The original PCPCM consists of a question followed by 11 items that cover a spectrum of primary care functional features. Respondents are prompted to answer using a four-point Likert scale, with options ranging from "Definitely" to "Not at all”17. In this study, we adhered to the cross-cultural translation, adaptation, and validation guidelines proposed by Sousa and Rojjanasrirat24, employing a three-step process to develop a Simplified Chinese version of the PCPCM for patients under the family doctor contract service program (PCPCM-SC-FDCP).
Development of pre-final version of PCPCM-SC-FDCP
The initial phase in developing the PCPCM-SC-FDCP was grounded in a meticulous and culturally sensitive translation process. This phase involved two bilingual translators, both possessing fluency in English and Simplified Chinese. Their expertise extended beyond language proficiency; the first translator brought practical experience in general practice and public health, while the second translator was deeply familiar with the local primary care contexts and nuances of the family doctor contract service, although with a more limited background in health sciences. To ensure translation fidelity, these translators independently converted the PCPCM from English to Simplified Chinese. Special attention was given to aligning the translation with the specific needs and experiences of our target population—patients under family doctor contracts. Their independent translations were then scrutinized by a third bilingual translator, an active general practitioner in a Chinese primary care setting. This translator's role was pivotal in identifying and resolving inconsistencies between the two translations, focusing on terminology, sentence structure, conveyed meaning, and the suitability of the adaptations made. Through collaborative efforts, these translations were harmonized, culminating in a preliminary version of the PCPCM-SC-FDCP.
Further refining the translation, two additional bilingual translators, both native English speakers studying in China, independently back-translated the preliminary version into English. One translator specialized in general practice, while the other, lacking a specialized background in health sciences, brought a different perspective. A comprehensive review session with all five translators was then organized. The insights gained from this session were instrumental in refining and finalizing the translation, culminating in the development of the pre-final version of the PCPCM-SC-FDCP.
Pilot Testing of PCPCM-SC-FDCP
The pilot testing of the pre-final versions of the PCPCM-SC-FDCP was conducted in two distinct phases. In the initial phase, the PCPCM-SC-FDCP was administered to a group of 20 primary care patients who were under contract with family doctors. These patients were reached through general practitioners in five provinces (Beijing, Chongqing, Henan, Liaoning, and Shanghai). The survey was conducted using an online questionnaire. They were requested to evaluate the clarity of the instructions, items, and response format of the translated scale using a straightforward dichotomous scale (clear or unclear). The advancement to the next phase of testing was contingent on achieving clarity as reported by over 80% of the participants, encompassing the instructions, response format, and individual items.
Additionally, we assembled a panel of 10 experts from mainland China, all well-versed in the functional features of primary care. These experts were selected from general practice and public health departments within both practice and research institutes. Following their feedback, we made meticulous adjustments to the wording, proceeding only after more than 80% of the panel agreed that the instructions, response format, and each item were sufficiently clear to confirm conceptual equivalence.
During the second phase, we engaged these ten experts to evaluate the content relevance of each item using a four-point scale, where 1=not relevant, 2=unable to assess relevance, 3=relevant but requiring minor alteration, and 4=very relevant and succinct. Items receiving a rating of 1 (not relevant) or 2 (unable to assess relevance) were further refined. To ensure robust content validity, we set a minimum threshold of Scale-Content Validity Index/Average (S-CVI/Ave) ≥ 0.9024.
Psychometric testing of PCPCM-SC-FDCP
In Shanghai, China, we successfully recruited a total of 583 primary care patients under family doctor contract service program from 10 primary care facilities. These institutions were strategically selected across urban (4 facilities), suburban (3 facilities), and rural (3 facilities) settings to ensure diverse representation. Each institution enrolled between 50 to 100 patients. In accordance with established empirical standards, this sample size was considered adequate for the psychometric analysis of the eleven dimensions of the pre-final versions of the PCPCM-SC-FDCP24. The inclusion criteria included: (1) being aged 18 years or older; (2) cognitive alertness and ability to read or understand the relevant informed consent documents; (3) having utilized at least one primary care service from a family doctor in the past 12 months, consistent with the implementation recommendations for the target population set forth by the American Academy of Family Physicians 25.
As indicated in Table 1, we collected data intended to support psychometric analyses of the PCPCM-SC-FDCP. Additionally, we gathered data on participants' gender, age, educational level, mean annually income, EQ-5D utility scores, duration of family doctor contracts, and frequency of consultations with a family doctor in the past year. Using this data, we analyzed the internal consistency reliability, stability reliability, homogeneity, construct-related validity, criterion-related validity, dimensionality, and model fit of the PCPCM-SC-FDCP. We established adequate standards for these analyses based on relevant methodological guidelines26-30. Moreover, we conducted two subgroup analyses as sensitivity analysis, specifically focusing on individuals with diabetes and/or hypertension, and seniors aged 65 and above. These groups represent the primary and largest demographics for Family doctor contract service program in mainland China15. The statistical analyses were carried out using several software tools, including Stata 17.0 SE (StataCorp LLC, College Station, TX, USA), IBM SPSS Statistics V.26.0 (IBM Corp., Armonk, NY, USA), R version 4.3.2 (R Foundation for Statistical Computing, Vienna, Austria), and Winsteps 3.72.3 (Winsteps.com, Beaverton, OR, USA).
Ethics Approval and Consent to Participate
Ethical approval for this study was granted by the ethics review board at Peking University, with the approval number IRB00001052-23077. In accordance with the permissions granted by the ethics committee, informed consent was obtained verbally from all participants. The participants were fully informed about the purpose of the study, their right to withdraw at any time without any consequences, and the measures taken to ensure their privacy and the confidentiality of their responses. Verbal consent was deemed appropriate by the ethics committee due to the nature of the study and was documented accordingly.