ST-NET in quality systems for Clinical Trials
ST-NET is an international automated network with free access for Scrambler Therapy users. This network has been set up for various purposes, but its main one is to support Clinical Trials and Pilot Centers in reducing to a minimum operator dependent variability results. By so doing, a quality system is created that regardless of clinical trials chosen by researchers, guarantees reproducibility and consistent results differently not achievable, therefore a reliable scientific clinical trial. The same is true for Pilot Centers, that cannot be defined as such without a specific quality system in this methodology.
ST-NET is focused on a clinical “intelligent” folder based on a dedicated software designed exclusively for Scrambler Therapy. You can ask for this free software to the medical device provider in your country, or through this website contact area if you are a Scrambler Therapy user.
The medical record based on STDM software (Scrambler Therapy Data Manager) collects all treatment data in an easy to use visual database. During compilation, STDM automatically informs the operator of possible critical features, and suggests most fit treatment protocol for any patient and enables to use specific research tools such as Brief Pain Inventory, Pain Dtecet, DN4 and much more.This software can simultaneously (while you are working on the record) open patient's data on other traditional software such as Excel, Word or simply Notepad. It is also possible to analyze treatment trends with graphs that do not require previous configuration. The entire Database can be exported in standard formats with filtering criteria based on data, pain type or other meaningful characteristics in clinical trials.
By clicking on “Automatic analysis” an algorithm analyzes the treatment data and highlights the main control parameters, indicating the percentage shift from the normal values.Meaningful shifts or serious anomalies are highlighted.
The software is automatically connected to ST-NET, and if necessary it sends in just a couple seconds and little PC and network commitment, completely anonymous 256 bit encrypted data. This data is collected in an International Hub, and becomes a shared reference knowledge. This reference can be used by Scrambler Therapy users as an extended source of information and even to speed reimbursement procedures in countries where they are adopted.
Data sent over ST-NET network are rendered anonymous, and pertain exclusively to folders managed by STDM. No other data type belonging to the system where the software is installed (including information rendered available by the operating system) is analyzed or sent over the network.
Health Insurance Portability And Accountability Act (HIPAA) and Safe Harbor Compliance
ST-NET is fully compliant to HIPAA and Safe Harbor privacy standards. Implemented multi-level protection requirements are higher than those in most popular commercial software. HIPPA acknowledges the Safe Harbor method as complaint to privacy protection. Currently there is no official body to certify compliance to HIPPA, but HIPPA acknowledges the Safe Harbor method as complaint to privacy protection (http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html ).
STDM uses simultaneously the two de-identification methods envisaged by HIPAA (Expert Determination method and “Safe Harbor” method).
In a nutshell, via ST-NET multi-centric phase IV studies can be carried out on an international scale to the benefit of the scientIfic community and social healthcare policies. Data collected in the International Hub is automatically analyzed by an algorithm that detect possible treatment mistakes. If in your country there is a local authorized training facility, you will quickly receive free consultancy to solve possible criticality in methodology implementation, non standard protocols, “complicated” patients, or other problem-solving support. If there is no local support in your country, you can receive help through Skype , or also email in solving minor issues.
Data protection for publications
Clinical trial data is intrinsically protected by being put together with all those of other countries in the same Database, therefore coupled with anonymous patient data, they loose their feature of main and exclusive source. However, when you open a patient medical record in STDM you can easily add the confidentiality feature by ticking on a specific option. By so doing your research data is automatically sent into a secondary Hub and frozen for the selected time span (0 to 5 years), that can be extended just via email.
If you include ST-NET use in the protocol to be approved by the Ethical Committee/IRB as a quality and reproducible support system for clinical trials underway, you can establish within the protocol itself further constraints deemed necessary for data protection, together with approved monitoring on protocol compliance to Scrambler Therapy guideline.
You will receive a formal acknowledgement on correct methodology implementation in clinical trials , and optimization on unbiased research that in some past publications has led to partially unreliable data. The issue of unreliable data from general official guidelines that you can find in this website has been documented by published scientific literature.
Currently ST-NET and standard official training represents the most updated methodology solution to develop high quality reproducible clinical trials, generating methodology-reliable scientific data to compensate the operator-dependent variable.
ST-NET from its international activation, together with primary international training courses for clinical researchers and trainers (held without cost by Prof. Giuseppe Marineo) in Italy or secondary training specifically for Scrambler Therapy users, held in Italy and other countries by certified trainers, are the official golden standard acknowledged to be used as a quality and reproducibility system in clinical research on Scrambler Therapy.