Global research priorities to better understand the burden of iatrogenic harm in primary care: an international Delphi exercise.

Using a modified Delphi exercise, Aziz Sheikh and colleagues identify research priorities for patient safety research in primary care contexts. Please see later in the article for the Editors' Summary.

Disease-specific health-related quality of life (HRQL) instruments for food allergy: 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 aim of this systematic review will be to determine which validated instruments can be employed to enable assessment of the impact of, and investigations and interventions for, food allergy on health-related quality of life. METHODS: Seven bibliographic databases were searched from their inception to September 30, 2012 for disease-specific HRQL questionnaires that were specifically designed for use with patients/carers and any articles relating to the description, development and/or the validation of the above identified HRQLs. There were no language or geographic restrictions. We will assess the development of the instruments identified and their performance properties including: validity; generalizability; responsiveness; managing missing data; how variation in patient demography was managed; and cross-cultural and linguistic adaptation, using a previously reported quality assessment tool. DISCUSSION: Using appropriately developed and validated instruments is critical to the accurate evaluation of HRQL in people with food allergy. This review will systematically appraise the evidence on the subject and help to identify any gaps.

Patient safety in orthopedic surgery: prioritizing key areas of iatrogenic harm through an analysis of 48,095 incidents reported to a national database of errors.

BACKGROUND: With scientific and technological advances, the practice of orthopedic surgery has transformed the lives of millions worldwide. Such successes however have a downside; not only is the provision of comprehensive orthopedic care becoming a fiscal challenge to policy-makers and funders, concerns are also being raised about the extent of the associated iatrogenic harm. The National Reporting and Learning System (NRLS) in England and Wales is an underused resource which collects intelligence from reports about health care error. METHODS: Using methods akin to case-control methodology, we have identified a method of prioritizing the areas of a national database of errors that have the greatest propensity for harm. Our findings are presented using odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: The largest proportion of surgical patient safety incidents reported to the NRLS was from the trauma and orthopedics specialty, 48,095/163,595 (29.4%). Of those, 14,482/48,095 (30.1%) resulted in iatrogenic harm to the patient and 71/48,095 (0.15%) resulted in death. The leading types of errors associated with harm involved the implementation of care and on-going monitoring (OR 5.94, 95% CI 5.53, 6.38); self-harming behavior of patients in hospitals (OR 2.14, 95% CI 1.45, 3.18); and infection control (OR 1.91, 95% CI 1.69, 2.17). We analyze these data to quantify the extent and type of iatrogenic harm in the specialty, and make suggestions on the way forward. CONCLUSION AND LEVEL OF EVIDENCE: Despite the limitations of such analyses, it is clear that there are many proven interventions which can improve patient safety and need to be implemented. Avoidable errors must be prevented, lest we be accused of contravening our fundamental duty of primum non nocere. This is a level III evidence-based study.

Analysing the benefits of laparoscopic hernia repair compared to open repair: A meta-analysis of observational studies.

BACKGROUND: The purpose of this study is to compare the difference of incidence of post-operative complications, operative time, length of stay and recurrence of patients undergoing laparoscopic or open repair of their ventral/incisional hernia a meta-analytic technique for observational studies. MATERIALS AND METHODS: A literature search was performed using Medline, PubMed, Embase and Cochrane databases for studies reported between 1998 and 2009 comparing laparoscopic and open surgery for the treatment of ventral (incisional) hernia. This meta-analysis of all the observational studies compared the post-operative complications recurrence rate and length of stay. The random effects model was used. Sensitivity and heterogeneity were analysed. RESULTS: Analysis of 15 observational studies comprising 2452 patients qualified for meta-analysis according to the study's inclusion criteria. Laparoscopic surgery was attempted in 1067 out of 2452. The results showed that the length of stay (odds ratio [OR], - 1.00; 95% confidence interval [CI], - 1.09 to - 0.91; P < 0.00001) and operative time (OR, 59.33; 95% CI, 58.55 to 60.11; P < 0.00001) was significantly lower in the laparoscopic group. The results also showed that there was a significant reduction in the formation of abscesses (OR, 0.38; 95% CI, 0.16 to 0.92; P = 0.03) and wound infections (OR, 0.49; 95% CI, 0.29 to 0.82; P = 0.007) post-operatively. There is a trend which indicates that the recurrence of the hernia using laparoscopic repair versus open repair was overall lower with the laparoscopic repair (OR, 0.48; 95% CI, 0.22 to 1.04; P = 0.06), however, this was not significant. CONCLUSION: Laparoscopic incisional hernia repair was associated with a reduced length of stay, operative time and lower incidence of abscess and wound infection post-operatively. This study also highlights the benefit of using observational studies as a form of research and its value as a tool in answering questions where large sample sizes of patient groups would be impossible to accumulate in a reasonable length of time.

Laparoscopic cholecystectomy: device-related errors revealed through a national database.

Laparoscopic techniques represent a key milestone in the development of modern surgery, offering a step change in quality of care, patient satisfaction and efficiency in use of health service resources. Laparoscopy is most widely used for gall bladder surgery. As would be expected with the introduction of any new technology, the early phase of development was accompanied by complications in its use. Arguably some of these should have been anticipated, but nevertheless standards and training programs were subsequently put in place to secure a more consistent standard of care across the UK. Now that this early learning curve has largely been negotiated, we wanted to examine the nature of the errors associated with laparoscopic gall bladder surgery, particularly in relation to equipment. We used data from the largest error-reporting system in the world to examine the problem of equipment-related incidents amongst patients who had laparoscopic cholecystectomy. Over the 6-year period 2004-2010, the number of such reports increased 15-fold, whilst the growth in use of the procedure itself increased 1.3-fold. The majority of the increase was in device-related errors. User-related errors constituted a smaller proportion of errors. Whilst most surgeons appear to carry out laparoscopic surgery with a low level of harm to their patients, problems with their equipment remains a risk for many procedures. In some ways, this is an easier problem to address than one associated with competency. A risk associated with faulty, substandard or misused equipment is one that should be minimized in a 21st Century surgical service.