Impact of First-Line Advice on IBS Patients Case Study

Evaluating FLA in Irritable Bowel Syndrome Treatment

Literature Review

Irritable bowel syndrome as a global burden

IBS is among the common disorders affecting the stomach, intestines along intestinal tract. As said by Halmaos et al. (2014), it mainly involves a range of intestinal conditions that get triggered without a specific biochemical or structural cause. NICE has defined this condition as a chronic and relapsing disorder that has the potential to make an affected individual suffer their whole life. However, as mentioned by Vasant et al. (2021), the symptoms that specifically define IBS include abdominal pain, cramps, gas, bloating, constipation, diarrhea, and in some cases both together. Around 5-10% of the global population fall victim to this condition but hardly 30% of them approach treatment. As opined by Manning et al. (2022), people under 50 years of age are most susceptible to IBS and females tend to be more affected. Although the mortality rate associated with this condition is significantly lower, one primary consequence is that it reduces the quality of life in affected people. This is mostly because of the symptoms that prevent people from working, affecting their moods and even leading to anxiety or depression.

Figure 1: Common symptoms and the most affected population in IBS

Effectiveness of FLA in IBS treatment

The current approaches in IBS treatment are suboptimal since the pathophysiology behind this condition is yet to be understood clearly. As mentioned by Masclee et al. (2021), gut-brain axis abnormalities might be a major reason behind this abnormal condition. Based on this assumption, medications are prescribed to affected individuals that tend to relieve their symptoms. However, as said by Lovell and Ford, (2012), nutritional deficiencies due to inappropriate diet are a crucial factor that leads to IBS and awareness would be the only possible thing that could prevent IBS in such cases. FLA is a written form of advice that involves some basic recommendations that could be followed to prevent the deterioration of IBS and the worsening of symptoms. FLA involves dietary advice that includes nutrients to be taken, their amounts, and the respective time to take them. As opined by Lacy et al. (2021), unlike other IBS treatment options, to ensure an FLA is effective on a patient, the ideal time to provide them would be prior to their initial consultations. Studies have demonstrated that prior awareness and prevention reduce the symptomatic burden, preventing the need to spend ransom amounts on extensive treatments.

Figure 2: Key elements in IBS care

Patient perception regarding FLA and IBS self-management

Dietary changes are among the primary recommendations made in the FLA of Irritable bowel syndrome. As said by Torrance et al. (2009), changing a persistent diet and adopting a new one requires strong willpower and cognitive ability. Besides, the body of the patient has to adjust to this changed diet such that the repercussions do not outweigh the benefits. As mentioned by Marshall et al. (2010), most patients choose to rely on FLA as their only option to avoid life-disruptive symptoms. They give up on their likable foods and even adapt to a new lifestyle that affects their psychosocial functioning. However, as said by Manning et al. (2022), self-management might be difficult for some, and reluctance to change their diet and lifestyle fails to prevent the symptoms burden of IBS. In either case, medical counseling might be preferred, to prevent the triggering of mental disorders due to changing habits in the first case and to help belief in FLA in the latter.

Theoretical framework

The initial requirement to manage change is to adapt to the change which is only possible when an individual accepts that the change was necessary. As mentioned by Holton, (2020), Lewin’s change model has mentioned about three stages of adopting change and these are “unfreeze”, “change” and “refreeze”. The first step is perception management which implies that an individual has to align their thoughts accordingly with the belief that the change was necessary. Followed by change, the final stage is refreezing where the change is supported. FLA mainly involves advice regarding changes to be made in the diet to prevent and control IBS symptoms. The primary requirement, in this case, would be to accept that that change is necessary to get rid of the symptom burden, and only then could that change be implemented.

Figure 3: Lewin’s change model

Literature gap

The existing literature has effectively provided demographic data to state the urgency of IBS being considered a public health issue. It has also been evident from the findings obtained by authors that FLA might be a safe option to get rid of the symptom burden in IBS. However, the major factor that has been missing in these research works is how the perception of IBS patients needs to align with the fact that dietary changes are necessary. The current perceptions of affected people regarding the effectiveness of self-management and an FLA to save them from their symptom burdens have also not been highlighted which this study will try to point out.

Rationale

The global prevalence of IBS is almost 20%, which tends to keep increasing with time. Although there is limited evidence on the actual reason behind the increasing rates, most researchers suggest that changing lifestyles and specifically dietary inconsistencies contribute to this condition. The issue is not the mortality rates, but rather the symptom burden that hampers their quality of life. The graph below displays the most common symptoms taking place in affected individuals and all of these reasons behind tremendous discomfort (Van den Houte et al. 2019). Besides, most of these symptoms affect the mental health of these individuals due to mood disruptions that make them avoid work. This justifies why this issue of IBS deserves similar medical attention to other health conditions.

Figure 4: Prevalence of IBS symptoms

The current issue is a lack of awareness among people who mistake IBS for some other minor digestive disorder and avoid treatment options. The graph below shows the willingness of health professionals to diagnose IBS and a significant percentage are unsure of their diagnosis. FLA or First line advice might be a futuristic approach to reduce the burden of symptoms of IBS but lack of awareness plays a role there as well (Torrance et al. 2009). The existing perceptions in people regarding FLA and their inability to self-management are some of the factors that prevent IBS treatment. However, there has been limited research on this area despite these perceptions affecting FLA’s potential effectiveness. This study will shed light on the effectiveness of FLA in reducing IBS symptom burden and highlight those perceptions that might prevent affected individuals from relying on FLA.

Figure 5: Willingness of diagnosing IBS

Research question

What is the effect of FLA advice on symptom burden and the quality of life in IBS patients before their primary consultation?

Table 1: PICO table for research question

Research objectives

RO1: To recruit Rome In IBS patients and randomize this sample into an intervention group

RO2: To apply inferential statistics to find differences between collected IBS and QOL data

RO3: To gain insights on affective and cognitive observations by conducting semi-structured interviews

RO4: To conclude the effectiveness of FLA advice on IBS patients in terms of symptom burden

Research methods

Research design

This study will be conducted on the basis of an explanatory mixed method that will be a combination of qualitative and quantitative analysis. As opined by Marshall et al. (2010), a mixed method provides a much more comprehensive understanding of a topic than one specific approach alone. The study will be conducted on a public health issue and to prove the urgency of a health issue to be taken seriously, core data is mandatory. Hence, quantitative data would be required in this case. On the other hand, this study will also highlight the perception of IBS patients regarding FLA and self-management that existing research works have failed to point out. These opinions will be provided in the form of qualitative data and hence this research will involve mixed methods.

Participants (Sampling)

The participants in this study would be selected by proportional quota sampling which is a type of non-random sampling, this is a specific sampling where the participants are selected on the basis of certain criteria they are required to meet (Iliyasu and Etikan, 2021). This study will rely on rational selection because there are three distinct types of IBS and adhering to other forms of selection might exceed the time frame of this study. However, one potential drawback of this approach is that it would reduce the chances of generalising the results on a large population which would be necessary in case of a public health issue. A total of 90 patients will be recruited for this study and rational sampling will be applied to categorize them into subcategories based on the type of IBS they have.

Study design (Allocation)

Intervention groups would be created by randomly allocating selected participants into them randomly. As mentioned by Bhushan et al. (2021), the random sampling approach presets bias in a study which makes the findings authentic and reliable, hence this approach has been chosen specifically for obtaining qualitative data. However, there is a significant drawback of this type of sampling because it makes the findings too generalized. There would be a risk involved in this study due to relying on this sampling and that is the fact that patients having significant co-morbidities might fail to be accounted for. Hence, patients with crucial comorbidities will be eliminated from this study beforehand. A randomization software d Graphpad will be used in this study for this randomization.

Recruitment strategy

Patients in this study will be approached through telephone calls by one research team and a gist of this study will be provided to them. An information leaflet would be provided to them where the protocols and methods of data collection would be enlisted. Also, a comment form would be provided to them to avoid any ethical obligation. It would be mentioned that their participation in the stuffy is on their will and that they would have the liberty to quit at any time. Followed by that, those participants who provided their consent would be approached by the team and randomized into intervention groups. ;

Inclusion and Exclusion criteria

Table 2: Inclusion and Exclusion Table ;

Data collection

This study will be conducted on both qualitative and quantitative primary data and distinct methods will be followed to collect them. As opined by Mazhar et al. (2021), the authenticity of primary data makes a study finding more reliable for which it has been decided that this study will rely on primary data. In the case of quantitative data, questionnaires will be used to collect the perceptions of patients regarding FLA and self-management. The “Kings College gastrointestinal symptom questionnaire” will be used in this process and the “Medical Outcomes Study Short Form-36” will be utilized to assess the quality of their lives. This would be conducted within 8-10 weeks of a participant's first consultation with a professional. However, one drawback of questionnaires is that they involve a high chance of incorrect feedback, and the emotions behind the provided answers remain uncovered (Pesec et al. 2021). Besides, the sensitivity of a topic might be different in participants due to which they might avoid some questions that would alter the expected outcomes of this study.

Figure 6: Data collection procedure

Focus groups will be the chosen method in this study to collect qualitative data. Two semi-structured groups will be created for this that would include participants from both the control group and the experimental group. Discussion topics will be reviewed with two participants representing each group. The main aim of creating a focus group would be communication between members. These groups would be audio-recorded which will, later on, be transcribed. One major drawback of collecting primary data is that it involves excessive time which could be utilized in other stages (Mazhar et al. 2021). However, it would be noted here that much time is not dedicated to this stage and the interviewer would take field notes that would be later used to design themes for analysis.

Data analysis

Statistical analysis will be conducted on quantitative data and thematic analysis will be conducted on the qualitative data. In the case of quantitative data, straightforward parametric tests like t-tests would be conducted. Obtained data will be analyzed to test whether they meet the null hypothesis and Spydergrams will be used to present SF 36 data. As said by Strand et al (2009), Spydergrams facilitate analysis but one problem with them is that they can be messy. Hence, it would be assured in this study that they are represented in a neat manner. On the other hand, themes will be designed on qualitative data based on a grounded theory approach.

Research gap

One potential gap that this study is likely to involve is the risk of patient or investigator bias during the sharing of consultation data. Another unavoidable gap is that there would be a difference in the level of sensitivity among participants which would raise questions regarding the authenticity of their provided data in the questionnaires. Most importantly, this study will be conducted on primary data and hence ample time would be lost in collection alone which could be used in other aspects.

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Ethical and feasibility considerations

Research works conducted in primary data involve several ethical obligations which would be a possible case here as well. Primarily, there might be an issue regarding the consent of participant patients for which it will be ensured that they are willingly participating. It would be also included in these consent forms that they can willingly quit the study as power their convenience. The Data Protection Act provides a right to every individual to demand to keep their personal information confidential (Legislation, 2018). Participants would be assured that their data would be secure and various steps will be taken to ensure that. Firstly, all raw data including questionnaires, audio recordings, and consultations would be stored in an encrypted format in secured hard drives and the passwords to these drives would be accessible only to researchers. It would also be ensured that “The Sheffield Teaching Hospital Ethic and Research Committee (REC)” has provided its approval on this study. Translations might be required in some cases if audio recordings are not in English. Also, articles for literature review will only be ones that have full-text availability because that would imply that those authors accept their work being reused.

Expected timeline

Figure 7: Timeline for the project

References

Provided

Halmaos PE, Power Va, Shepard Sj, and Gibson PR., 2014. A Diet Low in FODMAP’s ReduecesSysptoms of Irritable Bowel Syndrome. Gastroenterology. 146:67-75.

Lovell RM. and Ford AC., 2012. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol; 10(7):712–721. e4.

Marshall C. and Rossman G., 2010. Designing Qualitative Research. SAGE Publications Inc.

Strand V, Crawford B, Singh J, Choy E, Smolen JS., and Khanna D., 2009. Use of “spydergrams” to present and interpret SF-36 health-related quality of life data across rheumatic diseases. Annals of the Rheumatic Diseases. 68(12): 1800–1804.

Torrance N, Blair H, Smith MD., and Bennett MI., 2009. Analyzing the SF-36 in population-based research. A comparison of methods of statistical approaches using chronic pain as an example. Journal of Evaluation in Clinical Practice. 15 328–334.

Others

Articles

Bhushan, S., Kumar, A., Pandey, A.P. and Singh, S., 2021. Estimation of population mean in the presence of missing data under simple random sampling. ; Communications in Statistics-Simulation and Computation, pp.1-22.

Holton, J.A., 2020. Social movements thinking for managing change in large-scale systems. ;Journal of Organizational Change Management, ;33(5), pp.697-714.

Iliyasu, R. and Etikan, I., 2021. Comparison of quota sampling and stratified random sampling.  ; Biom. Biostat. Int. J. Rev, ;10, pp.24-27.

Lacy, B.E., Pimentel, M., Brenner, D.M., Chey, W.D., Keefer, L.A., Long, M.D. and Moshiree, B., 2021. ACG clinical guideline: management of irritable bowel syndrome. ;Official journal of the American College of Gastroenterology| ACG, ;116(1), pp.17-44.

Manning, L.P., Tuck, C.J. and Biesiekierski, J.R., 2022. The lived experience of irritable bowel syndrome: A focus on dietary management. ;Australian Journal of General Practice, ;51(6), pp.395-400.

Masclee, G., Snijkers, J.T., Boersma, M., Masclee, A.A. and Keszthelyi, D., 2021. Patient preferences of healthcare delivery in irritable bowel syndrome: a focus group study. ;BMC gastroenterology, ;21(1), pp.1-8.

Mazhar, S.A., Anjum, R., Anwar, A.I. and Khan, A.A., 2021. Methods of data collection: A fundamental tool of research. ; Journal of Integrated Community Health (ISSN 2319-9113),;10(1), pp.6-10.

Pesec, M., Spigel, L., Granados, J.M.M., Bitton, A., Hirschhorn, L.R., Brizuela, J.A.J., Pignone, M., Sáenz, M.D.R., Schwarz, D., Villegas del Carpio, O. and Wilson, I.B., 2021. Strengthening data collection and use for quality improvement in primary care: the case of Costa Rica. ;Health Policy and Planning, ;36(5), pp.740-753.

Tracy, J.A., 2020. Be a champion for change by using Lewin’s 3-stage Model of Change. ;RDH, ;40(2), pp.18-20.

Van den Houte, K., Carbone, F., Pannemans, J., Corsetti, M., Fischler, B., Piessevaux, H. and Tack, J., 2019. Prevalence and impact of self-reported irritable bowel symptoms in the general population. ;United European Gastroenterology Journal, ;7(2), pp.307-315.

Vasant, D.H., Paine, P.A., Black, C.J., Houghton, L.A., Everitt, H.A., Corsetti, M., Agrawal, A., Aziz, I., Farmer, A.D., Eugenicos, M.P. and Moss-Morris, R., 2021. British Society of Gastroenterology guidelines on the management of irritable bowel syndrome. ;Gut, ;70(7), pp.1214-1240.