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.
Highlights
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 difficult
Surgical trials often focus on outcomes relevant to surgeons, and there is a lack of RCTs in surgery with high-quality patient-reported outcome (PRO) data [5, 6]
PROs can be assessed using questionnaires known as patient-reported outcome measures (PROMs)
Summary
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 difficult. Well designed and conducted randomised control trials (RCTs) in surgery are uncommon, and surgical treatments are estimated to be half as likely to be based on evidence when compared with medical therapies [1]. This difference may be explained by the underlying challenges of designing and conducting RCTs in surgery, and surgeons often lack familiarity with these processes [2]. There are additional challenges to designing high-quality RCTs in emergency surgery as admission to the hospital is unplanned, and patients are acutely unwell making acquisition of informed consent for research and baseline data collection difficult. The long term impact of emergency surgery on PROs is needed to establish clinical effectiveness of treatments, but this can be difficult if patients have returned to normal activities and recovered from the acute illness before follow-up data is sought
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