Denise Forshaw

Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke

BACKGROUND The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. METHODS In a pragmatic, cluster‐randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying‐flat position or a sitting‐up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). RESULTS The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying‐flat group were less likely than patients in the sitting‐up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional‐odds model, there was no significant shift in the distribution of 90‐day disability outcomes on the global modified Rankin scale between patients in the lying‐flat group and patients in the sitting‐up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying‐flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying‐flat group and 7.4% among the patients in the sitting‐up group (P=0.83). There were no significant between‐group differences in the rates of serious adverse events, including pneumonia. CONCLUSIONS Disability outcomes after acute stroke did not differ significantly between patients assigned to a lying‐flat position for 24 hours and patients assigned to a sitting‐up position with the head elevated to at least 30 degrees for 24 hours. (Funded by the National Health and Medical Research Council of Australia; HeadPoST ClinicalTrials.gov number, NCT02162017.)

Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial

BackgroundUrinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients.MethodsWe conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death.ResultsIt was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence.ConclusionsThe trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered.Trial registrationISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

Study protocol: ICONS: Identifying continence options after stroke: A randomised trial

BackgroundUrinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding) have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients.Methods/DesignA cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm). The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months) twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process.Trial RegistrationISRCTN: ISRCTN08609907

Icons: identifying continence options after stroke trial: utility of a logic model in the design and implementation of a process evaluation

Background: ICONS is a cluster randomised controlled pilot trial designed to provide preliminary evidence of the effectiveness of a systematic voiding programme (SVP) for the management of continence after stroke. Stroke services were randomised to receive the SVP, the SVP plus supported implementation, or usual care. Process evaluations are designed to evaluate fidelity and provide explanatory evidence around trial outcomes; these need to be underpinned by a theoretical framework to explain linkages between intervention processes and outcomes. Process evaluation: We conducted an evaluation to describe SVP implementation and assist in explaining intervention outcomes. Reflecting best practice in complex intervention research, we developed a logic model to underpin the evaluation representing practitioners’ implementation activities. To increase explanatory power of the model, we synthesised principles from theoretical frameworks underpinning the study (e.g. the Normalisation Process Model) into mechanisms of action to explain conditions necessary for activities to impact on outcomes. Mechanisms were: • Understanding and agreeing: conceptual work associated with the SVP, e.g. increasing awareness. • Driving and aligning: organising systems or processes to align and drive new practice. • Building and supporting: enacting the SVP. • Learning and evaluation: reflecting on performance and progress. Findings: We will discuss the utility of the logic model in explaining conditions necessary for the intervention to work, the success of implementation strategies adopted and variations in patient outcome across trial arms. We will also consider the challenges of synthesising across multiple data sources to understand variation in intervention delivery, maintenance and outcome in cluster trials.

Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke

We explored health professionals’ views of implementing a systematic voiding program (SVP) in a multi-site qualitative process evaluation in stroke services recruited to the intervention arms of a cluster randomized controlled feasibility trial during 2011-2013. We conducted semi-structured group or individual interviews with 38 purposively selected nursing, managerial, and care staff involved in delivering the SVP. Content analysis of transcripts used normalization process theory (NPT) as a pre-specified organization-level exploratory framework. Barriers to implementing the SVP included perceived lack of suitability for some patient groups, patient fear of extending hospital stay, and difficulties with SVP enactment, scheduling, timing, recording, and monitoring. Enablers included the guidance provided by the SVP, patient and relative involvement, extra staff, improved nursing skill and confidence, and experience of success. Three potential mechanisms of consistency, visibility, and individualization linked the SVP process with improvements in outcome, and should be emphasized in SVP implementation.

Role of emergency care staff in managing acute stroke

In June, the University of Central Lancashire opened its clinical trials unit, where staff will run complex intervention trials in a range of care areas, including stroke, musculoskeletal health, public health and mental health. One of the first trials looks at how hospital nursing policies in the first 24 hours after patients have had stroke affect their subsequent survival and disabilities. Known as HeadPoST, the study will recruit 20,000 patients globally, with the 6,000 UK research participants managed by Lancashire. This article explores the role of emergency nurses in supporting the research.

Assessing fidelity to complex interventions: the icons experience

Background Assessing fidelity to complex healthcare interventions in clinical trials is a challenging area. ‘ICONS’ is a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP), incorporating bladder training and prompted voiding, to promote post-stroke continence. Here we describe feasibility of one aspect of fidelity assessment: the day-to-day implementation of the SVP through analysis of clinical logs. Methods Nurses completed clinical logs daily, which included documenting: the toileting interval, proposed toileting times and times toileted. Clinical logs were sampled across trial sites. The original intention was to assess fidelity by exploring the degree of concordance between proposed times and times toileted. Initial analysis revealed the unfeasibility of this method due to documentation errors in toileting intervals and proposed times. Consequently, the planned method was changed to identification of key ‘quality indicators’ (QIs) for documentation of practice. Results The need to revise the method of measurement demonstrates the difficulty in assessing fidelity. Assessment of clinical logs revealed low levels of adherence to key quality indicators. However, it is unclear whether this indicates poor fidelity or an imprecise method of fidelity assessment. Conclusion

Practical and methodological challenges in the design and implementation of a cluster-randomised feasibility trial of the management of urinary incontinence after stroke

Methods Twelve stroke services were cluster-randomised to 3 intervention groups (systematic voiding programme with/without supported implementation; usual care) in 4 strata based on: having separate/combined acute and rehabilitation units; above/below median performance on the ‘nine key indicators of stroke care’ in the National Sentinel Stroke Audit (NSSA) [1]; number of annual stroke admissions. Target recruitment was 780 patients overall; the recruitment period was 9 or 12 months, depending on a Trust’s annual stroke admissions, to reduce variability in numbers across services. Each service gained an additional 2.8 whole time equivalent health care assistants (HCAs) supporting introduction of the intervention or maintaining parity of staffing in ‘usual care’ services.