Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label patient centered research. Show all posts
Showing posts with label patient centered research. Show all posts

Thursday, January 17, 2013

Monumental regulatory fail: metal on metal hips


http://www.nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html?emc=tnt&tntemail1=y

After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop manufacturers from selling such implants.
Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.



Joshua Borough for The New York Times

Some all-metal hip implants have failed prematurely, forcing thousands of patients to undergo operations to replace them.

Wednesday, December 5, 2012

Rheumatoid Arthritis Study: Hip, Knee Replacement


http://www.emaxhealth.com/11306/caution-advised-rheumatoid-arthritis-patients-considering-hip-or-knee-replacement


By Robin Wulffson Md on November 30, 2012 - 5:26pm  for eMaxHealth
                Arthritis Pain Treatment Current News


Victims of rheumatoid arthritis can develop problems with their joints throughout the body, including the knee and hip. These joints can be replaced with an artificial one with a procedure known as arthroplasty. Researchers affiliated with the University of Toronto (Toronto, Ontario, Canada) conducted a study to evaluate the complication rate of a total hip or knee arthroplasty among patients with rheumatoid arthritis, compared to patients with osteoarthritis. They published their findings online on November 28 in the journal Arthritis & Rheumatism.
The researchers noted that most of the evidence regarding complications following total hip arthroplasty and total knee arthroplasty is based on studies of patients with osteoarthritis; thus, little information regarding the outcomes in patients with rheumatoid arthritis has been published. Therefore, they conducted a study with the objective of reviewing the current evidence regarding rates of total hip and knee arthroplasty complications in rheumatoid arthritis patients compared to osteoarthritis patients.
The researchers reviewed data from Medline, EMBase, Cinahl, Web of Science, and reference lists of articles. They included reports published between 1990 and 2011 that described studies of primary total joint arthroplasty of the hip or knee and contained information on outcomes in 200 or more rheumatoid arthritis and osteoarthritis joints. Outcomes of interest included revision, hip dislocation, infection, 90-day mortality, and venous thromboembolic (blood clot) events. Two reviewers independently evaluated each study for quality and extracted data. Where appropriate, meta-analysis was performed; if this was not possible, the level of evidence was assessed qualitatively.
The review comprised 40 studies. The investigators found that patients with rheumatoid arthritis are at increased risk of dislocation following a total hip arthroplasty (2.16 times greater risk). In addition, the found fair evidence to support the concept that risk of infection and risk of early revision following total knee arthroplasty are increased in rheumatoid arthritis, compared to osteoarthritis. There was no evidence of any differences in rates of revision at later time points, 90-day mortality, or rates of venous thromboembolic events following total hip replacement or total knee replacement in patients with rheumatoid arthritis versus osteoarthritis. Rheumatoid arthritis was explicitly defined in only three studies (7.5%), and only 11 studies (27.5%) included adjustment for covariates (i.e., age, sex, and comorbidity
The researchers concluded that the findings of their literature review and meta-analysis indicate that, compared to patients with osteoarthritis, patients with rheumatoid arthritis are at higher risk of dislocation following total hip arthroplasty and higher risk of infection following total knee arthroplasty.
Arthritis is inflammation of one or more joints, which results in pain, swelling, stiffness, and limited movement. There are over 100 different types of arthritis. Rheumatoid arthritis is considered an autoimmune disease. The body's immune system normally fights off foreign substances, such as viruses. But in an autoimmune disease, the immune system confuses healthy tissue for foreign substances. As a result, the body attacks itself. Osteoarthritis is related to aging. In osteoarthritis, the cushioning (cartilage) between the bones wears away in the joints. As osteoarthritis gets worse, the cartilage disappears and bone rubs on bone. Bony spurs or growths usually form around the joint. The ligaments and muscles around the joint loosen and become weaker.

Saturday, October 27, 2012

PCORI webcast today & Sunday October 27,28






PCORI   Patient Centered Outcomes Research Institute
Watch a live webcast of the patient-engagement workshop plenary session “Transforming Patient-Centered Research: Building Partnerships and Promising Models”:

Saturday, October 27, 8:30 a.m.-11:00 a.m. ET

Sunday, October 28, 8:00 a.m.-12:30 p.m. ET
 
Join the conversation on Twitter by following @PCORI and using the #PCORI hashtag during the workshop.

Provide feedback to PCORI on the workshop topics by email to GetInvolved@pcori.org. Feedback received will be considered as PCORI develops a report on the workshop

I will be watching the webcast although I applied to participate in person.   It is important to our community of patients with failed implanted devices that we are represented and participate in the discussion.
Workshop participants will help PCORI establish procedures for identifying research questions, reviewing research proposals for funding, and ensuring patient participation throughout the research process. It is the first in a series of workshops aimed at bringing PCORI’s vision for patient and stakeholder engagement to life.
The workshop’s five topics:
1.             Identifying and Selecting Research Questions
2.            Reviewing Research Proposals for Funding
3.            Matching Patients and Stakeholders with Researchers
4.            Disseminating Research to the Community
5.             Evaluating PCORI’s Patient and Stakeholder Engagement Programs