Jeremy C. Wyatt

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

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

Commentary: Prognostic models: clinically useful or quickly forgotten?

We are all familiar with using single items of patient data such as age or smoking history to help in making difficult clinical decisions.1 Prognostic models are more complex tools for helping decision making that combine two or more items of patient data to predict clinical outcomes.2 They are of potential value when doctors are making difficult clinical decisions (such as ordering invasive tests or selecting which patients should benefit from scarce resources),3 conducting comparative audit,4 or selecting uniform groups of patients for clinical trials.5 Another prognostic model appears in this weeks BMJ6 to join the hundreds published every year.7 However, apart from exceptions such as the Glasgow coma scale8 and APACHE III,9 few of these models are routinely used to inform difficult clinical decisions. It might be argued that doctors never prognosticate, working always in the present, but studies of medical decision making show this is untrue.10 11 Some doctors might claim that they can foretell patient outcomes better than any statistical model, but again there is contrary evidence.9 12 A journal editors view might be that most published models reflect preliminary work and need further research before clinical adoption.13 Finally, some models predict events that are of no clinical relevance or do not generate predictions in time to inform clinical decisions, suggesting that their developers wished merely to publish journal articles, not build clinically useful tools.14 We believe that the main reasons why doctors reject published prognostic models are lack of clinical credibility and lack of evidence that a prognostic model can support decisions about patient care (that is, evidence of accuracy, generality, and effectiveness). We examine each of these issues in …

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

IntroductionContinuous 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.MethodsWe 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.ResultsOf 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.ConclusionRobust 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.

When to Use Web-based Surveys

Even in this randomized trial era, surveys of patients and professionals remain an important epidemiologic technique for capturing cross-sectional or longitudinal data, providing fundamental insights about health and disease.1 There are several alternative methods for collecting such data, which include conducting face-to-face or telephone interviews; circulating a questionnaire by mail, fax, or e-mail; and eliciting responses to a survey posted on an open Web site. Other methods that are currently less widely exploited include digital interactive television; use of a software package to capture survey data, either by mailed floppy disks or as a Java applet over the Web; and automatic telephone menu systems. The preceding article by Schleyer and Forrest2 explores some of the issues arising from a Web survey, but it may be useful first to consider the range of survey methods that are available. Two major features define a survey method: how participants are identified and the data capture technique. Let us consider these features and their implications in turn. How participants are identified determines how much control the investigators exert over their selection. For complete control, eligible participants are selected according to specific characteristics.3 We can check characteristics from an existing database or mailing list, including an e-mail discussion list, or carry out a preliminary mailing or interview to capture the necessary eligibility data. If, instead, we wish only a modest degree of control, we can distribute copies of the survey to a group known to us and ask them in turn to send it out to their contacts—the “snowball” technique (e.g., Forsstrom et al.4). With this method we have much less control over who receives a copy of the survey, and it makes sending reminders or follow-up surveys more difficult, too. We often do not even know how many copies of …

Evaluating medical expert systems: what to test and how?

Many believe that medical expert systems have great potential to improve health care, but few of these systems have been rigorously evaluated, and even fewer are in routine use. We propose the evaluation of medical expert systems in two stages: laboratory and field testing. In the former, the perspectives of both prospective users and experts responsible for implementation are valuable. In the latter, the study must be designed to test, in an unbiased manner, whether the system is used in clinical practice, and if it is used, how it affects the structure, process and outcome of health care encounters. We conclude with proposals for encouraging the objective evaluation of these systems.

Computerised decision support systems in order communication for diagnostic, screening or monitoring test ordering: systematic reviews of the effects and cost-effectiveness of systems

BACKGROUND Order communication systems (OCS) are computer applications used to enter diagnostic and therapeutic patient care orders and to view test results. Many potential benefits of OCS have been identified including improvements in clinician ordering patterns, optimisation of clinical time, and aiding communication processes between clinicians and different departments. Many OCS now include computerised decision support systems (CDSS), which are information systems designed to improve clinical decision-making. CDSS match individual patient characteristics to a computerised knowledge base, and software algorithms generate patient-specific recommendations. OBJECTIVES To investigate which CDSS in OCS are in use within the UK and the impact of CDSS in OCS for diagnostic, screening or monitoring test ordering compared to OCS without CDSS. To determine what features of CDSS are associated with clinician or patient acceptance of CDSS in OCS and what is known about the cost-effectiveness of CDSS in diagnostic, screening or monitoring test OCS compared to OCS without CDSS. DATA SOURCES A generic search to identify potentially relevant studies for inclusion was conducted using MEDLINE, EMBASE, Cochrane Controlled Trials Register (CCTR), CINAHL (Cumulative Index to Nursing and Allied Health Literature), DARE (Database of Abstracts of Reviews of Effects), Health Technology Assessment (HTA) database, IEEE (Institute of Electrical and Electronic Engineers) Xplore digital library, NHS Economic Evaluation Database (NHS EED) and EconLit, searched between 1974 and 2009 with a total of 22,109 titles and abstracts screened for inclusion. REVIEW METHODS CDSS for diagnostic, screening and monitoring test ordering OCS in use in the UK were identified through contact with the 24 manufacturers/suppliers currently contracted by the National Project for Information Technology (NpfIT) to provide either national or specialist decision support. A generic search to identify potentially relevant studies for inclusion in the review was conducted on a range of medical, social science and economic databases. The review was undertaken using standard systematic review methods, with studies being screened for inclusion, data extracted and quality assessed by two reviewers. Results were broadly grouped according to the type of CDSS intervention and study design where possible. These were then combined using a narrative synthesis with relevant quantitative results tabulated. RESULTS Results of the studies included in review were highly mixed and equivocal, often both within and between studies, but broadly showed a beneficial impact of the use of CDSS in conjunction with OCS over and above OCS alone. Overall, if the findings of both primary and secondary outcomes are taken into account, then CDSS significantly improved practitioner performance in 15 out of 24 studies (62.5%). Only two studies covered the cost-effectiveness of CDSS: a Dutch study reported a mean cost decrease of 3% for blood tests orders (639 euros) in each of the intervention clinics compared with a 2% (208 euros) increase in control clinics in test costs; and a Spanish study reported a significant increase in the cost of laboratory tests from 41.8 euros per patient per annum to 47.2 euros after implementation of the system. LIMITATIONS The response rate from the survey of manufacturers and suppliers was extremely low at only 17% and much of the feedback was classified as being commercial-in-confidence (CIC). No studies were identified which assessed the features of CDSS that are associated with clinician or patient acceptance of CDSS in OCS in the test ordering process and only limited data was available on the cost-effectiveness of CDSS plus OCS compared with OCS alone and the findings highly specific. Although CDSS appears to have a potentially small positive impact on diagnostic, screening or monitoring test ordering, the majority of studies come from a limited number of institutions in the USA. CONCLUSIONS If the findings of both primary and secondary outcomes are taken into account then CDSS showed a statistically significant benefit on either process or practitioner performance outcomes in nearly two-thirds of the studies. Furthermore, in four studies that assessed adverse effects of either test cancellation or delay, no significant detrimental effects in terms of additional utilisation of health-care resources or adverse events were observed. We believe the key current need is for a well designed and comprehensive survey, and on the basis of the results of this potentially for evaluation studies in the form of cluster randomised controlled trials or randomised controlled trials which incorporate process, and patient outcomes, as well as full economic evaluations alongside the trials to assess the impact of CDSS in conjunction with OCS versus OCS alone for diagnostic, screening or monitoring test ordering in the NHS. The economic evaluation should incorporate the full costs of potentially developing, testing, and installing the system, including staff training costs. STUDY REGISTRATION Study registration 61.

mHealth and Mobile Medical Apps: A Framework to Assess Risk and Promote Safer Use

The use of mobile medical apps by clinicians and others has grown considerably since the introduction of mobile phones. Medical apps offer clinicians the ability to access medical knowledge and patient data at the point of care, but several studies have highlighted apps that could compromise patient safety and are potentially dangerous. This article identifies a range of different kinds of risks that medical apps can contribute to and important contextual variables that can modify these risks. We have also developed a simple generic risk framework that app users, developers, and other stakeholders can use to assess the likely risks posed by a specific app in a specific context. This should help app commissioners, developers, and users to manage risks and improve patient safety.

Verifying quality and safety in health informatics services

Information and its handling and transmission form an essential part of health care and are reflected in professional standards. Automated information systems in health care—health informatics services—will improve these functions and bring new opportunities through the harnessing of modern information and communications technologies. Thus, computer support is now essential in many parts of medicine, the US Institute of Medicine has long espoused the value of computerised patient records,1 and many countries have developed strategies on this topic, and there are countless health related internet sites. However, as new information and communication technologies in health bring new opportunities, they also bring new risks. Emphasis has rightly been placed on ensuring appropriate levels of confidentiality in electronic information systems—to the point that the highly exacting requirements being demanded by independent commentators and professional bodies2 are difficult to satisfy without jeopardising the functioning of core services 3 4 or the interests of the most vulnerable groups.5 In contrast, much less thought has been given so far to ensuring the appropriateness of the design and integrity of functioning of health informatics services. #### Summary points Like drugs 40 years ago, products in health informatics are unregulated with regard to safety and efficacy A European project has now recommended ways of accrediting healthcare related software, telemedicine, and internet sites A scheme like CE marking of electrical goods is recommended for software, national regulatory bodies should be identified for telemedicine, and a European certification of integrity scheme developed for websites If informatics systems are increasingly essential in the delivery of health care then their integrity and quality must be of equal importance, but this has been scarcely recognised to date. In 1963 the then UK secretary of state for health stated to the House of Commons: “The House and the public suddenly …

Randomised trial of educational visits to enhance use of systematic reviews in 25 obstetric units.

Abstract Objective To evaluate the effectiveness of an educational visit to help obstetricians and midwives select and use evidence from a Cochrane database containing 600 systematic reviews. Design Randomised single blind controlled trial with obstetric units allocated to an educational visit or control group. Setting 25 of the 26 district general obstetric units in two former NHS regions. Subjects The senior obstetrician and midwife from each intervention unit participated in educational visits. Clinical practices of all staff were assessed in 4508 pregnancies. Intervention Single informal educational visit by a respected obstetrician including discussion of evidence based obstetrics, guidance on implementation, and donation of Cochrane database and other materials. Main outcome measures Rates of perineal suturing with polyglycolic acid, ventouse delivery, prophylactic antibiotics in caesarean section, and steroids in preterm delivery, before and 9 months after visits, and concordance of guidelines with review evidence for same marker practices before and after visits. Results Rates varied greatly, but the overall baseline mean of 43% (986/2312) increased to 54% (1189/2196) 9 months later. Rates of ventouse delivery increased significantly in intervention units but not in control units; there was no difference between the two types of units in uptake of other practices. Pooling rates from all 25 units, use of antibiotics in caesarean section and use of polyglycolic acid sutures increased significantly over the period, but use of steroids in preterm delivery was unchanged. Labour ward guidelines seldom agreed with evidence at baseline; this hardly improved after visits. Educational visits cost 860

When and how to evaluate health information systems

each (at 1995 prices). Conclusions There was considerable uptake of evidence into practice in both control and intervention units between 1994 and 1995. Our educational visits added little to this, despite the informal setting, targeting of senior staff from two disciplines, and donation of educational materials. Further work is needed to define cost effective methods to enhance the uptake of evidence from systematic reviews and to clarify leadership and roles of senior obstetric staff in implementing the evidence.