Translation and validation of Indonesian hemorrhoidal disease symptom score (HDSS) and short health scale hemorrhoidal disease (SHSHD)

Abstract

Objective: Hemorrhoidal disease, which affects nearly 40% of people, is characterized by pathological alterations and distal displacement of hemorrhoidal tissue. The short health scale (SHSHD) and the hemorrhoidal disease symptom score (HDSS) are two tools that can be utilized to assess the quality of life of hemorrhoidal patients. The present study aims to translate, modify, and validate the HDSS and SHSHD questionnaires in Indonesian.

Material and Methods: This cross-sectional study assessed the validity and reliability of the HDSS and SHSHD Indonesian adaptation instrument in hemorrhoidal patients from April 15, 2022, and April 1, 2023.

Results: There were 91 study subjects, 55 males and 36 females. The study showed that the subscale interpretations of the R-values and the full scale scored above 0.25, indicating weak to very strong correlations. These results mean that the HDSS and SHSHD questionnaires are valid for use. Based on the study’s results, the R-value of each item, domain, and total score ≥0.8 (p< 0.05) indicates that the HDSS and SHSHD instruments are reliable.

Conclusion: The Indonesian adaptation of the HDSS and SHSHD demonstrates validity and reliability as an assessment tool for measuring the healthrelated quality of life in Indonesian patients diagnosed with hemorrhoidal disease.

Keywords: Disease, hemorrhoid, quality of life, questionnaires

Introduction

Hemorrhoidal disease, which affects nearly 40% of people, is characterized by distal hemorrhoidal tissue displacement and pathological alterations (1,2). Symptoms of hemorrhoidal disease can be severe discomfort, physical limitations, and decreased quality of life (3). Hemorrhoids are typically categorized as internal or external based on where they are discovered. The columnar epithelium is the layer that covers internal hemorrhoids that are visible above the dentate line. In contrast, squamous epithelium covers external hemorrhoids (4-6).

Every year, many people are diagnosed with hemorrhoids. The degree of their pathology will determine available treatments. Non-operative treatment is an option for first, second, and third-degree hemorrhoids (7,8). Non-operative treatment cannot reverse structural abnormalities in the hemorrhoidal tissue. At the same time, invasive procedures frequently result in problems and recurrence. In addition, if hemorrhoidal disease is not appropriately controlled, the severity and symptoms can worsen with time. Hemorrhoid disease is supposed to be avoided by focusing on dietary behaviors and reducing risk factors (3).

There are questionnaires developed to measure the severity of hemorrhoid disease. The hemorrhoid severity score (HSS), initially suggested by Nystrom, has been created with a multi-symptom approach based on five primary symptoms of hemorrhoidal disease (pain, itching, bleeding, soiling, and prolapse) (9-12). The SHS is divided into four categories: symptoms, functional status, specific problems that arise, and overall well-being. Each category is comprised of one question. A simplified hemorrhoidal-related quality-of-life tool is the SHS (12-14). Then Khan et al. have created the “PNR-Bleed” classification system based on four primary aspects to more precisely describe hemorrhoidal disease: the degree of prolapse (P), the number (N) of primary columns affected, the relationship (R) of hemorrhoidal tissue to the dentate line, and the amount of bleeding (B) (15).

The hemorrhoidal disease symptom score (HDSS) and short health scale hemorrhoidal disease (SHSHD) have yet to be translated into Indonesian, which is the primary consideration in translating and verifying them. In the present study, HDSS and the SHSHD are translated, modified, and validated for Indonesian.

Material and Methods

Patient

This study was longitudinal. Surgical departments in several hospitals selected patients with hemorrhoidal disease symptoms for this study. Between April 15, 2022, and April 1, 2023, all patients diagnosed with hemorrhoidal disease and treated surgically or conservatively were included in the validity and reliability analysis. The surgeons used the patient’s medical history, physical examination, and medication to diagnose and evaluate hemorrhoidal disease. The process of the patient’s treatment was unaffected by this study. The patients conducted the informed consent form supplied with the questionnaire. Patients who were cognitively or linguistically impaired were not included in the study. The survey was distributed to patients using Google Forms. Patients had to complete the informed consent forms before completing the questionnaire. In this study, incomplete responses were not assessed.

Measurements

This study started with adapting the original HDSS and SHSHD questionnaires into the Indonesian language. The HDSS and SHSHD questionnaires were translated into Indonesian using World Health Organization (WHO) guidelines that have been altered for cross-cultural adaptation. These steps include forward translation, back translation, pre-testing including expert committee, and documentation. For forward translation, the questionnaire was translated into Indonesian by two qualified translators who were also fluent in English and familiar with the terms used in the HDSS and SHSHD questionnaires. To confirm the accuracy of the translation, it is necessary to independently back-translate to the initial translation, meaning to translate it back from the target language into the original language. For backward translation, it is recommended to have at least two translators proficient in their native language (the original language) execute the translation. To prevent bias, it is preferable that back-translators are not informed about the particular subjects that the questionnaire aims to measure. The results of the backward translation of the two translators were discussed with one of the reviewers, who had a medical background and English language skills. Then, a backward translation synthesis was produced. The expert committee evaluated all translations and assessed if they accomplished semantic, idiomatic, experiential, and conceptual equivalence with the original versions. To create a prefinal version of the translated questionnaire, any inconsistencies would need to be resolved, and the expert committee members would need to agree on all aspects. The final phase involved conducting pretesting, cognitive interviews, and face validity testing using the face-to-face approach. Before finalizing the translated questionnaire, conducting a pilot test on a small group of the expected respondents is essential. This methodology enables the researchers to verify that the translated items have preserved the identical meaning to the original items, eliminating any potential ambiguity in the translated questionnaire. This step may be iterated several times to achieve the ultimate translated version of the questionnaire. Following the pre-testing phase, the researchers found several instances of ambiguity and reached a consensus on the definitive form of the questionnaire. The researchers engaged in extensive deliberation on the initial questionnaire and the outcomes of the pre-testing phase, ultimately arriving at a consensus. As part of the translation process, certain components were modified to better align with the Indonesian context. Nevertheless, there were no substantial alterations; hence, the translated version remained consistent with the original questionnaire. The frequency of patient-reported symptoms, such as discomfort, itching, bleeding, and prolapse, examined patient problems. Patients were asked about their recent three-month symptoms. Then each symptom was scored between 0 and 20 based on the following criteria: 0= never, 1= Less than once a month, 2= Less than once a week, 3= 1-6 days per week, 4= Every day (always) (Figure 1).

Figure 1. HDSS and SHSHD. HDSS: Hemorrhoidal disease symptom score, SHSHD: Short health scale adapted for hemorrhoidal disease.

Data Analysis

Data analysis for this study used descriptive presentation employing frequency distribution, proportion, and average calculations for each variable. SPSS software was used to process the research data that had been gathered. The validity test of the Indonesian translation of the HDSS and SHSHD questionnaires was used in data analysis. The validity test was carried out using the Pearson correlation test, which evaluates the relationship between the possible answers and the final score on the question. The test items are valid when the significance level is p< 0.05.

Results

The present study included 91 respondents, with a higher number of 55 (60.4%) male subjects and 36 female subjects (39.6%) (Table 1). Respondents in the age range of 18-34 years were most prevalent, namely 33 (36.3%). Thirty-nine respondents (39.6%) were high school graduates, and most (31.9%) were self-employed. Furthermore, 34 (37.3%) had difficulty straining, and 57 (62.6%) said they typically have bowel movements more than four times per week. Based on the reported information, 51 (56%) respondents did not have a family history of hemorrhoids, and 49 (53.8%) had medical treatment. Additionally, the lump could be entered with the help of the respondents’ fingers in 39 (42.9%). Fifty-nine (64.8%) of the respondents reported internal-type hemorrhoids.

Table 1. Demographics and clinical characteristics of the patients

This study conducted a validity test on 91 respondents. The results showed that all questions on the HDSS and SHSHD questionnaires had an R-value greater than the R table. This indicates that the HDSS and SHSHD questionnaires are valid for use. The reliability test performed in this study aimed to determine whether or not the questionnaire was consistent. The reliability test was carried out, and the findings revealed that the reliability test value on this questionnaire was 0.822 (Table 2). These results indicated that this questionnaire was reliable since they proved it passed the reliability test. It is determined to be reliable because the reliability test value is greater than the Cronbach alpha value, which is set at 0.7.

Table 2. Results of reliability tests

As an obvious result, a comparative approach was selected for the analysis. A plot and a Bland-Altman analysis (mean difference or limits of agreement), as shown in Figure 2, were utilized to compare two different values for the same variable. Both the HDSS and SHSHD instruments had a bias of -0.5, while the standard deviation was 5.78, the lower LOA was -16, and the upper LOA was 6.

Figure 2. Bland-Altman plot.

Discussion

One of the most common diseases in Indonesian society is hemorrhoids, characterized by swelling of the veins (return vessels) around the anus due to inflammation. Bleeding and prolapse, which are most frequently related to internal hemorrhoids, are the most common symptoms of hemorrhoids. External hemorrhoids that have thrombosis expand in painful conditions. Most people with piles symptoms improve with changes in diet and bowel habits. Patients who have internal hemorrhoids will not experience itching or pain. Still, symptoms can be detected when blood is seen during bowel movements. The hemorrhoid lump may emerge and feel severely obstructed in cases of severe swelling.

Many factors might lead to hemorrhoids, including defecating too forcefully or spending too much time on the toilet, which may also affect the blood vessels surrounding the anus. As a result, hemorrhoids may develop. According to this study, 62.6% of respondents with hemorrhoids had bowel movements more than four times each week due to the possibility of swollen veins around the anus from frequent defecation; a higher frequency of bowel movements might result in hemorrhoids. Hemorrhoids are also associated with a high frequency of straining. However, only 18.7% of responders to this survey strained more than four times every week.

The Goligher classification system, which is frequently used, bases the severity of hemorrhoid disease on the amount of rectal prolapse. Hemorrhoids come into four categories: Grade 1 hemorrhoids bleed but do not prolapse; Grade 2 hemorrhoids may prolapse after straining but heal naturally; Grade 3 hemorrhoids may prolapse after exertion but can be cured, and Grade 4 hemorrhoids prolapse permanently and cannot be treated (16). The prolapse degree must be known to select an efficient hemorrhoid treatment plan. Unfortunately, due to the omission of symptoms associated with quality of life, disease etiopathogenesis, and particular clinical circumstances, Goligher’s classification has limitations (17).

Several grading systems have been created to get around these limitations. The existence and frequency of various symptoms are the primary objectives of all grading systems based on patient self-reported scores. The frequency of pain, irritation, itching, soiling, and prolapse hemorrhoid reduction were all examined by Nystrom in 2009 using a five-point scale (9). The system passed good validation and is straightforward to use and replicate. However, it disregards the prevalence and occurrence of prolapses that may be reduced manually (18).

A comparable method was demonstrated in 2011 by Giordano et al. The severity of hemorrhoidal symptoms was evaluated using a specially designed questionnaire. Five criteria were each rated on a range of 0 to 4, with 0 representing no symptoms and 4 representing recurrent symptoms (19). The Nystrom score was recently modified by Roervik et al. to take the frequency of prolapse experienced by the patient into account rather than the requirement for manual reduction (12). In addition, they modified the SHS, which had previously been used to evaluate individuals who suffered from inflammatory bowel illness, so that it could be applied to hemorrhoidal disease. Even when considering SHS standards for quality of life, this technique preserves an exceptionally high degree of accuracy to the Goligher classification (14).

A remarkable score was produced by combining the SHSHD with the HDSS. The HDSS scores each item based on one of five different hemorrhoidal disease categories. The scores range from 0 to 4. A score of 0 meant that the symptom was gone entirely. In contrast, a score of 20 indicated that the clinical condition was in its worst possible condition. The overall score for each of the five parameters was added to arrive at an overall score for the patient’s condition. The SHS is a quality of life-based score that considers patients’ concerns, their general sense of well-being, the intensity of their illnesses, and how these things impact their daily lives. The scale is depicted in Figure 1, extending from 1 (representing the best clinical situation) to 28 (representing the worst clinical situation) (9,12,20).

The study’s results demonstrated that the whole scale and the subscale interpretations of the R-values scored above 0.25, indicating weak to very strong correlations. The HDSS and SHSHD questionnaires can be used because of these findings. Item Var0002 on the questionnaire has the lowest R-value, which is 0.390. However, it suggests a weak correlation between the two factors. Var00007 and Var00001, which have R-values of 0.2061 (p= 0.001) on the questionnaire, show a significant correlation between the two variables.

This study used mean rank (k= 2), absolute consistency, and a two-way mixed effects model to evaluate results. For the total score outcome, the HDSS and SHSHD questionnaires demonstrated excellent reliability (0.822, 95% CI= 0.818-0.776). Additionally, the domains of the individual and physical scores displayed excellent reliability. The letter r (-1≤ r≤ 1), which indicates Pearson’s coefficient correlation, is a method to measure the correlation between two tests. A score of r≥ 0.7 is regarded as acceptable for questionnaire reliability. According to study findings, the HDSS and SHSHD instruments are reliable, which shows that the r= value of each item, domain, and overall score is ≥0.8 (p< 0.05). On Plot and Bland-Altman analysis, the HDSS and SHSHD instruments showed a bias score of -0.5 with a cut-off score of 0 (95% CI= -0.16-0.6) to 12 (95% CI= -0.16-0.6). The HDSS and SHSHD measurement results will be at least 0.6 points, according to this assessment’s 95% confidence level, if additional population testing is carried out.

This study demonstrates that the Goligher hemorrhoid classification system relies on the rectal prolapse degree, which is in line with the research of Dekker et al. (2022), where a systematic review and meta-analysis has been carried out to compare various scoring systems used in evaluating hemorrhoidal disease (16). The results show that some of these scoring systems have good validity and reliability in measuring the severity of hemorrhoidal disease.

The results emphasized the importance of choosing the most effective treatment strategy based on the appropriate classification of hemorrhoidal disease. Gallo et al. (2020) have also highlighted the need for common standards for trials and guidelines in treating hemorrhoids (17). Thus, this study suggests that developing a comprehensive classification that considers factors such as associated symptoms, quality of life, and specific clinical situations will help choose the right treatment strategy and improve the care of patients with hemorrhoids.

The findings show the importance of Goligher’s classification and quality of life assessment using SHS in hemorrhoidal disease. Additionally, as Rørvik et al. (2019) have demonstrated that using SHS as an evaluation method may provide detailed data regarding how hemorrhoidal symptoms affect patients’ daily lives (12). The findings of this study further support the significance of considering psychosocial factors and patients’ well-being when managing hemorrhoids. As a result, combining the SHS with the Goligher classification may offer a more comprehensive approach to diagnosing and treating hemorrhoidal disease. Following research by Jin et al in 2020, the study findings noted that the SHSHD and the HDSS were combined to produce a remarkable score. Jin et al. also stated that combining these two scores can assist doctors in determining the most efficient treatment strategy for patients with hemorrhoids (21).

Conclusion

After translation, modification, and validation, the HDSS and SHSHD questionnaires were verified for the Indonesian language. The qualities and objectivity of the concept, such as validity and reliability, must be emphasized when developing the questionnaire. These Indonesian HDSS and SHSHD questionnaires demonstrate validity and reliability as an assessment tool for measuring the health-related quality of life in patients diagnosed with hemorrhoidal disease.

Cite this article as: Amsriza FR, Fakhriani R, Pangki AA. Translation and validation of Indonesian hemorrhoidal disease symptom score (HDSS) and short health scale hemorrhoidal disease (SHSHD). Turk J Surg 2023; 39 (4): 336-343.

This study was approved by Muhammadiyah University of Yogyakarta Faculty of Medicine Health Research Ethics Committee (Decision no: 130/EC-KEPK FKIK UMY/V/2022, Date: 17.05.2022).

Externally peer-reviewed.

Concept - FRA, RF; Design - FRA, RF; Supervision - FRA; Materials - FRA; Data Collection and/or Processing - FRA, RF; Analysis and/or Interpretation - FRA; Literature Search - RF; Writing Manuscript - FRA, RF; Critical Reviews -FRA, RF.

The authors have no conflicts of interest to declare.

The authors declared that this study has received no financial support.

The study was published with the written consent of the patient.

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