4. Discussion
Pain, IBD, intentional behavior, UC
CORONAVIRUS, DISEASE, CROSS, CHRONIC DISEASES
The intervention program was not able to produce significant differences for the primary outcome (medication adherence), but was able to improve three QoL domains.The need to include non-adherent patients in clinical trials had previously been signaled as a strategy to improve the quality of published studies [Most participants were women, with an average age of 47 years, black or mixed race, residing in urban area. It seems that in Latin America there is a predominance of women and residents in urban areas [As for the clinical status for UC, most of them had active disease at baseline, comparable to the proportion of patients with moderate to severe UC in Brazil [Most participants used oral and/or rectal amino salicylates. Findings converge with previously published results, where the largest proportion of patients were using salicylates for UC [It is necessary to emphasize that rectal medication use for IBD treatment has been considered a risk factor for low adherence when compared to the oral route. This is possibly due to the discomfort related to administration, difficulty in use during working hours or on trips, as well as the lack of adherence in these cases has been associated with intentional behavior [At baseline, significant differences were observed in the distribution of types of non-adherence between groups. Studies with similar objectives that used MGLT, with patients diagnosed with UC, did not show baseline distribution of this variable, therefore, we could not compare how this variable behaved in other studies [The intervention program proposed by this research is considered to be multicomponent, as it contains multiple strategies, educational, behavioral and motivational [The multicomponent approach can be complex, as it involves different combinations of interventions with regard to type, frequency, intensity and quality [In the present study, educational measures were carried out in a single moment, while motivational and reminder messages were repeated. It is possible that the most immediate result of these interventions was not captured due to the time elapsed until data collection at visit 2 (after 6 months), therefore, an increase on the frequency of educational intervention and instruments application to measure adherence would be desirable. In a meta-analysis it was found that the longer the follow-up time, the smaller the differences for the outcome of adherence between comparative groups [It is possible that the intervention program of this research did not have a greater impact because it did not include changes in the interaction routine between participants and health professionals. Multiple interventions through a virtual platform have already been proposed, in which, in addition to educational approach and reminders, the data entered by patients were analyzed using a pre-defined automatic protocol, and if necessary, the assistance team was activated for appropriate measures. Del Hoyo As for QoL, in this research there was an improvement in the scores of the domains “Pain” and “Vitality” in the IG when compared to the CG, a result maintained after adjustment for confounders. Other studies have already found the impact of multicomponent interventions with an improvement in QoL. Although Cross According to observed results in the present research, multicomponent interventions may contribute to improve QoL for UC patients, despite no significant impact for medication adherence having been found. Other clinical trials aiming to improve adherence to chronic diseases have shown improvement in QoL [Some limitations of the present study may have interfered with the observed results. The sample size was calculated to identify differences of 30% in the primary outcome, therefore, it is possible that statistical differences in adherence between the comparative groups were not observed due to insufficient power. It is suggested that in future designs, differences of lesser magnitude of the outcome should be considered for the sample calculation. Another point was the impossibility of blinding the participants regarding the allocation, exposing the results to the risk of performance bias, eventually improving the provision of usual attention perceived by the CG participants, which may have attenuated the differences between the groups [We must discuss the atypical moment experienced during the execution of the research after declaring the state of emergency due to the new coronavirus, which may have affected participants’ QoL and adherence to treatment. A recent study identified that stress due to the pandemic was reported by 22% of IBD patients as high and 38% as moderate. In addition, 62% of the patients had concern about medications increasing the risk of developing COVID-19. Additionally, 14% of patients considered discontinuing, while 11% effectively discontinued treatment because of pandemic [