Showing papers by "Steve Goodacre published in 2014"

A system-wide approach to explaining variation in potentially avoidable emergency admissions: national ecological study

Abstract: Background Some emergency admissions can be avoided if acute exacerbations of health problems are managed by the range of health services providing emergency and urgent care Aim To identify system-wide factors explaining variation in age sex adjusted admission rates for conditions rich in avoidable admissions Design National ecological study Setting 152 emergency and urgent care systems in England Methods Hospital Episode Statistics data on emergency admissions were used to calculate an age sex adjusted admission rate for conditions rich in avoidable admissions for each emergency and urgent care system in England for 2008–2011 Results There were 3 273 395 relevant admissions in 2008–2011, accounting for 22% of all emergency admissions The mean age sex adjusted admission rate was 2258 per year per 100 000 population, with a 34-fold variation between systems (1268 and 4359) Factors beyond the control of health services explained the majority of variation: unemployment rates explained 72%, with urban/rural status explaining further variation (R2=75%) Factors related to emergency departments, hospitals, emergency ambulance services and general practice explained further variation (R2=85%): the attendance rate at emergency departments, percentage of emergency department attendances converted to admissions, percentage of emergency admissions staying less than a day, percentage of emergency ambulance calls not transported to hospital and perceived access to general practice within 48 h Conclusions Interventions to reduce avoidable admissions should be targeted at deprived communities Better use of emergency departments, ambulance services and primary care could further reduce avoidable emergency admissions

Prehospital noninvasive ventilation for acute respiratory failure: systematic review, network meta-analysis, and individual patient data meta-analysis.

Abstract: Objectives This meta-analysis aimed to determine the effectiveness of prehospital continuous positive airway pressure (CPAP) or bilevel inspiratory positive airway pressure (BiPAP) in acute respiratory failure. Methods Fourteen electronic databases and research registers were searched from inception to August 2013. Randomized or quasi-randomized controlled trials that reported mortality or intubation rate for prehospital CPAP or BiPAP were selected and compared to a relevant comparator in patients with acute respiratory failure. An aggregate data network meta-analysis was used to jointly estimate intervention effects relative to standard care. A network meta-analysis using a mixture of individual patient-level data and aggregate data was carried out to assess potential treatment effect modifiers. Results Eight randomized and two quasi-randomized controlled trials (six CPAP, four BiPAP, sample sizes 23 to 207) were identified. The aggregate data network meta-analysis suggested that CPAP was the most effective treatment in terms of mortality (probability = 0.989) and intubation rate (probability = 0.639) and reduced both mortality (odds ratio [OR] = 0.41; 95% credible interval [CrI] = 0.20 to 0.77) and intubation rate (OR = 0.32; 95% CrI = 0.17 to 0.62), compared to standard care. The effect of BiPAP on mortality (OR = 1.94; 95% CrI = 0.65 to 6.14) and intubation rate (OR = 0.40; 95% CrI = 0.14 to 1.16) was uncertain. The network meta-analysis using individual patient-level data and aggregate data suggested that sex was a modifier of the effect of treatment on mortality. Conclusions Prehospital CPAP can reduce mortality and intubation rates compared to standard care, while the effectiveness of prehospital BiPAP is uncertain.

Comparison of contemporary troponin assays with the novel biomarkers, heart fatty acid binding protein and copeptin, for the early confirmation or exclusion of myocardial infarction in patients presenting to the emergency department with chest pain

Abstract: Objective To examine the diagnostic accuracy of novel biomarkers of myocardial injury and troponin assays for diagnosis of myocardial infarction. Methods 850 patients randomised to the point-of-care testing arm of the Randomised Assessment of Panel Assay of Cardiac markers (RATPAC) study in six emergency departments of low-risk patients presenting with chest pain were studied. Blood samples were obtained on admission and 90 min from admission. Myocardial infarction was defined by the universal definition of myocardial infarction. The following diagnostic strategies were compared by receiver operator characteristic curve analysis and comparison of area under the curve: individual marker values and the combination of presentation heart fatty acid binding protein (HFABP) and copeptin with troponin. Results 68 patients had a final diagnosis of myocardial infarction. Admission samples were available from 838/1132 patients enrolled in the study. Areas under the curve were as follows (CIs in parentheses): cardiac troponin I (cTnI) Stratus CS 0.94 (0.90 to 0.98), cTnI Beckmann 0.92 (0.88 to 0.96), cTnI Siemens ultra 0.90 (0.85 to 0.95), cardiac troponin T high sensitivity 0.92 (0.88 to 0.96), HFABP 1 0.84 (0.77 to 0.90) copeptin 0.62 (0.57 to 0.68). HFABP and copeptin were diagnostically inferior to troponin. The combination of HFABP (at the 95th percentile) and troponin (at the 99th percentile) increased diagnostic sensitivity. Conclusions High-sensitivity cardiac troponin is the best single marker. Addition of HFABP to high-sensitivity troponin increased diagnostic sensitivity. Additional measurement of copeptin is not useful in the chest pain population.

Interventions to improve the management of pain in emergency departments: systematic review and narrative synthesis.

Abstract: Introduction Pain management in emergency departments (ED) is often inadequate despite the availability of effective analgesia, with many patients receiving insufficient and untimely analgesia. We conducted a systematic literature review to identify interventions that could improve pain management in the ED. Methods We systematically searched seven databases for studies reporting pain management outcomes after intervention to change professional practice to improve pain management in the ED, compared with pain management before or without intervention. Data was synthesised using principles of narrative synthesis. Results We identified 43 relevant studies, including 40 uncontrolled before-and-after studies. Interventions included implementation of guidelines and protocols, educational interventions, pain scoring tools and changes in nursing roles, with many multifaceted interventions incorporating two or more of these elements. Interventions aimed to improve assessment and documentation of pain, knowledge and awareness of pain management and reduce time to analgesia. Due to the high probability of bias in study design and significant variation between studies, it was not possible to estimate the overall effectiveness of interventions, or identify which had the greatest impact. Intervention to improve pain management was reported to have some positive impact in most studies, but these findings may be explained by limitations in study design. Conclusions Many interventions reported improvements in pain management, but current evidence is insufficient to recommend any for widespread adoption. In order to improve pain management we need to understand more about the theory underlying interventions, the context in which interventions work, and develop interventions based on this stronger theoretical understanding.

Illness representations, psychological distress and non-cardiac chest pain in patients attending an emergency department.

Abstract: Objective: Many patients who attend an emergency department (ED) with chest pain receive a diagnosis of non-cardiac chest pain (NCCP), and often suffer poor psychological outcomes and continued pain. This study assessed the role of illness representations in explaining psychological distress and continued chest pain in patients attending an ED.Methods: ED NCCP patients (N = 138) completed measures assessing illness representations, anxiety, depression and quality of life (QoL) at baseline, and chest pain at one month.Results: Illness representations explained significant amounts of the variance in anxiety (Adj. R² = .38), depression (Adj. R² = .18) and mental QoL (Adj. R² = .36). A belief in psychological causes had the strongest associations with outcomes. At one month, 28.7% of participants reported experiencing frequent pain, 13.2% infrequent pain and 58.1% no pain. Anxiety, depression and poor QoL, but not illness representations, were associated with continued chest pain.Conclusions: The findings sug...

Explaining variation in emergency admissions: a mixed-methods study of emergency and urgent care systems

Abstract: OBJECTIVE: To identify factors affecting variation in avoidable emergency admissions that are not usually identified in statistical regression. METHODS: As part of an ethnographic residual analysis, we compared six emergency and urgent care systems in England, interviewing 82 commissioners and providers of key emergency and urgent care services. RESULTS: There was variation between the six cases in how interviewees described three parts of their emergency and urgent care systems. First, interviewees' descriptions revealed variation in the availability of services before patients decided to attend emergency departments. Poor availability of general practice out of hours services in some of the cases reportedly made attendance at emergency departments the easier option for patients. Second, there was variation in how interviewees described patients being dealt with during their emergency department visit in terms of availability of senior review by specialists and in coding practices when patients were at risk of breaching the NHS's 4-hour waiting time target. Third, there was variability in services described as facilitating discharge home from emergency departments. In some cases, emergency department staff described dealing with multiple agencies in multiple localities outside the hospital, making admission the easier option. In other cases, proactive multidisciplinary rapid assessment teams were described as available to avoid admissions. Perceptions of resources available out of hours and the extent of integration between different health services, and between health and social services, also differed by case. CONCLUSIONS: This comparative case study approach identified further factors that may affect avoidable emergency admissions. Initiatives to improve GP out of hours services, make coding more accurately reflect patient experience, increase senior review in emergency departments, offer proactive multidisciplinary admission avoidance teams, improve the availability of out of hours care in the wider emergency and urgent care system, and increase service integration may reduce avoidable admissions. Evaluation of such initiatives would be necessary before wide-scale adoption.

The 3Mg Trial: A randomised controlled trial of intravenous or nebulised magnesium sulphate versus placebo in adults with acute severe asthma

Abstract: Background Magnesium sulphate, administered by the intravenous (i.v.) or inhaled (nebulised) route, has been proposed as a treatment for adults with acute severe asthma. Existing trials show mixed results and uncertain evidence of benefit. Objectives We aimed to determine whether i.v. or nebulised magnesium sulphate improves symptoms of breathlessness and reduces the need for hospital admission in adults with acute severe asthma. Design Multicentre, double-blind, placebo-controlled, three-arm, randomised trial. Setting The emergency departments of 34 acute hospitals in the UK. Participants We recruited 1109 adults (age > 16 years) with acute severe asthma [peak expiratory flow rate (PEFR) < 50% of best/predicted, respiratory rate > 25 breaths per minute, heart rate > 110 beats per minute or inability to complete sentences in one breath]. Patients with life-threatening features or a contraindication to either nebulised or intravenous magnesium sulphate were excluded. Interventions Participants were randomly allocated to i.v. magnesium sulphate (2 g over 20 minutes) or nebulised magnesium sulphate (3 × 500 mg over 1 hour) or standard therapy alone. Main outcome measures The primary outcome was the proportion of patients admitted to hospital (either after emergency department treatment or at any time over the subsequent 7 days) and breathlessness measured on a 100-mm visual analogue scale (VAS) over 2 hours after initiation of treatment. Results We randomised 406 patients to i.v. magnesium sulphate, 339 to nebulised magnesium sulphate and 364 to placebo. Hospital admission was recorded for 394, 332 and 358 patients, respectively, and VAS breathlessness for 357, 296 and 323 patients respectively. Mean age was 36.1 years and 763 out of 1084 (70%) patients were female. Intravenous magnesium sulphate was associated with an odds ratio (OR) of 0.73 [95% confidence interval (CI) 0.51 to 1.04; p = 0.083] for hospital admission, an improvement in VAS breathlessness that was 2.6 mm (95% CI –1.6 to 6.8 mm; p = 0.231) greater than that associated with placebo and an improvement in PEFR that was 2.4 l/minute (95% CI –8.8 to 13.6 l/minute; p = 0.680) greater than that associated with placebo. Nebulised magnesium sulphate was associated with an OR of 0.96 (95% CI 0.65 to 1.40; p = 0.819) for hospital admission, an improvement in VAS breathlessness that was 2.6 mm (95% CI –1.8 mm to 7.0 mm; p = 0.253) less than that associated with placebo and an improvement in PEFR that was 2.6 l/minute (95% CI –9.2 to 14.5 l/minute; p = 0.644) less than that associated with placebo. There were no significant differences between i.v. or nebulised magnesium sulphate and placebo for any other outcomes. The number (%) of patients reporting any side effect was 61 (15.5%) in the i.v. group, 52 (15.7%) in the nebuliser group and 36 (10.1%) in the placebo group. The ORs for suffering any side effect were 1.68 (95% CI 1.07 to 2.63; p = 0.025) for i.v. compared with placebo and 1.67 (95% CI 1.05 to 2.66; p = 0.031) for nebuliser compared with placebo. Conclusions We were unable to demonstrate a clinically worthwhile benefit from magnesium sulphate in acute severe asthma. There was some weak evidence of an effect of i.v. magnesium sulphate on hospital admission, but no evidence of an effect on VAS breathlessness or PEFR compared with placebo. We found no evidence that nebulised magnesium sulphate was more effective than placebo. Trial registration Current Controlled Trials ISRCTN04417063. Source of funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 22. See the NIHR Journals Library programme website for further project information.

Disaster management in low- and middle-income countries: scoping review of the evidence base

Abstract: Introduction Globally, there has been an increase in the prevalence and scale of disasters with low- and middle-income countries (LMICs) tending to be more affected. Consequently, disaster risk reduction has been advocated as a global priority. However, the evidence base for disaster management in these settings is unclear. Methods This study is a scoping review of the evidence base for disaster management in LMIC. Potentially relevant articles between 1990 and 2011 were searched for, assessed for relevance and subsequently categorised using a thematic coding framework based on the US Integrated Emergency Management System model. Results Out of 1545 articles identified, only 178 were from LMIC settings. Most were of less robust design such as event reports and commentaries, and 66% pertained to natural disasters. There was a paucity of articles on disaster mitigation or recovery, and more were written on disaster response and preparedness issues. Discussion Considerably more articles were published from high-income country settings that may reflect a publication bias. Current grey literature on disaster management tends not to be peer reviewed, is not well organised and not easy to access. The paucity of peer-reviewed publications compromises evidence review initiatives that seek to provide an evidence-base for disaster management in LMIC. As such, there is an urgent need for greater research and publication of findings on disaster management issues from these settings.

Paramedic perceptions of the feasibility and practicalities of prehospital clinical trials: a questionnaire survey

Abstract: Background Clinical trials are required to strengthen the evidence base for prehospital care. This questionnaire study aimed to explore paramedics’ perceptions of prehospital research and barriers to conducting prehospital clinical trials. Methods A self-completed questionnaire was developed to explore paramedic perceptions and barriers to undertaking prehospital trials based upon a review of existing research and semistructured qualitative interviews with five paramedics. The questionnaire was distributed by ‘research champions’ to 300 paramedics at randomly selected ambulance stations in Yorkshire. Results Responses were received from 96/300 participants (32%). Interest in clinical trials was reported, but barriers were recognised, including perceptions of poor knowledge and limited use of evidence, that conducting research is not a paramedics’ responsibility, limited support for involvement in trials, concerns about the practicalities of randomisation and consent, and time pressures. No association was found between training route and perceived understanding of trials (p=0.263) or feeling that involvement in trials was a professional responsibility (p=0.838). Previous involvement in prehospital research was not associated with opinions on importance of an evidence base (p=0.934) or gaining consent (p=0.329). The number of years respondents had been practicing was not associated with opinions on personal experience versus scientific evidence (p=0.582) or willingness to receive training for clinical trials (p=0.111). However, the low response rate limited the power of the study to detect potential associations. Conclusions Paramedics reported interest and understanding of research, but a number of practical and ethical barriers were recognised that need to be addressed if prehospital clinical trials are to increase.

Evaluation of the DAVROS (Development And Validation of Risk-adjusted Outcomes for Systems of emergency care) risk-adjustment model as a quality indicator for healthcare

Abstract: Background and objective Risk-adjusted mortality rates can be used as a quality indicator if it is assumed that the discrepancy between predicted and actual mortality can be attributed to the quality of healthcare (ie, the model has attributional validity). The Development And Validation of Risk-adjusted Outcomes for Systems of emergency care (DAVROS) model predicts 7-day mortality in emergency medical admissions. We aimed to test this assumption by evaluating the attributional validity of the DAVROS risk-adjustment model. Methods We selected cases that had the greatest discrepancy between observed mortality and predicted probability of mortality from seven hospitals involved in validation of the DAVROS risk-adjustment model. Reviewers at each hospital assessed hospital records to determine whether the discrepancy between predicted and actual mortality could be explained by the healthcare provided. Results We received 232/280 (83%) completed review forms relating to 179 unexpected deaths and 53 unexpected survivors. The healthcare system was judged to have potentially contributed to 10/179 (8%) of the unexpected deaths and 26/53 (49%) of the unexpected survivors. Failure of the model to appropriately predict risk was judged to be responsible for 135/179 (75%) of the unexpected deaths and 2/53 (4%) of the unexpected survivors. Some 10/53 (19%) of the unexpected survivors died within a few months of the 7-day period of model prediction. Conclusions We found little evidence that deaths occurring in patients with a low predicted mortality from risk-adjustment could be attributed to the quality of healthcare provided.

Prediction of unsuccessful treatment in patients with severe acute asthma

Abstract: Background Clinical assessment can be used to identify which patients with acute asthma are at risk of unsuccessful initial treatment. Objective To determine which elements of clinical assessment predict unsuccessful treatment, defined as needing critical care or any unplanned additional treatment. Methods We analysed data from a large multicentre trial (the 3Mg trial). Adults with severe acute asthma underwent standardised clinical assessment, including peak expiratory flow rate (PEFR), up to 2 h after initiation of treatment. Standard care was provided other than blinded random allocation to trial treatment or placebo. Patients were followed up by record review up to 30 days. Unsuccessful treatment was defined as needing (1) critical care or (2) critical care or any unplanned additional treatment within 7 days of presentation. Logistic regression was used to identify predictors and derive a prediction model for each outcome. Results Out of 1084 patients analysed, 81 (7%) received critical care and 157 (14%) received critical care or unplanned additional treatment. Baseline PEFR (p=0.017), baseline heart rate (p Conclusions PEFR, heart rate and other serious illnesses are the best predictors of unsuccessful treatment, but models based on these variables provide modest predictive value.

Patient expectations of minor injury care: a cross-sectional survey.

Abstract: Background and objective Little is known about the expectations of patients attending the emergency department (ED) with minor injuries. Failure to address expectations may lead to dissatisfaction and poor compliance. We aimed to describe patient expectations of minor injury care and explore the association between unmet expectations and patient satisfaction. Methods We undertook a cross-sectional questionnaire survey of 300 patients attending the ED with minor injuries on weekdays between 9:00 and 17:00. Participants completed a questionnaire asking which tests and treatments they expected, which they consequently received, whether explanations were given for tests and treatments, and how they rated satisfaction with care. Results The most frequently expected interventions were x-ray, analgesia and bandage/strapping. In each case the proportion expecting intervention was significantly higher than the proportion receiving intervention: x-ray (58% vs 47%, p Conclusions Patients often expect interventions for minor injuries that they do not receive, but in most cases an explanation was given. We were unable to demonstrate an association between unmet expectations and reduced satisfaction with care.

Duplex ultrasound for the diagnosis of symptomatic deep vein thrombosis in the lower limb

Abstract: This is the protocol for a review and there is no abstract The objectives are as follows: To estimate the sensitivity and specificity of duplex ultrasound for the detection of distal and proximal DVT in symptomatic patients with prior testing by a clinical prediction rule (with or without additional D-dimer testing) The accuracy of ultrasound for DVT may be affected by body mass index and whether the patient has had a previous DVT If possible, we shall investigate both previous DVT and body mass index as possible sources of heterogeneity, but recognise that these are patient-specific rather than study-specific characteristics This means that results reported at the study level, for example average body mass index, may not be informative in an analysis and are more appropriately investigated with individual patient data However, such an analysis may be possible if studies report results stratified by previous DVT status or body mass index Two study-specific characteristics we shall investigate are the generation of the technology of the ultrasound scanner and type of reference standard: ascending venography, CT venography, or MR venography Moreover, as the accuracy of duplex ultrasound depends on whether the DVT is distal or proximal, we shall perform separate meta-analyses according to site

The ahead study: managing anticoagulated patients who suffer head injury

Abstract: Objectives & Background Existing practice in emergency departments (ED) in the UK for managing anticoagulated patients after blunt head trauma is variable and based on limited evidence. We aimed to determine the head injury complication rate within this group of patients and identify risk factors associated with a poor outcome. Methods A prospective observational multi-centre study enrolled patients taking warfarin who attended 33 emergency departments in England and Scotland after blunt head trauma. ED attendance data and patient reported outcomes were collected over an 18-month period from October 2011. Head injury complication was defined by head injury-related death, neurosurgery resulting from injury, clinically-significant CT head scan or re-attendance with significant head injury complications. Factors including neurological status (Glasgow Coma Score, GCS), level of anticoagulation (INR) and neurological symptoms were entered into multivariate logistic regression analyses as predictors of a poor outcome. Results A total of 3566 patients were enrolled; anonymised clinical data was submitted for 99.1% of patients. The age range was 18 to 101 years (median 81 yrs, IQR 12), 48.7% were men. Mean initial INR was 2.67 (SD 1.34, IQR 1.1), 80.5% patients had a GCS of 15 and 68.1% did not report any associated neurological symptoms. 59.3% of patients had a CT head scan with a significant head injury-related finding identified in 5.6%. Reversal therapy was given to 5.3% of patients, only 19 (0.5%) patients underwent neurosurgery and 42 (1.2%) patients died of a head injury-related death. The overall rate of head injury complication was found to be 6.1%. Multivariate logistic regression modelling found GCS 4 was associated with an increased risk of an adverse outcome, however it made no significant contribution to the multivariable models. Conclusion This is the largest cohort of anticoagulated head injury patients ever reported. The head injury complication rate was 6.1% which correlates well with previous findings. INR was not found to be associated with a poor outcome however GCS

Pre-hospital non-invasive ventilation for acute respiratory failure: a systematic review and network meta analysis

Abstract: Objectives & Background We aimed to determine the effectiveness of pre-hospital continuous positive airway pressure (CPAP) or bi-level inspiratory positive airway pressure (BiPAP) compared with usual care for adults presenting to the emergency services with acute respiratory failure. Methods We searched 14 electronic databases and research registers from inception to August 2013. Searches were supplemented by hand-searching the reference list of relevant articles (including citation searching), the World Wide Web and contacting experts in the field. We selected randomised or quasi-randomised controlled trials that compared pre-hospital NIV to a relevant comparator treatment in patients with acute respiratory failure. An aggregate data network meta-analysis was used to jointly estimate intervention effects relative to standard care. A network meta-analysis using a mixture of individual patient-level data (IPD) and aggregate data was carried out to assess potential treatment effect modifiers. Results The literature searches identified 2284 citations. Eight randomised and two quasi-randomised controlled trials (six CPAP; four BiPAP; sample sizes 23 to 207) were selected for inclusion. The aggregate data network meta-analysis suggested that CPAP was the most effective treatment in terms of mortality (probability=0.989) and intubation rate (probability=0.639), and reduced both mortality (odds ratio 0.41; 95% CrI (credible interval) 0.20 to 0.77) and intubation rate (0.32; 95% CrI 0.17 to 0.62) compared to standard care. The effect of BiPAP upon mortality (odds ratio 1.94; 95% CrI 0.65 to 6.14) and intubation rate (odds ratio 0.40; 95% CrI 0.14 to 1.16) was uncertain. The network meta-analysis using IPD and aggregate data suggested that sex was a modifier of the effect of treatment on mortality. Conclusion Pre-hospital CPAP can reduce mortality and intubation rates compared to standard care, while the effectiveness of pre-hospital BiPAP is uncertain.

Pre-hospital continuous positive aireway pressure (cpap) for acute respiratory failure: an economic analysis

Abstract: Objectives & Background We aimed to determine the cost-effectiveness of pre-hospital CPAP compared with standard care for adults presenting to the emergency services with acute respiratory failure. Methods An economic model was developed to explore the costs and health outcomes when pre-hospital CPAP provided by paramedics and standard care (in-hospital non-invasive ventilation (NIV)) were applied to a hypothetical cohort with acute respiratory failure. The model assigned each patient a probability of intubation or death depending upon their characteristics and whether they had pre-hospital CPAP or standard care. The patients that survived accrued lifetime quality-adjusted life year (QALYs) and health care costs according to their age and sex. Costs were accrued through costs of intervention and hospital treatment costs, which depended on patient outcomes. Results Pre-hospital CPAP was more effective than standard care but was also more expensive, with an incremental cost-effectiveness ratio (ICER) of £20,514/QALY and a 49.5% probability of being cost-effective at the £20,000/QALY threshold. The probability of pre-hospital CPAP being cost-effective at the £20,000/QALY threshold depended on the incidence of eligible patients, and varied from 35.4% when a low estimate of incidence was used to 91.3% with a high estimate. If a typical ambulance service treated 175 appropriate patients per year it could save around 11 lives while incurring £241,250 additional costs, whereas if a typical ambulance service treated 2000 appropriate patients per year it could save 124 lives while incurring £876,480 additional costs. Variation in the incidence of eligible patients also had a marked impact on the expected value of sample information for a future randomised trial. Conclusion The cost-effectiveness of pre-hospital CPAP is uncertain and current evidence is insufficient to support widespread implementation. The immediate research priority is to estimate the incidence of patients eligible for pre-hospital CPAP. This appears to be the key determinant of the cost-effectiveness of a future trial and of pre-hospital CPAP itself.

Trial registration: must take place before or at the onset of enrolment

Abstract: The case for trial registration was first advanced almost two decades ago.1 Clinicians need to have access to the entire evidence base when they make judgements about whether treatments are effective. If researchers can undertake trials and then bury unfavourable results, then clinicians will be acting on misleading information and may harm their patients. There is evidence that trials with negative outcomes are less likely to be published, which could lead to overestimation of treatment effects in meta-analyses.2 This ‘publication bias’ is not only due to authors failing to submit negative trials for publication, but journals preferentially …