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Introduction to A Compendium of Strategies to Prevent Healthcare-Associated Infections In Acute-Care Hospitals: 2022 Updates
Yokoe DS , Advani SD , Anderson DJ , Babcock HM , Bell M , Berenholtz SM , Bryant KA , Buetti N , Calderwood MS , Calfee DP , Deloney VM , Dubberke ER , Ellingson KD , Fishman NO , Gerding DN , Glowicz J , Hayden MK , Kaye KS , Kociolek LK , Landon E , Larson EL , Malani AN , Marschall J , Meddings J , Mermel LA , Patel PK , Perl TM , Popovich KJ , Schaffzin JK , Septimus E , Trivedi KK , Weinstein RA , Maragakis LL . Infect Control Hosp Epidemiol 2023 44 (10) 1533-1539 Since the initial publication of A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals in 2008, the prevention of healthcare-associated infections (HAIs) has continued to be a national priority. Progress in healthcare epidemiology, infection prevention, antimicrobial stewardship, and implementation science research has led to improvements in our understanding of effective strategies for HAI prevention. Despite these advances, HAIs continue to affect ∼1 of every 31 hospitalized patients, leading to substantial morbidity, mortality, and excess healthcare expenditures, and persistent gaps remain between what is recommended and what is practiced.The widespread impact of the coronavirus disease 2019 (COVID-19) pandemic on HAI outcomes in acute-care hospitals has further highlighted the essential role of infection prevention programs and the critical importance of prioritizing efforts that can be sustained even in the face of resource requirements from COVID-19 and future infectious diseases crises.The Compendium: 2022 Updates document provides acute-care hospitals with up-to-date, practical expert guidance to assist in prioritizing and implementing HAI prevention efforts. It is the product of a highly collaborative effort led by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Disease Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and The Joint Commission, with major contributions from representatives of organizations and societies with content expertise, including the Centers for Disease Control and Prevention (CDC), the Pediatric Infectious Disease Society (PIDS), the Society for Critical Care Medicine (SCCM), the Society for Hospital Medicine (SHM), the Surgical Infection Society (SIS), and others. |
Executive summary: A compendium of strategies to prevent healthcare-associated infections in acute-care hospitals: 2022 updates
Yokoe DS , Advani SD , Anderson DJ , Babcock HM , Bell M , Berenholtz SM , Bryant KA , Buetti N , Calderwood MS , Calfee DP , Dubberke ER , Ellingson KD , Fishman NO , Gerding DN , Glowicz J , Hayden MK , Kaye KS , Klompas M , Kociolek LK , Landon E , Larson EL , Malani AN , Marschall J , Meddings J , Mermel LA , Patel PK , Perl TM , Popovich KJ , Schaffzin JK , Septimus E , Trivedi KK , Weinstein RA , Maragakis LL . Infect Control Hosp Epidemiol 2023 44 (10) 1-15 Strategies to prevent catheter-associated urinary tract infections (CAUTIs) | Essential practices | Infrastructure and resources | 1 Perform a CAUTI risk assessment and implement an organization-wide program to identify and remove catheters that are no longer necessary using 1 or | more methods documented to be effective. (Quality of evidence: MODERATE) | 2 Provide appropriate infrastructure for preventing CAUTI. (Quality of evidence: LOW) | 3 Provide and implement evidence-based protocols to address multiple steps of the urinary catheter life cycle: catheter appropriateness (step 0), insertion | technique (step 1), maintenance care (step 2), and prompt removal (step 3) when no longer appropriate. (Quality of evidence: LOW) | 4 Ensure that only trained healthcare personnel (HCP) insert urinary catheters and that competency is assessed regularly. (Quality of evidence: LOW) | 5 Ensure that supplies necessary for aseptic technique for catheter insertion are available and conveniently located. (Quality of evidence: LOW) | 6 Implement a system for documenting the following in the patient record: physician order for catheter placement, indications for catheter insertion, date | and time of catheter insertion, name of individual who inserted catheter, nursing documentation of placement, daily presence of a catheter and | maintenance care tasks, and date and time of catheter removal. Record criteria for removal and justification for continued use. (Quality of evidence: | LOW) | 7 Ensure that sufficiently trained HCP and technology resources are available to support surveillance for catheter use and outcomes. (Quality of evidence: | LOW) | 8 Perform surveillance for CAUTI if indicated based on facility risk assessment or regulatory requirements. (Quality of evidence: LOW) | 9 Standardize urine culturing by adapting an institutional protocol for appropriate indications for urine cultures in patients with and without indwelling | catheters. Consider incorporating these indications into the electronic medical record, and review indications for ordering urine cultures in the CAUTI | risk assessment. (Quality of evidence: LOW) | Education and training | 1 Educate HCP involved in the insertion, care, and maintenance of urinary catheters about CAUTI prevention, including alternatives to indwelling | catheters, and procedures for catheter insertion, management, and removal. (Quality of evidence: LOW) | 2 Assess healthcare professional competency in catheter use, catheter care, and maintenance. (Quality of evidence: LOW) | 3 Educate HCP about the importance of urine-culture stewardship and provide indications for urine cultures. (Quality of evidence: LOW) | 4 Provide training on appropriate collection of urine. Specimens should be collected and should arrive at the microbiology laboratory as soon as possible, | preferably within an hour. If delay in transport to the laboratory is expected, samples should be refrigerated (no more than 24 hours) or collected in | preservative urine transport tubes. (Quality of evidence: LOW) | 5 Train clinicians to consider other methods for bladder management, such as intermittent catheterization or external male or female collection devices, | when appropriate, before placing an indwelling urethral catheter. (Quality of evidence: LOW) | 6 Share data in a timely fashion and report to appropriate stakeholders. (Quality of evidence: LOW) | Insertion of indwelling catheters | 1 Insert urinary catheters only when necessary for patient care and leave in place only as long as indications remain. (Quality of evidence: MODERATE) | 2 Consider other methods for bladder management such as intermittent catheterization, or external male or female collection devices, when appropriate. | (Quality of evidence: LOW) | 3 Use appropriate technique for catheter insertion. (Quality of evidence: MODERATE). | 4 Consider working in pairs to help perform patient positioning and monitor for potential contamination during placement. (Quality of evidence: LOW) | 5 Practice hand hygiene (based on CDC or WHO guidelines) immediately before insertion of the catheter and before and after any manipulation of the | catheter site or apparatus. (Quality of evidence: LOW) | 6 Insert catheters following aseptic technique and using sterile equipment. (Quality of evidence: LOW) | 7 Use sterile gloves, drape, and sponges, a sterile antiseptic solution for cleaning the urethral meatus, and a sterile single-use packet of lubricant jelly for | insertion. (Quality of evidence: LOW) | 8 Use a catheter with the smallest feasible diameter consistent with proper drainage to minimize urethral trauma but consider other catheter types and | sizes when warranted for patients with anticipated difficult catheterization to reduce the likelihood that a patient will experience multiple, sometimes | traumatic, catheterization attempts. (Quality of evidence: LOW) | Management of indwelling catheters | 1 Properly secure indwelling catheters after insertion to prevent movement and urethral traction. (Quality of evidence: LOW) | 2 Maintain a sterile, continuously closed drainage system. (Quality of evidence: LOW) | 3 Replace the catheter and the collecting system using aseptic technique when breaks in aseptic technique, disconnection, or leakage occur. (Quality of | evidence: LOW) | 4 For examination of fresh urine, collect a small sample by aspirating urine from the needleless sampling port with a sterile syringe/cannula adaptor after | cleansing the port with disinfectant. (Quality of evidence: LOW) | (Continued) | 2 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent central-line–associated bloodstream infections (CLABSIs) | (Continued ) | 5 Facilitate timely transport of urine samples to laboratory. If timely transport is not feasible, consider refrigerating urine samples or using samplecollection cups with preservatives. Obtain larger volumes of urine for special analyses (eg, 24-hour urine) aseptically from the drainage bag. (Quality of | evidence: LOW) | 6 Maintain unobstructed urine flow. (Quality of evidence: LOW) | 7 Employ routine hygiene. Cleaning the meatal area with antiseptic solutions is an unresolved issue, though emerging literature supports chlorhexidine | use prior to catheter insertion. Alcohol-based products should be avoided given concerns about the alcohol causing drying of the mucosal tissues. | (Quality of evidence: LOW) | Additional approaches | 1 Develop a protocol for standardizing diagnosis and management of postoperative urinary retention, including nurse-directed use of intermittent | catheterization and use of bladder scanners when appropriate as alternatives to indwelling urethral catheterization. (Quality of evidence: MODERATE) | 2 Establish a system for analyzing and reporting data on catheter use and adverse events from catheter use. (Quality of evidence: LOW) | 3 Establish a system for defining, analyzing, and reporting data on non–catheter-associated UTIs, particularly UTIs associated with the use of devices | being used as alternatives to indwelling urethral catheters. (Quality of evidence: LOW) | Essential practices | Before insertion | 1 Provide easy access to an evidence-based list of indications for CVC use to minimize unnecessary CVC placement. (Quality of evidence: LOW) | 2 Require education and competency assessment of healthcare personnel (HCP) involved in insertion, care and maintenance of CVCs about CLABSI | prevention. (Quality of evidence: MODERATE) | 3 Bathe ICU patients aged >2 months with a chlorhexidine preparation on a daily basis. (Quality of evidence: HIGH) | At insertion | 1 In ICU and non-ICU settings, a facility should have a process in place, such as a checklist, to ensure adherence to infection prevention practices at the | time of CVC insertion. (Quality of evidence: MODERATE) | 2 Perform hand hygiene prior to catheter insertion or manipulation. (Quality of evidence: MODERATE) | 3 The subclavian site is preferred to reduce infectious complications when the catheter is placed in the ICU setting. (Quality of evidence: HIGH) | 4 Use an all-inclusive catheter cart or kit. (Quality of evidence: MODERATE) | 5 Use ultrasound guidance for catheter insertion. (Quality of evidence: HIGH) | 6 Use maximum sterile barrier precautions during CVC insertion. (Quality of evidence: MODERATE) | After insertion | 1 Ensure appropriate nurse-to-patient ratio and limit use of float nurses in ICUs. (Quality of evidence: HIGH) | 2 Use chlorhexidine-containing dressings for CVCs in patients aged >2 months. (Quality of evidence: HIGH) | 3 For nontunneled CVCs in adults and children, change transparent dressings and perform site care with a chlorhexidine-based antiseptic at least every 7 | days or immediately if the dressing is soiled, loose, or damp. Change gauze dressings every 2 days or earlier if the dressing is soiled, loose, or damp. | (Quality of evidence: MODERATE) | 4 Disinfect catheter hubs, needleless connectors, and injection ports before accessing the catheter. (Quality of evidence: MODERATE) | 5 Remove nonessential catheters. (Quality of evidence: MODERATE) | 6 Routine replacement of administration sets not used for blood, blood products, or lipid formulations can be performed at intervals up to 7 days. | (Quality of evidence: HIGH) | 7 Perform surveillance for CLABSI in ICU and non-ICU settings. (Quality of evidence: HIGH) | Additional approaches | 1 Use antiseptic or antimicrobial-impregnated CVCs. (Quality of evidence: HIGH in adult patients; MODERATE in pediatric patients) | 2 Use antimicrobial lock therapy for long-term CVCs. (Quality of evidence: HIGH) | 3 Use recombinant tissue plasminogen activating factor (rt-PA) once weekly after hemodialysis in patients undergoing hemodialysis through a CVC. | (Quality of evidence: HIGH) | 4 Utilize infusion or vascular access teams for reducing CLABSI rates. (Quality of evidence: LOW) | 5 Use antimicrobial ointments for hemodialysis catheter-insertion sites. (Quality of evidence: HIGH) | 6 Use an antiseptic-containing hub, connector cap, or port protector to cover connectors. (Quality of evidence: MODERATE) | Infection Control & Hospital Epidemiology 3 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent Clostridioides difficile infections (CDIs) | Strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) transmission and infection | Essential practices | 1 Encourage appropriate use of antimicrobials through implementation of an antimicrobial stewardship program. (Quality of evidence: MODERATE) | 2 Implement diagnostic stewardship practices for ensuring appropriate use and interpretation of C. difficile testing. (Quality of evidence: LOW) | 3 Use contact precautions for infected patients, single-patient room preferred. (Quality of evidence: LOW for hand hygiene; MODERATE for gloves; LOW | for gowns; LOW for single-patient room) | 4 Adequately clean and disinfect equipment and the environment of patients with CDI. (Quality of evidence: LOW for equipment; LOW for environment) | 5 Assess the adequacy of room cleaning. (Quality of evidence: LOW) | 6 Implement a laboratory-based alert system to provide immediate notification to infection preventionists and clinical personnel about newly diagnosed | patients with CDI. (Quality of evidence: LOW) | 7 Conduct CDI surveillance and analyze and report CDI data. (Quality of evidence: LOW) | 8 Educate healthcare personnel (HCP), environmental service personnel, and hospital administration about CDI. (Quality of evidence: LOW) | 9 Educate patients and their families about CDI as appropriate. (Quality of evidence: LOW) | 10 Measure compliance with CDC or WHO hand hygiene and contact precaution recommendations. (Quality of evidence: LOW) | Additional approaches | 1 Intensify the assessment of compliance with process measures. (Quality of evidence: LOW) | 2 Perform hand hygiene with soap and water as the preferred method following care of or interacting with the healthcare environment of a patient with | CDI. (Quality of evidence: LOW) | 3 Place patients with diarrhea on contact precautions while C. difficile testing is pending. (Quality of evidence: LOW) | 4 Prolong the duration of contact precautions after the patient becomes asymptomatic until hospital discharge. (Quality of evidence: LOW) | 5 Use an EPA-approved sporicidal disinfectant, such as diluted (1:10) sodium hypochlorite, for environmental cleaning and disinfection. Implement a | system to coordinate with environmental services if it is determined that sodium hypochlorite is needed for environmental disinfection. (Quality of | evidence: LOW) | Essential practices | 1 Implement an MRSA monitoring program. (Quality of evidence: LOW) | 2 Conduct an MRSA risk assessment. (Quality of evidence: LOW) | 3 Promote compliance with CDC or World Health Organization (WHO) hand hygiene recommendations. (Quality of evidence: MODERATE) | 4 Use contact precautions for MRSA-colonized and MRSA-infected patients. A facility that chooses or has already chosen to modify the use of contact | precautions for some or all of these patients should conduct an MRSA-specific risk assessment to evaluate the facility for transmission risks and to | assess the effectiveness of other MRSA risk mitigation strategies (eg, hand hygiene, cleaning and disinfection of the environment, single occupancy | patient rooms) and should establish a process for ongoing monitoring, oversight, and risk assessment. (Quality of evidence: MODERATE) | 5 Ensure cleaning and disinfection of equipment and the environment. (Quality of evidence: MODERATE) | 6 Implement a laboratory-based alert system that notifies healthcare personnel (HCP) of new MRSA-colonized or MRSA-infected patients in a timely | manner. (Quality of evidence: LOW) | 7 Implement an alert system that identifies readmitted or transferred MRSA-colonized or MRSA-infected patients. (Quality of evidence: LOW) | 8 Provide MRSA data and outcome measures to key stakeholders, including senior leadership, physicians, nursing staff, and others. (Quality of evidence: | LOW) | 9 Educate healthcare personnel about MRSA. (Quality of evidence: LOW) | 10 Educate patients and families about MRSA. (Quality of evidence: LOW) | 11 Implement an antimicrobial stewardship program. (Quality of evidence: LOW) | Additional approaches | Active surveillance testing (AST) | 1 Implement an MRSA AST program for select patient populations as part of a multifaceted strategy to control and prevent MRSA. (Quality of evidence: | MODERATE) Note: specific populations may have different evidence ratings. | 2 Active surveillance for MRSA in conjunction with decolonization can be performed in targeted populations prior to surgery to prevent postsurgical | MRSA infection. (Quality of evidence: MODERATE) | (Continued) | 4 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent surgical-site infections (SSIs) | (Continued ) | 3 Active surveillance with contact precautions is inferior to universal decolonization for reduction of MRSA clinical isolates in adult ICUs. (Quality of | evidence: HIGH) | 4 Hospital-wide active surveillance for MRSA can be used in conjunction with contact precautions to reduce the incidence of MRSA infection. (Quality of | evidence: MODERATE) | 5 Active surveillance can be performed in the setting of an MRSA outbreak or evidence of ongoing transmission of MRSA within a unit as part of a | multifaceted strategy to halt transmission. (Quality of evidence: MODERATE) | Screen healthcare personnel for MRSA infection or colonization | 1 Screen HCP for MRSA infection or colonization if they are epidemiologically linked to a cluster of MRSA infections. (Quality of evidence: LOW) | MRSA decolonization therapy | 1 Use universal decolonization (ie, daily CHG bathing plus 5 days of nasal decolonization) for all patients in adult ICUs to reduce endemic MRSA clinical | cultures. (Quality of evidence: HIGH) | 2 Perform preoperative nares screening with targeted use of CHG and nasal decolonization in MRSA carriers to reduce MRSA SSI from surgical | procedures involving implantation of hardware. (Quality of evidence: MODERATE) | 3 Screen for MRSA and provide targeted decolonization with CHG bathing and nasal decolonization to MRSA carriers in surgical units to reduce | postoperative MRSA inpatient infections. (Quality of evidence: MODERATE) | 4 Provide CHG bathing plus nasal decolonization to known MRSA carriers outside the ICU with medical devices, specifically central lines, midline | catheters, and lumbar drains to reduce MRSA clinical cultures. (Quality of evidence: MODERATE) | 5 Consider postdischarge decolonization of MRSA carriers to reduce postdischarge MRSA infections and readmissions. (Quality of evidence: HIGH) | 6 Neonatal ICUs should consider targeted or universal decolonization during times of above-average MRSA infection rates or targeted decolonization for | patients at high risk of MRSA infection (eg, low birth weight, indwelling devices, or prior to high-risk surgeries). (Quality of evidence: MODERATE) | 7 Burn units should consider targeted or universal decolonization during times of above-average MRSA infection rates. (Quality of evidence: MODERATE) | 8 Consider targeted or universal decolonization of hemodialysis patients. (Quality of evidence: MODERATE) | 9 Decolonization should be strongly considered as part of a multimodal approach to control MRSA outbreaks. (Quality of evidence: MODERATE) | Universal use of gowns and gloves | 1 Use gowns and gloves when providing care to or entering the room of any adult ICU patient, regardless of MRSA colonization status. (Quality of | evidence: MODERATE) | Essential practices | 1 Administer antimicrobial prophylaxis according to evidence-based standards and guidelines. (Quality of evidence: HIGH) | 2 Use a combination of parenteral and oral antimicrobial prophylaxis prior to elective colorectal surgery to reduce the risk of SSI. (Quality of evidence: | HIGH) | 3 Decolonize surgical patients with an anti-staphylococcal agent in the preoperative setting for orthopedic and cardiothoracic procedures. (Quality of | evidence: HIGH) | Decolonize surgical patients in other procedures at high risk of staphylococcal SSI, such as those involving prosthetic material. (Quality of evidence: | LOW) | 4 Use antiseptic-containing preoperative vaginal preparation agents for patients undergoing cesarean delivery or hysterectomy. (Quality of evidence: | MODERATE) | 5 Do not remove hair at the operative site unless the presence of hair will interfere with the surgical procedure. (Quality of evidence: MODERATE) | 6 Use alcohol-containing preoperative skin preparatory agents in combination with an antiseptic. (Quality of evidence: HIGH) | 7 For procedures not requiring hypothermia, maintain normothermia (temperature >35.5 °C) during the perioperative period. (Quality of evidence: HIGH). | 8 Use impervious plastic wound protectors for gastrointestinal and biliary tract surgery. (Quality of evidence: HIGH) | 9 Perform intraoperative antiseptic wound lavage. (Quality of evidence: MODERATE) | 10 Control blood glucose level during the immediate postoperative period for all patients. (Quality of evidence: HIGH) | 11 Use a checklist and/or bundle to ensure compliance with best practices to improve surgical patient safety. (Quality of evidence: HIGH) | 12 Perform surveillance for SSI. (Quality of evidence: MODERATE) | 13 Increase the efficiency of surveillance by utilizing automated data. (Quality of evidence: MODERATE) | 14 Provide ongoing SSI rate feedback to surgical and perioperative personnel and leadership. (Quality of evidence: MODERATE) | 15 Measure and provide feedback to healthcare personnel (HCP) regarding rates of compliance with process measures. (Quality of evidence: LOW) | (Continued) | Infection Control & Hospital Epidemiology 5 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent ventilator-associated pneumonia (VAP) and ventilator-associated events (VAEs) | Adult patients | (Continued ) | 16 Educate surgeons and perioperative personnel about SSI prevention measures. (Quality of evidence: LOW) | 17 Educate patients and their families about SSI prevention as appropriate. (Quality of evidence: LOW) | 18 Implement policies and practices to reduce the risk of SSI for patients that align with applicable evidence-based standards, rules and regulations, and | medical device manufacturer instructions for use. (Quality of evidence: MODERATE) | 19 Observe and review operating room personnel and the environment of care in the operating room and in central sterile reprocessing. (Quality of | evidence: LOW) | Additional approaches | 1 Perform an SSI risk assessment. (Quality of evidence: LOW) | 2 Consider use of negative-pressure dressings in patients who may benefit. (Quality of evidence: MODERATE) | 3 Observe and review practices in the preoperative clinic, post-anesthesia care unit, surgical intensive care unit, and/or surgical ward. (Quality of | evidence: MODERATE) | 4 Use antiseptic-impregnated sutures as a strategy to prevent SSI. (Quality of evidence: MODERATE) | Essential practices | Interventions with little risk of harm and that are associated with decreases in duration of mechanical ventilation, length of stay, mortality, antibiotic utilization, | and/or costs | Avoid intubation and prevent reintubation if possible. | 1 Use high flow nasal oxygen or non-invasive positive pressure ventilation (NIPPV) as appropriate, whenever safe and feasible. (Quality of evidence: HIGH) | Minimize sedation. | 1 Minimize sedation of ventilated patients whenever possible. (Quality of evidence: HIGH) | 2 Preferentially use multimodal strategies and medications other than benzodiazepines to manage agitation. (Quality of evidence: HIGH) | 3 Utilize a protocol to minimize sedation. (Quality of evidence: HIGH) | 4 Implement a ventilator liberation protocol. (Quality of evidence: HIGH) | Maintain and improve physical conditioning. | 1 Provide early exercise and mobilization. (Quality of evidence: MODERATE) | Elevate the head of the bed to 30°–45°. (Quality of evidence: LOW) | Provide oral care with toothbrushing but without chlorhexidine. (Quality of evidence: MODERATE) | Provide early enteral rather than parenteral nutrition. (Quality of evidence: HIGH) | Maintain ventilator circuits. | 1 Change the ventilator circuit only if visibly soiled or malfunctioning (or per manufacturers’ instructions) (Quality of evidence: HIGH). | Additional approaches | May decrease duration of mechanical ventilation, length of stay, and/or mortality in some populations but not in others, and they may confer some risk of harm | in some populations. | 1 Consider using selective decontamination of the oropharynx and digestive tract to decrease microbial burden in ICUs with low prevalence of antibiotic | resistant organisms. Antimicrobial decontamination is not recommended in countries, regions, or ICUs with high prevalence of antibiotic-resistant | organisms. (Quality of evidence: HIGH) | Additional approaches | May lower VAP rates, but current data are insufficient to determine their impact on duration of mechanical ventilation, length of stay, and mortality. | 1 Consider using endotracheal tubes with subglottic secretion drainage ports to minimize pooling of secretions above the endotracheal cuff in patients | likely to require >48–72 hours of intubation. (Quality of evidence: MODERATE) | 2 Consider early tracheostomy. (Quality of evidence: MODERATE) | 3 Consider postpyloric feeding tube placement in patients with gastric feeding intolerance at high risk for aspiration. (Quality of evidence: MODERATE) | 6 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Preterm neonatal patients | Pediatric patients | Essential practices | Confer minimal risk of harm and may lower VAP and/or PedVAE rates. | Avoid intubation. (Quality of evidence: HIGH) | Minimize duration of mechanical ventilation. (Quality of evidence: HIGH) | 1 Manage patients without sedation whenever possible. (Quality of evidence: LOW) | 2 Use caffeine therapy for apnea of prematurity within 72 hours after birth to facilitate extubation. (Quality of evidence: HIGH) | 3 Assess readiness to extubate daily. (Quality of evidence: LOW) | 4 Take steps to minimize unplanned extubation and reintubation. (Quality of evidence: LOW) | 5 Provide regular oral care with sterile water (extrapolated from practice in infants and children, no data in preterm neonates). (Quality of evidence: | LOW) | 6 Change the ventilator circuit only if visibly soiled or malfunctioning or according to the manufacturer’s instructions for use (extrapolated from studies in | adults and children, no data in preterm neonates). (Quality of evidence: LOW) | Additional approaches | Minimal risks of harm, but impact on VAP and VAE rates is unknown. | 1 Lateral recumbent positioning. (Quality of evidence: LOW) | 2 Reverse Trendelenberg positioning. (Quality of evidence: LOW) | 3 Closed or in-line suctioning. (Quality of evidence: LOW) | 4 Oral care with maternal colostrum. (Quality of evidence: MODERATE) | Essential practices | Confer minimal risk of harm and some data suggest that they may lower VAP rates, PedVAE rates, and/or duration of mechanical ventilation. | Avoid intubation. | 1 Use noninvasive positive pressure ventilation (NIPPV) or high-flow oxygen by nasal cannula whenever safe and feasible. (Quality of evidence: | MODERATE) | Minimize duration of mechanical ventilation. | 1 Assess readiness to extubate daily using spontaneous breathing trials in patients without contraindications. (Quality of evidence: MODERATE) | 2 Take steps to minimize unplanned extubations and reintubations. (Quality of evidence: LOW) | 3 Avoid fluid overload. (Quality of evidence: MODERATE) | Provide regular oral care (ie, toothbrushing or gauze if no teeth). (Quality of evidence: LOW) | Elevate the head of the bed unless medically contraindicated. (Quality of evidence: LOW) | Maintain ventilator circuits. | 1 Change ventilator circuits only when visibly soiled or malfunctioning (or per manufacturer’s instructions). (Quality of evidence: MODERATE) | 2 Remove condensate from the ventilator circuit frequently and avoid draining the condensate toward the patient. (Quality of evidence: LOW) | Endotracheal tube selection and management | 1 Use cuffed endotracheal tubes. (Quality of evidence: LOW) | 2 Maintain cuff pressure and volume at the minimal occlusive settings to prevent clinically significant air leaks around the endotracheal tube, typically | 20-25cm H2O. This “minimal leak” approach is associated with lower rates of post-extubation stridor. (Quality of evidence: LOW) | 3 Suction oral secretions before each position change. (Quality of evidence: LOW) | Additional approaches | Minimal risks of harm and some evidence of benefit in adult patients but data in pediatric populations are limited. | 1 Minimize sedation. (Quality of evidence: MODERATE) | 2 Use endotracheal tubes with subglottic secretion drainage ports for patients ≥10 years of age. (Quality of evidence: LOW) | 3 Consider early tracheostomy. (Quality of evidence: LOW) | Infection Control & Hospital Epidemiology 7 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent nonventilator hospital-acquired pneumonia (NV-HAP) | Strategies to prevent healthcare-associated infections through hand hygiene | Essential practices | Promote the maintenance of healthy hand skin and nails. (Quality of evidence: HIGH) | 1 Promote the preferential use of alcohol-based hand sanitizer (ABHS) in most clinical situations. (Quality of evidence: HIGH) | 2 Perform hand hygiene as indicated by CDC or the WHO Five Moments. (Quality of evidence: HIGH) | 3 Include fingernail care in facility-specific policies related to hand hygiene. (Quality of evidence: HIGH) | a) Healthcare personnel (HCP) should maintain short, natural fingernails. | b) Nails should not extend past the fingertip. | c) HCP who provide direct or indirect care in high-risk areas | (eg, ICU or perioperative) should not wear artificial fingernail extenders. | d) Prohibitions against fingernail polish (standard or gel shellac) are at the discretion of the infection prevention program, except among scrubbed | individuals who interact with the sterile field during surgical procedures; these individuals should not wear fingernail polish or gel shellac. | 4 Engage all HCP in primary prevention of occupational irritant and allergic contact dermatitis. (Quality of evidence: HIGH) | 5 Provide cotton glove liners for HCP with hand irritation and educate these HCP on their use. (Quality of evidence: MODERATE) | Select appropriate products. | 1 For routine hand hygiene, choose liquid, gel, or foam ABHS with at least 60% alcohol. (Quality of evidence: HIGH) | 2 Involve HCP in selection of products. (Quality of evidence: HIGH) | 3 Obtain and consider manufacturers’ product-specific data if seeking ABHS with ingredients that may enhance efficacy against organisms anticipated to | be less susceptible to biocides. (Quality of evidence: MODERATE) | 4 Confirm that the volume of ABHS dispensed is consistent with the volume shown to be efficacious. (Quality of evidence: HIGH) | 5 Educate HCP about an appropriate volume of ABHS and the time required to obtain effectiveness. (Quality of evidence: HIGH) | 6 Provide facility-approved hand moisturizer that is compatible with antiseptics and gloves. (Quality of evidence: HIGH) | 7 For surgical antisepsis, use an FDA-approved surgical hand scrub or waterless surgical hand rub. (Quality of evidence: HIGH) | Ensure the accessibility of hand hygiene supplies. (Quality of evidence: HIGH) | 1 Ensure ABHS dispensers are unambiguous, visible, and accessible within the workflow of HCP. (Quality of evidence: HIGH) | 2 In private rooms, consider 2 ABHS dispensers the minimum threshold for adequate numbers of dispensers: 1 dispenser in the hallway, and 1 in the | patient room. (Quality of evidence: HIGH) | 3 In semiprivate rooms, suites, bays, and other multipatient bed configurations, consider 1 dispenser per 2 beds the minimum threshold for adequate | numbers of dispensers. Place ABHS dispensers in the workflow of HCP. (Quality of evidence: LOW) | 4 Ensure that the placement of hand hygiene supplies (eg, individual pocket-sized dispensers, bed mounted ABHS dispenser, single use pump bottles) is | easily accessible for HCP in all areas where patients receive care. (Quality of evidence: HIGH) | 5 Evaluate for the risk of intentional consumption. Utilize dispensers that mitigate this risk, such as wall-mounted dispensers that allow limited numbers | of activations within short periods (eg, 5 seconds). (Quality of evidence: LOW) | 6 Have surgical hand rub and scrub available in perioperative areas. (Quality of evidence: HIGH) | 7 Consider providing ABHS hand rubs or handwash with FDA-approved antiseptics for use in procedural areas and prior to high-risk bedside procedures | (eg, central-line insertion). (Quality of evidence: LOW) | (Continued) | Practices supported by interventional studies suggesting lower | NV-HAP rates | 1 Provide regular oral care. | 2 Diagnose and manage dysphagia. | 3 Provide early mobilization. | 4 Implement multimodal interventions to prevent viral infections. | 5 Use prevention bundles. | 8 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Implementing strategies to prevent healthcare-associated infections | Standard approach to implementation | Examples of implementation frameworks | (Continued ) | Ensure appropriate glove use to reduce hand and environmental contamination. (Quality of Evidence: HIGH) | 1 Use gloves for all contact with the patient and environment as indicated by standard and contact precautions during the care of individuals with | organisms confirmed to be less susceptible to biocides (e.g., C. difficile or norovirus) | 2 Educate HCP about the potential for self-contamination and environmental contamination when gloves are worn. (Quality of evidence: HIGH) | 3 Educate and confirm the ability of HCP to doff gloves in a manner that avoids contamination. (Quality of evidence: HIGH) | Take steps to reduce environmental contamination associated with sinks and sink drains. (Quality of evidence: HIGH) | Monitor adherence to hand hygiene. (Quality of evidence: HIGH) | Provide timely and meaningful feedback to enhance a culture of safety. (Quality of evidence: MODERATE) | Additional approaches during outbreaks | 1 Consider educating HCP using a structured approach (eg, WHO Steps) for handwashing or hand sanitizing. Evaluate HCP adherence to technique. | (Quality of evidence: LOW) | 2 For waterborne pathogens of premise plumbing, consider disinfection of sink drains using an EPA-registered disinfectant with claims against biofilms. | Consult with state or local public health for assistance in determining appropriate protocols for use and other actions needed to ensure safe supply. | (Quality of evidence: LOW) | 3 For C. difficile and norovirus, in addition to contact precautions, encourage hand washing with soap and water after the care of patients with known or | suspected infections. (Quality of evidence: LOW) | 1 Assess determinants of change and | classify as follows: | • Facilitators: promote practice or | change, or | • Barriers: hinder practice or change | Individual level: healthcare personnel, leaders, patients, and visitors’ preferences, needs, attitudes, and | knowledge. | Facility level: team composition, communication, culture, capacity, policies, resources. | Partners: degree of support and buy-in. | 2 Choose measures Measurement methods must be appropriate for the question(s) they seek to answer and adhere to the | methods’ data collection and analysis rules: | • Outcome measure: ultimate goal (eg, HAI reduction). | • Process measure: action reliability (eg, bundle adherence). | • Balancing measure: undesired outcome of change (eg, staff absences due to required vaccine side effects). | 3 Select framework(s) See below and “Implementing Strategies to Prevent Infections in Acute Care Settings” (Table 3) | 32 | Framework Published Experience Resources | 4Es Settings | • Healthcare facilities | • Large-scale projects including multiple | sites | Infection prevention and control | • HAI prevention (including mortality | reduction and cost savings) | • 4Es Framework11 | • HAI reduction12–14 | • Mortality reduction15 | • Cost savings16 | Behavior Change Wheel Settings | • Community-based practice | • Healthcare facilities | Healthy behaviors | • Smoking cessation | • Obesity prevention | • Increased physical activity | Infection prevention and control | • Hand hygiene adherence | • Antibiotic prescribing17 | • Behavior Change Wheel: A Guide to Designing Interventions18 | • Stand More at Work (SMArT Work)19 | (Continued) | Infection Control & Hospital Epidemiology 9 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Acknowledgments. The Compendium Partners thank the authors for their | dedication to this work, including maintaining adherence to the rigorous | process for the development of the Compendium: 2022 Updates, involving but | not limited to screening of thousands of articles; achieving multilevel consensus; | and consideration of, response to, and incorporation of many organizations’ | feedback and comments. We acknowledge these efforts especially because they | occurred as the authors handled the demands of the COVID-19 pandemic. The | authors thank Valerie Deloney, MBA, for her organizational expertise in the | development of this manuscript and Janet Waters, MLS, BSN, RN, for her | expertise in developing the strategies used for the literature searches that | informed this manuscript. The authors thank the many individuals and | organizations who gave their time and expertise to review and provide | (Continued ) | Comprehensive Unit-based | Safety Program (CUSP) | Settings | • Intensive care units | • Ambulatory centers | Improvements | • Antibiotic prescribing | • CLABSI prevention | • CAUTI prevention | • CUSP Implementation Toolkit20 | • AHA/HRET: Eliminating CAUTI (Stop CAUTI)21 | • AHRQ Toolkit to Improve Safety in Ambulatory Surgery Centers22 | European Mixed Methods Settings | • European institutions of varied | healthcare systems and cultures | Improvements: | • CLABSI prevention | • Hand hygiene | • PROHIBIT: Description and Materials23 | Getting to Outcomes (GTO)® Settings | • Community programs and services | Improvements | • Sexual health promotion | • Dual-disorder treatment program in | veterans | • Community emergency preparedness | • RAND Guide for Emergency Preparedness24 (illustrated overview of GTO® methodology) | Model for Improvement Settings | • Healthcare (inpatient, perioperative, | ambulatory) | • Public health | Interventions | • PPE use | • HAI prevention | • Public health process evaluation | • Institute for Healthcare Improvement25 | • The Improvement Guide26 | • Deming’s System of Profound Knowledge27 | Reach, Effectiveness, Adoption, | Implementation, Maintenance | (RE-AIM) | Settings | • Healthcare | • Public health | • Community programs | • Sexual health | Evaluations | • Antimicrobial stewardship in the ICU | • Clinical practice guidelines for STIs | • Promotion of vaccination | • Implementation of contact tracing | • RE-AIM.org28 | • Understanding and applying the RE-AIM framework: Clarifications and | resources29 | Replicating Effective Practices | (REP) | Settings | • Healthcare | • Public health | • HIV prevention | Interventions that have produced | positive results are reframed for local | relevance | CDC Compendium of HIV Prevention Interventions with Evidence of | Effectiveness30 (see Section C, Intervention Checklist) | Theoretical Domains Settings | • Healthcare (inpatient, perioperative, | ambulatory) | • Community (individual and communitybased behaviors) | Health maintenance | • Diabetes management in primary care | • Pregnancy weight management | HCP practice | • ICU blood transfusion | • Selective GI tract decontamination | • Preoperative testing | • Spine imaging | • Hand hygiene |
Vaccine Effectiveness of Primary Series and Booster Doses against Omicron Variant COVID-19-Associated Hospitalization in the United States (preprint)
Adams K , Rhoads JP , Surie D , Gaglani M , Ginde AA , McNeal T , Ghamande S , Huynh D , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hicks M , Hager DN , Ali H , Prekker ME , Frosch AE , Exline MC , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Lauring AS , Khan A , Hough CL , Busse LW , ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Chappell JD , Halasa N , Grijalva CG , Rice TW , Stubblefield WB , Baughman A , Lindsell CJ , Hart KW , Lester SN , Thornburg NJ , Park S , McMorrow ML , Patel MM , Tenforde MW , Self WH . medRxiv 2022 14 Objectives: To compare the effectiveness of a primary COVID-19 vaccine series plus a booster dose with a primary series alone for the prevention of Omicron variant COVID-19 hospitalization. Design(s): Multicenter observational case-control study using the test-negative design to evaluate vaccine effectiveness (VE). Setting(s): Twenty-one hospitals in the United States (US). Participant(s): 3,181 adults hospitalized with an acute respiratory illness between December 26, 2021 and April 30, 2022, a period of SARS-CoV-2 Omicron variant (BA.1, BA.2) predominance. Participants included 1,572 (49%) case-patients with laboratory confirmed COVID-19 and 1,609 (51%) control patients who tested negative for SARS-CoV-2. Median age was 64 years, 48% were female, and 21% were immunocompromised; 798 (25%) were vaccinated with a primary series plus booster, 1,326 (42%) were vaccinated with a primary series alone, and 1,057 (33%) were unvaccinated. Main Outcome Measure(s): VE against COVID-19 hospitalization was calculated for a primary series plus a booster and a primary series alone by comparing the odds of being vaccinated with each of these regimens versus being unvaccinated among cases versus controls. VE analyses were stratified by immune status (immunocompetent; immunocompromised) because the recommended vaccine schedules are different for these groups. The primary analysis evaluated all COVID-19 vaccine types combined and secondary analyses evaluated specific vaccine products. Result(s): Among immunocompetent patients, VE against Omicron COVID-19 hospitalization for a primary series plus one booster of any vaccine product dose was 77% (95% CI: 71-82%), and for a primary series alone was 44% (95% CI: 31-54%) (p<0.001). VE was higher for a boosted regimen than a primary series alone for both mRNA vaccines used in the US (BNT162b2: primary series plus booster VE 80% (95% CI: 73-85%), primary series alone VE 46% (95% CI: 30-58%) [p<0.001]; mRNA-1273: primary series plus booster VE 77% (95% CI: 67-83%), primary series alone VE 47% (95% CI: 30-60%) [p<0.001]). Among immunocompromised patients, VE for a primary series of any vaccine product against Omicron COVID-19 hospitalization was 60% (95% CI: 41-73%). Insufficient sample size has accumulated to calculate effectiveness of boosted regimens for immunocompromised patients. Conclusion(s): Among immunocompetent people, a booster dose of COVID-19 vaccine provided additional benefit beyond a primary vaccine series alone for preventing COVID-19 hospitalization due to the Omicron variant. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. |
Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing Covid-19 Hospitalizations in the United States (preprint)
Tenforde MW , Patel MM , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , McNeal T , Ghamande S , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Exline MC , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CT , Busse L , Lohuis CCT , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Gershengorn HB , Babcock HM , Kwon JH , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Olson SM , Stephenson M , Schrag SJ , Kobayashi M , Verani JR , Self WH . medRxiv 2021 BACKGROUND: As SARS-CoV-2 vaccination coverage increases in the United States (US), there is a need to understand the real-world effectiveness against severe Covid-19 and among people at increased risk for poor outcomes. METHODS: In a multicenter case-control analysis of US adults hospitalized March 11 - May 5, 2021, we evaluated vaccine effectiveness to prevent Covid-19 hospitalizations by comparing odds of prior vaccination with an mRNA vaccine (Pfizer-BioNTech or Moderna) between cases hospitalized with Covid-19 and hospital-based controls who tested negative for SARS-CoV-2. RESULTS: Among 1210 participants, median age was 58 years, 22.8% were Black, 13.8% were Hispanic, and 20.6% had immunosuppression. SARS-CoV-2 lineage B.1.1.7 was most common variant (59.7% of sequenced viruses). Full vaccination (receipt of two vaccine doses ≥14 days before illness onset) had been received by 45/590 (7.6%) cases and 215/620 (34.7%) controls. Overall vaccine effectiveness was 86.9% (95% CI: 80.4 to 91.2%). Vaccine effectiveness was similar for Pfizer-BioNTech and Moderna vaccines, and highest in adults aged 18-49 years (97.3%; 95% CI: 78.9 to 99.7%). Among 45 patients with vaccine-breakthrough Covid hospitalizations, 44 (97.8%) were ≥50 years old and 20 (44.4%) had immunosuppression. Vaccine effectiveness was lower among patients with immunosuppression (59.2%; 95% CI: 11.9 to 81.1%) than without immunosuppression (91.3%; 95% CI: 85.5 to 94.7%). CONCLUSION: During March-May 2021, SARS-CoV-2 mRNA vaccines were highly effective for preventing Covid-19 hospitalizations among US adults. SARS-CoV-2 vaccination was beneficial for patients with immunosuppression, but effectiveness was lower in the immunosuppressed population. |
Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults - United States, March-July 2021.
Tenforde MW , Self WH , Naioti EA , Ginde AA , Douin DJ , Olson SM , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , McNeal T , Ghamande S , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Stephenson M , Schrag SJ , Kobayashi M , Verani JR , Patel MM , IVY Network Investigators . MMWR Morb Mortal Wkly Rep 2021 70 (34) 1156-1162 Real-world evaluations have demonstrated high effectiveness of vaccines against COVID-19-associated hospitalizations (1-4) measured shortly after vaccination; longer follow-up is needed to assess durability of protection. In an evaluation at 21 hospitals in 18 states, the duration of mRNA vaccine (Pfizer-BioNTech or Moderna) effectiveness (VE) against COVID-19-associated hospitalizations was assessed among adults aged ≥18 years. Among 3,089 hospitalized adults (including 1,194 COVID-19 case-patients and 1,895 non-COVID-19 control-patients), the median age was 59 years, 48.7% were female, and 21.1% had an immunocompromising condition. Overall, 141 (11.8%) case-patients and 988 (52.1%) controls were fully vaccinated (defined as receipt of the second dose of Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines ≥14 days before illness onset), with a median interval of 65 days (range = 14-166 days) after receipt of second dose. VE against COVID-19-associated hospitalization during the full surveillance period was 86% (95% confidence interval [CI] = 82%-88%) overall and 90% (95% CI = 87%-92%) among adults without immunocompromising conditions. VE against COVID-19- associated hospitalization was 86% (95% CI = 82%-90%) 2-12 weeks and 84% (95% CI = 77%-90%) 13-24 weeks from receipt of the second vaccine dose, with no significant change between these periods (p = 0.854). Whole genome sequencing of 454 case-patient specimens found that 242 (53.3%) belonged to the B.1.1.7 (Alpha) lineage and 74 (16.3%) to the B.1.617.2 (Delta) lineage. Effectiveness of mRNA vaccines against COVID-19-associated hospitalization was sustained over a 24-week period, including among groups at higher risk for severe COVID-19; ongoing monitoring is needed as new SARS-CoV-2 variants emerge. To reduce their risk for hospitalization, all eligible persons should be offered COVID-19 vaccination. |
Effectiveness of a Third Dose of Pfizer-BioNTech and Moderna Vaccines in Preventing COVID-19 Hospitalization Among Immunocompetent and Immunocompromised Adults - United States, August-December 2021.
Tenforde MW , Patel MM , Gaglani M , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , McNeal T , Ghamande S , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Botros M , Lauring AS , Shapiro NI , Halasa N , Chappell JD , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Rhoads JP , Lindsell CJ , Hart KW , Zhu Y , Naioti EA , Adams K , Lewis NM , Surie D , McMorrow ML , Self WH , IVY Network . MMWR Morb Mortal Wkly Rep 2022 71 (4) 118-124 COVID-19 mRNA vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) provide protection against infection with SARS-CoV-2, the virus that causes COVID-19, and are highly effective against COVID-19-associated hospitalization among eligible persons who receive 2 doses (1,2). However, vaccine effectiveness (VE) among persons with immunocompromising conditions* is lower than that among immunocompetent persons (2), and VE declines after several months among all persons (3). On August 12, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third mRNA vaccine dose as part of a primary series ≥28 days after dose 2 for persons aged ≥12 years with immunocompromising conditions, and, on November 19, 2021, as a booster dose for all adults aged ≥18 years at least 6 months after dose 2, changed to ≥5 months after dose 2 on January 3, 2022 (4,5,6). Among 2,952 adults (including 1,385 COVID-19 case-patients and 1,567 COVID-19-negative controls) hospitalized at 21 U.S. hospitals during August 19-December 15, 2021, effectiveness of mRNA vaccines against COVID-19-associated hospitalization was compared between adults eligible for but who had not received a third vaccine dose (1,251) and vaccine-eligible adults who received a third dose ≥7 days before illness onset (312). Among 1,875 adults without immunocompromising conditions (including 1,065 [57%] unvaccinated, 679 [36%] 2-dose recipients, and 131 [7%] 3-dose [booster] recipients), VE against COVID-19 hospitalization was higher among those who received a booster dose (97%; 95% CI = 95%-99%) compared with that among 2-dose recipients (82%; 95% CI = 77%-86%) (p <0.001). Among 1,077 adults with immunocompromising conditions (including 324 [30%] unvaccinated, 572 [53%] 2-dose recipients, and 181 [17%] 3-dose recipients), VE was higher among those who received a third dose to complete a primary series (88%; 95% CI = 81%-93%) compared with 2-dose recipients (69%; 95% CI = 57%-78%) (p <0.001). Administration of a third COVID-19 mRNA vaccine dose as part of a primary series among immunocompromised adults, or as a booster dose among immunocompetent adults, provides improved protection against COVID-19-associated hospitalization. |
Absolute and relative vaccine effectiveness of primary and booster series of COVID-19 vaccines (mRNA and adenovirus vector) against COVID-19 hospitalizations in the United States, December 2021-April 2022
Lewis NM , Murray N , Adams K , Surie D , Gaglani M , Ginde AA , McNeal T , Ghamande S , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hager DN , Ali H , Prekker ME , Frosch AE , Exline MC , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Lauring AS , Khan A , Hough CL , Busse LW , Bender W , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Chappell JD , Halasa N , Grijalva CG , Rice TW , Stubblefield WB , Baughman A , Lindsell CJ , Hart KW , Rhoads JP , McMorrow ML , Tenforde MW , Self WH , Patel MM . Open Forum Infect Dis 2023 10 (1) ofac698 BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccine effectiveness (VE) studies are increasingly reporting relative VE (rVE) comparing a primary series plus booster doses with a primary series only. Interpretation of rVE differs from traditional studies measuring absolute VE (aVE) of a vaccine regimen against an unvaccinated referent group. We estimated aVE and rVE against COVID-19 hospitalization in primary-series plus first-booster recipients of COVID-19 vaccines. METHODS: Booster-eligible immunocompetent adults hospitalized at 21 medical centers in the United States during December 25, 2021-April 4, 2022 were included. In a test-negative design, logistic regression with case status as the outcome and completion of primary vaccine series or primary series plus 1 booster dose as the predictors, adjusted for potential confounders, were used to estimate aVE and rVE. RESULTS: A total of 2060 patients were analyzed, including 1104 COVID-19 cases and 956 controls. Relative VE against COVID-19 hospitalization in boosted mRNA vaccine recipients versus primary series only was 66% (95% confidence interval [CI], 55%-74%); aVE was 81% (95% CI, 75%-86%) for boosted versus 46% (95% CI, 30%-58%) for primary. For boosted Janssen vaccine recipients versus primary series, rVE was 49% (95% CI, -9% to 76%); aVE was 62% (95% CI, 33%-79%) for boosted versus 36% (95% CI, -4% to 60%) for primary. CONCLUSIONS: Vaccine booster doses increased protection against COVID-19 hospitalization compared with a primary series. Comparing rVE measures across studies can lead to flawed interpretations of the added value of a new vaccination regimen, whereas difference in aVE, when available, may be a more useful metric. |
Effectiveness of the Ad26.COV2.S (Johnson & Johnson) COVID-19 Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States.
Lewis NM , Self WH , Gaglani M , Ginde AA , Douin DJ , Keipp Talbot H , Casey JD , Mohr NM , Zepeski A , Ghamande SA , McNeal TA , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown AM , Martin ET , Monto AS , Khan A , Busse LW , Ten Lohuis CC , Duggal B , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Lauring AS , Halasa N , Chappell JD , Grijalva CG , Rice TW , Rhoads JP , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Adams K , Patel MM , Tenforde MW . Clin Infect Dis 2022 75 S159-S166 BACKGROUND: Adults in the United States (US) began receiving the viral vector COVID-19 vaccine, Ad26.COV2.S (Johnson & Johnson [Janssen]), in February 2021. We evaluated Ad26.COV2.S vaccine effectiveness (VE) against COVID-19 hospitalization and high disease severity during the first 10 months of its use. METHODS: In a multicenter case-control analysis of US adults (≥18 years) hospitalized March 11-December 15, 2021, we estimated VE against susceptibility to COVID-19 hospitalization (VEs), comparing odds of prior vaccination with a single dose Ad26.COV2.S vaccine between hospitalized cases with COVID-19 and controls without COVID-19. Among hospitalized patients with COVID-19, we estimated VE against disease progression (VEp) to death or invasive mechanical ventilation (IMV), comparing odds of prior vaccination between patients with and without progression. RESULTS: After excluding patients receiving mRNA vaccines, among 3,979 COVID-19 case-patients (5% vaccinated with Ad26.COV2.S) and 2.229 controls (13% vaccinated with Ad26.COV2.S), VEs of Ad26.COV2.S against COVID-19 hospitalization was 70% (95% CI: 63%-75%) overall, including 55% (29%-72%) among immunocompromised patients, and 72% (64%-77%) among immunocompetent patients, for whom VEs was similar at 14-90 days (73% [59%-82%]), 91-180 days (71% [60%-80%]), and 181-274 days (70% [54%-81%]) post-vaccination. Among hospitalized COVID-19 case-patients, VEp was 46% (18%-65%) among immunocompetent patients. CONCLUSIONS: The Ad26.COV2.S COVID-19 vaccine reduced the risk of COVID-19 hospitalization by 72% among immunocompetent adults without waning through 6 months post-vaccination. After hospitalization for COVID-19, vaccinated immunocompetent patients were less likely to require IMV or die compared to unvaccinated immunocompetent patients. |
Protection of mRNA vaccines against hospitalized COVID-19 in adults over the first year following authorization in the United States.
Tenforde MW , Self WH , Zhu Y , Naioti EA , Gaglani M , Ginde AA , Jensen K , Talbot HK , Casey JD , Mohr NM , Zepeski A , McNeal T , Ghamande S , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Ten Lohuis C , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Botros MM , Lauring AS , Shapiro NI , Halasa N , Chappell JD , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Rhoads JP , Lindsell CJ , Hart KW , Turbyfill C , Olson S , Murray N , Adams K , Patel MM . Clin Infect Dis 2022 76 (3) e460-e468 BACKGROUND: COVID-19 mRNA vaccines were authorized in the United States in December 2020. Although vaccine effectiveness (VE) against mild infection declines markedly after several months, limited understanding exists on the long-term durability of protection against COVID-19-associated hospitalization. METHODS: Case control analysis of adults (≥18 years) hospitalized at 21 hospitals in 18 states March 11 - December 15, 2021, including COVID-19 case patients and RT-PCR-negative controls. We included adults who were unvaccinated or vaccinated with two doses of a mRNA vaccine before the date of illness onset. VE over time was assessed using logistic regression comparing odds of vaccination in cases versus controls, adjusting for confounders. Models included dichotomous time (<180 vs ≥180 days since dose two) and continuous time modeled using restricted cubic splines. RESULTS: 10,078 patients were included, 4906 cases (23% vaccinated) and 5172 controls (62% vaccinated). Median age was 60 years (IQR 46-70), 56% were non-Hispanic White, and 81% had ≥1 medical condition. Among immunocompetent adults, VE <180 days was 90% (95%CI: 88-91) vs 82% (95%CI: 79-85) at ≥180 days (p < 0.001). VE declined for Pfizer-BioNTech (88% to 79%, p < 0.001) and Moderna (93% to 87%, p < 0.001) products, for younger adults (18-64 years) [91% to 87%, p = 0.005], and for adults ≥65 years of age (87% to 78%, p < 0.001). In models using restricted cubic splines, similar changes were observed. CONCLUSION: In a period largely pre-dating Omicron variant circulation, effectiveness of two mRNA doses against COVID-19-associated hospitalization was largely sustained through 9 months. |
Clinical severity of, and effectiveness of mRNA vaccines against, covid-19 from omicron, delta, and alpha SARS-CoV-2 variants in the United States: prospective observational study.
Lauring AS , Tenforde MW , Chappell JD , Gaglani M , Ginde AA , McNeal T , Ghamande S , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Exline MC , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , TenLohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Halasa N , Grijalva CG , Rice TW , Stubblefield WB , Baughman A , Womack KN , Rhoads JP , Lindsell CJ , Hart KW , Zhu Y , Adams K , Schrag SJ , Olson SM , Kobayashi M , Verani JR , Patel MM , Self WH . BMJ 2022 376 e069761 Objectives To characterize the clinical severity of covid-19 associated with the alpha, delta, and omicron SARS-CoV-2 variants among adults admitted to hospital and to compare the effectiveness of mRNA vaccines to prevent hospital admissions related to each variant. Design Case-control study. Setting 21 hospitals across the United States. Participants 11 690 adults (>=18 years) admitted to hospital: 5728 with covid-19 (cases) and 5962 without covid-19 (controls). Patients were classified into SARS-CoV-2 variant groups based on viral whole genome sequencing, and, if sequencing did not reveal a lineage, by the predominant circulating variant at the time of hospital admission: Alpha (11 March to 3 July 2021), delta (4 July to 25 December 2021), and omicron (26 December 2021 to 14 January 2022). Main outcome measures Vaccine effectiveness calculated using a test negative design for mRNA vaccines to prevent covid-19 related hospital admissions by each variant (alpha, delta, omicron). Among patients admitted to hospital with covid-19, disease severity on the World Health Organization's clinical progression scale was compared among variants using proportional odds regression. Results Effectiveness of the mRNA vaccines to prevent covid-19 associated hospital admissions was 85% (95% confidence interval 82% to 88%) for two vaccine doses against the alpha variant, 85% (83% to 87%) for two doses against the delta variant, 94% (92% to 95%) for three doses against the delta variant, 65% (51% to 75%) for two doses against the omicron variant; and 86% (77% to 91%) for three doses against the omicron variant. In-hospital mortality was 7.6% (81/1060) for alpha, 12.2% (461/3788) for delta, and 7.1% (40/565) for omicron. Among unvaccinated patients with covid-19 admitted to hospital, severity on the WHO clinical progression scale was higher for the delta versus alpha variant (adjusted proportional odds ratio 1.28, 95% confidence interval 1.11 to 1.46), and lower for the omicron versus delta variant (0.61, 0.49 to 0.77). Compared with unvaccinated patients, severity was lower for vaccinated patients for each variant, including alpha (adjusted proportional odds ratio 0.33, 0.23 to 0.49), delta (0.44, 0.37 to 0.51), and omicron (0.61, 0.44 to 0.85). Conclusions mRNA vaccines were found to be highly effective in preventing covid-19 associated hospital admissions related to the alpha, delta, and omicron variants, but three vaccine doses were required to achieve protection against omicron similar to the protection that two doses provided against the delta and alpha variants. Among adults admitted to hospital with covid-19, the omicron variant was associated with less severe disease than the delta variant but still resulted in substantial morbidity and mortality. Vaccinated patients admitted to hospital with covid-19 had significantly lower disease severity than unvaccinated patients for all the variants. Copyright Author(s) (or their employer(s)) 2019. |
mRNA Vaccine Effectiveness Against COVID-19 Hospitalization Among Solid Organ Transplant Recipients.
Kwon JH , Tenforde MW , Gaglani M , Talbot HK , Ginde AA , McNeal T , Ghamande S , Douin DJ , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Caspers SD , Exline MC , Botros M , Gong MN , Li A , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Khan A , Hough CL , Busse LW , Duggal A , Wilson JG , Perez C , Chang SY , Mallow C , Rovinski R , Babcock HM , Lauring AS , Felley L , Halasa N , Chappell JD , Grijalva CG , Rice TW , Womack KN , Lindsell CJ , Hart KW , Baughman A , Olson SM , Schrag S , Kobayashi M , Verani JR , Patel MM , Self WH . J Infect Dis 2022 226 (5) 797-807 BACKGROUND: The study objective was to evaluate 2 and 3 dose COVID-19 mRNA vaccine effectiveness (VE) in preventing COVID-19 hospitalization among adult solid organ transplant (SOT) recipients. METHODS: 21-site case-control analysis of 10,425 adults hospitalized March-December 2021. Cases were hospitalized with COVID-19; controls were hospitalized for an alternative diagnosis (SARS-CoV-2 negative). Participants were classified as: SOT recipient (n=440), other immunocompromising condition (n=1684), or immunocompetent (n=8301). VE against COVID-19 associated hospitalization was calculated as 1-adjusted odds ratio of prior vaccination among cases compared with controls. RESULTS: Among SOT recipients, VE was 29% (95% CI: -19 to 58%) for 2 doses and 77% (95% CI: 48 to 90%) for 3 doses. Among patients with other immunocompromising conditions, VE was 72% (95% CI: 64 to 79%) for 2 doses and 92% (95% CI: 85 to 95%) for 3 doses. Among immunocompetent patients, VE was 88% (95% CI: 87 to 90%) for 2 doses and 96% (95% CI: 83 to 99%) for 3 doses. CONCLUSION: Effectiveness of COVID-19 mRNA vaccines was lower for SOT recipients than immunocompetent people and those with other immunocompromising conditions. Among SOT recipients, vaccination with 3 doses of an mRNA vaccine led to substantially greater protection than 2 doses. |
Effectiveness of mRNA Vaccination in Preventing COVID-19-Associated Invasive Mechanical Ventilation and Death - United States, March 2021-January 2022.
Tenforde MW , Self WH , Gaglani M , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , McNeal T , Ghamande S , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Frosch AE , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Botros M , Lauring AS , Shapiro NI , Halasa N , Chappell JD , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Rhoads JP , Lindsell CJ , Hart KW , Zhu Y , Adams K , Surie D , McMorrow ML , Patel MM . MMWR Morb Mortal Wkly Rep 2022 71 (12) 459-465 COVID-19 mRNA vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) are effective at preventing COVID-19-associated hospitalization (1-3). However, how well mRNA vaccines protect against the most severe outcomes of these hospitalizations, including invasive mechanical ventilation (IMV) or death is uncertain. Using a case-control design, mRNA vaccine effectiveness (VE) against COVID-19-associated IMV and in-hospital death was evaluated among adults aged ≥18 years hospitalized at 21 U.S. medical centers during March 11, 2021-January 24, 2022. During this period, the most commonly circulating variants of SARS-CoV-2, the virus that causes COVID-19, were B.1.1.7 (Alpha), B.1.617.2 (Delta), and B.1.1.529 (Omicron). Previous vaccination (2 or 3 versus 0 vaccine doses before illness onset) in prospectively enrolled COVID-19 case-patients who received IMV or died within 28 days of hospitalization was compared with that among hospitalized control patients without COVID-19. Among 1,440 COVID-19 case-patients who received IMV or died, 307 (21%) had received 2 or 3 vaccine doses before illness onset. Among 6,104 control-patients, 4,020 (66%) had received 2 or 3 vaccine doses. Among the 1,440 case-patients who received IMV or died, those who were vaccinated were older (median age = 69 years), more likely to be immunocompromised* (40%), and had more chronic medical conditions compared with unvaccinated case-patients (median age = 55 years; immunocompromised = 10%; p<0.001 for both). VE against IMV or in-hospital death was 90% (95% CI = 88%-91%) overall, including 88% (95% CI = 86%-90%) for 2 doses and 94% (95% CI = 91%-96%) for 3 doses, and 94% (95% CI = 88%-97%) for 3 doses during the Omicron-predominant period. COVID-19 mRNA vaccines are highly effective in preventing COVID-19-associated death and respiratory failure treated with IMV. CDC recommends that all persons eligible for vaccination get vaccinated and stay up to date with COVID-19 vaccination (4). |
Lessons Learned From a Centers for Disease Control and Prevention Virtual Partner Services Technical Assistance Pilot Project to Respond to a Local Syphilis Outbreak.
Davis C , Wright SS , Babcock M , Kingdon E , Broussard D , Oyervides O , Carr D . Sex Transm Dis 2022 49 (2) 166-168 A virtual partner services technical assistance (TA) project was piloted with the Minnesota Department of Health to address an ongoing syphilis outbreak. The TA reduced the health department's disease intervention specialist workload, achieved partner services outcomes comparable with in-person methods, and identified lessons learned to replicate with other jurisdictions. |
Stopping Hospital Infections with Environmental Services (shine): A cluster-randomized trial of intensive monitoring methods for terminal room cleaning on rates of multidrug-resistant organisms in the intensive care unit
Ziegler MJ , Babcock HH , Welbel SF , Warren DK , Trick WE , Tolomeo P , Omorogbe J , Garcia D , Habrock-Bach T , Donceras O , Gaynes S , Cressman L , Burnham JP , Bilker W , Reddy SC , Pegues D , Lautenbach E , Kelly BJ , Fuchs B , Martin ND , Han JH . Clin Infect Dis 2022 75 (7) 1217-1223 BACKGROUND: Multidrug-resistant organisms (MDROs) frequently contaminate hospital environments. We performed a multicenter, cluster-randomized, crossover trial of two methods for monitoring of terminal cleaning effectiveness. METHODS: Six intensive care units (ICUs) at three medical centers received both interventions sequentially, in randomized order. Ten surfaces were surveyed each in five rooms weekly, after terminal cleaning, with ATP monitoring or an ultraviolet fluorescent marker (UV/F). Results were delivered to environmental services staff in real-time with failing surfaces recleaned. We measured monthly rates of MDRO infection or colonization, including methicillin-resistant Staphylococcus aureus, Clostridioides difficile, vancomycin-resistant Enterococcus, and MDR gram-negative bacilli (MDR-GNB) during a 12-month baseline period and sequential 6-month intervention periods, separated by a 2-month washout. Primary analysis compared only the randomized intervention periods, while secondary analysis included the baseline. RESULTS: The ATP method was associated with a reduction in incidence rate of MDRO infection or colonization compared to the UV/F period (incidence rate ratio (IRR) 0.876, 95% confidence-interval (CI) 0.807 - 0.951, P=0.002). Including the baseline period, the ATP method was associated with reduced infection with MDROs (IRR 0.924, 95% CI 0.855 - 0.998, P=0.04), and MDR-GNB infection or colonization (IRR 0.856, 95% CI 0.825 - 0.887, P<0.001). The UV/F intervention was not associated with a statistically significant impact on these outcomes. Room turn-around time increased by a median of one minute with the ATP intervention and 4.5 minutes with UV/F compared to baseline. CONCLUSIONS: Intensive monitoring of ICU terminal room cleaning with an ATP modality is associated with a reduction of MDRO infection and colonization. |
Effectiveness of mRNA vaccines in preventing COVID-19 hospitalization by age and burden of chronic medical conditions among immunocompetent US adults, March-August 2021.
Lewis NM , Naioti EA , Self WH , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , Ghamande SA , McNeal TA , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Hubel K , Hough CL , Busse LW , Ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Rhoads JP , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Schrag SJ , Kobayashi M , Verani JR , Patel MM , Tenforde MW . J Infect Dis 2021 225 (10) 1694-1700 In a multi-state network, vaccine effectiveness (VE) against COVID-19 hospitalizations was evaluated among immunocompetent adults (≥18-years) during March-August 2021 using a case-control design. Among 1669 hospitalized COVID-19 cases (11% fully vaccinated) and 1950 RT-PCR-negative controls (54% fully vaccinated), VE was higher at 96% (95% CI: 93-98%) among patients with no chronic medical conditions than patients with ≥3 categories of conditions (83% [95% CI: 76-88%]). VE was similar between those aged 18-64 years vs ≥65 years (p>0.05). Vaccine effectiveness against severe COVID-19 was very high among adults without chronic conditions and lessened with increasing burden of comorbidities. |
Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity.
Tenforde MW , Self WH , Adams K , Gaglani M , Ginde AA , McNeal T , Ghamande S , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Exline MC , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Rhoads JP , Lindsell CJ , Hart KW , Zhu Y , Olson SM , Kobayashi M , Verani JR , Patel MM . JAMA 2021 326 (20) 2043-2054 IMPORTANCE: A comprehensive understanding of the benefits of COVID-19 vaccination requires consideration of disease attenuation, determined as whether people who develop COVID-19 despite vaccination have lower disease severity than unvaccinated people. OBJECTIVE: To evaluate the association between vaccination with mRNA COVID-19 vaccines-mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech)-and COVID-19 hospitalization, and, among patients hospitalized with COVID-19, the association with progression to critical disease. DESIGN, SETTING, AND PARTICIPANTS: A US 21-site case-control analysis of 4513 adults hospitalized between March 11 and August 15, 2021, with 28-day outcome data on death and mechanical ventilation available for patients enrolled through July 14, 2021. Date of final follow-up was August 8, 2021. EXPOSURES: COVID-19 vaccination. MAIN OUTCOMES AND MEASURES: Associations were evaluated between prior vaccination and (1) hospitalization for COVID-19, in which case patients were those hospitalized for COVID-19 and control patients were those hospitalized for an alternative diagnosis; and (2) disease progression among patients hospitalized for COVID-19, in which cases and controls were COVID-19 patients with and without progression to death or mechanical ventilation, respectively. Associations were measured with multivariable logistic regression. RESULTS: Among 4513 patients (median age, 59 years [IQR, 45-69]; 2202 [48.8%] women; 23.0% non-Hispanic Black individuals, 15.9% Hispanic individuals, and 20.1% with an immunocompromising condition), 1983 were case patients with COVID-19 and 2530 were controls without COVID-19. Unvaccinated patients accounted for 84.2% (1669/1983) of COVID-19 hospitalizations. Hospitalization for COVID-19 was significantly associated with decreased likelihood of vaccination (cases, 15.8%; controls, 54.8%; adjusted OR, 0.15; 95% CI, 0.13-0.18), including for sequenced SARS-CoV-2 Alpha (8.7% vs 51.7%; aOR, 0.10; 95% CI, 0.06-0.16) and Delta variants (21.9% vs 61.8%; aOR, 0.14; 95% CI, 0.10-0.21). This association was stronger for immunocompetent patients (11.2% vs 53.5%; aOR, 0.10; 95% CI, 0.09-0.13) than immunocompromised patients (40.1% vs 58.8%; aOR, 0.49; 95% CI, 0.35-0.69) (P < .001) and weaker at more than 120 days since vaccination with BNT162b2 (5.8% vs 11.5%; aOR, 0.36; 95% CI, 0.27-0.49) than with mRNA-1273 (1.9% vs 8.3%; aOR, 0.15; 95% CI, 0.09-0.23) (P < .001). Among 1197 patients hospitalized with COVID-19, death or invasive mechanical ventilation by day 28 was associated with decreased likelihood of vaccination (12.0% vs 24.7%; aOR, 0.33; 95% CI, 0.19-0.58). CONCLUSIONS AND RELEVANCE: Vaccination with an mRNA COVID-19 vaccine was significantly less likely among patients with COVID-19 hospitalization and disease progression to death or mechanical ventilation. These findings are consistent with risk reduction among vaccine breakthrough infections compared with absence of vaccination. |
An Emergency Preparedness Response to Opioid-Prescribing Enforcement Actions in Maryland, 2018-2019
Acharya JC , Lyons BC , Murthy V , Stanley J , Babcock C , Jackson K , Adams S . Public Health Rep 2021 136 9s-17s Federal and state enforcement authorities have increasingly intervened on the criminal overprescribing of opioids. However, little is known about the health effects these enforcement actions have on patients experiencing disrupted access to prescription opioids or medication-assisted treatment/medication for opioid use disorder. Simultaneously, opioid death rates have increased. In response, the Maryland Department of Health (MDH) has worked to coordinate mitigation strategies with enforcement partners (defined as any federal, state, or local enforcement authority or other governmental investigative authority). One strategy is a standardized protocol to implement emergency response functions, including rapidly identifying health hazards with real-time data access, deploying resources locally, and providing credible messages to partners and the public. From January 2018 through October 2019, MDH used the protocol in response to 12 enforcement actions targeting 34 medical professionals. A total of 9624 patients received Schedule II-V controlled substance prescriptions from affected prescribers under investigation in the 6 months before the respective enforcement action; 9270 (96%) patients were residents of Maryland. Preliminary data indicate fatal overdose events and potential loss of follow-up care among the patient population experiencing disrupted health care as a result of an enforcement action. The success of the strategy hinged on endorsement by leadership; the establishment of federal, state, and local roles and responsibilities; and data sharing. MDH's approach, data sources, and lessons learned may support health departments across the country that are interested in conducting similar activities on the front lines of the opioid crisis. |
Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions - United States, March-August 2021.
Self WH , Tenforde MW , Rhoads JP , Gaglani M , Ginde AA , Douin DJ , Olson SM , Talbot HK , Casey JD , Mohr NM , Zepeski A , McNeal T , Ghamande S , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Mills L , Lester SN , Stumpf MM , Naioti EA , Kobayashi M , Verani JR , Thornburg NJ , Patel MM . MMWR Morb Mortal Wkly Rep 2021 70 (38) 1337-1343 Three COVID-19 vaccines are authorized or approved for use among adults in the United States (1,2). Two 2-dose mRNA vaccines, mRNA-1273 from Moderna and BNT162b2 from Pfizer-BioNTech, received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) in December 2020 for persons aged ≥18 years and aged ≥16 years, respectively. A 1-dose viral vector vaccine (Ad26.COV2 from Janssen [Johnson & Johnson]) received EUA in February 2021 for persons aged ≥18 years (3). The Pfizer-BioNTech vaccine received FDA approval for persons aged ≥16 years on August 23, 2021 (4). Current guidelines from FDA and CDC recommend vaccination of eligible persons with one of these three products, without preference for any specific vaccine (4,5). To assess vaccine effectiveness (VE) of these three products in preventing COVID-19 hospitalization, CDC and collaborators conducted a case-control analysis among 3,689 adults aged ≥18 years who were hospitalized at 21 U.S. hospitals across 18 states during March 11-August 15, 2021. An additional analysis compared serum antibody levels (anti-spike immunoglobulin G [IgG] and anti-receptor binding domain [RBD] IgG) to SARS-CoV-2, the virus that causes COVID-19, among 100 healthy volunteers enrolled at three hospitals 2-6 weeks after full vaccination with the Moderna, Pfizer-BioNTech, or Janssen COVID-19 vaccine. Patients with immunocompromising conditions were excluded. VE against COVID-19 hospitalizations was higher for the Moderna vaccine (93%; 95% confidence interval [CI] = 91%-95%) than for the Pfizer-BioNTech vaccine (88%; 95% CI = 85%-91%) (p = 0.011); VE for both mRNA vaccines was higher than that for the Janssen vaccine (71%; 95% CI = 56%-81%) (all p<0.001). Protection for the Pfizer-BioNTech vaccine declined 4 months after vaccination. Postvaccination anti-spike IgG and anti-RBD IgG levels were significantly lower in persons vaccinated with the Janssen vaccine than the Moderna or Pfizer-BioNTech vaccines. Although these real-world data suggest some variation in levels of protection by vaccine, all FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization. |
Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing Covid-19 Hospitalizations in the United States.
Tenforde MW , Patel MM , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , McNeal T , Ghamande S , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Exline MC , Gong MN , Mohamed A , Henning DJ , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CT , Busse L , Ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Gershengorn HB , Babcock HM , Kwon JH , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Olson SM , Stephenson M , Schrag SJ , Kobayashi M , Verani JR , Self WH . Clin Infect Dis 2021 74 (9) 1515-1524 BACKGROUND: As SARS-CoV-2 vaccination coverage increases in the United States (US), there is a need to understand the real-world effectiveness against severe Covid-19 and among people at increased risk for poor outcomes. METHODS: In a multicenter case-control analysis of US adults hospitalized March 11-May 5, 2021, we evaluated vaccine effectiveness to prevent Covid-19 hospitalizations by comparing odds of prior vaccination with an mRNA vaccine (Pfizer-BioNTech or Moderna) between cases hospitalized with Covid-19 and hospital-based controls who tested negative for SARS-CoV-2. RESULTS: Among 1212 participants, including 593 cases and 619 controls, median age was 58 years, 22.8% were Black, 13.9% were Hispanic, and 21.0% had immunosuppression. SARS-CoV-2 lineage B.1.1.7 (Alpha) was the most common variant (67.9% of viruses with lineage determined). Full vaccination (receipt of two vaccine doses ≥14 days before illness onset) had been received by 8.2% of cases and 36.4% of controls. Overall vaccine effectiveness was 87.1% (95% CI: 80.7 to 91.3%). Vaccine effectiveness was similar for Pfizer-BioNTech and Moderna vaccines, and highest in adults aged 18-49 years (97.4%; 95% CI: 79.3 to 99.7%). Among 45 patients with vaccine-breakthrough Covid hospitalizations, 44 (97.8%) were ≥50 years old and 20 (44.4%) had immunosuppression. Vaccine effectiveness was lower among patients with immunosuppression (62.9%; 95% CI: 20.8 to 82.6%) than without immunosuppression (91.3%; 95% CI: 85.6 to 94.8%). CONCLUSION: During March-May 2021, SARS-CoV-2 mRNA vaccines were highly effective for preventing Covid-19 hospitalizations among US adults. SARS-CoV-2 vaccination was beneficial for patients with immunosuppression, but effectiveness was lower in the immunosuppressed population. |
Interim Estimates of Vaccine Effectiveness of Pfizer-BioNTech and Moderna COVID-19 Vaccines Among Health Care Personnel - 33 U.S. Sites, January-March 2021.
Pilishvili T , Fleming-Dutra KE , Farrar JL , Gierke R , Mohr NM , Talan DA , Krishnadasan A , Harland KK , Smithline HA , Hou PC , Lee LC , Lim SC , Moran GJ , Krebs E , Steele M , Beiser DG , Faine B , Haran JP , Nandi U , Schrading WA , Chinnock B , Henning DJ , LoVecchio F , Nadle J , Barter D , Brackney M , Britton A , Marceaux-Galli K , Lim S , Phipps EC , Dumyati G , Pierce R , Markus TM , Anderson DJ , Debes AK , Lin M , Mayer J , Babcock HM , Safdar N , Fischer M , Singleton R , Chea N , Magill SS , Verani J , Schrag S . MMWR Morb Mortal Wkly Rep 2021 70 (20) 753-758 Throughout the COVID-19 pandemic, health care personnel (HCP) have been at high risk for exposure to SARS-CoV-2, the virus that causes COVID-19, through patient interactions and community exposure (1). The Advisory Committee on Immunization Practices recommended prioritization of HCP for COVID-19 vaccination to maintain provision of critical services and reduce spread of infection in health care settings (2). Early distribution of two mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) to HCP allowed assessment of the effectiveness of these vaccines in a real-world setting. A test-negative case-control study is underway to evaluate mRNA COVID-19 vaccine effectiveness (VE) against symptomatic illness among HCP at 33 U.S. sites across 25 U.S. states. Interim analyses indicated that the VE of a single dose (measured 14 days after the first dose through 6 days after the second dose) was 82% (95% confidence interval [CI] = 74%-87%), adjusted for age, race/ethnicity, and underlying medical conditions. The adjusted VE of 2 doses (measured ≥7 days after the second dose) was 94% (95% CI = 87%-97%). VE of partial (1-dose) and complete (2-dose) vaccination in this population is comparable to that reported from clinical trials and recent observational studies, supporting the effectiveness of mRNA COVID-19 vaccines against symptomatic disease in adults, with strong 2-dose protection. |
Reported variability in healthcare facility policies regarding healthcare personnel working while experiencing influenza-like illnesses: An emerging infections network survey
Babcock HM , Beekmann SE , Pillai SK , Santibanez S , Lee L , Kuhar DT , Campbell AP , Patel A , Polgreen PM . Infect Control Hosp Epidemiol 2019 41 (1) 1-6 BACKGROUND: Presenteeism, or working while ill, by healthcare personnel (HCP) experiencing influenza-like illness (ILI) puts patients and coworkers at risk. However, hospital policies and practices may not consistently facilitate HCP staying home when ill. OBJECTIVE AND METHODS: We conducted a mixed-methods survey in March 2018 of Emerging Infections Network infectious diseases physicians, describing institutional experiences with and policies for HCP working with ILI. RESULTS: Of 715 physicians, 367 (51%) responded. Of 367, 135 (37%) were unaware of institutional policies. Of the remaining 232 respondents, 206 (89%) reported institutional policies regarding work restrictions for HCP with influenza or ILI, but only 145 (63%) said these were communicated at least annually. More than half of respondents (124, 53%) reported that adherence to work restrictions was not monitored or enforced. Work restrictions were most often not perceived to be enforced for physicians-in-training and attending physicians. Nearly all (223, 96%) reported that their facility tracked laboratory-confirmed influenza (LCI) in patients; 85 (37%) reported tracking ILI. For employees, 109 (47%) reported tracking of LCI and 53 (23%) reported tracking ILI. For independent physicians, not employed by the facility, 30 (13%) reported tracking LCI and 11 (5%) ILI. CONCLUSION: More than one-third of respondents were unaware of whether their institutions had policies to prevent HCP with ILI from working; among those with knowledge of institutional policies, dissemination, monitoring, and enforcement of these policies was highly variable. Improving communication about work-restriction policies, as well as monitoring and enforcement, may help prevent the spread of infections from HCP to patients. |
Respiratory viral surveillance of healthcare personnel and patients at an adult long-term care facility
O'Neil CA , Kim L , Prill MM , Talbot HK , Whitaker B , Sakthivel SK , Zhang Y , Zhang J , Tong S , Stone N , Garg S , Gerber SI , Babcock HM . Infect Control Hosp Epidemiol 2019 40 (11) 1-4 We conducted active surveillance of acute respiratory viral infections (ARIs) among residents and healthcare personnel (HCP) at a long-term care facility during the 2015-2016 respiratory illness season. ARIs were observed among both HCP and patients, highlighting the importance of including HCP in surveillance programs. |
An Analysis of Cancer Registry Cost Data: Methodology and Results
Beebe MC , Subramanian S , Tangka FK , Weir HK , Babcock F , Trebino D . J Registry Manag 2018 45 (2) 58-64 The Centers for Disease Control and Prevention initiated an economic analysis of the National Program of Cancer Registries (NPCR) in 2005 to estimate the true economic costs of operating a cancer registry, identify costs associated with registry activities, and evaluate the factors that may affect the efficiency of registry operations. We developed a Web-based NPCR cost assessment tool (NPCR-CAT) to collect activity-based cost data from all 48 NPCR registries. We collected data on registry funding, actual expenditures, and factors that may affect the efficiency of operating a central cancer registry. Key lessons learned during data collection and analysis include the importance of working closely with registry staff and balancing the need for standardized data elements with an understanding of individual registry characteristics. Our findings and lessons can be adapted to develop costing tools for other surveillance systems and cancer control programs, both domestically and internationally. |
The history and use of cancer registry data by public health cancer control programs in the United States
White MC , Babcock F , Hayes NS , Mariotto AB , Wong FL , Kohler BA , Weir HK . Cancer 2017 123 Suppl 24 4969-4976 Because cancer registry data provide a census of cancer cases, registry data can be used to: 1) define and monitor cancer incidence at the local, state, and national levels; 2) investigate patterns of cancer treatment; and 3) evaluate the effectiveness of public health efforts to prevent cancer cases and improve cancer survival. The purpose of this article is to provide a broad overview of the history of cancer surveillance programs in the United States, and illustrate the expanding ways in which cancer surveillance data are being made available and contributing to cancer control programs. The article describes the building of the cancer registry infrastructure and the successful coordination of efforts among the 2 federal agencies that support cancer registry programs, the Centers for Disease Control and Prevention and the National Cancer Institute, and the North American Association of Central Cancer Registries. The major US cancer control programs also are described, including the National Comprehensive Cancer Control Program, the National Breast and Cervical Cancer Early Detection Program, and the Colorectal Cancer Control Program. This overview illustrates how cancer registry data can inform public health actions to reduce disparities in cancer outcomes and may be instructional for a variety of cancer control professionals in the United States and in other countries. Cancer 2017;123:4969-76. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. |
Preventing respiratory viral transmission in long-term care: Knowledge, attitudes, and practices of healthcare personnel
O'Neil CA , Kim L , Prill MM , Stone ND , Garg S , Talbot HK , Babcock HM . Infect Control Hosp Epidemiol 2017 38 (12) 1-8 OBJECTIVE To examine knowledge and attitudes about influenza vaccination and infection prevention practices among healthcare personnel (HCP) in a long-term-care (LTC) setting. DESIGN Knowledge, attitudes, and practices (KAP) survey. SETTING An LTC facility in St Louis, Missouri. PARTICIPANTS All HCP working at the LTC facility were eligible to participate, regardless of department or position. Of 170 full- and part-time HCP working at the facility, 73 completed the survey, a 42.9% response rate. RESULTS Most HCP agreed that respiratory viral infections were serious and that hand hygiene and face mask use were protective. However, only 46% could describe the correct transmission-based precautions for an influenza patient. Correctly answering infection prevention knowledge questions did not vary by years of experience but did vary for HCP with more direct patient contact versus less patient contact. Furthermore, 42% of respondents reported working while sick, and 56% reported that their coworkers did. In addition, 54% reported that facility policies made staying home while ill difficult. Some respondents expressed concerns about the safety (22%) and effectiveness (27%) of the influenza vaccine, and 28% of respondents stated that they would not get the influenza vaccine if it was not required. CONCLUSIONS This survey of staff in an LTC facility identified several areas for policy improvement, particularly sick leave, as well as potential targets for interventions to improve infection prevention knowledge and to address HCP concerns about influenza vaccination to improve HCP vaccination rates in LTCs. Infect Control Hosp Epidemiol 2017;1-8. |
Use of Adjuvant Chemotherapy among Stage II Colon Cancer Patients in 10 Population-Based National Program of Cancer Registries
Eheman CR , O'Neil ME , Styles TS , Thompson TD , Morris CR , Babcock FA , Chen VW . J Registry Manag 2016 43 (4) 179-186 BACKGROUND: Some guidelines advise adjuvant chemotherapy be considered after surgical resection for high-risk stage II colon cancer patients; however, high-risk criteria are poorly defined and the long-term benefits are still debated. This study documents patterns of care by selected patient and tumor characteristics using a US population-based cohort of stage II colon cancer patients diagnosed in 2011. METHODS: Data were collected from 10 specialized cancer registries participating in the Centers for Disease Control and Prevention's National Program of Cancer Registries' Enhancing Cancer Registry Data for Comparative Effectiveness Research project. The data were used to describe characteristics of stage II colon cancer patients treated by surgery to evaluate factors associated with receiving adjuvant chemotherapy. RESULTS: Of the 3,891 stage II colon cancer patients, 14.3% were treated with surgery and adjuvant chemotherapy compared to 82.9% by surgery alone. The patients treated with adjuvant chemotherapy were predominately non-Hispanic white (66.1%), of younger age, and had private insurance (39.9%). Compared to surgery alone, the 5 characteristics associated with adjuvant therapy were younger age (adjusted odds ratio [AOR] for 5-year decrease below 75 years, 1.25; P < .001); more advanced stage (IIB/IIC vs IIA) (AOR, 4.79; P < .001); lymphovascular invasion (AOR, 1.76, P < .001); higher grade (III/IV vs I/II) (AOR, 1.84; P < .001); and registry area. CONCLUSIONS: In this population-based cohort, younger patients with more advanced stage II colon tumors, with lymphovascular invasion, and poor differentiation were more likely to receive adjuvant chemotherapy in addition to surgery. These characteristics align with high-risk profiles defined in guidelines. Ongoing data collection on outcomes, including recurrence and survival, will help clarify the benefits of adjuvant treatments for stage II colon patients. |
Population-Based Testing and Treatment Characteristics for Chronic Myelogenous Leukemia
Styles T , Wu M , Wilson R , Babcock F , Butterworth D , West DW , Richardson LC . J Registry Manag 2016 41 (3) 134-142 INTRODUCTION: National and international hematology/oncology practice guidelines recommend testing for the BCR-ABL mutation for definitive diagnosis of chronic myeloid leukemia (CML) to allow for appropriate treatment with a tyrosine kinase inhibitor (TKI). The purpose of our study was to describe population-based testing and treatment practice characteristics for patients diagnosed with CML. METHODS: We analyzed cases of CML using 2011 data from 10 state registries that are part of the Centers for Disease Control and Prevention (CDC)'s National Program of Cancer Registries. We describe completeness of testing for the BCR-ABL gene and availability of outpatient treatment with TKIs and associated characteristics. RESULTS: A total of 685 cases of CML were identified; 55 percent (374) had a documented BCR-ABL gene test with 96 percent (360) of these being positive for the BCR-ABL gene and the remaining 4 percent (14) either testing negative or having a missing result. Registries were able to identify the use of TKIs in 54 percent (369) of patients, though only 43 percent (296) had a corresponding BCR-ABL gene test documented. One state registry reported a significantly lower percentage of patients being tested for the BCR-ABL gene (25 percent) and receiving TKI treatment (21 percent). Limiting analysis to CML case reports from the remaining 9 comparative effectiveness research registries, 78 percent (305) patients had a documented BCR-ABL gene test and 79 percent (308) had documented treatment with a TKI. Receipt of testing or treatment for these 9 states did not vary by sex, race, ethnicity, census tract poverty level, census tract urbanization, or insurance status; BCR-ABL testing varied by state of residence, and BCR-ABL testing and TKI therapy occurred less often with increasing age (BCR-ABL testing: odds ratio [OR], 0.97; 95 percent CI, 0.95-0.99; and TKI therapy: OR, 0.97; 95 percent CI, 0.96-0.99). CONCLUSIONS: Collection of detailed CML data vary significantly by states. A majority of the case patients had appropriate testing for the BCR-ABL gene and treatment with tyrosine kinase inhibitors. However, BCR-ABL testing and TKI treatment decreased with increasing age. Further research is needed to understand CML coding, testing, and treatment disparities. |
Humoral and cell mediated immune responses to alternate booster schedules of anthrax vaccine adsorbed in humans
Quinn CP , Sabourin CL , Schiffer JM , Niemuth NA , Semenova VA , Li H , Rudge TL , Brys AM , Mittler RS , Ibegbu CC , Wrammert J , Ahmed R , Parker SD , Babcock J , Keitel W , Poland GA , Keyserling HL , Sahly HE , Jacobson RM , Marano N , Plikaytis BD , Wright JG . Clin Vaccine Immunol 2016 23 (4) 326-38 Protective antigen (PA)-specific antibody and cell mediated immune (CMI) responses to annual and alternate booster schedules of Anthrax Vaccine Adsorbed (AVA, BioThrax(R)) were characterized in humans over 43 months. Study participants received 1 of 6 vaccination schedules: 3-dose intramuscular (IM) priming series (0, 1, 6 months) with a single booster at 42 months (4-IM); 3-dose IM priming with boosters at 18 and 42 months (5-IM); 3-dose IM priming with boosters at 12, 18, 30 and 42 months (7-IM); the 1970 licensed priming series of 6 doses (0, 0.5, 1, 6, 12, 18 months) and two annual boosters (30, 42 months) administered either subcutaneous (SQ) (8-SQ) or IM (8-IM); or saline placebo control at all eight time-points.Antibody response profiles included serum anti-PA IgG levels, subclass distributions, avidity, and lethal toxin neutralization activity (TNA). CMI profiles included frequencies of IFN-gamma and IL-4 secreting cells and memory B cells (MBCs), lymphocyte proliferation indices (SI) and induction of IFN-gamma, IL-2, IL-4, IL-6, IL-1beta and TNF-alpha mRNA levels.All active schedules elicited high avidity PA-specific IgG, TNA, MBCs and T cell responses with a mixed Th1/Th2 profile and Th2 dominance. Anti-PA IgG and TNA were highly correlated (e.g. Month 7, r2 = 0.86, p < 0.0001, log10 transformed) and declined in the absence of boosters. Boosters administered IM generated the highest antibody responses. Increasing time intervals between boosters generated faster and statistically superior antibody responses to the final Month 42 vaccination. CMI responses to the 3-dose IM priming remained elevated up to 43 Months. |
The cost of cancer registry operations: Impact of volume on cost per case for core and enhanced registry activities
Subramanian S , Tangka FK , Beebe MC , Trebino D , Weir HK , Babcock F . Eval Program Plann 2015 55 1-8 BACKGROUND: Cancer registration data is vital for creating evidence-based policies and interventions. Quantifying the resources needed for cancer registration activities and identifying potential efficiencies are critically important to ensure sustainability of cancer registry operations. METHODS: Using a previously validated web-based cost assessment tool, we collected activity-based cost data and report findings using 3 years of data from 40 National Program of Cancer Registry grantees. We stratified registries by volume: low-volume included fewer than 10,000 cases, medium-volume included 10,000-50,000 cases, and high-volume included >50,000 cases. RESULTS: Low-volume cancer registries incurred an average of $93.11 to report a case (without in-kind contributions) compared with $27.70 incurred by high-volume registries. Across all registries, the highest cost per case was incurred for data collection and abstraction ($8.33), management ($6.86), and administration ($4.99). Low- and medium-volume registries have higher costs than high-volume registries for all key activities. CONCLUSIONS: Some cost differences by volume can be explained by the large fixed costs required for administering and performing registration activities, but other reasons may include the quality of the data initially submitted to the registries from reporting sources such as hospitals and pathology laboratories. Automation or efficiency improvements in data collection can potentially reduce overall costs. |
Cost of operating central cancer registries and factors that affect cost: Findings from an economic evaluation of Centers for Disease Control and Prevention National Program Of Cancer Registries
Tangka FK , Subramanian S , Beebe MC , Weir HK , Trebino D , Babcock F , Ewing J . J Public Health Manag Pract 2015 22 (5) 452-60 CONTEXT: The Centers for Disease Control and Prevention evaluated the economics of the National Program of Cancer Registries to provide the Centers for Disease Control and Prevention, the registries, and policy makers with the economics evidence-base to make optimal decisions about resource allocation. Cancer registry budgets are under increasing threat, and, therefore, systematic assessment of the cost will identify approaches to improve the efficiencies of this vital data collection operation and also justify the funding required to sustain registry operations. OBJECTIVES: To estimate the cost of cancer registry operations and to assess the factors affecting the cost per case reported by National Program of Cancer Registries-funded central cancer registries. METHODS: We developed a Web-based cost assessment tool to collect 3 years of data (2009-2011) from each National Program of Cancer Registries-funded registry for all actual expenditures for registry activities (including those funded by other sources) and factors affecting registry operations. We used a random-effects regression model to estimate the impact of various factors on cost per cancer case reported. RESULTS: The cost of reporting a cancer case varied across the registries. Central cancer registries that receive high-quality data from reporting sources (as measured by the percentage of records passing automatic edits) and electronic data submissions, and those that collect and report on a large volume of cases had significantly lower cost per case. The volume of cases reported had a large effect, with low-volume registries experiencing much higher cost per case than medium- or high-volume registries. CONCLUSIONS: Our results suggest that registries operate with substantial fixed or semivariable costs. Therefore, sharing fixed costs among low-volume contiguous state registries, whenever possible, and centralization of certain processes can result in economies of scale. Approaches to improve quality of data submitted and increasing electronic reporting can also reduce cost. |
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