Opinions on Access to Medical Research Data
Affordable Care Act Summaries
An easy way to follow the Supreme Court oral arguments on the Affordable Care Act is to read the summaries at http://healthaffairs.org/blog/
Advice On Some Quasi-Experimental Alternatives To Randomization
We have found a lot of help over the years in reading the advice and postings of statistician, Dr. Steve Simon. Here’s an entry in which he discusses some considerations when dealing with quasi-experimental designs. You can sign up for his newsletter to receive it directly. (Note: if you keep reading to the next entry about how much in practice is estimated to be evidence-based, we suspect that the reported percent might be inflated if the reviewers were not applying a solid critical appraisal approach.) You can read Steve’s advice about quasi-experimental design considerations here:
Improving Results Reporting in Clinical Trials: Case Study—Time-to-Event Analysis and Hazard Ratio Reporting Advice
We frequently see clinical trial abstracts—especially those using time-to-event analyses—that are not well-understood by readers. Fictional example for illustrative purposes:
In a 3-year randomized controlled trial (RCT) of drug A versus placebo in women with advanced breast cancer, the investigators presented their abstract results in terms of relative risk reduction for death (19%) along with the hazard ratio (hazard ratio = 0.76, 95% confidence interval [CI] 0.56 to 0.94, P = 0.04). They also stated that, “This reduction represented a 5-month improvement in median survival (24 months in the drug A group vs. 19 months in the placebo group).” Following this information, the authors stated that the three-year survival probability was 29% in the drug A group versus 21.0% in the placebo group.
Many readers do not understand hazard ratios and will conclude that a 5 month improvement in median survival is not clinically meaningful. We believe it would have been more useful to present mortality information (which the authors frequently present in results section, but is not easily found by many readers).
A much more meaningful abstract statement would go something like this: After 3 years, the overall mortality was 59% in the drug A group compared with 68% in the placebo group which represents an absolute risk reduction (ARR) of 9%, P=0.04, number needed to treat (NNT) 11. This information is much more impressive and much more easily understood than a 5-month increase in median survival and uses statistics familiar to clinicians.
If You Feel O.K., Maybe You Are O.K.
H. Gilbert Welch MD is a physician at Dartmouth and the author of “Overdiagnosed: Making People Sick in the Pursuit of Health.” We liked his OP-ED piece—If You Feel O.K., Maybe You Are O.K.—published in the New York Times, Feb. 27, 2012
Dr. Welch points out that most Americans used to believe that “catching” diseases early and starting treatment is always beneficial. He points out that, in fact, we don’t have good evidence for screening and early diagnosis of prostate cancer, breast cancer, ovarian cancer, adult-onset diabetes, elevated cholesterol in children, etc., and yet many groups encourage screening for these conditions. Dr. Welch suggests that maybe we should all learn how we can, in some cases, prevent the condition rather than enter the medical system with blind faith that healthcare interventions can do more than the evidence shows.
A Controlled Trial of Sildenafil in Advanced Idiopathic Pulmonary Fibrosis Study (STEP_IPF Study): Evidence-based Student Review
New publication of an evidence-based student review at our California Pharmacist page. Link: http://www.delfini.org/Showcase_Publication_CPhA.htm
Class Effect? Caution Urged!
A recent chat with a colleague the other day resulted in a discussion about class effect. Should evidence-based proof of drug efficacy be extrapolated to a “class of agents?” We think it is risky to do so. Our biologics safety review is one example. Read more from our archives at DelfiniClick™: Class Effect—Caution Urged.
Three Questions Patients Should Ask To Improve the Information They Receive
According to Shepherd et al , the following questions appear to be powerful catalysts for good information exchanges between clinicians and patients:
1. “What are my options?”
2. “What are the benefits and harms of each?”
3. “How likely are the benefits and harms?”
Let’s start with Shepherd’s cross-over trial using the three questions above. In order to make informed decisions and improve outcomes, patients need reliable information about benefits and risks of the various options. In this randomized cross-over trial, Shepherd et al. used two standardized patients with identical symptoms— one patient asked the three questions (and also about doing nothing if the physician did not mention this option), the other did not. The patient presented as an otherwise healthy divorced middle-aged female with one prior undiagnosed episode of depression and 3 months of worsening moderate symptoms of depression. Depression was chosen as the condition because evidence is available and patients express differences in preference for treatment. The authors found that the 3 questions were associated with greater provision of information and behavior supporting patient involvement without extending appointment time.
Stiggelbout et al. remind us that shared decision-making (SDM) should be routinely employed to ensure patient autonomy, beneficence (balancing risks and benefits), non-malfeasance (avoiding harm) and justice (patients frequently decline procedures when adequate information has been provided and this may result in improved sharing of limited resources). Pamphlets, videos, tools of various sorts may be employed to facilitate SDM. Tactics and tools that appear to increase SDM include—
- Creating awareness of equipoise (there is no best choice but a decision must be made—even if it is to do nothing);
- Presenting or encouraging patients to ask about options and benefits and risks of each option;
- Use of graphical displays to present risks;
- Use absolute risk information such as the number of similar patients/100 or number/1000 who will benefit*;
- Encouraging patients to pay attention to their preferences;
- Provide appropriate support to help patients make decisions—respect the patient’s preference about his or her role—independent, shared or delegated decision-making role.
*We would add that this information is only useful when also providing information that provides a more complete picture. To hear that one’s chance of benefiting from an intervention is 5 out of a hundred has a very different meaning depending upon the specific context:
- Scenario 1: Out of 100 patients, 10 taking drug A improved as compared to 5 taking placebo, versus—
- Scenario 2: Out of 100 patients, 90 taking drug A improved as compared to 95 taking placebo.
Examples of decision-aids are available from the following: http://shareddecisions.mayoclinic.org.
Delfini Comment: “Patient demand,” i.e., activating patients to voice their information needs, has been proposed as a method of improving healthcare consultations for several decades. In our experience, educational programs aimed at increasing the use of evidence-based information sharing with patients has been hampered by clinicians frequently not possessing accurate answers to the three questions studied here. The two studies discussed above [3,4] indicate that patient-mediated approaches may be at least part of the answer to improved clinical decision-making.
1. Shepherd HL et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: a cross-over trial. Patient Educ Couns. 2011 Sep;84(3):379-85. Epub 2011 Aug 9.PubMed PMID: 21831558.
2. Stiggelbout AM et al. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256. PubMed PMID:22286508.
3. Bell RA et al. Encouraging patients with depressive symptoms to seek care: a mixed methods approach to message development. Patient Educ Couns. 2010 Feb;78(2):198-205. Epub 2009 Aug 11. PubMed PMID: 19674862.
4. Kravitz RL et al. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005 Apr 27;293(16):1995-2002. Erratum in: JAMA. 2005 Nov 16;294(19):2436. PubMed PMID: 15855433; PubMed Central PMCID: PMC3155410.
Chronic Kidney Disease Guideline
Update to the Chronic Kidney Disease Guideline from our Kaiser Permanente Hawaii: Nephrology Project for Primary Care. Available at Sample Projects at http://www.delfini.org. Direct link: http://www.delfini.org/Showcase_Project_NephrologyCPG.htm