Furthermore, despite physicians assessing that over half of all patients had mild UC or were in remission at baseline, nearly two-thirds of patients who reported sick leave said their sick leave was attributable to UC. These differences warrant further investigation in the future. One factor potentially contributing to differences between patients and physicians in appraising UC-related burden is the quality of physician-patient communication, but other factors may also be influential.
As an adjunct to standard measures of disease assessment, PRISM can serve as a tool for improving patient-physician communication. Overall, the study showed that burden and suffering for patients with early UC reduced over time through 2 years of follow-up.
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Furthermore, both physician and patient assessments indicated an increase in UC remission and a reduction in disease severity over the 2-year study period. The improvement in disease severity may have resulted from patients receiving more stringent management, or improved patient compliance during the study. As ICONIC was a non-interventional study, the influence of treatment regimen on disease activity is out of scope for this study.
Associated comorbid diseases and symptoms were also common among patients in the study, consistent with findings elsewhere, 28 affecting almost half of the patients at baseline. Fatigue was the most common symptom experienced at baseline, and it increased in incidence over time, despite patients experiencing an improvement in disease severity; indeed, fatigue has been reported as a prevalent and frequently under-recognised, undermanaged symptom in patients with UC.
Although the analyses from each geographical region followed the same trends as the overall results of the study, some regional differences were observed. Throughout the 2-year follow-up period, patients in Japan generally had lower patient- and physician-reported PRISM scores [indicating that patients from Japan appraised their suffering as greater] compared with other geographical regions.
Despite this, patients in Japan showed consistently more favourable results with the other patient- and physician-reported outcomes Supplementary Table 3. Visual metaphors—including PRISM—are interpreted by people in personally meaningful ways, and therefore yield personal assessments.
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The observed differences between regions may, in part, reflect differing perceptions across cultures of what constitutes suffering and to what degree one suffers as a product of disease. Cross-cultural comparisons may be complicated by different understandings between cultures of the chosen subject, in this case suffering associated with UC.
There is also evidence that perceptual processes may differ between cultures, with people from Eastern cultures paying more attention to context than those from Western cultures. ICONIC has several strengths, including its prospective design, large sample size, and the fact that patient outcomes were measured using a variety of patient and physician assessment tools. The findings are limited by the fact that it is not a population based study and has no predefined region-specific sample size.
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Despite ICONIC being a non-interventional study, some patients may have received more stringent management, or patient compliance may have improved over time. By its nature, UC is a progressive disease in a significant proportion of patients, advancing from limited to more extensive involvement of the colon, and it can lead to complications, such as neoplasia.
Studies over a longer period will be necessary to establish whether the suffering of the patients is related to disease progression. Finally, self-reported outcomes, such as questionnaire results, are inherently prone to self-presentational and recall biases. These longitudinal data support the use of PRISM as an additional outcome measure in future clinical trials in UC, to sit alongside standardised UC questionnaires that measure more specific patient- and physician- reported outcomes.
Furthermore, this study also adds to the evidence base that, in patients with UC, disease burden and suffering continue to be underestimated by physicians. PRISM may be used to enhance patient-physician communication and identify patients with UC who have a high level of suffering and may be at risk of developing psychological disorders, and therefore require increased care.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymised, individual, and trial-level data [analysis datasets], as well as other information [eg, protocols and clinical study reports], as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan, and execution of a data sharing agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. TS: Nothing to declare. AbbVie was the study sponsor and contributed to study design, data collection, analysis and interpretation, reviewing, and approval of the final version.
All authors had access to relevant data and participated in the drafting, review, and approval of this manuscript. No honoraria or payments were made for authorship.
All authors contributed equally to data analysis and interpretation and contributed to the development of the manuscript. The authors reviewed drafts and approved and maintained control of the final content. AbbVie contributed to the study design, research, analysis, data collection and interpretation, and the writing, review, and approval of the final version of the publication. Ulcerative colitis. Lancet ; : — Google Scholar.
Experiences of patients with chronic gastrointestinal conditions: in their own words.
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Inflamm Bowel Dis ; 17 : — 9. Longitudinal trajectory of fatigue with initiation of biologic therapy in inflammatory bowel diseases: a prospective cohort study. J Crohns Colitis ; — Inflammatory bowel disease-related fatigue is correlated with depression and gender. Australas Psychiatry ; 26 : — Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Joongbu University. Sign In. Advanced Search.