Sood 2014.
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 calculated after weighing statistical and logistical considerations. To detect a difference between groups with a 2‐sided, 5% significance level and power of 85% using continuous outcomes, a sample size of 20 participants per group was necessary; level of power achieved not specified Imputation of missing data: for 4 participants (IG = 2, CG = 2) who did not complete the week 12 assessments, baseline values were carried forward to week 12, to provide the most conservative estimate of efficacy; intention‐to‐treat analysis |
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Participants |
Country: USA Setting: Department of Radiology, Mayo Clinic, Rochester Age: mean = 47.8 (SD = 7.09) years Sample size (randomised): 26 Sex: 11 women, 15 men Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: faculty members of the Department of Radiology at Mayo Clinic (physicians or scientists) Inclusion criteria: 1) staff members (physicians or scientists) within the Department of Radiology; 2) able and willing to participate in all aspects of the study; 3) able to understand and sign the informed consent Exclusion criteria: 1) a psychotic episode within the previous 6 months; 2) clinically significant, acute, unstable neurological, psychiatric, hepatic, renal, cardiovascular, or respiratory disease that would prevent participation in the study Attrition (withdrawals and exclusions): 4 (IG = 2/13 (15.4%), CG = 2/13 (15.4%)) completed the baseline questionnaires but did not complete the 12‐week questionnaires Reasons for missing data: scheduling issue |
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Interventions |
Intervention: SMART (n = 13)
Control: wait‐list control (n = 13) |
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Outcomes |
Outcomes collected and reported: Primary outcome
Time points measured and reported: 1) pre‐intervention; 2) 3‐month follow‐up (3 months after single‐session intervention, at week 12) Adverse events: not specified |
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Notes |
Contact with authors: no correspondence required Study start/end date: enrolment for the study ran from April 2010 to May 2011; end date not specified Funding source: supported by a Mayo Clinic Department of Radiology Small Grant No.94147001 and gift from Terrance D. and Judith A. Paul Declaration of interest: not specified Ethical approval needed/obtained for study: study protocol was reviewed and approved by the IRB Comments by authors: study methods overlap with those described in previously published studies Miscellaneous outcomes by the review authors: not relevant Correspondence: Varun Sharma, MD, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905; vdsharma.md@gmail.com |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "After obtaining informed consent, participants were assigned to one of two groups: an active arm or a wait‐list control arm using a simple randomization schedule generated by the Department of Biomedical Statistics and Informatics." Quote: "Mean scores at baseline differed significantly between groups (two‐sample t test, P = 0.021)." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’ (only "randomization schedule", exact method not described); RCT, but not verified baseline comparability of groups for outcome quality of life; baseline comparability for sociodemographic variables and other outcomes of interest unclear |
Allocation concealment (selection bias) | Unclear risk | Quote: "The allocation sequence was available only to the study coordinator and concealed from the researchers involved in recruitment." Judgement comment: investigators enrolling participants could not foresee assignment; unclear if allocation was also concealed from participants; exact method not described |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote: "single‐blind trial" Judgement comment: blinding of study personnel not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding; blinding of participants probably ensured (single‐blind trial) |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Quote: "Subjects were de‐identified and assigned a coded study identification number. This code was maintained by the statistician and unavailable to study investigators ensuring blinding of the investigators to the outcome measures." Judgement comment: insufficient information about blinding of outcome assessment to permit judgement of 'Low risk' or 'High risk' (unclear who provided the questionnaires to the participants, e.g. blinded investigators?) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Flow diagram of the progress in a randomized clinical trial to assess the effect of SMART program among radiologists." Quote: "Two subjects from each arm completed the baseline questionnaires but did not complete the 12‐week questionnaires" Quote: "For the four subjects (two SMART and two Control) who did not complete the week 12 assessments, the baseline values were carried forward to week 12 to provide the most conservative estimate of efficacy." Judgement comment: reasons for missing data unlikely to be related to true outcome with balance in missing data between groups (IG: n = 2, CG: n = 2); baseline‐observation‐carried‐forward (BOCF) for missing outcome data; intention‐to‐treat analysis |
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 |