Internet-based technology facilitates clinical outcome data collection and adverse event monitoring

Introduction

In this day and age of increasing health care costs combined with limited payer resources, comparative-effectiveness research is required to determine the best and most cost-effective methods for treating patients. However, barriers to clinical outcomes research include limitations in surgeon and clinical research staff time and expertise, as well as the cost of conducting the research itself.

Twenty-first century, Internet-based technology offers a solution to these challenges. Specifically, the use of web-based clinical outcome data collection and adverse event monitoring mitigates against time limitations due to the efficiency of automated, electronic systems, mitigates against lack of expertise as a consequence of compliant, standardized and expertly designed software incorporating, validated outcome measures, and mitigates against cost as a result of the efficiencies and remote capacities of the Internet. In addition, timely adverse event monitoring improves patient safety and limits surgeon liability.

In this Orthopedics Today Round Table, physician-early adaptors of such technology share their experience and expertise.

— James H. Lubowitz, MD
Moderator

Round Table Participants Moderator James H. Lubowitz, MD Taos, N.M. Julie A. Dodds, MD East Lansing, Mich. Patrick A. Smith, MD Columbia, Mo. Nancy E. Lane, MD Sacramento, Calif.

James H. Lubowitz, MD: You are identified as using Internet-based technology for prospective outcome data collection and complication monitoring. What is the purpose of your research?

Nancy E. Lane, MD: The purpose of the level 1 clinical trial we will be conducting is to determine the effectiveness of a highly evolved magnetic field for amelioration of knee pain in patients with mild to moderate osteoarthritis (OA) (Sponsor: Ivivi Orthopedic Health Inc., Seattle).

Research indicates that DTP studies could work in 20% of U.S. clinical trials annually. That is $7 billion in annual research spending, according to CenterWatch data. Our study seemed to be a good fit for a direct-to-patient methodology. We are using a simple, patient friendly website with a 21 Code of Federal Regulations (CFR) Part 11 infrastructure behind the scenes. Part of the system’s appeal is a set of pleasantly clear computer screens. In visual terms, the system is more advanced than the tiny, indecipherable rows and numbers of most clinical trial systems.

The system adheres to all existing clinical trial regulations. It combines elements of an electronic data capture (EDC) system, patient diary system, safety reporting system, electronic health record and a clinical trial management system. It is a single database with an unusually attractive user interface (Contract research organization: Mytrus, Inc., San Francisco).

Patrick A. Smith, MD: As physicians, we are charged with improving the effectiveness and appropriateness of medical practice. The purpose of the Orthoillustrated Surgical Outcomes System ([SOS]; Sponsor: Arthrex Inc., Naples, Fla.) is twofold – to develop decision making for best practices in orthopedic care; and to facilitate research on common surgical procedures relative to both patient outcomes and cost-effectiveness.

Julie A. Dodds, MD: The Knee and Shoulder Arthroscopic Complications (KSAC) Study is a landmark study that will determine the incidence of acute complications in knee and shoulder arthroscopy and the associated risk factors for these complications. This study is supported by a grant from the Education Foundation of the Arthroscopy Association of North America.

Lubowitz: How you are using Internet-based technology to facilitate data collection?

Lane: Patients respond to web advertisements or doctor referrals to the study. It is important to note that these patients can live anywhere within a state that we are including in the study. Unlike traditional trials, participants do not need to live near a clinical study site because they will be interacting with a remote central site. Patients can conveniently join a study and sponsors do not need to spend as much time and money starting up sites across the United States.

If a patient is interested in our study, they screen and consent themselves online, go through an identity verification system and then are randomized into the study. There are points where the site speaks with them over the phone or via email to address questions and assure their viability as candidates for the study. In the OA study, we require the patient to send us X-rays of both knees so we can read all patients X-rays centrally to confirm eligibility.

While the patient is on study, all data forms, safety data and daily questionnaires are entered into the web-based study system. This allows the patients to provide data from anywhere and anytime they have access the Internet. If a patient falls behind in data entry, the central site is automatically alerted and the patient can be contacted and kept on track.

Smith: Web innovations have opened up new opportunities to collect and enhance data exchange in health care, especially for needed outcome information, as well as clinical research. I am participating in a large international web-based clinical registry orchestrated by Arthrex Inc. (Naples, Fla). Primary data exchange is accomplished through a patient portal – an interactive, easy to use online application where “enrolled patients” submit health information as patient-reported clinical outcomes. This is collected online and even from wireless devices.

Patients are notified via email at predefined time milestones, and are asked to submit health and survey questions online to a central registry. Links that are part of the email direct the patient seamlessly and rapidly to the portal. Surveys and communication are as if they were face-to-face. Once submitted, surgeons can track the survey results online and compare their outcomes anonymously to other surgeons. This provides powerful information and stimulus for modification of one’s own practice interventions in order to improve outcomes. Furthermore, it provides easily collected data to facilitate clinical research.

An important component of the registry is the surgeon portal. This allows the surgeon to enter in the record for each operative case specific data, such as implants used and operative time, which in turn allows for cost comparisons. Also, the surgeon can enter procedure data relative to how the surgery was done including details, such as graft choice and associated joint pathology, to further fine tune the clinical research.

Currently, I enroll patients undergoing knee and shoulder surgery after obtaining informed consent. I am interested in amassing a database so ultimately, I can compare different surgical techniques such as single vs. double ACL reconstruction, and single vs. double row rotator cuff repair in my patients. Research projects are enhanced because of the valid outcome data that is easily collected with use of standard knee and shoulder surveys such as the KOOS, Marx Activity, American Shoulder and Elbow Surgeons, Simple Shoulder, SF-36 and Visual Analog Scale. Plus, with the operative data added through the surgeon portal, the cost-effectiveness of the different procedures can be analyzed and compared.

Dodds: The KSAC study uses a secure web portal for surgeons to input data on themselves and the patients on which they are performing knee and shoulder arthroscopies. Through this portal, surgeons can input initial data on patient risk factors for complications and enter intraoperative complication data. A “timer” is set within the system so that all patients entered will have follow-up data at 2-week, 4-week and 6-week intervals to assess if any complications occurred postoperatively. The system is programmed so reminder emails are sent to surgeons to obtain any missing postoperative data on patients.

Through the development of this initial survey, the computer program has been created so that subsequent and concurrent, if desired, studies can be conducted on other areas of interest in arthroscopic surgery and has created the ability to monitor not only adverse events, but also perform multi-center outcomes studies.

Lubowitz: What do you see as the advantages of 21st century technology? How does this compare with previous methods?

Lane: This kind of access to clinical trials allows patients to more easily participate and can save sponsors tremendous costs in setting up and managing multiple brick-and-mortar study sites. Patients are routinely using the Internet to research and manage their medical conditions. This direct-to-patient research technology also makes heavy use of devices patients want to use for convenience, such as handheld mobile devices and iPads. Other web-enabled devices can be used to provide real data directly from home like weight scales, blood pressure monitors and sleep measurement devices that can connect the patient to medical staff without requiring a site visit.

New technology allowing sophisticated identity verification over the Internet has been used by financial institutions and is being used in direct to patient studies. We are also leveraging significant advancements in multimedia and online learning tools to bring patients a much better informed consent process. Our goal is to enroll and retain patients who really learn and understand the details of the study and want to participate.

Smith: Significant advantages of electronic data collection in medicine include time efficiency, as well as improvement in the quality of data collection while decreasing costs through the elimination of secondary data entry. Plus, data retrieval and analysis is instantaneous, which is another major benefit.

The greatest advantage of 21st century computer technology is the collection of primary data – in this case through the administration of electronic questionnaires over the Internet. It is all done through email, which is an efficient, automated way to conduct outcome surveys. Websites can be accessed by users worldwide, so information from an international sample can be gathered easily. The results are available almost instantly, as the responses can be checked and analyzed in real-time as they are received. The research is of high quality, quick, and done in multiple diverse settings. Furthermore, when part of a registry, interactive graphics easily provide the means for surgeons performing the same surgery to compare patient outcomes, as well as compare their patient outcomes with other surgeons around the world.

Compared with paper medical records, the time-saving capacity and rapid accessibility to electronic data is obviously apparent. Research is made easier on several fronts. First of all, there is less risk of interviewer or response bias to the data collected because a patient responding to a computer survey is providing a focused response to the questions with no potential influence from a clinician, unlike the scenario of a clinician asking the same questions in the office and potentially “interpreting” the patient responses. In addition, there is no secondary chance for error as is the case with paper methods where data has to be transferred by a secondary person.

Electronic data is secure and takes up less space than traditional paper files. It also can be shared instantly with other researchers via email or on shared websites where data can be updated and housed. Plus, there is a basic convenience benefit for patients and clinicians alike as less office visits are required but relevant clinical data is collected at regular intervals.

Dodds: Several attempts have previously been made to determine the risk of complications in arthroscopic surgery. It is difficult to get a sufficient number of cases to reach statistical significance due to the relative rarity of complications in this type of surgery. The Internet allows us to gather a large volume of cases to get a valid study.

A computerized study also allows anonymity of both surgeons and patients as all data is de-identified as it is entered into the database. This encourages integrity in reporting as data cannot be traced back to an individual or institution.

Internet-based technology also allows the surgeon to submit data from anywhere and at anytime. Our study data can be input via laptop, PC or smart phone from anywhere in the world where the Internet is available. This allows for immediate input and reception of data, thus decreasing the potential for errors in reporting.

Lubowitz: What are the risks or limitations, if any, of web-based technology for outcome data collection and adverse event monitoring?

Lane: Safety data needs to be closely monitored in all studies. This new study model is no different. In our study, patients can report events any time and we do the follow-up by contacting them or their local care providers to collect details and follow-up information. In some ways, we are hoping that this model may even provide a better safety profile of the things patients experience in a study. Since they do not have to wait several weeks for the next visit to report issues, we can potentially get more accurate day-to-day details of their adverse events.

Institutional review boards (IRBs) and the FDA are showing their support for this new clinical trials model. Studies have been reviewed and approved by multiple IRBs, and the FDA has been encouraging. “As part of our ongoing efforts in clinical trial modernization, the FDA is very interested in exploring the potential utility, both the benefits and the limitations, of direct to participant research and acknowledges that the Internet may be a useful tool in reaching, educating and engaging patients who participate,” Jeff Ventura, a media official at the FDA, said recently.

This type of study design is not going to work for every trial. There are cases where specialized technology or frequent face-to-face interactions with the site are irreplaceable. In those kinds of protocols, patient-reported outcomes do not constitute the primary endpoint data of the study and a more traditional data collection methodology may be more appropriate.

Smith: As far as risks and limitations with this powerful computer use in medicine, the main risk, of course, revolves around protecting the privacy of individuals. This is an understandable risk, although it is one that has a solution. Risk-intelligent technology and secure maintenance are the hallmarks of most secure clients. In the case of this registry, HIPAA security is employed in the system and does not allow identification of anything personal. Codes, encrypted addresses and password-protected access are a few examples.

As far as limitations, a major potential limitation with the system I use relates to adverse event reporting. Actually, the reporting of such events would be timely from the patient’s perspective as described above, but the issue is the surgeon response to the event. This is more of a “risk” factor because the immediate reporting of an adverse event by a patient does not necessary guarantee the most rapid response that we as providers would like due to the fact that notification to the clinician of such an event may be delayed for many reasons. This is not a fault of technology, but leans more to the response in the human realm as technology still “runs faster than we humans can.”

Dodds: The major struggle for the KSAC study has been the development of the web-based portal and the various links and transitions required with a secure, anonymous computer-based system. It has been a challenge to get computer programmers to think like orthopedic surgeons to allow a user-friendly interface. This chasm should slowly disappear as more web-based data systems are created for orthopedic surgery.

• Julie A. Dodds, MD, can be reached at Michigan State University, Division Sports Medicine. 2900 Hannah Blvd. #212 East Lansing, MI 48823; 517-319-1831; email: julie.dodds@hc.msu.edu.
• Nancy E. Lane, MD, can be reached at University of California at Davis School of Medicine, Department of Internal Medicine, 4150 V St., Suite 3100, Sacramento, CA 95817; 916-734-2812; email: nancy.lane@ucdmc.ucdavis.edu.
• James H. Lubowitz, MD, can be reached at Taos Orthopaedic Institute, Research Foundation, and Orthopaedic Sports Medicine Fellowship, Taos, NM; 575-758-0009; fax: 575-758-8736 email: jlubowitz@kitcarson.net.
• Patrick A. Smith, MD, can be reached at Clinical Practice at the Columbia Orthopaedic Group, L.L.P., 1 South Keene St., Columbia, MO 65201; 573-443-2402; fax: 573-876-8646; email: psmithmudoc@aol.com.
• Disclosures: Dodds has no relevant financial disclosures; Lane is a consultant for Mytrus Inc.; Lubowitz is a consultant for and received royalties rom Arthrex, is a consultant for Ivivi and is a member, committee member and employee for the Arthroscopy Association of North America; Smith is a consultant for Arthrex, the company that formulated and devised the Internet system that he uses for outcomes.