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1.  Safety relevant knowledge of orally anticoagulated patients without self-monitoring: a baseline survey in primary care 
BMC Family Practice  2014;15:104.
Background
Effective and safe management of oral anticoagulant treatment (OAT) requires a high level of patient knowledge and adherence. The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge.
Methods
This is a baseline survey of a cluster-randomized controlled trial in 22 general practices with an educational intervention for patients or their caregivers. We assessed knowledge about general information on OAT and key facts regarding nutrition, drug-interactions and other safety precautions of 345 patients at baseline.
Results
Participants rated their knowledge about OAT as excellent to good (56%), moderate (36%) or poor (8%). However, there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps. Half of the participants (49%) were unaware of dietary recommendations. The majority (80%) did not know which non-prescription analgesic is the safest and 73% indicated they would not inform pharmacists about OAT. Many participants (35-75%) would not recognize important emergency situations. After adjustment in a multivariate analysis, older age and less than 10 years education remained significantly associated with lower overall score, but not with self-rated knowledge.
Conclusions
Patients have relevant knowledge gaps, potentially affecting safe and effective OAT. There is a need to assess patient knowledge and for structured education programs.
Trial registration
Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586.
Universal Trial Number (UTN U1111-1118-3464).
doi:10.1186/1471-2296-15-104
PMCID: PMC4045910  PMID: 24885192
2.  Efficacy of Ambroxol lozenges for pharyngitis: a meta-analysis 
BMC Family Practice  2014;15:45.
Background
Ambroxol has a local anaesthetic action and is marketed for pain relief for sore throat. The objective is to examine the efficacy and safety of ambroxol for the relief of pain associated with acute uncomplicated sore throat.
Methods
A systematic review of the literature and meta-analysis. Selection criteria consisted of randomized controlled trials which compared ambroxol to placebo or any other treatment for sore throat. Two reviewers independently assessed for relevance, inclusion, and risk of bias. Weighted mean differences (WMDs) were calculated and are reported with corresponding 95% confidence intervals (CIs).
Results and conclusion
From 14 potentially relevant citations, five trials reported in three publications met the inclusion criteria, three of them were published twice. Ambroxol lozenges were compared in different dosages (5–30 mg) with mint flavoured lozenges and once with benzocaine. Main outcome was a ratio of pain reduction measured repeatedly over 3 h compared to baseline on 6-item verbal rating scale. A total of 1.772 adult patients participated in the trials. Pain intensity decreased in both study arms. A meta-analysis of the 5 controlled trials resulted in a difference in pain reduction compared to placebo of -0.11 (95% CI [-0.15, -0.07]; p < 0.0001) favouring ambroxol 20 mg. Quality of reporting of the studies was low. Ambroxol is slightly more effective in relieving pain in acute sore throat than mint flavoured lozenges over a period of 3 h. However, the additional benefits of ambroxol beyond three hours, remain unclear given that more than 50% of patients using mint flavoured lozenges for pain relief reported good or very good efficacy after 1 day compared to 69% with ambroxol. Ambroxol is a safe option for individual patients with mainly local symptoms asking for treatment.
doi:10.1186/1471-2296-15-45
PMCID: PMC3975147  PMID: 24621446
Pharyngitis; Sore throat; Mint flavoured lozenges; Ambroxol; Primary care; Pain relief; Meta-analysis
3.  Are Sample Sizes Clear and Justified in RCTs Published in Dental Journals? 
PLoS ONE  2014;9(1):e85949.
Sample size calculations are advocated by the CONSORT group to justify sample sizes in randomized controlled trials (RCTs). The aim of this study was primarily to evaluate the reporting of sample size calculations, to establish the accuracy of these calculations in dental RCTs and to explore potential predictors associated with adequate reporting. Electronic searching was undertaken in eight leading specific and general dental journals. Replication of sample size calculations was undertaken where possible. Assumed variances or odds for control and intervention groups were also compared against those observed. The relationship between parameters including journal type, number of authors, trial design, involvement of methodologist, single-/multi-center study and region and year of publication, and the accuracy of sample size reporting was assessed using univariable and multivariable logistic regression. Of 413 RCTs identified, sufficient information to allow replication of sample size calculations was provided in only 121 studies (29.3%). Recalculations demonstrated an overall median overestimation of sample size of 15.2% after provisions for losses to follow-up. There was evidence that journal, methodologist involvement (OR = 1.97, CI: 1.10, 3.53), multi-center settings (OR = 1.86, CI: 1.01, 3.43) and time since publication (OR = 1.24, CI: 1.12, 1.38) were significant predictors of adequate description of sample size assumptions. Among journals JCP had the highest odds of adequately reporting sufficient data to permit sample size recalculation, followed by AJODO and JDR, with 61% (OR = 0.39, CI: 0.19, 0.80) and 66% (OR = 0.34, CI: 0.15, 0.75) lower odds, respectively. Both assumed variances and odds were found to underestimate the observed values. Presentation of sample size calculations in the dental literature is suboptimal; incorrect assumptions may have a bearing on the power of RCTs.
doi:10.1371/journal.pone.0085949
PMCID: PMC3897561  PMID: 24465806
4.  Sources of Information and Behavioral Patterns in Online Health Forums: Observational Study 
Background
Increasing numbers of patients are raising their voice in online forums. This shift is welcome as an act of patient autonomy, reflected in the term “expert patient”. At the same time, there is considerable concern that patients can be easily misguided by pseudoscientific research and debate. Little is known about the sources of information used in health-related online forums, how users apply this information, and how they behave in such forums.
Objective
The intent of the study was to identify (1) the sources of information used in online health-related forums, and (2) the roles and behavior of active forum visitors in introducing and disseminating this information.
Methods
This observational study used the largest German multiple sclerosis (MS) online forum as a database, analyzing the user debate about the recently proposed and controversial Chronic Cerebrospinal Venous Insufficiency (CCSVI) hypothesis. After extracting all posts and then filtering relevant CCSVI posts between 01 January 2008 and 17 August 2012, we first identified hyperlinks to scientific publications and other information sources used or referenced in the posts. Employing k-means clustering, we then analyzed the users’ preference for sources of information and their general posting habits.
Results
Of 139,912 posts from 11,997 threads, 8628 posts discussed or at least mentioned CCSVI. We detected hyperlinks pointing to CCSVI-related scientific publications in 31 posts. In contrast, 2829 different URLs were posted to the forum, most frequently referring to social media, such as YouTube or Facebook. We identified a total of 6 different roles of hyperlink posters including Social Media Fans, Organization Followers, and Balanced Source Users. Apart from the large and nonspecific residual category of the “average user”, several specific behavior patterns were identified, such as the small but relevant groups of CCSVI-Focused Responders or CCSVI Activators.
Conclusions
The bulk of the observed contributions were not based on scientific results, but on various social media sources. These sources seem to contain mostly opinions and personal experience. A small group of people with distinct behavioral patterns played a core role in fuelling the discussion about CCSVI.
doi:10.2196/jmir.2875
PMCID: PMC3958625  PMID: 24425598
Internet utilization; information dissemination; data mining; social media; social networks; multiple sclerosis; CCSVI
5.  The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov 
PLoS ONE  2013;8(10):e77086.
Background
There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio.
Methods
We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007–2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID was manually confirmed for each programmatically identified trial, yielding 3570 ID trials and 37,400 non-ID trials for analysis.
Results
The number of ID trials was similar to the number of trials identified as belonging to cardiovascular medicine (n = 3437) or mental health (n = 3695) specialties. Slightly over half of ID trials were treatment-oriented trials (53%, vs. 77% for non-ID trials) followed by prevention (38%, vs. 8% in non-ID trials). ID trials tended to be larger than those of other specialties, with a median enrollment of 125 subjects (interquartile range [IQR], 45–400) vs. 60 (IQR, 30–160) for non-ID trials. Most ID studies are randomized (73%) but nonblinded (56%). Industry was the funding source in 51% of ID trials vs. 10% that were primarily NIH-funded. HIV-AIDS trials constitute the largest subset of ID trials (n = 815 [23%]), followed by influenza vaccine (n = 375 [11%]), and hepatitis C (n = 339 [9%]) trials. Relative to U.S. and global mortality rates, HIV-AIDS and hepatitis C virus trials are over-represented, whereas lower respiratory tract infection trials are under-represented in this large sample of ID clinical trials.
Conclusions
This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov, providing a framework to discuss prioritization, methodology, and policy.
doi:10.1371/journal.pone.0077086
PMCID: PMC3797691  PMID: 24146958
6.  Equal Contributions and Credit: An Emerging Trend in the Characterization of Authorship in Major Anaesthesia Journals during a 10-Yr Period 
PLoS ONE  2013;8(8):e71430.
Background
The practice of giving certain authors equal credit in original research publications was increasingly common in some specialty. This study aimed to investigate the prevalence and characteristics of designating some authors with equally credited authors (ECAs) in major anaesthesia journals.
Methodology/Principal Findings
The practice of giving authors equal credit was searched and identified in the three major anaesthesia journals between January 1, 2002 and December 31, 2011. Papers with ECAs had a higher proportion of the total number of articles in 2011 versus published in 2002 (Anesthesiology, 8.8% vs. 0.9%; British Journal of Anaesthesia, 8.8% vs. 0%; Anesthesia & Analgesia, 3.4% vs. 0.3%; totally, 6.4% vs. 0.4%). A significant increasing trend in annual proportion of articles with ECA was found in the three journals. The first two authors listed in the byline had equal credit in most cases.
Conclusions/Significance
The practice of giving authors equal credit in original research papers is increasingly common in major anaesthesia journals. It may be warranted for the journals to guide the authors how to regard this practice.
doi:10.1371/journal.pone.0071430
PMCID: PMC3734064  PMID: 23940753
7.  A Re-Analysis of the Cochrane Library Data: The Dangers of Unobserved Heterogeneity in Meta-Analyses 
PLoS ONE  2013;8(7):e69930.
Background
Heterogeneity has a key role in meta-analysis methods and can greatly affect conclusions. However, true levels of heterogeneity are unknown and often researchers assume homogeneity. We aim to: a) investigate the prevalence of unobserved heterogeneity and the validity of the assumption of homogeneity; b) assess the performance of various meta-analysis methods; c) apply the findings to published meta-analyses.
Methods and Findings
We accessed 57,397 meta-analyses, available in the Cochrane Library in August 2012. Using simulated data we assessed the performance of various meta-analysis methods in different scenarios. The prevalence of a zero heterogeneity estimate in the simulated scenarios was compared with that in the Cochrane data, to estimate the degree of unobserved heterogeneity in the latter. We re-analysed all meta-analyses using all methods and assessed the sensitivity of the statistical conclusions. Levels of unobserved heterogeneity in the Cochrane data appeared to be high, especially for small meta-analyses. A bootstrapped version of the DerSimonian-Laird approach performed best in both detecting heterogeneity and in returning more accurate overall effect estimates. Re-analysing all meta-analyses with this new method we found that in cases where heterogeneity had originally been detected but ignored, 17–20% of the statistical conclusions changed. Rates were much lower where the original analysis did not detect heterogeneity or took it into account, between 1% and 3%.
Conclusions
When evidence for heterogeneity is lacking, standard practice is to assume homogeneity and apply a simpler fixed-effect meta-analysis. We find that assuming homogeneity often results in a misleading analysis, since heterogeneity is very likely present but undetected. Our new method represents a small improvement but the problem largely remains, especially for very small meta-analyses. One solution is to test the sensitivity of the meta-analysis conclusions to assumed moderate and large degrees of heterogeneity. Equally, whenever heterogeneity is detected, it should not be ignored.
doi:10.1371/journal.pone.0069930
PMCID: PMC3724681  PMID: 23922860
8.  Cross cultural evaluation of the Warwick-Edinburgh mental well-being scale (WEMWBS) -a mixed methods study 
Background
We aimed to validate the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) among English speaking adults representing two of the minority ethnic groups living in the UK, self-identified as Chinese or Pakistani by background, in a mixed methods study.
Methods
Quantitative data were collected in two cities in the West Midlands, UK. Item response, dimensionality, internal consistency, and construct validity of the WEMWBS were assessed in Chinese and Pakistani groups separately, using data from both cities combined.
Qualitative data were collected in the first city in eight focus groups of different ages recruited by the community workers. Three mixed sex Chinese and five single sex Pakistani groups discussed ease of completion and comprehension of items, together with overall reactions to the scale and underlying concept.
Results of quantitative and qualitative analysis were examined for commonalities and differences.
Results
Item completion and item total correlations were satisfactory in both groups. In the Chinese data, Exploratory Factor Analysis showed a single factor with loadings ranging from 0.60 to 0.82 for all 14 items. In the Pakistani data, three factors reached statistical significance; however, a substantial drop in eigenvalues between the first and second factors and the limited variance explained by the second and third factors supported a one-factor model. All items loaded on this factor from 0.51 to 0.83.
In the Chinese and Pakistani data respectively, Cronbach’s alpha was 0.92 (0.89 – 0.94) and 0.91 (0.88 – 0.94); Spearman’s correlation with GHQ-12 was - 0.63 (−0.73 to −0.49) and −0.55 (−0.70 to −0.36), and with the WHO-5 0.62 (0.46-0.75) and 0.64 (0.50 to 0.76).
Qualitative analysis revealed good comprehension and ease of completion of almost all items. Some culturally determined differences in understanding of mental well-being, which varied both between and within communities, emerged.
Conclusions
The WEMWBS was well received by members of both Pakistani and Chinese communities. It showed high levels of consistency and reliability compared with accepted criteria. Data were sufficiently strong to recommend the WEMWBS for use in general population surveys.
doi:10.1186/1477-7525-11-27
PMCID: PMC3610169  PMID: 23445544
Mental well-being; WEMWBS; Cross cultural; Validation; PROMS (patient reported outcome measures); Ethnicity (MeSH: ethnic groups)
9.  Safety and Efficacy of the ACE-Inhibitor Ramipril in Alport Syndrome: The Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III EARLY PRO-TECT Alport Trial in Pediatric Patients 
ISRN Pediatrics  2012;2012:436046.
Introduction. Retrospective observational data show that ACE-inhibitor therapy delays renal failure and improves life expectancy in Alport patients with proteinuria. The EARLY PRO-TECT Alport trial assesses the safety and efficacy of early therapy onset with ramipril in pediatric Alport patients. Methods and analysis. This double-blind, randomized, placebo-controlled, multicenter phase III trial (NCT01485978; EudraCT-number 2010-024300-10) includes 120 pediatric patients aged 24 months to 18 years with early stages of Alport syndrome (isolated hematuria or microalbuminuria). From March 2012, up to 80 patients will be randomized 1:1 to ramipril or placebo. In the event of disease progression during 3-year treatment, patients are unblinded and ramipril is initiated, if applicable. Approximately 40 patients receive open-label ramipril contributing to the safety database. Primary end-points are “time to progression to next disease level” and “incidence of adverse drug events before disease progression.” Treatment effect estimates from the randomized comparison and Alport registry data will be combined in supportive analyses to maximize evidence. Conclusion. Without this trial, ACE inhibitors may become standard off-label treatment in Alport syndrome without satisfactory evidence base. The results are expected to be of relevance for therapy of all pediatric patients with kidney disease, and the trial protocol might serve as a model for other rare pediatric glomerulopathies.
doi:10.5402/2012/436046
PMCID: PMC3395192  PMID: 22811928
11.  Rationale, objectives, and design of the EUTrigTreat clinical study: a prospective observational study for arrhythmia risk stratification and assessment of interrelationships among repolarization markers and genotype 
Europace  2011;14(3):416-422.
Aims
The EUTrigTreat clinical study has been designed as a prospective multicentre observational study and aims to (i) risk stratify patients with an implantable cardioverter defibrillator (ICD) for mortality and shock risk using multiple novel and established risk markers, (ii) explore a link between repolarization biomarkers and genetics of ion (Ca2+, Na+, K+) metabolism, (iii) compare the results of invasive and non-invasive electrophysiological (EP) testing, (iv) assess changes of non-invasive risk stratification tests over time, and (v) associate arrythmogenomic risk through 19 candidate genes.
Methods and results
Patients with clinical ICD indication are eligible for the trial. Upon inclusion, patients will undergo non-invasive risk stratification, including beat-to-beat variability of repolarization (BVR), T-wave alternans, T-wave morphology variables, ambient arrhythmias from Holter, heart rate variability, and heart rate turbulence. Non-invasive or invasive programmed electrical stimulation will assess inducibility of ventricular arrhythmias, with the latter including recordings of monophasic action potentials and assessment of restitution properties. Established candidate genes are screened for variants. The primary endpoint is all-cause mortality, while one of the secondary endpoints is ICD shock risk. A mean follow-up of 3.3 years is anticipated. Non-invasive testing will be repeated annually during follow-up. It has been calculated that 700 patients are required to identify risk predictors of the primary endpoint, with a possible increase to 1000 patients based on interim risk analysis.
Conclusion
The EUTrigTreat clinical study aims to overcome current shortcomings in sudden cardiac death risk stratification and to answer several related research questions. The initial patient recruitment is expected to be completed in July 2012, and follow-up is expected to end in September 2014.
Clinicaltrials.gov identifier: NCT01209494.
doi:10.1093/europace/eur352
PMCID: PMC3283222  PMID: 22117037
Sudden cardiac death risk stratification; Implantable cardioverter defibrillator; Cardiomyocyte ion metabolism; Ventricular repolarization; Electrocardiogram; Programmed electrical stimulation; Repolarization alternans
12.  Reporting FDR analogous confidence intervals for the log fold change of differentially expressed genes 
BMC Bioinformatics  2011;12:288.
Background
Gene expression experiments are common in molecular biology, for example in order to identify genes which play a certain role in a specified biological framework. For that purpose expression levels of several thousand genes are measured simultaneously using DNA microarrays. Comparing two distinct groups of tissue samples to detect those genes which are differentially expressed one statistical test per gene is performed, and resulting p-values are adjusted to control the false discovery rate. In addition, the expression change of each gene is quantified by some effect measure, typically the log fold change. In certain cases, however, a gene with a significant p-value can have a rather small fold change while in other cases a non-significant gene can have a rather large fold change. The biological relevance of the change of gene expression can be more intuitively judged by a fold change then merely by a p-value. Therefore, confidence intervals for the log fold change which accompany the adjusted p-values are desirable.
Results
In a new approach, we employ an existing algorithm for adjusting confidence intervals in the case of high-dimensional data and apply it to a widely used linear model for microarray data. Furthermore, we adopt a concept of different relevance categories for effects in clinical trials to assess biological relevance of genes in microarray experiments. In a brief simulation study the properties of the adjusting algorithm are maintained when being combined with the linear model for microarray data. In two cancer data sets the adjusted confidence intervals can indicate significance of large fold changes and distinguish them from other large but non-significant fold changes. Adjusting of confidence intervals also corrects the assessment of biological relevance.
Conclusions
Our new combination approach and the categorization of fold changes facilitates the selection of genes in microarray experiments and helps to interpret their biological relevance.
doi:10.1186/1471-2105-12-288
PMCID: PMC3154206  PMID: 21756370
13.  Warwick-Edinburgh Mental Well-being Scale (WEMWBS): Validated for teenage school students in England and Scotland. A mixed methods assessment 
BMC Public Health  2011;11:487.
Background
Understanding and measuring mental health and wellbeing amongst teenagers has recently become a priority. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is validated for measuring mental wellbeing in populations aged 16 years and over in the UK. We report here a study designed to establish the validity and reliability of WEMWBS in teenagers in the UK.
Methods
WEMWBS and comparator scales, together with socio-demographic information and self-reported health, were incorporated into a self-administered questionnaire given to pupils aged 13 to 16 years in six schools in Scotland and England. Psychometric properties including internal consistency, correlations with comparator scales, test-retest stability and unidimensionality were investigated for WEMWBS. Twelve focus groups were undertaken to assess acceptability and comprehensibility of WEMWBS and were taped, transcribed and analysed thematically.
Results
A total of 1,650 teenagers completed the questionnaire (response rate 80.8%). Mean WEMWBS score was 48.8 (SD 6.8; median 49). Response scores covered the full range (from 14 to 70). WEMWBS demonstrated strong internal consistency and a high Cronbach's alpha of 0.87 (95% CI (0.85-0.88), n = 1517). Measures of construct validity gave values as predicted. The correlation coefficient for WEMWBS total score and psychological wellbeing domain of the Kidscreen-27 was 0.59 (95% CI [0.55; 0.62]); for the Mental Health Continuum Short Form (MHC-SF) was 0.65, 95% CI [0.62; 0.69]; and for the WHO (WHO-5) Well-being Index 0.57 (95% CI [0.53; 0.61]). The correlation coefficient for the Strengths and Difficulties Questionnaire (SDQ) was -0.44 (95% CI [-0.49; -0.40]) and for the 12-item General Health Questionnaire (GHQ12) -0.45 (95% CI [-0.49; -0.40]). Test-retest reliability was acceptable (Intraclass correlation coefficient (ICC) 0.66 (95% CI [0.59; 0.72] n = 212)). Confirmatory factor analysis demonstrated one underlying factor.
WEMWBS was significantly associated with the Family Affluence Score (WEMWBS increased with increasing household socio-economic status) and had a positive association with the physical health dimension of the Kidscreen-27, but was unrelated to age, gender or location/school. Eighty students took part in focus groups. In general, although some students considered some items open to misunderstanding or misinterpretation, WEMWBS was received positively and was considered comprehensible, and acceptable.
Conclusions
WEMWBS is a psychometrically strong population measure of mental wellbeing, and can be used for this purpose in teenagers aged 13 and over.
doi:10.1186/1471-2458-11-487
PMCID: PMC3141456  PMID: 21693055
14.  Development of oral immunomodulatory agents in the management of multiple sclerosis 
The emergence of oral disease-modifying therapies in multiple sclerosis (MS) will have a significant impact on the evolving scenario of immunomodulatory treatments in MS where current therapies are all injectable. Reducing relapses in trials translates for individuals with MS into a therapeutic aim of stopping future events. Thus the possible absence of any perceived benefits to the individual together with the long disease course, variable outcome, and a younger age group affected in MS makes side effects the major issue. The use of disease-modifying therapies as a whole needs to be placed in the context of a widening therapeutic indication where the use of these therapies is being justified at an increasingly early stage and in pre-MS syndromes such as clinically isolated and radiologically isolated syndromes where no fixed disability is likely to have accumulated. The five oral therapies discussed (cladribine, fingolimod, laquinimod, BG-12, and teriflunomide) have just completed Phase III studies and some have just been licensed. New oral drugs for MS need to be placed within this evolving marketplace where ease of delivery together with efficacy and side effects needs to be balanced against the known issues but also the known long-term safety of standard injectables.
doi:10.2147/DDDT.S10498
PMCID: PMC3100222  PMID: 21625416
multiple sclerosis; immunomodulatory treatment; cladribine; fingolimod; laquinimod; BG-12; teriflunomide
15.  Practice nursed-based, individual and video-assisted patient education in oral anticoagulation - Protocol of a cluster-randomized controlled trial 
BMC Family Practice  2011;12:17.
Background
Managing oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only.
Methods and design
This trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range.
Discussion
This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we expect to discover differences in secondary outcomes, such as the time spent in the therapeutic range.
Trial registration
Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586
Universal Trial Number (UTN U1111-1118-3464)
doi:10.1186/1471-2296-12-17
PMCID: PMC3089775  PMID: 21477372
16.  Automated electronic reminders to facilitate primary cardiovascular disease prevention: randomised controlled trial 
The British Journal of General Practice  2010;60(573):e137-e143.
Background
Primary care databases contain cardiovascular disease risk factor data, but practical tools are required to improve identification of at-risk patients.
Aim
To test the effects of a system of electronic reminders (the ‘e-Nudge’) on cardiovascular events and the adequacy of data for cardiovascular risk estimation.
Design of study
Randomised controlled trial.
Setting
Nineteen general practices in the West Midlands, UK.
Method
The e-Nudge identifies four groups of patients aged over 50 years on the basis of estimated cardiovascular risk and adequacy of risk factor data in general practice computers. Screen messages highlight individuals at raised risk and prompt users to complete risk profiles where necessary. The proportion of the study population in the four groups was measured, as well as the rate of cardiovascular events in each arm after 2 years.
Results
Over 38 000 patients' electronic records were randomised. The intervention led to an increase in the proportion of patients with sufficient data who were identifiably at risk, with a difference of 1.94% compared to the control group (95% confidence interval [CI] = 1.38 to 2.50, P<0.001). A corresponding reduction occurred in the proportion potentially at risk but requiring further data for a risk estimation (difference = –3.68%, 95% CI = –4.53 to –2.84, P<0.001). No significant difference was observed in the incidence of cardiovascular events (rate ratio = 0.96, 95% CI = 0.85 to 1.10, P = 0.59).
Conclusion
Automated electronic reminders using routinely collected primary care data can improve the adequacy of cardiovascular risk factor information during everyday practice and increase the visibility of the at-risk population.
doi:10.3399/bjgp10X483904
PMCID: PMC2845504  PMID: 20353659
cardiovascular diseases; primary prevention; reminder systems; risk assessment; informatics
17.  Study protocol: Improving patient choice in treating low back pain (IMPACT - LBP): A randomised controlled trial of a decision support package for use in physical therapy 
Background
Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient.
Methods/Design
Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study.
Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research.
Discussion
Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction.
Trial registration
Current Controlled Trials ISRCTN46035546
doi:10.1186/1471-2474-12-52
PMCID: PMC3063252  PMID: 21352528

Results 1-17 (17)