West 2014.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): Of the 37 participants in each arm of the study, 34 (91.9%) provided survey responses. With this sample size, power was 80% to detect a moderate Cohen f2 effect size of 0.15; no sample size calculation reported Imputation of missing data: no imputation of missing data (information received from authors; West 2017 [pers comm]); per‐protocol analysis (with participants who took part in allocated intervention, i.e. without 2 participants in IG who withdrew consent) and available‐case analysis (with participants for whom outcomes were obtained) |
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Participants |
Country: USA Setting: Department of Medicine at the Mayo Clinic Rochester Age: see Population description; age not specified Sample size (randomised): 74 Sex: 25 women, 49 men Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: IG had slightly higher rates of high emotional exhaustion and overall burnout (MBI); burnout, n (%): full high depersonalisation: IG = 9 (24.3%), CG = 9 (25.7%); full high emotional exhaustion: IG = 17 (45.9%), CG = 12 (34.3%); full overall burnout: IG = 20 (54.1%), CG = 15 (42.9%); depression, n (%): positive depression screen (2‐question approach): IG = 11 (29.7%), CG = 11 (31.4%) Population description: practising physicians in the Mayo Clinic Department of Medicine Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): 2/37 (5.4%) in IG withdrew consent and therefore could not be analysed; number who did not complete assessments (information received from authors; West 2017 [pers comm]): pre‐intervention: n = 7; 3‐month follow‐up: 5 ‐ 6 for different outcomes; 12‐month follow‐up: 8) Reasons for missing data: not specified |
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Interventions |
Intervention: small‐group curriculum (n = 37)
Control: no intervention; could schedule and use this hour of protected time in any manner they believed was most useful but did not participate in the formal curriculum (n = 37) |
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Outcomes |
Outcomes collected and reported:
Outcomes reported:
Time points measured and reported: 1) pre‐intervention; 2) during intervention at 3 months (during 9‐month intervention); 3) during intervention at 6 months (during 9‐month intervention); 4) post‐intervention (at 9 months, i.e. end of 9‐month intervention); 5) 3‐month follow‐up (3 months post‐intervention); 6) 12‐month follow‐up (12 months post‐intervention) Adverse events: not specified |
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Notes |
Contact with authors: We contacted the authors to ask for the means and SDs for the outcomes at all time points and the procedures in dealing with missing data (West 2017 [pers comm]). Study start/end date: study conducted between September 2010 and June 2012 Funding source: supported by the Mayo Clinic Program on Professionalism and Ethics and the Department of Medicine at Mayo Clinic Rochester; funding source had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication Declaration of interest: no conflicts of interest reported Ethical approval needed/obtained for study: approved by the Mayo Clinic IRB Comments by authors: trial registration: clinicaltrials.gov Identifier: NCT0115997 Miscellaneous outcomes by the review authors: not relevant Correspondence: Colin P. West, MD, PhD, Division of General Internal Medicine, Department of Medicine, Mayo Clinic, 200 First St, Rochester, MN 55905; west.colin@mayo.edu |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomized in a concealed fashion into 2 groups via a computer‐generated algorithm. Randomization was stratified by sex and specialty (general internal medicine or other internal medicine specialty) using permuted blocks." Quote: "Baseline characteristics of the 2 trial groups were generally similar, with no statistically significant differences observed, although the intervention arm had slightly higher rates of high emotional exhaustion and overall burnout." Quote: "Because of baseline differences across groups for several variables, all analyses were adjusted for levels of distress at study onset." Judgement comment: The investigators describe a random component in the sequence‐generation process (computer‐generated algorithm) and there is verified baseline comparability of groups for sociodemographic characteristics and outcomes of interest on the basis of analysis |
Allocation concealment (selection bias) | Unclear risk | Quote: "Participants were randomized in a concealed fashion into 2 groups via a computer‐generated algorithm." Judgement comment: insufficient information to permit judgement of ‘Low risk’ or ‘High risk’; exact method of concealment not specified; unclear if random‐sequence generation was concealed from personnel and/or participants |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement comment: Insufficient information about blinding of outcome assessment (online questionnaires); however, due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Of the 37 participants in each arm of the study, 34 (91.9%) provided survey responses." Quote: "The changes in each well‐being metric from study baseline to study end, as well as at 3 and 12 months following the study, were analyzed according to the intent‐to‐treat principle using generalized estimating equations to account for the repeated‐measures design." Judgement comment: reasons for missing data unlikely to be related to true outcome with relative balance in missing data between groups (IG: 2 withdrawals, CG: 0; no reasons reported); no imputation of missing data (information received from authors); per‐protocol analysis (with participants who took part in allocated intervention, i.e. without 2 participants in IG who withdrew consent) and available‐case analysis (with participants for whom outcomes were obtained) |
Selective reporting (reporting bias) | High risk | Judgement comment: trial registration available (clinicaltrials.gov/ct2/show/NCT01159977); several reported outcomes were not prespecified; PRESPECIFIED in trial registration: job satisfaction, burnout; AND: not all of the prespecified outcomes (prespecified in the publication) were reported; PRESPECIFIED in publication: job satisfaction, perceived stress, quality of life, empowerment and engagement at work, burnout, mental and physical well‐being, fatigue, empathy; REPORTED: all outcomes except for mental and physical well‐being, fatigue and empathy |