Meta-analysis: A practical decision making tool for surgeons

AbstractBackgroundThe exponential rise in published medical research on a yearly basis demands a method to summarise best evidence towards its application to patient care in clinical practice. A robust meta-analysis is a valid tool. It is often considered to be a simple process of pooling results from different studies. This is not true. It appears that surgeons lack a reference guide to help them conduct and appraise a meta-analysis.MethodsThis paper provides a structural framework to perform a meta-analysis. It guides the surgeon on a journey from identification of the correct clinical question to data analysis and through to producing a structured report. Statistical methods are discussed briefly as most commercial software calculates most results in the background. An example of a recent meta-analysis is given. However, important caveats are mentioned as there are limitations of the meta-analytical technique.ConclusionWhereas meta-analyses of homogeneous studies are the highest form of evidence, poorly conducted meta-analyses create confusion and serve to harm the patient. Surgeons practising their art in an era of evidence-based surgery need to understand the principles of meta-analyses

Identifying systems failures in the pathway to a catastrophic event: an analysis of national incident report data relating to vinca alkaloids.

BACKGROUND: Catastrophic errors in healthcare are rare, yet the consequences are so serious that where possible, special procedures are put in place to prevent them. As systems become safer, it becomes progressively more difficult to detect the remaining vulnerabilities. Using inadvertent intrathecal administration of vinca alkaloids as an example, we investigated whether analysis of incident report data describing low-harm events could bridge this gap. METHODS: We studied nine million patient safety incidents reported from England and Wales between November 2003 and May 2013. We searched for reports relating to administration of vinca alkaloids in patients also receiving intrathecal medication, and classified the failures identified against steps in the relevant national protocol. RESULTS: Of 38 reports that met our inclusion criteria, none resulted in actual harm. The stage of the medication process most commonly involved was 'supply, transport and storage' (15 cases). Seven cases related to dispensing, six to documentation, and four each to prescribing and administration. Defences most commonly breached related to separation of intravenous vinca alkaloids and intrathecal medication in timing (n=16) and location (n=8); potential for confusion due to inadequate separation of these drugs therefore remains. Problems involved in six cases did not align with the procedural defences in place, some of which represented major hazards. CONCLUSIONS: We identified areas of concern even within the context of a highly controlled standardised national process. If incident reporting systems include and encourage reports of no-harm incidents in addition to actual patient harm, they can facilitate monitoring the resilience of healthcare processes. Patient safety incidents that produce the most serious harm are often rare, and it is difficult to know whether patients are adequately protected. Our approach provides a potential solution

What is the risk of death or severe harm due to bone cement implantation syndrome among patients undergoing hip hemiarthroplasty for fractured neck of femur? A patient safety surveillance study.

OBJECTIVE: To estimate the risk of death or severe harm due to bone cement implantation syndrome (BCIS) among patients undergoing hip hemiarthroplasty for fractured neck of femur. SETTING: Hospitals providing secondary and tertiary care throughout the National Health Service (NHS) in England and Wales. PARTICIPANTS: Cases reported to the National Reporting and Learning System (NRLS) in which the reporter clearly describes severe acute patient deterioration associated with cement use in hip hemiarthroplasty for fractured neck of femur (assessed independently by two reviewers). OUTCOME MEASURES: Primary-number of reported deaths, cardiac arrests and periarrests per year. Secondary-timing of deterioration and outcome in relation to cement insertion. RESULTS: Between 2005 and 2012, the NRLS received 62 reports that clearly describe death or severe harm associated with the use of cement in hip hemiarthroplasty for fractured neck of femur. There was one such incident for every 2900 hemiarthroplasties for fractured neck of femur during the period. Of the 62 reports, 41 patients died, 14 were resuscitated from cardiac arrest and 7 from periarrest. Most reports (55/62, 89%) describe acute deterioration occurring during or within a few minutes of cement insertion. The vast majority of deaths (33/41, 80%) occurred on the operating table. CONCLUSIONS: These reports provide narrative evidence from England and Wales that cement use in hip hemiarthroplasty for fractured neck of femur is associated with instances of perioperative death or severe harm consistent with BCIS. In 2009, the National Patient Safety Agency publicised this issue and encouraged the use of mitigation measures. Three-quarters of the deaths in this study have occurred since that alert, suggesting incomplete implementation or effectiveness of those mitigation measures. There is a need for stronger evidence that weighs the risks and benefits of cement in hip hemiarthroplasty for fractured neck of femur

Patient-safety-related hospital deaths in England: thematic analysis of incidents reported to a national database, 2010-2012.

BACKGROUND: Hospital mortality is increasingly being regarded as a key indicator of patient safety, yet methodologies for assessing mortality are frequently contested and seldom point directly to areas of risk and solutions. The aim of our study was to classify reports of deaths due to unsafe care into broad areas of systemic failure capable of being addressed by stronger policies, procedures, and practices. The deaths were reported to a patient safety incident reporting system after mandatory reporting of such incidents was introduced. METHODS AND FINDINGS: The UK National Health Service database was searched for incidents resulting in a reported death of an adult over the period of the study. The study population comprised 2,010 incidents involving patients aged 16 y and over in acute hospital settings. Each incident report was reviewed by two of the authors, and, by scrutinising the structured information together with the free text, a main reason for the harm was identified and recorded as one of 18 incident types. These incident types were then aggregated into six areas of apparent systemic failure: mismanagement of deterioration (35%), failure of prevention (26%), deficient checking and oversight (11%), dysfunctional patient flow (10%), equipment-related errors (6%), and other (12%). The most common incident types were failure to act on or recognise deterioration (23%), inpatient falls (10%), healthcare-associated infections (10%), unexpected per-operative death (6%), and poor or inadequate handover (5%). Analysis of these 2,010 fatal incidents reveals patterns of issues that point to actionable areas for improvement. CONCLUSIONS: Our approach demonstrates the potential utility of patient safety incident reports in identifying areas of service failure and highlights opportunities for corrective action to save lives

The acute and long-term management of anaphylaxis: protocol for a systematic review

Background:The European Academy of Allergy and Clinical Immunology is in the process of developing its Guideline for Food Allergy and Anaphylaxis, and this systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management and impact on quality of life, which will be used to inform clinical recommendations.The aims of this systematic review will be to assess the effectiveness of interventions for the acute management of anaphylaxis, and pharmacological and non-pharmacological approaches for the long-term management of anaphylaxis. Methods:A highly sensitive search strategy has been developed, and validated study design filters will be applied to retrieve all articles pertaining to the management of anaphylaxis from electronic bibliographic databases. We will systematically review the literature on the acute management of anaphylaxis by assessing the effectiveness of epinephrine, H1-antihistamines (versus placebo), systemic glucocorticosteroids, methylxanthines or any other treatments for the emergency management of people experiencing anaphylaxis. The main interventions that have been studied in the context of long-term management are anaphylaxis management plans and allergen-specific immunotherapy. Discussion:There is at present little in the way of robust evidence to guide decisions on the acute and/or long-term management of anaphylaxis. Given the risk of death and the considerable morbidity associated with anaphylaxis these evidence gaps need to be filled wherever possible; this systematic review will make a start in this area

Preventing food allergy: protocol for a rapid systematic review

BACKGROUND: The European Academy of Allergy and Clinical Immunology is developing guidelines about how to prevent and manage food allergy. As part of the guidelines development process, a systematic review is planned to examine published research about the prevention of food allergy. This systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management, and impact on quality of life, which will be used to inform clinical recommendations. The aim of this systematic review will be to assess the effectiveness of approaches for the primary prevention of food allergy. METHODS: Seven bibliographic databases will be searched from their inception to September 30, 2012 for systematic reviews, randomized controlled trials, quasi-randomized controlled trials, controlled clinical trials, controlled before-and-after studies, interrupted time series and cohort studies. Cohort studies will be included due to an inability to randomize with interventions such as breastfeeding. Studies that focused on the development of either food sensitization (a proxy measure) or food allergy will also be eligible for inclusion. Studies will be critically appraised using the Critical Appraisal Skills Program and Cochrane Risk of Bias tools, as appropriate. DISCUSSION: There is a lack of rigorous evidence to support recommendations about how to prevent the development of food allergy. It would appear that it is important to see the prevention of food allergy in the context of individual, family and wider factors that may influence its development. There is much left to learn about preventing food allergy, and this is a priority given the high societal and healthcare costs involved. This systematic review will help to further this learning

Hemostasis and Biosurgicals in Trauma and Orthopedic Surgery

Trauma and orthopedics is a specialty in which significant blood loss can be incurred both in terms of traumatic injuries and operative management. This chapter starts with a brief review of the biology of hemostasis followed by the importance of hemostasis in surgery. This is followed by a discussion on the ideal hemostatic agent. Various strategies of achieving hemostasis will be discussed including mechanical, thermal, pharmacological and topical agents in both elective orthopedic and spine surgery as well as in trauma. Specifically, we will look at synthetic agents such as cyanoacrylate, polyethylene glycol hydrogel and glutaraldehyde cross-linked albumin and absorbable agents such as gelatin foams and oxidized cellulose. We will also look at biological agents such as topical thrombin, sealants and platelet gels. Hemostatic dressings will be discussed in detail