Development of a short questionnaire to assess the quality of life in Crohn's disease and ulcerative colitis.

BACKGROUND AND AIMS: Most of the disease-specific quality of life (QoL) measures for inflammatory bowel disease (IBD) are lengthy and time consuming. None have been established for routine use in clinical practice. We designed this study to develop a short QoL measure in IBD. METHODS: A 32-item questionnaire, the Crohn's and ulcerative colitis questionnaire (CUCQ)-32 was developed by reviewing the literature of the previously validated questionnaires and by consultation with patients and experts. Construct validity was carried out using the Short Form 12 and the EuroQol 5 dimensions questionnaires and two disease severity measures (the Simple Clinical Colitis Activity Index and the Harvey-Bradshaw Index). Test-retest analysis was done by asking patients to complete the CUCQ questionnaire twice within a period of two weeks. RESULTS: Data were obtained from 205 patients with IBD who completed the CUCQ-32. Psychometric analysis showed that Cronbach's α was 0.88, item-total correlations were good, and there were no ceiling or flooring effects. Stepwise regression identified eight items that accounted for >95% of the variance in the CUCQ-32. The resulting CUCQ-8 demonstrated good internal consistency (Cronbach's α = 0.84), had good reproducibility (intraclass correlation coefficient = 0.94), was well correlated with the EuroQol 5 dimensions questionnaire (r = 0.58) and the Short Form-12 (r = 0.65 for physical component and r = 0.63 for mental component), and was responsive to change (responsiveness ratio was 0.64, p-value < 0.05). CONCLUSIONS: CUCQ-8 is a short questionnaire that has the potential to be an efficient tool for assessing the QoL of all patients with IBD in clinical practice.

Development and validation of a new disease severity index: the Inflammatory Bowel Disease Index (IBDEX).

OBJECTIVE: To develop, validate and apply a generic clinical severity index applicable to all adult patients with inflammatory bowel disease (IBD). DESIGN: A review of the literature and an expert focus group consultation were carried out in order to draw out relevant items from existing literature. The new index was called the IBD Index (IBDEX). Standard psychometric analysis was carried out. The construct validity was assessed against biochemical markers, clinical and endoscopic indices. The new index was completed again within 6 weeks to check responsiveness and reproducibility. RESULTS: IBDEX was used to assess 255 adult patients with IBD (125 with Crohn's disease and 130 with ulcerative colitis), and 64 patients were re-evaluated within 6 weeks. It had good internal consistency (Cronbach's α=0.79) and correlated very well with the Harvey Bradshaw Index (r=0.94), the Simple Clinical Colitis Activity Index (r=0.92), the Mayo Clinic Index (r=0.87) and the Simple Endoscopic Score (r=0.76), all with p values <0.05. IBDEX had a moderate but positive correlation with C reactive protein (r=0.51) and erythrocyte sedimentation rate (r=0.36) p values both <0.05. The test-retest reliability was good (intraclass correlation coefficient 0.97) and responsiveness ratio was 2.27. CONCLUSIONS: IBDEX is the first properly validated Clinical Disease Severity Index in IBD. Our results showed that it is valid, reliable and reproducible and has the potential to be used in clinical practice.

Support and Assessment for Fall Emergency Referrals (SAFER 1): cluster randomised trial of computerised clinical decision support for paramedics.

OBJECTIVE: To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall. DESIGN: Cluster trial randomised by paramedic; modelling. SETTING: 13 ambulance stations in two UK emergency ambulance services. PARTICIPANTS: 42 of 409 eligible paramedics, who attended 779 older patients for a reported fall. INTERVENTIONS: Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture. MAIN OUTCOME MEASURES: Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care. SAFETY: Further emergency contacts or death within one month. COST-EFFECTIVENESS: Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness. RESULTS: 17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without. CONCLUSIONS: Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture. TRIAL REGISTRATION: ISRCTN Register ISRCTN10538608.

New models of emergency prehospital care that avoid unnecessary conveyance to emergency department: translation of research evidence into practice?

BACKGROUND: Achieving knowledge translation in healthcare is growing in importance but methods to capture impact of research are not well developed. We present an attempt to capture impact of a programme of research in prehospital emergency care, aiming to inform the development of EMS models of care that avoid, when appropriate, conveyance of patients to hospital for immediate care. METHODS: We describe the programme and its dissemination, present examples of its influence on policy and practice, internationally, and analyse routine UK statistics to determine whether conveyance practice has changed. RESULTS: The programme comprises eight research studies, to a value of > £4 m. Findings have been disseminated through 18 published papers, cited 274 times in academic journals. We describe examples of how evidence has been put into practice, including new models of care in Canada and Australia. Routine statistics in England show that, alongside rising demand, conveyance rates have fallen from 90% to 58% over a 12-year period, 2,721 million fewer journeys, with publication of key studies 2003-2008. COMMENT: We have set out the rationale, key features, and impact on practice of a programme of publicly funded research. We describe evidence of knowledge translation, whilst recognising limitations in methods for capturing impact.