BLIPS 8 Overview
BLIPS Version 8 comprises several software modules with role based functionality, which may be made available to some users but not others, dependent on their role and permissions. This simplifies the user interface since users only need to focus on their relevant modules, rather than navigate complex menu systems. This simplification leads to faster and more accurate data entry. The modular approach also benefits software development, so functional enhancements and custom changes are faster because we only need to update the codebase for a module, not the entire software suite.
BLIPS Certify is the first port of call for all users. Our login system will not allow data entry until a physician has completed the Assessment Training and Exam, and the Data Entry person has completed the Software Training and Exam. BLIPS Certify contains slide based training courses, Case Studies and multiple choice tests. All user training activities are audit-trailed and users are awarded certificates upon successful completion. Certify can be customised to deliver additional training and exams.
BLIPS Entry is the only module used in clinics to add new patients, add new assessment data, or change existing data. Deletion of data can be restricted to individual users. BLIPS Entry is for clinic based users. There are three specific roles -
Investigator - a physician who is certified to assess patients.
Data Entry - a clinic member certified to enter data.
Inv+DE - which combines both the above roles
Individual account permissions may be modified to restrict / allow :Read only, data deletion, data, extraction, multi-clinic usage.
BLIPS Quality uses automated checking algorithm to check for missing data, out of range data, plus clinical anomalies. The latest Edit Check algorithm includes over 200 checks, and includes checks of BILAG v SLEDAI, SLEDAI v BILAG, SLEDAI v SFI and BILAG v SFI. Edit check reports are producesd on every assessment, itemising any errors or anomalies found.
Additional checks on new or existing assessments may be programmed on request.
BLIPS quality is used by Physicians and Data Entry staff to monitor the quality of their own assessments. In Clinical trials the CRA, Clinical Monitor and the Study Management team can also view Quality over all the sites in the study.
BLIPS Analysis is predominantly used by Physicians and Researchers allowing them to query, graph, compare and report on their patients assessments. The latest version of Analysis allows users to construct their own graphs from assessment items and scores and plot against lab results and medication. Popular filters and queries created by users can be stored for re-use.
Several Lupus Resonders have been concieved in recent years based on combinational processing of BILAG, SLEDAI, Flare and PGA scores. Traditionally responders have been used a post-study analysis tool. BLIPS Responder can be used to generate the popular responders such as SRI-4, SRI-6, SRI-8, BICLA in real time. We have also programmed custom real-time responders which have been used to trigger reductions in medication in a clinical trial environment.
BLIPS Query allows audit-trailed dialogue between remote clinical sites and study management teams.
Queries may be raised concerning a patient, an assessment, a score, or an item value in anassemnt, or just a reminder about an unresolved Edit Check.
BLIPS Query becomes a powerful tool for data cleansing and clinical monitoring, and for expert adjudication
Expert adjudication is very common in clinical trials, especially those involving BILAG. Adjudication usually involves a member of BILAG or a recommended colleague poring over huge arrays of data looking for anomalies. Traditionally this was a cumbersome paper excercise, but in 2017 BLIPS Adjudicator was succesfully used in for online adjudication in a clinical trial. BLIPS Adjudicator can present these matrices online. Every item in every assesment is hyperlinked, and can instantly generate a BLIPS Query, whish is automatically sent to the site. An Adjudicator's Dashboard completes the module,
BLIPS Dashboard is the Site and User Management Module. This is predominantly used by ADS-Limathon, but can also be activated for senior users at large sites. In clinical trials or studies, it may be used by a Study co-ordinator to set up users at all sites, or Country Managers to set up CRA accounts in their countries.
BLIPS Dashboard controls the hierarchy within the BLIPS environment, allowing creation of Countries, Sites, and User Accounts. The user 's Role is also assigned in Dashboard along with the user permissions.
BLIPS Dashboard also displays the training and exam records associated with each users accounts.
As the name suggests, CRA Dashboard is predominantly used by CRA's for data cleansing and verification. Before Adjudication can commence there are three data requirements - Completeness, Quality and Verification. This Dashboard provides Red-Amber-Green status indicators which can be set to the appropriate colour by CRAs. When all three are Green, then the patient has completed all their visits, the Edit Checks are all resolved and the data entered into BLIPS has been verified against physicians records. At this point the Adjudication can commence for this patient. These indicators are also displayed on the Adjudicators Dashboard.
BLIPS Extract is used by researchers, and in Clinical Studies and Trials by Data Managers. Access to this module is strictly controlled.
Extract allows users to select the assesment data they require wish to extract, and apply filters based on study, country, site or patient, a date range, and any specific filter. They can then select the uputput fotmat from a range of options such as CSV, XLS, MDB, HTML, XML, pdf, etc, and finaly set the email of the recipient. The extract is run at the server, and when complete a link to the file is sent to the reciient for download.
Exctract is complimaneted by a second module called Scheduler which allows Extracts parameters to be stored, and run on a schedule to deliver reports or extracts on a regular basis.
BLIPS Pregnancy is an optional module designed for the use with pregnancy patients, or in pregnancy studies. The module keeps a record of each pregnancy and outcome, and also uses a diferent scoring algorithm for BILAG during Pregnancy, to accomodate the differences in biochemistry, renal and haematological results and ranges.
The module is designed such that the patients data is continuous, but the parameters and scoring are different during pregnancy.
Further research and development of this module is ongoing with UCL and Doncaster hospitals