Impact of pain, fatigue and bowel incontinence on the quality of life of people living with inflammatory bowel disease: A UK cross-sectional survey.

BACKGROUND AND AIMS: People with inflammatory bowel disease (IBD) often experience pain, fatigue and bowel incontinence and are at an increased risk of anxiety and depression. Our aim was to assess the impact of these symptoms on health-related quality of life (QoL) in IBD. METHODS: In the IBD-BOOST survey, over 26,000 people with IBD across the UK were approached; 8486 participant-completed surveys were returned. Participants' QoL was measured using the EQ-5D-5L questionnaire and their QoL was calculated on a scale ranging from 1 (perfect health) to -0.594 (worst health). Item non-response was imputed. Stages of linear regression models assessed the associations of symptoms with QoL controlling for IBD type, socio-demographic characteristics, co-morbidities and, in further analysis, for IBD activity and IBD control. RESULTS: The EQ-5D-5L questionnaire was fully completed by 8093 (95.4%) participants (mean age of 50 years [SD 15]; 49% with Crohn's disease). The mean QoL was 0.76 (SD 0.23). From the three IBD-related symptoms, pain was associated with the largest QoL decrement (-0.159), followed by fatigue (-0.140) and bowel incontinence (-0.048). Co-occurrence of pain and fatigue further reduced QoL. Clear graded associations were observed between symptom severity and QoL decrements (all trend p < 0.001). Depression and anxiety were also associated with significant QoL decrements (-0.102 and -0.110 for moderate-to-severe anxiety and moderately severe depression, respectively). Worse IBD control and higher IBD activity were associated with lower QoL. CONCLUSIONS: We report strong associations between symptoms of pain, fatigue, bowel incontinence, anxiety, depression, and their severity and reduced QoL in IBD. These estimates could inform future IBD management interventions.

Development and test-retest reliability of a new, self-report questionnaire assessing healthcare use and personal costs in people with inflammatory bowel disease: the Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ).

Background and aims: The increasing prevalence of inflammatory bowel disease (IBD) poses a substantial economic burden globally on health systems and societies. Validated instruments to collect data on healthcare and other service utilisation by patients with IBD are lacking. We developed a self-report patient questionnaire to capture key resource utilisation from health services, patient and societal perspectives. Methods: The IBD Resource Use Questionnaire (IBD-RUQ), developed by a multidisciplinary team, including patients, comprises 102 items across the six categories of outpatient visits, diagnostics, medication, hospitalisations, employment and out-of-pocket expenses over the past three months. The test-retest reliability of the IBD-RUQ was studied by administering it twice among patients with IBD with a 2-week time gap. The intraclass correlation coefficients and the average cost from the healthcare, societal and patient perspectives, between test and retest assessments, overall and by service category, were summarised. Results: The IBD-RUQ captures health service use, employment and out-of-pocket expenses. Of 55 patients who completed the first questionnaire, 48 completed the retest questionnaires and were included in the analyses. Test-retest reliability for categories of medications, diagnostics, specialist outpatient and inpatient services, and days off work due to IBD ranged from moderate to excellent; primary care visits showed more limited reliability. The annualised average self-reported health service, out-of-pocket and loss of productivity costs were £4844, £320 and £545 per patient, respectively. Conclusions: The IBD-RUQ is a reliable and valid self-report measure of resource utilisation in adults with IBD and can be used to measure costs associated with IBD.

Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial.

BACKGROUND: Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support. PRIMARY RESEARCH QUESTION: In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0-10 scale) compared with care as usual? METHODS: A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups. DISCUSSION: The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients' quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals. TRIAL REGISTRATION: ISRCTN71618461 . Registered on 9 September 2019.

Developing core economic parameter sets for asthma studies: a realist review and an analytical framework.

OBJECTIVE: To develop a standardised set of economic parameters (core economic parameter set) for economic evaluations in asthma studies. DESIGN: A systematic literature review and an analytical framework. OUTCOME MEASURES: Economic parameters used to evaluate costs and cost-effectiveness of healthcare interventions for people with asthma. DATA SOURCES: PubMed, the Cochrane Database of Systematic Reviews, the National Health Service Economic Evaluation Database, the Database of Abstracts of Reviews of Effects and the Health Technology Aaaessment Library starting from 1990. REVIEW METHODS: Research methods were based on the realist review methodology and included a number of non-sequential, iterative and overlapping components, such as developing an analytical framework for the realist review; systematic literature review of economic parameters; identifying and categorising economic parameters; producing preliminary list of core economic parameters. RESULTS: Database searches found 2531 publications of which 224 were included in the systematic review. We identified 65 economic parameters that were categorised into 11 groups to enable the realist synthesis. Parameters related to secondary care, primary care, medication use, emergency care and work productivity comprised 84% of all economic parameters. An analytical framework was used to investigate the rationale behind the choices of economic parameters in these studies. The main framework domains included type of intervention, research population, study design, study setting and a stakeholder's perspective. CONCLUSION: Past research thus suggests that in asthma study parameters depicting the use of secondary care, primary care, medication, emergency care and work productivity can be considered as core economic parameters, since they apply to different types of studies. Parameters including diagnostics, healthcare delivery, school activity, informal care, medical devices and health utility apply to a particular type of study (or research question), and thus can be recommended as supplemental parameters. PROSPERO REGISTRATION NUMBER: CRD42017067867.

Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence.

BACKGROUND: Subcutaneous sacral nerve stimulation is recommended by the United Kingdom (UK) National Institute for Health and Care Excellence (NICE) as a second-line treatment for patients with faecal incontinence who failed conservative therapy. Sacral nerve stimulation is an invasive procedure associated with complications and reoperations. This study aimed to investigate whether delivering less invasive and less costly percutaneous tibial nerve stimulation prior to sacral nerve stimulation is cost-effective. METHODS: A decision analytic model was developed to estimate the cost-effectiveness of percutaneous tibial nerve stimulation with subsequent subcutaneous sacral nerve stimulation versus subcutaneous sacral nerve stimulation alone. The model was populated with effectiveness data from systematic reviews and cost data from randomized studies comparing both procedures in a UK National Health Service (NHS) setting. RESULTS: Offering percutaneous tibial nerve stimulation prior to sacral nerve stimulation (compared with delivering sacral nerve stimulation straight away) was both more effective and less costly in all modeled scenarios. The estimated savings from offering percutaneous tibial nerve stimulation first were £662-£5,697 per patient. The probability of this strategy being cost-effective was around 80% at £20,000-£30,000 per quality-adjusted life-year (QALY). CONCLUSION: Our analyses suggest that offering patients percutaneous tibial nerve stimulation prior to sacral nerve stimulation can be both cost-effective and cost-saving in the treatment of faecal incontinence.