THE USE OF DENTAL PATIENT-REPORTED OUTCOMES AMONG RANDOMIZED CONTROLLED TRIALS IN ORTHODONTICS: A METHODOLOGICAL STUDY.

Abstract

To identify and summarize the use and characteristics of dental patient-reported outcomes (dPROs) and dental patient-reported outcome measures (dPROMs) within randomized controlled trials (RCTs) published in 5 leading orthodontic journals. A manual search was conducted to identify intervention (therapeutic or preventive) related RCTs published in selected journals between 2015 and 2021. Two authors extracted the characteristics of each included trial, as well as all outcomes and outcome measures used in these trials independently and in duplicate. Thereafter, the use of dPROs and dPROMs was identified and summarized. We classified all dPROs into 2 general types (oral health-related quality of life [OHRQoL] and others) and dPROMs into 3 categories (single-item questionnaires, generic multiple-item questionnaires, and specific multiple-item questionnaires). We also identified whether these dPROMs assessed 4 dimensions of OHRQoL (Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact). From 4631 examined articles, a total of 315 RCTs were included, of which 76 (24.1%) used dPROs and dPROMs. Eight different dPROs (OHRQoL, patients' satisfaction with treatment, difficulty, compliance, preference, efficacy, duration, and unwanted events) and 34 different dPROMs (including 13 single-item questionnaires, 7 generic multiple-item questionnaires, and 14 specific multiple-item questionnaires) were identified in these trials. OHRQoL was the most commonly used dPRO (n = 71; 93.4%), followed by patients' satisfaction with treatment (n = 10; 13.2%), patient-reported difficulty (n = 5; 6.6%), and patient-reported compliance (n = 4, 5.3%). The 4 most frequently used dPROMs were pain measured with 10 mm Visual Analogue Scale (n = 20; 24.1%), pain measured with Numerical Rating Scale (n = 11; 13.3%), the Feldmann's Questionnaire (2007) (n = 6; 7.2%), and the Oral Health Impact Profile 14 (n = 5; 6.0%). Only about one-fourth of RCTs published in leading orthodontic journals can reflect patients' perspectives. OHRQoL was the most commonly used dPRO in these trials. Substantial heterogeneity exists among dPROMs used for OHRQoL assessment. Efforts are needed from researchers, reviewers, editors and other stakeholders to promote the wide and standardized use of dPROs in orthodontic research.