Enhancing reporting of process evaluations in healthcare: A preliminary Checklist for RepOrting Process evaluations...

Health-care faces increasing complexity in addressing multimorbidity, integrating social and medical care, and implementing innovative technologies. While complex interventions are increasingly used to address these challenges, their success heavily relies on proper implementation and evaluation. Process evaluations are crucial for understanding how interventions work in reality, yet they remain rather rare in health-care research. Despite growing attention to evaluation frameworks, inconsistent reporting and lack of transparency in process evaluation methodologies make it difficult for researchers to design and replicate these evaluations effectively.

The Checklist for RepOrting Process evaluations (CROP) was developed through a systematic two-phase approach. First, we created an initial rehabilitation-focused version based on literature analysis of process evaluations in rehabilitation, the Medical Research Council framework, and reporting guidelines for qualitative, implementation, and process evaluation evidence synthesis. Second, the checklist was refined through a five-round international online Delphi survey with experts in process evaluation and implementation research. Experts evaluated 31 initial items for relevance, clarity, and importance using four-point Likert scales. Content and face validity were assessed using validity indices. Expert feedback prompted expansion from rehabilitation-specific to health care-wide applicability from round 2 onward.

The five-part Delphi study involved between eight and 11 experts participating in each round. Starting with 31 items, only nine initially achieved consensus on both clarity and relevance. From round 2 onward, importance was added as a third evaluation criterion. Through iterative refinement, scale content validity improved from 0.73-0.90 for clarity and remained high for relevance (0.93-0.96). Items achieving consensus on importance consistently paralleled relevance patterns. Face validity exceeded 0.80 from round 3 onward. The final CROP comprises 29 items achieving expert consensus (90%-100%) across all three dimensions and health care-wide appropriateness. Expert consensus confirmed the checklist's expansion from rehabilitation programs to broader health-care applications.

The CROP achieved robust content validity and expert consensus, evolving from a rehabilitation-specific tool to provide the first standardized reporting instrument for process evaluations across health-care settings. This addresses a significant methodological gap and has potential to improve quality and transparency of process evaluation research, supporting researchers, practitioners, journal editors, and peer reviewers in health-care programs.