CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

July 7th, 2010

• NEJM Editorial: DSMBs Need Protection and Independence
• Promising Results for Telemonitoring and Self-Management to Control Hypertension

NEJM Editorial: DSMBs Need Protection and Independence: Data and safety monitoring boards (DSMBs) need more protection and independence, according to an editorial in the New England Journal of Medicine by the journal’s editor, Jeffrey M. Drazen, and Alastair J.J. Wood. Responding to recently uncovered events, in which company sponsors interfered with the independence and authority of the DSMBs in the RECORD, SHARP, and IMPROVE-IT trials, the editorialists “propose fundamental changes in the way DSMBs are constituted, are funded, and report,” and say that DSMBs “should be chosen and convened under the aegis of an independent public body.”

Promising Results for Self-Management of Hypertension: Some 527 hypertensive patients in the U.K. were randomized to either usual care or a self-managed strategy utilizing self-monitoring and telemonitoring of blood pressure and self-titration of antihypertensive drugs. Results of the TASMINH2 (Telemonitoring and Self-Management in the Control of Hypertension) study, which appear in the Lancet, show that patients in the self-management group achieved greater reductions in blood pressure than patients in the usual-care group. The authors conclude that “self-management represents an important new addition to the control of hypertension in primary care.”

In an accompanying comment, Gbenga Ogedegbe writes that “self-titration of antihypertensive drugs has come of age in terms of its feasibility, safety, and efficacy,” but cautions that “widespread dissemination into primary care practices might be premature until these findings are replicated by other investigators.”

Categories: General


You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

One Response to “• NEJM Editorial: DSMBs Need Protection and Independence
• Promising Results for Telemonitoring and Self-Management to Control Hypertension”

  1. Milan Kostek, MD says:
    July 8, 2010 at 2:02 am

    There should exist two independent bodies as outlined below. Let the company pay for credibiltiy and doctors performing clinical trials be checked by others (both parts being presumed not guilty).
    Each trial should be conducted by two groups – investigators with ensuing conflicts of interests (doing their job for the company, paid by the company and therefore in position of industry employees) and independent surveyors without conflicts of interest (paid by independent organisation e.g. ACC or national institute of health, that would get the money from the company). Though this would entail bigger costs for the company, the results of the trial would be made unbiased in this way. Drug or device companies could publish their reports only when the trial has been conducted this way. Another step to be taken is to ask some money for basic research or the research to solve practical issues since a lot of practical questions in medicine is to be answered and lack of money is the obstacle. Doctor of medicine has but one of two choices – either to embark a career of investigator and hold the position industry employee or to hold the position of independent doctor without conflicts of interest.
    Sorry to repeat myself (I can have no other comment to this “revealing information” published in NEJM on June 7th, 2010 than the same one I had sent on 29 June 2010 about the topic “Industry Employees May Not Be Allowed to Speak at the AHA ” at CARDIOEXCHANGE from 16 Jun 2010).