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Introduction: Health literacy (HL) refers to individuals' abilities to process and use health information to promote health. This study aimed to develop the first HL measurement tool for the Chinese Hong Kong population. Methods: A two‐phase methodology was adopted. In Phase I, evidence synthesis with a deductive method was conducted to formulate the item list from the literature. In Phase II, a modified e‐Delphi survey was conducted among stakeholders (i.e., healthcare providers and healthcare consumers) to confirm the content validity of the item list. The stakeholders were invited to rate the relevance of each draft item on a 4‐point scale and provide suggestions for revisions, removal or adding new items. Results: In Phase I, a total of 34 items covering functional, interactive and critical HL were generated. In Phase II, to obtain a balanced view from experts and laypeople, healthcare professionals (n = 12) and consumers (n = 12) were invited to participate in the Delphi panel. The response rates of the three rounds were 100%. After the third round, the consensus was reached for 31 items, and no further comments for adding or revising items were received. All items exhibited excellent content validity (item content validity index: 0.79–1.00; K*: 0.74–1.00). Conclusions: A Health Literacy Scale for Hong Kong was developed. Compared with existing HL scales, the scale fully operationalized the skills involved in functional, interactive and critical HL. The Delphi study shows evidence supporting the high content validity of all items in the scale. In future studies, these items should undergo rigorous testing to examine their psychometric properties in our target population groups. By illuminating the details in the development process, this paper provides a deeper understanding of the scale's scope and limitations for others who are interested in using this tool. Patient or Public Contribution: Public as healthcare consumers, in addition to healthcare providers, were involved in developing a new HL scale for this study. The input from the public contributed to examining the scale's content validity by judging whether all items reflected the skills that they need to find and use health‐related information in their daily life. [ABSTRACT FROM AUTHOR]

Objective Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs). Methods We developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT. Results Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT ( P = 0.02). Conclusion We have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc. [ABSTRACT FROM AUTHOR]