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extacy
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slave
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slavely
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sleaze
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sleazy
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sluting
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slutkissed
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slutkissing
slutkissly
slutkisss
slutly
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slutsed
slutser
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slutsing
slutsly
slutss
smegma
smegmaed
smegmaer
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smegmaing
smegmaly
smegmas
smut
smuted
smuter
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smuting
smutly
smuts
smutty
smuttyed
smuttyer
smuttyes
smuttying
smuttyly
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snatch
snatched
snatcher
snatches
snatching
snatchly
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sniper
snipered
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snipering
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snort
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sumofabiatch
sumofabiatched
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sumofabiatching
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tard
tarded
tarder
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tawdry
tawdryed
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tawdrying
tawdryly
tawdrys
teabagging
teabagginged
teabagginger
teabagginges
teabagginging
teabaggingly
teabaggings
terd
terded
terder
terdes
terding
terdly
terds
teste
testee
testeed
testeeed
testeeer
testeees
testeeing
testeely
testeer
testees
testeing
testely
testes
testesed
testeser
testeses
testesing
testesly
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testicle
testicleed
testicleer
testiclees
testicleing
testiclely
testicles
testis
testised
testiser
testises
testising
testisly
testiss
thrusted
thruster
thrustes
thrusting
thrustly
thrusts
thug
thuged
thuger
thuges
thuging
thugly
thugs
tinkle
tinkleed
tinkleer
tinklees
tinkleing
tinklely
tinkles
tit
tited
titer
tites
titfuck
titfucked
titfucker
titfuckes
titfucking
titfuckly
titfucks
titi
titied
titier
tities
titiing
titily
titing
titis
titly
tits
titsed
titser
titses
titsing
titsly
titss
tittiefucker
tittiefuckered
tittiefuckerer
tittiefuckeres
tittiefuckering
tittiefuckerly
tittiefuckers
titties
tittiesed
tittieser
tittieses
tittiesing
tittiesly
tittiess
titty
tittyed
tittyer
tittyes
tittyfuck
tittyfucked
tittyfucker
tittyfuckered
tittyfuckerer
tittyfuckeres
tittyfuckering
tittyfuckerly
tittyfuckers
tittyfuckes
tittyfucking
tittyfuckly
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tittying
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toke
tokeed
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tramp
tramped
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transsexualed
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transsexualing
transsexually
transsexuals
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tubgirl
tubgirled
tubgirler
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tubgirling
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tubgirls
turd
turded
turder
turdes
turding
turdly
turds
tush
tushed
tusher
tushes
tushing
tushly
tushs
twat
twated
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twating
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uzied
uzier
uzies
uziing
uzily
uzis
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valiumed
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virgined
virginer
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vixen
vixened
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vixening
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vodkaing
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voyeuring
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vulgared
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wang
wanged
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wankly
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wazoo
wazooed
wazooer
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wazooing
wazooly
wazoos
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wedgieed
wedgieer
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wedgieing
wedgiely
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weeder
weedes
weeding
weedly
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weewee
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weeweeer
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weeweeing
weeweely
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weinerer
weineres
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weiners
weirdo
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weirdoes
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weirdoly
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wench
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whore
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whored
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wigger
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woody
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woodying
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wop
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wtf
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yeastying
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balls
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.
Not the Neck-tar of the Gods
ANSWER
The correct answer is cutaneous sinus tract of odontogenic origin (choice “d”).
DISCUSSION
These uncommon lesions are known by several names, including odontogenic fistula. Invariably, they are misdiagnosed as an “infection” and treated with antibiotics, which only calm these lesions until they inevitably return to their pretreatment appearance. Though bacteria (mostly Peptostreptococcus—the anaerobe predominating in the mouth) are involved, this is not an infection as it usually manifests.
The underlying process of this condition is caused by a periapical abscess: as it grows in size and pressure, it enters into the mouth or fistulizes out through the buccal tissue, continuing until it penetrates the skin and begins to release its pustular contents. Eighty percent manifest on the submental or chin area, while 20% tunnel inwards toward the oral cavity.
They initially manifest as papules with a 2-to-3-mm surface that soon drain pus from a central sinus. As this continues, the epithelium responds to the chronic inflammation by forming a mass of pseudoepitheliomatous hyperplasia. Biopsy would reveal that the mass also shows signs of chronic inflammation. Ordinary bacterial culture often shows nothing because the predominant organism is an anaerobe. At most, one might see a polymicrobial result.
TREATMENT
For affected patients, a dentist can be considered for radiography of the area to confirm the location of the periapical abscess. Then the tooth is usually extracted, resulting in a cure. No further treatment of the sinus tract is necessary because it will essentially disappear over time. The tract does not require excision because it is lined with reactive granulation tissue and not epithelium (as is the case for many other fistular processes).
If the dental exam and radiograph fail to show the expected result, the other diagnoses—thyroglossal duct cyst, branchial cleft cyst, squamous cell carcinoma—would have to be considered.
ANSWER
The correct answer is cutaneous sinus tract of odontogenic origin (choice “d”).
DISCUSSION
These uncommon lesions are known by several names, including odontogenic fistula. Invariably, they are misdiagnosed as an “infection” and treated with antibiotics, which only calm these lesions until they inevitably return to their pretreatment appearance. Though bacteria (mostly Peptostreptococcus—the anaerobe predominating in the mouth) are involved, this is not an infection as it usually manifests.
The underlying process of this condition is caused by a periapical abscess: as it grows in size and pressure, it enters into the mouth or fistulizes out through the buccal tissue, continuing until it penetrates the skin and begins to release its pustular contents. Eighty percent manifest on the submental or chin area, while 20% tunnel inwards toward the oral cavity.
They initially manifest as papules with a 2-to-3-mm surface that soon drain pus from a central sinus. As this continues, the epithelium responds to the chronic inflammation by forming a mass of pseudoepitheliomatous hyperplasia. Biopsy would reveal that the mass also shows signs of chronic inflammation. Ordinary bacterial culture often shows nothing because the predominant organism is an anaerobe. At most, one might see a polymicrobial result.
TREATMENT
For affected patients, a dentist can be considered for radiography of the area to confirm the location of the periapical abscess. Then the tooth is usually extracted, resulting in a cure. No further treatment of the sinus tract is necessary because it will essentially disappear over time. The tract does not require excision because it is lined with reactive granulation tissue and not epithelium (as is the case for many other fistular processes).
If the dental exam and radiograph fail to show the expected result, the other diagnoses—thyroglossal duct cyst, branchial cleft cyst, squamous cell carcinoma—would have to be considered.
ANSWER
The correct answer is cutaneous sinus tract of odontogenic origin (choice “d”).
DISCUSSION
These uncommon lesions are known by several names, including odontogenic fistula. Invariably, they are misdiagnosed as an “infection” and treated with antibiotics, which only calm these lesions until they inevitably return to their pretreatment appearance. Though bacteria (mostly Peptostreptococcus—the anaerobe predominating in the mouth) are involved, this is not an infection as it usually manifests.
The underlying process of this condition is caused by a periapical abscess: as it grows in size and pressure, it enters into the mouth or fistulizes out through the buccal tissue, continuing until it penetrates the skin and begins to release its pustular contents. Eighty percent manifest on the submental or chin area, while 20% tunnel inwards toward the oral cavity.
They initially manifest as papules with a 2-to-3-mm surface that soon drain pus from a central sinus. As this continues, the epithelium responds to the chronic inflammation by forming a mass of pseudoepitheliomatous hyperplasia. Biopsy would reveal that the mass also shows signs of chronic inflammation. Ordinary bacterial culture often shows nothing because the predominant organism is an anaerobe. At most, one might see a polymicrobial result.
TREATMENT
For affected patients, a dentist can be considered for radiography of the area to confirm the location of the periapical abscess. Then the tooth is usually extracted, resulting in a cure. No further treatment of the sinus tract is necessary because it will essentially disappear over time. The tract does not require excision because it is lined with reactive granulation tissue and not epithelium (as is the case for many other fistular processes).
If the dental exam and radiograph fail to show the expected result, the other diagnoses—thyroglossal duct cyst, branchial cleft cyst, squamous cell carcinoma—would have to be considered.
For 4 years, the lesion on this 66-year-old woman’s chin has been growing slowly, causing little or no pain. However, a foul-smelling cloudy liquid drains from the site about once a week and—understandably—causes her considerable distress. Her primary care provider (PCP) regarded the problem as an infection and prescribed an antibiotic, which reduced the lesion’s size for a time. However, it soon grew again after the patient completed the treatment.
The patient denies any other serious health conditions such as diabetes or immunosuppression. She states she never had an injury to this area. Concerned about the possibility of skin cancer, the PCP refers the patient to dermatology.
Physical exam reveals a patient in no particular distress, afebrile, and oriented in all 3 spheres. She is cooperative with the history and exam. Her husband, who has accompanied her, helps to corroborate her answers.
The lesion is striking both in size (2.8 cm) and mixed morphology. A deeply retracted 1.5-cm dimple is located on the right lower chin/submental interface, situated evenly with the right lateral oral commissure. There is no erythema in this area or elsewhere in or around the lesion.
A fleshy, vermicular, 2 × 4–mm, soft, friable linear mass protrudes from the dimple, extending toward the submental region. Gentle pressure produces a small amount of pustular material issuing from the center of the retracted area. There are no other nodes in the region. There is little or no evidence of past overexposure to ultraviolet sources (dyschromia, weathering, actinic keratoses, or telangiectasias).
Planning for a psychiatric COVID-19–positive unit
Identifying key decision points is critical
Reports have emerged about the unique vulnerability of psychiatric hospitals to the ravages of COVID-19.
In a South Korea psychiatric hospital, 101 of 103 patients contracted SARS-CoV-2 during an outbreak; 7 eventually died.1,2 This report, among a few others, have led to the development of psychiatric COVID-19–positive units (PCU). However, it remains highly unclear how many are currently open, where they are located, or what their operations are like.
We knew that we could not allow a medically asymptomatic “covertly” COVID-19–positive patient to be introduced to the social community of our inpatient units because of the risks of transmission to other patients and staff.
In coordination with our health system infection prevention experts, we have therefore required a confirmed negative COVID-19 polymerase chain reaction nasal swab performed no more than 48 hours prior to the time/date of acute psychiatric inpatient admission. Furthermore, as part of the broad health system response and surge planning, we were asked by our respective incident command centers to begin planning for a Psychiatric COVID-19–positive Unit (PCU) that might allow us to safely care for a cohort of patients needing such hospitalization.
It is worth emphasizing that the typical patient who is a candidate for a PCU is so acutely psychiatrically ill that they cannot be managed in a less restrictive environment than an inpatient psychiatric unit and, at the same time, is likely to not be medically ill enough to warrant admission to an internal medicine service in a general acute care hospital.
We have identified eight principles and critical decision points that can help inpatient units plan for the safe care of COVID-19–positive patients on a PCU.
1. Triage: Patients admitted to a PCU should be medically stable, particularly with regard to COVID-19 and respiratory symptomatology. PCUs should establish clear criteria for admission and discharge (or medical transfer). Examples of potential exclusionary criteria to a PCU include:
- Respiratory distress, shortness of breath, hypoxia, requirement for supplemental oxygen, or requirement for respiratory therapy breathing treatments.
- Fever, or signs of sepsis, or systemic inflammatory response syndrome.
- Medical frailty, significant medical comorbidities, delirium, or altered mental status;
- Requirements for continuous vital sign monitoring or of a monitoring frequency beyond the capacity of the PCU.
Discharge criteria may also include a symptom-based strategy because emerging evidence suggests that patients may be less infectious by day 10-14 of the disease course,3 and viral lab testing is very sensitive and will be positive for periods of time after individuals are no longer infectious. The symptom-based strategy allows for patients to not require retesting prior to discharge. However, some receiving facilities (for example residential or skilled nursing facilities) may necessitate testing, in which case a testing-based strategy can be used. The Centers for Disease Control and Prevention provides guidelines for both types of strategies.4
2. Infection control and personal protective equipment: PCUs require modifications or departures from the typical inpatient free-ranging environment in which common areas are provided for patients to engage in a community of care, including group therapy (such as occupational, recreational, Alcoholics Anonymous, and social work groups).
- Isolation: PCUs must consider whether they will require patients to isolate to their rooms or to allow modified or limited access to “public” or “community” areas. While there do not appear to be standard recommendations from the CDC or other public health entities regarding negative pressure or any specific room ventilation requirements, it is prudent to work with local infectious disease experts on protocols. Important considerations include spatial planning for infection control areas to don and doff appropriate personal protective equipment (PPE) and appropriate workspace to prevent contamination of non–COVID-19 work areas. Approaches can include establishing clearly identified and visually demarcated infection control “zones” (often referred to as “hot, warm, and cold zones”) that correspond to specific PPE requirements for staff. In addition, individuals should eat in their own rooms or designated areas because use of common areas for meals can potentially lead to aerosolized spread of the virus.
- Cohorting: Generally, PCUs should consider admitting only COVID-19–positive patients to a PCU to avoid exposure to other patients. Hospitals and health systems should determine protocols and locations for testing and managing “patients under investigation” for COVID-19, which should precede admission to the PCU.
- PPE: It is important to clearly establish and communicate PPE requirements and procedures for direct physical contact versus no physical contact (for example, visual safety checks). Identify clear supply chains for PPE and hand sanitizer.
3. Medical management and consultation: PCUs should establish clear pathways for accessing consultation from medical consultants. It may be ideal, in addition to standard daily psychiatric physician rounding, to have daily internal medicine rounding and/or medical nursing staff working on the unit. Given the potential of COVID-19–positive patients to rapidly devolve from asymptomatic to acutely ill, it is necessary to establish protocols for the provision of urgent medical care 24/7 and streamlined processes for transfer to a medical unit.
Clear protocols should be established to address any potential signs of decompensation in the respiratory status of a PCU unit, including administration of oxygen and restrictions (or appropriate precautions) related to aerosolizing treatment such as nebulizers or positive airway pressure.
4. Code blue protocol: Any emergent medical issues, including acute respiratory decompensation, should trigger a Code Blue response that has been specifically designed for COVID-19–positive patients, including considerations for proper PPE during resuscitation efforts.
5. Psychiatric staffing and workflows: When possible, it may be preferable to engage volunteer medical and nursing staff for the PCU, as opposed to mandating participation. Take into consideration support needs, including education and training about safe PPE practices, processes for testing health care workers, return-to-work guidance, and potential alternate housing.
- Telehealth: Clinicians (such as physicians, social workers, occupational therapists) should leverage and maximize the use of telemedicine to minimize direct or prolonged exposure to infectious disease risks.
- Nursing: It is important to establish appropriate ratios of nursing and support staff for a COVID-19–positive psychiatry unit given the unique work flows related to isolation precautions and to ensure patient and staff safety. These ratios may take into account patient-specific needs, including the need for additional staff to perform constant observation for high-risk patients, management of agitated patients, and sufficient staff to allow for relief and break-time from PPE. Admission and routine care processes should be adapted in order to limit equipment entering the room, such as computer workstations on wheels.
- Medication administration procedures: Develop work flows related to PPE and infection control when retrieving and administering medications.
- Workspace: Designate appropriate workspace for PCU clinicians to access computers and documents and to minimize use of non–COVID-19 unit work areas.
6. Restraints and management of agitated patients: PCUs should develop plans for addressing agitated patients, including contingency plans for whether seclusion or restraints should be administered in the patient’s individual room or in a dedicated restraint room in the PCU. Staff training should include protocols specifically designed for managing agitated patients in the PCU.
7. Discharge processes: If patients remain medically well and clear their COVID-19 PCR tests, it is conceivable that they might be transferred to a non–COVID-19 psychiatric unit if sufficient isolation time has passed and the infectious disease consultants deem it appropriate. It is also possible that patients would be discharged from a PCU to home or other residential setting. Such patients should be assessed for ability to comply with continued self-quarantine if necessary. Discharge planning must take into consideration follow-up plans for COVID-19 illness and primary care appointments, as well as needed psychiatric follow-up.
8. Patients’ rights: The apparently highly infectious and transmissible nature of SARS-CoV-2 creates novel tensions between a wide range of individual rights and the rights of others. In addition to manifesting in our general society, there are potentially unique tensions in acute inpatient psychiatric settings. Certain patients’ rights may require modification in a PCU (for example, access to outdoor space, personal belongings, visitors, and possibly civil commitment judicial hearings). These discussions may require input from hospital compliance officers, ethics committees, risk managers, and the local department of mental health and also may be partly solved by using video communication platforms.
A few other “pearls” may be of value: Psychiatric hospitals that are colocated with a general acute care hospital or ED might be better situated to develop protocols to safely care for COVID-19–positive psychiatric patients, by virtue of the close proximity of full-spectrum acute general hospital services. Direct engagement by a command center and hospital or health system senior leadership also seems crucial as a means for assuring authorization to proceed with planning what may be a frightening or controversial (but necessary) adaptation of inpatient psychiatric unit(s) to the exigencies of the COVID-19 pandemic.
The resources of a robust community hospital or academic health system (including infection prevention leaders who engage in continuous liaison with local, county, state, and federal public health expertise) are crucial to the “learning health system” model, which requires flexibility, rapid adaptation to new knowledge, and accessibility to infectious disease and other consultation for special situations. Frequent and open communication with all professional stakeholders (through town halls, Q&A sessions, group discussions, and so on) is important in the planning process to socialize the principles and concepts that are critical for providing care in a PCU, reducing anxiety, and bolstering collegiality and staff morale.
References
1. Kim MJ. “ ‘It was a medical disaster’: The psychiatric ward that saw 100 patients with new coronavirus.” Independent. 2020 Mar 1.
2. Korean Society of Infectious Diseases et al. J Korean Med Sci. 2020 Mar 16;35(10):e112.
3. Centers for Disease Control and Prevention. Symptom-based strategy to discontinue isolation for persons with COVID-19. Decision Memo. 2020 May 3.
4. He X et al. Nature Medicine. 2020. 26:672-5.
Dr. Cheung is associate medical director and chief quality officer at the Stewart and Lynda Resnick Neuropsychiatric Hospital at the University of California, Los Angeles. He has no conflicts of interest. Dr. Strouse is medical director, UCLA Stewart and Lynda Resnick Neuropsychiatric Hospital and Maddie Katz Professor at the UCLA department of psychiatry/Semel Institute. He has no conflicts of interest. Dr. Li is associate medical director of quality improvement at Yale-New Haven Psychiatric Hospital in Connecticut. She also serves as medical director of clinical operations at the Yale-New Haven Health System. Dr. Li is a 2019-2020 Health and Aging Policy Fellow and receives funding support from the program.
Identifying key decision points is critical
Identifying key decision points is critical
Reports have emerged about the unique vulnerability of psychiatric hospitals to the ravages of COVID-19.
In a South Korea psychiatric hospital, 101 of 103 patients contracted SARS-CoV-2 during an outbreak; 7 eventually died.1,2 This report, among a few others, have led to the development of psychiatric COVID-19–positive units (PCU). However, it remains highly unclear how many are currently open, where they are located, or what their operations are like.
We knew that we could not allow a medically asymptomatic “covertly” COVID-19–positive patient to be introduced to the social community of our inpatient units because of the risks of transmission to other patients and staff.
In coordination with our health system infection prevention experts, we have therefore required a confirmed negative COVID-19 polymerase chain reaction nasal swab performed no more than 48 hours prior to the time/date of acute psychiatric inpatient admission. Furthermore, as part of the broad health system response and surge planning, we were asked by our respective incident command centers to begin planning for a Psychiatric COVID-19–positive Unit (PCU) that might allow us to safely care for a cohort of patients needing such hospitalization.
It is worth emphasizing that the typical patient who is a candidate for a PCU is so acutely psychiatrically ill that they cannot be managed in a less restrictive environment than an inpatient psychiatric unit and, at the same time, is likely to not be medically ill enough to warrant admission to an internal medicine service in a general acute care hospital.
We have identified eight principles and critical decision points that can help inpatient units plan for the safe care of COVID-19–positive patients on a PCU.
1. Triage: Patients admitted to a PCU should be medically stable, particularly with regard to COVID-19 and respiratory symptomatology. PCUs should establish clear criteria for admission and discharge (or medical transfer). Examples of potential exclusionary criteria to a PCU include:
- Respiratory distress, shortness of breath, hypoxia, requirement for supplemental oxygen, or requirement for respiratory therapy breathing treatments.
- Fever, or signs of sepsis, or systemic inflammatory response syndrome.
- Medical frailty, significant medical comorbidities, delirium, or altered mental status;
- Requirements for continuous vital sign monitoring or of a monitoring frequency beyond the capacity of the PCU.
Discharge criteria may also include a symptom-based strategy because emerging evidence suggests that patients may be less infectious by day 10-14 of the disease course,3 and viral lab testing is very sensitive and will be positive for periods of time after individuals are no longer infectious. The symptom-based strategy allows for patients to not require retesting prior to discharge. However, some receiving facilities (for example residential or skilled nursing facilities) may necessitate testing, in which case a testing-based strategy can be used. The Centers for Disease Control and Prevention provides guidelines for both types of strategies.4
2. Infection control and personal protective equipment: PCUs require modifications or departures from the typical inpatient free-ranging environment in which common areas are provided for patients to engage in a community of care, including group therapy (such as occupational, recreational, Alcoholics Anonymous, and social work groups).
- Isolation: PCUs must consider whether they will require patients to isolate to their rooms or to allow modified or limited access to “public” or “community” areas. While there do not appear to be standard recommendations from the CDC or other public health entities regarding negative pressure or any specific room ventilation requirements, it is prudent to work with local infectious disease experts on protocols. Important considerations include spatial planning for infection control areas to don and doff appropriate personal protective equipment (PPE) and appropriate workspace to prevent contamination of non–COVID-19 work areas. Approaches can include establishing clearly identified and visually demarcated infection control “zones” (often referred to as “hot, warm, and cold zones”) that correspond to specific PPE requirements for staff. In addition, individuals should eat in their own rooms or designated areas because use of common areas for meals can potentially lead to aerosolized spread of the virus.
- Cohorting: Generally, PCUs should consider admitting only COVID-19–positive patients to a PCU to avoid exposure to other patients. Hospitals and health systems should determine protocols and locations for testing and managing “patients under investigation” for COVID-19, which should precede admission to the PCU.
- PPE: It is important to clearly establish and communicate PPE requirements and procedures for direct physical contact versus no physical contact (for example, visual safety checks). Identify clear supply chains for PPE and hand sanitizer.
3. Medical management and consultation: PCUs should establish clear pathways for accessing consultation from medical consultants. It may be ideal, in addition to standard daily psychiatric physician rounding, to have daily internal medicine rounding and/or medical nursing staff working on the unit. Given the potential of COVID-19–positive patients to rapidly devolve from asymptomatic to acutely ill, it is necessary to establish protocols for the provision of urgent medical care 24/7 and streamlined processes for transfer to a medical unit.
Clear protocols should be established to address any potential signs of decompensation in the respiratory status of a PCU unit, including administration of oxygen and restrictions (or appropriate precautions) related to aerosolizing treatment such as nebulizers or positive airway pressure.
4. Code blue protocol: Any emergent medical issues, including acute respiratory decompensation, should trigger a Code Blue response that has been specifically designed for COVID-19–positive patients, including considerations for proper PPE during resuscitation efforts.
5. Psychiatric staffing and workflows: When possible, it may be preferable to engage volunteer medical and nursing staff for the PCU, as opposed to mandating participation. Take into consideration support needs, including education and training about safe PPE practices, processes for testing health care workers, return-to-work guidance, and potential alternate housing.
- Telehealth: Clinicians (such as physicians, social workers, occupational therapists) should leverage and maximize the use of telemedicine to minimize direct or prolonged exposure to infectious disease risks.
- Nursing: It is important to establish appropriate ratios of nursing and support staff for a COVID-19–positive psychiatry unit given the unique work flows related to isolation precautions and to ensure patient and staff safety. These ratios may take into account patient-specific needs, including the need for additional staff to perform constant observation for high-risk patients, management of agitated patients, and sufficient staff to allow for relief and break-time from PPE. Admission and routine care processes should be adapted in order to limit equipment entering the room, such as computer workstations on wheels.
- Medication administration procedures: Develop work flows related to PPE and infection control when retrieving and administering medications.
- Workspace: Designate appropriate workspace for PCU clinicians to access computers and documents and to minimize use of non–COVID-19 unit work areas.
6. Restraints and management of agitated patients: PCUs should develop plans for addressing agitated patients, including contingency plans for whether seclusion or restraints should be administered in the patient’s individual room or in a dedicated restraint room in the PCU. Staff training should include protocols specifically designed for managing agitated patients in the PCU.
7. Discharge processes: If patients remain medically well and clear their COVID-19 PCR tests, it is conceivable that they might be transferred to a non–COVID-19 psychiatric unit if sufficient isolation time has passed and the infectious disease consultants deem it appropriate. It is also possible that patients would be discharged from a PCU to home or other residential setting. Such patients should be assessed for ability to comply with continued self-quarantine if necessary. Discharge planning must take into consideration follow-up plans for COVID-19 illness and primary care appointments, as well as needed psychiatric follow-up.
8. Patients’ rights: The apparently highly infectious and transmissible nature of SARS-CoV-2 creates novel tensions between a wide range of individual rights and the rights of others. In addition to manifesting in our general society, there are potentially unique tensions in acute inpatient psychiatric settings. Certain patients’ rights may require modification in a PCU (for example, access to outdoor space, personal belongings, visitors, and possibly civil commitment judicial hearings). These discussions may require input from hospital compliance officers, ethics committees, risk managers, and the local department of mental health and also may be partly solved by using video communication platforms.
A few other “pearls” may be of value: Psychiatric hospitals that are colocated with a general acute care hospital or ED might be better situated to develop protocols to safely care for COVID-19–positive psychiatric patients, by virtue of the close proximity of full-spectrum acute general hospital services. Direct engagement by a command center and hospital or health system senior leadership also seems crucial as a means for assuring authorization to proceed with planning what may be a frightening or controversial (but necessary) adaptation of inpatient psychiatric unit(s) to the exigencies of the COVID-19 pandemic.
The resources of a robust community hospital or academic health system (including infection prevention leaders who engage in continuous liaison with local, county, state, and federal public health expertise) are crucial to the “learning health system” model, which requires flexibility, rapid adaptation to new knowledge, and accessibility to infectious disease and other consultation for special situations. Frequent and open communication with all professional stakeholders (through town halls, Q&A sessions, group discussions, and so on) is important in the planning process to socialize the principles and concepts that are critical for providing care in a PCU, reducing anxiety, and bolstering collegiality and staff morale.
References
1. Kim MJ. “ ‘It was a medical disaster’: The psychiatric ward that saw 100 patients with new coronavirus.” Independent. 2020 Mar 1.
2. Korean Society of Infectious Diseases et al. J Korean Med Sci. 2020 Mar 16;35(10):e112.
3. Centers for Disease Control and Prevention. Symptom-based strategy to discontinue isolation for persons with COVID-19. Decision Memo. 2020 May 3.
4. He X et al. Nature Medicine. 2020. 26:672-5.
Dr. Cheung is associate medical director and chief quality officer at the Stewart and Lynda Resnick Neuropsychiatric Hospital at the University of California, Los Angeles. He has no conflicts of interest. Dr. Strouse is medical director, UCLA Stewart and Lynda Resnick Neuropsychiatric Hospital and Maddie Katz Professor at the UCLA department of psychiatry/Semel Institute. He has no conflicts of interest. Dr. Li is associate medical director of quality improvement at Yale-New Haven Psychiatric Hospital in Connecticut. She also serves as medical director of clinical operations at the Yale-New Haven Health System. Dr. Li is a 2019-2020 Health and Aging Policy Fellow and receives funding support from the program.
Reports have emerged about the unique vulnerability of psychiatric hospitals to the ravages of COVID-19.
In a South Korea psychiatric hospital, 101 of 103 patients contracted SARS-CoV-2 during an outbreak; 7 eventually died.1,2 This report, among a few others, have led to the development of psychiatric COVID-19–positive units (PCU). However, it remains highly unclear how many are currently open, where they are located, or what their operations are like.
We knew that we could not allow a medically asymptomatic “covertly” COVID-19–positive patient to be introduced to the social community of our inpatient units because of the risks of transmission to other patients and staff.
In coordination with our health system infection prevention experts, we have therefore required a confirmed negative COVID-19 polymerase chain reaction nasal swab performed no more than 48 hours prior to the time/date of acute psychiatric inpatient admission. Furthermore, as part of the broad health system response and surge planning, we were asked by our respective incident command centers to begin planning for a Psychiatric COVID-19–positive Unit (PCU) that might allow us to safely care for a cohort of patients needing such hospitalization.
It is worth emphasizing that the typical patient who is a candidate for a PCU is so acutely psychiatrically ill that they cannot be managed in a less restrictive environment than an inpatient psychiatric unit and, at the same time, is likely to not be medically ill enough to warrant admission to an internal medicine service in a general acute care hospital.
We have identified eight principles and critical decision points that can help inpatient units plan for the safe care of COVID-19–positive patients on a PCU.
1. Triage: Patients admitted to a PCU should be medically stable, particularly with regard to COVID-19 and respiratory symptomatology. PCUs should establish clear criteria for admission and discharge (or medical transfer). Examples of potential exclusionary criteria to a PCU include:
- Respiratory distress, shortness of breath, hypoxia, requirement for supplemental oxygen, or requirement for respiratory therapy breathing treatments.
- Fever, or signs of sepsis, or systemic inflammatory response syndrome.
- Medical frailty, significant medical comorbidities, delirium, or altered mental status;
- Requirements for continuous vital sign monitoring or of a monitoring frequency beyond the capacity of the PCU.
Discharge criteria may also include a symptom-based strategy because emerging evidence suggests that patients may be less infectious by day 10-14 of the disease course,3 and viral lab testing is very sensitive and will be positive for periods of time after individuals are no longer infectious. The symptom-based strategy allows for patients to not require retesting prior to discharge. However, some receiving facilities (for example residential or skilled nursing facilities) may necessitate testing, in which case a testing-based strategy can be used. The Centers for Disease Control and Prevention provides guidelines for both types of strategies.4
2. Infection control and personal protective equipment: PCUs require modifications or departures from the typical inpatient free-ranging environment in which common areas are provided for patients to engage in a community of care, including group therapy (such as occupational, recreational, Alcoholics Anonymous, and social work groups).
- Isolation: PCUs must consider whether they will require patients to isolate to their rooms or to allow modified or limited access to “public” or “community” areas. While there do not appear to be standard recommendations from the CDC or other public health entities regarding negative pressure or any specific room ventilation requirements, it is prudent to work with local infectious disease experts on protocols. Important considerations include spatial planning for infection control areas to don and doff appropriate personal protective equipment (PPE) and appropriate workspace to prevent contamination of non–COVID-19 work areas. Approaches can include establishing clearly identified and visually demarcated infection control “zones” (often referred to as “hot, warm, and cold zones”) that correspond to specific PPE requirements for staff. In addition, individuals should eat in their own rooms or designated areas because use of common areas for meals can potentially lead to aerosolized spread of the virus.
- Cohorting: Generally, PCUs should consider admitting only COVID-19–positive patients to a PCU to avoid exposure to other patients. Hospitals and health systems should determine protocols and locations for testing and managing “patients under investigation” for COVID-19, which should precede admission to the PCU.
- PPE: It is important to clearly establish and communicate PPE requirements and procedures for direct physical contact versus no physical contact (for example, visual safety checks). Identify clear supply chains for PPE and hand sanitizer.
3. Medical management and consultation: PCUs should establish clear pathways for accessing consultation from medical consultants. It may be ideal, in addition to standard daily psychiatric physician rounding, to have daily internal medicine rounding and/or medical nursing staff working on the unit. Given the potential of COVID-19–positive patients to rapidly devolve from asymptomatic to acutely ill, it is necessary to establish protocols for the provision of urgent medical care 24/7 and streamlined processes for transfer to a medical unit.
Clear protocols should be established to address any potential signs of decompensation in the respiratory status of a PCU unit, including administration of oxygen and restrictions (or appropriate precautions) related to aerosolizing treatment such as nebulizers or positive airway pressure.
4. Code blue protocol: Any emergent medical issues, including acute respiratory decompensation, should trigger a Code Blue response that has been specifically designed for COVID-19–positive patients, including considerations for proper PPE during resuscitation efforts.
5. Psychiatric staffing and workflows: When possible, it may be preferable to engage volunteer medical and nursing staff for the PCU, as opposed to mandating participation. Take into consideration support needs, including education and training about safe PPE practices, processes for testing health care workers, return-to-work guidance, and potential alternate housing.
- Telehealth: Clinicians (such as physicians, social workers, occupational therapists) should leverage and maximize the use of telemedicine to minimize direct or prolonged exposure to infectious disease risks.
- Nursing: It is important to establish appropriate ratios of nursing and support staff for a COVID-19–positive psychiatry unit given the unique work flows related to isolation precautions and to ensure patient and staff safety. These ratios may take into account patient-specific needs, including the need for additional staff to perform constant observation for high-risk patients, management of agitated patients, and sufficient staff to allow for relief and break-time from PPE. Admission and routine care processes should be adapted in order to limit equipment entering the room, such as computer workstations on wheels.
- Medication administration procedures: Develop work flows related to PPE and infection control when retrieving and administering medications.
- Workspace: Designate appropriate workspace for PCU clinicians to access computers and documents and to minimize use of non–COVID-19 unit work areas.
6. Restraints and management of agitated patients: PCUs should develop plans for addressing agitated patients, including contingency plans for whether seclusion or restraints should be administered in the patient’s individual room or in a dedicated restraint room in the PCU. Staff training should include protocols specifically designed for managing agitated patients in the PCU.
7. Discharge processes: If patients remain medically well and clear their COVID-19 PCR tests, it is conceivable that they might be transferred to a non–COVID-19 psychiatric unit if sufficient isolation time has passed and the infectious disease consultants deem it appropriate. It is also possible that patients would be discharged from a PCU to home or other residential setting. Such patients should be assessed for ability to comply with continued self-quarantine if necessary. Discharge planning must take into consideration follow-up plans for COVID-19 illness and primary care appointments, as well as needed psychiatric follow-up.
8. Patients’ rights: The apparently highly infectious and transmissible nature of SARS-CoV-2 creates novel tensions between a wide range of individual rights and the rights of others. In addition to manifesting in our general society, there are potentially unique tensions in acute inpatient psychiatric settings. Certain patients’ rights may require modification in a PCU (for example, access to outdoor space, personal belongings, visitors, and possibly civil commitment judicial hearings). These discussions may require input from hospital compliance officers, ethics committees, risk managers, and the local department of mental health and also may be partly solved by using video communication platforms.
A few other “pearls” may be of value: Psychiatric hospitals that are colocated with a general acute care hospital or ED might be better situated to develop protocols to safely care for COVID-19–positive psychiatric patients, by virtue of the close proximity of full-spectrum acute general hospital services. Direct engagement by a command center and hospital or health system senior leadership also seems crucial as a means for assuring authorization to proceed with planning what may be a frightening or controversial (but necessary) adaptation of inpatient psychiatric unit(s) to the exigencies of the COVID-19 pandemic.
The resources of a robust community hospital or academic health system (including infection prevention leaders who engage in continuous liaison with local, county, state, and federal public health expertise) are crucial to the “learning health system” model, which requires flexibility, rapid adaptation to new knowledge, and accessibility to infectious disease and other consultation for special situations. Frequent and open communication with all professional stakeholders (through town halls, Q&A sessions, group discussions, and so on) is important in the planning process to socialize the principles and concepts that are critical for providing care in a PCU, reducing anxiety, and bolstering collegiality and staff morale.
References
1. Kim MJ. “ ‘It was a medical disaster’: The psychiatric ward that saw 100 patients with new coronavirus.” Independent. 2020 Mar 1.
2. Korean Society of Infectious Diseases et al. J Korean Med Sci. 2020 Mar 16;35(10):e112.
3. Centers for Disease Control and Prevention. Symptom-based strategy to discontinue isolation for persons with COVID-19. Decision Memo. 2020 May 3.
4. He X et al. Nature Medicine. 2020. 26:672-5.
Dr. Cheung is associate medical director and chief quality officer at the Stewart and Lynda Resnick Neuropsychiatric Hospital at the University of California, Los Angeles. He has no conflicts of interest. Dr. Strouse is medical director, UCLA Stewart and Lynda Resnick Neuropsychiatric Hospital and Maddie Katz Professor at the UCLA department of psychiatry/Semel Institute. He has no conflicts of interest. Dr. Li is associate medical director of quality improvement at Yale-New Haven Psychiatric Hospital in Connecticut. She also serves as medical director of clinical operations at the Yale-New Haven Health System. Dr. Li is a 2019-2020 Health and Aging Policy Fellow and receives funding support from the program.
FDA approves pomalidomide for Kaposi sarcoma
The Food and Drug Administration has granted accelerated approval to pomalidomide (Pomalyst, Bristol-Myers Squibb) for the treatment of AIDS-related Kaposi sarcoma that is resistant to highly active antiretroviral therapy (HAART) or that occurs in HIV-negative patients.
Pomalidomide is the only oral agent and first new treatment option for Kaposi sarcoma in more than 20 years, according to the company.
The drug, a thalidomide analogue, is already marketed for the treatment of multiple myeloma.
Pomalidomide has “shown positive results in Kaposi sarcoma patients, regardless of their HIV status,” said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch, National Cancer Institute, in a press statement.
The conditional approval is based on the 71% overall response rate observed in a phase 1/2 open-label, single-arm clinical trial that involved 28 patients, 18 of whom were HIV positive and 10 of whom were HIV negative.
Most of the responses were partial (57%; 16/28); 14% (4/28) were complete. Median duration of response was 12.1 months. Additionally, for half of the patients who showed a response, that response was maintained for more than 12 months.
Patients received 5 mg of pomalidomide once daily for 21 of 28-day cycles until disease progression or unacceptable toxicity occurred.
Permanent discontinuation because of an adverse reaction occurred in 11% (3/28) of patients.
Adverse reactions (≥20%) included maculopapular rash (71%), constipation (71%), fatigue (68%), nausea (36%), diarrhea (32%), cough (29%), dyspnea (29%), peripheral edema (29%), upper respiratory tract infection (29%), muscle spasms (25%), hypothyroidism (21%), dry skin (21%), and chills (21%).
Grade 3 or 4 adverse reactions included maculopapular rash (3.6%), diarrhea (3.6%), and peripheral edema (3.6%).
Grade 3 or 4 laboratory abnormalities (≥5%) that worsened from baseline included decreased absolute neutrophil count (50%), decreased phosphate level (25%), elevated glucose level (7%), and elevated creatine kinase level (7%).
As a thalidomide analogue, pomalidomide includes a boxed warning in the prescribing information; thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. Deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke can occur in patients treated with pomalidomide; thromboprophylaxis is recommended.
Pomalidomide is available only through a restricted distribution program, Pomalyst REMS.
This article first appeared on Medscape.com.
The Food and Drug Administration has granted accelerated approval to pomalidomide (Pomalyst, Bristol-Myers Squibb) for the treatment of AIDS-related Kaposi sarcoma that is resistant to highly active antiretroviral therapy (HAART) or that occurs in HIV-negative patients.
Pomalidomide is the only oral agent and first new treatment option for Kaposi sarcoma in more than 20 years, according to the company.
The drug, a thalidomide analogue, is already marketed for the treatment of multiple myeloma.
Pomalidomide has “shown positive results in Kaposi sarcoma patients, regardless of their HIV status,” said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch, National Cancer Institute, in a press statement.
The conditional approval is based on the 71% overall response rate observed in a phase 1/2 open-label, single-arm clinical trial that involved 28 patients, 18 of whom were HIV positive and 10 of whom were HIV negative.
Most of the responses were partial (57%; 16/28); 14% (4/28) were complete. Median duration of response was 12.1 months. Additionally, for half of the patients who showed a response, that response was maintained for more than 12 months.
Patients received 5 mg of pomalidomide once daily for 21 of 28-day cycles until disease progression or unacceptable toxicity occurred.
Permanent discontinuation because of an adverse reaction occurred in 11% (3/28) of patients.
Adverse reactions (≥20%) included maculopapular rash (71%), constipation (71%), fatigue (68%), nausea (36%), diarrhea (32%), cough (29%), dyspnea (29%), peripheral edema (29%), upper respiratory tract infection (29%), muscle spasms (25%), hypothyroidism (21%), dry skin (21%), and chills (21%).
Grade 3 or 4 adverse reactions included maculopapular rash (3.6%), diarrhea (3.6%), and peripheral edema (3.6%).
Grade 3 or 4 laboratory abnormalities (≥5%) that worsened from baseline included decreased absolute neutrophil count (50%), decreased phosphate level (25%), elevated glucose level (7%), and elevated creatine kinase level (7%).
As a thalidomide analogue, pomalidomide includes a boxed warning in the prescribing information; thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. Deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke can occur in patients treated with pomalidomide; thromboprophylaxis is recommended.
Pomalidomide is available only through a restricted distribution program, Pomalyst REMS.
This article first appeared on Medscape.com.
The Food and Drug Administration has granted accelerated approval to pomalidomide (Pomalyst, Bristol-Myers Squibb) for the treatment of AIDS-related Kaposi sarcoma that is resistant to highly active antiretroviral therapy (HAART) or that occurs in HIV-negative patients.
Pomalidomide is the only oral agent and first new treatment option for Kaposi sarcoma in more than 20 years, according to the company.
The drug, a thalidomide analogue, is already marketed for the treatment of multiple myeloma.
Pomalidomide has “shown positive results in Kaposi sarcoma patients, regardless of their HIV status,” said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch, National Cancer Institute, in a press statement.
The conditional approval is based on the 71% overall response rate observed in a phase 1/2 open-label, single-arm clinical trial that involved 28 patients, 18 of whom were HIV positive and 10 of whom were HIV negative.
Most of the responses were partial (57%; 16/28); 14% (4/28) were complete. Median duration of response was 12.1 months. Additionally, for half of the patients who showed a response, that response was maintained for more than 12 months.
Patients received 5 mg of pomalidomide once daily for 21 of 28-day cycles until disease progression or unacceptable toxicity occurred.
Permanent discontinuation because of an adverse reaction occurred in 11% (3/28) of patients.
Adverse reactions (≥20%) included maculopapular rash (71%), constipation (71%), fatigue (68%), nausea (36%), diarrhea (32%), cough (29%), dyspnea (29%), peripheral edema (29%), upper respiratory tract infection (29%), muscle spasms (25%), hypothyroidism (21%), dry skin (21%), and chills (21%).
Grade 3 or 4 adverse reactions included maculopapular rash (3.6%), diarrhea (3.6%), and peripheral edema (3.6%).
Grade 3 or 4 laboratory abnormalities (≥5%) that worsened from baseline included decreased absolute neutrophil count (50%), decreased phosphate level (25%), elevated glucose level (7%), and elevated creatine kinase level (7%).
As a thalidomide analogue, pomalidomide includes a boxed warning in the prescribing information; thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. Deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke can occur in patients treated with pomalidomide; thromboprophylaxis is recommended.
Pomalidomide is available only through a restricted distribution program, Pomalyst REMS.
This article first appeared on Medscape.com.
Glucose control linked to COVID-19 outcomes in largest-yet study
The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.
The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.
The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.
“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.
“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.
Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”
So “there was a great deal of overlap between the two groups,” he observed.
Diabetes itself was associated with worse COVID-19 outcomes
Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.
Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.
Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).
Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).
Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).
“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”
With T2D, tighter glycemic control predicted better outcome
Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A1c of 7.3%.
The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA1c of 8.1%.
Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.
They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).
In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
Stress hyperglycemia in COVID-19 associated with greater mortality
Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.
The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.
“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”
In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.
He is now working on a study aimed at answering that question.
The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.
A version of this article originally appeared on Medscape.com.
The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.
The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.
The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.
“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.
“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.
Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”
So “there was a great deal of overlap between the two groups,” he observed.
Diabetes itself was associated with worse COVID-19 outcomes
Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.
Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.
Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).
Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).
Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).
“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”
With T2D, tighter glycemic control predicted better outcome
Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A1c of 7.3%.
The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA1c of 8.1%.
Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.
They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).
In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
Stress hyperglycemia in COVID-19 associated with greater mortality
Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.
The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.
“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”
In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.
He is now working on a study aimed at answering that question.
The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.
A version of this article originally appeared on Medscape.com.
The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.
The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.
The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.
“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.
“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.
Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”
So “there was a great deal of overlap between the two groups,” he observed.
Diabetes itself was associated with worse COVID-19 outcomes
Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.
Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.
Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).
Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).
Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).
“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”
With T2D, tighter glycemic control predicted better outcome
Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A1c of 7.3%.
The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA1c of 8.1%.
Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.
They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).
In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
Stress hyperglycemia in COVID-19 associated with greater mortality
Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.
The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.
“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”
In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.
He is now working on a study aimed at answering that question.
The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.
A version of this article originally appeared on Medscape.com.
COVID-19 triggers new bariatric/metabolic surgery guidance
New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.
Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.
“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.
Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.
The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.
Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.
Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.
“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.
Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.
Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”
Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.
“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”
Risks of obesity, shifting away from BMI as the main metric
The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.
It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.
Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).
“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”
Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”
In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
“Pandemic forces us to do what was long overdue”
The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.
Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.
A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.
Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”
Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.
For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.
And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.
Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.
The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.
Appropriate personal protective equipment is, of course, advised for use by clinicians.
Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”
Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”
Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.
This article first appeared on Medscape.com.
New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.
Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.
“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.
Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.
The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.
Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.
Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.
“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.
Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.
Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”
Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.
“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”
Risks of obesity, shifting away from BMI as the main metric
The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.
It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.
Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).
“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”
Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”
In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
“Pandemic forces us to do what was long overdue”
The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.
Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.
A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.
Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”
Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.
For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.
And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.
Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.
The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.
Appropriate personal protective equipment is, of course, advised for use by clinicians.
Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”
Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”
Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.
This article first appeared on Medscape.com.
New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.
Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.
“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.
Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.
The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.
Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.
Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.
“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.
Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.
Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”
Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.
“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”
Risks of obesity, shifting away from BMI as the main metric
The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.
It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.
Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).
“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”
Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”
In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
“Pandemic forces us to do what was long overdue”
The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.
Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.
A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.
Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”
Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.
For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.
And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.
Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.
The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.
Appropriate personal protective equipment is, of course, advised for use by clinicians.
Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”
Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”
Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.
This article first appeared on Medscape.com.
Lessons learned during the COVID-19 pandemic
Each day, we’re inundated with news about the COVID-19 pandemic and how it continues to strain our health care system and resources. With more than 1.15 million positive cases in the United States and over 67,000 deaths as of this writing, it has been a scary yet humbling experience for everyone. There is no doubt this pandemic will be a defining moment in health care for several reasons. From supply chain disruptions and personal protective equipment (PPE) and ventilator shortages to exhausted caregivers – both physically and mentally – this event has pushed the envelope on finding answers from federal and state authorities. Hospital administrations are working harder than ever to rise to the challenge and do what is best for their frontline staff and, more importantly, the patients and the communities they serve.
The provider experience during COVID-19
Hospitalists are in a unique situation as frontline providers. Managing daily throughput of patients has always been a key role for the specialty. They also play an integral role in their own care teams alongside nurses, trainees, case managers, pharmacists, and others in cohorted COVID-19 units. Now more than ever, such a geographic placement of patients is quickly emerging as a must-have staffing model to reduce risk of cross-contamination and preserving critical PPE supplies. This heightened awareness, coupled with anxiety, sometimes leads to added stress and burnout risk for hospitalists.
Communication is critical in creating situational awareness and reducing anxiety within the teams. This is exactly where hospitalists can lead:
- Active presence in hospital incident command centers and infection control boards
- Close coordination with emergency medicine colleagues and bed placement navigators
- Developing protocols for appropriate testing
- Frequent daily huddles to discuss current state- and hospital-level testing guidelines
- Close involvement in the hospital operations committee
- Advocating for or securing more testing or supplies, especially PPE
- Effective communication about changes in PPE requirements and conservation strategies as per the Centers for Disease Control and Prevention, State Department of Health, and the hospital infection control board
- Crisis-driven changes, including development and review of triage and treatment protocols and elective procedure cancellations
- Census numbers and capacity/staffing adjustments within the team to meet temporary dips and surges in on-service patient volumes
- Frontline caregiver mental and physical health assessment
Daily huddles at key times (e.g., at shift start and end times) can help to identify these barriers. If operational issues arise, there should be a clear channel to escalate them to senior leadership.
Hospitalists could also use several strategies proven to improve staff morale and resilience. For instance, take this time to connect with friends and family virtually, unplug when off from work, explore one’s spiritual self through meditation and prayers, spend time with nature, exercise daily, seek humor, and develop or work on one’s hobby.
The patient experience during COVID-19
Some intriguing data is also being released about patient experience during the pandemic. A Press Ganey analysis of 350,000 comments between January and March 2020 shows that patients are looking for more information about their condition, primarily COVID-19 test delays and result notification time. There is also hypervigilance in patients’ minds about hand hygiene and overall cleanliness of the hospital. Patients also seek clarification and transparent explanation of their caregiver’s bedside mannerisms – for example, why did they gown up before entering – and their daily care plans.
Patients have been appreciative of providers and recognize the personal risk frontline staff put themselves through. Communication transparency seems to mitigate concerns about delays of care especially caused by operational challenges as a result of the pandemic.
In surveys specifically related to experiences including COVID-19, patients were more likely to rate more areas of service lower than in surveys that did not mention COVID-19. The patients also seemed to put more value on the quality of instructions and information they received and on perception of providers’ respect and listening abilities. These insights could prove invaluable in improving care delivery by hospitalists.
Isolation of patients has been shown in multiple studies to have negative outcomes. These patients are up to twice as likely to have an adverse event, and seven times more likely to have treatment-related avoidable adversity, poorer perceived patient experience, and overall perception of being cared for “less.” Add to this a higher level of depression and mental strain, and these patients quickly become “unsatisfied.”
At the ED level, the willingness to let family be present for care was the key area of concern listed – a metric that has changed rapidly since the early days of the pandemic.
The bottom line is these are trying times for everyone – both for providers and patients. Both look up to health system and group leadership for reassurance. Patients and families recognize the risks frontline providers are assuming. However, transparent communication across all levels is the key. Silos are disappearing and team based care is taking center stage.
Beyond the current public health crisis, these efforts will go a long way to create unshakable trust between health systems, providers, patients, and their loved ones.
Dr. Singh is currently the chief of inpatient operations at Adena Health System in Chillicothe, Ohio, where he also has key roles in medical informatics and health IT. He is also the president-elect of the Central Ohio Chapter of SHM.
Each day, we’re inundated with news about the COVID-19 pandemic and how it continues to strain our health care system and resources. With more than 1.15 million positive cases in the United States and over 67,000 deaths as of this writing, it has been a scary yet humbling experience for everyone. There is no doubt this pandemic will be a defining moment in health care for several reasons. From supply chain disruptions and personal protective equipment (PPE) and ventilator shortages to exhausted caregivers – both physically and mentally – this event has pushed the envelope on finding answers from federal and state authorities. Hospital administrations are working harder than ever to rise to the challenge and do what is best for their frontline staff and, more importantly, the patients and the communities they serve.
The provider experience during COVID-19
Hospitalists are in a unique situation as frontline providers. Managing daily throughput of patients has always been a key role for the specialty. They also play an integral role in their own care teams alongside nurses, trainees, case managers, pharmacists, and others in cohorted COVID-19 units. Now more than ever, such a geographic placement of patients is quickly emerging as a must-have staffing model to reduce risk of cross-contamination and preserving critical PPE supplies. This heightened awareness, coupled with anxiety, sometimes leads to added stress and burnout risk for hospitalists.
Communication is critical in creating situational awareness and reducing anxiety within the teams. This is exactly where hospitalists can lead:
- Active presence in hospital incident command centers and infection control boards
- Close coordination with emergency medicine colleagues and bed placement navigators
- Developing protocols for appropriate testing
- Frequent daily huddles to discuss current state- and hospital-level testing guidelines
- Close involvement in the hospital operations committee
- Advocating for or securing more testing or supplies, especially PPE
- Effective communication about changes in PPE requirements and conservation strategies as per the Centers for Disease Control and Prevention, State Department of Health, and the hospital infection control board
- Crisis-driven changes, including development and review of triage and treatment protocols and elective procedure cancellations
- Census numbers and capacity/staffing adjustments within the team to meet temporary dips and surges in on-service patient volumes
- Frontline caregiver mental and physical health assessment
Daily huddles at key times (e.g., at shift start and end times) can help to identify these barriers. If operational issues arise, there should be a clear channel to escalate them to senior leadership.
Hospitalists could also use several strategies proven to improve staff morale and resilience. For instance, take this time to connect with friends and family virtually, unplug when off from work, explore one’s spiritual self through meditation and prayers, spend time with nature, exercise daily, seek humor, and develop or work on one’s hobby.
The patient experience during COVID-19
Some intriguing data is also being released about patient experience during the pandemic. A Press Ganey analysis of 350,000 comments between January and March 2020 shows that patients are looking for more information about their condition, primarily COVID-19 test delays and result notification time. There is also hypervigilance in patients’ minds about hand hygiene and overall cleanliness of the hospital. Patients also seek clarification and transparent explanation of their caregiver’s bedside mannerisms – for example, why did they gown up before entering – and their daily care plans.
Patients have been appreciative of providers and recognize the personal risk frontline staff put themselves through. Communication transparency seems to mitigate concerns about delays of care especially caused by operational challenges as a result of the pandemic.
In surveys specifically related to experiences including COVID-19, patients were more likely to rate more areas of service lower than in surveys that did not mention COVID-19. The patients also seemed to put more value on the quality of instructions and information they received and on perception of providers’ respect and listening abilities. These insights could prove invaluable in improving care delivery by hospitalists.
Isolation of patients has been shown in multiple studies to have negative outcomes. These patients are up to twice as likely to have an adverse event, and seven times more likely to have treatment-related avoidable adversity, poorer perceived patient experience, and overall perception of being cared for “less.” Add to this a higher level of depression and mental strain, and these patients quickly become “unsatisfied.”
At the ED level, the willingness to let family be present for care was the key area of concern listed – a metric that has changed rapidly since the early days of the pandemic.
The bottom line is these are trying times for everyone – both for providers and patients. Both look up to health system and group leadership for reassurance. Patients and families recognize the risks frontline providers are assuming. However, transparent communication across all levels is the key. Silos are disappearing and team based care is taking center stage.
Beyond the current public health crisis, these efforts will go a long way to create unshakable trust between health systems, providers, patients, and their loved ones.
Dr. Singh is currently the chief of inpatient operations at Adena Health System in Chillicothe, Ohio, where he also has key roles in medical informatics and health IT. He is also the president-elect of the Central Ohio Chapter of SHM.
Each day, we’re inundated with news about the COVID-19 pandemic and how it continues to strain our health care system and resources. With more than 1.15 million positive cases in the United States and over 67,000 deaths as of this writing, it has been a scary yet humbling experience for everyone. There is no doubt this pandemic will be a defining moment in health care for several reasons. From supply chain disruptions and personal protective equipment (PPE) and ventilator shortages to exhausted caregivers – both physically and mentally – this event has pushed the envelope on finding answers from federal and state authorities. Hospital administrations are working harder than ever to rise to the challenge and do what is best for their frontline staff and, more importantly, the patients and the communities they serve.
The provider experience during COVID-19
Hospitalists are in a unique situation as frontline providers. Managing daily throughput of patients has always been a key role for the specialty. They also play an integral role in their own care teams alongside nurses, trainees, case managers, pharmacists, and others in cohorted COVID-19 units. Now more than ever, such a geographic placement of patients is quickly emerging as a must-have staffing model to reduce risk of cross-contamination and preserving critical PPE supplies. This heightened awareness, coupled with anxiety, sometimes leads to added stress and burnout risk for hospitalists.
Communication is critical in creating situational awareness and reducing anxiety within the teams. This is exactly where hospitalists can lead:
- Active presence in hospital incident command centers and infection control boards
- Close coordination with emergency medicine colleagues and bed placement navigators
- Developing protocols for appropriate testing
- Frequent daily huddles to discuss current state- and hospital-level testing guidelines
- Close involvement in the hospital operations committee
- Advocating for or securing more testing or supplies, especially PPE
- Effective communication about changes in PPE requirements and conservation strategies as per the Centers for Disease Control and Prevention, State Department of Health, and the hospital infection control board
- Crisis-driven changes, including development and review of triage and treatment protocols and elective procedure cancellations
- Census numbers and capacity/staffing adjustments within the team to meet temporary dips and surges in on-service patient volumes
- Frontline caregiver mental and physical health assessment
Daily huddles at key times (e.g., at shift start and end times) can help to identify these barriers. If operational issues arise, there should be a clear channel to escalate them to senior leadership.
Hospitalists could also use several strategies proven to improve staff morale and resilience. For instance, take this time to connect with friends and family virtually, unplug when off from work, explore one’s spiritual self through meditation and prayers, spend time with nature, exercise daily, seek humor, and develop or work on one’s hobby.
The patient experience during COVID-19
Some intriguing data is also being released about patient experience during the pandemic. A Press Ganey analysis of 350,000 comments between January and March 2020 shows that patients are looking for more information about their condition, primarily COVID-19 test delays and result notification time. There is also hypervigilance in patients’ minds about hand hygiene and overall cleanliness of the hospital. Patients also seek clarification and transparent explanation of their caregiver’s bedside mannerisms – for example, why did they gown up before entering – and their daily care plans.
Patients have been appreciative of providers and recognize the personal risk frontline staff put themselves through. Communication transparency seems to mitigate concerns about delays of care especially caused by operational challenges as a result of the pandemic.
In surveys specifically related to experiences including COVID-19, patients were more likely to rate more areas of service lower than in surveys that did not mention COVID-19. The patients also seemed to put more value on the quality of instructions and information they received and on perception of providers’ respect and listening abilities. These insights could prove invaluable in improving care delivery by hospitalists.
Isolation of patients has been shown in multiple studies to have negative outcomes. These patients are up to twice as likely to have an adverse event, and seven times more likely to have treatment-related avoidable adversity, poorer perceived patient experience, and overall perception of being cared for “less.” Add to this a higher level of depression and mental strain, and these patients quickly become “unsatisfied.”
At the ED level, the willingness to let family be present for care was the key area of concern listed – a metric that has changed rapidly since the early days of the pandemic.
The bottom line is these are trying times for everyone – both for providers and patients. Both look up to health system and group leadership for reassurance. Patients and families recognize the risks frontline providers are assuming. However, transparent communication across all levels is the key. Silos are disappearing and team based care is taking center stage.
Beyond the current public health crisis, these efforts will go a long way to create unshakable trust between health systems, providers, patients, and their loved ones.
Dr. Singh is currently the chief of inpatient operations at Adena Health System in Chillicothe, Ohio, where he also has key roles in medical informatics and health IT. He is also the president-elect of the Central Ohio Chapter of SHM.
Psoriasis patients with mental illness report lower satisfaction with physicians
according to a retrospective analysis of survey data.
The findings highlight the importance of clinicians being supportive and adaptable in their communication style when interacting with psoriasis patients with mental illness.
“This study aims to evaluate whether an association exists between a patient’s psychological state and the perception of patient-clinician encounters,” wrote Charlotte Read, MBBS, of Imperial College London, and April W. Armstrong, MD, MPH, of the University of Southern California, Los Angeles, in JAMA Dermatology.
The researchers retrospectively analyzed longitudinal data from over 8.8 million U.S. adults (unweighted, 652) with psoriasis who participated in the Medical Expenditure Panel Survey from 2004 to 2017. The nationally representative database includes various clinical information, such as data on patient demographics, health care use, and mental health comorbidities.
The primary outcome, patient satisfaction with their physician, was assessed using a patient-physician communication composite score. Mental health comorbidities were evaluated using standard questionnaires.
The mean age of study patients was 52.1 years (range, 0.7 years), and most were female (54%). In all, 73% of participants had no or mild psychological distress symptoms, and 27% had moderate or severe symptoms.
After analysis, the researchers found that patients with moderate psychological distress symptoms were 2.8 times more likely to report lower satisfaction with their physician than were those with no or mild symptoms (adjusted odds ratio, 2.8; P = .001). They also reported that patients with severe symptoms were more likely to report lower satisfaction (aOR, 2.3; P = .03).
“Patients with moderate or severe depression symptoms were less satisfied with their clinicians, compared with those with no or mild depression symptoms,” they further explained.
Based on the results, the coinvestigators emphasized the importance of bettering the patient experience for those with mental illness given the potential association with improved health outcomes.
“Because depressed patients can be more sensitive to negative communication, the clinician needs to be more conscious about using a positive and supportive communication style,” they recommended.
The authors acknowledged the inadequacy of evaluating clinician performance using patient satisfaction alone. As a result, the findings may not be generalizable to all clinical settings.
The study was funded by the National Psoriasis Foundation. Dr. Armstrong reported financial affiliations with several pharmaceutical companies.
SOURCE: Read C, Armstrong AW. JAMA Dermatol. 2020 May 6. doi: 10.1001/jamadermatol.2020.1054.
according to a retrospective analysis of survey data.
The findings highlight the importance of clinicians being supportive and adaptable in their communication style when interacting with psoriasis patients with mental illness.
“This study aims to evaluate whether an association exists between a patient’s psychological state and the perception of patient-clinician encounters,” wrote Charlotte Read, MBBS, of Imperial College London, and April W. Armstrong, MD, MPH, of the University of Southern California, Los Angeles, in JAMA Dermatology.
The researchers retrospectively analyzed longitudinal data from over 8.8 million U.S. adults (unweighted, 652) with psoriasis who participated in the Medical Expenditure Panel Survey from 2004 to 2017. The nationally representative database includes various clinical information, such as data on patient demographics, health care use, and mental health comorbidities.
The primary outcome, patient satisfaction with their physician, was assessed using a patient-physician communication composite score. Mental health comorbidities were evaluated using standard questionnaires.
The mean age of study patients was 52.1 years (range, 0.7 years), and most were female (54%). In all, 73% of participants had no or mild psychological distress symptoms, and 27% had moderate or severe symptoms.
After analysis, the researchers found that patients with moderate psychological distress symptoms were 2.8 times more likely to report lower satisfaction with their physician than were those with no or mild symptoms (adjusted odds ratio, 2.8; P = .001). They also reported that patients with severe symptoms were more likely to report lower satisfaction (aOR, 2.3; P = .03).
“Patients with moderate or severe depression symptoms were less satisfied with their clinicians, compared with those with no or mild depression symptoms,” they further explained.
Based on the results, the coinvestigators emphasized the importance of bettering the patient experience for those with mental illness given the potential association with improved health outcomes.
“Because depressed patients can be more sensitive to negative communication, the clinician needs to be more conscious about using a positive and supportive communication style,” they recommended.
The authors acknowledged the inadequacy of evaluating clinician performance using patient satisfaction alone. As a result, the findings may not be generalizable to all clinical settings.
The study was funded by the National Psoriasis Foundation. Dr. Armstrong reported financial affiliations with several pharmaceutical companies.
SOURCE: Read C, Armstrong AW. JAMA Dermatol. 2020 May 6. doi: 10.1001/jamadermatol.2020.1054.
according to a retrospective analysis of survey data.
The findings highlight the importance of clinicians being supportive and adaptable in their communication style when interacting with psoriasis patients with mental illness.
“This study aims to evaluate whether an association exists between a patient’s psychological state and the perception of patient-clinician encounters,” wrote Charlotte Read, MBBS, of Imperial College London, and April W. Armstrong, MD, MPH, of the University of Southern California, Los Angeles, in JAMA Dermatology.
The researchers retrospectively analyzed longitudinal data from over 8.8 million U.S. adults (unweighted, 652) with psoriasis who participated in the Medical Expenditure Panel Survey from 2004 to 2017. The nationally representative database includes various clinical information, such as data on patient demographics, health care use, and mental health comorbidities.
The primary outcome, patient satisfaction with their physician, was assessed using a patient-physician communication composite score. Mental health comorbidities were evaluated using standard questionnaires.
The mean age of study patients was 52.1 years (range, 0.7 years), and most were female (54%). In all, 73% of participants had no or mild psychological distress symptoms, and 27% had moderate or severe symptoms.
After analysis, the researchers found that patients with moderate psychological distress symptoms were 2.8 times more likely to report lower satisfaction with their physician than were those with no or mild symptoms (adjusted odds ratio, 2.8; P = .001). They also reported that patients with severe symptoms were more likely to report lower satisfaction (aOR, 2.3; P = .03).
“Patients with moderate or severe depression symptoms were less satisfied with their clinicians, compared with those with no or mild depression symptoms,” they further explained.
Based on the results, the coinvestigators emphasized the importance of bettering the patient experience for those with mental illness given the potential association with improved health outcomes.
“Because depressed patients can be more sensitive to negative communication, the clinician needs to be more conscious about using a positive and supportive communication style,” they recommended.
The authors acknowledged the inadequacy of evaluating clinician performance using patient satisfaction alone. As a result, the findings may not be generalizable to all clinical settings.
The study was funded by the National Psoriasis Foundation. Dr. Armstrong reported financial affiliations with several pharmaceutical companies.
SOURCE: Read C, Armstrong AW. JAMA Dermatol. 2020 May 6. doi: 10.1001/jamadermatol.2020.1054.
FROM JAMA DERMATOLOGY
Bariatric surgery in advanced heart failure wins transplant eligibility
Bariatric surgery is a safe and effective means for obese patients with advanced heart failure supported by a left ventricular assist device to qualify for heart transplantation, Praneet Wander, MD, reported in an abstract released as part of the annual Digestive Disease Week®.
She presented a systematic review and meta-analysis of nine retrospective or cross-sectional cohort studies totaling
Of the 86 patients, 50 (58%) were able to drop their BMI below 35, a requirement for inclusion on the heart transplant waiting list, noted Dr. Wander, a gastroenterology fellow at Hofstra University, Hempstead, N.Y., and North Shore LIJ Hospital in Manhasset, N.Y.
“A lot of bariatric surgeons don’t feel comfortable operating on patients who have a low ejection fraction,” she explained in an interview. “This study should encourage bariatric surgeons to do procedures even in patients with advanced heart failure so they can meet the BMI requirement for heart transplantation.”
Even if patients don’t actually undergo heart transplantation because of the perpetual donor organ shortage or inability to meet non–BMI-related eligibility criteria, they gain other major benefits from bariatric surgery: Their blood pressure goes down, their diabetes improves, and they become better able to engage in physical activity, she added.
Of the 86 patients in the meta-analysis, 84 underwent laparoscopic sleeve gastrectomy. That’s the preferred bariatric operation in patients with advanced heart failure at the Mayo Clinic as well, according to Andres J. Acosta, MD, PhD, a gastroenterologist at the medical center in Rochester, Minn.
There’s less weight loss achieved than with an open Roux-en-Y gastric bypass, but it’s a simpler operation in these high-risk patients, who typically have multiple comorbid conditions, he explained.
He predicted that Dr. Wander’s study will indeed influence bariatric surgeons at tertiary medical centers around the country to become more willing to consider weight-loss surgery in patients with advanced heart failure, while those in community practice will likely continue to be most comfortable operating on more stable patients with minimal comorbidities aside from their obesity.
“Data such as [these] will be reassuring to bariatric surgery programs such as ours, where we’re able to say: ‘Yes, there are risks, but these patients will benefit in the long term if we assume those risks,’ ” Dr. Acosta said.
He’s confident that, in the near future, the preferred form of bariatric surgery in patients with advanced heart failure will be a minimally invasive procedure performed endoscopically by gastroenterologists. He and his Mayo Clinic colleagues have already established a track record of success with endoscopic sleeve gastrectomy in patients with advanced kidney, liver, or lung disease in order to make them eligible for transplantation, as well as for the ancillary benefits provided by massive weight loss.
“There’s a little less weight loss than with laparoscopic sleeve gastrectomy, but it’s a significantly less risky operation. Shorter operative time, shorter hospital length of stay, less risk of infections and leaks,” he said in an interview. “We haven’t done it yet in heart disease, but I think based on this study this should be the next step at Mayo.”
Radha Gopalan, MD, director of heart failure and transplantation at Banner–University Medical Center in Phoenix, pronounced Dr. Wander’s meta-analysis “a positive study that’s very supportive of what we’re doing at our center.
“At a busy heart transplant center like ours, we are comfortable managing these patients, so the bariatric surgeons are reassured that the heart failure team is behind them. The risk of the procedure is mitigated by the availability of the multidisciplinary team to get the patient with obesity and heart failure through the surgery,” he explained.
Dr. Gopalan heads a novel bariatric heart failure program at Banner. While Dr. Wander’s meta-analysis focused on bariatric surgery in heart failure patients on LVAD circulatory support, Dr. Gopalan and colleagues are moving the intervention upstream. Roughly roughly 80% of patients in his bariatric heart failure program who meet criteria for LVAD implantation are now offered bariatric surgery before an LVAD is put in.
“I am moving away from putting the LVAD in first and then doing bariatric surgery. We have gotten comfortable taking these patients for bariatric surgery with inotropic support before going to the LVAD, which has the potential to even eliminate the requirement for an LVAD. Some patients get so much better that they become transplant ineligible,” Dr. Gopalan said.
Dr. Wander reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Wander P. DDW 2020 Abstract, #Mo2010.
Bariatric surgery is a safe and effective means for obese patients with advanced heart failure supported by a left ventricular assist device to qualify for heart transplantation, Praneet Wander, MD, reported in an abstract released as part of the annual Digestive Disease Week®.
She presented a systematic review and meta-analysis of nine retrospective or cross-sectional cohort studies totaling
Of the 86 patients, 50 (58%) were able to drop their BMI below 35, a requirement for inclusion on the heart transplant waiting list, noted Dr. Wander, a gastroenterology fellow at Hofstra University, Hempstead, N.Y., and North Shore LIJ Hospital in Manhasset, N.Y.
“A lot of bariatric surgeons don’t feel comfortable operating on patients who have a low ejection fraction,” she explained in an interview. “This study should encourage bariatric surgeons to do procedures even in patients with advanced heart failure so they can meet the BMI requirement for heart transplantation.”
Even if patients don’t actually undergo heart transplantation because of the perpetual donor organ shortage or inability to meet non–BMI-related eligibility criteria, they gain other major benefits from bariatric surgery: Their blood pressure goes down, their diabetes improves, and they become better able to engage in physical activity, she added.
Of the 86 patients in the meta-analysis, 84 underwent laparoscopic sleeve gastrectomy. That’s the preferred bariatric operation in patients with advanced heart failure at the Mayo Clinic as well, according to Andres J. Acosta, MD, PhD, a gastroenterologist at the medical center in Rochester, Minn.
There’s less weight loss achieved than with an open Roux-en-Y gastric bypass, but it’s a simpler operation in these high-risk patients, who typically have multiple comorbid conditions, he explained.
He predicted that Dr. Wander’s study will indeed influence bariatric surgeons at tertiary medical centers around the country to become more willing to consider weight-loss surgery in patients with advanced heart failure, while those in community practice will likely continue to be most comfortable operating on more stable patients with minimal comorbidities aside from their obesity.
“Data such as [these] will be reassuring to bariatric surgery programs such as ours, where we’re able to say: ‘Yes, there are risks, but these patients will benefit in the long term if we assume those risks,’ ” Dr. Acosta said.
He’s confident that, in the near future, the preferred form of bariatric surgery in patients with advanced heart failure will be a minimally invasive procedure performed endoscopically by gastroenterologists. He and his Mayo Clinic colleagues have already established a track record of success with endoscopic sleeve gastrectomy in patients with advanced kidney, liver, or lung disease in order to make them eligible for transplantation, as well as for the ancillary benefits provided by massive weight loss.
“There’s a little less weight loss than with laparoscopic sleeve gastrectomy, but it’s a significantly less risky operation. Shorter operative time, shorter hospital length of stay, less risk of infections and leaks,” he said in an interview. “We haven’t done it yet in heart disease, but I think based on this study this should be the next step at Mayo.”
Radha Gopalan, MD, director of heart failure and transplantation at Banner–University Medical Center in Phoenix, pronounced Dr. Wander’s meta-analysis “a positive study that’s very supportive of what we’re doing at our center.
“At a busy heart transplant center like ours, we are comfortable managing these patients, so the bariatric surgeons are reassured that the heart failure team is behind them. The risk of the procedure is mitigated by the availability of the multidisciplinary team to get the patient with obesity and heart failure through the surgery,” he explained.
Dr. Gopalan heads a novel bariatric heart failure program at Banner. While Dr. Wander’s meta-analysis focused on bariatric surgery in heart failure patients on LVAD circulatory support, Dr. Gopalan and colleagues are moving the intervention upstream. Roughly roughly 80% of patients in his bariatric heart failure program who meet criteria for LVAD implantation are now offered bariatric surgery before an LVAD is put in.
“I am moving away from putting the LVAD in first and then doing bariatric surgery. We have gotten comfortable taking these patients for bariatric surgery with inotropic support before going to the LVAD, which has the potential to even eliminate the requirement for an LVAD. Some patients get so much better that they become transplant ineligible,” Dr. Gopalan said.
Dr. Wander reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Wander P. DDW 2020 Abstract, #Mo2010.
Bariatric surgery is a safe and effective means for obese patients with advanced heart failure supported by a left ventricular assist device to qualify for heart transplantation, Praneet Wander, MD, reported in an abstract released as part of the annual Digestive Disease Week®.
She presented a systematic review and meta-analysis of nine retrospective or cross-sectional cohort studies totaling
Of the 86 patients, 50 (58%) were able to drop their BMI below 35, a requirement for inclusion on the heart transplant waiting list, noted Dr. Wander, a gastroenterology fellow at Hofstra University, Hempstead, N.Y., and North Shore LIJ Hospital in Manhasset, N.Y.
“A lot of bariatric surgeons don’t feel comfortable operating on patients who have a low ejection fraction,” she explained in an interview. “This study should encourage bariatric surgeons to do procedures even in patients with advanced heart failure so they can meet the BMI requirement for heart transplantation.”
Even if patients don’t actually undergo heart transplantation because of the perpetual donor organ shortage or inability to meet non–BMI-related eligibility criteria, they gain other major benefits from bariatric surgery: Their blood pressure goes down, their diabetes improves, and they become better able to engage in physical activity, she added.
Of the 86 patients in the meta-analysis, 84 underwent laparoscopic sleeve gastrectomy. That’s the preferred bariatric operation in patients with advanced heart failure at the Mayo Clinic as well, according to Andres J. Acosta, MD, PhD, a gastroenterologist at the medical center in Rochester, Minn.
There’s less weight loss achieved than with an open Roux-en-Y gastric bypass, but it’s a simpler operation in these high-risk patients, who typically have multiple comorbid conditions, he explained.
He predicted that Dr. Wander’s study will indeed influence bariatric surgeons at tertiary medical centers around the country to become more willing to consider weight-loss surgery in patients with advanced heart failure, while those in community practice will likely continue to be most comfortable operating on more stable patients with minimal comorbidities aside from their obesity.
“Data such as [these] will be reassuring to bariatric surgery programs such as ours, where we’re able to say: ‘Yes, there are risks, but these patients will benefit in the long term if we assume those risks,’ ” Dr. Acosta said.
He’s confident that, in the near future, the preferred form of bariatric surgery in patients with advanced heart failure will be a minimally invasive procedure performed endoscopically by gastroenterologists. He and his Mayo Clinic colleagues have already established a track record of success with endoscopic sleeve gastrectomy in patients with advanced kidney, liver, or lung disease in order to make them eligible for transplantation, as well as for the ancillary benefits provided by massive weight loss.
“There’s a little less weight loss than with laparoscopic sleeve gastrectomy, but it’s a significantly less risky operation. Shorter operative time, shorter hospital length of stay, less risk of infections and leaks,” he said in an interview. “We haven’t done it yet in heart disease, but I think based on this study this should be the next step at Mayo.”
Radha Gopalan, MD, director of heart failure and transplantation at Banner–University Medical Center in Phoenix, pronounced Dr. Wander’s meta-analysis “a positive study that’s very supportive of what we’re doing at our center.
“At a busy heart transplant center like ours, we are comfortable managing these patients, so the bariatric surgeons are reassured that the heart failure team is behind them. The risk of the procedure is mitigated by the availability of the multidisciplinary team to get the patient with obesity and heart failure through the surgery,” he explained.
Dr. Gopalan heads a novel bariatric heart failure program at Banner. While Dr. Wander’s meta-analysis focused on bariatric surgery in heart failure patients on LVAD circulatory support, Dr. Gopalan and colleagues are moving the intervention upstream. Roughly roughly 80% of patients in his bariatric heart failure program who meet criteria for LVAD implantation are now offered bariatric surgery before an LVAD is put in.
“I am moving away from putting the LVAD in first and then doing bariatric surgery. We have gotten comfortable taking these patients for bariatric surgery with inotropic support before going to the LVAD, which has the potential to even eliminate the requirement for an LVAD. Some patients get so much better that they become transplant ineligible,” Dr. Gopalan said.
Dr. Wander reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Wander P. DDW 2020 Abstract, #Mo2010.
FROM DDW 2020
Hazard pay included in new COVID-19 relief bill
Hazard pay for frontline health care workers – an idea that has been championed by President Donald J. Trump and Senate Minority Leader Chuck Schumer, among others – is included in a just-released COVID-19 relief package assembled by Democrats in the House of Representatives.
according to a report in the Washington Post.
But it is far from a done deal. “The Democrats’ spending bill is a Pelosi-led pipe dream written in private,” said House Republican Leader Kevin McCarthy (Calif.) in a Fox News interview posted May 12 on Facebook.
Senate Majority Leader Mitch McConnell condemned the package. “This is exactly the wrong approach,” he said in a prepared statement that instead laid out a variety of liability protections, which he said should be the first priority.
“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” said Sen. McConnell, adding that his plan would “raise the liability threshold for COVID-related malpractice lawsuits.”
Ingrida Lusis, vice president of government affairs and health policy at the American Nurses Association, said in an interview that the ANA had lobbied for hazard pay and was told it would be in the next relief package.
“Though there is an inherent risk in the nursing profession, we think that this is really critical to ensuring that we have a workforce to meet the intense demands of this pandemic,” said Ms. Lusis.
“If health care workers are not treated and compensated appropriately for what they’re going through right now, then we may not have a next generation that will want to enter the field,” she said.
Various nursing organizations, nurses’ unions, and health care unions, such as the American Federation of State, County and Municipal Employees (AFSCME) and the Service Employees International Union, have advocated for hazard pay.
Physicians’ organizations have not been vocal on the issue, however. The American Medical Association, for instance, pushed for hazard pay for residents but has not made any further public statements. An AMA spokesman said that the group was monitoring the situation but declined further comment.
Multiple online petitions seeking hazard pay for health care workers have been circulated, including one seeking the same $600 bump for essential workers that was given out as part of unemployment benefits in the first COVID-19 relief package. More than 1.2 million had signed the petition as of May 12.
‘Heroes fund’
The president first suggested hazard pay for health care workers on March 30 Fox News broadcast. “These are really brave people,” he said, adding that the administration was considering different ways of boosting pay, primarily through hospitals.
“We are asking the hospitals to do it and to consider something, including bonuses,” said Trump. “If anybody’s entitled to it, they are.”
On April 7, Sen. Schumer proposed a “Heroes Fund.” It would give public, private, and tribal frontline employees – including doctors, nurses, first responders, and transit, grocery, and postal workers – a $13 per hour raise up to $25,000 in additional pay through Dec. 31 for workers earning up to $200,000 and $5,000 in additional pay for those earning more than $200,000. It would also provide a $15,000 signing bonus to those who agree to take on such a position.
Rep. Matt Cartwright (D-Pa.) introduced a bill in mid-April, the Coronavirus Frontline Workers Fair Pay Act (HR 6709), that would provide similar pay increases. Health care workers would receive an additional $13 per hour. It would be retroactive to Jan. 31, 2020, and would be available through the end of 2020.
Molly Kinder of the Brookings Institution, a self-described nonpartisan Washington policy institute, estimates that Sen. Schumer’s proposal would represent the equivalent of double-time pay for the average low-wage worker, a 50% pay increase for a mail carrier, a 20% boost for a pharmacist, and less than a 15% increase for a surgeon, as determined from median 2018 wages.
Before the House Democrats unveiled their bill, Isabel Soto of the center-right group American Action Forum estimated that a $13 per hour wage increase could cost $398.9 billion just from the end of March to the end of September. A great proportion of that amount – $264 billion – would go to some 10 million health care workers, Ms. Soto calculated.
Some already offering pay boost
A few states and hospital systems are already offering hazard pay.
On April 12, Massachusetts agreed to give about 6,500 AFSCME union members who work at state human services facilities and group homes a $5 or a $10 per hour pay increase, depending on duties. It was to stay in effect until at least May 30.
Maine Governor Janet Mills (D) also agreed to increase pay by $3-$5 an hour for AFSCME workers in state correctional and mental health facilities beginning March 29.
In New York City, the biggest hospital network, Northwell Health, in late April gave 45,000 workers – including nurses, physicians, respiratory therapists, environmental services workers, housekeepers, and people in outpatient and corporate roles – a lump sum bonus payment of up to $2,500 and 1 week of paid time off. The money came out of the system’s general fund.
“As an organization, we want to continue to support, motivate and inspire our team members,” said Northwell President and CEO Michael Dowling in a statement at the time.
On April 2, New York–Presbyterian Hospital’s chair of the department of surgery, Craig Smith, MD, announced that the facility was “providing a $1,250 bonus for everyone who has worked in or supported the COVID-19 front lines, for at least 1 week.”
Advocate Aurora, with 15 hospitals and 32,000 employees in Wisconsin, said in early April that it was giving increases of $6.25-$15.00 an hour at least through the end of May.
A version of this article originally appeared on Medscape.com.
Hazard pay for frontline health care workers – an idea that has been championed by President Donald J. Trump and Senate Minority Leader Chuck Schumer, among others – is included in a just-released COVID-19 relief package assembled by Democrats in the House of Representatives.
according to a report in the Washington Post.
But it is far from a done deal. “The Democrats’ spending bill is a Pelosi-led pipe dream written in private,” said House Republican Leader Kevin McCarthy (Calif.) in a Fox News interview posted May 12 on Facebook.
Senate Majority Leader Mitch McConnell condemned the package. “This is exactly the wrong approach,” he said in a prepared statement that instead laid out a variety of liability protections, which he said should be the first priority.
“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” said Sen. McConnell, adding that his plan would “raise the liability threshold for COVID-related malpractice lawsuits.”
Ingrida Lusis, vice president of government affairs and health policy at the American Nurses Association, said in an interview that the ANA had lobbied for hazard pay and was told it would be in the next relief package.
“Though there is an inherent risk in the nursing profession, we think that this is really critical to ensuring that we have a workforce to meet the intense demands of this pandemic,” said Ms. Lusis.
“If health care workers are not treated and compensated appropriately for what they’re going through right now, then we may not have a next generation that will want to enter the field,” she said.
Various nursing organizations, nurses’ unions, and health care unions, such as the American Federation of State, County and Municipal Employees (AFSCME) and the Service Employees International Union, have advocated for hazard pay.
Physicians’ organizations have not been vocal on the issue, however. The American Medical Association, for instance, pushed for hazard pay for residents but has not made any further public statements. An AMA spokesman said that the group was monitoring the situation but declined further comment.
Multiple online petitions seeking hazard pay for health care workers have been circulated, including one seeking the same $600 bump for essential workers that was given out as part of unemployment benefits in the first COVID-19 relief package. More than 1.2 million had signed the petition as of May 12.
‘Heroes fund’
The president first suggested hazard pay for health care workers on March 30 Fox News broadcast. “These are really brave people,” he said, adding that the administration was considering different ways of boosting pay, primarily through hospitals.
“We are asking the hospitals to do it and to consider something, including bonuses,” said Trump. “If anybody’s entitled to it, they are.”
On April 7, Sen. Schumer proposed a “Heroes Fund.” It would give public, private, and tribal frontline employees – including doctors, nurses, first responders, and transit, grocery, and postal workers – a $13 per hour raise up to $25,000 in additional pay through Dec. 31 for workers earning up to $200,000 and $5,000 in additional pay for those earning more than $200,000. It would also provide a $15,000 signing bonus to those who agree to take on such a position.
Rep. Matt Cartwright (D-Pa.) introduced a bill in mid-April, the Coronavirus Frontline Workers Fair Pay Act (HR 6709), that would provide similar pay increases. Health care workers would receive an additional $13 per hour. It would be retroactive to Jan. 31, 2020, and would be available through the end of 2020.
Molly Kinder of the Brookings Institution, a self-described nonpartisan Washington policy institute, estimates that Sen. Schumer’s proposal would represent the equivalent of double-time pay for the average low-wage worker, a 50% pay increase for a mail carrier, a 20% boost for a pharmacist, and less than a 15% increase for a surgeon, as determined from median 2018 wages.
Before the House Democrats unveiled their bill, Isabel Soto of the center-right group American Action Forum estimated that a $13 per hour wage increase could cost $398.9 billion just from the end of March to the end of September. A great proportion of that amount – $264 billion – would go to some 10 million health care workers, Ms. Soto calculated.
Some already offering pay boost
A few states and hospital systems are already offering hazard pay.
On April 12, Massachusetts agreed to give about 6,500 AFSCME union members who work at state human services facilities and group homes a $5 or a $10 per hour pay increase, depending on duties. It was to stay in effect until at least May 30.
Maine Governor Janet Mills (D) also agreed to increase pay by $3-$5 an hour for AFSCME workers in state correctional and mental health facilities beginning March 29.
In New York City, the biggest hospital network, Northwell Health, in late April gave 45,000 workers – including nurses, physicians, respiratory therapists, environmental services workers, housekeepers, and people in outpatient and corporate roles – a lump sum bonus payment of up to $2,500 and 1 week of paid time off. The money came out of the system’s general fund.
“As an organization, we want to continue to support, motivate and inspire our team members,” said Northwell President and CEO Michael Dowling in a statement at the time.
On April 2, New York–Presbyterian Hospital’s chair of the department of surgery, Craig Smith, MD, announced that the facility was “providing a $1,250 bonus for everyone who has worked in or supported the COVID-19 front lines, for at least 1 week.”
Advocate Aurora, with 15 hospitals and 32,000 employees in Wisconsin, said in early April that it was giving increases of $6.25-$15.00 an hour at least through the end of May.
A version of this article originally appeared on Medscape.com.
Hazard pay for frontline health care workers – an idea that has been championed by President Donald J. Trump and Senate Minority Leader Chuck Schumer, among others – is included in a just-released COVID-19 relief package assembled by Democrats in the House of Representatives.
according to a report in the Washington Post.
But it is far from a done deal. “The Democrats’ spending bill is a Pelosi-led pipe dream written in private,” said House Republican Leader Kevin McCarthy (Calif.) in a Fox News interview posted May 12 on Facebook.
Senate Majority Leader Mitch McConnell condemned the package. “This is exactly the wrong approach,” he said in a prepared statement that instead laid out a variety of liability protections, which he said should be the first priority.
“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” said Sen. McConnell, adding that his plan would “raise the liability threshold for COVID-related malpractice lawsuits.”
Ingrida Lusis, vice president of government affairs and health policy at the American Nurses Association, said in an interview that the ANA had lobbied for hazard pay and was told it would be in the next relief package.
“Though there is an inherent risk in the nursing profession, we think that this is really critical to ensuring that we have a workforce to meet the intense demands of this pandemic,” said Ms. Lusis.
“If health care workers are not treated and compensated appropriately for what they’re going through right now, then we may not have a next generation that will want to enter the field,” she said.
Various nursing organizations, nurses’ unions, and health care unions, such as the American Federation of State, County and Municipal Employees (AFSCME) and the Service Employees International Union, have advocated for hazard pay.
Physicians’ organizations have not been vocal on the issue, however. The American Medical Association, for instance, pushed for hazard pay for residents but has not made any further public statements. An AMA spokesman said that the group was monitoring the situation but declined further comment.
Multiple online petitions seeking hazard pay for health care workers have been circulated, including one seeking the same $600 bump for essential workers that was given out as part of unemployment benefits in the first COVID-19 relief package. More than 1.2 million had signed the petition as of May 12.
‘Heroes fund’
The president first suggested hazard pay for health care workers on March 30 Fox News broadcast. “These are really brave people,” he said, adding that the administration was considering different ways of boosting pay, primarily through hospitals.
“We are asking the hospitals to do it and to consider something, including bonuses,” said Trump. “If anybody’s entitled to it, they are.”
On April 7, Sen. Schumer proposed a “Heroes Fund.” It would give public, private, and tribal frontline employees – including doctors, nurses, first responders, and transit, grocery, and postal workers – a $13 per hour raise up to $25,000 in additional pay through Dec. 31 for workers earning up to $200,000 and $5,000 in additional pay for those earning more than $200,000. It would also provide a $15,000 signing bonus to those who agree to take on such a position.
Rep. Matt Cartwright (D-Pa.) introduced a bill in mid-April, the Coronavirus Frontline Workers Fair Pay Act (HR 6709), that would provide similar pay increases. Health care workers would receive an additional $13 per hour. It would be retroactive to Jan. 31, 2020, and would be available through the end of 2020.
Molly Kinder of the Brookings Institution, a self-described nonpartisan Washington policy institute, estimates that Sen. Schumer’s proposal would represent the equivalent of double-time pay for the average low-wage worker, a 50% pay increase for a mail carrier, a 20% boost for a pharmacist, and less than a 15% increase for a surgeon, as determined from median 2018 wages.
Before the House Democrats unveiled their bill, Isabel Soto of the center-right group American Action Forum estimated that a $13 per hour wage increase could cost $398.9 billion just from the end of March to the end of September. A great proportion of that amount – $264 billion – would go to some 10 million health care workers, Ms. Soto calculated.
Some already offering pay boost
A few states and hospital systems are already offering hazard pay.
On April 12, Massachusetts agreed to give about 6,500 AFSCME union members who work at state human services facilities and group homes a $5 or a $10 per hour pay increase, depending on duties. It was to stay in effect until at least May 30.
Maine Governor Janet Mills (D) also agreed to increase pay by $3-$5 an hour for AFSCME workers in state correctional and mental health facilities beginning March 29.
In New York City, the biggest hospital network, Northwell Health, in late April gave 45,000 workers – including nurses, physicians, respiratory therapists, environmental services workers, housekeepers, and people in outpatient and corporate roles – a lump sum bonus payment of up to $2,500 and 1 week of paid time off. The money came out of the system’s general fund.
“As an organization, we want to continue to support, motivate and inspire our team members,” said Northwell President and CEO Michael Dowling in a statement at the time.
On April 2, New York–Presbyterian Hospital’s chair of the department of surgery, Craig Smith, MD, announced that the facility was “providing a $1,250 bonus for everyone who has worked in or supported the COVID-19 front lines, for at least 1 week.”
Advocate Aurora, with 15 hospitals and 32,000 employees in Wisconsin, said in early April that it was giving increases of $6.25-$15.00 an hour at least through the end of May.
A version of this article originally appeared on Medscape.com.
Summary of the IDSA guidelines on the diagnosis of COVID-19
These guidelines were developed using a rigorous evidence-based approach, the GRADE framework, which involved identifying the important questions that need to be addressed ahead of time and, later, integrating the best available evidence into the recommendations.
The Food and Drug Administration’s Emergency Use Authorization is useful for understanding any recommendations related to COVID-19 testing. Under usual FDA approval, a manufacturer has to submit data on the performance of a test in human subjects. Under the Emergency Use Authorization for development and approval of SARS-CoV-2 testing, approval is based on “acceptable analytical accuracy,” meaning that a test is assessed using manufactured reagents. The approved test is not tested in real-world clinical situations prior to FDA approval, and the test’s sensitivity and specificity are not well described.
IDSA formulated 15 recommendations, of which the most relevant to primary care clinicians are described and discussed below. The complete set of recommendations can be viewed on the IDSA website:
Recommendation 1
The IDSA panel recommends a SARS-CoV-2 nucleic acid amplification test in symptomatic individuals in the community suspected of having COVID-19, even when the clinical suspicion is low (strong recommendation, very low certainty of evidence). The panel placed a high value on accurate assessment of COVID-19 with the intent of minimizing overdiagnosis of COVID-19 using clinical diagnosis alone. Without testing, the rate of overdiagnosis ranges from 62% to 98%.
If patients are misdiagnosed as having COVID-19, they may spend unnecessary time in quarantine and then may stop taking appropriate safety precautions to protect themselves from infection.
Recommendation 2
The IDSA panel suggests collecting nasopharyngeal, or mid-turbinate or nasal swabs, rather than oropharyngeal swabs or saliva alone for SARS-CoV-2 RNA testing in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, very low certainty of evidence).
The rationale for this recommendation is that comparative data showed a much lower sensitivity for oral sampling, compared with nasopharyngeal, mid-turbinate, or nasal sampling.
The average sensitivity of oral swabs is 56%, compared with nasopharyngeal at 97%, mid-turbinate at 100%, and nasal sampling at 95%. Given these test characteristics, there are far less false-negative tests with nasopharyngeal, mid-turbinate, and nasal swabs. Fewer false negatives means fewer instances of incorrectly telling COVID-19–positive patients that they do not have the illness. An exciting new area of testing that is being evaluated is saliva, which appears to have a sensitivity of 85%.
Recommendation 3
The IDSA panel suggests that nasal and mid-turbinate swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or health care providers in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, low certainty of evidence).
This recommendation is particularly exciting because patient self-collection provides the potential for health care personnel to avoid exposure to infection, as can occur when health care personnel are swabbing a patient; this is ow testing has been done at most testing centers.
While the data are limited, it appears that patient self-collection of nasal or mid-turbinate swabs results in similar detection rates as occurs with health care personnel–collected nasopharyngeal swabs.
Recommendation 6
The IDSA panel suggests repeating viral RNA testing when the initial test is negative (versus performing a single test) in symptomatic individuals with an intermediate or high clinical suspicion of COVID-19 (conditional recommendation, low certainty of evidence).
Since none of the tests are perfect and any can have false negatives, the panel places a high value on detecting infection when present. If there is a low clinical likelihood of disease, the panel recommends not retesting. When the clinical likelihood of COVID-19 is moderate to high, in the event that the initial test is negative, the panel recommends retesting for COVID-19 1-2 days after the initial test.
Recommendation 8
The IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, very low certainty of evidence).
For this recommendation, a known contact is defined as someone who has had direct contact with a confirmed case.
A suspected exposure occurs when someone is working or living in a congregate setting such as long-term care, a correctional facility, or a cruise ship in which there is an outbreak. The time frame during which to do post-exposure testing is five to seven days after the exposure.
Recommendation 10
The IDSA panel recommends direct SARS-CoV-2 RNA testing in asymptomatic individuals with no known contact with COVID-19 who are being hospitalized in areas with a high prevalence of COVID-19 in the community (conditional recommendation, very low certainty of evidence).
The idea is to do rapid testing to identify individuals entering the hospital either for other illnesses or for procedures, in order to be able to institute appropriate precautions and decrease the likelihood of nosocomial transmission and/or transmission to health care personnel. It is worth noting that the recommendations do not address testing in areas with a low or intermediate prevalence of COVID-19. In the absence of an official guideline-based-recommendation, the decision about testing needs to made by the local hospital system.
Recommendations 11, 12, and 13
The IDSA panel recommends SARS-CoV-2 RNA testing in immunocompromised asymptomatic individuals who are being admitted to the hospital and in asymptomatic individuals prior to receiving immunosuppressive therapy regardless of exposure to COVID-19. It is also recommended to test asymptomatic individuals planning to undergo major surgery.
The rationale for this recommendation is that patients who are to receive chemotherapy, other immunosuppressive procedures, or surgery are at high risk if they have COVID-19 and may be better off delaying the procedure.
Some additional issues were addressed, though not in the form of additional recommendations. It was clarified that some individuals remain nucleic acid positive after their symptoms resolve, and sometimes even after seroconversion. It is not clear if those individuals remain infectious to others. The recommendations did not address serologic testing for public health surveillance.
Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
SOURCE: Hanson KE et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19.
These guidelines were developed using a rigorous evidence-based approach, the GRADE framework, which involved identifying the important questions that need to be addressed ahead of time and, later, integrating the best available evidence into the recommendations.
The Food and Drug Administration’s Emergency Use Authorization is useful for understanding any recommendations related to COVID-19 testing. Under usual FDA approval, a manufacturer has to submit data on the performance of a test in human subjects. Under the Emergency Use Authorization for development and approval of SARS-CoV-2 testing, approval is based on “acceptable analytical accuracy,” meaning that a test is assessed using manufactured reagents. The approved test is not tested in real-world clinical situations prior to FDA approval, and the test’s sensitivity and specificity are not well described.
IDSA formulated 15 recommendations, of which the most relevant to primary care clinicians are described and discussed below. The complete set of recommendations can be viewed on the IDSA website:
Recommendation 1
The IDSA panel recommends a SARS-CoV-2 nucleic acid amplification test in symptomatic individuals in the community suspected of having COVID-19, even when the clinical suspicion is low (strong recommendation, very low certainty of evidence). The panel placed a high value on accurate assessment of COVID-19 with the intent of minimizing overdiagnosis of COVID-19 using clinical diagnosis alone. Without testing, the rate of overdiagnosis ranges from 62% to 98%.
If patients are misdiagnosed as having COVID-19, they may spend unnecessary time in quarantine and then may stop taking appropriate safety precautions to protect themselves from infection.
Recommendation 2
The IDSA panel suggests collecting nasopharyngeal, or mid-turbinate or nasal swabs, rather than oropharyngeal swabs or saliva alone for SARS-CoV-2 RNA testing in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, very low certainty of evidence).
The rationale for this recommendation is that comparative data showed a much lower sensitivity for oral sampling, compared with nasopharyngeal, mid-turbinate, or nasal sampling.
The average sensitivity of oral swabs is 56%, compared with nasopharyngeal at 97%, mid-turbinate at 100%, and nasal sampling at 95%. Given these test characteristics, there are far less false-negative tests with nasopharyngeal, mid-turbinate, and nasal swabs. Fewer false negatives means fewer instances of incorrectly telling COVID-19–positive patients that they do not have the illness. An exciting new area of testing that is being evaluated is saliva, which appears to have a sensitivity of 85%.
Recommendation 3
The IDSA panel suggests that nasal and mid-turbinate swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or health care providers in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, low certainty of evidence).
This recommendation is particularly exciting because patient self-collection provides the potential for health care personnel to avoid exposure to infection, as can occur when health care personnel are swabbing a patient; this is ow testing has been done at most testing centers.
While the data are limited, it appears that patient self-collection of nasal or mid-turbinate swabs results in similar detection rates as occurs with health care personnel–collected nasopharyngeal swabs.
Recommendation 6
The IDSA panel suggests repeating viral RNA testing when the initial test is negative (versus performing a single test) in symptomatic individuals with an intermediate or high clinical suspicion of COVID-19 (conditional recommendation, low certainty of evidence).
Since none of the tests are perfect and any can have false negatives, the panel places a high value on detecting infection when present. If there is a low clinical likelihood of disease, the panel recommends not retesting. When the clinical likelihood of COVID-19 is moderate to high, in the event that the initial test is negative, the panel recommends retesting for COVID-19 1-2 days after the initial test.
Recommendation 8
The IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, very low certainty of evidence).
For this recommendation, a known contact is defined as someone who has had direct contact with a confirmed case.
A suspected exposure occurs when someone is working or living in a congregate setting such as long-term care, a correctional facility, or a cruise ship in which there is an outbreak. The time frame during which to do post-exposure testing is five to seven days after the exposure.
Recommendation 10
The IDSA panel recommends direct SARS-CoV-2 RNA testing in asymptomatic individuals with no known contact with COVID-19 who are being hospitalized in areas with a high prevalence of COVID-19 in the community (conditional recommendation, very low certainty of evidence).
The idea is to do rapid testing to identify individuals entering the hospital either for other illnesses or for procedures, in order to be able to institute appropriate precautions and decrease the likelihood of nosocomial transmission and/or transmission to health care personnel. It is worth noting that the recommendations do not address testing in areas with a low or intermediate prevalence of COVID-19. In the absence of an official guideline-based-recommendation, the decision about testing needs to made by the local hospital system.
Recommendations 11, 12, and 13
The IDSA panel recommends SARS-CoV-2 RNA testing in immunocompromised asymptomatic individuals who are being admitted to the hospital and in asymptomatic individuals prior to receiving immunosuppressive therapy regardless of exposure to COVID-19. It is also recommended to test asymptomatic individuals planning to undergo major surgery.
The rationale for this recommendation is that patients who are to receive chemotherapy, other immunosuppressive procedures, or surgery are at high risk if they have COVID-19 and may be better off delaying the procedure.
Some additional issues were addressed, though not in the form of additional recommendations. It was clarified that some individuals remain nucleic acid positive after their symptoms resolve, and sometimes even after seroconversion. It is not clear if those individuals remain infectious to others. The recommendations did not address serologic testing for public health surveillance.
Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
SOURCE: Hanson KE et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19.
These guidelines were developed using a rigorous evidence-based approach, the GRADE framework, which involved identifying the important questions that need to be addressed ahead of time and, later, integrating the best available evidence into the recommendations.
The Food and Drug Administration’s Emergency Use Authorization is useful for understanding any recommendations related to COVID-19 testing. Under usual FDA approval, a manufacturer has to submit data on the performance of a test in human subjects. Under the Emergency Use Authorization for development and approval of SARS-CoV-2 testing, approval is based on “acceptable analytical accuracy,” meaning that a test is assessed using manufactured reagents. The approved test is not tested in real-world clinical situations prior to FDA approval, and the test’s sensitivity and specificity are not well described.
IDSA formulated 15 recommendations, of which the most relevant to primary care clinicians are described and discussed below. The complete set of recommendations can be viewed on the IDSA website:
Recommendation 1
The IDSA panel recommends a SARS-CoV-2 nucleic acid amplification test in symptomatic individuals in the community suspected of having COVID-19, even when the clinical suspicion is low (strong recommendation, very low certainty of evidence). The panel placed a high value on accurate assessment of COVID-19 with the intent of minimizing overdiagnosis of COVID-19 using clinical diagnosis alone. Without testing, the rate of overdiagnosis ranges from 62% to 98%.
If patients are misdiagnosed as having COVID-19, they may spend unnecessary time in quarantine and then may stop taking appropriate safety precautions to protect themselves from infection.
Recommendation 2
The IDSA panel suggests collecting nasopharyngeal, or mid-turbinate or nasal swabs, rather than oropharyngeal swabs or saliva alone for SARS-CoV-2 RNA testing in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, very low certainty of evidence).
The rationale for this recommendation is that comparative data showed a much lower sensitivity for oral sampling, compared with nasopharyngeal, mid-turbinate, or nasal sampling.
The average sensitivity of oral swabs is 56%, compared with nasopharyngeal at 97%, mid-turbinate at 100%, and nasal sampling at 95%. Given these test characteristics, there are far less false-negative tests with nasopharyngeal, mid-turbinate, and nasal swabs. Fewer false negatives means fewer instances of incorrectly telling COVID-19–positive patients that they do not have the illness. An exciting new area of testing that is being evaluated is saliva, which appears to have a sensitivity of 85%.
Recommendation 3
The IDSA panel suggests that nasal and mid-turbinate swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or health care providers in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, low certainty of evidence).
This recommendation is particularly exciting because patient self-collection provides the potential for health care personnel to avoid exposure to infection, as can occur when health care personnel are swabbing a patient; this is ow testing has been done at most testing centers.
While the data are limited, it appears that patient self-collection of nasal or mid-turbinate swabs results in similar detection rates as occurs with health care personnel–collected nasopharyngeal swabs.
Recommendation 6
The IDSA panel suggests repeating viral RNA testing when the initial test is negative (versus performing a single test) in symptomatic individuals with an intermediate or high clinical suspicion of COVID-19 (conditional recommendation, low certainty of evidence).
Since none of the tests are perfect and any can have false negatives, the panel places a high value on detecting infection when present. If there is a low clinical likelihood of disease, the panel recommends not retesting. When the clinical likelihood of COVID-19 is moderate to high, in the event that the initial test is negative, the panel recommends retesting for COVID-19 1-2 days after the initial test.
Recommendation 8
The IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, very low certainty of evidence).
For this recommendation, a known contact is defined as someone who has had direct contact with a confirmed case.
A suspected exposure occurs when someone is working or living in a congregate setting such as long-term care, a correctional facility, or a cruise ship in which there is an outbreak. The time frame during which to do post-exposure testing is five to seven days after the exposure.
Recommendation 10
The IDSA panel recommends direct SARS-CoV-2 RNA testing in asymptomatic individuals with no known contact with COVID-19 who are being hospitalized in areas with a high prevalence of COVID-19 in the community (conditional recommendation, very low certainty of evidence).
The idea is to do rapid testing to identify individuals entering the hospital either for other illnesses or for procedures, in order to be able to institute appropriate precautions and decrease the likelihood of nosocomial transmission and/or transmission to health care personnel. It is worth noting that the recommendations do not address testing in areas with a low or intermediate prevalence of COVID-19. In the absence of an official guideline-based-recommendation, the decision about testing needs to made by the local hospital system.
Recommendations 11, 12, and 13
The IDSA panel recommends SARS-CoV-2 RNA testing in immunocompromised asymptomatic individuals who are being admitted to the hospital and in asymptomatic individuals prior to receiving immunosuppressive therapy regardless of exposure to COVID-19. It is also recommended to test asymptomatic individuals planning to undergo major surgery.
The rationale for this recommendation is that patients who are to receive chemotherapy, other immunosuppressive procedures, or surgery are at high risk if they have COVID-19 and may be better off delaying the procedure.
Some additional issues were addressed, though not in the form of additional recommendations. It was clarified that some individuals remain nucleic acid positive after their symptoms resolve, and sometimes even after seroconversion. It is not clear if those individuals remain infectious to others. The recommendations did not address serologic testing for public health surveillance.
Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
SOURCE: Hanson KE et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19.