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 Department of Health and Human Services Agency for Healthcare Research and Quality
 AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
 ACTION: Request for supplemental evidence and data submission.
 SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on 
                        *Impact of Healthcare Worker Safety and Wellness: A Systematic Review,*
                         which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
 DATES: *Submission Deadline*
                         on or before January 21, 2025.
 ADDRESSES:  *Email submissions: epc@ahrq.hhs.gov*. *Print submissions:* *Mailing Address:*
                         Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857 *Shipping Address (FedEx, UPS, etc.):*
                         Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857
 FOR FURTHER INFORMATION CONTACT: Kelly Carper, eelephone: 301-427-1656 or email: 
                        *epc@ahrq.hhs.gov.*


SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for 
                    *Impact of Healthcare Worker Safety and Wellness: A Systematic Review.*
                     AHRQ is conducting this review pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 299a. The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the 
                    ( print page 103829)
                    literature by requesting information from the public (
                    *e.g.,*
                     details of studies conducted). We are looking for studies that report on 
                    *Impact of Healthcare Worker Safety and Wellness: A Systematic Review.*
                     The entire research protocol is available online at: 
                    *https://effectivehealthcare.ahrq.gov/​products/​worker-safety-wellness/​protocol.* This is to notify the public that the EPC Program would find the following information on 
                    *Impact of Healthcare Worker Safety and Wellness: A Systematic Review*
                     helpful: A list of completed studies that your organization has sponsored for this topic. In the list, please 
                    *indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.* *For completed studies that do not have results on ClinicalTrials.gov,*
                     a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. *A list of ongoing studies that your organization has sponsored for this topic.*
                     In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. Description of whether the above studies constitute 
                    *ALL Phase II and above clinical trials*
                     sponsored by your organization for this topic and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: 
                    *https://effectivehealthcare.ahrq.gov/​email-updates.* *The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.* *Contextual Question:*
                     What are the manifestations of impaired safety and wellbeing of HCWs, such as burnout, moral injury, emotional exhaustion, staff turnover, and physical injuries? Key Questions (KQ) *KQ 1:*
                     What are the associations between healthcare delivery conditions and HCW burnout? *KQ 2:*
                     What are the associations between HCW burnout and outcomes for patients, HCW families, healthcare delivery organizations, and society? *KQ 3:*
                     What are the effectiveness and harms of system-level interventions targeting HCW burnout? PECOTS (Populations, Exposures, Comparators, Outcomes, Timing and Setting) Eligibility Criteria for All Key Questions
Element
Key Question 1
Key Question 2
Key Question 3Population
HCWs at all organizational levels (
                            *e.g.,*
                             those who provide direct patient care, support personnel, managers, executives) Examples:
                             • Physicians. 
                             • Nurses: registered nurses and advanced practice nurses.• Pharmacists.
                             
                                • Allied healthcare professionals (
                                *e.g.,*
                                 respiratory therapists, physical therapists, social workers, emergency medical technicians).
                             
                             
                                • Support personnel (
                                *e.g.,*
                                 environmental services).
                             
                             • Managers. 
                             • Executives.Exposure
All healthcare delivery conditions associated with the included studies will be recorded as exposures, including
                             • Societal conditions, including federal and state laws like nurse staffing laws, policies like pandemic restrictions and credentialing, and unemployment, healthcare utilization, and unionization rates. 
                             • Organizational factors such as payment model, level of care, precarious and unstable scheduling, safety culture. 
                             • Job and task-specific factors, such as occupational class, shift characteristics, working hours, occupational stressors, support, teamwork, and workplace hazards Individual factors, such as age and experience.
HCW burnout, including instruments such as:
                             • Maslach Burnout Inventory 
                             • Oldenburg Burnout Inventory 
                             • Copenhagen Burnout Inventory 
                             • Two-Item Maslach Burnout Inventory 
                             • Physician Worklife Study Single Item Question 
                             • ProQOL Burnout scale 
                             • Institute for Professional Worklife Mini Z Survey
*System-level programs:*
                            interventions that intend to reduce or prevent HCW burnout through the elimination or substitution of occupational hazards.
                             
                                *Exclude:*
                                 interventions that enable the occupational hazard to remain in place (engineering, administrative controls) or increase the individual capacity to cope with the hazard (PPE, resilience training).Comparator
Other healthcare delivery condition.
Other levels of HCW burnout.
• Other intervention.
                             • No intervention.( print page 103830)Outcomes
HCW burnout, including instruments such as:
                             • Maslach Burnout Inventory 
                             • Oldenburg Burnout Inventory 
                             • Copenhagen Burnout Inventory 
                             • Two-Item Maslach Burnout Inventory 
                             • Physician Worklife Study Single Item Question 
                             • Professional Quality of Life (ProQOL) Burnout scale 
                             • Institute for Professional Worklife Mini Z Survey
• HCW family outcomes, such as:
                             ○ Marital/relationship stress measured by a partner 
                             ○ Divorce/separation rates 
                             • Patient outcomes, such as: 
                             ○ Safety 
                             ○ Satisfaction 
                             ○ Adverse events 
                             ○ Mortality 
                             • Healthcare organization outcomes, such as: 
                             ○ Productivity (including presenteeism, absenteeism, work-related injuries and illnesses) 
                             ○ Staff turnover (including due to retirement, leaving the profession, mortality, or suicide) 
                             • Societal outcomes, such as: 
                             ○ Workforce shortages
HCW burnout, including instruments such as:
                             • Maslach Burnout Inventory. 
                             • Oldenburg Burnout Inventory. 
                             • Copenhagen Burnout Inventory. 
                             • Two-Item Maslach Burnout Inventory. 
                             • Physician Worklife Study Single Item Question. 
                             • ProQOL Burnout scale. 
                             • Institute for Professional Worklife Mini Z Survey.Mediating Factors
• Individual factors such as stress, satisfaction, wellbeing, engagement, sleep quality, suicidal ideation, depression, anxiety, meaningful work, mattering, moral distress or injury, workplace injury or illness.Modifying Factors
○ Demographic characteristics: (
                            *e.g.,*
                             age, sex, race, ethnicity).
                             
                                ○ Occupational title (
                                *e.g.,*
                                 physician, nurse, allied health professional, other).
                             
                             
                                ○ Educational attainment (
                                *e.g.,*
                                 high school, some college, college degree, graduate degree).
                             
                             
                                ○ Experience (
                                *e.g.,*
                                 number of years employed).
                             
                             
                                ○ Income (
                                *e.g.,*
                                 household income, socioeconomic status).
                             
                             
                                ○ Time (
                                *e.g.,*
                                 year of outcome ascertainment, or binned by pre-, concurrent and post-pandemic).
                             
                             
                                ○ Shift characteristics: (
                                *e.g.,*
                                 timing, duration, knowledge of shift, mandatory overtime).
                             
                             
                                ○ Job tasks (
                                *e.g.,*
                                 patient-facing vs. non-patient-facing, physical demands as high, moderate, low).
                             
                             
                                ○ Geographic location (
                                *e.g.,*
                                 U.S. census region, urban vs. suburban vs. rural).Study Designs
• Cross-sectional studies.
                             • Cohort studies.
• Randomized controlled trials.
                             • Non-randomized controlled trials. 
                             • Observational cohort studies with a comparison group. 
                             • Pre-post studies (with adjustment for confounders).Timing
Published since 2014.Settings
All U.S. healthcare delivery settings where HCWs work (
                            *e.g.,*
                             ambulatory, prehospital, emergency, various inpatient services, post-acute or skilled nursing/long-term care, including medical, surgical, and mental health care settings).Abbreviations: HCW = healthcare worker; PPE = personal protective equipment, ProQOL = Professional Quality of Life.
 Dated: December 12, 2024. Marquita Cullom, Associate Director.


[FR Doc. 2024-30259 Filed 12-18-24; 8:45 am] BILLING CODE 4160-90-P