The Pain of the Timeout

Reference as : Robbins RA. The pain of the timeout. Southwest J Pulm Crit Care 2011:2:102-5. (Click here for a PDF version)

An article in the Washington Post entitled “The Pain of Wrong Site Surgery” (1) caught my eye earlier this month. In 2004 the Joint Commission of Healthcare Organizations (Joint Commission or JCAHO), prompted by media reports of wrong site surgery, mandated the “universal protocol” or surgical timeout. These rules require preoperative verification of correct patient, correct site, marking of the surgical site and a timeout to confirm everything just before the procedure starts. In announcing the rules, Dr. Dennis O’Leary, then president of the Joint Commission, stated “This is not quite ‘Dick and Jane,’ but it’s pretty close,” and that the rules were “very simple stuff” to prevent events such as wrong site or patient surgery which are so egregious and avoidable that they should be “never events” because they should never happen. During the following years different components have been added to the timeout and the timeout has been extended to cover most procedures in the hospital.

However, the article goes on to state that “some researchers and patient safety experts say the problem of wrong-site surgery has not improved and may be getting worse, although spotty reporting makes conclusions difficult”. Last year 93 cases were reported to the Joint Commission in 2009 compared to 49 in 2004. Furthermore the article states that reporting data from Minnesota and Pennsylvania, two states that require reporting have not shown a decrease over the past few years.

The reason for the increasing incidence of wrong site or wrong patient operations is not totally clear. Dr. Mark Chassin, who replaced O’Leary as president of the Joint Commission in 2008, said he thinks such errors are growing in part because of increased time pressures. Preventing wrong-site surgery also “turns out to be more complicated to eradicate than anybody thought,” he said, because it involves changing the culture of hospitals and getting doctors — who typically prize their autonomy, resist checklists and underestimate their propensity for error — to follow standardized procedures and work in teams. Dr. Peter Pronovost, medical director of the Johns Hopkins Center for Innovation in Quality Patient Care, echoed those sentiments by suggesting that doctors only pay lip service to the rules. Studies of wrong-site errors have consistently revealed a failure by physicians to participate in a timeout. Dr. Ken Kizer, former Undersecretary at the Department of Veterans Affairs and President of the National Quality Forum, advocates reporting doctors to a federal agency so wrong site surgery or patient cases can be investigated and the results publicly reported.

Several points made in the article need to be clarified

1. The reason that it is unclear whether the present Joint Commission mandates actually prevents wrong site or patient surgery is that no data was systematically collected prior to implementation of the timeout to ensure that it works and no data has been collected since implementation. As with most bureaucracies, the Joint Commission emphasis has been more on ensuring compliance rather than studying the effectiveness of an intervention.
2. Although no one condones wrong site or patient surgery, it is fortunately relatively rare. Stahel et al. (2) reported 132 wrong-site and wrong-patient cases during a 6 and a half year period by over 5000 physicians. They found only one death which was attributed to a wrong-sided chest tube placement for respiratory failure (2). This is questionable because a wrong sided chest tube does  not necessarily result in a patient’s death (3). Another 43 patients had significant harm from their wrong site or patient procedure and are listed below (Table 1). 
3. Based on the above, occurrence of these wrong site or patient operations would appear to be mostly in the operating room. The surgeon often enters the operating room after the patient is under general anesthesia, prepped and draped. Unless the surgeon saw the patient in the operating room prior to anesthesia and marked the operative site, it would not be possible for the surgeon to know that the correct site and patient are present.  It is not stated in the article how many of the operations reported had a timeout or the surgeon labeled the operative site but it is implied in the article that it was few. The first author of the manuscript, Philip Stahel, an orthopedic surgeon from the University of Colorado, explained the results stating that “many doctors resent the rules, even though orthopedists have a 25 percent chance of making a wrong-site error during their career….” Dr. John R. Clarke, a professor of surgery at Drexel University College of Medicine and clinical director of the Pennsylvania Patient Safety Authority, agreed stating, “There’s a big difference between hospitals that take care of patients and those that take care of doctors…The staff needs to believe the hospital will back them against even the biggest surgeon.”
4. Dr. Peter Pronost extends this sentiment by stating “Health care has far too little accountability for results. . . . All the pressures are on the side of production; that’s how you get paid.” He adds that increased pressure to turn over operating rooms quickly has trumped patient safety, increasing the chance of error.

I would offer some suggestions:

1. Focus should be on the operating room since this is where most of the wrong site or wrong patient procedures occur. I’m frustrated by the unnecessary timeouts that occur during bronchoscopy. For example, where the patient is known to me, enters the bronchoscopy suite awake and alert, and the biopsies are done under direct vision, fluoroscopic or CT guidance there is no real chance of wrong site or patient surgery. Similar procedures do not need a timeout. The Joint Commission needs to recognize this and stop its “one size fits all” approach.
2. What is needed is data. Right now it is unclear whether a timeout makes any difference. A scientific valid study of the timeout procedure is needed but not observational studies, designed only to create political statistics that a timeout works. The Joint Commission and other regulatory health care organizations need to break the habit of mandating interventions based on no or little evidence.
3. The Joint Commission mandates have apparently had little impact on reducing wrong site or patient operations. Making further mandates would seem to offer little hope. If, as Dr. Chassin believes, that time is the issue, adding more items to a checklist will not likely improve the problem and probably make it worse.
4. If time is the culprit in the operating room then simplifying the process as much as possible might be useful. I have been told of one operating room in Phoenix where a timeout is so extensive that it can take up to 30 minutes. Marking the site by the surgeon should be mandatory and a simplified, standardized checklist read and confirmed by the nurse, anesthesiologist and/or surgeon will hopefully simplify the timeout and enhance data collection.
5. I would agree with both Provost and Kizer that accountability needs to be present. However, Kizer’s idea of a Federal repository may be ineffectual at improving outcomes. Witness the National Practioner Databank which has done nothing to improve health care and blames only physicians for lapses in healthccare. It would seem that many of the physicians quoted above do the same, i.e., blame only the doctors. Dr. Chassin suggests a team approach to medicine, i.e., an operating room team. I agree but it seems inconsistent to refer to a team approach and only hold the physicians accountable. Instead, I would suggest a mandatory reporting system with a free, transparent and searchable data base available to everyone. This data bank should report not only the surgeon(s) but everyone else in the operating room. Hospitals also need to be identified so that they cannot deflect their accountability by blaming surgeons while emphasizing operating room turn around over patient safety. This means not only the hospital but the CEO or administrator needs to accept some responsibility. The CEO or administrator controls the finances and often touts their “accountability”. It is time to put some teeth to that claim. Such a transparent data base will not only allow patients to check on surgeons but also hospitals, nurses, and anesthesiologists. Furthermore, it will allow the healthcare providers to check on each other as well as substandard hospitals and their administrators.

Richard A. Robbins, M.D.

Editor, Southwest Journal of Pulmonary and Critical Care

References

1. Boodman SG. The pain of wrong site surgery. Washington Post. Published June 20, 2011. Available at URL http://www.washingtonpost.com/national/the-pain-of-wrong-site-surgery/2011/06/07/AGK3uLdH_story.html (accessed 6-21-11).
2. Stahel PF, Sabel AL, Victoroff MS, Varnell J, Lembitz A, Boyle DJ, Clarke TJ, Smith WR, Mehler PS. Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences. Arch Surg.2010;145:978-84
3. Singarajah C, Park K. A case of mislabeled identity. Southwest J Pulm Crit Care 2010;1:22-27.

The opinions expressed in this editorial are the opinions of the author and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona Thoracic Society.

Guidelines, Recommendations and Improvement in Healthcare

“You will never understand bureaucracies until you understand that for bureaucrats procedure is everything and outcomes are nothing.”-Thomas Sowell

Reference as: Robbins RA, Thomas AR, Raschke RA. Guidelines, recommendations and improvement in healthcare. Southwest J Pulm Crit Care 2011;2:34-37. (Click here for PDF version)

In the February, 2011 Critical Care Journal Club two articles were reviewed that dealt with Infectious Disease Society of America (IDSA) guidelines (click here for Critical Care Journal Club). The first by Lee and Vielemeyer (1) reviewed the evidence basis for the 4218 IDSA recommendations and found that only 14% were based on Level 1 evidence (data from >1 properly randomized controlled trial). The graph summarizing the data in Figure 1 of the manuscript is exemplary in its capacity to communicate the weak evidence basis for many of the IDSA recommendations.

A second study by Kett et al. (2) examined the outcomes when the American Thoracic Society (ATS)/IDSA therapeutic guidelines for management of possible multidrug-resistant pneumonia were followed. The authors found a 14% difference in survival when the guidelines were followed, but surprisingly, the survival was better if the guidelines were not followed. Dr. Kett and colleagues are to be congratulated for their candor in reporting their retrospective analysis of empirical antibiotic regimens for patients at risk for multidrug-resistant pathogens. The ATS/IDSA guidelines (3) state that “combination therapy should be used if patients are likely to be infected with MDR pathogens (Level II or moderate evidence that comes from well designed, controlled trials without randomization…”. However, the ATS/IDSA guidelines go on to state, “No data have documented the superiority of this approach compared with monotherapy, except to enhance the likelihood of initially appropriate empiric therapy (Level I evidence…from well conducted, randomized controlled trials)” (4).

The problem comes with the interpretation and implementation of these and other guidelines. Some, usually inexperienced clinicians or nonclinicians, seem to believe that following any set of guidelines will enhance the “quality” of patient care. Not all guidelines or studies are created equally. Some are evidence-based, important, correct and likely to make a real difference. These usually come from professional societies and are authored by well-respected, experts in the field whose goal is improve patient outcomes. As suggested by Kett’s article even these guidelines may not be infallible. Other guidelines are not evidence-based, unimportant, incorrect and can border on the trivial. These are often authored by nonprofessional, nonexperts to create a “political statistic” (5) rather than improve patient care.

If some guidelines are bad, how can those be separated from the good? We suggest 5 traits of quality guidelines: 

1. The guideline’s authors are identified and are well-respected, experts in the field appropriate to the guideline.
2. The authors identify potential conflicts of interest.
3. The evidence is graded and supported by references to relevant scientific literature.
4. The guidelines state how they selected and reviewed the references on which the guidelines are based.
5. After completion, the guidelines are reviewed by a group of reasonably knowledgeable individuals (for example the IDSA Board of Directors) that can be identified and are willing to risk the reputation of themselves and their organization on the guidelines.

Even with the above safeguards guidelines may be non-evidence-based, unimportant, incorrect or trivial, and if so, implementation may be at best a waste of resources, or at worst harmful to patient care. We ask that guideline writing committees show restraint in authoring documents which are little more than their opinions. Not every medical question, especially the trivial and the unimportant, needs a guideline. Furthermore, we would ask an endorsement from professional organizations that only guidelines based on randomized clinical trials be given a strong recommendation. As pointed out by Lee and Vielemeyer (1) only 23% of the IDSA guidelines were supported by randomized trials while 37% of strong recommendations were supported only by opinion or descriptive studies.

IDSA states on their guidelines website, “It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to the guidelines listed below to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances” (6). Despite this and other disclaimers, guidelines often take on a life onto themselves, frequently carrying the weight of law, regardless of the supporting evidence. We call for professional societies to end the practice of strongly recommending those guidelines based on opinion. Such practices have led and will continue to lead to systematic patient harm. Only those guidelines based on strong evidence should be given a strong recommendation. If the professional societies believe an opinion on a particular issue is appropriate despite a lack of evidence, a different designation such as recommendation or suggestion should be used to clearly separate it from a guideline.  The term guideline should be reserved for those statements that are evidence-based, important, and almost certainly correct and can make a real difference to patients.

Richard A Robbins MD, Allen R Thomas MD, and Robert A Raschke MD

References

1. Lee DH, Vielemeyer O. Analysis of overall level of evidence behind infectious diseases society of America practice guidelines. Arch Intern Med. 2011;171:18-22.
2. Kett DH, Cano E, Quartin AA, Mangino JE, Zervos MJ, Peyrani P, Cely CM, For KD, Scerpella EG, Ramirez JA. Implementation of guidelines for management of possible multidrug-resistant pneumonia in intensive care: an observational, multicentre cohort study.  Lancet Infect Dis 2011 Jan 19. [Epub ahead of print].
3. American Thoracic Society, Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 2005;171:388–416.
4. Paul M, Benuri-Silbiger I, Soares-Weiser K, Liebovici L. Beta-Lactam monotherapy versus beta-lactam–aminoglycoside combination therapy for sepsis in immunocompetent patients: systematic review and metaanalysis of randomised trials. BMJ, doi:10.1136/bmj.38028.520995.63 (published March 2, 2004). Available at URL http://bmj.bmjjournals.com/cgi/reprint/bmj.38028.520995.63v1.pdf?ck_nck (accessed February 11, 2011).
5. Churchill, Winston. London, UK. 1945. as cited in The Life of Politics, 1968,  Henry Fairlie, Methuen, pp. 203-204.
6. Infectious Disease Society of American. Standards, Practice Guidelines, and Statements Developed and/or Endorsed by IDSA. Available at URL http://www.idsociety.org/content.aspx?id=9088 (accessed February 12, 2011).

COPD, COOP and BREATH at the VA

Reference as: Robbins RA. COPD, COOP and BREATH at the VA. Southwest J Pulm Crit Care 2011;2:27-28. (Click here for PDF version)

The February 2011 Pulmonary Journal Club reviews a study by Rice and colleagues (1) of high-risk COPD patients (click here for Pulmonary Journal Club). This review was authored by Kevin Park who also authored an ACP Journal Club review (2). In Rice’s study a single educational session, an individualized care plan, and monthly case-manager telephone calls, resulted in a 41% decrease in hospitalizations and emergency room visits and a nonsignficant trend toward decreased mortality.

Rice’s study was supported and conducted in the Veterans Integrated Service Network (VISN) 23 (Minnesota, Iowa, Nebraska and the Dakotas). The COPD patients in this study were recruited and followed primarily using the VA computer system. The study represents a potential model of data-based management leading to improved patient outcomes. The authors; Robert Petzel MD, then VISN 23 Director (now Veterans Healthcare Administration Undersecretary); and Janet Murphy, then VISN Primary Care Service Line CEO (now VISN 23 Director) are to be congratulated for their insight into conducting and supporting this study. Unfortunately, many VA administrators are not as far-sighted and restrict or place unreasonable obstacles to investigators’ access to VA data. VA administrators at the National, VISN and local levels should be encouraged to follow Dr. Petzel’s and Ms. Murphy’s lead in utilizing the VA computer system to conduct studies such as Rice’s.

At the time this study was ongoing, a similar study was also being conducted through the VA Cooperative studies program known as Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH) trial (3). Like Rice’s study, the BREATH study incorporated self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to COPD. However, in contrast to Rice’s study, the patients in BREATH had all been hospitalized within the past year and likely had more severe underlying COPD. Although this multi-center, randomized study which was planned for 5 years was on target for recruitment (425 subjects), it was cancelled after about 2 years. The reasons for the cancellation were never shared with the site investigators (of which this editor was one). It seems unlikely that a behavior study such as BREATH would result in a significant medically adverse outcome to mandate study cancellation. However, if such an outcome occurred in BREATH, it would throw the largely positive results of Rice’s study into question.

Richard A. Robbins MD, Editor, SWJPCC

References

1. Rice KL, Dewan N, Bloomfield HE, Grill J, Schult TM, Nelson DB, Kumari S, Thomas M, Geist LJ, Beaner C, Caldwell M, Niewoehner DE. Disease Management Program for Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Am J Respir Crit Care Med 2010;182:890-6.

2. Park K, Robbins RA. ACP Journal Club: A COPD disease management program reduced a composite of hospitalizations or emergency department visits.  ACP Journal Club 2011;154:JC3-5.

3. http://clinicaltrials.gov/ct/show/NCT00395083?order=1. Accessed 2/9/2011.

SWJPCC: The first three months

Reference as: Robbins RA. SWJPCC: The first three months. Southwest J Pulm Crit Care 2011;2:1-2. (click here for PDF)

During the Arizona Thoracic Society meeting on 1-18-11 a report was given to our sponsoring organization regarding the progress of the SWJPCC. Below is a synopsis of the report along with a link to a PowerPoint slide presentation at the end.

Planning for the journal began in August, 2010 with discussions at the Arizona Thoracic Society.  Several decisions were made at that meeting: 1. To proceed with the creation of an on-line journal; 2. To adopt the name Southwest Journal of Pulmonary and Critical Care; 3. To emphasize clinical medicine; 4. To peer review all manuscripts; and 5. To accept no sponsorship from organizations with a potential conflicts of interest such as hospitals, pharmaceuticals companies, etc. unless it was clear that such sponsorship was unrestricted.  During September and October, 2010 a web site manager was hired, Eric Reece from Bethesda, MD; the domain registered; a website created; and editorial board established. The first posting was an editorial on October 16^th, 2010 and our first manuscript was submitted on November 7^th, 2010.  This manuscript was peer reviewed, revised, and posted on November 11^th 2010. During 2010 we posted 8 articles: 2 in Imaging; one in Proceedings of the Arizona Thoracic Society; one Pulmonary Journal Club; two Critical Care Journal Clubs; one Sleep Journal Club; and one Editorial.  At the suggestion of Stuart Quan, a member of the editorial board, volumes and page numbers were assigned to each publication for ease of reference and the reference is given under the title of each posting.

As of 1-24-11 we have had 1043 page views for an average of 35/day.  One hundred and forty-three unique visitors have visited the site for an average of 4 unique visitors/day.  Hopefully, this will continue to grow.

A special thanks to our authors and reviewers, the latter are listed below. Without their help SWJPCC could not function:  Mike Gotway, Manny Mathew, Vijay Nair, Allen Thomas, and Lew Wesselius.

For the future, we are planning a short synopsis of each Arizona Thoracic Society meeting which can be found in a new section titled "Arizona Thoracic Society Notes" under "Proceedings of the Arizona Thoracic Society" on the left hand portion of the home page. We hope to soon post material authored outside the Phoenix area and to proceed with full-length manuscript publications under the Pulmonary, Critical Care and Sleep headings at the top of the home page.

Richard A. Robbins, M.D. , Editor, SWJPCC

Powerpoint Slide Set

Why Start A New Pulmonary/Critical Care Journal?

Reference as: Robbins RA. Why start a new pulmonary/critical care journal? Southwest J Pulm Crit Care 2010:1:1-2. (Click here for PDF Version)

With apologies to Paul McCartney, “You'd think that people would have had enough of [pulmonary and critical care journals]. But I look around me and I see it isn't so” (1). With the inception of the Southwest Journal of Pulmonary and Critical Care (SWJPCC) we have several goals, not adequately filled by the present pulmonary and critical care publications.

First, the primary goal of the SWJPCC is pulmonary and critical care medicine fellow education. The American College of Graduate Medical Education has placed increasing requirements for clinical education in post-graduate medical education while simultaneously increasing the requirements for scholarly activity for fellows and faculty, yet restricting fellow work hours (2). It seems that these conflicting goals are unrealistic, unless clinical scholarly activity can be incorporated into a training program. In starting the SWJPCC, we hope to fulfill the scholarly needs of both fellows and faculty while emphasizing clinical medicine through the publication of such time honored activities as case presentations and reviews of the literature.

Second, peer-reviewed journals send articles out for review. While we will do the same, we have certain expectations of our reviewers. Unfortunately, reviewers are not always carefully chosen.  Sometimes inexperienced reviewers, feeling the need to establish themselves, indulge their own sense of self-importance by becoming “nagging nabobs of negativism” (3) demanding the answer to “the ultimate question of life, the universe and everything” (4) before a manuscript will see the light of publication. While emphasizing the highest medical journal standards, we realize that fellow and faculty time is limited and we hope to be reasonable regarding expectations of our authors.

Third, there has been a trend in some journals towards publishing articles emphasizing the “short-comings” of physicians while emphasizing the virtues of identifying these “faults”. For example, the New England Journal of Medicine published an article from a health regulatory organization (the Joint Commission), touting improved healthcare through administration of the pneumococcal vaccine to adults (5). This article implied that physicians who did not provide this vaccination to their adult patients were delinquent, and the Joint Commission’s efforts “corrected” this deficiency. However, previous publications have shown that pneumococcal vaccination in older adults results in a slight increase in the risk for hospitalization, but does not decrease mortality nor the risk for pneumonia (6), findings largely confirmed by a recent meta-analysis (7). Publication of articles substituting politics or opinions (especially when they are self-serving) for evidence-based care is not part of the mission of the SWJPCC.

Last, the SWPCC aspires to be a resource for practicing physician education, emphasizing case presentations, clinical articles, review articles, imaging, and journal clubs. We hope this journal will be useful for busy clinicians, assisting them in better serving the needs of their patients while also providing insight regarding practice matters of interest to the pulmonary and critical care medicine community.

With that, we begin.

Richard A. Robbins, M.D. on behalf of the Editors

References

1. McCartney, Paul. “Silly Love Songs”. Wings at the Speed of Sound. Palorphone/EMI, 1976.
2. http://www.acgme.org/acWebsite/nav/Pages/navPDcoord.asp
3. Agnew, Spiro. San Diego, CA. 1970.
4. Adams, Douglas. Life, the Universe and Everything. ISBN 0-330-26738-8.
5. Jha AK, Li Z, Orav EJ, Epstein AM. Care in U.S. hospitals--the Hospital Quality Alliance program. N Engl J Med. 2005;353:265-74.
6. Jackson LA, Neuzil KM, Yu O, Benson P, Barlow WE, Adams AL, Hanson CA, Mahoney LD, Shay DK, Thompson WW; Vaccine Safety Datalink. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N Engl J Med. 2003;348:1747-55.
7. Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ. 2009;180:48-58.