Access to medical records for research purposes:Varying perceptions across research ethics boards

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Medical versus surgical interventions for open angle glaucoma.

BACKGROUND: Open angle glaucoma (OAG) is a common cause of blindness.

OBJECTIVES: To assess the effects of medication compared with initial surgery in adults with OAG.

SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2012), EMBASE (January 1980 to August 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to August 2012), Biosciences Information Service (BIOSIS) (January 1969 to August 2012), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1937 to August 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), Zetoc, the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 1 August 2012. The National Research Register (NRR) was last searched in 2007 after which the database was archived. We also checked the reference lists of articles and contacted researchers in the field.

SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing medications with surgery in adults with OAG.

DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for missing information.

MAIN RESULTS: Four trials involving 888 participants with previously untreated OAG were included. Surgery was Scheie's procedure in one trial and trabeculectomy in three trials. In three trials, primary medication was usually pilocarpine, in one trial it was a beta-blocker.The most recent trial included participants with on average mild OAG. At five years, the risk of progressive visual field loss, based on a three unit change of a composite visual field score, was not significantly different according to initial medication or initial trabeculectomy (odds ratio (OR) 0.74, 95% confidence interval (CI) 0.54 to 1.01). In an analysis based on mean difference (MD) as a single index of visual field loss, the between treatment group difference in MD was -0.20 decibel (dB) (95% CI -1.31 to 0.91). For a subgroup with more severe glaucoma (MD -10 dB), findings from an exploratory analysis suggest that initial trabeculectomy was associated with marginally less visual field loss at five years than initial medication, (mean difference 0.74 dB (95% CI -0.00 to 1.48). Initial trabeculectomy was associated with lower average intraocular pressure (IOP) (mean difference 2.20 mmHg (95% CI 1.63 to 2.77) but more eye symptoms than medication (P = 0.0053). Beyond five years, visual acuity did not differ according to initial treatment (OR 1.48, 95% CI 0.58 to 3.81).From three trials in more severe OAG, there is some evidence that medication was associated with more progressive visual field loss and 3 to 8 mmHg less IOP lowering than surgery. In the longer-term (two trials) the risk of failure of the randomised treatment was greater with medication than trabeculectomy (OR 3.90, 95% CI 1.60 to 9.53; hazard ratio (HR) 7.27, 95% CI 2.23 to 25.71). Medications and surgery have evolved since these trials were undertaken.In three trials the risk of developing cataract was higher with trabeculectomy (OR 2.69, 95% CI 1.64 to 4.42). Evidence from one trial suggests that, beyond five years, the risk of needing cataract surgery did not differ according to initial treatment policy (OR 0.63, 95% CI 0.15 to 2.62).Methodological weaknesses were identified in all the trials.

AUTHORS' CONCLUSIONS: Primary surgery lowers IOP more than primary medication but is associated with more eye discomfort. One trial suggests that visual field restriction at five years is not significantly different whether initial treatment is medication or trabeculectomy. There is some evidence from two small trials in more severe OAG, that initial medication (pilocarpine, now rarely used as first line medication) is associated with more glaucoma progression than surgery. Beyond five years, there is no evidence of a difference in the need for cataract surgery according to initial treatment.The clinical and cost-effectiveness of contemporary medication (prostaglandin analogues, alpha2-agonists and topical carbonic anhydrase inhibitors) compared with primary surgery is not known.Further RCTs of current medical treatments compared with surgery are required, particularly for people with severe glaucoma and in black ethnic groups. Outcomes should include those reported by patients. Economic evaluations are required to inform treatment policy.

Successful medical treatment of Acanthamoeba keratitis

Purpose: To describe the outcome of a series of Acanthamoeba keratitis treated with a similar regimen. Methods: All cases diagnosed with Acanthamoeba keratitis in a referral centre from June 1994 through June 1997 were included. Diagnosis of Acanthamoeba keratitis was based in clinical presentation and laboratory results. Positive laboratory identification of Acanthamoeba from corneal scraping or contact lens was required, unless the patient had very characteristic symptoms (severe pain) and signs of the infection, including perineural infiltrates. Initial intensive treatment included topical polyhexamethylene biguanide (PHMB) 0.02%, propamidine isothionate 0.1% and broad-spectrum antibiotics. The treatment was gradually tapered. After documented response to anti-acanthamoeba therapy, topical steroids were introduced; they were discontinued before cessation of the antiAcanthamoeba regimen. Results: Six males and four females, with a mean age of 30.0 ± 7.4 years were included in this study. All cases weared contact lenses. On presentation all cases had severe pain, and epitheliopathy was associated with stromal infiltrate in most (seven of ten) cases. Four patients had anterior uveitis. Perineural infiltrates were present in three cases and ring infiltrate in one patient. Anti-amoebic treatment was started 12.7 ± 7.2 days after beginning of symptoms. The clinical response to therapy was very satisfactory in all patients. Within two to three weeks all patients had remarkable lessening of pain and photophobia, and improvement of clinical signs. At two to three months, visual acuity had improved in all patients. Two patients required penetrating keratoplasty for visual rehabilitation. Conclusion: The use of PHMB and propamidine cured all cases of Acanthamoeba keratitis. Cautious introduction of steroids was associated with expedited resolution of inflammation and provided symptomatic relief.

Medical versus surgical interventions for open angle glaucoma.

BACKGROUND: Open angle glaucoma (OAG) is the commonest cause of irreversible blindness worldwide. OBJECTIVES: To study the relative effects of medical and surgical treatment of OAG. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to February 2005), EMBASE (1988 to February 2005), and reference lists of articles. We also contacted researchers in the field. SELECTION CRITERIA: Randomised controlled trials comparing medications to surgery in adults. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted trial investigators for missing information. MAIN RESULTS: Four trials involving 888 participants with previously untreated OAG were included. Surgery was Scheie's procedure in one trial and trabeculectomy in three trials. In three trials, primary medication was usually pilocarpine, in one trial a beta-blocker.In the most recent trial, participants with mild OAG, progressive visual field (VF) loss, after adjustment for cataract surgery, was not significantly different for medications compared to trabeculectomy (Odds ratio (OR) 0.74; 95% CI 0.54 to 1.01). Reduction of vision, with a higher risk of developing cataract (OR 2.69, 95%% CI 1.64 to 4.42), and more patient discomfort was more likely with trabeculectomy than medication.There is some evidence, from three trials, for people with moderately advanced glaucoma that medication is associated with more progressive VF loss and 6 to 8 mmHg less intraocular pressure (IOP) lowering than surgery, either by a Scheie's procedure or trabeculectomy. There was a trend towards an increased risk of failed IOP control over time for initial pilocarpine treatment compared to trabeculectomy. In the longer-term (two trials) the risk of failure was significantly greater with medication than trabeculectomy (OR 3.90, 95% CI 1.60 to 9.53; HR 7.27, 95% CI 2.23 to 25.71). Medicine and surgery have evolved since these trials were undertaken, and additionally the evidence is potentially subject to detection and attrition bias. AUTHORS' CONCLUSIONS: Evidence from one trial suggests, for mild OAG, that VF deterioration up to five-years is not significantly different whether treatment is initiated with medication or trabeculectomy. Reduced vision, cataract and eye discomfort are more likely with trabeculectomy. There is some evidence, for more severe OAG, that initial medication (pilocarpine, now rarely used as first line medication) is associated with greater VF deterioration than surgery. In general, surgery lowers IOP more than medication.There was no evidence to determine the effectiveness of contemporary medication (prostaglandin analogues, alpha2-agonists and topical carbonic anhydrase inhibitors) compared to surgery in severe OAG, and in people of black African ethnic origin who have a greater risk of more severe open angle glaucoma. More research is required.

Non-medical prescribers and pharmacovigilance:participation, competence and future needs

To determine UK non-medical prescribers' (NMPs) (supplementary or independent) current participation and self-reported competence in pharmacovigilance, and their perceptions of training and future needs.

Development of a Portable Tissue Micro Array Instrument

Tissue micro array (TMA) is based on the idea of applying miniaturization and a high throughput approach to hybridization-based analyses of tissues. It facilitates biomedical research on a large scale in a single experiment; thus representing one of the most commonly used technologies in translational research. A critical analysis of the existing TMA instruments indicates that there are potential constraints in terms of portability, apart from costs and complexity. This paper will present the development of an affordable, configurable, and portable TMA instrument to allow an efficient collection of tissues, especially in instrument-to-tissue scenarios. The purely mechanical instrument requires no energy sources other than the user, is light weight, portable, and simple to use. [DOI: 10.1115/1.4004922]

Mechanical characterization of the varian Exact-arm and R-arm support systems for eight aS500 electronic portal imaging devices

The aim of this study is to compare the positioning accuracy at different gantry angles of two electronic portal imaging devices (EPIDs) support arm systems by using EPID difference images as a measure for displacement. This work presents a comparison of the mechanical performance of eight Varian aS500 (Varian Medical Systems, Palo Alto, CA) EPIDs, mounted using either the Varian Exact-arm or R-arm.

Optimising the locations of thermally sensitive equipment in an aircraft crown compartment

A Design of Experiments (DoE) analysis was undertaken to generate a list of configurations for CFD numerical simulation of an aircraft crown compartment. Fitted regression models were built to predict the convective heat transfer coefficients of thermally sensitive dissipating elements located inside this compartment. These are namely the SEPDC and the Route G. Currently they are positioned close to the fuselage and it is of interest to optimise the heat transfer for reliability and performance purposes. Their locations and the external fuselage surface temperature were selected as input variables for the DoE. The models fit the CFD data with values ranging from 0.878 to 0.978, and predict that the optimum locations in terms of heat transfer are when the elements are positioned as close to the crown floor as possible ( and ?min. limits), where they come in direct contact with the air flow from the cabin ventilation system, and when they are positioned close to the centreline ( and ?CL). The methodology employed allows aircraft thermal designers to optimise equipment placement in confined areas of an aircraft during the design phase. The determined models should be incorporated into global aircraft numerical models to improve accuracy and reduce model size and computational time. © 2012 Elsevier Masson SAS. All rights reserved.

Developing virtual patients for medical microbiology education

The landscape of medical education is changing as students embrace the accessibility and interactivity of e-learning. Virtual patients are e-learning resources that may be used to advance microbiology education. Although the development of virtual patients has been widely considered, here we aim to provide a coherent approach for clinical educators.

Layered RF Phantom Characterization for Wireless Medical Vital Sign Monitors

Wearable antenna performance measurements were used to characterize a synthetic variable layered phantom testbed, representative of human tissue for operation in the 868/915 MHz, and 2400 MHz industrial, scientific and medical frequency bands. Antenna radiation efficiency measurements on the phantom were compared with measurements on the thorax region of a human test subject. The results show that the phantom is representative of the human body for the application of wireless vital sign monitors, where conductive connections are made to the tissue.

Evaluation of the contribution of theatre attendance to medical undergraduate neuroscience teaching - a pilot study.

Introduction: Medical students often attend the neurosurgical theatre during their clinical neurosciences attachment. However, few studies have been performed to objectively assess the value of this theatre-based learning experience. The main aim of this study was to explore student perceptions on the contribution of neurosurgical theatre attendance to clinical neuroscience teaching.

Materials and Methods: Third-year medical students undergoing their 2-week clinical neurosciences rotation at the Royal Hospitals Belfast were invited to participate in this study. A multi-method strategy was employed using a survey questionnaire comprising of closed and open-ended questions followed by semi-structured interviews to gain a greater 'in-depth' analysis of the potential contribution of neurosurgical theatre attendance to neuroscience teaching.

Results: Based on the completed survey responses of 22 students, the overall experience of neurosurgical theatre-based learning was a positive one. 'In-depth' analysis from semi-structured interviews indicated that students felt that some aspects of their neurosurgical theatre attendance could be improved. Better preparation such as reading up on the case in hand and an introduction to simple theatre etiquette to put the student at ease (in particular, for students who had never attended theatre previously), would improve the learning experience. In addition, having an expectation of what students are expected to learn in theatre making it more learning outcomes-based would probably make it feel a more positive experience by the student.

Conclusions: The vast majority of students acknowledged the positive learning outcomes of neurosurgical theatre attendance and felt that it should be made a mandatory component of the curriculum.