Developing a Patient Reported Outcome Measure in Intestinal Failure

• Research type

  Research Study

• Full title

  Developing a Patient Reported Outcome Measurement Scale in Intestinal Failure

• IRAS ID

  91929

• Contact name

  Simon Lal

• Contact email

  simon.lal@srft.nhs.uk

• Sponsor organisation

  Salford Royal NHS Foundation Trust

• Research summary

  Intestinal Failure (IF) has a major impact on the lives of patients and the main treatment currently is parenteral nutrition. There were 624 adult patients reported as requiring home parenteral nutrition (HPN) in the UK in 2010. HPN patients suffer from significant limitations to their lifestyle and quality of life (QoL). Patients on HPN also can suffer complications. Even in the absence of these complications, patients on HPN suffer from significant limitations to their lifestyle and quality of life (QoL). The lives and well-being of these patients depend on regular intravenous feeding and fluid therapy, usually delivered through dedicated, implanted intravenous access devices. Patients on HPN report frequent complaints of interference with sleep, mobility, fatigue, social isolation and psychological problems related to the difficulties associated with a demanding and highly regimented lifestyle. The aim of this study is to develop disease-specified patient related scales to assess impairment (patient-perceived symptoms), activity limitations and QoL associated with IF. It is necessary to develop patient report outcome measurement scales as currently there are not any tools available to assess the effect of HPN on patients' lives for use in clinical practice or research.
  There will be 295 participants recruited from the Intestinal Failure Unit at Salford Royal NHS Foundation Trust and St Mark’s NHS Foundation Trust. A separate sample of patients will be recruited for each stage of the study.
  There are three key stages involved in the study:
  Stage I: Conducting patient interviews (n=30) and use interpretive phenomenology to determine participant’s main concerns and factors that impact on their QoL in context of their lived everyday life.
  Stage II: Assessment of face and content validity by cognitive debriefing interviews (n=15)
  Stage III:
  Postal test-retest validation survey (n=250)
  Scaling and psychometric analysis of survey data
  Production of final scales for patient reported outcomes measures

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  14/NW/1047

• Date of REC Opinion

  20 Jun 2014

• REC opinion

  Favourable Opinion