Assessing the quality of gynaecological care in China: protocol for a nationwide survey using mixed-methods.

Industrialisation, urbanisation, population growth and lifestyle changes have increased the global burden of gynaecological diseases. These changes affect women’s reproductive health and quality of life and also impact their families. With declining global fertility rates, tackling gynaecological diseases is crucial, especially in low-income countries. The mortality, morbidity and disability rates among reproductive-age women from these diseases exceed those of other major health issues, highlighting the need for better prevention and treatment. 1 2 For example, female reproductive tract infections can lead to a range of serious reproductive complications, including infertility, ectopic pregnancy and adverse pregnancy outcomes, such as miscarriage, stillbirth and preterm birth. 3 5 Pelvic organ prolapse (POP) and stress urinary incontinence are profoundly more common in middle-aged and older women. 6 In 2021, a multicentre cross-sectional survey conducted in China revealed that symptomatic POP affects 9.6% of adult women. 7 The global prevalence of uterine fibroids is estimated to be between 4.5% and 68.6%. 8 Cervical, ovarian and endometrial cancers are the three major reproductive system malignancies, posing a global burden. In 2020, according to data from GLOBOCAN (the global cancer statistics database), their global incidence rates ranked among the top ten cancers affecting women. 9 Reproductive endocrine diseases are another important category and include conditions such as abnormal uterine bleeding, amenorrhoea, polycystic ovary syndrome, 10 11 dysmenorrhoea and menopausal syndrome. Endometriosis, a common chronic gynaecological condition, causes severe symptoms like dysmenorrhoea and chronic pelvic pain. It affects about 10% (190 million) of reproductive-age women and girls globally. 12 Although gynaecological diseases impose a substantial burden on public health, they have been persistently neglected in the long term. In recent decades, global women’s health has advanced, especially in maternal health. Reducing maternal mortality is a priority in international and national strategies. By 2019, China cut its maternal and infant mortality rates from 1500 and 200 per 100 000 births before 1949 to 17.8 and 5.0–6.0 per 100 000 births, respectively. 13 They receive little attention in international development goals and national health programmes, especially in low-income countries. The scarcity of large-scale, high-quality epidemiological data on these diseases further exacerbates this neglect, hindering their recognition as global health priorities. 1 As an editorial in The Lancet noted, the undervaluation of women’s contributions reflects an outdated view of women’s health that overemphasises their reproductive roles. 14 In view of the severe situation of gynaecological diseases and the long-term neglect of gynaecological medical services, the systematic evaluation of the quality of gynaecological care appears to be particularly urgent. Healthcare quality is an important aspect of hospital administration in the 21st century. The World Health Organization (WHO) has identified healthcare quality improvement as a worldwide priority, encouraging governments to take ongoing measures to improve it. Improving the quality of gynaecological care will enhance patient recovery and improve outcomes of gynaecological diseases. However, despite its significance, there are only a few practical implementations in this regard. Internationally, the development of healthcare quality evaluation tools specifically tailored to gynaecology remains limited. There are few data on the quality of gynaecological procedures, and there is a lack of specific healthcare quality indicators for various gynaecological diseases. 15 23 In China, no nationwide large-scale survey data have been reported on the capacities and medical quality of grassroots gynaecology departments. Overall, the historical emphasis on maternal health in global women’s health initiatives has led to a primary focus on reducing maternal mortality rates and improving obstetric outcomes. Consequently, the development of the gynaecological care quality evaluation system has lagged behind that of obstetrics. 16 To address this gap, Tsinghua University (TU) and the Department of Obstetrics and Gynaecology at Peking Union Medical College Hospital (DOGPUMCH) will conduct a nationwide study to assess the quality of gynaecological care in China. This protocol was developed with reference to the GRAMMS (Good Reporting of A Mixed Methods Study) framework proposed by O’Cathain et al. (2008), which provides structured guidance for the transparent reporting of mixed-methods research in healthcare. 24 The objectives of this study are as follows: Establish a comprehensive evaluation index system for the quality of gynaecological services in China and develop standardised assessment tools. Systematically assess the development level and quality status of regional gynaecological medical services, revealing multidimensional heterogeneity and key disparity dimensions. Analyse the structural causes and mechanisms of these disparities based on multidimensional empirical data and propose evidence-based optimisation pathways and systematic policy recommendations. By achieving these objectives, this study is expected to provide methodological guidance for advancing the scientific evaluation of gynaecological care quality. Additionally, the findings of this study will offer valuable insights to healthcare regulators for formulating and enhancing policies.

We conducted a small-sample pilot survey with patients in the gynaecology departments of two healthcare facilities in February 2024 to test the effectiveness and feasibility of the questionnaire. No patients and the public will be directly involved in the design and conception of the study or the analysis or interpretation of the results. The results of the survey will be disseminated through the publication of publicly accessible survey reports and presented at the National Conference on Gynaecological Healthcare Improvement in 2025. A sequential explanatory mixed-methods design is employed in this study to assess the quality of gynaecological care in China ( figure 1 ). This design consists of two phases: a qualitative phase followed by a quantitative one. In the qualitative phase, we develop questionnaires and conduct semistructured interviews. These instruments are subsequently tested and validated during the quantitative data collection and analysis stages. 25 27 The structure of this study follows three main steps: Step 1: questionnaire development. A literature review, indepth interviews, expert consultations and small-sample pilot investigations were conducted to develop the questionnaire. Step 2: data collection. A cross-sectional survey, titled the China Gynaecological Healthcare Quality Survey (CGHQS), was conducted across 31 provinces, municipalities and autonomous regions in mainland China. The survey gathered data at three levels: gynaecology departments (institutional level), gynaecological care providers (service provision level) and outpatients and inpatients using gynaecological services (user level). This multilevel design allowed the linking of institutional, service provider and patient information. Step 3: interpretation of results. Joint displays 25 will be used to merge and interpret the quantitative data (collected through the cross-sectional survey) and the qualitative data (gathered from expert consultations and indepth interviews). The study commenced on 1 June 2023 and is currently ongoing, with an anticipated completion date of 1 June 2025. 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). 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). 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. 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. 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). 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. 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. 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. 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 CHIES 36 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. 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. We conducted a cross-sectional survey, the CGHQS, across all 31 provinces, municipalities and autonomous regions in mainland China from April to December 2024. This survey employed the aforementioned questionnaires to collect comprehensive information on the gynaecological system, service availability and the perspectives of health professionals and patients. This effort aimed to create a database for extensive research on various gynaecological problems. 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. This survey included three types of participants: Gynaecology department: the gynaecology department of each participating healthcare facility was included in the survey, with the departmental head or designated representative completing the department questionnaire. Gynaecological care providers: all healthcare providers working in the participating gynaecology departments were recruited for this survey. Healthcare providers include physicians, nurses and assistants. Gynaecological patients: we used random sampling to anonymously select inpatients and outpatients from the gynaecology department to participate in the survey. According to the requirements of the CPEQ questionnaire, patients aged ≥15 years were included in this study, with additional inclusion criteria for the CPEQ-A (outpatients who had completed and paid for their medical consultation) and the CPEQ-I (inpatients who received a discharge notice). During data collection, each sample facility placed survey QR codes in the gynaecology ward (the patient consultation area of the inpatient ward nurse station and the exterior wall of the doctor consultation room). We enrolled research assistants from the nursing department as research assistants and invited eligible patients to complete the survey using an online platform. The respondents were asked to scan the QR code to access the questionnaire using their mobile phones. Participation was voluntary and informed consent was obtained from the respondents before the survey. Based on national data, we are analysing the current state and disparities in the development and quality of gynaecological care in China, exploring the underlying causes of these disparities and proposing strategies for improvement. Both qualitative and quantitative data analysis are being used and integrated in this study ( table 2 ). Quantifiable data related to the scale of gynaecology departments, such as the number of beds, floor area, etc. The quantity of equipment, like the specific number of various medical devices. Operational indicators, including average daily patient reception volume, hospitalisation turnover rate, etc. A large-scale cross-sectional survey carried out across 31 provinces, municipalities and autonomous regions in mainland China. A small-sample pilot survey in the gynaecology departments of two healthcare facilities. The indepth interviews conducted in 21 healthcare facilities across nine provinces. The focus group discussion conducted on 10 January 2024. A modified Delphi method was conducted with 30 consultants who were relevant to this study. The indepth interviews conducted in 21 healthcare facilities across nine provinces. The focus group discussion conducted on 10 January 2024. A large-scale cross-sectional survey carried out across 31 provinces, municipalities and autonomous regions in mainland China. A small-sample pilot survey in the gynaecology departments of two healthcare facilities. 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. 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 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 displays 25 will be used to merge and interpret the results of the analysis of both quantitative and qualitative data. To ensure data quality, we developed a set of guidelines and procedures focusing on 3 areas: Software design: an online survey platform for mobile devices (self-adaptation for both smartphones and tablets) was developed with logic checks to identify illogical responses and incomplete records. A predefined coding system was embedded using a composite key index for participant identification, which is derived from healthcare facility identity document, questionnaire category, data acquisition time, interviewer number and respondent sequence number. Appropriate training: before the survey began, we organised survey training for key personnel at participating facilities through a webinar organised by TU and DOGPUMCH. A standardised training package prepared by TU was provided to each participating healthcare facility to ensure uniform administration. 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.