An empirical study on the preferred size of the participant information sheet in research

Background: Informed consent is a requirement for all research. It is not, however, clear how much information is sufficient to make an informed decision about participation in research. Information on an online questionnaire about childhood development was provided through an unfolding electronic participant sheet in three levels of information. \ud Methods: 552 participants, who completed the web-based survey, accessed and spent time reading the participant information sheet (PIS) between July 2008 and November 2009. The information behaviour of the participants was investigated. The first level contained less information than might be found on a standard PIS, the second level corresponded to a standard PIS, and the third contained more information than on a standard PIS. The actual time spent on reading the information provided in three incremental levels and the participants' evaluation of the information were calculated. \ud Results: 77% of the participants chose to access the first level of information, whereas 12% accessed the first two levels, 6% accessed all three levels of information and 23% participated without accessing information. The most accessed levels of information were those that corresponded to the average reading times. \ud Conclusion: The brief information provided in the first level was sufficient for participants to make informed decisions, while a sizeable minority of the participants chose not to access any information at all. This study adds to the debate about how much information is required to make a decision about participation in research and the results may help inform the future development of information sheets by providing data on participants' actual needs when deciding about questionnaire surveys.\u

Muscle testing for lie detection: Grip strength dynamometry is inadequate

Introduction Although DMT is primarily used in the diagnosis of neuromusculoskeletal (NMS) disorders, previous studies have attempted to use other forms of manual muscle testing (MMT) to detect conditions other than NMS. For instance, muscle response testing (MRT) was used to distinguish lies (a known stressor) from truth. Therefore, it is hypothesised that DMT might be used to detect deceit as well, and the aim of this study was to investigate if grip strength via dynamometric muscle testing (DMT) could be used to distinguish lies from truth. Methods A prospective study of diagnostic test accuracy was carried out. Twenty participants, aged 18-65 years, with healthy hands, were recruited. Participants were given a visual stimulus and followed an auditory instruction to lie or to tell the truth about the stimulus, before recording grip strength with a dynamometer. Testing proceeded in this manner until 20 DMTs were performed, 10 by each hand. We analysed the accuracy of grip strength for detecting lies. Results The mean grip strength after true statements was found to be 24.9 kg (95% CI 20.3 to 29.6), and after false statements, 24.8 (95% CI 20.2 to 29.5), which were not statistically different (p = 0.61). Conclusion DMT via hand-held grip strength dynamometry failed to distinguish lies from truth. These results seem to suggest that strength as measured by DMT is not impacted by deceit. A limitation of this study is it is not generalisable to other types or applications of MMT or MRT or to other target conditions

Publication bias – teaching materials

The attached slides can be used to teach people about publication bias. There are notes beneath the slides with suggestions of how they might be used Prepared by Professor Amanda Burls and available from www.testingtreatments.org. Task purpose: to help people understand publication bias by working through a real concrete example. Key slides can be used usefully in a five minute slot in a session on appraising systematic reviews. However the extended use of the slides with group work could take up to an hour depending on how the teacher organises the session. Assumes no prior knowledge but can be used for quite a high level of prior skill group (i.e. those with previous training in the critical appraisal of systematic reviews) and indeed works well for a group with heterogenous skill levels. Skill area: making sense of the evidence from systematic review

Does evidence-based practice improve patient outcomes

Background Evidence based practice (EBP) is widely promoted, but does EBP practice produce better patient outcomes? We report a natural experiment when part of the internal medicine service in a hospital was reorganized in 2003 to form an EBP unit, the rest of the service remaining unchanged. The units attended similar patients until 2012 permitting comparisons of outcomes and activity. Methods We used routinely collected statistics (2004 11) to compare the two different methods of practice and test whether patients being seen by the EBP unit differed from standard practice (SP) patients. Data were available by doctor and year. To check for differences between the EBP and SP doctors prior to reorganization, we used statistics from 2000 2003. We looked for changes in patient outcomes or activity following reorganization and whether the EBP unit was achieving significantly different results from SP. Data across the periods were combined and tested using Mann-Whitney. Results No statistically significant differences in outcomes were detected between the EBP and the SP doctors prior to reorganization. Following the unit’s establishment, the mortality of patients being treated by EBP doctors compared to their previous performance dropped from 7.4% to 6.3% (P<0.02) and length of stay from 9.15 to 6.01 days (P=0.002). No statistically significant improvements were seen in SP physicians’ performance. No differences in the proportion of patients admitted or their complexity between the services were detected. Despite this, EBP patients had a clinically significantly lower risk of death 6.27% vs 7.75% (P<0.001) and a shorter length of stay 6.01 vs 8.46 days (P<0.001) than SP patients. Readmission rates were similar: 14.4% (EBP); 14.5% (SP). EBP doctors attended twice as many patients/doctor as SP doctors. Conclusion The EBP unit was associated with better patient outcomes and more efficient performance than achieved by the same physicians previously or by SP concurrently

Green Care: a Conceptual Framework. A Report of the Working Group on the Health Benefits of Green Care

‘Green Care’ is a range of activities that promotes physical and mental health and well-being through contact with nature. It utilises farms, gardens and other outdoor spaces as a therapeutic intervention for vulnerable adults and children. Green care includes care farming, therapeutic horticulture, animal assisted therapy and other nature-based approaches. These are now the subject of investigation by researchers from many different countries across the world

Immunoprophylaxis against respiratory syncytial virus (RSV) with palivizumab in children: a systematic review and economic evaluation

Objectives: To systematically review the effectiveness and cost-effectiveness of palivizumab for the prevention of respiratory syncytial virus (RSV) in children and examine prognostic factors to determine whether subgroups can be identified with important differences in cost-effectiveness. Data sources: Bibliographic databases were searched from inception to March 2007 for literature on the effectiveness and cost-effectiveness of prophylaxis with palivizumab. Review methods: The literature was systematically reviewed and current economic evaluations were analysed to identify which parameters were driving the different cost-effectiveness estimates. A probabilistic decision-analytical model was built to assess the cost-effectiveness of prophylaxis with palivizumab for children at risk of RSV infection and the parameters populated with the best estimates thought most applicable to the UK. We also constructed a new model, the Birmingham Economic Evaluation (BrumEE). Cost-effectiveness analyses were undertaken from both NHS and societal perspectives. Results: Two randomised controlled trials (RCTs) were identified. Prophylaxis with palivizumab for preterm infants without chronic lung disease (CLD) or children with CLD resulted in a 55% reduction in RSV hospital admission: 4.8% (48/1002) in the palivizumab group and 10.6% (53/500) in the no prophylaxis group (p=0.0004). Prophylaxis with palivizumab was associated with a 45% reduction in hospitalisation rate RSV among children with coronary heart disease (CHD). Hospitalisation rates for RSV were 5.3% (34/639) in the palivizumab group and 9.7% (63/648) in the no prophylaxis group (p=0.003). Of existing economic evaluations, 3 systematic reviews and 18 primary studies were identified. All the systematic reviews concluded that the potential costs of palivizumab were far in excess of any potential savings achieved by decreasing hospital admission rates, and that the use of palivizumab was unlikely to be cost-effective in all children for whom it is recommended, but that its continued use for particularly high-risk children may be justified. The incremental cost-effectiveness ratios (ICERs) of the primary studies varied 17-fold for life-years gained (LYG), from £25,800/ LYG to £404,900/LYG, and several hundred-fold for quality-adjusted life years (QALYs), from £3200/QALY to £1,489,700/QALY for preterm infants without CLD or children with CLD. For children with CHD, the ICER varied from £5300/LYG to £7900/LYG and from £7500/ QALY to £68,700/QALY. An analysis of what led to the discrepant ICERs showed that the assumed mortality rate for RSV infection was the most important driver. The results of the BrumEE confirm that palivizumab does not reach conventional levels of cost-effectiveness in any of the licensed indications if used for all eligible children. Conclusions: Prophylaxis with palivizumab is clinically effective for the reducing the risk of serious lower respiratory tract infection caused by RSV infection and requiring hospitalisation in high-risk children, but if used unselectively in the licensed population, the ICER is double that considered to represent good value for money in the UK. The BrumEE shows that prophylaxis with palivizumab may be cost-effective (based on a threshold of £30,000/QALY) for children with CLD when the children have two or more additional risk factors. Future research should initially focus on reviewing systematically the major uncertainties for patient subgroups with CLD and CHD and then on primary research to address the important uncertainties that remain

Effectiveness of autologous chondrocyte transplantation for hyaline cartilage defects in knees: a rapid and systematic review.

Background \ud \ud Proposed service Autologous chondrocyte transplantation (ACT) is a novel surgical approach used to treat full-thickness cartilage defects in knee joints. Small grafts of normal cartilage removed from the patient’s diseased joint are treated in a laboratory to obtain cartilage cells. These cells are cultured to expand the cell population and reimplanted a few weeks later into areas where cartilage is denuded by disease. The aim of this procedure is to restore normal cartilage to the ends of bones and thereby restore normal joint function. \ud \ud Epidemiology \ud \ud There are no reliable estimates of the prevalence of cartilage defects in the knee. Lesions are most likely to arise in sportsmen and women as a result of injury. Up to 20% of individuals sustaining a haemarthrosis following a knee injury may have cartilage damage. \ud \ud Objectives \ud \ud This systematic review of the available evidence was performed to: \ud \ud 1. Describe the types of knee disease for which ACT has been applied, the natural history and epidemiology of these conditions, and alternative treatment options \ud 2. Determine long-term clinical outcomes following ACT and other surgical procedures for knee cartilage defects \ud 3. Examine the economic evidence and consider the economic gains resulting from ACT. \ud \ud Methods \ud \ud To analyse the effectiveness of treatment and the resultant economic impact, a systematic review of the literature, involving a range of databases, was performed. In addition, contact was made with leading researchers and industry. Full details are described in the main report. \ud \ud Results \ud \ud Number and quality of studies and direction of evidence Of 46 identified reports, 17 met the criteria for inclusion in this review. Eight of the included reports were available as abstracts only. At least 2600 patients appear to have been treated with ACT. All included reports were case series with a variable length of follow-up. With one exception, all the studies reported improvement in patient status, usually over a follow-up period of less than 2 years. \ud \ud Summary of benefits \ud \ud The outcome of ACT surgery was rated as ‘good’ or ‘excellent’ by approximately 70% of patients 2 years after treatment. Approximately 16% of patients required further arthroscopic surgical procedures during follow-up, and treatment was judged to have failed in 3–7% of patients. For comparator treatments, the outcome was rated as ‘good’ or ‘excellent’ in 10–95% of patients 2 years after treatment. \ud \ud Economic review \ud \ud The reports of two studies, one based in the USA and the other in Sweden, included economic data. Neither study compared ACT with other treatments. Using data from these studies and other sources, it was estimated that ACT performed in the UK would cost £4667 or £8167 for cell culture and surgery, depending on which service provider was used for cell culture. Incremental cost over 2 years, when set against comparator treatments, was estimated to be £3771 or £7271 (base case) for cell culture, surgery and rehabilitation. Using the OsCell facility for cell culture (Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust), this figure would be £3167. \ud \ud Conclusions \ud \ud The reported literature on ACT and comparators is subject to bias because of the inherent weaknesses of case series. In addition, the long-term impact of conventional surgical treatments or no surgical treatment is poorly documented. The cost-effectiveness analysis is similarly limited by the poverty of the effectiveness data on both ACT and comparators, the lack of long-term follow-up and the lack of empirical data for some of the parameters in the model used. \ud \ud Recommendations for research \ud \ud Further studies are required to: \ud \ud 1. Provide more accurate data on the occurrence of hyaline cartilage defects, including defects that arise acutely and those that are secondary to other types of knee injuries \ud 2. Clarify the relationship of cartilage defects to clinical symptoms \ud 3. Evaluate in detail the natural history of cartilage defects diagnosed by modern arthroscopic methods \ud 4. Compare ACT with other treatments deemed appropriate, based on randomised trials currently in progress or planned \ud 5. Examine, in prospective randomised trials, issues such as differences in outcome in patient subgroups (e.g. the suggested poor outcomes in patients with patellar defects), with patients followed for as long as possible \ud 6. Address the deficiencies in evaluating the clinical outcomes of knee injury and incorporate measures of general health status \ud 7. Consider study designs, other than randomised trials, that might be used to assess complex interventions such as those required in complex knee injuries

SMOOTH (Self-Management of Open Online Trials in Health) analysis found improvements were needed for reporting methods of internet-based trials

Background The growth of trials conducted over the internet has increased, but with little practical guidance for their conduct and it is sometimes challenging for researchers to adapt the conventions used in face-to-face trials and maintain the validity of the work. Aim To systematically explore existing self-recruited online randomized trials of self-management interventions and analyze the trials to assess their strengths and weaknesses, the quality of reporting and the involvement of lay persons as collaborators in the research process. Methods The Online Randomized Controlled Trials of Health Information Database (ORCHID) was used as the sampling frame to identify a subset of self-recruited online trials of self-management interventions. The authors cataloged what these online trials were assessing, appraised study quality, extracted information on how trials were run and assessed the potential for bias. We searched out how public and patient participation was integrated into online trial design and how this was reported. We recorded patterns of use for registration, reporting, settings, informed consent, public involvement, supplementary materials, and dissemination planning. Results The sample included 41 online trials published from 2002-2015. The barriers to replicability and risk of bias in online trials included inadequate reporting of blinding in 28/41 (68%) studies; high attrition rates with incomplete or unreported data in 30/41 (73%) of trials; and 26/41 (63%) of studies were at high risk for selection bias as trial registrations were unreported. The methods for (23/41, 56%) trials contained insufficient information to replicate the trial, 19/41 did not report piloting the intervention. Only 2/41 studies were cross-platform compatible. Public involvement was most common for advisory roles (n=9, 22%), and in the design, usability testing and piloting of user materials (n=9, 22%) Conclusions This study catalogs the state of online trials of self-management in the early 21st century and provides insights for online trials development as early as the protocol planning stage. Reporting of trials was generally poor and, in addition to recommending that authors report their trials in accordance with CONSORT guidelines, we make recommendations for researchers writing protocols, reporting on and evaluating online trials. The research highlights considerable room for improvement in trial registration, reporting of methods, data management plans, and public and patient involvement in self-recruited online trials of self-management interventions