title: Investigating the collection and assessment of patient-reported outcome data amongst unplanned surgical hospital admissions: a feasibility study.
abstract: BACKGROUND
  Randomised controlled trials (RCTs) in surgery can be challenging to conduct, and trials in the emergency surgical setting when patients have unplanned hospital admissions are particularly difficult. One area of challenge is capturing baseline patient-reported outcome (PRO) data. This study examined the feasibility and optimal methods for the collection of baseline and follow-up PRO data in the setting of unplanned surgical hospital admissions.
  
  
  METHODS
  Clinically stable adult patients with unplanned admissions through the day and night under the care of general surgeons at two acute NHS trusts were approached during working week days and asked to complete validated PRO measures (European Quality of Life-5 Dimension, Short Form-12, and Gastrointestinal Quality of Life Index) on admission and 6 weeks following discharge. Feasibility of PRO data collection was determined by the proportions of admitted patients eligible and recruited and by questionnaire-response rates at baseline and follow up. Reasons for non-recruitment and non-completion of questionnaires were sought and recorded.
  
  
  RESULTS
  There were 276 admissions, of whom 235 (85.1 %) were eligible. Reasons for ineligibility were the following: age under 18 years old (n= 5, 1.8 %), non-surgical presenting complaint (n= 6, 2.2 %) and clinical instability (n= 30, 10.9 %). One hundred and sixty-six patients (70.6 %) were recruited (98 female, 59.0 %); median age 53, range 19-100). Common reasons for non-recruitment included patients being discharged home before approached by researchers (n= 29, 12.3 %) or declining participation because they felt unwell (n= 15, 6.4 %). The most common reason for admission to the hospital was abdominal pain (n= 120, 72.3 % recruited patients), of whom 50 (30.1 %) required operative intervention. Baseline PRO data was obtained from 153 patients (93.3 %), and 74 (48.4 %) returned follow-up questionnaires.
  
  
  CONCLUSIONS
  Collection of baseline PRO data amongst unplanned admissions in general surgery is feasible. Methods for optimising retention and follow up are needed.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: John D
authors.initials: JD
authors.lastname: Mason
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK ; Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Marlborough Street, Bristol, BS2 8HW UK.
authors.forename: Natalie S
authors.initials: NS
authors.lastname: Blencowe
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Angus Gk
authors.initials: AG
authors.lastname: McNair
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, Headington OX3 9DU UK.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Stevens
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Kerry N
authors.initials: KN
authors.lastname: Avery
authors.affiliation: Department of Surgery, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Bristol, BS10 5NB UK.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Pullyblank
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK ; Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Marlborough Street, Bristol, BS2 8HW UK.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
keywords: Emergency surgery; Feasibility; Methodology; Patient reported outcomes; Trial design