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. 2020 Jul 5;2020(7):CD012527. doi: 10.1002/14651858.CD012527.pub2

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
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
Interventions Intervention: SMART (n = 13)
  • delivery: face‐to‐face small‐group session (with PowerPoint slide presentation); reading materials that covered the skills discussed; optional phone calls

  • providers: not specified

  • duration of treatment period and timing: single 90‐minute session; brief structured relaxation intervention (practise deep diaphragmatic breathing once or twice a day); optional 30‐ to 60‐minute follow‐up session; 2 optional follow‐up phone calls at weeks 4 and 8

  • description:

    • SMART programme teaches learners to focus their attention on the external world and to defer unrefined judgements. Learners also are taught to cultivate and guide their interpretations by 5 higher‐order principles: gratitude, compassion, acceptance, meaning, and forgiveness.

    • brief structured relaxation intervention (paced breathing meditation ‐‐> guided to practise deep diaphragmatic breathing at 5 breaths a minute for 5 or 15 minutes, once or twice a day)

    • optional 30‐ to 60‐minute follow‐up session and 2 follow‐up phone calls

  • compliance: all 13 participants completed the initial 90‐minute group training; 8 participants had an additional 30‐minute follow‐up session and phone calls

  • integrity of delivery: not specified

  • economic information: not specified

  • theoretical basis: abbreviated adaptation of AIT; AIT developed as a scientific and structured programme at Mayo Clinic Rochester to decrease personal stress and enhance resiliency. AIT and SMART focus on 2 aspects of human experience: attention and interpretation. Human attention prioritises focus on threats.These threats, in modern times, are often symbolic psychological threats (hurts, regrets, worries, and fears) that draw attention away from the present moment. This predisposes to ruminative thinking, avoidance, and ineffective thought suppression, all contributing to stress


Control: wait‐list control (n = 13)
Outcomes Outcomes collected and reported:
Primary outcome
  • resilience ‐ CD‐RISC

  • perceived stress ‐ PSS

  • anxiety ‐ SAS

  • quality of life ‐ Linear Analog Self‐Assessment Scale

  • mindfulness ‐ MAAS


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
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
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