Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment

Purpose: To develop an agreed upon set of outcomes known as a “core outcome set” (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials. Design: Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting. Participants: Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners. Methods: A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of “include,” “exclude,” or “for discussion” that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS. Main Outcome Measure: Items recommended for inclusion in the COS for NIU-PS. Results: A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control. Conclusions: This study builds on international work across the clinical trials community and our qualitative research to construct the world's first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development

The psycho-social impact of malocclusions and treatment expectations of adolescent orthodontic patients

Objectives: To evaluate the short- and long-term orthodontic treatment (OT) expectations, malocclusion severity, and oral health-related quality of life (OHRQoL) status of adolescent patients using qualitative and quantitative methodology. Materials and Methods: Adolescents (n = 105; 42 males and 63 females) aged between 12 and 17 years participated in this interview and questionnaire-based study. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) and the Oral Impacts on Daily Performances (OIDP) scale evaluated OHRQoL status. Study casts were analysed using the Dental Aesthetics Index (DAI) and the Index of Complexity, Outcome and Need (ICON). Mann-Whitney test and Spearman's correlations tested various univariate variables. Results: With similar index-determined OT need (DAI, P = 0.371 and ICON, P = 0.932) females tended to have worse OHRQoL status (PIDAQ scores, P-values ranged from 0.006 to 0.0001 and scores for the OIDP question related to smiling, laughing, and showing teeth without embarrassment, P-value = 0.015). Occlusal index scores did not have statistically significant associations with the OHRQoL scales. Better dental appearance was expected by 85 per cent of the adolescents in the short-term and by 51 per cent in the long-term after OT. The associated psycho-social expectations were: 1. improved dental self-confidence, 2. positive psychological impact/improved self-worth, and 3. positive social impact. Conclusions: Female adolescent patients tended to experience worse psycho-social impacts related to their malocclusions compared with males with similar index-determined OT need. Index-determined OT need scores did not correlate with the OHRQoL scales. Adolescent patients expected OT to improve their dental appearance and QoL aspects.Eugene Twigge, Rachel M. Roberts, Lisa Jamieson, Craig W. Dreyer and Wayne J. Sampso

Qualitative evaluation of pretreatment patient concerns in orthodontics

Introduction: A discrepancy exists between objective and subjective measures of orthodontic treatment need, highlighting the importance of patients' perceptions. Limited qualitative information is available regarding patients' perceptions and orthodontic concerns. For the first time, patient facial images and qualitative methodology were used to assess patients' orthodontic concerns, which are incorporated into and are important in treatment planning and consent. Methods: An interview-based, cross-sectional study of adolescent patients eligible to receive orthodontic treatment in a public dental hospital was conducted with 105 adolescents (42 boys, 63 girls) aged between 12 and 17 years. Each patient's face was video recorded, and 3 images were selected from each recording to assess the patient's orthodontic concerns. The initial chief concerns were compared with concerns articulated after the patients assessed their facial images. In addition, patient concerns were compared with occlusal features visible on smiling using the Dental Aesthetic Index and patient study casts. Results: For 37% of the adolescent patients, smiling images helped to identify additional concerns. For 87%, their smiling images helped them to describe their concerns in more detail. In addition, a few patients did not articulate any concern about features measurable on the Dental Aesthetic Index that were visible on smiling. Conclusions: Showing adolescent patients images of their face and smile helped them to identify and better describe their concerns. Adolescents are not always overly concerned about visible and quantifiable malocclusion features. This might influence orthodontic treatment planning and consent.Eugene Twigge, Rachel M. Roberts, Lisa Jamieson, Craig W. Dreyer, and Wayne J. Sampso