Breaking the Guidelines for Better Care

Two events happened this past week that inspired this editorial. First, on Wednesday morning I read the editorial titled “Breaking the Rules for Better Care” by Don Berwick et al. in JAMA (1). Berwick reports a survey of about 40 hospitals done by The Institute of Healthcare Improvement (IHI). The survey asked the question “If you could break or change any rule in service of a better care experience for patients or staff, what would it be?”. The answers were not surprising. Most centered on annoying hospital rules such as visiting hours, not waking patients, correct HIPPA interpretation, and eliminating the 3-day rule. Although these are correct, in the whole they have minimal effect on healthcare. Other suggestions more likely to improve patient care included improving access, reducing wait times and earlier patient mobility. From the suggestions, it seems likely that most were from administrators. In the editorial Berwick decried, “Habits embedded in organizational behaviors, based on misinterpretations and with little to no actual foundation in legal, regulatory, or administrative requirements”. He goes on to say, “Health care leaders may be well advised to ask their clinicians, staffs, and patients which habits and rules appear to be harming care without commensurate benefits and, with prudence and circumspection, to change them.” As a clinician, I thoroughly agree with both of Berwick’s points.

Later that afternoon, I listened to a lecture by Clement Singarajah on sepsis guidelines. He reviewed the severe sepsis bundles promoted by the Surviving Sepsis Campaign and IHI, the latter being Berwick’s organization who wrote the editorial noted above (Table 1) (2,3).

Table 1.  Severe Sepsis Bundles.

The Severe Sepsis 3-Hour Resuscitation Bundle contains the following elements, to be completed within 3 hours of the time of presentation with severe sepsis:

• Measure Lactate Level
• Obtain Blood Cultures Prior to Administration of Antibiotics
• Administer Broad Spectrum Antibiotics
• Administer 30 mL/kg Crystalloid for Hypotension or Lactate ≥4 mmol/L

The 6-Hour Septic Shock Bundle contains the following elements, to be completed within 6 hours of the time of presentation with severe sepsis:

• Apply Vasopressors (for Hypotension That Does Not Respond to Initial Fluid Resuscitation to Maintain a Mean Arterial Pressure (MAP) ≥65 mm Hg)
• In the Event of Persistent Arterial Hypotension Despite Volume Resuscitation (Septic Shock) or Initial Lactate ≥4 mmol/L (36 mg/dL):
  • Measure Central Venous Pressure (CVP)
  • Measure Central Venous Oxygen Saturation (ScvO2)
• Remeasure Lactate If Initial Lactate Was Elevated

We carefully reviewed each of the metrics, and concluded most were non-evidence based, outdated, or contradicted by more recent and better trials. The only exception was early antibiotic administration. Most of us reaffirmed our belief in the germ theory and felt that early administration of the correct antibiotics was probably mostly evidence-based and reasonable (4).

Is it possible that most of the metrics in the bundle are merely a waste of time as we concluded or could some be harmful? First, a recent meta-analysis examined a conservative fluid strategy in sepsis compared with a liberal strategy (the goal-directed therapy as advocated by the sepsis bundles) (5). Although there was no change in mortality, a conservative strategy resulted in increased ventilator-free days and reduced length of ICU stay. The meta-analysis concluded that the studies were underpowered to show a mortality benefit. Second, most of us had experienced delays in initiating antibiotics, the only guideline that makes a difference, while waiting for blood cultures to be drawn. None of us knew data that drawing blood cultures makes a difference in patient outcomes.

Berwick recommended asking clinicians which rules may be harming care. Rather than chiding others to do something, a good place to start might be IHI’s sepsis guidelines. The issue of continued support for non-evidence based or outdated guidelines points out the rigid dichotomy between self-delusional beliefs and science. Many (some would say most) guidelines are based on opinions and not science (6). Healthcare would be better if groups such as the Surviving Sepsis Campaign, IHI and the Centers for Medicare and Medicaid Services would follow their own advice and not burden healthcare providers with non-evidence based guidelines. Instead, they should only issue guidelines after carefully conducted, randomized, controlled trials establish a guideline rather than mandating the self-delusional beliefs of a few.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Berwick DM, Loehrer S, Gunther-Murphy C. Breaking the rules for better care. JAMA. 2017 Jun 6;317(21):2161-2. [CrossRef] [PubMed]
2. Surviving Sepsis Campaign. Updated bundles in response to new evidence. Available at: http://www.survivingsepsis.org/SiteCollectionDocuments/SSC_Bundle.pdf (accessed 6/9/17).
3. Institute for Healthcare Improvement. Severe sepsis bundles. Available at: http://www.ihi.org/resources/Pages/Tools/SevereSepsisBundles.aspx (accessed 6/9/17).
4. Seymour CW, Gesten F, Prescott HC, et al. Time to treatment and mortality during mandated emergency care for sepsis. N Engl J Med. 2017 Jun 8;376(23):2235-44. [CrossRef] [PubMed]
5. Silversides JA, Major E, Ferguson AJ, et al. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. [CrossRef] [PubMed]
6. 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. [CrossRef] [PubMed]

Cite as: Robbins RA. Breaking the guidelines for better care. Southwest J Pulm Crit Care. 2017;14(6):285-7. doi: https://doi.org/10.13175/swjpcc072-17 PDF 

Remembering the 100,000 Lives Campaign

Earlier this week the Institute for Healthcare Improvement (IHI) emailed its weekly bulletin celebrating that it has been ten years since the end of the 100,000 Lives Campaign (Appendix 1). This was the campaign, according to the bulletin, that put IHI on the map. The Campaign started at the IHI National Forum in December 2004, when IHI's president, Don Berwick, announced that IHI would work together with nearly three-quarters of the US hospitals to reduce needless deaths by 100,000 over 18 months. A phrase borrowed from political campaigns became IHI's cri de coeur: “Some is not a number. Soon is not a time.”

The Campaign relied on six key interventions:

• Rapid Response Teams
• Improved Care for Acute Myocardial Infarction
• Medication Reconciliation
• Preventing Central Line Infections
• Preventing Surgical Site Infections
• Preventing Ventilator-Associated Pnemonia [sic]

According to the bulletin, the Campaign’s impact rippled across the organization and the world. IHI listed some of the lasting impacts:

• IHI followed with the 5 Million Lives Campaign – a campaign to avoid 5 million instances of harm.
• Don Berwick and Joe McCannon brought lessons from leading the Campaigns to Centers for Medicare and Medicaid Services (CMS) and the Partnership for Patients.
• Related campaigns were launched in Canada, Australia, Sweden, Denmark, UK, Japan, and elsewhere.

IHI's profile definitely grew. One indicator tracked by IHI was media impressions, which rose to 250 million in the final year of the Campaign. IHI even put a recreational vehicle on the streets to promote their Campaign (Appendix 1). Campaign Manager Joe McCannon was on CNN to discuss the results of the Campaign.

How did IHI achieve such remarkable results in saving patients' lives? The answer is they did not. Review of the evidence basis for at least 3 of these interventions revealed fundamental flaws (1). The largest trial of rapid response teams failed to result in any improvements and the interventions to prevent central line infections and ventilator-associated pneumonia were non- or weakly-evidenced based and unlikely to improve patient outcomes (2-4). The poor methodology and sloppy estimation of the number of lives saved were pointed out in the Joint Commission’s Journal of Quality and Safety by Wachter and Pronovost (5). IHI failed to adjust their estimates of lives saved for case-mix which accounted for nearly three out of four "lives saved." The actual mortality data were supplied to the IHI by hospitals without audit, and 14% of the hospitals submitted no data at all. Moreover, the reports from even those hospitals that did submit data were usually incomplete. The most striking example is that the IHI was so anxious to announce their success that the data was based on only 15 months of data. The final three months were extrapolated from hospitals’ previous submissions. Important confounders such as the background of declining inpatient mortality rates were ignored. Even if the Campaign "saved" lives, it would be unclear if the Campaign had anything to do with the reduction (5). Buoyed by their success, the IHI proceeded with the 5,000,000 Lives Campaign (6). However, this campaign ended in 2008 and was apparently not successful (7). Although IHI promised to publish results in major medical journals, to date no publication is evident.

A fundamental flaw in the logic behind the 100,000 Lives Campaign was that preventing a complication, for example an infection, results in a life saved. Many of our patients in the ICU have an infection as their life-ending event. However, the patients are often in the ICU because their underlying disease(s). In many instances their underlying disease(s) such as cancer, heart disease, or chronic obstructive pulmonary disease are so severe that survival is unlikely. It is akin to poisoning, stabbing, shooting and decapitating a hapless victim and saying that had the decapitation been prevented, survival was assured. IHI also assumed that the data was collected completely and honestly. However, the data was incomplete as pointed out above and the honesty of self-reported hospital data has also been called into question (8).

The bulletin correctly pointed out that Berwick did carry this political campaign with its sloppy science to Washington as CMS' administrator. Under Berwick's leadership, CMS would announce a campaign, have the hospitals collect the data, extrapolate the mortality or other benefit, and prepare a press release. This scheme continues until this day (9). CMS further confounded the data by providing financial incentives to hospitals, often resulting in bonuses to hospital executives, making the data further suspect. Certainly, CMS would not examine the hospital data with skepticism because the success of their campaign was in their own political best interest.

The 100,000 Lives Campaign also had one other outcome. It made many of us who believe in the power of evidence-based medicine to enrich patients' lives to be suspicious of these political maneuvers. To rephrase a well-known quote, "The first victim of politics is the truth". These campaigns certainly financially benefit hospitals and their administrators and politically benefit bureaucrats, but whether they benefit patients is questionable. The bulletin from IHI should be viewed for what it is, a political self-promotion to rewrite the failed history of the 100,000 Lives Campaign.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]
2. Hillman K, Chen J, Cretikos M, Bellomo R, Brown D, Doig G, Finfer S, Flabouris A; MERIT study investigators. Introduction of the medical emergency team (MET) system: a cluster-randomised controlled trial. Lancet. 2005;365(9477):2091-7. [CrossRef] [PubMed]
3. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care 2012;4:163-73.
4. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care 2011;3:40-8.
5. Wachter RM, Pronovost PJ. The 100,000 Lives Campaign: A scientific and policy review. Jt Comm J Qual Patient Saf. 2006;32(11):621-7. [PubMed]
6. Institute for Healthcare Improvement. 5 million lives campaign. Available at: http://www.ihi.org/about/Documents/5MillionLivesCampaignCaseStatement.pdf (accessed 6/24/16).
7. DerGurahian J. IHI unsure about impact of 5 Million campaign. Available at: http://www.modernhealthcare.com/article/20081210/NEWS/312109976 (accessed 6/24/16).
8. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med. 2012;157:305-12. [CrossRef] [PubMed]
9. AHRQ Report: Hospital-Acquired Conditions Continue To Decline, Saving Lives and Costs. Dec 1, 2015. Available at: http://www.ahrq.gov/news/newsletters/e-newsletter/496.html#1 (accessed 6/24/16).

Cite as: Robbins RA. Remembering the 100,000 lives campaign. Southwest J Pulm Crit Care. 2016;12(6):255-7. doi: http://dx.doi.org/10.13175/swjpcc058-16 PDF 

What's Wrong with Expert Opinion?

In this month's Pulmonary Journal Club Dr. Mathew reviews an article by Feuerstein et al. (1) from Beth Israel Deaconess Medical Center and Harvard Medical School published in the Mayo Clinic Proceedings (2). The authors reviewed  the evidence basis for 153 interventional guidelines including 2 from the American College of Chest Physicians and the American Thoracic Society. Of the 3425 recommendations reviewed, 11% were supported by level A evidence, 42% by level B, and 48% by level C. These numbers are very close to the results published by Lee and Vielemeyer (3) for the Infectious Disease Society of America guidelines where only 14% of the guidelines were based on level A evidence and 55% by level C.

So what's wrong with the majority of guidelines based on expert opinion? After all, these are experts in the field and it can be argued that most of these opinions are probably right and that physicians want guidance from the experts. The problem is that they are opinion and sometimes wrong. When they are wrong the potential exists for causing large and devastating harm to patients. This has become an increasingly frequent. As examples:

1. Tight control of glucose in the intensive care unit which according to the largest and best done multi-center trial, causes a 14% increase in ICU mortality (4).
2. Xigris (activated protein C) for adults with septic shock which caused an increase in bleeding and a small but insignificant increase in mortality leading to withdrawal of the drug (5).
3. Perioperative beta blockers which Cole and Francis calculated caused an excess mortality of 800,000 deaths in Europe over the past 5 years (6).
4. Fluid boluses for in African children with severe infection which caused a 49% increase in mortality (7).

Guideline interventions leading to a decrease in mortality are rare and there are no carefully-done, randomized trials of guidelines that have shown a 14% decrease in mortality in the ICU, saved 800,000 lives or improved mortality by 49% in severe infection. So the question arises why were these guidelines put in place, and in some cases, why do they persist? In an editorial which was to be published on January 21 in the European Heart Journal, Cole and Francis raised the possibility that the responsibility for misconduct lies not just with misguided researchers but also the institutions and the institutional leaders that provide uncritical support to research factories. Further, they discussed the role of journal editors and, even, journal readers. However, the two editorials were withdrawn about an hour after the first was published.

It appears that some guidelines have become a cesspool of conflicts of interest (COI). As pointed out in the article Dr. Mathew reviewed, 62% of the guidelines failed to comment on COIs; when disclosed, 91% of guidelines reported COIs. In a egregious example of COI influencing guidelines, the research done by Don Poldermans on perioperative beta blockers has been discredited and he has been dismissed from his university (6). Poldermans also chaired the guideline writing committee for the European Society of Cardiology on perioperative beta blockers. The previously mentioned editorials by Cole and Francis discussing Poldermans' research and its implications were retracted by the European Heart Journal. Why the journal chose to retract the editorials is unclear but one wonders if threats of loss of advertising or lawsuits from pharmaceutical company lawyers may have had something to do with it.

The story of Xigris is a further example of COIs gone amuck (8,9). Eli Lilly, the manufacturer of Xigris, provided a $1.8 million grant to fund a task force on “Values, Ethics and Rationing in Critical Care” reportedly to further the concept that it was unethical to withhold Xigris from septic patients. Eli Lilly provided over 90% of the funding for The Surviving Sepsis Campaign, launched in October 2002 to create guidelines for the treatment of sepsis.  Many of the international experts who formulated the recommendations of this group had significant outside financial relationships with Eli Lilly. As subsequent prospective trials began to raise important concerns regarding the safety and efficacy of Xigris, these concerns were repeatedly and conspicuously absent from published recommendations of the Surviving Sepsis campaign. In 2004, Eli Lilly started a program of offering unrestricted grants to institutions for implementing Surviving Sepsis Campaign patient management bundles.

The leaders in healthcare from the Institute of Healthcare Improvement (IHI) to the local leaders often have substantial COIs combined with a weak backgrounds in medicine and research. For example, the evidence basis for IHI's 100,000 Lives Campaign was weak (10). However, the non-peer reviewed press releases allowed IHI to receive a landslide of “brand recognition” which undoubtedly led to substantial new revenues and philanthropic dollars (10). Locally, many CEOs and managers are operating under incentive systems that tie bonuses to guideline compliance. One chairman of medicine, asked me, "Why is my bonus tied to how many pneumococcal vaccines are administered?". Others may not be so willing to question the hand that feeds them.

It is unclear why professional societies and medical boards have been so silent about guidelines with a weak evidence base. Both were created to protect the public's health. Practice of medicine and nursing has been restricted to those with appropriate education and licensure who accept the responsibility for their actions. The guideline process can allow the unscrupulous to side step these regulations and responsibility, sometimes for their own financial gain. If the medical societies and medical boards are unwilling to intervene, perhaps a federal agency or regulator not vulnerable to such concerns might be better suited to regulate the implementation of guidelines.

Richard A. Robbins, MD*

Editor

References

1. Feuerstein JD, Akbari M, Gifford AE, Hurley CM, Leffler DA, Sheth SG, Cheifetz AS. Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines. Mayo Clin Proc. 2014;89(1):16-24. [CrossRef] [PubMed] 
2. Mathew M. January 2014 pulmonary journal club: interventional guidelines. Southwest J Pulm Crit Care. 2014;8(1):70. [CrossRef]
3. 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. [CrossRef] [PubMed] 
4. NICE-SUGAR Study Investigators, Finfer S, Chittock DR, et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360(13):1283-97. [CrossRef] [PubMed] 
5. Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 2012; 366:2055-64. [CrossRef] [PubMed] 
6. Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011;364(26):2483-95. [CrossRef] [PubMed] 
7. Eichacker PQ, Natanson C, Danner RL. Surviving Sepsis – Practice guidelines, marketing campaigns and Eli Lilly. N Engl J Med 2006;355:1640-2. [CrossRef] [PubMed]
8. Raschke RA. July 2012 critical care journal club. Southwest J Pulm Crit Care 2012;5:54-7.
9. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]

*The views expressed in this editorial are those of the author and do not necessarily represent the views of the Arizona, New Mexico, Colorado or California Thoracic Societies or the Mayo Clinic.

Reference as: Robbins RA. What's wrong with expert opinion? Southwest J Pulm Crit Care. 2014;8(1):71-3. doi: http://dx.doi.org/10.13175/swjpcc008-14 PDF