The Process of Developing a Disease Activity Index in Microscopic Colitis.

BACKGROUND AND AIMS: Patient-reported outcome measures [PROMs] aim to measure patients' perception of how their disorder influences everyday functioning. The objective of this study was to develop a PROM to assess disease activity in microscopic colitis [MC] fulfilling the requirements of the Food and Drug Administration [FDA]. METHODS: The European Microscopic Colitis Activity Index [E-MCAI] was developed in four steps. [1] A list of symptoms associated with active MC was created by a group of experts in the field. [2] Content validity of the symptoms was performed by experts [n = 14] and patients [n = 79] using the Content Validity Index. [3] Questions and response alternatives were created for each symptom, and validity of the E-MCAI was evaluated with cognitive interviews with patients [n = 7] and by the experts. [4] A pilot postal survey was performed to ensure usability. RESULTS: Seven of the symptoms related to active MC fulfilled the criteria for content validity and were included in the E-MCAI: stool consistency, stool frequency, stools at night, feel a need to pass more stools shortly after a bowel movement, urgent need to empty the bowel, leakage of stool and abdominal pain. The development and validation process resulted in the current version of the E-MCAI consisting of six questions related to MC. CONCLUSIONS: The E-MCAI was developed using the methods advocated by the FDA. The evaluation indicates good content validity. Further evaluation will be performed to achieve construct validity, reliability and responsiveness in future cross-sectional and longitudinal studies.

Health care as perceived by persons with inflammatory bowel disease - a focus group study.

AIMS AND OBJECTIVES: The aim of this study was to explore the perceptions of health care among persons living with inflammatory bowel disease. BACKGROUND: The quality of care plays an important role in the life of persons with a chronic disease. To define what persons with inflammatory bowel disease perceive as high-quality care, greater focus must be placed on the individual's own perspective of living with the condition. DESIGN: A qualitative exploratory study was conducted based on focus groups. METHODS: Five focus groups were conducted with adult persons living with inflammatory bowel disease, 14 men and 12 women aged 19-76 years. The interviews were performed between January-June 2014. RESULTS: The perceptions of health care from the perspective of persons living with inflammatory bowel disease were summarised in two categories: 'professional attitudes of healthcare staff' and 'structure of the healthcare organisation'. Persons with inflammatory bowel disease want to be encountered with respect, experience trust and obtain information at the right time. They also expect shared decision-making, communication and to encounter competent healthcare professionals. Furthermore, the expectations on and perceptions of the structure of the healthcare organisation comprise access to care, accommodation, continuity of care, as well as the pros and cons of specialised care. CONCLUSION: The findings show the importance of establishing a respectful and trusting relationship, facilitating healthcare staff and persons with inflammatory bowel disease to work as a team in fulfilling individual care needs - but there is room for improvement in terms of quality of care. RELEVANCE TO CLINICAL PRACTICE: A person-centred approach, which places the individual and her/his family at the centre, considering them experts on their own health and enabling them to collaborate with healthcare staff, seems important to reach a high-quality healthcare organisation for patients with Inflammatory bowel disease.