ABSTRACT
Background: Fatigue, pain and faecal incontinence are common in people with IBD. However, little is known about co-existence of these multiple symptoms, how they inter-relate and whether people want help for these symptoms. In qualitative interviews, patients have reported that these symptoms are often ignored in clinical consultations where the focus is on inflammation, but that they are very bothered by these symptoms, even when disease is apparently in remission The aim of this study was to determine the presence and relationship between fatigue, pain and incontinence in people with inflammatory bowel disease, and desire for intervention for these symptoms Methods: A purpose-designed survey (online or postal), incorporating validated tools and demographic details, was sent to unselected UK clinic and UK IBD-BioResource adult patients. When the covid-19 pandemic halted clinic recruitment, additional self-selected UK recruits were solicited via social media. Using the validated PROMIS tools the following definitions were used for presence of symptoms: Fatigue: PROMIS fatigue T-score of 60 or more;pain: PROMIS pain intensity T-score of 60 or more;PROMIS bowel incontinence: Raw score of 50 or more. Participants also reported disease activity using the relevant PRO-2 score, IBD-Control, anxiety (GAD-7), depression (PHQ-9) and quality of life (EQ-5D-5L) which will all be reported elsewhere Results: A total of 8486 useable responses were received (7716 online 770 postal). 4176 reported Crohn's disease, 4255 had ulcerative colitis or other form of IBD. There were 3281 men and 4883 women. Median age was 51 years (range 18 - 92). 2550 (30%) reported fatigue 1766 (21%) pain and 4565 (54%) faecal incontinence according to the above definitions;925 (10.9%) reported having all three symptoms Demographics by symptom are shown in Table 1. Table 2 reports those participants indicating the presence of each symptom and each combination of symptoms. Table 3 shows a summary of self-defined severity and impact of symptoms (scoring scale 0-10 for both severity and impact of each symptom). Participants scored severity and impact a mean between 3.3 and 4.8, with a wide variation. 56% of all respondents (not just those with symptoms) "definitely" wanted help for fatigue;42% wanted help for pain;53% wanted help for incontinence. 29% reported "definitely" wanting help for all three symptoms (Table 4) Conclusion(s): This study confirms that fatigue, pain and urgency are common in IBD and for the first time reports the co-existence and unmet need for help with these symptoms.
ABSTRACT
BACKGROUND: DIALOG+ is a digital psychosocial intervention aimed at making routine meetings between patients and clinicians therapeutically effective. This study aimed to evaluate the cost-effectiveness of implementing DIALOG+ treatment for patients with psychotic disorders in five low- and middle-income countries in Southeast Europe alongside a cluster randomised trial. METHODS: Resource use and quality of life data were collected alongside the multi-country cluster randomised trial of 468 participants with psychotic disorders. Due to COVID-19 interruptions of the trial's original 12-month intervention period, adjusted costs and quality-adjusted life years (QALYs) were estimated at the participant level using a mixed-effects model over the first 6 months only. We estimated the incremental cost-effectiveness ratio (ICER) with uncertainty presented using a cost-effectiveness plane and a cost-effectiveness acceptability curve. Seven sensitivity analyses were conducted to check the robustness of the findings. RESULTS: The average cost of delivering DIALOG+ was 91.11 per participant. DIALOG+ was associated with an incremental health gain of 0.0032 QALYs (95% CI -0.0015, 0.0079), incremental costs of 84.17 (95% CI -8.18, 176.52), and an estimated ICER of 26,347.61. The probability of DIALOG+ being cost-effective against three times the weighted gross domestic product (GDP) per capita for the five participating countries was 18.9%. CONCLUSION: Evidence from the cost-effectiveness analyses in this study suggested that DIALOG+ involved relatively low costs. However, it is not likely to be cost-effective in the five participating countries compared with standard care against a willingness-to-pay threshold of three times the weighted GDP per capita per QALY gained.