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Gastroenterology and hepatology
Protocol
Shared decision-making improving efficacy in diarrhoea-dominant irritable bowel syndrome in Chinese outpatient setting: protocol of a prospective, randomised controlled trial
  1. Kai Song,
  2. Zhengyang Fan,
  3. Yang Chen,
  4. Guijun Fei,
  5. Xiaoqing Li,
  6. Dong Wu
  1. Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
  1. Correspondence to Professor Xiaoqing Li; lixq{at}pumch.cn; Professor Dong Wu; wudong{at}pumch.cn

Abstract

Introduction Diarrhoea-dominant irritable bowel syndrome (IBS-D) is a disorder with multiple pathogenesis; many people with IBS-D may have psychosocial issues which can make assessment and treatment more difficult. Routine treatment procedure might not always achieve the desired outcome. Therefore, patients may not be satisfied with the conventional experience and would like to be more involved in clinical decision-making. A shared decision-making (SDM) model, that requires patient participation, has been demonstrated to have a powerful effect on the diagnosis and treatment of other diseases, which improves patients’ compliance, satisfaction, thus refining the clinical outcome. However, there is no corresponding evidence in IBS-D. Herein, we hope to verify the effect of SDM through clinical studies, and we anticipate that SDM can improve the therapeutic effect in patients with IBS-D.

Methods The study is a prospective, randomised, single-centre trial. 166 IBS-D outpatients who attend Peking Union Medical College Hospital will be allocated into routine treatment group and SDM group. The primary endpoint is the severity of bowel symptoms, measured by the IBS symptom severity scale. Secondary endpoints include impact of disease and quality of life, negative psychology and the evaluation of diagnosis and treatment process.

Ethics and dissemination Ethical approval has been obtained from the research ethics committee of Peking Union Medical College Hospital (I-23PJ470). This protocol has been approved by Chinese Clinical Trial Register (ChiCTR2300073681) in July 2023. The results of this trial will be published in an open-access way and disseminated among gastrointestinal physicians.

Trial registration number Chinese Clinical Trial Register (ChiCTR2300073681).

  • irritable bowel syndrome
  • decision making
  • therapeutics
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-077605

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • The treatment efficacy is evaluated from multiple perspectives.

    • This is a single-centre trial, which may cause bias in terms of demographic characteristics.

    • The long follow-up intervals require offline participation, which may result in dropouts and missing data.

    Introduction

    Functional gastrointestinal disorders (FGIDs), also known as disorders of gut–brain interaction, is a group of disorders with prominent symptoms and no organic diseases. Irritable bowel syndrome (IBS) is the most common type of FGIDs, mainly including diarrhoea-dominant irritable bowel syndrome (IBS-D), constipation-dominant IBS, IBS with mixed stool pattern and IBS unclassified.1 The diagnosis of IBS, currently based on Rome IV criteria, relied on recurrent abdominal pain which was associated with defecation or a change in stool form or frequency, occurring at least 6 months prior to diagnosis. The Bristol Stool Form Scale is used to determine the stool form. According to Rome IV criteria, IBS-D should fulfil the criterion that ≥25% of bowel movements of Bristol Stool Form types are 6 or 7, and <25% of Bristol Stool Form types are 1 or 2.2 The management of IBS aims to improve the symptoms including abdominal pain and bowel habit. The first-line treatment incorporates diet change and antispasmodic drugs, antidiarrhoeal drugs acting on opioid or 5-HT receptors. The non-absorbable antibiotic rifaximin or probiotics may also be used. For patients with severe symptoms, neuromodulators such as tricyclic antidepressants and psychotherapy may be considered.

    However, the efficacy of the treatments mentioned above are not always successful and previous studies show that most treatment can only improve the symptoms of about 44% IBS patients.3 Therefore, this can result in frequent visits to the doctor which has both cost and capacity issues.4 5 Patients often feel frustrated,6 isolated,7–9 anxious10 and are dissatisfied with the healthcare system.11–15 The patients, always with incorrect understanding of the disease due to lack of information,16 17 also would like to get more medical information from specialists, and participate in the treatment process.13 18–20 However, the following problems exist in clinical practice within the traditional medical model: (1) insufficient information about the disease provided by physicians. (2) Doctors’ wrong perception of the condition of patients (eg, doctors think patients exaggerate the condition, or doctors have different concerns with patients in diagnosis and treatment).11 13 21–23 The above characteristics may have adverse impact on the clinical practice, which caused the dissatisfaction with the treatment.

    Shared decision-making (SDM) is a model, in which physicians and patients share the best available evidence in decision-making, and patients are supported to consider options to achieve informed preferences.24 25 Different from traditional diagnosis and treatment procedures, SDM requires that clinicians provide alternative choices of examinations and treatments, and describe the associated risks and benefits, while patients express their preferences and values, and both sides ultimately make decisions that are appropriate and are consistent with patients’ best interests.26 As for the above perceived inadequacy in current clinical practice, the implementation of SDM has positive effect on diminishing negative emotions of patients, aids physicians to build good relationship with patients, assists patients to acquire information about their disease, which can improve compliance of patients.14 27–32 Up to now, SDM has been shown to have a good effect on the diagnosis and treatment of other diseases, including chronic abdominal pain, type 2 diabetes, hypertension, juvenile idiopathic arthritis.33–36 However, it is disappointing that there were no clinical trials that evaluated benefits on clinical practice in IBS-D. Therefore, we would like to compare the treatment efficacy of SDM with routine clinical procedures. We suggest that SDM can enhance treatment effect, improve living quality and reduce negative emotions of patients with IBS-D, compared with routine clinical procedures recommended by Rome IV guidelines.

    Methods

    Design

    This is a prospective, randomised controlled, unblinded (blind for statisticians only), single-centre trial. The patients with IBS-D who first visit our hospital will be allocated under randomisation into routine treatment group (control group) and SDM group (intervention group) after diagnosis. The diagnosis of IBS-D was made using the Rome IV criteria, that is, the patients present with recurrent abdominal pain (on average for at least 1 day/week in the past 3 months), associated with two or more of the following: related to defecation, a change in frequency of stool, a change in stool form (≥25% of bowel movements of Bristol Stool Form types 6 or 7, and<25% of Bristol Stool Form types 1 or 2).1 And the criteria must be fulfilled for the past 3 months, with symptom onset at least 6 months before diagnosis. Our trial aims to compare the routine treatment and SDM method, to demonstrate whether SDM can improve clinical outcome, quality of life and reduce negative emotions at the same time. Figure 1 summarises our trial design, and the following sectors describe the detail of our trial.

    Figure 1
    Figure 1

    Trial design. IBS, irritable bowel syndrome; SDM, shared decision-making.

    Study population

    All patients with IBS-D presenting to Peking Union Medical College Hospital, a tertiary hospital in Beijing, China, will be assessed for eligibility during the appointment, starting from January 2024 and being estimated to be completed in December 2024.

    Inclusion criteria

    1. Age 18–75 years.

    2. Meet with IBS-D diagnostic criteria of Rome IV and the severity is moderate or above, namely the points of IBS Severity Scoring System (IBS-SSS)≥175.37 38

    3. Educational levels of junior high school or above.

    4. Patients or family members have no communication difficulties.

    5. Be able to sign and provide written informed consent.

    6. Willing to participate in SDM, and can also cooperate with the physicians when divided into control groups.

    7. Willing to receive treatment.

    Exclusion criteria

    Patient who meets any of the following criteria will be excluded:

    1. Diagnosed with organic gastrointestinal diseases or gastrointestinal motility disorders.

    2. Diagnosed with gastrointestinal malignancies and/or operations (excluding appendectomy and cholecystectomy more than 6 months prior to enrolment).

    3. IBS-SSS<175 points.

    4. Diagnosed with severe heart, kidney or liver diseases.

    5. Pregnant or on lactation period.

    6. Alcohol or drug abuse.

    7. Currently using probiotics, antibiotics, antispasmodic, antidiarrhoeal and neuromodulators.

    Withdrawal criteria

    1. Subjective willingness of withdrawal from the study because of various considerations after enrolment.

    2. Patients cannot complete the SDM process for any reason.

    Randomisation and assignments

    Patients who meet the Rome IV diagnostic criteria for IBS-D will be introduced to the study protocol. After obtaining written consent form, patients will be randomly assigned to control group or SDM group by lottery.

    A total of five experienced gastroenterologists, with the title of attending physician, deputy chief/chief physician, will participate in the study. Each physician is assigned to either the control group or the SDM group, and the process of clinical practice will be determined accordingly. The above methods will aim to minimise the bias caused by different clinical experience and clinical thinking of individual doctors.

    Intervention group: the SDM group

    The clinical practice of SDM group will be implemented under the guidance of ‘Three talk’ model,39 40 which mainly includes the following key steps: (1) the physician introduces alternative treatment plans to patient, and provides relative, high-quality and accessible information which includes the interpretation of IBS-D as well as the pros and cons of the alternatives. The pros refer to the favourable effects, while the cons are mainly to the side effects. (2) The physician engages conversations around the primary treatment target, the possible clinical outcome, and collect viewpoints towards the alternate plan with patients. (3) The physician and patient weigh the advantages and disadvantages, and develops a treatment plan with collective efforts. In the team talk and option talk steps, we will use self-developed patient decision aid (PDA) based on International Patient Decision Aid Standards (version 4.0), for all information that needs to be provided to patients.41 The PDA are shown in the online online supplemental material 2. The patients in SDM group must finish the detailed procedure illustrated in figure 2. Patients who fail to complete these steps would be withdrawn from the study.

    Figure 2
    Figure 2

    Flow chart of shared decision-making in diarrhoea-dominant irritable bowel syndrome (IBS-D).

    Control group: the routine treatment group

    The patients in the control group received the routine diagnosis and treatment process according to Rome IV suggestions for IBS-D. The patient’s preference will not be actively taken into consideration in the decision-making process. The physician team will give enough information for patients to choose between treatment plans solely made according to the guidelines and the physician’ own clinical experience.

    Methodology of communication

    As mentioned above, patients with IBS-D often display bowel symptoms in the absence of organic disease, making them vulnerable to anxiety or other psychological disorders. Three kind of ‘stigma’ may accompany with these patients: enacted stigma, internalised stigma, perceived stigma.42 Therefore, in clinical practice, although neuromodulators such as low dose of tricyclic antidepressant could improve IBS-D symptoms, and can be difficult in discussing use of antidepressants, as doing so may aggravate the stigma by reinforcing the perception that IBS is a mental illness.42 For these reasons, we will train physicians in terms of communication methodology before the study, including: (1) the rationale for neuromodulator in the treatment of IBS; (2) exception management for treatment; and (3) the formation of good relationships between physicians and patients.43

    The rationale for neuromodulator in the treatment of IBS

    We use neuromodulator instead of antidepressants to describe these drugs, and explain the mechanism by introducing nerves in gut, which will be a suitable approach for patients’ acceptance of neuromodulator. For example, we may say: “because the gut has the most nerve population compared to the spinal cord and the brain in the entire body, it’s a selectable treatment to use neuromodulator to regulate the sensation of gut nerves”; or “we use such neuromodulator mainly influences nerves in gut rather than brain, and the dosage is smaller than those used in antidepression treatment”.

    Exception management for treatment

    Patients who suffer from chronic symptoms often wish to treat their major symptoms; however, this can be difficult to achieve. Therefore, we need to guide patients to live with their symptoms and appropriately reduce their expectations without destroying their hope. We could have conversations such as “I think it’s reasonable for wanting to get rid of your discomfort, and I hope so, too. With my experience, it will take a long time before we reach the final goal, where the middle step is fewer symptoms or less severity so that improved quality of life can be achieved”.43 In addition, research data on neuromodulators indicate the incidence of side effects is higher than that of other drugs such as antispasmodic and antidiarrhoeal drugs, but those unfavourable comorbidities such as dry mouth and dry eyes are often not serious. Patients need to be informed of these potential side effects yet reassured as to the lack of concern regarding them. For example, we can tell “Despite the possibility of having mild side effects we suggest if possible to continue to try this treatment, unless the side effects are too bothersome.”

    The formation of good relationships

    Establishing a good doctor–patient relationship in discussing usage of neuromodulators requires empathy. The physician needs to listen carefully to the patient’s concerns in an open posture, and emphasise the application of non-verbal skills, such as sitting towards patients, smiling and maintaining eye contact during the whole process.

    Primary endpoint

    The primary endpoint is the severity of irritable bowel symptom, which is demonstrated by the scores of IBS-SSS.44 45 We will compare the scores of two group after the 8-week trial, and the scores will also be collected at 6 and 12 months after the trial. IBS-SSS is a scale widely used in clinical trial of IBS-D in assessing the severity of abdominal pain, bloating and diarrhoea of patients with IBS-D, with a score from 0 to 500.46 We will collect the IBS-SSS scores of two groups at enrolment and after 8 weeks of treatment, and at 6 and 12 months after the trial, to compare the difference before and after treatment, as well as the difference between the two groups.3 47

    Secondary endpoints

    Secondary endpoints are divided into four main categories: (1) the impact of disease on quality of life, (2) negative psychology, (3) the process of treatment planning and (4) patients’ satisfaction.

    Evaluation of impact of disease and quality of life

    We will use the IBS Quality of Life Questionnaire (IBS-QOL) to evaluate the impact of disease and quality of life. The questionnaire, developed by Drossman et al,48–50 is an evaluation system with excellent validity and ability in assessing the degree of impact on patients’ daily quality of life. The scale contains 34 items, which can evaluate from the aspects of emotionality, psychological state, sleep quality, energy, daily activities, eating habits and other aspects. Each item is on a 5-point scale, ranging from 1 (symptoms never occur) to 5 (symptoms description is completely accurate). Scores for each item are added up for an overall score, with higher scores indicating a poorer quality of life.

    Evaluation of negative psychology

    The evaluation of psychology is expressed by the Hospital Anxiety and Depression Scale (HADS), which incorporates anxiety and depression subscales with seven items, respectively.51 The scale is specially designed for patients within a hospital setting. For each subscale, a score of 8 is used as a cut-off value; that means the score of 0–7 represents no symptoms of anxiety or depression, while the score of 8–10 refers to uncertainty, and the score of 11–21 indicates certain mental illness. The scale is convenient, and has good reliability and calibration.52

    Evaluation of the process of treatment planning

    Since the SDM process varies in the implementation of different diseases, there is no unified SDM process. Therefore, in order to evaluate the differences between the SDM group and the control group in the diagnosis and treatment process and evaluate the effectiveness of SDM, the 9-item Shared Decision Making Questionnaire (SDM-Q-9) is used.53 The patients will answer the questionnaire immediately after the first visit to ensure the accuracy of the answers to the greatest extent. The reliability of its Chinese version has been verified in previous literature.54

    Evaluation of patients’ satisfaction

    Patients’ feelings in the treatment decision-making is of significance in the SMD process. In order to evaluate the patients’ degree of satisfaction, which reflects the compliance to medication of patients to some extent, we will use the Decisional Conflict Scale (DCS, score range from 0 to 100).55 56 DCS is mainly for the assessment of uncertainty and satisfaction on health-related decision. Higher scores indicate greater decisional conflict. The Chinese as well as English version are available on https://decisionaid.ohri.ca/eval_dcs.html. The patients will fill in the scale immediately after the first visit, to ensure the accuracy of the answers to the greatest extent.

    Sample size calculation

    Our trial is a superiority test with quantitative index as primary endpoint. The sample size estimation was based on the two-sided α=0.05 and a power probability of 80% (β=0.2). Based on the experience of other clinical trials, the SD is set as 76 and we assume that the score of IBS-SSS in SDM group was 35 points lower than that in control group.3 57 We calculate that at least 74 evaluable patients would be required per group for the study to achieve this power. As we assume the loss rate of follow-up is 10%, so the required sample size for each group is at least 83.

    Data management

    Data collection before the treatment includes IBS-SSS score, IBS-QOL score, HADS score, SDM-Q-9 score and DCS score. In the meantime, we collect the demographic information at baseline including: age, gender, body mass index, education level, annual income, lifestyle habits (including smoking, alcohol consumption and exercise), diet habits (vegetarian, meat-eating, or balanced diet), and diagnosis of anxiety or depression.

    IBS-SSS score, IBS-QOL score, HADS score collection will be implemented at screening period (baseline), 8 weeks, 6 months and 12 months after treatment. We would help patients make appointments beforehand to promote participant retention and complete follow-up on time. An independent coordinator will contact patients regularly to resolve doubts about the trial.

    Suitably trained doctor will guide each patient to fill out a questionnaire face-to-face before undergoing assessments. The same doctor will then continue to help the parents in each visit avoid possible biases. Then, the data statistics were carried out by a statistician team that are unaware of the study group assignment.

    Descriptive statistics

    SPSS V.26.0 will be used as statistical software. Quantitative data in accordance with normal distribution will be presented as the mean and SD, and t test or rank sum test will be used for comparison between groups. Quantitative data that do not conform to normal distribution or homogeneity of variance will be presented as median and IQR, and comparison between groups will be performed by Mann-Whitney U test. Enumeration data will be presented as rates and percentages, and χ2 test will be used for comparison. A two-tailed p<0.05 is considered statistically significant. The statistical analysis will be performed by a medical staff who is unaware of the study group assignment.

    Analysis

    All data will be analysed according to the intention-to-treat approach in which all randomised patients are included. Average of scores of the primary and secondary endpoints will be compared between the two groups. Results will be presented as difference in two proportions. Our data statistics will be carried out by paper questionnaires. If there are missing items in the questionnaire, we will abandon the questionnaire, or fill in the missing values if necessary.

    Trial management

    The trial will be managed by a steering committee. Recruitment and screening will be reviewed at monthly meetings. An independent data and safety monitoring committee (DSMC) will meet regularly to ensure patients’ safety and data quality. And DSMC will check all the primary and secondary endpoints, as well as at least 10% of raw data, in case the report forms are not in accordance with the on-site source data. Discrepancies detected by the committee will be discussed by two investigators unaware of the study group assignment and not involved in diagnosis and treatment process until consensus is reached.

    In addition, patient selection, grouping, treatment and follow-ups will be conducted in strict accordance with the study design requirements. We will implement the method of document management to ensure the authenticity, integrity, reliability and comparability of data. The analysis of experimental data will be scientific, the research report will be written truthfully and rigorously, and the research data will be properly archived and stored as per research storage guidelines.

    Termination of the trial

    An interim analysis will be conducted on the primary endpoint when 25%, 50% and 75% of patients have been enrolled. The interim analysis will be performed by statisticians who is blind to the study group assignment. The DSMC, which has the unrestricted access to all data, will be briefed independently by statisticians and will discuss the results with the steering committee in meeting. The steering committee decides whether the trial can continue and will be responsible of reporting to the central ethics committee. The Peto approach will be used to terminate the trial when the intervention group has a significant benefit from SDM at p<0.001. The trial will not be stopped in case of no statistical differences unless the DSMC advises in safety monitoring. In this case, DSMC will discuss potential stopping due to futility with the trial steering committee.

    Safety

    The DSMC will monitor safety of the trial quarterly. When DSMC requires details of the study, study coordinator will submit unblinded data. After the full explanation of the data is presented, the DSMC will discusses all the available data, and the study coordinator will leave the study and not participate in subsequent analyses. If the study requires further assistance, we will recruit alternative qualified personnel instead. Adverse events are defined as ‘any undesirable experience occurring to a patient during a clinical trial, whether or not considered related to the intervention’. All participating physicians will be asked to report any potential adverse event for DSMC to discuss. The consensus reached by DSMC will be further discussed with the steering committee, and the final result be sent to the institutional review board of the Peking Union Medical College Hospital. The DSMC will also evaluate the data from the deceased patients in terms of the possible trial-related severe adverse events.

    Patients and public involvement

    Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this trial.

    Ethics and dissemination

    Ethical approval has been obtained from the research ethics committee of the Peking Union Medical College Hospital (I-23PJ470). The ethical approval was obtained from one site only because all the procedures will be conducted at the Peking Union Medical College Hospital. This protocol has been approved by Chinese Clinical Trial Register (ChiCTR2300073681). The results of this trial will be published in an open-access way and disseminated among gastrointestinal physicians.

    Ethics statements

    Patient consent for publication

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    Supplementary materials

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    Footnotes

    • Contributors KS conceived and designed the study and drafted the manuscript. ZF contributed to the concept and management of the research, planning the study. YC and GF gave necessary advice about the study plan and further supervised the manuscript, contributes to improving the methodology of this trial. DW and XL conceived the study, revised the manuscript and gave the final approval for the version to be published. All authors read and approved the final version of the manuscript.

    • Funding This work was supported by CAMS Innovation Fund for Medical Sciences [grant numbers 2022-I2M-1-003].

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.