Collection and Determination of Clinical Questions and Outcome Indicators for the Guideline for the Diagnosis and Treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine

ZHI Congcong¹, CHENG Yicheng¹, HUANG Zichen², WANG Xiaolong², LI Xue², ZHENG Lihua¹*

¹ China-Japan Friendship Hospital, Beijing 100029, China
² Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China

Corresponding author: ZHENG Lihua, Chief physician; E-mail: btv126@126.com

Abstract

Background: Hemorrhoids are the most common diseases in the anorectal department, with a large patient population. The clinical integrated diagnosis and treatment of traditional Chinese and Western medicine has obvious advantages. Currently, there is a lack of relevant high-quality guidelines or recommended standards. Standardizing the integrated diagnosis and treatment of hemorrhoids with traditional Chinese and Western medicine is of great significance.

Objective: To screen and define the core clinical issues and outcome indicators of the Guideline for the Integrated Diagnosis and Treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine, and to provide support for subsequent evidence integration and guideline writing.

Methods: A preliminary list of questions was formed through literature analysis, expert interviews, and clinical research. Two rounds of expert consultation were conducted using the Delphi method. Data analysis was performed using SPSS Statistics 26 and Excel 2021. Positive coefficients, mean values, full score rates, coefficient of variation, and Cronbach's α values were calculated. Inclusion criteria were: clinical issue mean score ≥ 3 points, outcome indicator mean score ≥ 7 points, full score rate ≥ 50%, and coefficient of variation <30%. Quality control standards were: expert positive coefficient ≥ 75%, Kendall's harmony coefficient >0.7, and Cronbach's α ≥ 0.7 as the quality control standard for the Delphi questionnaire.

Results: After preliminary investigation, 27 clinical issues (9 basic issues and 18 PICO-based clinical issues) and 9 outcome indicators were formulated. After two rounds of Delphi method surveys among 34 experts in related fields, 28 clinical issues (9 basic issues and 19 PICO-based clinical issues) and 9 key outcome indicators were formed. The positive coefficients of the two rounds of questionnaires were 85% and 97%, respectively. The Kendall's harmony coefficients were 0.837 and 0.826, respectively. The Cronbach's α coefficients for each item of clinical issues and outcome indicators were 0.929, 0.866, 0.923, and 0.803, respectively, indicating that experts had high attention to this study, small differences, high coordination, good questionnaire reliability, and high result reliability. Finally, after discussion among the experts in the research group, 28 clinical issues (9 basic issues and 19 PICO-based clinical issues) were determined to be included in the guideline. The clinical issues cover the characteristics of traditional Chinese medicine in hemorrhoids, preoperative assessment, integrated diagnosis and treatment methods of Western medicine and traditional Chinese medicine, perioperative management, etc.

Conclusion: The clinical issues and outcome indicator system established based on multi-dimensional research and the Delphi method provides a scientific framework for guideline compilation, highlighting the importance of multi-disciplinary consensus in the formulation of integrated medical guidelines.

Keywords: Hemorrhoids; Clinical practice guidelines; Problem construction; Efficacy evaluation; Integrated traditional Chinese and western medicine; Delphi method

Hemorrhoids are common clinical anorectal diseases. Although prevalence estimates vary domestically and internationally, hemorrhoids represent a widespread condition globally [1-3], with over 2.2 million patient visits for hemorrhoids annually in the United States [3]. According to census results reported by Chinese colorectal disease organizations, the overall incidence of anorectal diseases in China is 59.1%, with hemorrhoids having the highest prevalence (51.56%), accounting for 87.25% of all anorectal diseases [1]. Circumferential mixed hemorrhoids present particular challenges for clinicians, especially those at primary care facilities, due to numerous postoperative complications and patient dissatisfaction with treatment outcomes. In recent years, extensive clinical practice and research have been conducted on the integrated traditional Chinese and Western medicine treatment of hemorrhoids, but there remains a lack of relevant standardized diagnosis and treatment protocols. The Delphi method, as an approach for anonymous expert consultation, has been widely applied in clinical guideline development [6-7]. The guideline development group employed the Delphi method to organize national experts in colorectal surgery and methodology, following international and professional society principles and requirements for guideline development, integrating new knowledge and advances in traditional Chinese and Western medicine diagnosis and treatment to construct clinical questions for this guideline. This study summarizes and introduces the clinical question construction process, laying a foundation for subsequent development of integrated traditional Chinese and Western medicine guidelines for hemorrhoids.

1.1 Formation of Expert Panel

The expert panel consisted of specialists in traditional Chinese medicine, Western medicine, and integrated TCM-Western medicine from the field of colorectal surgery, as well as methodological experts. The panel involved multiple clinical disciplines including TCM colorectal surgery, general surgery, gastrointestinal surgery, and dermatology, with members representing six major geographical regions of China. All experts held senior professional titles, ensuring extensive clinical experience, broad academic perspectives, familiarity with current research status and hotspots in the field, and high professional authority.

1.2 Literature Search and Expert Interviews

Based on preliminary literature research and expert interviews conducted by the guideline development group, a preliminary list of clinical questions was established. The development team conducted a preliminary literature search using search terms including "hemorrhoids," "integrated traditional Chinese and Western medicine," "surgery," "postoperation," "traditional Chinese medicine," "lifestyle interventions," "hemorrhoids," "traditional Chinese medicine," "operation," "postoperation," and "lifestyle interventions" in databases including CNKI, Wanfang Data, VIP, PubMed, Embase, and Cochrane Library. Literature retrieval materials were compiled, and a question collection team of two interviewers conducted interviews with four senior experts from China-Japan Friendship Hospital who specialize in hemorrhoid diagnosis and treatment. Interview duration was 10-20 minutes and covered: (1) questionnaire purpose, requirements, and significance; (2) basic expert information including name, gender, age, education, department, professional title, and specialty background; and (3) clinical questions, with clarification of core content for each question including hemorrhoid classification, diagnosis and treatment, and outcome indicators. Interview content was summarized and combined with expert clinical experience to draft initial clinical questions and outcome indicators for the guideline. Based on these discussions and the initial draft, a Delphi method expert questionnaire was designed and two rounds of expert surveys were conducted with statistical analysis of questionnaire data.

1.3 Delphi Method for Determining Clinical Questions

This study employed the Delphi method to construct a clinical question and outcome indicator evaluation system. Clinical question importance was assessed using a 5-point scale (1-5 points), while outcome indicators used a 9-point scale (1-9 points), with higher scores indicating greater importance. Based on the scoring criteria, outcome indicators were divided into three levels: 7-9 points for critical outcome indicators, 4-6 points for important outcome indicators, and 1-3 points for general outcome indicators. The study established a two-round expert consultation process: the first-round questionnaire used a composite design (scoring combined with open-ended questions) for preliminary assessment of clinical questions and outcome indicators. Items with clinical question mean scores <3 points, outcome indicator mean scores <5 points, or coefficient of variation >30% were eliminated, while semantically redundant entries were consolidated and items outside the research scope were excluded. Based on first-round results, a second-round questionnaire was optimized and, after statistical analysis, final inclusion criteria were applied: clinical question mean score ≥3 points, outcome indicator mean score ≥7 points, full score rate ≥50%, and coefficient of variation <30%. Items meeting these criteria would serve as the basis for forming guideline recommendations.

1.4 Statistical Methods

Data analysis was performed using SPSS 26.0 and Excel 2021 software. Count data were expressed as frequency and percentage (%), and normally distributed measurement data were expressed as (x̄±s). Importance evaluation was conducted by calculating expert positive coefficient, mean (X), full score rate (K), and coefficient of variation (CV) [8].

1.4.1 Expert Positive Coefficient: This refers to the questionnaire effective response rate, calculated as: effective response rate (%) = number of valid returned questionnaires / total number of questionnaires × 100%. An expert positive coefficient ≥75% was considered valid. High questionnaire response rates indicate high expert enthusiasm and attention, ensuring questionnaire accuracy [8].

1.4.2 Expert Opinion Concentration: Expert opinion concentration was quantified through item importance score mean (X) and full score rate (K). X represents the arithmetic mean of item scores, while K (%) represents the percentage of experts who gave full marks out of the total expert panel. Higher values for both indicators demonstrate greater item importance for the guideline and higher expert consensus: items with X ≥2.50 and K ≥50.00% were considered highly important, while items with X<1.00 or K<30.00% were flagged for deletion. These metrics effectively reflect consensus levels among experts regarding item importance in Delphi studies.

1.4.3 Expert Opinion Coordination: Expert opinion coordination was quantified through coefficient of variation (CV) and Kendall's harmony coefficient (W). CV reflects the dispersion of item scores, with values positively correlated with expert opinion divergence. Effective consensus was determined when CV<30%. W represents the overall coordination of expert panel evaluation of the item set and serves as a classic test indicator in health research, with a value range of 0-1; values approaching 1 indicate significantly improved coordination. This dual indicator system scientifically measures consistency and coordination of expert scoring in Delphi studies [9].

1.4.4 Questionnaire Reliability: Cronbach's α coefficient was applied to reflect the reliability of the overall questionnaire and/or each major category of items, as well as the reliability of survey results. A value ≥0.70 was considered to indicate good questionnaire reliability and high result reliability.

Results

2.1 Basic Information of Experts

The expert panel comprised 34 specialists from integrated TCM-Western medicine colorectal surgery, general surgery, gastrointestinal surgery, and dermatology from across China, including 24 males and 10 females. Twenty experts (58.82%) were over 50 years old. In terms of professional titles, all held senior positions with extensive clinical experience, broad academic perspectives, and familiarity with current research status and hotspots in the field, demonstrating high professional authority. Thirty-one experts (91.18%) had over 15 years of work experience. Panel members came from 15 regions including Beijing, Hebei, Inner Mongolia, Shandong, Jiangsu, Shanghai, and Guangdong [TABLE:1].

2.2 Screening Process for Clinical Questions and Outcome Indicators

The first round of consultation included 27 clinical questions (9 basic questions and 18 PICO-formatted clinical questions) and 9 outcome indicators. After the first round of Delphi expert surveys, scoring results for each item were obtained and expert supplementary questions were collected, resulting in the addition of one new clinical question (Table 2 [TABLE:2]). This was incorporated into the second round of Delphi expert surveys (Table 3 [TABLE:3]). After discussion and evaluation of clinical questions by the research group experts, 28 clinical questions (9 basic questions and 19 PICO-formatted clinical questions) and 9 key outcome indicators were ultimately determined for further evidence grading and recommendation formulation (Table 4 [TABLE:4]).

2.3.1 Positive Coefficient: The first-round questionnaire response rate was 85% (29/34), and the second-round response rate was 97% (33/34), indicating high expert attention to this study.

2.3.2 Expert Opinion Concentration: As shown in Table 3, the mean scores (X) for all 28 clinical questions were >4 points with full score rates (K) >50%, while the mean scores for all 9 outcome indicators were >7 points with nearly all K>40%, indicating high concentration of expert opinion on the importance of included questions and indicators.

2.3.3 Expert Opinion Coordination: In Table 3, the CV for all 28 clinical questions and 9 outcome indicators was <30.0%, with a Kendall's harmony coefficient of 0.826, indicating small expert divergence and high coordination.

Questionnaire Reliability: The Cronbach's α coefficients for clinical question and outcome indicator items were 0.929 and 0.866 in the first round, and 0.923 and 0.803 in the second round, respectively. Both rounds achieved reliability >0.7, indicating good questionnaire reliability and high result reliability.

The Delphi method is an important approach for expert surveys and a critical step in constructing clinical questions and outcome indicators for clinical guidelines, ultimately leading to recommendation formulation [10]. The development of the Guideline for the Diagnosis and Treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine synthesizes the best available evidence from comprehensive clinical research in the field of integrated TCM-Western medicine for hemorrhoids to inform clinical decision-making. Clinical questions related to guidelines form the basis for literature search and systematic review, and the number of clinical questions and outcome indicators directly determines the scope of the guideline and the number of recommendations [11-12].

The project team employed the Delphi method, following extensive clinical investigation, expert interview discussions, and multiple rounds of questionnaires, to clearly define 19 PICO-structured clinical questions for inclusion in the guideline. The team conducted preliminary literature searches and investigations to ensure the quality of clinical questions and outcome indicators included in the guideline. Specifically, based on preliminary expert interviews and relevant clinical investigations, the key focus areas for clinical questions in the integrated TCM-Western medicine treatment of hemorrhoids were identified as the integration points between TCM and Western medicine and the selection of surgical procedures. Building on these findings, an initial list of 27 clinical questions and 9 outcome indicators was formulated. The 9 basic questions focused on: definition, etiology, clinical symptoms and signs, clinical classification, pathological features, diagnosis and differential diagnosis, auxiliary examinations, TCM syndrome differentiation, and TCM treatment methods. Regarding surgical treatment of hemorrhoids, procedure selection and surgical quality are crucial for postoperative recovery. Currently, numerous TCM and Western surgical approaches exist without relatively unified recommendations, and the optimal clinical treatment protocol requires further clarification. Therefore, the 18 PICO-formatted clinical questions and 9 outcome indicators focused on: TCM treatment methods and formulas for hemorrhoids [13-14], surgical methods for internal hemorrhoids, surgical methods for external hemorrhoids, surgical methods for mixed hemorrhoids [15-17], hemorrhoid injection therapy, hemorrhoid ligation [18-19], hemorrhoid radiofrequency ablation, copper ion electrochemical therapy, Doppler-guided hemorrhoidal artery ligation, stapled hemorrhoidopexy (PPH) [20-21], non-surgical treatment of hemorrhoids, and prevention and nursing care of hemorrhoids. All questions and outcome indicators were designed to address actual clinical problems and aimed to form optimal integrated TCM-Western medicine treatment protocols for hemorrhoids.

After the first round of Delphi surveys, based on mean scores for clinical questions and outcome indicators, all items were retained, indicating that these were important issues of common concern to experts. Through careful analysis of relevant supplementary opinions and integration with clinical experience, treatment for special populations with hemorrhoids or hemorrhoids complicated by underlying diseases was also deemed critical, resulting in the addition of one clinical question. Following the first round, 9 basic questions, 19 PICO-formatted clinical questions, and 9 outcome indicators were included in the second round survey. Based on second-round Delphi statistical results, using inclusion criteria of clinical question mean score ≥3 points, outcome indicator mean score ≥7 points, full score rate >50%, and CV ≤30%, and following discussion and analysis by project team experts, 28 clinical questions (9 basic questions and 19 PICO-formatted clinical questions) and 9 outcome indicators were ultimately included. All final clinical questions require recommendation formulation in the guideline, and all included outcome indicators are critical outcomes.

This study demonstrates several notable strengths. First, the project strictly adhered to international standard development protocols and followed relevant standardized office procedures. Clinical questions covered hemorrhoid etiology, basic diagnosis, integrated TCM-Western medicine treatment, and preventive care, while outcome indicators were established based on preliminary literature searches and refined through expert interviews and clinical investigations to ensure professional comprehensiveness. Second, the composition of Delphi method expert members plays a crucial role in the quality of clinical questions and outcome indicators. The expert panel included TCM physicians, Western physicians, and integrated TCM-Western medicine physicians from colorectal surgery, general surgery, gastrointestinal surgery, and colorectal dermatology. All experts held senior professional titles, with 30 experts (88.24%) having over 15 years of experience in the field. The wide geographical distribution across six major regions of China ensured comprehensive and authoritative guideline content. Statistical analysis of questionnaire returns showed total response rates ≥85.0% for both rounds, indicating high expert enthusiasm and attention. Mean CV values were 12.36% and 12.81%, with Kendall's harmony coefficients of 0.837 and 0.826, demonstrating small expert divergence and effective consensus. Cronbach's α coefficients for both rounds exceeded 0.7 for both clinical questions and outcome indicators, indicating high result reliability. Furthermore, all clinical questions and outcome indicators were oriented toward solving actual clinical problems, ensuring clinical practicality and providing industry standards for integrated TCM-Western medicine hemorrhoid treatment for clinical practitioners.

This study also has certain limitations. The Guideline for the Diagnosis and Treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine will be applied in primary care medical institutions, but the expert selection lacked representation from primary care providers, with most experts coming from large tertiary comprehensive hospitals, resulting in strong professional opinions but slightly weaker comprehensive representation. Additionally, the breadth of expert specialties was suboptimal, lacking experts from nursing, anesthesiology, and methodology fields. Although experts were distributed across six geographical regions including East and North China, representation from Northeast China was missing. Moreover, considering the specialized nature of the questions, this study did not survey patient populations, resulting in a relative lack of patient perspectives—an additional imperfection. Regarding clinical questions, while treatment methods for hemorrhoids were extensively discussed, further refinement is needed regarding surgical procedure selection for different severity levels of hemorrhoids.

In summary, the Guideline for the Diagnosis and Treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine has established 19 guideline-related clinical questions (PICO-structured questions) and 18 key content items through preliminary literature research, problem summarization, expert interview discussions, clinical investigation, and Delphi method screening, forming the basic framework of the guideline with high credibility, authority, and representativeness. The formulation of clinical questions and outcome indicators for the guideline has laid a foundation for subsequent development of the main guideline framework and recommendation formulation, provided evidence for leveraging the distinctive advantages of integrated TCM-Western medicine in hemorrhoid treatment, offered methodological references for constructing core clinical questions and outcome indicators in the colorectal field, and provided references for developing evidence-based TCM guidelines.

Author Contributions: ZHI Congcong was responsible for drafting the manuscript; ZHI Congcong, CHENG Yicheng, HUANG Zichen, WANG Xiaolong, and LI Xue were responsible for distributing and collecting questionnaires; CHENG Yicheng, HUANG Zichen, WANG Xiaolong, and LI Xue were responsible for organizing and analyzing returned questionnaires; ZHENG Lihua was responsible for conceptualizing clinical questions; ZHI Congcong and ZHENG Lihua were responsible for questionnaire production during clinical question construction, manuscript review and quality control, and take responsibility for the article.

Conflict of Interest: The authors declare no conflict of interest.

ORCID IDs:
ZHI Congcong: https://orcid.org/0000-0003-3151-8382
ZHENG Lihua: https://orcid.org/0000-0001-8643-9855

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