Moving forward through consensus: protocol for a modified Delphi approach to determine the top research priorities in the field of orthopaedic oncology.

IntroductionOrthopaedic oncology researchers face several obstacles in the design and execution of randomised controlled trials, including finite fiscal resources to support the rising costs of clinical research and insufficient patient volume at individual sites. As a result, high-quality research to guide clinical practice has lagged behind other surgical subspecialties. A focused approach is imperative to design a research programme that is economical, streamlined and addresses clinically relevant endpoints. The primary objective of this study will be to use a consensus-based approach to identify research priorities for international clinical trials in orthopaedic oncology.Methods and analysisWe will conduct a 3-phase modified Delphi method consisting of 2 sequential rounds of anonymous web-based questionnaires (phases I and II), and an in-person consensus meeting (phase III). Participants will suggest research questions that they believe are of particular importance to the field (phase I), and individually rate each proposed question on 5 criteria (phase II). Research questions that meet predetermined consensus thresholds will be brought forward to the consensus meeting (phase III) for discussion by an expert panel. Following these discussions, the expert panel will be asked to assign scores for each research question, and research questions meeting predetermined criteria will be brought forward for final ranking. The expert panel will then be asked to rank the top 3 research questions, and these 3 research questions will be distributed to the initial group of participants for validation.Ethics and disseminationAn ethics application is currently under review with the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The results of this initiative will be disseminated through peer-reviewed publications and conference presentations

Spinal cord morphology in degenerative cervical myelopathy patients ; assessing key morphological characteristics using Mmchine vision tools

ABSTRACT: Despite Degenerative Cervical Myelopathy (DCM) being the most common form of spinal cord injury, effective methods to evaluate patients for its presence and severity are only starting to appear. Evaluation of patient images, while fast, is often unreliable; the pathology of DCM is complex, and clinicians often have difficulty predicting patient prognosis. Automated tools, such as the Spinal Cord Toolbox (SCT), show promise, but remain in the early stages of development. To evaluate the current state of an SCT automated process, we applied it to MR imaging records from 328 DCM patients, using the modified Japanese Orthopedic Associate scale as a measure of DCM severity. We found that the metrics extracted from these automated methods are insufficient to reliably predict disease severity. Such automated processes showed potential, however, by highlighting trends and barriers which future analyses could, with time, overcome. This, paired with findings from other studies with similar processes, suggests that additional non-imaging metrics could be added to achieve diagnostically relevant predictions. Although modeling techniques such as these are still in their infancy, future models of DCM severity could greatly improve automated clinical diagnosis, communications with patients, and patient outcomes

Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study.

IntroductionLimb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours.Methods and analysisThis is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibiotic-related adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05.Ethics and disseminationThis study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow

Lost in translation: animal models and clinical trials in cancer treatment

Due to practical and ethical concerns associated with human experimentation, animal models have been essential in cancer research. However, the average rate of successful translation from animal models to clinical cancer trials is less than 8%. Animal models are limited in their ability to mimic the extremely complex process of human carcinogenesis, physiology and progression. Therefore the safety and efficacy identified in animal studies is generally not translated to human trials. Animal models can serve as an important source of in vivo information, but alternative translational approaches have emerged that may eventually replace the link between in vitro studies and clinical applications. This review summarizes the current state of animal model translation to clinical practice, and offers some explanations for the general lack of success in this process. In addition, some alternative strategies to the classic in vivo approach are discussed

Retractions in cancer research: a systematic survey

Abstract Background The annual number of retracted publications in the scientific literature is rapidly increasing. The objective of this study was to determine the frequency and reason for retraction of cancer publications and to determine how journals in the cancer field handle retracted articles. Methods We searched three online databases (MEDLINE, Embase, The Cochrane Library) from database inception until 2015 for retracted journal publications related to cancer research. For each article, the reason for retraction was categorized as plagiarism, duplicate publication, fraud, error, authorship issues, or ethical issues. Accessibility of the retracted article was defined as intact, removed, or available but with a watermark over each page. Descriptive data was collected on each retracted article including number of citations, journal name and impact factor, study design, and time between publication and retraction. The publications were screened in duplicated and two reviewers extracted and categorized data. Results Following database search and article screening, we identified 571 retracted cancer publications. The majority (76.4%) of cancer retractions were issued in the most recent decade, with 16.6 and 6.7% of the retractions in the prior two decades respectively. Retractions were issued by journals with impact factors ranging from 0 (discontinued) to 55.8. The average impact factor was 5.4 (median 3.54, IQR 1.8–5.5). On average, a retracted article was cited 45 times (median 18, IQR 6–51), with a range of 0–742. Reasons for retraction include plagiarism (14.4%), fraud (28.4%), duplicate publication (18.2%), error (24.2%), authorship issues (3.9%), and ethical issues (2.1%). The reason for retraction was not stated in 9.8% of cases. Twenty-nine percent of retracted articles remain available online in their original form. Conclusions Retractions in cancer research are increasing in frequency at a similar rate to all biomedical research retractions. Cancer retractions are largely due to academic misconduct. Consequences to cancer patients, the public at large, and the research community can be substantial and should be addressed with future research. Despite the implications of this important issue, some cancer journals currently fall short of the current guidelines for clearly stating the reason for retraction and identifying the publication as retracted