Using the hybrid type 1 implementation study "The Shared Medical Appointment for diabetes in China: an optimization trial(SMART)" as an example, this study introduces the methods of constructing and validating an outcome indicator set for hybrid type 1 studies.

Based on principles such as comprehensiveness and operability, we selected the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, the Implementation Outcomes Framework (IOF), and the PRECEDE-PROCEED model. After comparison and screening, an outcome evaluation indicator item pool was formed. Two rounds of expert consultation were conducted, and the content validity was evaluated using the item-level content validity index (I-CVI), coefficient of variation (CV), and adjusted Kappa value, combined with experts' qualitative opinions and on-site implementation to optimize the indicators.

This study integrated the RE-AIM framework and three pre-evaluation dimensions from the IOF, forming an initial item pool for shared medical appointments (SMA) that included 8 dimensions (acceptability, appropriateness, feasibility, reach, effectiveness, adoption, implementation, and maintenance), 14 secondary indicators, and 24 tertiary indicators. The response rate of the two rounds of expert consultation was 100%, with an expert authority coefficient of 0.90. The I-CVI ranged from 0.75 to 1.00, the CV from 0 to 0.32, and the adjusted Kappa from 0.75 to 1.00, indicating good content validity and high expert consensus. After two rounds of consultation, one secondary indicator and three tertiary indicators were deleted, one new secondary indicator was added, and the dimension attribution of one indicator was adjusted. Following pilot implementation and stakeholder feedback, two tertiary indicators were added, four were deleted, and the measurement tool of one indicator was adjusted. The finalized implementation outcome indicator set for the SMART study comprises 8 dimensions, 14 secondary indicators, and 19 tertiary indicators.

The outcome indicator set constructed in this study demonstrates good validity and operability, and the construction and validation process can serve as a reference for other researchers. Different implementation outcome frameworks have different applicable scenarios; researchers should select appropriate frameworks or integrate them according to their own needs to comprehensively evaluate outcomes and enhance the systematization and comparability of research.

This study aimed to localize the workplace readiness questionnaire (WRQ) and validate its applicability for assessing readiness for implementation of evidence-based practices (EBP) in primary care settings in China. The localization of the instrument will provide a practical instrument for assessing organizational readiness for change (ORC).

The WRQ was translateed into Chinese version using the modified Brislin translation model, and its cross-cultural validity, content validity, and generalizability were evaluated by the Delphi method, and the expert feedback was evaluated using the item-level content validity index (I-CVI), scale-level content validity index (S-CVI), and corrected Kappa value. The index weights were evaluated by the analytic hierarchical process (AHP). The target users of the scale were invited to quantitatively evaluate its item importance score (IIS), and the surface validity was evaluated by combining the qualitative feedback from their cognitive interviews.

To clarify the purpose of the scale, we revised its name to the Organizational Readiness of Implementing Evidence-Based Practices (ORIEBP) Scale. The ORIEBP scale contained five dimensions, which were Change Context, Change Valence, Information Evaluation, Change Commitment, Change Efficiency, and 32 items. After two rounds of the Delphi method to refine the construction of three dimensions and expressions of 11 items, the I-CVI were from 0.73 to 1.00, the Kappa value were from 0.70 to 1.00, and the S-CVI was over 0.92. All evaluation matrices of the hierarchical analysis method met the requirement of consistency ratio (CR < 0.1), and the weights of five dimensions were 0.2083, 0.2022, 0.1907, 0.2193, and 0.1795, in sequence. Nine out of eleven experts identified that items were applicable to other readiness assessment scenarios. The IIS scores for the five dimensions and 32 items were ranged from 2.93 to 3.54, and 2.71 to 3.42, presenting good face validity. The cognitive interview results showed that professional expressions were complex to understand.

This study validated the ORIEBP scale and has good content validity and generalizability. The scale can be further improved by expanding its scope of use and validating its structure validity and reliability in different settings.

The success of implementation research is closely tied to the institution's pre-implementation readiness. This study aims to explore the organizational readiness for change (ORC) and its influencing factors on primary healthcare settings in the implementation of the "Shared Medical Appointment for Diabetes (SMART) in China: design of an optimization trial" and to enhance ORC and provide insights to support the effective implementation of the program.

Qualitative interviews and quantitative surveys were conducted to evaluate the ORC level and its influencing factors in 12 institutions implementing the SMART program. The Scale for Assessing the Institution's Readiness to Implement Evidence-Based Practices was utilized to measure ORC levels. Qualitative interviews were conducted among change implementers to gather information regarding the status of influencing factors. Thematic analysis was applied to extract factors from the interview data, and an assessment questionnaire was developed to measure the perceived impact of these factors. A fuzzy-set qualitative comparative analysis (fsQCA) method was employed to identify the influencing factors of ORC and pathways leading to high-level ORC.

Seventy implementers from 12 institutions, encompassing administrators, clinicians, and health managers, participated in the interviews and surveys. The median and interquartile of the ORC scores were 105.20 (101.23, 107.33). The fsQCA indicated that a clear understanding of specific tasks and responsibilities, the active engagement of key participants, sufficient preliminary preparation, and the use of audits and feedback mechanisms were critical pathways to a high-level ORC. Conversely, institutions lacking key participants, preliminary preparation, or marginal influence demonstrated a low-level ORC.

Before implementing innovation, Coherence and Cognitive Participation were identified as critical factors in influencing ORC. Strong leadership from key participants played pivotal role in enhancing readiness for change and was essential for improving implementation fidelity and overall program success.