James Maskalyk

Investigator experiences with financial conflicts of interest in clinical trials

BackgroundFinancial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.MethodsEmail survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.Results844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.ConclusionFull adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

Immunohistochemical determination and grading of CerbB-2 expression in breast cancer: correlation with interpectoral, apical nodal involvement and other prognostic factors

We aimed to investigate the correlation between quantitative CerbB-2 expressions with conventional prognostic factors, and distinct nodal involvement in patients with invasive breast carcinoma. One hundred fifty seven consecutive breast carcinoma patients were retrospectively analysed. Level I–II, Level III, and Rotter (Interpectoral) group lymph nodes were separately examined and recorded. For each patient estrogen receptor (ER), progesteron receptor (PR), CerbB-2, P53 status were defined using immunohistochemistry. Age, tumor localisation, menopausal status, grade and the presence of intraductal component were also recorded. CerbB-2 expression did not correlate with age, localisation and menopausal status. There was a reverse, but weak correlation with tumor size and CerbB-2 expression (p=0.034). In subgroup analysis of CerbB-2 positive cases, the magnitude of CerbB-2 positivity did not correlate with tumor size (p=0.551). In univariate analysis CerbB-2 expression did not correlate with nodal involvement in Level I-II, and Rotter. In subgroup analysis of patients with positive CerbB-2, positivity of CerbB-2 linearly increased with the number of positive lymph nodes in Level I-II, and this difference was significant (p=0,039). There was a significant correlation between CerbB-2 expression and Level III nodal metastases (p=0.005). But this correlation was not significant among CerbB-2 positive patients (p=0.82). P53, PR positivity and the presence of intraductal component did not differ according to oncogene expression. We detected a reverse correlation with ER positivity and CerbB-2 positivity (p=0.011). It is concluded that quantitative expression of CerbB2 positivity increases with nodal involvement in Level I–II axillary lymph nodes, and ER. Also, CerbB-2 positivity is more common among patients with Level III lymph node metastases.

Open Medicine is indexed in PubMed

Editors’ note: This corrected editorial replaces the version published on 5 January 2010, which stated that Open Medicine is indexed in MEDLINE, when in fact it is indexed in PubMed (of which MEDLINE is a subset). Open Medicine currently has an application under review for indexing in MEDLINE. The Open Medicine team is pleased to announce our recent acceptance for indexing in PubMed—an official stamp of approval from the US National Library of Medicine (NLM) for the scientific and technical quality of articles published in our journal. Why is this development such an important milestone? PubMed indexing ensures that new and previously published articles in Open Medicine are searchable online (http://www.ncbi.nlm.nih.gov/sites/entrez) and are archived on PubMed Central, the NLM’s comprehensive online archive of nearly 2 million full-text articles. The ability to find Open Medicine’s articles through PubMed literature searches will make it easier for both researchers and readers to find, assess and download them.1 Indexing by the NLM and accessibility through PubMed Central ensures, in addition to enhanced visibility, the permanence of our publishing record for years to come. As a result of PubMed indexing, we anticipate an increase in article submissions. To date, we have managed the journal with mostly volunteer input—despite some logistical challenges in doing so. We remain committed to maintaining a medical journal based on editorial independence, open-source publishing and open access.2,3 To sustain this while managing the expected increase in workflow, we are introducing a publication charge for articles accepted by Open Medicine. This fee will be C

Epidemiology, clinical characteristics and outcomes of head injured patients in an Ethiopian emergency centre

1200 for research and review articles and C

Evaluation of a point-of-care ultrasound scan list in a resource-limited emergency centre in Addis Ababa Ethiopia

300 for commentary and analysis pieces that meet our author guidelines in format and word count. The fee will allow us to continue publishing articles 3 to 4 months after acceptance and eventually to improve turnaround times. We will implement the publication charge for all articles submitted on or after March 1, 2010 that we subsequently accept. Maintaining high standards and making improvements to a high-quality medical journal takes expertise and considerable resources. These new fees represent a small proportion of the funds required to produce the journal; Table 1 shows some of our major operating costs. Considerable value is added during the editorial process, which makes articles more readable and absolutely clear in purpose.4 The modest fee covers most of the copyediting costs as well as the production and layout costs required to meet NLM standards; the remaining costs are covered by our editorial team of volunteers. Table 1 Time spent processing research articles at Open Medicine For funded research, we expect that this new fee will not limit an author’s ability to publish in the journal. Increasingly, granting agencies such as CIHR (the Canadian Institutes of Health Research) permit funds to cover any reasonable fee that an open access journal charges for the publication of accepted articles.5 In addition, partial or complete fee waivers will be available to authors with little or no means to pay, as is done at other open access journals.6 We believe this may be important for our growing authorship in low- and middle-income countries. Much has been made of publishers’ recent attempts to use questionable methods to increase revenue.7 The misuse of publishing platforms for self-interest, whether through advertising revenue or charges for services, is a serious problem in biomedical publishing. Open Medicine will never use fees to solicit manuscripts, and we will uphold our peer review and editorial policies rigorously. Since publication charges will apply only after an article is accepted, the fees will not influence our editorial decisions at either the review or the editing stages. Although many medical journals do not charge fees, they nonetheless incur costs through the publication cycle. How do publishers usually absorb these costs? Typically, they are met through pharmaceutical advertising, post-publication marketing reprint fees, subscriptions fees for individuals and university libraries and sponsorship by professional societies. Traditional publishing models are superficially convenient for authors, but we believe they are fundamentally flawed.8 Editors face pressures to publish research that supports the sale of specific products and devices, and to accept advertising revenue and reprint profits.9 Authors may be required to sign over their copyright as well as any revenue resulting from the sale of their intellectual work, a practice that is equally pernicious. Finally, access to a journal’s full text is limited to those who are able to pay. The need to re-purpose biomedical publishing for greater academic freedom and editorial independence is one of our reasons for being.8 Put simply, instituting publication charges is the price that academics, granting agencies, research institutes and medical schools must be prepared to pay to move toward more equitable publishing models. We call for greater leadership from academic institutions to “walk the walk” by covering publication charges for faculty. As a result, biomedical research can be placed into as many capable hands as possible, thereby releasing its true potential. Although publishing in indexed journals such as Open Medicine is important, we also encourage all authors to “self-archive” articles at their local digital libraries and institutional repositories. Self-archiving adds a second layer of openness to published medical research because web search engines typically scour these repositories. If you are unsure about how to deposit your research in this manner, speak to your local open access librarian for more information. The growth of Open Medicine — and its recognition by NLM — would never have been possible without the enthusiastic support of many people. We want to thank our board of directors, editorial board, authors, reviewers, university libraries, and our readers, who have supported Open Medicine and given their time throughout our development.

The clinical profile and acute care of patients with traumatic spinal cord injury at a tertiary care emergency centre in Addis Ababa, Ethiopia

Introduction Head injury is a leading cause of mortality in Africa. We characterise the epidemiology and outcomes of head injury at an Ethiopian emergency centre. Methods We conducted a prospective cohort study of all head injured patients presenting to the Emergency Centre of Tikur Anbessa Specialised Hospital, Addis Ababa. Data was collected via a standardised form from the patient’s chart, radiology reports and operative reports. Patients were followed until discharge, facility transfer, death, or 7 days in hospital. Consent was obtained from the patient or substitute decision maker. Results Among 204 head injured patients enrolled, the majority were <30 years old (51.0%) and male (86.8%). Forty-one percent of injuries occurred from road traffic accidents (RTAs). A significant number of patients had at least one indicator of severe injury on presentation: 51 (25.0%) had a GCS < 9, 53 (26.0%) had multi-system trauma, 95 (46.6%) had ≥1 abnormal vital sign and of the 133 patients with data available, 37 (27.8%) had a Revised Trauma Score (RTS) < 6. Patients injured by RTA were more likely to have indicators of severe injury than other mechanisms, including multi-system trauma (OR 3.2, 95% CI 1.7–6.2, p = 0.00), GCS < 9 (OR 3.7, 95% CI 1.8–7.4, p = 0.00), ≥1 abnormal vital sign (OR 2.5, 95% CI 1.4–4.6, p = 0.00) or an RTS score < 6 (OR 3.6, 95% CI 1.6–8.1, p = 0.00). Overall, 149 (73.0%) patients were discharged from hospital, 34 (16.7%) were transferred to another hospital, and 21 patients died (10.3%). In multivariable analysis, death was significantly associated with age over 60 years (aOR 68.8, 95% CI 2.0–2329.0, p = 0.02), GCS < 9 (aOR 14.8, 95% CI 2.2–99.5, p = 0.01), fixed bilateral pupils (aOR 39.1, 95% CI 4.2–362.8, p < 0.01) and hypoxia (oxygen saturation <90%; aOR 14.2%, 95% CI 2.6–123.9, p = 0.01). Conclusion Head injury represents a significant risk for morbidity and mortality in Ethiopia, of which RTA’s increase injury severity. Targeted approaches to improving care of the injured may improve outcomes.

Drinking and driving

Introduction Emergency centres (EC) in low- and middle-income countries often have limited diagnostic imaging capabilities. Point-of-care ultrasound (POCUS) is used in high-income countries to diagnose and guide treatment of life-threatening conditions. This study aims to identify high impact POCUS scans most relevant to practice in an Ethiopian EC. Methods A prospective observational study where patients presenting to Tikur Anbessa Specialized Hospital EC in Addis Ababa were eligible for inclusion. Physicians referred patients with a clinical indication for POCUS from a pre-determined 15-scan list. Scans were performed and interpreted, at the bedside, by qualified emergency physicians with POCUS training. Results A convenience sample of 118 patients with clinical indications for POCUS was enrolled. The mean age was 35 years and 42% were female. In total, 338 scans were performed for 145 indications in 118 patients. The most common scans performed were pericardial (n = 78; 23%), abdominal free fluid (n = 73; 22%), pleural effusion/haemothorax (n = 51; 15%), inferior vena cava (n = 43; 13%), pneumothorax (n = 38; 11%), and global cardiac activity (n = 25; 7%). One hundred and twelve (95%) POCUS scans provided clinically useful information. In 53 (45%) patients, ultrasound findings changed patient management plans by altering the working diagnosis (n = 32; 27%), resulting in a new treatment intervention (n = 28; 24%), resulting in a procedure/surgical intervention (n = 17; 14%) leading to consultation with a specialist (n = 16; 14%), and/or changing a disposition decision (n = 9; 8%). Discussion In this urban, low-resource, academic EC in Ethiopia, POCUS provided clinically relevant information for patient management, particularly for polytrauma, undifferentiated shock and undifferentiated dyspnea. Results have subsequently been used to develop a locally relevant emergency department ultrasound curriculum for Ethiopia’s first emergency medicine residency program.

Poor reporting of scientific leadership information in clinical trial registers.

Introduction Traumatic spinal cord injuries can have catastrophic physical, psychological, and social consequences, particularly in low resource settings. Since many of these injuries result in irreversible damages, it is essential to understand risk factors for them and focus on primary prevention strategies. The objectives of this study are to describe the demographics, injury characteristics, and management of traumatic spinal cord injury victims presenting to the Adult Emergency Centre of Tikur Anbessa Specialised Hospital in Addis Ababa, the tertiary referral centre for emergency care in Ethiopia. Methods A prospective cross sectional survey was conducted from October 2013 to March 2014 in the Adult Emergency Centre of Tikur Anbessa Specialised Hospital. Patients were identified at triage and followed through admission to discharge from the emergency centre. Results Eighty-four patients with traumatic spinal cord injuries were identified. The mean age was 33 years and 86% were male. The most common mechanisms of injury were motor vehicle collisions (37%), falls (31%), and farming injuries (11%). The cervical spine (48%) was the most commonly injured region and 41% were complete spinal cord injuries. Most patients (77%) did not receive any prehospital care or medical care at other facilities prior to arrival in the Emergency Centre. Conclusion In our context, traumatic spinal cord injuries predominantly affect young men, and the majority of victims suffer severe injuries with little chance of recovery. Attention to occupational and road traffic safety is essential to mitigate the personal and societal burdens of traumatic spinal cord injuries. It is also imperative to focus on improving prehospital care and rehabilitation services for traumatic spinal cord injury victims.