GI leaders call for updated guidelines from industry medical professional societies for breath testing amidst ongoing COVID-19 concerns caused by aerosol-generating procedures (AGPs)
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"Breath Testing and Aerosol-Generating Procedures in Gastroenterology"
As of early May 2020, the CDC listed aerosol inhalation as one of the coronavirus’s most significant ways to spread.
Aerosol scientists have acknowledged that “COVID-19 has redefined airborne transmission”. We now know that airborne transmission does not only concern large droplets, such as those from a cough or sneeze. Both symptomatic and asymptomatic patients produce many small respiratory particles (bioaerosols) with each exhale, and these particles are now also known to be full of the coronavirus or other communicable diseases.
New studies from the National Institute of Allergy and Infectious Diseases, as reported this month by New York Times, showed that small aerosols of the new variants, including Alpha and Delta, were traveling longer distances than larger droplets and were much more likely to cause new infections via aerosol transmission. Experts are now concerned that newer variants may turn out to be even more transmissible.
While masks, social distancing, ventilation, and reducing indoor occupancy help prevent the usual transmission methods, these respiratory particles can be suspended and remain airborne for hours, putting those in the area, even hours after aerosol generation, at risk of contracting COVID-19.
Compared to the knowledge we had at the start of the pandemic and based on the acknowledgment that aerosol inhalation plays a prominent form of coronavirus transmission, we now know that wearing masks, maintaining a social distance, and establishing good airflow is much more critical for reducing the spread of coronavirus compared to surface cleaning, temperature checks, and plexiglass barriers.
Additionally, many scientists believe that more than 50% of all transmissions occur via asymptomatic carriers, further emphasizing the need for each individual to be wary of aerosol generation and transmission.
Aerosol Transmission and Medical Procedures
Aerosol transmission necessitates a discussion on which medical procedures put those surrounding the individual or entering the room while suspended particles are still present at a greater risk.
Experts utilize four factors to categorize transmission risk during a medical procedure:
- forced air
- symptoms/disease severity
As expected, combining multiple factors will also increase the risk of transmission.
“[Cedars-Sinai], like all hospitals, has taken a large number of measures to reduce aerosol transmission within our clinics and facilities. These include mandatory masking of all patients and staff, social distancing, judicious use of plexiglass barriers, temperature checks, and other related processes of care.”
– Brennan Spiegel, MD, MSHS, Professor of Medicine and Public Health and Director of Health Services Research at Cedars-Sinai.
The World Health Organization states that definite aerosol-generating procedures include intubation, noninvasive positive pressure ventilation, tracheotomy, cardiopulmonary resuscitation, bronchoscopy, and sputum induction.
Higher grade respiratory personal protection equipment (PPE) may be necessary for healthcare workers performing these procedures or practicing in high-prevalence settings. Furthermore, even when not performing traditionally defined aerosol-generating procedures, those treating highly symptomatic patients should also utilize the highest grade PPE.
“We need to drive home the point that you have to be more careful protecting yourself in every way. I think everyone is now more cognizant of the importance of PPE in GI procedures and will continue to use appropriate gowns, masks, and gloves aggressively to be safe.”
– Rajiv Sharma, MD, Integrative Gastroenterologist at Digestive Health Associates in Terre Haute, Ind. (via Gastroenterology & Endoscopy News)
Breath Testing for Gastrointestinal Conditions: A Comparison
When diagnosing Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and Carbohydrate Malabsorption Disorders, the recommended method of diagnosis is breath testing, which providers can oversee at healthcare facilities or patients can complete in the comfort of their own home.
In-Office Breath Testing
A standard session of breath testing in the office consists of the patient exhaling into a point-of-care breath collection device or breathalyzer instrument ten or more times over two to three hours. A nurse or medical assistant typically administers the test in a medical exam room.
While there are many conveniences to in-office breath testing, the point-of-care device model is dated and no longer provides the same clinical value, nor does it follow the safety protocols necessary in a COVID-19 environment.
In-office breath testing requires patients to wait in the provider facility for an extended period—often three or more hours—to obtain the necessary breath samples. Additionally, administration and data collection are time-consuming and involve manual data entry, leading to more significant data recording and transmission errors.
There is also a higher likelihood that this test uses inferior or dated instrumentation that does not meet the same rigorous standards as a Clinical Laboratory Improvement Amendments (CLIA) laboratory. The samples are usually not run by professional lab technicians.
Finally, disinfection of devices, patient area, equipment, and PPE must occur between each patient, which severely limits the number of patients tested each day. In a snowball effect, this can cause longer wait times for both diagnoses and treatment. Staffing requirements and space limitations can also increase wait times.
Despite the apparent drawbacks, many institutions and healthcare providers still utilize the point-of-care device model.
At-Home Breath Testing
Compared to the two to three hours spent in the office completing an in-office breath test, at-home breath testing allows patients to collect these samples from the comfort and safety of their own home and on their own time.
Most at-home breath test kits are FDA registered, CE marked, and ISO-13485 certified. However, it is essential to note that not all kits follow these standards, so healthcare providers and patients should carefully choose a test kit.
In addition to kit manufacturing, it is also essential to consider how and where samples are analyzed. Healthcare providers should utilize test kits analyzed by experienced laboratory staff at a CLIA-certified laboratory, assuring optimal process quality, precise data accuracy, and timely data transmission.
In-Office Versus At-Home Breath Testing Costs
Provider and patient cost also come to play when considering in-office versus at-home breath testing diagnostics.
The cost of the diagnostic procedure or test itself differs between in-office and at-home. At-home breath testing kits can cost anywhere from $150 to $200 and includes sample analysis by laboratory professionals. In-office point-of-care testing can cost upwards of $1,000 for the same test, except nurses or administrative staff run the procedure and analyze the results from the machine.
The higher procedure cost is often passed onto either the insurance company or the patient directly. Cost passed to insurance companies often drives market inefficiencies and incentivizes costly and wasteful healthcare expenditures. Patients who do not have insurance or have high deductibles may be stuck with a higher-cost procedure with less than optimal results.
Other direct and indirect costs for in-office testing include money spent on transportation to and from the provider office, time spent missing school or work, or using paid time off for the appointment.
While insurance companies do not cover all at-home breath testing, companies like Commonwealth Diagnostics International (CDI) focus on delivering value to the entire healthcare system through better patient outcomes and robust cost savings while also improving patient comfort and safety.
COVID-19 Implications on Functional GI Diagnostics
As mentioned previously, aerosol-generating procedures are hazardous during the COVID-19 pandemic, increasing the risk of transmission. Breath testing for functional GI diagnostics is one such aerosol-generating procedure, and it carries one of the highest risks of viral transmission of COVID-19 and other communicable diseases. This realization will have lasting effects on the GI and healthcare industry well beyond the current pandemic as WHO and the United Nations predict an ongoing concern for the emergence of more diseases that pass from animals to humans, such as COVID-19.
In addition, aerosol-generating procedures require level 2 PPE, which is currently in high demand and, as such, is being strictly prioritized by healthcare administration in terms of clinical need. Lack of PPE can mean that those performing breath testing do not have adequate protection to perform the procedure safely.
When there are resource constrictions, breath tests are one of the first to get shuffled around or postponed due to lack of equipment since the GI conditions tested for with a breath test are not life-threatening. Although these conditions are not life-threatening, they majorly affect an individual’s quality of life, especially when stress levels and other symptom triggers are highly prevalent.
These breath tests are, truthfully, best suited for at-home usage. As society has modified itself with the introduction of COVID-19, this fact is becoming even more evident.
Using at-home breath testing kits will benefit the individual by ensuring that their test, and eventual diagnosis and treatment, are not postponed. Also, at-home breath tests allow healthcare centers to reserve their limited PPE stock for urgent procedures, allowing them to save on costs while keeping staff and patients safe.
Duke University Case Study
In the early part of the COIVD-19 pandemic, we stopped all procedures as very little was known regarding the mode of transmission and the risks of transmission with GI procedures, and we had difficulty obtaining sufficient personal protective equipment (PPE) for staff. Our endoscopy procedures resumed several months into the pandemic, but breath testing was on hold until just late Summer 2021. [In-office] breath testing was felt to be a higher risk procedure to staff because it involved being in a closed room with a patient producing a large amount of aerosols. With the vaccination of staff and the improvement in PPE availability, we have resumed breath testing on site.
When we paused in-office breath testing, it impacted our ability to perform diagnostics for small bowel bacterial overgrowth (SIBO) and h. pylori, among others. As a result of the lack of diagnostics, I originally elected to treat more patients empirically with antibiotics when presenting with symptoms compatible with SIBO. After learning about at-home breath testing for SIBO from a colleague, I began to refer many of my patients for home testing. This allowed me to minimize the use of empiric antibiotics.
The transition from in-office to at-home breath testing was relatively seamless with CDI. It was very easy to order the testing online, and the results were reliably returned to me electronically. Many of my patients appreciated the ability to complete this testing at home, especially when the pandemic was at its worst.
Ziad F. Gellad, MD MPH AGAF
Associate Professor of Medicine
Associate Vice Chair, Ambulatory Services, Department of Medicine
Medical Director, Duke Health North Durham
Duke University Medical Center
A GI Industry Call to Action
In June of 2020, US-based GI medical societies banded together to issue a joint statement that endorsed physical separation and wearing face masks to prevent the spread of COVID-19. Within that same year, they also listed recommendations for managing endoscopies and endoscopy processes. Since then, these societies and associations have not recommended new safety protocols for breath testing and other aerosol-generating procedures in this COVID-19 environment.
Internationally, several GI groups and associations, including the British Society of Gastroenterology, have made strong recommendations regarding aerosol-generating procedures, including where and how breath testing should occur. In 2020, the British Society of Gastroenterology stated that non-urgent breath tests undertaken by GI physiology departments could be considered AGPs. And with this acknowledgment, they then emphasized at-home kits, encouraging institutions to use them instead to protect both the patients and the facility staff.
“As a national committee set with the task of providing safety guidelines for GI Physiology testing across the U.K., we quickly detected the potential risk of in-office breath testing. The combination of housing multiple patients in waiting areas coupled with the aerosol generated from blowing into bags or machines was untenable. However, we have a duty of care to patients and could not just abandon them during the prolonged lockdown periods. Our recommendation was to utilize at-home testing and provide virtual support for those who need it. At-home testing is not only safe and effective but is now becoming the norm across the U.K., meaning that physiology departments can focus on only necessary face-to-face encounters for invasive procedures which improves safety all around.”
– Anthony Hobson PhD MPhil, internationally renowned clinical GI scientist, chair of the Association of GI Physiologists for the British Society of Gastroenterology, and founder of U.K.-based Functional Gut Diagnostics and Functional Gut Clinic
The GI industry needs to take a stand and play a role in mitigating the spread of communicable aerosol-related diseases, including COVID-19 and the seasonal flu/influenza virus. GI practices can play their part by switching from in-office breath testing to at-home testing. In addition to limiting the risk of exposure and transmission, at-home breath testing is safer, healthier, and a lower-cost diagnostic plan for both patients and the facility.
The paradigm of the healthcare delivery model needs to shift towards specialized, affordable, and safe diagnostic tests as the frontline method of screening. While some healthcare systems have already successfully transitioned their GI diagnostics to at-home breath testing, a unilateral recommendation from GI medical societies is necessary to move the industry forward together.
– Craig S. Strasnick, President & CEO of Commonwealth Diagnostics International
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"Breath Testing and Aerosol-Generating Procedures in Gastroenterology"
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