Effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET)

Objective To compare the clinical effectiveness of doctors and nurses in undertaking upper and lower gastrointestinal endoscopy. Design Pragmatic trial with Zelen's randomisation before consent to minimise distortion of existing practice. Setting 23 hospitals in the United Kingdom. In six hospitals, nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 centres. Participants 67 doctors and 30 nurses. Of 4964 potentially eligible patients, we randomised 4128 (83%) and recruited 1888 (38%) from July 2002 to June 2003. Interventions Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy, undertaken with or without sedation, with the standard preparation, techniques, and protocols of participating hospitals. After referral for either procedure, patients were randomised between doctors and nurses. Main outcome measures Gastrointestinal symptom rating questionnaire (primary outcome), gastrointestinal endoscopy satisfaction questionnaire and state-trait anxiety inventory (all analysed by intention to treat); immediate and delayed complications; quality of examination and corresponding report; patients' preferences for operator; and new diagnoses at one year (all analysed according to who carried out the procedure). Results There was no significant difference between groups in outcome at one day, one month, or one year after endoscopy, except that patients were more satisfied with nurses after one day. Nurses were also more thorough than doctors in examining the stomach and oesophagus. While quality of life scores were slightly better in patients the doctor group, this was not statistically significant. Conclusions Diagnostic endoscopy can be undertaken safely and effectively by nurses. Trial registration International standard RCT 8276570

Randomised controlled trial of exercise for low back pain : clinical outcomes, costs and preferences

Objective: To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities. Design: Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients' preferences for type of management were elicited independently of randomisation. Participants: 187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months' duration. Interventions: Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used. Main outcome measures: Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services. Results: At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients' preferences. Conclusions: The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective

Designing and analysing feasibility studies of complex interventions: challenges related to assessing stop/go criteria

Randomised controlled trials (RCTs) are time-consuming and costly so funders often require evidence of feasibility before they will fund large scale trials1. Feasibility studies can provide invaluable evidence relating to the practicalities of conducting large RCTs and can improve their likelihood of success. However, conducting feasibility studies of complex interventions and deciding whether or not to proceed to a full RCT, is not always straightforward. We will present the challenges encountered during the design and analysis of two feasibility studies: OBI (Optimised Behavioural Intervention for avoidant chronic low back pain patients) and MIDSHIPS (Multicentre Intervention Designed for Self-Harm using Interpersonal Problem Solving) and discuss the steps taken to overcome them. Recruiting and treating participants in a limited number of centres, with few therapists, is a complex challenge for both of these feasibility studies and crucial to determining their success; we will present the lessons learnt from our experience. We will also discuss the impact of missing data on our ability to assess stop/go criteria with respect to proof-of-concept. Estimating follow-up questionnaire response rates is an important objective in both studies, hence we will discuss the methods employed to maximise data collection and present our approach for providing robust estimates of response rates for the phase III trials

Investigation of ward fidelity to a multicomponent delirium prevention intervention during a multicentre, pragmatic, cluster randomised, controlled feasibility trial

Background delirium is a frequent complication of hospital admission for older people and can be reduced by multicomponent interventions, but implementation and delivery of such interventions is challenging. Objective to investigate fidelity to the prevention of delirium system of care within a multicentre, pragmatic, cluster randomised, controlled feasibility trial. Setting five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales. Data collection research nurse observations of ward practice; case note reviews and examination of documentation. Assessment 10 health care professionals with experience in older people’s care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). Results the mean score (range) for each domain was: installation 4.5 (3.5–5); delivery 32.6 (range 27.3–38.3); coverage 7.9 (range 4.2–10.1); and duration 0.38 (0–1). Of the 10 delirium risk factors, infection, nutrition, hypoxia and pain were the most and cognitive impairment, sensory impairment and multiple medications the least consistently addressed. Overall fidelity to the intervention was assessed as high (≥80%) in two wards, medium (51–79%) in five wards and low (≤50%) in one ward. Conclusion the trial was designed as a pragmatic evaluation, and the findings of medium intervention fidelity are likely to be generalisable to delirium prevention in routine care and provide an important context to interpret the trial outcomes

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK

Background Researchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availability of routinely collected data for research, whether healthcare or administrative, has increased, and infrastructure funding has enabled much of this. However, challenges remain at all stages of a trial life cycle. This study, COMORANT-UK, aimed to systematically identify, with key stakeholders across the UK, the ongoing challenges related to trials that seek to use routinely collected data. Methods This three-step Delphi method consisted of two rounds of anonymous web-based surveys and a virtual consensus meeting. Stakeholders included trialists, data infrastructures, funders of trials, regulators, data providers and the public. Stakeholders identified research questions or challenges that they considered were of particular importance and then selected their top 10 in the second survey. The ranked questions were taken forward to the consensus meeting for discussion with representatives invited from the stakeholder groups. Results In the first survey, 66 respondents yielded over 260 questions or challenges. These were thematically grouped and merged into a list of 40 unique questions. Eighty-eight stakeholders then ranked their top ten from the 40 questions in the second survey. The most common 14 questions were brought to the virtual consensus meeting in which stakeholders agreed a top list of seven questions. We report these seven questions which are within the following domains: trial design, Patient and Public Involvement, trial set-up, trial open and trial data. These questions address both evidence gaps (requiring further methodological research) and implementation gaps (requiring training and/or service re-organisation). Conclusion This prioritised list of seven questions should inform the direction of future research in this area and should direct efforts to ensure that the benefits in major infrastructure for routinely collected data are achieved and translated. Without this and future work to address these questions, the potential societal benefits of using routinely collected data to help answer important clinical questions will not be realised