Sood 2011.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): A sample size of 40 was selected for this pilot study after weighing statistical considerations along with logistical and resource constraints. In general, for a continuous outcome variable, a sample size of 40 provides statistical power (2‐tailed, α = 0.05) of > 85% to detect a difference of 1 SD between groups. Imputation of missing data: no imputation of missing data; per‐protocol analysis with participants who complied with allocated intervention and for whom outcomes were obtained |
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Participants |
Country: USA Setting: Department of Medicine Faculty, clinic Age: IG mean = 46.8 (SD = 8.3) years, CG mean = 50.2 (SD = 5.7) years (unclear for total sample as number of participants considered for baseline characteristics not specified) Sample size (randomised): 40 Sex: comparable gender distribution across 2 study arms (IG = 55% men; CG = 50% men) Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: anxiety (SAS): IG = 55.2 (13.6), CG = 50.5 (23.0) Population description: physicians of Department of Medicine Faculty, all academic clinicians Inclusion criteria: 1) being a faculty member of the Department of Medicine; 2) being able and willing to participate Exclusion criteria: 1) a recent (within the past 6 months) psychotic episode; 2) clinically significant, acute, unstable neurological, psychiatric, hepatic, renal, cardiovascular, or respiratory disease that prevented participation in the study Attrition (withdrawals and exclusions): of the 40 enrolled, 32 (80%) physicians completed the study; 8/20 (40%) participants in the CG declined to participate after randomisation and prior to filling out any assessments Reasons for missing data: scheduling issues in CG |
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Interventions |
Intervention: SMART (n = 20)
Control: wait‐list control (n = 20)
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Outcomes |
Outcomes collected and reported: Primary outcome
Time points measured and reported: 1) pre‐intervention; 2) 2‐month follow‐up (8 weeks after single session intervention) Adverse events: not specified |
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Notes |
Contact with authors: no correspondence required Study start/end date: not specified Funding source: Department of Medicine, Mayo Clinic, Rochester, MN Declaration of interest: none disclosed Ethical approval needed/obtained for study: study protocol reviewed and approved by Mayo Foundation IRB Comments by authors: not specified Miscellaneous outcomes by the review authors: not relevant Correspondence: Amit Sood, MD, Complementary and Integrative Medicine Program, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA; sood.amit@mayo.edu |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "After obtaining the informed consent, physicians were randomly assigned to one of two groups an active arm or a wait‐list control arm." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; RCT and no apparent baseline differences between randomised groups for mean age, gender, baseline stress and resilience measures; verified baseline comparability of groups for some sociodemographic variables (age, gender) and outcome measures (stress, resilience); but statistical (non)significance not reported and baseline comparability for other variables also unclear |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ |
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; 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: "Figure 1. Flow diagram of the progress in a randomized clinical trial to assess the effect of resiliency training among physicians." Quote: "Of the 40 enrolled (all academic clinicians), 32 (80%) physicians completed the study. Eight participants (all in the control arm) declined to participate after randomization and prior to filling out any assessments because of scheduling issues (Fig. 1)." Judgement comment: reasons for missing outcome data likely to be related to true outcome with imbalance in numbers for missing data (only missing data in CG, n = 8); per‐protocol analysis with participants who complied with allocated intervention and for whom outcomes were obtained |
Selective reporting (reporting bias) | Low risk | Judgement comment: no study protocol available, but it is clear that the published report includes all expected outcomes, including those that were prespecified |