As this New Year comes up, it is our pleasure on behalf of the entire OrthoWave Staff, to present to each of you our very sincere wishes of happiness and fruitfulness. Be sure we will do more than our very best, all along this coming year, to make you taking advantage of the huge work we have been achieving during the past 12 months. In the course of 2009, we have afforded enormous resources in order to take up the challenge of making OrthoWave stay as the “ultimate tool in outcomes studies in Orthopaedics”, while fulfilling on the one hand strictness of legal duties with respect to privacy and computerized safety, and on the other hand resorting to the most powerful and modern computer systems.
These critical developments regard firstly the new “web-based” platform to get access to the DataBase, then the “OrthoWave Orthopaedic Community” through a totally redesigned OrthoWave web site, and finally a necessary adaptation to extremely changing regulations about clinical studies with the development of a third group of OW databases, i.e. the “MDB” monitored Data Bases…
A sound change can be anticipated, willingly or reluctantly, regarding mentality among Orthopaedic Surgeons, with respect to their participation in clinical studies and scientific reports. OrthoWave then has to be empowered to meet with these various changes at best, while staying in accordance with its concept of software designed by surgeons for surgeons, under the aegis of Scientific Societies, and in conformity with legal related recommendations by Health Departments…
1 – THE “WEB-BASED” PLATFORM
The first change regards the “web-based” OrthoWave interface calling for the novel Ajax concept (Asynchronous Java scripts and XML), announced by the beginning of this year, and currently available for our OW users. This “web-based” platform does not mean any new version, simply a new interface to reach our Global Server, faster, better working, and moreover making reference to the modern concept of “cloud computing“, under which the User has no longer to download any program on his computer unit, while data are similarly stored on the global secured server. In such a way, anybody can get access to and use OrthoWave from any computer provided that it is connected to Internet through a high speed connection via the secured https://web.orthowave.net web site, exactly as anyone can check on line his bank account. This became critical as it was an absolute need for OrthoWave to be easily used in Hospitals and Clinics, which was often complicated and sometimes impossible due to the access restrictions to our Java platform via the open 8080 port.
At present, OrthoWave can be launched upon two platforms, i.e. Web-based and Java, which can be used in parallel, by using the same login/password, as both of them address the same Server. Moreover, we have redesigned all web pages to make them become more attractive and user-friendly. This Web platform will be soon the only one to be maintained on duty, because of its numerous assets as compared to the java one: it is no longer necessary whatever the platform Windows or Mac is used, to download programs or various updates and patches, collection of data (EDC) is faster, multicriteria search is improved, and above all easy access is gained from any computer unit without any interference with local restrictions about administrator rights or complex procedures of firewall, proxies and others… By the way, we strongly recommend the use as Internet browser of Mozilla Firefox or Google Chrome, rather than Internet Explorer, which is significantly less performing and reliable than its competitors.
Please notice that the off line Java version will be maintained solely as a free “viewer” in order to allow Users for working off line after previous transfer of their data, wholly or in part, from their related web database. Former off line Java databases will be converted to on line databases upon request, in order to take benefit of technical improvements of OrthoWave.
2-THE VERY NEW ORTHOWAVE WEB SITE
The second major advance refers to our web site www.orthowave.net : thanks to our talented developers and graphic designers from Adspring Company, the OW web site has been fully re-designed, enhanced, completed, offering now a truly professional “look & feel”. This site goes on with the four classic themes (1) firstly of presentation and guided tour of the software suite, (2) then allowing for free trials and on line purchase of licenses. (3) A very efficient section of support features FAQs, tutorials, public and private forums and on-line help. Finally (4) the Community section gives access to the existing blog, through personal accounts and profiles. The “look & feel” looks great and appealing. Hopefully each of the present and future OrthoWave Users will be enthusiastic to join our “OrthoWave Community”!…
With respect to the free trials and purchase of licenses, please notice that from now on, all is done via the web-platform. There is no longer any need for downloading the program, simply get connected with either the trial “Demo” database or purchasing licenses to settle and use one’s own database. By the way we would point an important modification while ordering OrthoWave: to date, the maximal number of licenses addressed the maximal number of registered Users of the given data base, with no limitation about the number of surgeons. However, in some cases, numerous different persons got connected to their database by using the same login/password, which can cause a major problem with respect to the traceability of data inputs and global audit trail. It seemed logical in such a way to respect regulations and prevent from any legal issue, and thus from now on, the number of licenses will refer to a maximal number of surgeons, with an unlimited number of Users. Pricing procedures remain identical, and can be addressed on the Web Site, the difference solely refers to the mode of allowed licenses, based upon the Surgeons belonging to the database, be it a RDB or a SDB.
3-THE NEW MONITORED “MDB” DATA BASES
A third change appeared to be critical, while bearing in mind the new regulations about Clinical Studies carried out by Orthopaedic Devices Manufacturers, which are no longer under the realm of marketing departments, but nowadays depend on the Clinical Affairs Departments, upon an evolution which can be seen as similar to clinical studies about pharmaceutical drugs. As a matter of fact, Orthopaedic Surgeons have not been used dealing with so strict rigour while collecting and analyzing data and clinical results. A necessary adaptation to new policy and behavior facing these clinical studies will have to be settled among the Orthopaedic Community, which would lead to much gnashing of teeth, for sure…
While considering these new facts, OrthoWave had to be adapted appropriately to the coming new procedures of carrying out studies, although retaining its very main aim, which consists in publishing clinical series and findings, be they related to “pre-marketing” or “post-marketing” studies in the very long run. We also wanted to preserve what constitutes the real novelty of OrthoWave, i.e. the permanent control by each surgeon of all data of his own via the “Regular” Data Bases RDB and the ability to get dynamically linked (under a de-identified mode) to the selected “Scientific” Data Bases SDBs. We have thus got the project started of creating a third type of databases, i.e. the “monitored databases” MDB, devoted to these very regulated clinical studies, which must be very strict in terms at any step of the given study. We have taken advantage in that matter of numerous meetings and advices from Clinical Study coordinators and managers from Pharmaceutical Companies, to whom we would like to express our warmest thanks. Details about this MDB project can be found in a recent article of this blog…
More than ever, thanks to this third type of databases, OrthoWave will thus merit more again the label of “integrated data processing software”, embracing all matters related to clinical outcomes studies in Arthroplasty, for Surgeons facing the patients of his own, for specific studies in the view of regulations matters about brands and devices systems, as well as for multicenter studies and participating in global Joint Registries.