Investigating the collection and assessment of patient-reported outcome data amongst unplanned surgical hospital admissions: a feasibility study

Abstract

BackgroundRandomised 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.MethodsClinically 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.ResultsThere 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.ConclusionsCollection of baseline PRO data amongst unplanned admissions in general surgery is feasible. Methods for optimising retention and follow up are needed.

Laparoscopic versus open colorectal surgery in the acute setting (LaCeS trial): a multicentre randomized feasibility trial

“…LaCeS has demonstrated that it is possible to collect high-volume, good-quality clinical and patient-reported outcome data in the emergency setting both at baseline and during follow-up. Although attrition was noted during follow-up with regard to HRQoL data, response rates in this study were much higher than previously reported at all candidate follow-up time points 37 ; the lowest response rate of 58⋅3 per cent was observed at 12 months. Data from qualitative patient interviews suggested that the burden of questionnaire completion was high and some questionnaires were deemed irrelevant to the patients' clinical status.…”

“…The routine collection of patient‐reported outcome data in the emergency setting was previously documented to be of low quality, with poor reporting of baseline data 36 . This is coupled with high rates of attrition, with Mason and colleagues 37 reporting 6‐week response rates of 48·4 per cent, despite an initial baseline compliance rate of 93 per cent among 156 patients presenting to emergency general surgery services. LaCeS has demonstrated that it is possible to collect high‐volume, good‐quality clinical and patient‐reported outcome data in the emergency setting both at baseline and during follow‐up.…”

Feasibility of collecting and assessing patient-reported outcomes for emergency admissions: laparotomy for gastrointestinal conditions

“…It was shown that with high response rates, any responder bias is slight and will not undermine comparisons of providers. The higher response rates achieved in our study compared with a prior study in England 9 may reflect the severity of emergency laparotomy as a subset of emergency surgical admissions. In elective surgery, higher response rates are observed with major procedures such as hip replacement than minor procedures such as inguinal hernia repair.…”

“…The relevance of the available evidence is unclear as studies either involved only a few centres or were restricted to protocol-driven intervention trials instead of routine use. 9 10 In addition, studies were mostly conducted in other countries, so the results may not be applicable in England. 11–18 Response rates ranged between 51% and 71% for mailed questionnaires, and between 51% and 84% for interviewer-administered questionnaires.…”

Methodological overview of systematic reviews to establish the evidence base for emergency general surgery

“…These are compounded in the emergency surgical setting, with particular challenges to recruitment and data collection. Although little is known about how to optimize data collection in this setting, a recent study has examined the feasibility of collecting patient‐reported outcome data during unplanned hospital admissions. It found that, with specific research support during the working week, good baseline response rates to questionnaires could be achieved.…”