In a previous rapid realist review (RRR) of international literature insight was provided into how, why, and under what circumstances person-centred care (PCC) in primary care works (or not) among others for people with low health literacy skills and for people with a diverse ethnic and socioeconomic background, by establishing a middle-range programme theory (PT), which describes the relationship between context items, mechanisms, and outcomes. Since the application of PCC in primary care in the Dutch setting is expected to differ from other countries, the objective of this study is to validate the items (face validity) resulting from the RRR for the Dutch setting by assessing consensus on the relevance of items. Four focus group discussions with patient representatives and patients with limited health literacy skills (n = 14), and primary care professionals (n = 11) were held partly combined with a Delphi-study. Items were added to refine the middle-range PT for the Dutch primary care setting. These items indicated that in order to optimally align care to the patient tailored supporting material that is developed together with the target group is important, next to providing tailored communication. Healthcare providers (HCPs) and patients need to have a shared vision and set up goals and action plans together. HCPs should stimulate patient's self-efficacy, need to be aware of the patient's (social) circumstances and work in a culturally sensitive way. Better integration between information and communications technology systems, flexible payment models, and patients access to documents, and recorded consultations should be in place. This may result in better alignment of care to the needs of patients, improved accessibility to care, improved patient's self-efficacy, and improved health-related quality of life. On the long-term higher cost-effectiveness and a higher quality of healthcare can be realised. In conclusion, this study shows that for PCC to be effective in Dutch primary care, the PT based on ...