Table 2a, Overview of the systematic reviews - Making Healthcare Safer IV

Table 2aOverview of the systematic reviews

Author, Year Setting	Objective	Literature Search-End Date # Included Studies Study Design	Work Schedule or Mitigation Comparisons Description	Main Outcome Findings [as reported in the review]
Weaver, 2023⁴⁴ Hospital	To evaluate the impact of work hour policies (i.e., the ACGME’s 2003 and 2011 resident physicians work hour guidelines) and work schedules on patient safety	2019 N=68 RCT: 4 Observational: 6	Limit all resident physicians to 80-hour work weeks and 28-hour shifts in 2003.	Incidence of medical errors or adverse events: Limited shift durations and shorter work weeks were associated with improved patient safety in clinical trials, as well as in observational studies on work shift duration differences not specifically tied to policy changes. Mortality: Limiting all resident physicians to 80-hour work weeks and 28-hour shifts in 2003 was associated with an 11% reduction in patient mortality (p < 0.001). The overall quality of evidence was moderate.
Di Muzio, 2019³⁴ Hospital	To analyze the correlation between clinical risk management and the occurrence of medication errors and the effects of shift work on inpatient nurses.	2017 N=19 Cross-sectional survey: 7 Prospective study: 1 Descriptive study: 4 Web-based study:1 Survey: 2 Case study: 1 Longitudinal study: 1 Observational study: 2	Nursing shift work (night shifts, reduced staffed shifts (i.e., number of nursing staff is limited), 12-hour shifts, and working greater than 40 hours a week)	Incidence of medical errors or adverse events: The main reasons behind medication errors are stress, fatigue, increased workload, night shifts, nurse staffing ratio, and workflow interruptions. Strength of evidence: NR
Gates, 2018⁴⁰ Independent practices	To synthesize evidence on the (1) impact of insufficient sleep and fatigue on health, performance, and patient safety; and (2) effectiveness of interventions targeting insufficient sleep and fatigue.	2017 N=47 RCT: 2 Observational: 45	Shift work schedule (e.g., 24-hour shift versus standard workday, overnight work, 17-hour night shift and usual day, long on-call shifts)	Incidence of medical errors or adverse events: Results showed no association between fatigue or insufficient sleep with surgical performance, and mixed findings for psychomotor performance, work performance, and medical errors. Mortality or complications: For sleep deprived versus non-sleep deprived surgeons, no difference was found in patient mortality or postoperative complications. The findings for intraoperative complications and length of stay were mixed. Strength of evidence: The overall quality of the body of research was poor based upon generally unclear or high risk of bias (62% of studies). All cohort studies were at low risk of bias.
Harris,2015⁴⁵ Surgical units	To assess the impact of work-hour restrictions on clinician quality-of-life, skill development, resident education, patient care outcomes, and resident attitudes.	2012 N=11 Prospective analysis: 1 Surgical case logs and survey results: 10	Reduction in resident work hours (i.e., resident duty hour restrictions, limiting number of hours worked).	Incidence of medical errors or adverse events: Found inconclusive results on patient outcomes. Strength of evidence: NR
Leroyer, 2014³⁸ Surgical units	To determine association between extended medical shifts and consequences for patients.	2009 N=6 RCT: 1 Observational: 5	Extended duration shifts worked by medical interns (e.g., number worked in the last month, comparing extended shifts to regular shifts), day procedures following emergency night procedures versus not following a night procedure, and duty hour restrictions	Incidence of medical errors or adverse events: Extended-duration shifts are weakly associated with an increased occurrence of serious medical errors. Mortality: Extended-duration shifts are weakly associated with increased mortality among patients. Strength of evidence: Selected studies meet the high methodological quality criteria based off of the Consort 2010 checklist.⁴⁶
Lawrence,2014³⁹ Not specified	To evaluate extended-duty shifts to develop evidence-based recommendations for student nurse-midwives/student midwives.	2012 N=40 RCT: 13 Correlational: 9 Descriptive: 17 Meta-analysis: 1	Extended-duty shifts, or work schedules having a longer than normal workday; (e.g., time worked in excess of 8 hours, shifts longer than 12 hours)	Incidence of medical errors or adverse events: Extended-duty shifts may cause cognitive errors (e.g., attention lapses, visual tracking errors, worsened recall) and physical errors (e.g., decreased motor skills, increased time to react to changes) by clinicians, leading to safety concerns. Strength of evidence: NR
Smith-Miller, 2014³⁶ Acute care setting	To examine current research related to nurse fatigue and identify effective prevention strategies.	2013 N=22 Does not give specific breakdown of study types	Limiting the frequency of day-night rotations, having minimum interval of 48 hours after a night shift before scheduling a day shift, restricting the number of consecutive 12-hour shifts and curbing shift duration to 12 hours. Unit procedures that limit involuntary overtime, on-call status, and the practice of calling nonscheduled nurses. Duty-free breaks giving nurses responsibility-free work breaks (quiet & nap time).	Incidence of medical errors or adverse events: Shifts longer than 12 hours contribute to increased fatigue and errors. The number of hours of sleep in the preceding 24 hours is predictive of individuals’ propensity to make errors and their alertness to detect errors made by others. Strength of evidence: The quality of the evidence was assessed using the GRADE guidelines process. The included studies were reviewed by the authors and ranked as low (N = 3), moderate (N = 11), or high (N = 9).
Stec, 2018³⁷ Radiology	To review current literature regarding radiologist fatigue.	2017 N=27 Reviews: 14 Primary research studies: 10 Other: 3	Radiologist work hours changes and lengths. Ergonomic design of reading workstations, such as adjusting ambient lighting, brightness difference between monitor and surroundings, reducing screen flickers, reducing daily readings, increasing breaks, reading while sitting versus standing up, and adjusting technology specific to user work habits and preferences.	Incidence of medical errors or adverse events: Radiologists are more prone to errors after 10 hours of clinical interpretation. A controlled increase in ambient lighting and maintaining a significant difference between brightness of the monitor and surroundings could increase radiologist’s detection and identification capacity of low-contrast objects. Additionally, they found that ocular fatigue can be reduced by taking breaks, reducing daily readings, and eliminating screen flickers. Strength of evidence: NR
Bolster,2015⁴¹ Patient care settings (various settings including radiology, surgery, pediatrics, internal medicine)	To determine Impact of duty hour restrictions conducted 1 year prior to the implementation of the ACGME’s 2011 regulations.	2013 N=27 RCT: 14 Non-RCT: 3 Observational: 10	Duty hour restrictions included night float, shortened shifts, and number of consecutive night shifts Protected time for sleep (a period during a work shift in which residents transfer all of their responsibilities to another individual, so that they can obtain uninterrupted sleep).	Incidence of medical errors or adverse events: The impact of duty hour restrictions most frequently had no impact on patient care. When analyzed by intervention type, the most frequent result of shift length changes was no impact, and that of night float was an unfavorable impact. For protected time for sleep, one study reported no impact on patient care. Strength of evidence: NR
Parker, 2016³⁵ ICU	To examine the impact of sleep deprivation on cognitive performance in military surgical teams.	2016 N=14 Does not give specific breakdown of study types	Strategic scheduling of work hours and improved working conditions Prophylactic sleep, activity breaks, stimulants, and hypnotics	Incidence of medical errors or adverse events: Recommends implementing on-call periods of no more than 12 hours in duration, with adequate rest periods every 24 hours, as sleep deprivation after 24 hours on-call duty affects cognitive performance, increasing the number of errors and omissions. Strength of evidence: NR
Bae,2021⁴² Various settings	To review the comprehensive characteristics of adverse nurse work schedules and to synthesize the evidence of their relationships with adverse patient outcomes.	2019 N=22 Cross-sectional: 18 Retrospective cohort study: 2 Longitudinal: 2	Nurse work schedule characteristics, including long work hours, overtime, and consecutive shift work. Nurse break time, including breaks, lack of time away, and insufficient work breaks.	Incidence of medical errors or adverse events or mortality: Nurses’ breaks were indirectly related to patient safety. Found a conclusive relationship between excessive nurse work hours and adverse patient outcomes. Working more than 12 hours in a day had an adverse effect on patient outcomes, as did working more than 40 hours per week. There were mixed findings in the relationship between nurse overtime and adverse patient outcomes. Insufficient time away between shifts was related to increased patient mortality. Nurses’ insufficient breaks were indirectly related to adverse patient outcomes. Strength of evidence: NR
Sephien,2023⁴³ Hospital	To synthesize the evidence associated with resident duty hour restrictions and its impact on resident- and patient-based outcomes.	2020 N = 9 RCT: 9	Longer resident physician work hours compared to shorter resident physician work hours. Sleep interventions included promoting sleep before night shift and protected nap/sleep time.	Incidence of medical errors or adverse events: There was no significant association between reduced shift length and length of stay, and the odds of serious medical errors, or preventable adverse events per 1000 events. Strength of evidence: The overall certainty of evidence of included RCTs ranged from very low to low.

Author, Year

Setting

Objective

Literature Search-End Date

# Included Studies

Study Design

Work Schedule or Mitigation Comparisons Description

Main Outcome Findings

[as reported in the review]

Weaver, 2023⁴⁴

Hospital

To evaluate the impact of work hour policies (i.e., the ACGME’s 2003 and 2011 resident physicians work hour guidelines) and work schedules on patient safety

2019

N=68

RCT: 4

Observational: 6

Limit all resident physicians to 80-hour work weeks and 28-hour shifts in 2003.

Incidence of medical errors or adverse events: Limited shift durations and shorter work weeks were associated with improved patient safety in clinical trials, as well as in observational studies on work shift duration differences not specifically tied to policy changes.

Mortality: Limiting all resident physicians to 80-hour work weeks and 28-hour shifts in 2003 was associated with an 11% reduction in patient mortality (p < 0.001).

The overall quality of evidence was moderate.

Di Muzio, 2019³⁴

Hospital

To analyze the correlation between clinical risk management and the occurrence of medication errors and the effects of shift work on inpatient nurses.

2017

N=19

Cross-sectional survey: 7

Prospective study: 1

Descriptive study: 4

Web-based study:1

Survey: 2

Case study: 1

Longitudinal study: 1

Observational study: 2

Nursing shift work (night shifts, reduced staffed shifts (i.e., number of nursing staff is limited), 12-hour shifts, and working greater than 40 hours a week)

Incidence of medical errors or adverse events: The main reasons behind medication errors are stress, fatigue, increased workload, night shifts, nurse staffing ratio, and workflow interruptions.

Strength of evidence: NR

Gates, 2018⁴⁰

Independent practices

To synthesize evidence on the (1) impact of insufficient sleep and fatigue on health, performance, and patient safety; and (2) effectiveness of interventions targeting insufficient sleep and fatigue.

2017

N=47

RCT: 2

Observational: 45

Shift work schedule (e.g., 24-hour shift versus standard workday, overnight work, 17-hour night shift and usual day, long on-call shifts)

Incidence of medical errors or adverse events: Results showed no association between fatigue or insufficient sleep with surgical performance, and mixed findings for psychomotor performance, work performance, and medical errors.

Mortality or complications: For sleep deprived versus non-sleep deprived surgeons, no difference was found in patient mortality or postoperative complications. The findings for intraoperative complications and length of stay were mixed.

Strength of evidence:

The overall quality of the body of research was poor based upon generally unclear or high risk of bias (62% of studies). All cohort studies were at low risk of bias.

Harris,2015⁴⁵

Surgical units

To assess the impact of work-hour restrictions on clinician quality-of-life, skill development, resident education, patient care outcomes, and resident attitudes.

2012

N=11

Prospective analysis: 1

Surgical case logs and survey results: 10

Reduction in resident work hours (i.e., resident duty hour restrictions, limiting number of hours worked).

Incidence of medical errors or adverse events: Found inconclusive results on patient outcomes.

Strength of evidence: NR

Leroyer, 2014³⁸

Surgical units

To determine association between extended medical shifts and consequences for patients.

2009

N=6

RCT: 1

Observational: 5

Extended duration shifts worked by medical interns (e.g., number worked in the last month, comparing extended shifts to regular shifts), day procedures following emergency night procedures versus not following a night procedure, and duty hour restrictions

Incidence of medical errors or adverse events: Extended-duration shifts are weakly associated with an increased occurrence of serious medical errors.

Mortality: Extended-duration shifts are weakly associated with increased mortality among patients.

Strength of evidence: Selected studies meet the high methodological quality criteria based off of the Consort 2010 checklist.⁴⁶

Lawrence,2014³⁹

Not specified

To evaluate extended-duty shifts to develop evidence-based recommendations for student nurse-midwives/student midwives.

2012

N=40

RCT: 13

Correlational: 9

Descriptive: 17

Meta-analysis: 1

Extended-duty shifts, or work schedules having a longer than normal workday; (e.g., time worked in excess of 8 hours, shifts longer than 12 hours)

Incidence of medical errors or adverse events: Extended-duty shifts may cause cognitive errors (e.g., attention lapses, visual tracking errors, worsened recall) and physical errors (e.g., decreased motor skills, increased time to react to changes) by clinicians, leading to safety concerns.

Strength of evidence: NR

Smith-Miller, 2014³⁶

Acute care setting

To examine current research related to nurse fatigue and identify effective prevention strategies.

2013

N=22

Does not give specific breakdown of study types

Limiting the frequency of day-night rotations, having minimum interval of 48 hours after a night shift before scheduling a day shift, restricting the number of consecutive 12-hour shifts and curbing shift duration to 12 hours. Unit procedures that limit involuntary overtime, on-call status, and the practice of calling nonscheduled nurses.
Duty-free breaks giving nurses responsibility-free work breaks (quiet & nap time).

Incidence of medical errors or adverse events: Shifts longer than 12 hours contribute to increased fatigue and errors. The number of hours of sleep in the preceding 24 hours is predictive of individuals’ propensity to make errors and their alertness to detect errors made by others.

Strength of evidence:

The quality of the evidence was assessed using the GRADE guidelines process.

The included studies were reviewed by the authors and ranked as low (N = 3), moderate (N = 11), or high (N = 9).

Stec, 2018³⁷

Radiology

To review current literature regarding radiologist fatigue.

2017

N=27

Reviews: 14

Primary research studies: 10

Other: 3

Radiologist work hours changes and lengths.
Ergonomic design of reading workstations, such as adjusting ambient lighting, brightness difference between monitor and surroundings, reducing screen flickers, reducing daily readings, increasing breaks, reading while sitting versus standing up, and adjusting technology specific to user work habits and preferences.

Incidence of medical errors or adverse events: Radiologists are more prone to errors after 10 hours of clinical interpretation.

A controlled increase in ambient lighting and maintaining a significant difference between brightness of the monitor and surroundings could increase radiologist’s detection and identification capacity of low-contrast objects. Additionally, they found that ocular fatigue can be reduced by taking breaks, reducing daily readings, and eliminating screen flickers.

Strength of evidence: NR

Bolster,2015⁴¹

Patient care settings (various settings including radiology, surgery, pediatrics, internal medicine)

To determine Impact of duty hour restrictions conducted 1 year prior to the implementation of the ACGME’s 2011 regulations.

2013

N=27

RCT: 14

Non-RCT: 3

Observational: 10

Duty hour restrictions included night float, shortened shifts, and number of consecutive night shifts
Protected time for sleep (a period during a work shift in which residents transfer all of their responsibilities to another individual, so that they can obtain uninterrupted sleep).

Incidence of medical errors or adverse events: The impact of duty hour restrictions most frequently had no impact on patient care. When analyzed by intervention type, the most frequent result of shift length changes was no impact, and that of night float was an unfavorable impact. For protected time for sleep, one study reported no impact on patient care.

Strength of evidence: NR

Parker, 2016³⁵

ICU

To examine the impact of sleep deprivation on cognitive performance in military surgical teams.

2016

N=14

Does not give specific breakdown of study types

Strategic scheduling of work hours and improved working conditions
Prophylactic sleep, activity breaks, stimulants, and hypnotics

Incidence of medical errors or adverse events: Recommends implementing on-call periods of no more than 12 hours in duration, with adequate rest periods every 24 hours, as sleep deprivation after 24 hours on-call duty affects cognitive performance, increasing the number of errors and omissions.

Strength of evidence: NR

Bae,2021⁴²

Various settings

To review the comprehensive characteristics of adverse nurse work schedules and to synthesize the evidence of their relationships with adverse patient outcomes.

2019

N=22

Cross-sectional: 18

Retrospective cohort study: 2

Longitudinal: 2

Nurse work schedule characteristics, including long work hours, overtime, and consecutive shift work.
Nurse break time, including breaks, lack of time away, and insufficient work breaks.

Incidence of medical errors or adverse events or mortality: Nurses’ breaks were indirectly related to patient safety.

Found a conclusive relationship between excessive nurse work hours and adverse patient outcomes.

Working more than 12 hours in a day had an adverse effect on patient outcomes, as did working more than 40 hours per week. There were mixed findings in the relationship between nurse overtime and adverse patient outcomes. Insufficient time away between shifts was related to increased patient mortality.

Nurses’ insufficient breaks were indirectly related to adverse patient outcomes.

Strength of evidence: NR

Sephien,2023⁴³

Hospital

To synthesize the evidence associated with resident duty hour restrictions and its impact on resident- and patient-based outcomes.

2020

N = 9

RCT: 9

Longer resident physician work hours compared to shorter resident physician work hours.
Sleep interventions included promoting sleep before night shift and protected nap/sleep time.

Incidence of medical errors or adverse events: There was no significant association between reduced shift length and length of stay, and the odds of serious medical errors, or preventable adverse events per 1000 events.

Strength of evidence:

The overall certainty of evidence of included RCTs ranged from very low to low.

: ACGME = Accreditation Council for Graduate Medical Education; GRADE = Grading of Recommendations, Assessment; N = number; NR = not reported; RCT = randomized controlled trial;

From: Fatigue and Sleepiness of Clinicians Due to Hours of Service

Making Healthcare Safer IV: A Continuous Updating of Patient Safety Harms and Practices [Internet].

Rockville (MD): Agency for Healthcare Research and Quality (US); 2023 Jul-.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.