Fathers and grandfathers of science: checklists, statin myalgia and breast cancer

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This week: surgical checklists, statin myalgia and breast cancer radiotherapy

Janice, Nathan, and Amol want you to:

1. Understand the effect of surgical safety checklist implementation on surgical complication rates.

2. Understand the use of n-of-1 trials in evaluating the association between statin use and myalgia.

3. Recognize that intraoperative radiotherapy for breast cancer may be a viable alternative to standard postoperative external beam radiation therapy in terms of local recurrence.

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The papers

David Urbach et al. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med. 2014;  370:1029-1038. (PubMed)

Tisha Joy et al. N-of-1 (Single-Patient) Trials for Statin-Related Myalgia. Ann Intern Med. 2014;160(5):301-310.

Jayant Vaidya et al. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2013; 383:603-613.  (PubMed)

Good stuff

Janice – When checklists work and when they don’t, Atul Gawande, The Incidental Economist, March 15, 2014.

Nathan – Weed 2, a documentary by CNN’s Dr. Sanjay Gupta.

Amol – Malcolm Gladwell: Tell People What It’s Really Like To Be A Doctor, Robert Pearl, Forbes, March 13, 2014.

Other Links Discussed this Week

Judith Finegold et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice, Eur J Prev Cardiol, 2014 Apr;21(4):464-74.

Elizabeth Lillie et al. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011 March ; 8(2): 161–173. (PubMed)

Question of the Week

Is it the surgical checklist or safety culture that matters to reduce surgical complication rates?

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  • andreas laupacis says:

    Enjoyed this Rounds Table. Two questions:

    The study of intraoperative radiotherapy for breast cancer seems pretty compelling. Is this technology now being introduced in Canada? If not, why not?

    I have only conducted an Nof1 trial once in my practice (someone withouth biochemical evidence of iron deficiency who was convinced iron supplementation improved symptoms of fatigue). It was useful. However, arranging for the hospital pharmacy to manufacture identical looking iron and placebo capsules was a non-trivial matter. The Rounds Table didn’t discuss the practicalities of making a placebo for Nof1 trials. Any thoughts?

    • Amol Verma says:

      Thanks for the questions, Andreas. I will leave your question about intraoperative radiotherapy for Nathan or any of our other readers/listeners who are more familiar with surgical oncology.

      Regarding the practicalities of N-of-1 trials, we briefly mentioned that N-of-1 trials can demand more intensive patient outcome measurement, and that wireless technologies can help overcome this challenge. However, as you say, there are many other challenges pertaining to the resources required to set up N-of-1 trials, including pharmacy support. These might be prohibitive for the widespread use of N-of-1 trials in clinical practice without more formal infrastructure. Some academic health centres (I believe McMaster University and the University of Washington) have had central N-of-1 trial services and they found that the cost per trial was about $500. http://www-ncbi-nlm-nih-gov.myaccess.library.utoronto.ca/pubmed/8133588

      One of the most common applications of n-of-1 trials in medical literature is in pain treatment, often demonstrating a reduction in the prescription of ineffective (and sometimes expensive) medication. This strikes me as something that might be worth investing in.

    • Nathan Zilbert says:

      Hi Dr. Laupacis,

      I haven’t seen or heard of intraoperative radiotherapy being used for breast cancer in Toronto. I will ask one of the academic breast surgeons if they know of any sites across the country where it is being used. In the trial there were American and Australian sites involved and it does appear to be offered in the states: http://www.cancercenter.com/breast-cancer/iort/

      I think one practical issue for more widespread use in Canada is that many (most) centres offering breast surgery don’t provide radiation oncology services, so in order for this to be provided there would have to a significant reorganization in the way breast surgery is offered. Bringing in radiation oncology services to non cancer centre hospitals seems even less practical to me.

    • Nathan Zilbert says:

      So they have done some of these cases at PMH as part of the trial it seems but only about a dozen in ~6-7 years. The inclusion criteria in the trial were pretty broad–women over 45 years old with invasive ductal CA considered eligible for lumpectomy–but individual centres could narrow the criteria even further. I was told it had been done here for “small tumours” but don’t knowhow that was defined. I am not sure if they had difficulty recruiting, had limited resources (in terms of the necessary equipment and OR time) to offer the trial widely, or had narrowed the inclusion criteria extensively.

  • Elizabeth Rankin BScN says:

    Below is an attached copy of an email I sent to J. Finegold after reading her article on statin drugs.

    “I am curious to know how you gauged patients reactions to understanding whether the drug they were taking was associated with the symptoms they said they experienced.

    I was on statin drugs for over 3 years and had several trips to hospital with side-effects while on statin drugs. My symptoms were pretty overwhelming HOWEVER, no doctor could find anything wrong with me! They told me all my tests were negative! Even when they diagnosed me with Transient Global Amnesia the doctors never made the connection it was from the statin drugs.

    I quit my statin drugs because I got to the point I could barely move, not sleep or roll over in bed, after 3 years of misery. The doctor dismissed me from his practice in a round about way. As a consultant of Internal Medicine he told me he didn’t need to see me any more!

    From my own frustration I developed a method for patients, doctors, nurses and pharmacists to understand how to recognize whether the drug they take is responsible for the symptoms they have and this method I’ve trademarked.

    Interestingly, since stopping the drugs I never had another problem, other than living with a permanent side-effect daily which is getting worse.

    Four years after not being on the drugs I was put on another statin I’d not had before [as a trial to see if “this one” might work without side-effects!] and on the 13th. day was taken by ambulance to hospital. Again, no doctor could explain my problem. The following day I had another severe problem, but the problem was one I recognized because that is the one set of side-effects I have and is my permanent side-effect and then I knew it was the drug that had caused the severe side-effect that took me to the hospital the day before.

    It seems to me that there needs to be more guidelines when doing random clinical trials. I also strongly believe there needs to be mandatory follow-up trials for those taking statin drugs or any class of drug that is expected by be taken for life!

    My protocol would be most helpful.”

    Thought I’d add this in case anyone else has queries about statin drugs or any other class of drug they take or have taken and never had a satisfactory answer provided them for the problems they developed after taking a drug over a period of time. I’d be happy to talk to you.

    Elizabeth Rankin BScN

  • Elizabeth Rankin BScN says:

    The question of the week: Is (it) the surgical checklist or (the) safety culture that matters, to reduce surgical complications?

    After studying THE SCIENCE OF PATIENT SAFETY offered by Johns Hopkins under the tutelage of Dr. Peter Pronovost M.D., author, “Smart Hospitals, Safe Patients,” and Dr. Cheryl Dennison-Himmelweiss, I can say that CREATING BOTH A CULTURE OF SAFETY AND USING PROPERLY CREATED./DESIGNED CHECK LISTS APPROPRIATE TO THE SETTING is absolutely needed. One won’t happen without the other.
    For more information I urge readers to explore the program details. Dr. Pronovost can be reached at Johns Hopkins Hospital: ppronovost@jhmi.edu

    Elizabeth Rankin BScN

  • Alex says:

    How about parents and grandparents of science? #unnecessarygendering

    • Amol Verma says:

      Hi Alex,
      Thanks for your comment. The title was drawn from the spontaneous banter that occurred in the podcast. We were talking about male scientists (Gawande and Leape), and hence ‘fathers’ and ‘grandfathers’. We appreciate and share you concern about gender sensitivity.

  • Bharti Verma says:

    Surgical checklist Vs. safety and surgical complications: I think the surgical check lists were devised to improve surgical safety. However, tick marks on surgical check lists are likely not sufficient to assure surgical safety. Thanks for a well rounded and unbiased presentation on all three topics.

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