with SCI? It is beneficial to understand their input and use it to guide best practices, but it’s not the responsibility of marginalized/unempowered individuals to correct the system that disenfranchises them.

Reviewer #2: Thank you for the opportunity to review your manuscript. The paper entitled "Development of a Minimum Uniform Dataset applicable to the international wheelchair sector" reports essential findings concerning techniques for unstable intertrochanteric fractures. This study aims to provide a Minimum Uniform Dataset (MUD) for wheelchair services worldwide with the intent to gather data that is comparable globally. The paper is worth to be published in PONE after major revision. There is a global need to inform policy, practice and direct investments based on an evidence that might be gained through the present approach.

The translation process needs to be reconsidered as they might still bear a significant risk of bias in the current state. Afterwards, the analysis of the questionnaires reliability and validity needs to be adjusted and reported in the manuscript.

TITLE

-

INTRODUCTION

-

METHODS AND RESULTS

- Please provide a flowchart or table indicating the response rate of your Member survey for each item or a bar plot giving the absolute counts per item.

- Regarding the occupation, did you offer to select more than one option?

- Did you define criteria to exclude any response with a certain percentage of missing information? If yes, please specify.

- Please explain in detail why you decided not to forward-backward-forward translate the questionnaire before finalizing the translated versions.

- For a better understanding, please provide a detailed flowchart of the process including the present status and the steps missing before completing a state of the art questionnaire development process (please consider to refer to (https://www.who.int/substance_abuse/research_tools/translation/en/ and the chart attached for further information).

- Please provide measurements of the reliability (internal consistency, test-retest reliability and inter-rater reliability) and validity (content and construct validity) of the questionnaires in different languages.

DISCUSSION

- The study aims to develop a Minimum Uniform Dataset (MUD) for wheelchair services worldwide with the intent to gather data that is comparable globally.

- To ensure the comparability between the different translations, a forward-backward-forward translation process is recommended as the translation process might bias the results

- Further measurements are needed to ensure the reliability and validity of the questionnaire before the MUD is ready to serve as a reference on a global scale

CONCLUSION

- The present results and steps completed are promising, and the analysis is well designed.

- However, the questionnaires are difficult to compare due to missing further characteristics of the different language versions.

- Without providing further information, the questionnaires aims are challenging to fulfil, and the conclusions derived from the future data still bear a significant risk of bias.

- These limitations are partwise reflected in conclusion. Nevertheless, in the current state, the promotion of the MUD globally with the intention to inform policy, practice and direct investments appear challenging.

TABLES

-

APPENDICES

-

REFERENCES

-

I am looking forward to the revised manuscript.

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If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

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Attachment

Submitted filename: PLoS_one_04.07.20.docx

PLoS One. 2020 Sep 11;15(9):e0238851. doi: 10.1371/journal.pone.0238851.r002

Author response to Decision Letter 0


23 Jul 2020

July 19, 2020

Dear Reviewers and Editor:

We appreciate your thoughtful comments and recommendations. We have responded to them point-by-point and modified the manuscript using track changes. The line number reference in the response correspond to the numbering in the market version. We also uploaded an unmarked version of the revised manuscript.

Thank you.

Response to Reviewer’s 1 comments:

Reviewer #1:

Comment 1. I am unfamiliar with statistical analysis on development of questionnaires and related restrictions on including datasets. Citations/literature on this would be helpful.

Response 1. Two references have guided our work and are now cited in the methods section:

Streiner DL, Norman GR, Cairney J. Selecting items. In: Streiner DL, Norman GR, Cairney J, editors. Health Measurement Scales: A practical guide to their development and use. 5th ed. New York: Oxford University Press; 2015.

Portney LG, Watkins MP. Surveys and Questionnaires. In: Portney LG, Watkins MP, editors. Foundations of Clinical Research Applications to Practice. Third ed. New Jersey: Pearson Prentice Hall; 2008.

General comments:

Comment 2. The text contains a lot of jargon that people outside this area would be unfamiliar with – wheelchair sector, wheelchair stakeholders, etc. – that should be defined in the introduction. I am in the SCI field and I’ve never heard the term “wheelchair sector” and I’m unclear as to who a stakeholder is. Also, if “wheelchair sector” refers to individuals what use wheelchairs for mobility, it should be replaced with people-first language (“individuals that use wheelchairs” etc.).

Response 2. The wheelchair sector and stakeholders are now defined in the introduction.

Lines 144-154: “A full picture of the need for appropriate wheelchair products and services, including the policies and personnel that support them, is necessary for strategic planning and capacity building to realize the human right to personal mobility (7, 48)”

Lines 154-159: “In fact, a global wheelchair sector stakeholders (e.g., users, WHO, aid agencies, academia, international and local NGOs, humanitarian organizations, professional organizations, service providers, governments) meeting in 2018 held to reflect on past achievements, challenges, current initiatives, and to strategize a future of better access to wheelchairs, identified one of the global priorities to be:”

Comment 3. The introduction could benefit from restructuring/reorganization: it’s long and there’s a lot of (necessary) information presented, but it’s hard to keep track of the aims of the paper and some of the ideas are repeated in each paragraph. For example, you talk about datasets in paragraphs 1 and 3, use of AP is introduced in paragraphs 1, 2, and 3, LMICs are discussed in paragraphs 2 and 3, and that there is no comparable research for clinicians to use is discussed in paragraphs 1 and 3. It would be easier to follow/understand if the structure were first paragraph – unmet need/significance; second paragraph: current datasets/evidence available; third paragraph: what is missing from datasets and why is it necessary.

Response 3. We have followed your recommendation and the introduction has been revised for clarity and conciseness.

Comment 4. Methods – there should be a sentence that summarizes this methodology in the beginning (needs assessment, rounds of pilot testing, refinement, etc.) with citations so the reader can know this methodology is standard for development and application of questionnaires/surveys.

Response 4. This information is now included in Lines 175-177: “The iterative process included initial question development, pilots, revisions based on pilots’ results, and launch (Figure 1) (51, 52).”

Comment 5. Regarding the discussion – there was a lot of emphasis in the introduction on AP but no mention of it in the discussion. If it’s necessary and now included in the dataset, how is that going to improve the lives of individuals with SCI? How is that going to change rehabilitative outcomes?

Response 5. We believe that we have addressed this in the first paragraph of the introduction but may have not been explicit enough. We now included “wheelchair services” and/or “wheelchair products” in lines 147, 442, 479.

Specific comments

Comment 6. 31 Rehabilitation is a strategy to promote functioning and a prerequisite to achieve health and well 32 being for all (1) “functioning” is awkward, and the tense doesn’t agree with the rest of the sentence – maybe “functional gains” or something similar is better

Response 6. We consider that using the term “functioning” is most appropriate to the current WHO Rehabilitation 2030 initiative definition which is based on the ICF. The sentence was revised to “The World Health Organization (WHO) defines rehabilitation as a strategy to optimize an individual’s functioning (1). WHO has also recognized that rehabilitation is a prerequisite to achieve health and well-being for all (1).”

Comment 7. 41 outcome measures which are useful to compare rehabilitation outcomes among type of services “which are useful” should be replaced with “in order to”

Response 7. Change included.

Comment 8. 46 hospitalization, diagnostic, functional status data, but do not measure assistive technology use 47 at discharge (7, 8, 10, 12). The use of assistive products (AP) has been identified globally as an The abstract and line 46 have “assistive technology” but the abbreviation is for assistive products – should be consistent throughout

Response 8. The text now uses assistive products consistently.

Comment 9. 52 For many people, access to AP, and learning how to use them, is needed to improve functioning Change “functioning”

Response 9. This information is now in Lines 43-54 and reads: “For many people, access to assistive products (AP), and learning how to use them, is needed to realize the right to fully participate in their communities (1, 7-9).”

Comment 10. 67 rehabilitation services both in quantity and quality (4). A full picture of the wheelchair sector is 68 necessary for strategic planning and the capacity building to realize the right to personal mobility “a full picture” of what? AP use/needs?

Response 10. A description of the wheelchair sector is now included in Lines 144-154: “A full picture of the wheelchair sector (i.e. met and unmet need, products, service provision, personnel, and policies) is necessary for strategic planning and the capacity building to realize the right to personal mobility (7, 48).”

Comment 11. 69 (15, 30). In fact, a global wheelchair sector stakeholders meeting in 2018 identified as one of the 70 sector’s 10 priorities to: Who is in the sector and who is a stakeholder? What was the meeting?

Response 11. The wheelchair sector is now described as mentioned in the previous comment. Additional information on the goal of the meeting and examples of the stakeholders is now presented (Lines 155-159): “In fact, a global wheelchair sector stakeholders (e.g., users, WHO, aid agencies, academia, international and local NGOs, humanitarian organizations, professional organizations, service providers, governments) meeting in 2018 held to reflect on past achievements, challenges, current initiatives, and to strategize a future of better access to wheelchairs, identified one of the global priorities to be:

Comment 12. 74 to support current recommendations on wheelchair service delivery models, and the evidence. Recommendations by whom? What is a wheelchair service delivery model?

Response 12. Lines 78-124 have been revised to: “There is little research to support current wheelchair service delivery recommendations (e.g. WHO guidelines, professional organization guidelines), and the evidence that exists commonly involves small sample sizes, inconsistent definitions, and different outcome measurements (30, 31). ”

Comment 13. 79 measurements and had high attrition rates, making it impossible to aggregate the data (36-39). I don’t think I’ve ever seen attrition used in this manner and I’m unclear – turnover is high among individuals administering the assessment? Or are individuals that participate lost to follow-up?

Response 13. Lines 124-127 now read: “Efforts targeted at LMICs to measure wheelchair provision outcomes longitudinally have used different measurements and a significant group of people were lost to follow-up, making it impossible to aggregate the data (34-37).”

Comment 14. 97 To help bridge the gap in wheelchair provision data gathered and comparable in LMIC, the 98 International Society of Wheelchair Professionals (50) developed a Minimum Uniform Dataset 99 with the objective to promote the global use of a common language to strengthen the evidence 100 (29) and to foster comparison among interventions (33). Something similar to this statement should be moved earlier in the introduction, there’s a lot of background presented and it’s very easy to lose sight of the message

Response 14. We included in Lines 57-58: “Specific to wheelchairs, there is a need for comparable wheelchair provision data, mostly in LMICs, to strengthen the evidence on different interventions (15, 16).”

Comment 15. 101 present the development process and final composition of ISWP’s

I’m assuming this is an abbreviation for International Society of Wheelchair Professionals but it wasn’t defined on line 98 117 On May 5, 2015, ISWP sent an e-mail to 353 ISWP wheelchair sector stakeholders who are ISWP […] 121 identified, aggregated data; and suggested data to be collected. Forty-one individuals (41)

122 responded, for an 11.6% response rate.

Is this typical survey method and a typical response rate for this type of analysis? It seems low and maybe would have benefitted from multiple emails/methodologies/etc. How can we be sure this is a representative sample of clinicians/professionals necessary to make the standards valid?

Response 16. ISWP’s acronym is mentioned first in the introduction in line 1604 We revised lines 267-270 to clarify that the respondents represented all stakeholder groups and a broad variety of countries.

Lines 267-270: “Forty-one individuals (41) responded (11.6%) representing all stakeholder groups and 18 countries, providing a representative sample for this first step of identifying the types and extent of data collection.”

Lines 279-280: “The survey was distributed only in English; this may have prevented stakeholders whose first language is not English from responding.”

Comment 16. 137 satisfaction, feedback or impact surveys Need comma after “feedback”

Response 16. Comma added.

Comment 17. 197 The 2016 pilot feedback and additional working group and subcommittee review and input 198 resulted in a standard version of the MUD with 40 data points and a short form with 28 data point It’s unclear why a short form and standard form were considered necessary 233 and some questions were double barreled.

What is “double barreled”?

Response 17. The rationale behind creating two version is now presented in lines 366-368: “The subcommittee decided to offer a standard and short form version to provide flexibility while promoting consistency in the implementation as time constraints in services may vary across LMICs.”

Double-barreled is now defined in line 405: “some questions were double-barreled (i.e. an item that asks two or more questions at the same time and each one can be answered differently(52)).”

Comment 18. 238 Feedback from the 2017 pilots was incorporated, along with input from domain experts in 239 instrument development at the University of Washington and University of Pittsburgh. A citation of some sort would be useful here, to demonstrate this is the standard method for modifying survey questionnaires based on pilot data.

Response 18. Streiner et a. 2015 and Portney and Watkins 2008 are referenced now in this section.

Comment 19. 271 tool of its kind intended to promote global wheelchair service data collection and developed 272 iteratively with input from global stakeholders

Again – it’s unclear who the stakeholders are, and what “wheelchair service” refers to.

Response 19. Line 454-457 was revised to: “This is the first measurement tool of its kind intended to promote global wheelchair service data collection and developed iteratively with input from global stakeholders (e.g. service providers in LMICs, researchers, service managers, users, non-government organizations, manufacturers).”

Comment 20. 274 has been identified as key for the success (8, 56).

Are you saying it’s already been successful? Or the collaboration will make it successful?

Response 20. Lines 457-460 now reads: “We believe that this collaboration will be key for a successful implementation; previous outcome measures research has identified the engagement of clinicians, as well as wheelchair users, managers, and providers, in the development of this type of clinical dataset as key for the success (18, 58).”

Comment 21. 279 disaggregated by disability (5, 22). In addition, as the global wheelchair sector strives to set 280 service standards (31) […] 287 to illustrate the factors that affect the cost effectiveness of wheelchair provision (58). These lines are all related to the same idea (standards/development of best practices), it can be decreased to one sentence. It’s speculation.

Response 21. The information has been condensed in Lines 463-466: “The MUD has the potential to contribute to closing the Policy Implementation Monitoring Gap which has been defined as a lack of explicit disability disaggregated indicators for monitoring and evaluation at the national, regional, and global-levels (5, 14, 27)(49)(59). ”

Comment 22. 294 feasible. In addition, preliminary data from the registry in the US has shown that administering “shown” should be replaced with a more quantitative word

Response 22. Shown was changed to “demonstrated”

Comment 23. 296 the clinical routine (44). The dataset being used in the US has 31 questions as compared to 29 297 questions in the short version MUD and 38 questions in the standard version MUD (44). Why is the dataset different?

Response 23. The following sentence was added in line 510 “They differ in that the US dataset has context-specific questions (42) and the MUD is intended to be context-neutral”

Comment 24. 303 has accompanying written instructions on how to use it. Future work is needed to maximize data 304 quality. What specifically needs to be improved and why?

Response 24. The sentence was expanded and the connector modified for clarity. Line 516-518 now reads “Future work in data collector training, periodical centralizing of the global data, and frequent audit is needed to maximize data quality. Specifically, …”

Comment 25. 312 A potential limitation that this MUD presents is that it is a self-report measure, which is expected. It seems a limitation is also the small response during creation of the questionnaire by stakeholders, and the fact that implementation is mostly limited to ISWP stakeholders. How do the authors propose to get this dataset used by a wider audience?

Response 25. We feel the number of responses to the initial survey to assess the types of data being collected and potential data types needed was adequate due to diverse stakeholder and geographical representation. The dataset was developed from additional steps that involved expert input, consensus and pilot testing. Implementation is planned as future work and addressed in the last paragraph of the discussion.

Comment 26. 332 grass roots organizations of people with disabilities who can contribute to gathering, monitoring 333 and evaluating data points in addition to providing users’ perspective (22, 27). Is improving their own care and health outcomes really an appropriate burden to give individuals with SCI? It is beneficial to understand their input and use it to guide best practices, but it’s not the responsibility of marginalized/unempowered individuals to correct the system that disenfranchises them.

Response 26. The sentence was reworded: “Future work should involve local service providers and grass roots organizations to ensure that the data collected is responding to the needs of local wheelchair providers and users (14, 25).”

Response to Reviewer’s 2 comments:

Comment 27. Thank you for the opportunity to review your manuscript. The paper entitled "Development of a Minimum Uniform Dataset applicable to the international wheelchair sector" reports essential findings concerning techniques for unstable intertrochanteric fractures. This study aims to provide a Minimum Uniform Dataset (MUD) for wheelchair services worldwide with the intent to gather data that is comparable globally. The paper is worth to be published in PONE after major revision. There is a global need to inform policy, practice and direct investments based on an evidence that might be gained through the present approach. The translation process needs to be reconsidered as they might still bear a significant risk of bias in the current state. Afterwards, the analysis of the questionnaires reliability and validity needs to be adjusted and reported in the manuscript.

Response 27. To clarify that the translated versions are in a preliminary stage, the subheading “ISWP Minimum Uniform Dataset Preliminary Translation” was added in Line 396.

The need to test psychometric properties of the questionnaire and complete translation steps is stated as future work in lines 533.

Comment 28. Please provide a flowchart or table indicating the response rate of your Member survey for each item or a bar plot giving the absolute counts per item.

Response 28. We added the following information in Lines 291-292: “Overall, the 13 questions had a response rate of 76% or higher. Two questions were responded by 76% of the respondents, one by 88%, and 10 questions were responded by 90% or higher“

Comment 29. Regarding the occupation, did you offer to select more than one option?

Response 29. No, it was a single-answer multiple-choice question: “select the occupation that best describes you”. Line 272 was revised to reflect this and now reads: Among 39 respondents who selected the occupation that best described them, 28% (n=11) were clinicians; 15% (n=6) worked for non-government organizations; 15% (n=6) were researchers; and 10% (n=4) were manufacturers.

Comment 30. Did you define criteria to exclude any response with a certain percentage of missing information? If yes, please specify.

Response 30. Line 301 now reads: “No criteria were set a-priori to delete items based on missing responses.”

Comment 31. For a better understanding, please provide a detailed flowchart of the process including the present status and the steps missing before completing a state of the art questionnaire development process (please consider to refer to (https://www.who.int/substance_abuse/research_tools/translation/en/ and the chart attached for further information).

Response 31. We added figure 3 in the new section ISWP Minimum Uniform Dataset Preliminary Translation.

Comment 32. Please explain in detail why you decided not to forward-backward-forward translate the questionnaire before finalizing the translated versions. Please provide measurements of the reliability (internal consistency, test-retest reliability and inter-rater reliability) and validity (content and construct validity) of the questionnaires in different languages. The study aims to develop a Minimum Uniform Dataset (MUD) for wheelchair services worldwide with the intent to gather data that is comparable globally. To ensure the comparability between the different translations, a forward-backward-forward translation process is recommended as the translation process might bias the results. Further measurements are needed to ensure the reliability and validity of the questionnaire before the MUD is ready to serve as a reference on a global scale. The present results and steps completed are promising, and the analysis is well designed. However, the questionnaires are difficult to compare due to missing further characteristics of the different language versions. Without providing further information, the questionnaires aims are challenging to fulfil, and the conclusions derived from the future data still bear a significant risk of bias. These limitations are partwise reflected in conclusion. Nevertheless, in the current state, the promotion of the MUD globally with the intention to inform policy, practice and direct investments appear challenging.

Response 32. The title has been revised to “Preliminary steps of the development of a Minimum Uniform Dataset applicable to the international wheelchair sector”.

Edits have been made to clarify the steps completed and remaining, including the addition of the flowchart (figure 3) and that the completion of the translation and validation in the future work. We acknowledge the limitations of not having completed the psychometrics analysis and the complete translation cycle. Due to the open-access and global scope of the MUD, we see that there is value in publishing this preliminary translation steps, other groups may be able to build upon this work. This is now included in lines 448 “The English, Spanish, and French MUD versions are open-access resources that may be used by other groups for validation and/or to complete or conduct a full translation cycle (58).”

Line 530 was added: “However, future measurements are needed to ensure the reliability and validity of the MUD before it can serve as a reference on a global scale.”

Line 533 was expanded: “Future work should include evaluating the psychometric properties of the MUD (53) and a complete forward-backward-forward translation process into other languages.”

The last two paragraphs in the discussion section and the conclusion have been revised to reflect the fact that validation and translation are work in progress.

Lines 540-542: “Currently, ISWP members are encouraged to contribute to the MUD’s psychometrics properties assessment and/or complete translation process. These steps must precede the use of the questionnaires in their practices.”

Line 545 “ISWP could explore collaborations to complete the validation and translation steps in settings that have taken steady steps towards improving their wheelchair sector.”

Line 577: “Upon the validation and complete translation process of the MUD, and with appropriate resources, ISWP has the potential to manage the MUD as a global resource to bridge the gap in wheelchair service evidence that is needed to drive investment and foster the change that is needed so wheelchair users can exercise their human right to personal mobility in LMICs.”

Journal Requirements:

Comment 33. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

Response 33. Our manuscript files meet PLOS ONE’s style.

Comment 34. In your methods section, please describe how feedback on the questionnaire was collected; provide more information on questionnaire validation (for example on whether internal consistency and reliability were assessed) ; and describe how the samples used for pilot testing was recruited and selected. "

Response 34.

The methods now describe that feedback was consolidated by MUD administrators in Excel files based on regular calls with working group members who provided regular input on the dataset. Lines 372-378 state: “MIT and the University of Washington provided feedback to ISWP by e-mail in December 2017.”

Comments related to the MUD’s validation were addressed in responses to reviewer’s 2 comments #27, 31, 32

Comment 35. Please provide additional details regarding participant consent. As your study included minors, state whether you obtained consent from parents or guardians.

Response 35. Lines 346-347: Students from two schools who used a wheelchair were invited to participate in the pilot.

Lines 350-525 now read: “Participants 18 years or older signed the informed consent and participants younger than 18 provided assent and their guardian signed the written consent.”

Lines 384 now read: “Ethical approval and recruitment and consent processes were as described above.”

Lines 398-399 were added: “Guardians signed the informed consent on behalf of participants younger than 18 years old.”

Comment 36. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, as you developed different questionnaires as part of this study (both the ISWP Member Survey and the Minimum Uniform Dataset Questionnaire) please include a copy as Supporting Information, both in English and in Bahasa. Please also explain in more detail the methods used for its translation. "

Response 36. Line 577 includes the website <www.wheelchairnetwork.org> where the current MUD versions are available.

Lines 397-399 now read: “The questionnaire was forward translated and administered in Bahasa, and written consent was obtained from all research participants.”

The following Supplemental Information has been included and captions referenced added in the text:

Supplemental information 1 ISWP Member Survey; referenced in line 264

Supplemental information 2 ISWP Member Survey de-identified information, referenced in line 270

Supplemental information 3 data collector MUD feedback from Kenya pilots in 2016 and 2017; referenced in line 361 and 391

Supplemental information 4 MUD in Bahasa; reference in line 400

Comment 37. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

In your revised cover letter, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories.

We will update your Data Availability statement on your behalf to reflect the information you provide.

Response 37. The development of the MUD did not involve the collection or analysis of data to support research findings, thus there is no data set to share or archive.

Comment 38. Thank you for stating the following in the Competing Interests section:

'NO authors have competing interests'

We note that one or more of the authors are employed by a commercial company: Specialized Mobility Operations and Innovation Pvt. Ltd.

1. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form.

Please also include the following statement within your amended Funding Statement.

“The funder provided support in the form of salaries for authors [insert relevant initials], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.”

If your commercial affiliation did play a role in your study, please state and explain this role within your updated Funding Statement.

2. Please also provide an updated Competing Interests Statement declaring this commercial affiliation along with any other relevant declarations relating to employment, consultancy, patents, products in development, or marketed products, etc.

Within your Competing Interests Statement, please confirm that this commercial affiliation does not alter your adherence to all PLOS ONE policies on sharing data and materials by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests) . If this adherence statement is not accurate and there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared.

Please include both an updated Funding Statement and Competing Interests Statement in your cover letter. We will change the online submission form on your behalf.

Response 38.

Revised Funding Disclosure Statement

This research was made possible by the generous support of the International Society of Wheelchair Professionals (ISWP) and the University of Pittsburgh. University of Pittsburgh scientists are working with the U.S. Agency for International Development (USAID) under sub-awards to develop the International Society of Wheelchair Professionals, a global network to ensure a level of standardization, certification and oversight, to teach and professionalize wheelchair services, and to build affiliations to put better equipment in the right hands. Since 2002, USAID has granted more than $45 million to improve wheelchairs and wheelchair services worldwide. The sub-awards are: Agreement No. APC-GM-0068 and Agreement No. APC-GM-0107, presented by Advancing Partners & Communities, a cooperative agreement funded through USAID under Agreement No. AIDOAA-A-12-00047, beginning Oct. 1, 2012; and FY19-A01-6024, presented through University Research Co. LLC Health Evaluation and Applied Research Development (HEARD) Project. HEARD is funded by United States Agency for International Development (USAID) under cooperative agreement number AID-OAA-A-17-00002. The project team includes prime recipient, University Research Co., LLC (URC) and sub-recipient organizations. The contents of the findings of this study are the sole responsibility of Advancing Partners & Communities, University Research Co., LLC and the University of Pittsburgh and do not necessarily reflect the view of USAID or the United States Government. Jonathan Pearlman (JP) is the recipient of the above-mentioned awards.

The funder provided support in the form of salaries for authors NA, JP, MG, KK, MLTH, RS, MD, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. PK participated as a volunteer and not as part of her role with SMOI.

Revised competing interest statement

NO authors have competing interests. PK affiliation with SMOI does not alter our adherence to PLOS ONE policies on sharing data and materials.

Comment 39. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Response 39. Lines 790 onwards now includes the list of the Supporting information files

Comment 40. While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org. Please note that Supporting Information files do not need this step.

Response 40. Figures 1-3 were inspected using PACE.

Attachment

Submitted filename: Response to Reviewers.docx

Decision Letter 1

Sara Rubinelli

26 Aug 2020

Preliminary steps of the development of a Minimum Uniform Dataset applicable to the international wheelchair sector

PONE-D-20-02442R1

Dear Dr. Pearlman,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Sara Rubinelli

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

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Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: N/A

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #2: Yes

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Acceptance letter

Sara Rubinelli

3 Sep 2020

PONE-D-20-02442R1

Preliminary steps of the development of a Minimum Uniform Dataset applicable to the international wheelchair sector

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Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File. ISWP member survey.

    (DOCX)

    S2 File. Minimum Uniform Dataset questionnaire in Bahasa.

    (DOCX)

    S3 File

    (DOCX)

    S1 Dataset

    (XLSX)

    S2 Dataset

    (DOCX)

    Attachment

    Submitted filename: PLoS_one_04.07.20.docx

    Attachment

    Submitted filename: Response to Reviewers.docx

    Data Availability Statement

    All relevant data are within the manuscript and its Supporting Information files.


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