Efficacy and safety of non-invasive ventilation in the treatment of acute cardiogenic pulmonary edema – a systematic review and meta-analysis

INTRODUCTION: Continuous positive airway pressure ventilation (CPAP) and non-invasive positive pressure ventilation (NPPV) are accepted treatments in acute cardiogenic pulmonary edema (ACPE). However, it remains unclear whether NPPV is better than CPAP in reducing the need for endotracheal intubation (NETI) rates, mortality and other adverse events. Our aim was to review the evidence about the efficacy and safety of these two methods in ACPE management. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials on the effect of CPAP and/or NIPV in the treatment of ACPE, considering the outcomes NETI, mortality and incidence of acute myocardial infarction (AMI). We searched six electronic databases up to May 2005 without language restrictions, reviewed references of relevant articles, hand searched conference proceedings and contacted experts. RESULTS: Of 790 articles identified, 17 were included. In a pooled analysis, 10 studies of CPAP compared to standard medical therapy (SMT) showed a significant 22% absolute risk reduction (ARR) in NETI (95% confidence interval (CI), -34% to -10%) and 13% in mortality (95%CI, -22% to -5%). Six studies of NPPV compared to SMT showed an 18% ARR in NETI (95%CI, -32% to -4%) and 7% in mortality (95%CI, -14% to 0%). Seven studies of NPPV compared to CPAP showed a non-significant 3% ARR in NETI (95%CI, -4% to 9%) and 2% in mortality (95%CI, -6% to 10%). None of these methods increased AMI risk. In a subgroup analysis, NPPV did not lead to better outcomes than CPAP in studies including more hypercapnic patients. CONCLUSION: Robust evidence now supports the use of CPAP and NPPV in ACPE. Both techniques decrease NETI and mortality compared to SMT and none shows increased AMI risk. CPAP should be considered a first line intervention as NPPV did not show a better efficacy, even in patients with more severe conditions, and CPAP is cheaper and easier to implement in clinical practice

Determinants of frequency and longevity of hospital encounters' data use

<p>Abstract</p> <p>Background</p> <p>The identification of clinically relevant information enables improvement in user interfaces and in data management. However, it is difficult to identify what information is important in daily clinical care, and what is used occasionally. This study aims to determine for how long clinical documents are used in a Hospital Information System (HIS).</p> <p>Methods</p> <p>The access logs of 3 years of usage of a HIS were analysed concerning report departmental source, type of hospital encounter, and inpatient encounter ICD-9-CM main diagnosis. Reports median life indicates the median time elapsed between information creation and its usage. The models that better explains report views over time were explored.</p> <p>Results</p> <p>The number of report views in the study period was 656 583. Fifty two percent of the reports viewed by medical doctors in emergency encounters were from previous encounters - 21% at outpatient attendance, 19% in inpatient (wards) and 12% during emergency encounters. In an inpatient setting, 20% of the reports viewed were produced in previous encounters. The median life of information in documents is 1.5 days for emergency, 4.8 days for inpatient and 37.8 days for outpatient encounters. Immune-haemotherapy reports reach their median lives faster (7 days) than clinical pathology (15 days), gastroenterology (80 days) and pathology (118 days). The median life of reports produced in inpatient encounters varied from 36 days for neoplasms as the main diagnosis to 0.7 days for injury and poisoning. The model with the best fit (R²> 0.9) was the exponential.</p> <p>Conclusions</p> <p>The usage of past patient information varied significantly according to patient age, type of information, type of hospital encounter and medical cause (main diagnosis) for the encounter. The exponential model is a good fit to model how the reports are seen over time, so the design of user interfaces and repository management algorithms should take it in consideration.</p

Real-world evidence was feasible for estimating effectiveness of chemotherapy in breast cancer; a cohort study

Objective: Evidence-based guidelines recommend adjuvant chemotherapy in early stage breast cancer whenever treatment benefit is considered sufficient to outweigh the associated risks. However, many groups of patients were either excluded from or underrepresented in the clinical trials that form the evidence base for this recommendation. This study aims to determine whether using administrative healthcare data – Real World Data (RWD) - and econometric methods for causal analysis to provide ‘Real World Evidence’ (RWE) are feasible methods for addressing this gap.Methods: Cases of primary breast cancer in women from 2001 to 2015 were extracted from the Scottish cancer registry (SMR06) and linked to other routine health records (inpatient and outpatient visits). Four methods were used to estimate the effect of adjuvant chemotherapy on disease-specific and overall mortality: (1) regression with adjustment for covariates (2) propensity score matching (3) instrumental variables analysis and (4) regression discontinuity design. Hazard ratios for breast cancer mortality and all-cause mortality were compared to those from a meta-analysis of randomised trials.Results: 39,805 cases included in the analyses. Regression adjustment, propensity score matching and instrumental variables were feasible while regression discontinuity was not. Effectiveness estimates were similar between RWE and randomised trials for breast cancer mortality but not for all-cause mortality.Conclusions: RWE methods are a feasible means to generate estimates of effectiveness of adjuvant chemotherapy in early stage breast cancer. However, such estimates must be interpreted in the context of the available randomised evidence and the potential biases of the observational methods.<br/

The Scottish Emergency Care Summary – an evaluation of a national shared record system aiming to improve patient care: technology report

Background In Scotland, out-of-hours calls are all triaged by the National Health Service emergency service (NHS24) but the clinicians receiving calls have no direct access to patient records.Objective To improve the safety of patient care in unscheduled consultations when the usual primary care record is not available.Technology The Emergency Care Summary (ECS) is a record system offering controlled access to medication and adverse reactions details for nearly every person registered with a general practice in Scotland. It holds a secure central copy of these parts of the GP practice record and is updated automatically twice daily. It is accessible under specified unplanned clinical circumstances by clinicians working in out-of-hours organisations, NHS24 and accident and emergency departments if they have consent from the patient and a current legitimate relationship for that patient’s care.Application We describe the design of the security model, management of data quality, deployment, costs and clinical benefits of the ECS over four years nationwide in Scotland, to inform the debate on the safe and effective sharing of health data in other nations.Evaluation Forms were emailed to 300 NHS24 clinicians and 81% of the 113 respondents said that the ECS was helpful or very helpful and felt that it changed their clinical management in 20% of cases.Conclusion The ECS is acceptable to patients and helpful for clinicians and is used routinely for unscheduled care when normal medical records are unavailable. Benefits include more efficient assessment and reduced drug interaction, adverse reaction and duplicate prescribing

Better reporting of interventions : template for intervention description and replication (TIDieR) checklist and guide

Peer reviewedPublisher PD

Effect of guideline based computerised decision support on decision making of multidisciplinary teams: cluster randomised trial in cardiac rehabilitation

Objective To determine the extent to which computerised decision support can improve concordance of multidisciplinary teams with therapeutic decisions recommended by guidelines

Computer decision support systems for asthma:a systematic review

BACKGROUND: Increasing use of electronic health records offers the potential to incorporate computer decision support systems (CDSSs) to prompt evidence-based actions within routine consultations.AIM: To synthesise the evidence for the use of CDSSs by professionals managing people with asthma.MATERIALS AND METHODS: We systematically searched Medline, Embase, Health Technology Assessment, Cochrane and Inspec databases (1990 to April 2012, no language restrictions) for trials, and four online repositories for unpublished studies. We also wrote to authors. Eligible studies were randomised controlled trials of CDSSs supporting professional management of asthma. Studies were appraised (Cochrane Risk of Bias Tool) and findings synthesised narratively.RESULTS: A total of 5787 articles were screened, and eight trials were found eligible, with six at high risk of bias. Overall, CDSSs for professionals were ineffective. Usage of the systems was generally low: in the only trial at low risk of bias the CDSS was not used at all. When a CDSS was used, compliance with the advice offered was also low. However, if actually used, CDSSs could result in closer guideline adherence (improve investigating, prescribing and issuing of action plans) and could improve some clinical outcomes. The study at moderate risk of bias showed increased prescribing of inhaled steroids.CONCLUSIONS: The current generation of CDSSs is unlikely to result in improvements in outcomes for patients with asthma because they are rarely used and the advice is not followed. Future decision support systems need to align better with professional workflows so that pertinent and timely advice is easily accessible within the consultation.</p

Diagnostic omission errors in acute paediatric practice: impact of a reminder system on decision-making

BACKGROUND: Diagnostic error is a significant problem in specialities characterised by diagnostic uncertainty such as primary care, emergency medicine and paediatrics. Despite wide-spread availability, computerised aids have not been shown to significantly improve diagnostic decision-making in a real world environment, mainly due to the need for prolonged system consultation. In this study performed in the clinical environment, we used a Web-based diagnostic reminder system that provided rapid advice with free text data entry to examine its impact on clinicians' decisions in an acute paediatric setting during assessments characterised by diagnostic uncertainty. METHODS: Junior doctors working over a 5-month period at four paediatric ambulatory units consulted the Web-based diagnostic aid when they felt the need for diagnostic assistance. Subjects recorded their clinical decisions for patients (differential diagnosis, test-ordering and treatment) before and after system consultation. An expert panel of four paediatric consultants independently suggested clinically significant decisions indicating an appropriate and 'safe' assessment. The primary outcome measure was change in the proportion of 'unsafe' workups by subjects during patient assessment. A more sensitive evaluation of impact was performed using specific validated quality scores. Adverse effects of consultation on decision-making, as well as the additional time spent on system use were examined. RESULTS: Subjects attempted to access the diagnostic aid on 595 occasions during the study period (8.6% of all medical assessments); subjects examined diagnostic advice only in 177 episodes (30%). Senior House Officers at hospitals with greater number of available computer workstations in the clinical area were most likely to consult the system, especially out of working hours. Diagnostic workups construed as 'unsafe' occurred in 47/104 cases (45.2%); this reduced to 32.7% following system consultation (McNemar test, p < 0.001). Subjects' mean 'unsafe' workups per case decreased from 0.49 to 0.32 (p < 0.001). System advice prompted the clinician to consider the 'correct' diagnosis (established at discharge) during initial assessment in 3/104 patients. Median usage time was 1 min 38 sec (IQR 50 sec – 3 min 21 sec). Despite a modest increase in the number of diagnostic possibilities entertained by the clinician, no adverse effects were demonstrable on patient management following system use. Numerous technical barriers prevented subjects from accessing the diagnostic aid in the majority of eligible patients in whom they sought diagnostic assistance. CONCLUSION: We have shown that junior doctors used a Web-based diagnostic reminder system during acute paediatric assessments to significantly improve the quality of their diagnostic workup and reduce diagnostic omission errors. These benefits were achieved without any adverse effects on patient management following a quick consultation

Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device

Introduction: To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom. Methods: A briefing paper was circulated to a multi‐disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1‐day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions. Results: This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level. Conclusions: If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as “software as a medical device.” However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries