The Centers for Disease Control and Prevention’s principle infection control advisory committee is taking steps to clarify its recommendations, be more transparent about its review of research, and, to paraphrase Voltaire, quit making “perfect the enemy of good.”
The CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) discussed the new approach at a recent meeting. Historically, HICPAC recommendations have included exhaustive attempts to find conclusive data on various infection control practices.
For example, when many practices in surgical site infections received a “no recommendation” for lack of evidence, the Association for Professionals in Infection Control and Epidemiology warned that “this approach does not provide practical guidance to healthcare providers at the bedside.” (See Hospital Infection Control & Prevention, April 2014.)
It certainly is an ethical challenge to conduct randomized clinical trials on infection prevention measures. For example, a clinical trial typically includes a control group that by definition is denied the intervention. Given these limits, the challenge to HICPAC members is to weigh and balance the evidence — or lack thereof — for any given recommendation.
“This process started by way of a desire for us to simplify HICPAC’s recommendation categories and improve transparency around the rationale behind why a specific category was chosen, address practices for which evidence is scant or absent, and to hopefully improve the way we can address bundled practices,” Dan Diekema, MD, chairman of HICPAC, said at a recent meeting at the CDC.
Benefit vs. Harm
Running down some of the categories in this new approach, Diekema said a “recommendation” means the panel is confident that the benefits of the approach exceed the harms.
“Or, in the case of a negative recommendation, that the harms clearly exceed the benefits,” he said. “These recommendations ideally, of course, should be supported by high- to moderate-quality evidence, but there may be times when a recommendation can be made based on lesser evidence or expert opinion.”
If it is not possible to obtain high-quality evidence, but expected benefits strongly outweigh potential harms, HICPAC may still recommend a practice. Likewise, infection control measures required by federal law also are recommended by the CDC advisory committee.
“The implied obligation here is that healthcare personnel and healthcare facilities should implement the recommended approach unless there’s a clear and compelling rationale for an alternative approach,” he said.
A step down from this is a “conditional recommendation,” which would be used in a situation where the benefits of the recommended approach are “likely to exceed” the harms, or a negative recommendation, where harms are likely to exceed the benefits.
This could include simultaneous interventions in a bundled approach, where it may be difficult to determine which intervention is causing the overall effect. The HICPAC recommendations overall should be implemented within the context of setting and the patient population, he added.
“For example, something might be a conditional recommendation during an outbreak, but not during a non-outbreak setting, or in selected environments or selected populations,” he said.
To return to the aforementioned “no recommendation,” the committee will reserve this for situations where “there is both a lack of evidence and an unclear balance between benefits and harm,” he said.
“We really want to make a recommendation only when there’s a clear benefit that’s not offset by important harms or costs, or vice versa. When the benefit is small or offset by important adverse factors, the balance between benefit and harm would prevent a recommendation from being made,” he said.
Concerning cost and resources, the plan is to include this information when possible and applicable to inform a recommendation, he said.
“[We] would want to describe, if it’s applicable, the direct costs, opportunity costs, material or human resource requirements — facility needs that could be associated with following the recommendation,” he said. “We’re not obligating ourselves to address costs if these analyses are not available and no useful statements can be made, but we would like to state clearly if information is lacking.”
The committee also is attempting to address other gray areas, including “value judgments” that may be based on ethical matters and other considerations. “These might include guiding principles, ethical considerations, other beliefs or priorities,” he said. “We believe that stating them clearly will help users to understand what the influence was in interpreting the objective evidence.”
The desire for more transparency in the guidelines includes addressing “intentional vagueness,” he said.
“Sometimes there is some vagueness in the recommendation that may be intentional,” he said. “Obviously recommendations should be clear and specific, but if there is a vagueness that’s intentional, we ought to acknowledge the reasoning behind it.”
Reasons might include insufficient evidence or a lack of consensus among the panel regarding the quality of the evidence or the anticipated harms and benefits. There also may be “legal considerations, economic reasons, or ethical or religious issues,” he said.
“We had a discussion in the work group around how transparent to be about any remaining disagreements or differences of opinion, which are reflected in the minutes and also have been reflected in the past in votes,” he said.
“We decided it was perhaps more useful not to include a separate category or component that really got into the gory details about specific differences of opinion,” he added.
Recommendations may also include “exceptions,” where HICPAC may list situations or circumstances where the recommendation should not be applied.
The panel’s assessment of the quality of the evidence will be graduated from low, moderate, to high, with the latter including “a wide range of studies with no major limitations that come to the same conclusion.”
New Pertussis Draft
In other HICPAC action, the panel approved a draft of new pertussis guidelines for healthcare workers as part of a larger ongoing update of its Guideline for Infection Control in Healthcare Personnel.
Pertussis has become a recurrent problem, in part due to the fading efficacy of the vaccine over time. Bordetella pertussis can cause hospital outbreaks that expose healthcare workers.
The CDC reports that there are from 10,000 to 40,000 cases annually with about 20 deaths. Antibiotic post-exposure prophylaxis (PEP) is typically given to exposed healthcare workers to prevent transmission to vulnerable patients like infants. HICPAC member Hilary Babcock, MD, MPH, medical director of infection prevention and occupational health at Barnes-Jewish Hospital in St. Louis, outlined the pertussis recommendations at the meeting.
The CDC draft recommendations for asymptomatic healthcare personnel — regardless of vaccination status — who have unprotected exposure to pertussis are broken down into categories with the following recommendations.
Those likely to interact with persons at increased risk for severe pertussis:
• Administer PEP. If they do not receive PEP, restrict from contact (e.g., furlough, duty restriction/ reassignment) with patients and other persons at increased risk for severe pertussis for 21 days after their last exposure.
For similarly exposed workers not likely to interact with patients at high risk for pertussis, the HICPAC recommends:
• Administer PEP or implement daily monitoring for 21 days after the last exposure for development of signs and symptoms of pertussis.
“Work restrictions are not necessary for asymptomatic healthcare personnel who have had unprotected exposure to pertussis and receive post-exposure prophylaxis, regardless of their risk for interaction with persons at increased risk for severe [pertussis] complications,” the HICPAC draft states.
However, exclude symptomatic healthcare personnel with known or suspected pertussis from work for 21 days from the onset of cough, or until five days after the start of effective antimicrobial therapy.
“The objective of post-exposure prophylaxis is to prevent transmission and disease in others, and we recognize populations at particular risk for serious complications,” Babcock said at the meeting.
These high-risk patients include:
• infants under 12 months;
• women in their third trimester of pregnancy;
• people with pre-existing health conditions that may be exacerbated by a pertussis infection (e.g., immunocompromised individuals and individuals with moderate to severe asthma).
Healthcare settings may have patients at high risk for severe pertussis infections in neonatal and pediatric care settings as well as maternity, transplant, and oncology. “We tried to balance the discussion from the group last time about providing this information, but not be overly prescriptive so that healthcare facilities could identify these areas for themselves,” she said.
When finalized, the draft will note the limitations of the current vaccine, which can wane in immunity without booster shots. The HICPAC guidelines will incorporate the recommendations for pertussis vaccination of healthcare workers by the CDC’s Advisory Committee on Immunization Practices (ACIP).
ACIP currently recommends that healthcare workers be vaccinated and then receive a booster every 10 years thereafter. Pregnant personnel should be immunized against pertussis during each pregnancy.
The HICPAC guidelines also include a discussion of exposures, which will include not wearing a face mask when in close, face-to-face contact with an infectious patient.
“Close contact may include, but is not limited to, performing a physical examination, feeding or bathing a patient; bronchoscopy; intubation; or administration of bronchodilators,” the HICPAC draft guidelines state. “Determination of close contacts may be more inclusive in settings where interaction with persons at risk for severe pertussis is more likely.”
The guidance on exposures was appreciated by Darlene Carey, RN, the APIC liaison member of HICPAC.
“I think a lot of infection prevention and occupational health staff members have concerns about that whenever an exposure happens,” she said.