OBJECTIVES : To identify and critically appraise studies reporting the development, translation, and/or psychometric evaluation of patient-reported outcome (PRO) instruments for Arabic speaking population.

METHODS : The review was guided by a published guideline for systematic reviews of patient-reported outcome measures. We searched two databases: PubMed and Web of Science. The search strategy was guided by published search filters. There were no publication period or language restrictions. Studies of any design were included if reporting PRO instruments development in Arabic language; or explicitly reporting the assessment of one or more psychometric properties for PRO instruments (including reliability, validity, responsiveness, precision, interpretability, acceptability and feasibility) in Arabic population; or reporting cross-cultural validation of PRO instruments in Arabic population. We excluded studies if 1) using a PRO instrument as an outcome without any description of development, translation, and/or validation; or 2) published as conference abstracts. We categorised instruments into five categories: (1) Symptoms (impairments) and other aspects of well-being; (2) Functioning (disability/activity); (3) Health related quality of life (HRQoL); (4) Quality of life; and (5) utility. The review protocol Prospero registration number is CRD42018088991.

RESULTS : 149 studies met the inclusion criteria. The majority of studies were published after 2011 (106,71 %); carried out in Saudi Arabia (43, 29%); reported translation and/or validation (141, 95%); and reported a HRQoL measures (60, 40%). Major quality concerns regarding translation include lack of the reporting of the following components: obtaining permission, inviting developer to be involved, develop explanation of concepts in instruments. The most frequently reported measurement propriety is internal consistency, other measures such as construct validity, reproducibility, and responsiveness are less reported.

CONCLUSIONS : There is a growing interest in the use of Arabic version of PRO instruments, however, quality of published evidence indicate that further investigations are required before recommendation for use in practice.