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author:("burns, Amanda")
1.  Estimating the accuracy of muscle response testing: two randomised-order blinded studies 
Manual muscle testing (MMT) is a non-invasive assessment tool used by a variety of health care providers to evaluate neuromusculoskeletal integrity, and muscular strength in particular. In one form of MMT called muscle response testing (MRT), muscles are said to be tested, not to evaluate muscular strength, but neural control. One established, but insufficiently validated, application of MRT is to assess a patient’s response to semantic stimuli (e.g. spoken lies) during a therapy session. Our primary aim was to estimate the accuracy of MRT to distinguish false from true spoken statements, in randomised and blinded experiments. A secondary aim was to compare MRT accuracy to the accuracy when practitioners used only their intuition to differentiate false from true spoken statements.
Two prospective studies of diagnostic test accuracy using MRT to detect lies are presented. A true positive MRT test was one that resulted in a subjective weakening of the muscle following a lie, and a true negative was one that did not result in a subjective weakening of the muscle following a truth. Experiment 2 replicated Experiment 1 using a simplified methodology. In Experiment 1, 48 practitioners were paired with 48 MRT-naïve test patients, forming unique practitioner-test patient pairs. Practitioners were enrolled with any amount of MRT experience. In Experiment 2, 20 unique pairs were enrolled, with test patients being a mix of MRT-naïve and not-MRT-naïve. The primary index test was MRT. A secondary index test was also enacted in which the practitioners made intuitive guesses (“intuition”), without using MRT. The actual verity of the spoken statement was compared to the outcome of both index tests (MRT and Intuition) and their mean overall fractions correct were calculated and reported as mean accuracies.
In Experiment 1, MRT accuracy, 0.659 (95% CI 0.623 - 0.695), was found to be significantly different (p < 0.01) from intuition accuracy, 0.474 (95% CI 0.449 - 0.500), and also from the likelihood of chance (0.500; p < 0.01). Experiment 2 replicated the findings of Experiment 1. Testing for various factors that may have influenced MRT accuracy failed to detect any correlations.
MRT has repeatedly demonstrated significant accuracy for distinguishing lies from truths, compared to both intuition and chance. The primary limitation of this study is its lack of generalisability to other applications of MRT and to MMT.
Study registration
The Australian New Zealand Clinical Trials Registry (ANZCTR;; ID # ACTRN12609000455268, and US-based (ID # NCT01066312).
Electronic supplementary material
The online version of this article (doi:10.1186/s12906-016-1416-2) contains supplementary material, which is available to authorized users.
PMCID: PMC5131520  PMID: 27903263
Sensitivity; Specificity; Muscle weakness; Lie detection; Kinesiology
2.  A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project 
Trials  2016;17:19.
The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe.
Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence.
The principal communication materials developed were:A website ( in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN projectAn animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorialAn inventory of resources, available in 23 languages, searchable by topic, author, and media typeTwo educational games for young people, developed in six languagesTesting Treatments interactive in a dozen languages, including five official European Community languagesAn interactive tutorial slide presentation testing viewers’ knowledge about clinical trials
Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network.
PMCID: PMC4710012  PMID: 26758509
Independent clinical trial; Patients; Lay people; Health research; Information; Access to information
3.  Design Characteristics Influence Performance of Clinical Prediction Rules in Validation: A Meta-Epidemiological Study 
PLoS ONE  2016;11(1):e0145779.
Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules’ performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics.
Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described.
A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2–4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively.
Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved.
PMCID: PMC4701404  PMID: 26730980
4.  Exploring the Usability of a Mobile App for Adolescent Obesity Management 
JMIR mHealth and uHealth  2014;2(2):e29.
Obesity is a global epidemic. Behavioral change approaches towards improving nutrition, increasing physical activity level, improving sleep, and reducing sitting time are recommended as best practices in adolescent obesity management. However, access to evidence-based treatment is limited and portable technologies such as mobile apps may provide a useful platform to deliver such lifestyle interventions. No evidence-based validated app exists for obesity intervention; therefore, a novel mobile app (Reactivate) was developed for use in the Temple Street W82GO Healthy Lifestyles Program (W82GO).
This study aimed to test the usability (technical effectiveness, efficiency, and user satisfaction) of the Reactivate mobile app in obese adolescents.
Ten adolescents (7 males and 3 females, aged 12-17 years) who had been treated for obesity (>98th percentile for body mass index) at the Temple Street Children's University Hospital were recruited. Participants were given 8 tasks to complete in order to test the technical effectiveness of the app. A research assistant timed the user while completing each task in order to test the relative user efficiency of the app (time-on-task). The tasks fell into 5 categories and required the user to enter personal settings, find and answer surveys, create a message, use the goal setting feature, and enter details regarding their weight and height. In exploration of user satisfaction, each participant completed the standardized software usability measurement inventory (SUMI), which measures 5 aspects of user satisfaction: efficiency, effect, helpfulness, controllability, and learnability. Descriptive statistics were used to explore the mean relative user efficiency and SUMI scores.
Mean age was 14.26 (SD 1.58) years. All adolescents completed each of the tasks successfully. The mean relative user efficiency scores were two to three times that of an expert user. Users responded that they would use Reactivate to monitor their growth over time, for motivation, and for goal setting. All users described Reactivate as an important mobile app.
Our study describes the usability of a mobile app used in adolescent obesity management. Adolescents found Reactivate easy to use and their SUMI results indicated that the app scored high on user satisfaction. Usability testing is an important step towards refining the development of the Reactivate app, which can be used in the treatment of obesity. The study on the clinical efficacy of the Reactivate app is currently underway.
PMCID: PMC4114470  PMID: 25098237
obesity; mobile health; usability testing; adolescent; participatory health care
5.  A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial 
Trials  2014;15:43.
There are few evidence-based mobile health solutions for treating adolescent obesity. The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months, compared to the Temple Street W82GO Healthy Lifestyles intervention.
The primary outcome measure is change in body mass index standardised deviation score at 12 months. The secondary aim is to compare the effect of treatment on secondary outcomes, including waist circumference, insulin sensitivity, quality of life, physical activity and psychosocial health. Adolescents with a body mass index at or above the 98th percentile (12 to 17 years) will be recruited from the Obesity clinic at Temple Street Children’s University Hospital in Dublin, Ireland. W82GO is a family-based lifestyle change intervention delivered in two phases over 12 months. In the current study, participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application. One hundred and thirty-four participants will be randomised between the two study arms. An intention-to-treat analysis will be used to compare treatment differences between the groups at 12 months.
The results of this study will be disseminated via open access publication and will provide important information for clinicians, patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity.
Trial registration NCT01804855.
PMCID: PMC3937237  PMID: 24485327
Obesity; Smartphone; Adolescent; Behavioural intervention; Mobile health; Telemedicine
6.  Patterns of ‘leakage’ in the utilisation of clinical guidelines: a systematic review 
Postgraduate Medical Journal  2011;87(1032):670-679.
Research evidence is insufficient to change physicians' behaviour. In 1996, Pathman developed a four step model: that physicians need to be aware of, agree with, adopt, and adhere to guidelines.
To review evidence in different settings on the patterns of ‘leakage’ in the utilisation of clinical guidelines using Pathman's awareness-to-adherence model.
A systematic review was conducted in June 2010. Primary studies were included if they reported on rates of awareness and agreement and adoption and/or adherence.
11 primary studies were identified, reporting on 29 recommendations. Descriptive analyses of patterns and causes of leakage were tabulated and graphed. Leakage was progressive across all four steps. Median adherence from all recommendations was 34%, suggesting that potential benefits for patients from health research may be lost. There was considerable variation across different types of guidelines. Recommendations for drug interventions, vaccination and health promotion activities showed high rates of awareness. Leakage was most pronounced between adoption and adherence for drug recommendations and between awareness and agreement for medical management recommendations. Barriers were reported differentially for all steps of the model.
Leakage from research publication to guideline utilisation occurs in a wide variety of clinical settings and at all steps of the awareness-to-adherence pathway. This review confirms that clinical guidelines are insufficient to implement research and suggests there may be different factors influencing clinicians at each step of this pathway. Recommendations to improve guideline adherence need to be tailored to each step.
PMCID: PMC3181428  PMID: 21715571
Practice guideline; evidence-based practice; guideline adherence; protocols & guidelines; medical education & training; statistics & research methods
7.  Effectiveness of an e-learning course in evidence-based medicine for foundation (internship) training 
To evaluate the educational effectiveness of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content.
We conducted a cluster randomized controlled trial to compare a clinically integrated e-learning EBM course (intervention) to a lecture-based course (control) among postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midlands region. Knowledge gain among participants was measured with a validated instrument using multiple choice questions. Change in knowledge was compared between groups taking into account the cluster design and adjusted for covariates at baseline using generalized estimating equations (GEE) model.
There were seven clusters involving teaching of 237 trainees (122 in the intervention and 115 in the control group). The total number of postgraduate trainees who completed the course was 88 in the intervention group and 72 in the control group. After adjusting for baseline knowledge, there was no difference in the amount of improvement in knowledge of EBM between the two groups. The adjusted post course difference between the intervention group and the control group was only 0.1 scoring points (95% CI −1.2–1.4).
An e-learning course in EBM was as effective in improving knowledge as a standard lecture-based course. The benefits of an e-learning approach need to be considered when planning EBM curricula as it allows standardization of teaching materials and is a potential cost-effective alternative to standard lecture-based teaching.
PMCID: PMC2895523  PMID: 20522698
8.  On the resuscitation of clinical freedom 
This paper is a response to the suggestion by Sacristán et al that clinicians can increase their clinical freedom by undertaking individualised economic analyses that demonstrate that interventions, which at a population level do not reach conventional thresholds of cost-effectiveness, do so in particular patients.
In this reply, I question the presumption that "clinical freedom" is necessarily desirable and go on to argue that, even if it is, the proposal that clinicians should do individualised economic evaluation is flawed. Firstly, the additional clinical choice that may be gained from individualised economic analyses that demonstrate that an intervention, generally considered not to be cost-effective, is cost-effective in a particular patient, is likely to be counterbalanced by other analyses that produce the converse result (i.e. that an intervention that is cost-effective at a population level may not be so in a particular patient) - a complementary consequence, which is ignored by Sacristán et al in their paper. Secondly, the skills and time required to do an individualised economic analysis are likely to exceed those of most clinicians. Thirdly, and most importantly, asking clinicians to make rationing judgements at the point of care is a threat to patient trust and can harm the doctor-patient relationship.
Individualised economic evaluations are neither a desirable nor feasible method for increasing clinical choice.
PMCID: PMC2908614  PMID: 20584278
9.  The effectiveness of a clinically integrated e-learning course in evidence-based medicine: A cluster randomised controlled trial 
To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content.
We conducted a cluster randomised controlled trial in the Netherlands and the UK involving postgraduate trainees in six obstetrics and gynaecology departments. Outcomes (knowledge gain and change in attitude towards EBM) were compared between the clinically integrated e-learning course (intervention) and the traditional lecture based course (control). We measured change from pre- to post-intervention scores using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome).
There were six clusters involving teaching of 61 postgraduate trainees (28 in the intervention and 33 in the control group). The intervention group achieved slightly higher scores for knowledge gain compared to the control, but these results were not statistically significant (difference in knowledge gain: 3.5 points, 95% CI -2.7 to 9.8, p = 0.27). The attitudinal changes were similar for both groups.
A clinically integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted. Being less costly than traditional teaching and allowing for more independent learning through materials that can be easily updated, there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning.
Trial registration
Trial registration number: ACTRN12609000022268.
PMCID: PMC2688004  PMID: 19435520
10.  Harmonising Evidence-based medicine teaching: a study of the outcomes of e-learning in five European countries 
We developed and evaluated the outcomes of an e-learning course for evidence based medicine (EBM) training in postgraduate medical education in different languages and settings across five European countries.
We measured changes in knowledge and attitudes with well-developed assessment tools before and after administration of the course. The course consisted of five e-learning modules covering acquisition (formulating a question and search of the literature), appraisal, application and implementation of findings from systematic reviews of therapeutic interventions, each with interactive audio-visual learning materials of 15 to 20 minutes duration. The modules were prepared in English, Spanish, German and Hungarian. The course was delivered to 101 students from different specialties in Germany (psychiatrists), Hungary (mixture of specialties), Spain (general medical practitioners), Switzerland (obstetricians-gynaecologists) and the UK (obstetricians-gynaecologists). We analysed changes in scores across modules and countries.
On average across all countries, knowledge scores significantly improved from pre- to post-course for all five modules (p < 0.001). The improvements in scores were on average 1.87 points (14% of total score) for module 1, 1.81 points (26% of total score) for module 2, 1.9 points (11% of total score) for module 3, 1.9 points (12% of total score) for module 4 and 1.14 points (14% of total score) for module 5. In the country specific analysis, knowledge gain was not significant for module 4 in Spain, Switzerland and the UK, for module 3 in Spain and Switzerland and for module 2 in Spain. Compared to pre-course assessment, after completing the course participants felt more confident that they can assess research evidence and that the healthcare system in their country should have its own programme of research about clinical effectiveness.
E-learning in EBM can be harmonised for effective teaching and learning in different languages, educational settings and clinical specialties, paving the way for development of an international e-EBM course.
PMCID: PMC2386125  PMID: 18442424
11.  A clinically integrated curriculum in Evidence-based Medicine for just-in-time learning through on-the-job training: The EU-EBM project 
Over the last years key stake holders in the healthcare sector have increasingly recognised evidence based medicine (EBM) as a means to improving the quality of healthcare. However, there is considerable uncertainty about the best way to disseminate basic knowledge of EBM. As a result, huge variation in EBM educational provision, setting, duration, intensity, content, and teaching methodology exists across Europe and worldwide. Most courses for health care professionals are delivered outside the work context ('stand alone') and lack adaptation to the specific needs for EBM at the learners' workplace. Courses with modern 'adaptive' EBM teaching that employ principles of effective continuing education might fill that gap. We aimed to develop a course for post-graduate education which is clinically integrated and allows maximum flexibility for teachers and learners.
A group of experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions from eight European countries participated. We used an established methodology of curriculum development to design a clinically integrated EBM course with substantial components of e-learning. An independent European steering committee provided input into the process.
We defined explicit learning objectives about knowledge, skills, attitudes and behaviour for the five steps of EBM. A handbook guides facilitator and learner through five modules with clinical and e-learning components. Focussed activities and targeted assignments round off the learning process, after which each module is formally assessed.
The course is learner-centred, problem-based, integrated with activities in the workplace and flexible. When successfully implemented, the course is designed to provide just-in-time learning through on-the-job-training, with the potential for teaching and learning to directly impact on practice.
PMCID: PMC2228282  PMID: 18042271
12.  Commissioning for rare diseases: view from the frontline 
BMJ : British Medical Journal  2005;331(7523):1019-1021.
Deciding whether to fund treatments that do good one by one tends to lead to a positive decision. However, this can cause wider harmful effects, as West Midlands' experience in the funding of enzyme replacement therapy for lysosomal storage diseases shows
PMCID: PMC1273463  PMID: 16254306
13.  Sicily statement on evidence-based practice 
A variety of definitions of evidence-based practice (EBP) exist. However, definitions are in themselves insufficient to explain the underlying processes of EBP and to differentiate between an evidence-based process and evidence-based outcome. There is a need for a clear statement of what Evidence-Based Practice (EBP) means, a description of the skills required to practise in an evidence-based manner and a curriculum that outlines the minimum requirements for training health professionals in EBP. This consensus statement is based on current literature and incorporating the experience of delegates attending the 2003 Conference of Evidence-Based Health Care Teachers and Developers ("Signposting the future of EBHC").
Evidence-Based Practice has evolved in both scope and definition. Evidence-Based Practice (EBP) requires that decisions about health care are based on the best available, current, valid and relevant evidence. These decisions should be made by those receiving care, informed by the tacit and explicit knowledge of those providing care, within the context of available resources.
Health care professionals must be able to gain, assess, apply and integrate new knowledge and have the ability to adapt to changing circumstances throughout their professional life. Curricula to deliver these aptitudes need to be grounded in the five-step model of EBP, and informed by ongoing research. Core assessment tools for each of the steps should continue to be developed, validated, and made freely available.
All health care professionals need to understand the principles of EBP, recognise EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence. Without these skills, professionals and organisations will find it difficult to provide 'best practice'.
PMCID: PMC544887  PMID: 15634359
14.  How to make a compelling submission to NICE: tips for sponsoring organisations 
BMJ : British Medical Journal  2003;327(7429):1446-1448.
Evidence in support of products being assessed by the National Institute for Clinical Excellence can be presented in various ways to make products seem more attractive than they really are
PMCID: PMC300798  PMID: 14684641
15.  How to make a silk purse from a sow's ear—a comprehensive review of strategies to optimise data for corrupt managers and incompetent clinicians 
BMJ : British Medical Journal  2003;327(7429):1436-1439.
The introduction of performance league tables for UK surgeons and hospitals has forced them to learn how to present data in the best possible light. Though there is an urgent need for guidance, official guidelines on how to optimise performance data are lacking
PMCID: PMC300795  PMID: 14684638

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