Literature review

A comprehensive review of the academic literature, websites and Chinese policy documents on healthcare quality was conducted to understand the concepts, models, evaluation frameworks and practical methods used to assess healthcare quality in gynaecological healthcare settings. The review aimed to collect evaluation indicators related to healthcare quality, which were then organised into a pool of measures for assessing the quality of gynaecological healthcare in public healthcare facilities. The literature search was conducted using domestic and international databases, such as PubMed, Embase, Medline, Scopus, China National Knowledge Infrastructure and Wanfang. English keywords included ‘health care’, ‘quality indicator’, ‘quality assessment’, ‘hospital accreditation’, and ‘gynaecology’, while Chinese keywords focused on ‘medical quality’ and ‘gynaecology’. A strategy was established to systematically review pertinent research over the past 10 years (1 January 2013–24 June 2023) and policy documents since 1989, in order to collect and categorise healthcare quality evaluation indicators. The search was conducted from 19 June 2023 to 24 June 2023 (online supplemental appendix 1: Literature Search Records and Results; online supplemental appendix 2: National Policy Documents in Chinese).

On-site indepth interview

Based on a preliminary literature review, we developed a semistructured interview guide for gynaecology department directors at healthcare facilities (online supplemental appendix 3: Interview Guide) to understand their views on the current state of gynaecological care development. We selected at least one province from each of China’s seven geographical regions between June 2023 and December 2023, taking into consideration their representativeness and feasibility. In each province, we chose at least one public hospital and one maternal and child healthcare facility for on-site indepth interviews with the directors of gynaecology departments. A total of 21 healthcare facilities across nine provinces participated in the interviews (online supplemental appendix 4: Interview List).

Focus group interview

On 10 January 2024, we convened a focus group discussion involving key stakeholders, including hospital directors, hospital medical quality management personnel, gynaecological medical staff and personnel involved in healthcare quality policymaking. This meeting was aimed at understanding the difficulties and challenges in evaluating gynaecological healthcare quality in public healthcare facilities in China and discussing and revising the current evaluation indicators.

Expert consultation

This study employed a modified Delphi method following the principles of authority,28 comprehensiveness and representativeness in the expert selection process. We assembled a panel of 30 consultants relevant to this study, including gynaecology clinical experts, hospital management professionals and the head of the gynaecology department. In the first round of expert consultation, each expert was asked to score the importance and feasibility of various indicators within the gynaecological care quality indicator system, which was constructed in earlier stages. Based on the feedback, we adjusted the relevant indicators and conducted a second round of expert consultation. The results showed a strong convergence of expert opinions (Kendall’s coefficient of concordance, w >0.5). Given the complexity and importance of the Delphi process in the development of an indicator system, we will present a detailed account of this process in a separate publication.

Field testing

Based on the gynaecological care quality indicator system for public healthcare facilities in China, a corresponding questionnaire was developed and validated.29 To test the effectiveness and feasibility of the questionnaire, the research team conducted a small-sample pilot survey in the gynaecology departments of two healthcare facilities in February 2024. Based on the findings, the questionnaire was further revised. The authors and other experts have reviewed the assessment tools (online supplemental appendix 5: List of assessment tool reviewers).

Questionnaire scope and sampling design

The following three types of questionnaires were developed: (1) organisational, (2) for healthcare providers and (3) for patients. English versions of these questionnaires are available in online supplemental appendix 6. Chinese versions of all questionnaires are available on request. The survey questions can be categorised into three major domains: the organisational structure, processes and outcomes of gynaecology departments (table 1). Data will be collected on elements such as workforce, service capacity, information systems, medical costs, patients’ experience and satisfaction with the gynaecology department.

Organisational questionnaire

The organisational questionnaire comprises the following four sections: basic information about the gynaecology departments, department operation overview, single-disease monitoring information and a medication configuration survey.

In the first section, we will collect basic information about the gynaecological surgeries and diagnostic techniques that each department can perform independently, as well as the number of diseases each department can diagnose and treat independently. We can thereby directly assess the institution’s ability to provide services. Moreover, we will investigate the utilisation of electronic medical records, appointment systems, patient follow-ups and clinical pathway management systems in these departments. Furthermore, to better understand the implementation of the hierarchical healthcare system, we will investigate each department’s participation in medical alliances, as well as the extent of support and assistance provided to lower-level medical institutions.

The second section will focus on the department’s personnel number and composition, bed capacity, patient visits and quality and safety metrics for 2023. The questions are formulated based on established Chinese surveys, including the ‘National Health Resources and Medical Services Survey System’, the ‘National Maternal and Child Health Survey System’, and the ‘Medical Quality Management and Control Indicators Compilation Version 5.0’.

The third section will collect data on the number of patients treated for various gynaecological diseases in 2023 to understand the distribution of disease types in gynaecology departments across the country. Moreover, considering the expert consultation results and data feasibility, we will collect information on hospital admissions, mortality rates, length of stay and hospitalisation costs for three specific diseases: uterine fibroids, ectopic pregnancy and cervical cancer.

In the fourth section, we will collect information on the availability of regularly used medications for gynaecological infectious diseases and cervical cancer in each department to better understand medication accessibility.

The questions were revised and updated based on feedback from the directors of the gynaecology department during the field-testing phase. The final version of the questionnaire was validated as reasonable and user-friendly through feedback from participating institutions.

Gynaecological care provider questionnaire

This questionnaire will collect information on gynaecological care providers regarding their education, training, service provision, income, career development opportunities, awareness of clinical guidelines, workload, psychological status (measured by the 5-item Mental Health Inventory subscale of the 36-Item Short Form Health Survey),30 turnover intention and satisfaction with work. The questions are mainly adapted from established surveys such as the China PEACE Primary Health Care survey,31 the China Healthcare Improvement Evaluation Survey (CHIES),32 the Seventh National Health Services Survey (NHSS) of China and the Nurses’ Health Study conducted in the USA,33 which have been used extensively in large and diverse study populations. Furthermore, because gynaecological infectious diseases are the most common gynaecological conditions, our questionnaire includes a survey on gynaecologists’ diagnostic and treatment abilities, as well as their perspectives regarding these infections.

To measure burnout, we also use the Maslach Burnout Inventory for Human Services Survey,34 a commonly used survey in China.35 At the end of the questionnaire, two open-ended questions are included to gather providers’ suggestions regarding further development of gynaecological services in their institutions and their needs for training in gynaecology-related techniques and management.

Patient questionnaire

Considering the different procedures that patients undergo, we designed separate questionnaires for outpatient and inpatient participants. These questionnaires will collect patients’ sociodemographic characteristics (such as region, age, education level, income and occupation), clinical information (such as disease diagnosis, symptoms and psychological status), reasons for seeking care, healthcare expenditure (out-of-pocket and insurance reimbursement), patient experience and rated care accessibility. The questions are mainly adapted from various validated survey instruments (patient questionnaire in the China PEACE Primary Health Care survey,31 inpatient and outpatient questionnaires in the CHIES36 and family health survey questionnaire in the Seventh NHSS of China). In the patient experience section, we use the Chinese Patient Experience Questionnaire (CPEQ) developed by the team at Peking Union Medical College, which has been widely used in large-scale population surveys.37 38 Finally, we will collect the patients’ home and work addresses along with their coordinates to understand the pattern of gynaecological patients seeking care outside of their local area.

Questionnaire administration

A computerised direct data entry method was used for all questionnaires. We specifically developed a WeChat mini-programme for this survey, enabling participants to fill out the questionnaire by scanning a quick-response (QR) code directly through WeChat (online supplemental appendix 7: Survey QR code). This approach ensured the survey’s feasibility, ease of use and awareness of the time needed for completion. The director of each participating gynaecology department was responsible for providing accurate answers to the questions in the organisation questionnaire, with assistance from the human resources, financing and operation departments. The organisational questionnaire required approximately 40 min to complete, and the healthcare provider and patient questionnaires typically required an average of 15 min each.

Setting and sampling

China has a hierarchical healthcare system that operates across the country (figure 2), composed of an extensive network extending from central to local levels. Public healthcare facilities are the foundation of China’s healthcare system. Considering the geographic diversity and willingness to participate, we included at least six county-level public health facilities, six municipal public health facilities and one provincial health facility per province. These facilities included general hospitals, maternal and child health facilities and traditional Chinese medicine hospitals.

Participants

This survey included three types of participants:

Table 2

The types of data adopted in this study

Quantitative data analysis

The quantitative data used in this study were obtained from a large-scale cross-sectional nationwide survey conducted in China.

First, to ensure comparability between different institutions,39 we will conduct risk adjustment on key medical quality indicators. We begin by identifying potential case-mix adjustors based on the previous literature and data analysis of influencing factors. Adjustors that have a significant relationship with medical quality indicators and show significant distribution differences between healthcare facilities will be included in the final risk adjustment model.40 Regression models will be used to calculate risk-adjusted results. Comparative analyses between different institutions and regions will be conducted based on these results.

Second, using the evaluation index system and risk adjustment model developed in this study, comprehensive evaluations of healthcare facilities will be conducted using methods such as combining Set Pair Analysis (SPA) with Technique for Order Preference by Similarity to an Ideal Solution (TOPSIS)41 and traditional TOPSIS.42

Finally, a linear regression model will explore factors affecting gynaecological healthcare quality, such as the healthcare facility level and nature, doctors’ medical service capabilities and resource allocation. This will provide the necessary evidence for proposing strategies to improve gynaecological care quality from a medical perspective.

All figures will be created using GraphPad Prism, V.8.4.0 (GraphPad Software, San Diego, California, USA). All statistical analyses will be performed using STATA V.16.0 (Stata Corp, College Station, Texas, USA). Statistical significance will be set at p<0.05.

Qualitative data analysis

The qualitative data were derived from healthcare quality-related policy documents published in China, interviews with the directors of gynaecology departments in 21 healthcare facilities and responses to open-ended questions from our national survey. We will conduct thematic and content analyses of the qualitative data. By coding and categorising the textual content, we aim to identify the strengths and weaknesses of gynaecological care. This approach also allows us to examine the management strategies employed by department directors and pinpoint the challenges they encounter. Qualitative analysis will be conducted using NVivo V.14 (Lumivero, Denver, Colorado, USA).

Integration of qualitative and quantitative results

Integration is the most critical characteristic of mixed-methods research, which involves the intentional combination of qualitative and quantitative data to provide a comprehensive understanding of the research question. In our study, joint displays25 will be used to merge and interpret the results of the analysis of both quantitative and qualitative data.

Quality control

To ensure data quality, we developed a set of guidelines and procedures focusing on 3 areas:

1. Real-time data monitoring: on-site training and inspections were conducted by coordinators from our team at each province to ensure data quality and adherence to the timeline.