Saving time and effort: Best practice for adapting existing patient-reported outcome measures in hepatology

Table 1 Keyword combinations used in the literature search

Keyword combinations
Patient Reported Outcome Measures OR patient reported outcome measure1 OR PROM1OR PRO1 OR patient reported outcome1 OR patient outcome1 OR clinical outcomes assessment	AND	Guidance OR guidelineOR recommend1 OR good practice OR best practice OR instrument development OR adapt1 OR modif1 OR develop1 OR establish1 OR efficien1 OR standard1 OR measurement properties

¹It indicates where truncated versions of the wrord was used. Search was restricted to the last 10 yr and publications in the English lang.

Table 2 Inclusion and exclusion criteria used when screening identified studies

Inclusion criteria	Exclusion criteria
(1) Articles presenting guidance and recommendations for use or adaptation of existing PROMs; and (2) PROMs methodology papers	(1) Papers detailing development and validation of new PROMs; (2) Papers not presenting guidance or recommendation for adaptation of PROMs; (3) Study protocols; (4) Papers that focus on implementation of PROMs in research or clinical practice; (5) Conference abstracts; (6) Not published in English; or (7) Published longer than 10 yr ago

PROMs: Patient reported outcome measures.

Table 3 Some examples of online resources that can be used to identify candidate patient reported outcome measures for adaptation

Resource name and web address	Resource Information
ePROVIDETM (https://eprovide.mapi-trust.org/)	This is an online service provided by Mapi Research Trust and is the official licensor and distributor of more than 450 clinical outcome assessments (or PROMs). This resource allows you to search for PROMs within a specific clinical area and presents: a summary of each tool; the authors of the tool; different version of the questionnaire; the copyright owner; the specific condition/disease in which the PROM has been used; the original language the PROM was developed in; references to the original PROM development publications; and a list of any validated translations of the original questionnaire. If a PROM is deemed appropriate but no valid translation exists, there is also an opportunity to submit a request to undertake a linguistic validation of the questionnaire
COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) (https://database.cosmin.nl/)	The COSMIN initiative (https://www.cosmin.nl/) aims to “develop methodology and practical tools for selecting the most suitable outcome measurement instrument). Their mission statement is: “to improve the selection of outcome measurement instruments of health outcomes by developing and encouraging the use of transparent methodology and practical tools for selecting the most suitable outcome measurement instrument in research and clinical practice”. The COSMIN website provides a link to the COSMIN Database for Systematic Reviews which can be searched to identify literature reviews that have been undertaken within specific clinical areas. The database provides a summary of the review and the PROMs that formed part of the review and links to the original publications. Examination of these reviews is useful in assessing whether an existing PROM may be appropriate to use. Many of these reviews will also present a synthesis of each PROM with an assessment of its methodological quality and validity according criteria outline in more or more of the guidance documents available[2,44,61-65]
International Consortium for Health Outcome Measurement (ICHOM) (https://www.ichom.org/)	As part of a wider initiative ICHOM publish Standard Sets. ICHOM Standard Sets are defined as ‘standardized outcomes, measurement tools and time points and risk adjustment factors for a given condition. Developed by a consortium of experts and patient representatives in the field, our Standard Sets focus on what matters most to the patient’
Measures for Person Centred Coordinated Care (http://p3c.org.uk/about)	Set-up as a result of an NHS England funded project. This online resource describes itself as providing information “about measures for Person Centred Coordinated Care (“P3C”) for people with long-term conditions (LTCs), multiple-LTCs, and those at the end of their life (EoL)”. It provides a compendium of measures — defined as PROMs and patient reported experience measures (PREMs) — that can be utilised within programs that aim to deliver or evaluate P3C in the target populations”
European Organisation for Research and Treatment of Cancer (EORTC) (https://www.eortc.org/tools/)	Amongst other resources, the EORTC website provides a list quality of life questionnaires that have been developed and validated for cancer patients that are available for academic use
Oxford University Innovation/University of Oxford Clinical Outcomes Assessments (https://innovation.ox.ac.uk/clinical-outcomes/patient-reported-outcomes-measures/)	The PRO portfolio is made up of condition-specific questionnaires aimed at assessing the outcome for patients being treated for a range of medical conditions

PROMs: Patient reported outcome measures.

Table 4 Categories of equivalence

Categories
Conceptual equivalence	The domains of the questionnaire have the same relevance, meaning and importance in both cultures
Item equivalence	Individual items have the same relevance in both cultures
Semantic equivalence	The meaning of the items is the same in both cultures
Operational equivalence	The questionnaire can be used in the same way by the target population in both cultures
Measurement equivalence	The two versions have similar psychometric properties
Functional equivalence	This is meant as a summary category of the preceding five categories. It is an overall statement that identifies if both versions “do what they are supposed to do equally as well”

Table 5 Scenarios in which different degrees of cross-cultural adaptation are required[25]

	Results in a change in			Adaptation required
	Culture	Language	Country of use	Translation	Cultural adaptation
Use in same population. No change in culture, language or country	-	-	-	-	-
Use in established immigrants in source country	Yes	--	-	-	Yes
Use in another country, but same language	Yes	-	-	-	Yes
Use in new immigrants, not source language speaking but in the source country	Yes	Yes	-	Yes	Yes
Use in another country and another language	Yes	Yes	Yes	Yes	Yes

Table 6 Stages within an patient reported outcome measure adaption process where patients may be involved

Stage	How can PI be involved
Establishing a need for a new or refined PROM	Review existing PROMs; Critique existing PROMs; Determine whether a new PROM is needed
Development of a conceptual model	Review of conceptual model to ensure validity
Identifying item content	Input on study design; Input on culturally appropriate issues; Input on participant facing documents; Input on ethics and governance issues
Item development	Analysis and interpretation of qualitative interviews; Advice and input on wording of potential items
Item reduction	Identify potentially redundant items; Identify items that could benefit from rewording; Input and advice on ordering of items
Pre-testing of items (cognitive interviews/debriefing)	Input on study design, methodology, recruitment, design and content of public facing documents and conducting the interviews; Analyse and/or interpret results
Selection of items for the PROM	Advice on final selection of items; Consideration of number of items to be included; Advice and input into how PROM may be used in clinical settings
Design of the PROM	Advice and input on format and layout of PROM; Advice on instructions of how to complete the PROM, framing of questions, wording of response options, and order of items

PI: Public involvement; PROMs: Patient reported outcome measures.