Dimple Rajgor

Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery Open Source versus Commercial Systems

BackgroundCollection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal.Questions/purposesOur purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system.Where are we now?Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems.Where do we need to go?To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process.How do we get there?Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.

What Leads Indians to Participate in Clinical Trials? A Meta-Analysis of Qualitative Studies

Background With the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials. Methods We conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus. Results Six qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers. Conclusion We identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India.

Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets.

Background Sharing of epidemiological and clinical data sets among researchers is poor at best, in detriment of science and community at large. The purpose of this paper is therefore to (1) describe a novel Web application designed to share information on study data sets focusing on epidemiological clinical research in a collaborative environment and (2) create a policy model placing this collaborative environment into the current scientific social context. Methodology The Database of Databases application was developed based on feedback from epidemiologists and clinical researchers requiring a Web-based platform that would allow for sharing of information about epidemiological and clinical study data sets in a collaborative environment. This platform should ensure that researchers can modify the information. A Model-based predictions of number of publications and funding resulting from combinations of different policy implementation strategies (for metadata and data sharing) were generated using System Dynamics modeling. Principal Findings The application allows researchers to easily upload information about clinical study data sets, which is searchable and modifiable by other users in a wiki environment. All modifications are filtered by the database principal investigator in order to maintain quality control. The application has been extensively tested and currently contains 130 clinical study data sets from the United States, Australia, China and Singapore. Model results indicated that any policy implementation would be better than the current strategy, that metadata sharing is better than data-sharing, and that combined policies achieve the best results in terms of publications. Conclusions Based on our empirical observations and resulting model, the social network environment surrounding the application can assist epidemiologists and clinical researchers contribute and search for metadata in a collaborative environment, thus potentially facilitating collaboration efforts among research communities distributed around the globe.

Patterns of herbal combination for the treatment of insomnia commonly employed by highly experienced Chinese medicine physicians

ObjectiveTo explore the most effective herbal combinations commonly used by highly experienced Chinese medicine (CM) physicians for the treatment of insomnia.MethodsWe collected and analyzed data related to insomnia treatment from the clinics of 7 highly experienced CM physicians in Beijing. The sample included 162 patients and 460 consultations in total. Patient outcomes, such as sleep quality and sleep time per day, were manually collected from the medical records by trained CM clinicians. Three data mining methods, support vector machine (SVM), logistic regression and decision tree, and multifactor dimensionality reduction (MDR), were used to determine and confirm the herbal combinations that resulted in positive outcomes in patients suffering from insomnia.ResultsResults show that MDR is the most efficient method to predict the effective herbal combinations. Using the MDR model, we identified several combinations of herbs with 100% positive outcomes, such as stir-fried spine date seed, Szechwan lovage rhizome, and prepared thinleaf milkwort root; white peony root, golden thread, and stir-fried spine date seed; and Asiatic cornelian cherry fruit with fresh rehmannia.ConclusionsResults indicate that herbal combinations are effective treatments for patients with insomnia compared with individual herbs. It is also shown that MDR is a potent data mining method to identify the herbal combination with high rates of positive outcome.

Obesity-related coagulation changes in pregnancy.

Obesity, a health concern of increasing importance in developed countries, is associated with a fourto five-fold increased risk of venous thromboembolism (VTE) in pregnancy [1,2]. In one study, obese pregnant womenwere three times more likely to suffer a pulmonary embolism (PE) than a deep vein thrombosis (DVT), placing them at greater risk for mortality than non-obese gravidas [2]. Obesity is also associated with poor pregnancy outcomes, including a 40 percent increased risk for stillbirth compared to non-obese gravidas [3]. A respectable body of literature has documented many of the changes in clotting and fibrinolysis during normal pregnancy, but little has been reported on the effect of obesity on these processes [4–8]. We hypothesize that the increased risk of VTE in pregnancy associated with obesity, while likely multifactorial, is partly explained by changes in coagulation proteins. We compared clotting factor levels in obese and non-obese pregnant women with the purpose of identifying specific changes in obese gravidas that might place them at higher risk for VTE than non-obese gravidas.

WriteSim TCExam--an open source text simulation environment for training novice researchers in scientific writing.

BackgroundThe ability to write clearly and effectively is of central importance to the scientific enterprise. Encouraged by the success of simulation environments in other biomedical sciences, we developed WriteSim TCExam, an open-source, Web-based, textual simulation environment for teaching effective writing techniques to novice researchers. We shortlisted and modified an existing open source application - TCExam to serve as a textual simulation environment. After testing usability internally in our team, we conducted formal field usability studies with novice researchers. These were followed by formal surveys with researchers fitting the role of administrators and users (novice researchers)ResultsThe development process was guided by feedback from usability tests within our research team. Online surveys and formal studies, involving members of the Research on Research group and selected novice researchers, show that the application is user-friendly. Additionally it has been used to train 25 novice researchers in scientific writing to date and has generated encouraging results.ConclusionWriteSim TCExam is the first Web-based, open-source textual simulation environment designed to complement traditional scientific writing instruction. While initial reviews by students and educators have been positive, a formal study is needed to measure its benefits in comparison to standard instructional methods.

Treinamento em pesquisa global em cirurgia ortopédica: semente para uma rede internacional

Despite the importance of delivering evidence-based health care, orthopedic surgeons have directed fewer efforts towards the generation of such evidence. Even when present, published evidence lacks methodological rigor and is known to be inaccurate. One of the main reasons for the lack of generation of quality evidence, and the low involvement in research among orthopedic surgeons, is the lack of structured research coaching environments where they can learn concepts and hone their research skills. There is a palpable need for a pragmatic and outcome-oriented approach that can equip orthopedic surgeons with effective ways of communicating their research in writing. We describe a pragmatic research coaching program, designed and developed by the Research on Research group, which aims to build a global network of orthopedic researchers trained in streamlined and standardized research methods. We also provide a brief overview of the course principles and tools, and the platforms used in this program.