Abstract
Background
In order to guide industry on medical product development, FDA developed an instrument to measure effectiveness as an endpoint of clinical trials. This patient oriented tool is called “Patient Related Outcomes Measures”. (PROMS). In 2009 NHS England adopted PROMS declaring that “the purpose is to collect information, from patients themselves, about how well the health service is treating them. Moreover “PROMs allows to understand the difference that healthcare interventions make to people’s quality of life”. Initially related to only certain surgical procedures, it eventually rolled out to many other conditions including IBD. This research looks at degree of success in implementation of PROMS for IBD patients on treatment with biologics in a sample district hospital of United Kingdom.
Methods
The IBD PROMs questionnaire is filled by patients themselves when treated with biologics. The questionnaire asks overall health status, treatment of bowel condition, effectiveness in controlling bowel condition, satisfaction with quality of treatment, Crohn’s and Colitis questionnaire CCQ12 and uses 12 dimensions: sleeping, appetite, energy level, rushing to the toilet, being bloated, incomplete emptying of bowels, blood in stool, generally unwell, faecal incontinence, nocturnal diarrhoea, passing wind and effect on leisure activity. It also has questions for patients with a stoma. We collected data from a sample district general hospital in United Kingdom for one year in retrospect and analysed the implementation of PROMS. We hoped at least 90% of patients would fill the PROMS questionnaire.
Results
45 patients with IBD who were on biologics were recruited in the study. They had repeated admissions for treatment and we kept check points at 3, 6 and 12 month follow up treatments. There were 21 patients on infliximab, 23 on vedolizumab, and 1 on ustekinumab with overall total number of infusions being 352 due to their recurrent admissions for biologic treatment. A minimum of 45 PROM responses could have been achieved and maximum of 352 for good implementation. In our data only 4 were filled (8.89% of minimum and 1.1 of maximum required). Thus PROMS for IBD was not implemented to any useful extent.
Conclusion
Our study did not look at the outcomes, but simply whether the PROMS was utilised sufficiently for IBD patients on biologics. We demonstrated low uptake by one sample district general hospital of United Kingdom. Further studies to evaluate practice of other IBD units in the country would help to understand the situation better. There can be various reasons for this low uptake including lack of resource, not knowing importance of PROMS or deficient motivation in staff.
P239 A study to evaluate uptake of PROMS for IBD patients on Biologics: a sample United Kingdom district general hospital experience