Research

DOC is an Orthopedic Center of Excellence with a significant commitment to research. Because we treat a high volume of musculoskeletal patients, we are in a unique position to study musculoskeletal conditions, treatments, and therapies. This commitment to research, combined with the dedication of our team, allows us to bring the latest advances and novel protocols in orthopedic care to our patients and set new standards of care nationally and internationally.

The surgeons at DOC take part in research independently as well as in association with researchers outside of DOC for clinical, translational, and patient-centered research. We also develop new educational initiatives geared toward training and mentoring a new generation of scientists and health care professionals.

RESEARCH MISSION STATEMENT

We will advance knowledge in musculoskeletal diseases and related disorders.

We will facilitate research groups at DOC, and collaborate with other investigators in clinical, translational and patient-centered outcomes research.

We will evaluate patient outcomes and quality of life.

We will develop educational initiatives focused on training and mentoring a new generation of scientists.

We will disseminate research findings nationally and internationally.

We will support and advance the DOC mission and Philosophy of Respect, Ownership, Superior Service, an Excellence.

DOC is committed to the treatment of all participants involved in research in a manner which protects their safety, dignity, confidentiality, and right to be fully informed.

THE NEXT FRONTIER OF ORTHOPEDIC RESEARCH

There is a strong foundation of research-driven innovation on which to build, including recent advances in multi-modal pain therapy and early mobilization after joint surgery. These best practices, among many others, have produced shorter hospital stays while maintaining superlative patient outcomes.

SERVICES OUR RESEARCH DIVISION CAN PROVIDE TO INVESTIGATORS

  • Study design guidance
  • Access to research methods
  • Creation and support of study forms and databases
  • Creating a study budget
  • Research Coordinator support
  • Institutional Review Board assistance
  • Registry assistance
  • Biostatistics support
  • Reporting and analysis of study results

BECOMING PART OF A RESEARCH STUDY

The Division of Research conducts a number of ongoing studies at all times. For more information about current studies, including the Principal Investigator and Study Coordinator, or to learn more about what it means to participate in a study, please contact us at             .

Please note that all studies conducted are reviewed and approved by the Institutional Review Board (IRB). An IRB is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The number one priority of IRBs is to protect human subjects from physical or psychological harm.

If you have any questions, please contact Betsy Draper, Manager of the IRB at 617-754-6684.

DOC feels it is very important to be educated before participating in a research study. Education can help you make an informed choice.

CONTACT RESEARCH

Mr XYZ

PH

EMAIL

Clinical Research

Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

Epidemiological and behavioral studies.

Outcomes research and health services research.

Translational Research

The process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.

Subheadings under research:-

Research Programs

  1. JOINT REPLACEMENT

DOC is a center of excellence for musculoskeletal conditions and has a world-class Joint Replacement Program.

DOC has a history of contributing to the success of joint replacement surgery. Surgeons consulted on and tested new implants, including the design and use of innovative materials. After the hospital became an established center for revisions, surgeons continued to address the complications associated with joint replacements. The impressively low post-surgical infection rate at DOC is evidence of this commitment.

2.NURSE-INITIATED RESEARCH

The Nursing Research and Evidence-Based Practice Council consists of nurses from various roles at DOC and seeks to:

  • Promote the professional practice of nursing through the application of nursing research
  • Establish the process and dissemination of current and available evidence in order to advance practice

Recent nurse-initiated research studies have focused on a variety of topics, including many that aim to improve patient care and current practices. As nurse-initiated research continues to grow, studies are beginning to be published and presented at local and national events.

3.INFECTION RELATED RESEARCH

Research related to surgical infections has increased significantly in recent years at DOC. With a particular focus on decreasing post-surgical infection rates, studies have been conducted throughout different areas of the hospital. Of particular interest to the researchers are methods that will help to limit unnecessary antibiotic prescriptions. Other studies have focused on risk factors for specific infections and validating tests to help diagnose and treat infections more efficiently.

Institutional Review Board

DOC is committed to treating all research participants in a manner which protects their safety, dignity, confidentiality, and right to be fully informed. To ensure this, the Division of Research supports and guides investigators in the research process.

 WHAT IS AN INSTITUTIONAL REVIEW BOARD (IRB)?

An Institutional Review Board (IRB) is a group of people formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect the rights and welfare of individuals who are participating as subjects in the research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. Once a project is approved, the IRB must monitor the progress of the ongoing research, prospectively approve modifications, and, if necessary to protect subjects, suspend a research project.

HOW OFTEN DOES THE IRB MEET?

The IRB meets on the 3rd Tuesday of each month at 7:00 am.

WHEN IS THE DEADLINE FOR IRB SUBMISSIONS?

Seven business days prior to the IRB meetings at 3:00 pm.

WHAT IS THE TURNAROUND TIME FOR IRB REVIEW AND APPROVAL?

Turnaround time depends on a number of factors, including but not limited to: completeness of submission; meeting dates; type of review; and the investigator’s responsiveness to an IRB request.

Full Board reviews are placed on the next available agenda. Notification of the outcome of the review occurs approximately seven business days after the date of the meeting.

Expedited/Exemption reviews occur approximately five business days after submission to the IRB.

WHAT IS EXPEDITED REVIEW?

Expedited review means that the convened IRB need not review the proposed research. Expedited review is appropriate for a protocol that presents not more than minimal risk to subjects. The IRB Chair or designated reviewer makes this decision.

HOW DO I SUBMIT A STUDY TO THE IRB?

Electronically, as well in physical form. Contact the IRB office for further instruction.

DOC maintains and supports the Institutional Review Board (IRB) utilizing the industry-leading suite of tools, bringing electronic on-line IRB submissions to the DOC research community.

I AM JUST REVIEWING MEDICAL RECORDS; DO I NEED IRB APPROVAL?

Yes, if the project meets the criteria for research with human subjects (your IRB office can help you determine this).

I’M JUST ADMINISTERING SURVEYS/QUESTIONNAIRES; DO I NEED IRB APPROVAL? EVEN IF I AM ONLY INTERVIEWING A FEW PEOPLE?

Yes. Any activity conducted by an individual who is affiliated with DOC that involves research on human subjects must be prospectively reviewed by the IRB.

WHAT ADVERSE EVENTS NEED TO BE REPORTED TO THE IRB?

Adverse events that are also unanticipated problems must be reported to the IRB. Unanticipated problems are any incident, experience, or outcome that meets all of the following criteria :

  • Unexpected (in terms of nature, severity, or frequency)
  • Related or possibly related to participation in the research
  • Suggests that the research places subjects or others at greater risk of harm than was previously known or recognized

WHAT CHANGES REQUIRE APPROVAL BY THE IRB AFTER THE PROTOCOL IS APPROVED?

Any proposed change to the protocol procedures (including subject selection, consent process), personnel, documents (including recruitment ads, study instruments) must be submitted to the IRB for review and approval prior to implementation. Any other changes that may affect a participant’s willingness to participate in the study must also be submitted for prospective IRB review.

DO I NEED TO LET THE IRB KNOW WHEN I HAVE COMPLETED A STUDY?

Yes, an investigator needs to inform the IRB that a study is being terminated or closed and complete a termination report. A study should not be terminated until all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis.

Orthopedic Registry

What is the Registry?

The IJR Registry is a program that enables research by providing valuable information to assist in making long-term decisions regarding orthopedic surgery.

Similar registry programs exist around the world to track the effectiveness of certain surgical procedures and implants. Along with clinical information collected at the time of surgery—such as types of implants we use—the patient perspective is a crucial piece to understanding how we can further ensure safety and improve the care we deliver at the Hospital.

The IJR Registry allows participating patients the opportunity to report their health status relating to:

  • Quality of Life
  • Joint function and pain
  • Activity levels
  • Long-term surgical success

Research is a major effort, where we seek new and better methods of care to enable our patients to succeed. Our mission is focused on patient outcomes.

Active Research Studies:

  1. Range of motion at discharge: Predicts need for knee manipulation following total knee arthroplasty

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