Quickly Finding Reliable Evidence

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Quickly Finding Reliable Evidence

Good clinical recommendations for various diagnostic and therapeutic interventions incorporate evidence from reliable published research evidence. Several online evidence-based textbooks are available for clinicians to use to assist them in making healthcare decisions. Large time lags in updating are a common problem for medical textbooks.  Online textbooks offer a solution to these delays.

For readers who plan to create decision support, we strongly recommend DynaMed [full disclosure: we are on the editorial board in an unpaid capacity, though a few years ago we did receive a small gift]. DynaMed is a point-of-care evidence-based medical information database created by Brian S. Alper MD, MSPH, FAAFP. It continues to grow from its current 30,000+ clinical topics that are updated frequently. DynaMed monitors the content of more than 500 medical journals and systematic evidence review databases.  Each item is thoroughly reviewed for clinical relevance and scientific reliability. DynaMed has been compared with several products, including in a new review by McMaster University. The DynaMed website is https://dynamed.ebscohost.com/.

The McMaster University maintains a Premium Literature Service (PLUS) database which is a continuously updated, searchable database of primary studies and systematic reviews. Each article from over 120 high quality clinical journals and evidence summary services is appraised by research staff for methodological quality, and articles that pass basic criteria are assessed by practicing clinicians in the corresponding discipline.  Clinical ratings are based on 7-point scales, where clinical relevance ranges from 1 (“not relevant”) to 7 (“directly and highly relevant”), and newsworthiness ranges from 1 (“not of direct clinical interest”) to 7 (“useful information, most practitioners in my discipline definitely don’t know this).

Investigators from McMaster evaluated four evidence-based textbooks—UpToDate, PIER, DynaMed and Best Practice [Jeffery 12].  For each they determined the proportion of 200 topics which had subsequent articles in PLUS with findings different from those reported in the topics. They also evaluated the number of topics available in each evidence-based textbook compared with the topic coverage in the PLUS database, and the recency of updates for these publications.  A topic was in need of an update if there was at least one newer article in PLUS that provided information that differed from the topic’s recommendations in the textbook.

Results

The proportion of topics with potential for updates was significantly lower for DynaMed than the other three textbooks, which had statistically similar values. For DynaMed topics, updates occurred on average of 170 days prior to the study, while the other textbooks averaged from 427 to 488 days. Of all evidence-based textbooks, DynaMed missed fewer articles reporting benefit or no effect when the direction of findings (beneficial, harmful, no effect) was investigated. The proportion of topics for which there was 1 or more recently published articles found in PLUS with evidence that differed from the textbooks’ treatment recommendations was 23% (95% CI 17 to 29%) for DynaMed, 52% (95% CI 45 to 59%) for UpToDate, 55% (95% CI 48 to 61%) for PIER, and 60% (95% CI 53 to 66%) for Best Practice (?23=65.3, P<.001). The time since the last update for each textbook averaged from 170 days (range 131 to 209) for DynaMed, to 488 days (range 423 to 554) for PIER (P<.001 across all textbooks).

Summary

Healthcare topic coverage varied substantially for leading evidence-informed electronic textbooks, and generally a high proportion of the 200 common topics had potentially out-of-date conclusions and missing information from 1 or more recently published studies. PIER had the least topic coverage, while UpToDate, DynaMed, and Best Practice covered more topics in similar numbers. DynaMed’s timeline for updating was the quickest, and it had by far the least number of articles that needed to be updated, indicating that quality was not sacrificed for speed.

Note: All textbooks have access to the PLUS database to facilitate updates, and also use other sources for updates such as clinical practice guidelines.

Conclusion

The proportion of topics with potentially outdated treatment recommendations in on-line evidence-based textbooks varies substantially.

Reference

Jeffery R, Navarro T, Lokker C, Haynes RB, Wilczynski NL, Farjou G. How current are leading evidence-based medical textbooks? An analytic survey of four online textbooks. J Med Internet Res. 2012 Dec 10;14(6):e175. doi: 10.2196/jmir.2105. PubMed PMID: 23220465.

 

 

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Delfini Treatment Messaging Scripts™ Update

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 Messaging Scripts ™ Update

Delfini Messaging Scripts  are scripts for scripts. Years ago we were asked by a consultancy pharmacy to come up with a method to create concise evidence-based statements for various therapies.  That’s how we came up with our ideas for Messaging Scripts, which are targeted treatment messaging & decision support tools for specific clinical topics. Since working with that group, we created a template and some sample scripts which have been favorably received wherever we have shown them.  The template is available at the link below, along with several samples.  Samples recently updated: Ace Inhibitors, Alendronate, Sciatica (Low Back Pain), Statins (two scripts) and Venous Thromboembolism (VTE) Prevention in Total Hip and Total Knee Replacement.

 http://www.delfini.org/page_SamePage_RxMessagingScripts.htm

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Canadian Knowledge Translation Website

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Canadian Knowledge Translation Website

The Knowledge Translation (KT) Clearinghouse is a useful website for EBM information and tools. It is funded by the Canadian Institute of Health Research (CIHR) and has a goal of improving the quality of care by developing, implementing and evaluating strategies that bridge the knowledge-to-practice gap and to research the most effective ways to translate knowledge into action. Now added to Delfini web links.

http://ktclearinghouse.ca/

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Critical Appraisal Matters

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Critical Appraisal Matters

Mike and I make it a practice to study the evidence on the evidence.  Doing effective critical appraisal to evaluate the validity and clinical usefulness of studies makes a difference.  This page on our website may be our most important one and we have now added a 1-page fact sheet for downloading: http://www.delfini.org/delfiniFactsCriticalAppraisal.htm

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The Elephant is The Evidence—Epidural Steroids

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The Elephant is The Evidence—Epidural Steroids: Edited & Updated 1/7/2013

Epidural steroids are commonly used to treat sciatica (pinched spinal nerve) or low back pain.  As of January 7, 2013 at least 40 deaths have been linked to fungal meningitis thought to be caused by contaminated epidural steroids, and 664 cases in 19 states have been identified with a clinical picture consistent with fungal infection [CDC]. Interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, MA. On October 3, 2012, the compounding center ceased all production and initiated recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration.

Thousands of patients receive epidural steroids without significant side effects or problems every week. In this case, patients received steroids that were mixed by a “compounding pharmacy” and contamination of the medication appears to have occurred during manufacture. But let’s consider other patients who received epidural steroids from uncontaminated vials. How much risk and benefit are there with epidural steroids? The real issue is the effectiveness of epidural steroids. Yes, there are risks with epidural steroids beyond contamination—e.g., a type of headache that occurs when the dura (the sac around the spinal cord) is punctured and fluid leaks out. This causes a pressure change in the central nervous system and a headache. Bleeding is also a risk. But people with severe pain from sciatica are frequently willing to take those risks if there are likely to be benefits. But, in fact, for many patients who receive epidural steroids the likelihood of benefit is very low. For example, patients with bone problems (spinal stenosis) rather than lumbar disc disease are less likely to benefit. Patients who have had a long history of sciatica are less likely to benefit.

We don’t know how many of these patients were not likely to benefit from the epidural steroids, but if the infected patients had been advised about the unproven benefits of epidural steroids in certain cases and the known risks, some patients may have chosen to avoid the injections and possibly be alive today.  This is an example of the importance of good information as the basis for decision-making. Basing decisions on poor quality or incomplete information and intervening with unproven—yet potentially risky treatments puts millions of people at risk every week.

Let’s look at the evidence. Recently, a fairly large, well-conducted RCT published in the British Medical Journal (BMJ) reported that there is no meaningful benefit from epidural steroid injections in patients who have had long term (26 to 57 weeks) of sciatica [Iverson].  As pointed out in an editorial, epidural steroids have been used for more than 50 years to treat low back pain and sciatica and are the most common intervention in pain clinics throughout the world [Cohen]. And yet, despite their widespread use, their efficacy for the treatment of chronic sciatica remains unproven. (We should add here that many times lacking good evidence of benefit does not mean a treatment does not work.) Iverson et al conclude that, “Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy [Iverson].”

Of more than 30 controlled studies evaluating epidural steroid injections, approximately half report some benefit. Systematic reviews also report conflicting results. Reasons for these discrepancies include differences in study quality, treatments, comparisons, co-interventions, study duration and patient selection. Results appear to be better for people with short term sciatica, but improvement should not be considered to be curative with epidural steroids. In this situation, it is very important that patients understand this fuzzy benefit-to-risk ratio. For many who are completely informed, the decision will be to avoid the risk.

With this recent problem of fungal meningitis from epidural steroids, it is important for patients to be informed about the world of uncertainty that surrounds risk, especially when science tells us that the evidence for benefit is not strong.  Since health care professionals frequently act as the eyes of the patient, we must seriously consider for every intervention we offer whether benefits clearly outweigh potential harms—and we must help patients understand details regarding the risks and benefits and be supportive when patients are “on the fence” about having a procedure. Remember Vioxx, arthroscopic lavage, vertebroplasy, encainide and flecainide, Darvon and countless other promising new drugs and other interventions? They seemed promising, but harms outweighed benefits for many patients.

References

1. http://www.cdc.gov/HAI/outbreaks/meningitis.html accessed 12/10/12

2.  Cohen SP. Epidural steroid injections for low back pain. BMJ. 2011 Sep 13;343:d5310. doi: 10.1136/bmj.d5310. PubMed PMID: 21914757.

3.  Iversen T, Solberg TK, Romner B, et al.   Effect of caudal epidural steroid or saline injection  in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial. BMJ. 2011 Sep 13;343:d5278. doi: 10.1136/bmj.d5278. PubMed PMID: 21914755.

 

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Best Care at Lower Cost: The Path to Continuously Learning Health Care in America

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Best Care at Lower Cost: The Path to Continuously Learning Health Care in America

“If home building were like health care, carpenters, electricians, and plumbers each would work with different blueprints, with very little coordination.”

“If airline travel were like health care, each pilot would be free to design his or her own preflight safety check, or not to perform one at all.”

The Institute of Medicine (IOM) has just released this latest “state of our health care” report which is well worth reading. [1]  We have a long ways to go before we have a health system. The report, released September 6, 2012, concludes that our dysfunctional health care system wastes about $760 billion each year. Much of the waste is due to inefficiencies and administrative duplications, but $210 billion of the waste is due to unnecessary services (e.g., overuse, unnecessary choice of higher cost services) and $55 billion is wasted on missed primary, secondary and tertiary prevention opportunities.

Here are just a few of the interesting points and recommendations the 18 authors make:

  • The volume of the biomedical and clinical knowledge base has rapidly expanded, with research publications having risen from more than 200,000 a year in 1970 to more than 750,000 in 2010;
  • We can achieve striking improvements in safety, quality, reliability, and value through the use of systematic evidence-based process improvement methods;
  • We need digital platforms supporting real-time access to knowledge;
  • We need to  engage empowered patients;
  • We need full transparency in all we do;
  • We need improved decision support; improved patient-centered care through tools that deliver reliable, current clinical knowledge to the point of care; and, organizations’ support for, and adoption of, incentives that encourage the use of these tools.

The pre-publication issue of this IOM report is currently available free of charge at this URL.[2]



[1] Smith M, Cassell G, Ferguson B, Jones C, Redberg R; Institute of Medicine of the National Academies. Best care at lower cost: the path to continuously learning health care in America. http://iom.edu/Activities/Quality/LearningHealthCare/2012- SEP-06.aspx.

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Divulging Information to Patients With Poor Prognoses

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Divulging Information to Patients With Poor Prognoses

We have seen several instances where our colleagues’ families have been given very little prognostic information by their physicians in situations where important decisions involving benefits versus harms, quality of life and other end of life decisions must be made. In both cases when a clinician in the family presented the evidence and prognostic information, decisions were altered.

We were happy to see a review of this topic by Mack and Smith in a recent issue of the BMJ.[1] In a nutshell the authors point out that—

  • Evidence consistently shows that healthcare professionals are hesitant to divulge prognostic information due to several underlying misconceptions. Examples of misconceptions—
    • Prognostic information will make patients depressed
    • It will take away hope
    • We can’t be sure of the patient’s prognosis anyway
    • Discussions about prognosis are uncomfortable
  • Many patients are denied discussion about code status, advance medical directives, or even hospice until there are no more treatments to give  and little time left for the patient
  • Many patients lose important  time with their families and and spend more time in the hospital and in intensive care units than would be if prognostic information had been provided and different decisions had been made.

Patients and families want prognostic information which is required to make decisions that are right for them. This together with the lack of evidence that discussing prognosis causes depression, shortens life, or takes away hope and the huge problem of unnecessary interventions at the end of life creates a strong argument for honest communication about poor prognoses.

Reference

1. Mack JW, Smith TJ. Reasons why physicians do not have discussions about poor prognosis, why it matters, and what can be improved. J Clin Oncol. 2012 Aug 1;30(22):2715-7. Epub 2012 Jul 2. PubMed PMID: 22753911.

 

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Critical Appraisal Matters

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Critical Appraisal Matters

Most of us know that there is much variation in healthcare that is not explained by patient preference, differences in disease incidence or resource availability. We think that many of the healthcare quality problems with overuse, underuse, misuse, waste, patient harms and more stems from a broad lack of understanding by healthcare decision-makers about  what constitutes solid clinical research.

We think it’s worth visiting (or revisiting) our webpage on “Why Critical Appraisal Matters.”

http://www.delfini.org/delfiniFactsCriticalAppraisal.htm

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Appendicitis 1889 to 2012: What, No Surgery?

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Appendicitis 1889 to 2012: What, No Surgery?

All medical students learn about McBurney’s point—that’s the spot, named for McBurney, in the right lower quadrant of the abdomen where classical appendicitis pain finally localizes.[1] If the patient’s history fits the classic history of appendicitis with vague abdominal pain eventually localizing to McBurney’s point, the norm has been—at least in the U.S. —to take the appendix out. However, as pointed out in a new systematic review done as a meta-analysis, starting in the late 1950s there were reports of success in treating appendicitis with conservative therapy (antibiotics) and good outcomes without resorting to appendectomy.[2]

This systematic review presents a review of our traditions and lack of conclusive evidence about best practices in managing appendicitis and suggests that, for many patients, avoiding appendectomy may be a reasonable option. The current meta-analysis of four selected randomized controlled trials from 59 eligible trials with a total of 900 patients, reported a relative risk reduction for complications (perforation, peritonitis, wound infection) from appendicitis of 31% for antibiotic treatment compared with appendectomy (risk ratio 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). There were no significant differences between antibiotic treatment and appendectomy for length of hospital stay, efficacy of treatment, or risk of complicated appendicitis.

The biggest problem in this meta-analysis is that the results are based on trials with significant threats to validity. Randomization sequence was computer generated in one trial, by “external randomization” in one trial, by date of birth in one trial and unclear in one trial. Concealment of allocation was by sealed envelopes in two trials and not reported in the other two trials. All trials were unblinded. Withdrawal rates are unclear. Therefore, it is uncertain how much the results of this meta-analysis may have been distorted by bias. In addition, as pointed out by an editorialist, in patients who have persistent problems despite antibiotic treatment, delayed appendectomy might be necessary.[3] Delayed appendectomy has been associated with a high complication rate. Also, if a patient develops an inflammatory phlegmon—a palpable mass at clinical examination or an inflammatory mass or abscess at imaging or at surgical exploration—appendectomy sometimes has to be converted to an ileocecal resection—a much more involved operation. Another important issue with antibiotic treatment is the chance of recurrence. The current meta-analysis found a 20% chance of recurrence of appendicitis after conservative treatment within one year. Of the recurrences, 20% of patients presented with a perforated or gangrenous appendicitis. The editorialist questions whether a failure rate of 20% within one year is acceptable.

These four trials and this meta-analysis suggest that antibiotics may be safe for some patients with uncomplicated appendicitis. If this option is considered, we believe detailed information about the uncertainties regarding benefits and risks should be made known to patients. Details are available at http://www.bmj.com/content/344/bmj.e2156

References

1. Thomas CG Jr. Experiences with Early Operative Interference in Cases of Disease of the Vermiform Appendix by Charles McBurney, M.D., Visiting Surgeon to the Roosevelt Hospital, New York City. Rev Surg. 1969 May-Jun;26(3):153-66. PubMed PMID: 4893208.

2. Varadhan KK, Neal KR, Lobo DN. Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials. BMJ. 2012 Apr 5;344:e2156. doi: 10.1136/bmj.e2156. PubMed PMID: 22491789.

3. BMJ 2012;344:e2546 (Published 5 April 2012).

 

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Unnecessary or Harmful Tests and Treatments You May Wish To Avoid

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Unnecessary or Harmful Tests and Treatments You May Wish To Avoid

The Dartmouth Atlas of Healthcare and others have estimated that at least 30% of US healthcare spending is unnecessary. The American Board of Internal Medicine, along with nine prominent physician groups, announced on April 4, 2012 released lists of 45 common tests and treatments they say are often unnecessary and may even harm patients. For example the American Board of Family Practice recommended against imaging for low back pain unless red flags are present. Other items on the lists included avoiding antibiotics for most acute mild to moderate sinusitis symptoms, screening EKGs (or other cardiac screenings) in people without symptoms, DEXA screening for osteoporosis in women younger than 65 and many more. For details go to Kaiser Health News—http://www.kaiserhealthnews.org/Stories/2012/April/04/physicians-unnecessary-treatments.aspx

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