Rebecca L Ashby

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial

BACKGROUND Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. METHODS We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. FINDINGS We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. INTERPRETATION Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. FUNDING NIHR Health Technology Assessment programme (07/60/26).

Methods to assess cost-effectiveness and value of further research when data are sparse: Negative-pressure wound therapy for severe pressure ulcers

Health care resources are scarce, and decisions have to be made about how to allocate funds. Often, these decisions are based on sparse or imperfect evidence. One such example is negative-pressure wound therapy (NPWT), which is a widely used treatment for severe pressure ulcers; however, there is currently no robust evidence that it is effective or cost-effective. This work considers the decision to adopt NPWT given a range of alternative treatments, using a decision analytic modeling approach. Literature searches were conducted to identify existing evidence on model parameters. Given the limited evidence base, a second source of evidence, beliefs elicited from experts, was used. Judgments from experts on relevant (uncertain) quantities were obtained through a formal elicitation exercise. Additionally, data derived from a pilot trial were also used to inform the model. The 3 sources of evidence were collated, and the impact of each on cost-effectiveness was evaluated. An analysis of the value of further information indicated that a randomized controlled trial may be worthwhile in reducing decision uncertainty, where from a set of alternative designs, a 3-arm trial with longer follow-up was estimated to be the most efficient. The analyses presented demonstrate how allocation decisions about medical technologies can be explicitly informed when data are sparse and how this kind of analyses can be used to guide future research prioritization, not only indicating whether further research is worthwhile but what type of research is needed and how it should be designed.

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034].

BackgroundNegative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial.MethodsThis was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up.ResultsThree hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months.ConclusionsThis pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial.Trial registrationCurrent Controlled Trials ISRCTN69032034.

A randomized trial of electronic reminders showed a reduction in the time to respond to postal questionnaires

OBJECTIVE To assess the effect of electronic reminders (ERs) on response rate and time to response for the return of postal questionnaires. STUDY DESIGN AND SETTING This open randomized controlled trial (RCT) was conducted at the University of York. Participants who were taking part in an established RCT and who provided an electronic mail address and/or mobile telephone number were eligible to take part in the study. The intervention group received ERs on the day they were expected to receive postal questionnaires. RESULTS One hundred forty-eight participants (19 male and 129 female) aged 47±11 (range, 19-65) years were studied. About 89.2% of participants returned postal questionnaires. There was no difference in questionnaire response rates in control (64 of 74 [86.5%]) vs. intervention (68 of 74 [91.9%]), groups (relative risk=1.063, 95% confidence interval: 0.949-1.189). Median questionnaire time to response was 4 days less in the intervention group (10.0±0.2; range, 10-14 days) compared with the control group (14.0±1.4; range, 10-23 days) (χ(2)(1df)=5.27, P=0.022). CONCLUSION ERs are useful tools for reducing participant time to response for postal questionnaires. We found little evidence for an effect of ERs on response rate for postal questionnaires.

Funding source and the quality of reports of chronic wounds trials: 2004 to 2011

BackgroundCritical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality.MethodsA systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed.ResultsA total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered.ConclusionsThis overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.

Diagnosis and treatment of failed back surgery syndrome in the UK: mapping of practice using a cross-sectional survey.

Background: Chronic back pain is a serious public health issue, associated with poor quality of life and disability. There is a specific group of chronic back pain sufferers whose pain persists despite their having undergone anatomically successful lumbosacral spine surgery. These patients are known as having failed back surgery syndrome (FBSS) and are frequently seen in pain clinics. It is currently unclear what constitutes routine practice in terms of diagnosis and treatment of FBSS in the UK. Aim: To map the diagnosis of and provision of care for patients with FBSS. Methods: A cross-sectional survey of specialist pain clinics in the UK. Results: This first attempt to survey 241 pain clinics in the UK achieved a response rate of 52%. The results of this survey suggest that patients at UK pain clinics were often diagnosed with FBSS between 6 and 12 months after surgery. Treatment is often initiated when patients report a level of pain between 3 and 5 cm (on a 10-cm visual analogue scale) and a range of therapeutic options are pursued in the hope of addressing the range of presenting symptoms. Conclusions: It is evident from the findings of this survey that, though there is some variation, pain specialists in the UK identify and handle patients with FBSS as a separate clinical entity. Direct, randomised comparisons of interventions should be the focus of research into appropriate treatment regimens going forward. Also, evidence of clinical effectiveness will need to incorporate elements of patient acceptance of interventions.

Developing Interventions for Children’s Exercise (DICE): A Pilot Evaluation of School-Based Exercise Interventions for Primary School Children Aged 7 to 8 Years

BACKGROUND Developing Interventions for Childrens Exercise (DICE) is an initiative aimed at determining effective school-based exercise programs. To assess feasibility, we conducted a pilot study of exercise sessions which varied in duration and frequency. METHODS Exercise interventions were delivered to Year 3 pupils (age 7-8 years; n = 73) in primary schools within Yorkshire, UK. Evaluations were conducted using focus group sessions, questionnaires and observations. RESULTS The study revealed positive aspects of all interventions, including favorable effects on childrens concentration during lessons and identified the value of incorporation of the DICE concept into curriculum lessons. Children appeared enthused and reported well-being and enjoyment. Areas requiring attention were the need for appropriate timetabling of sessions and ensuring the availability of space. CONCLUSION The concept and sessions were well-accepted by teachers who confirmed their full support of any future implementation There appears to be potential for the encouragement and empowerment of teachers to support physical activity and healthy school environments, and to take an interest in the health of their pupils. Ultimately, these findings should assist in the design of successful exercise interventions in the school setting.