Loiselle 2018.

Study characteristics
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): There is an effect size of 0.6225 when using change scores for treatment and control groups, and their respective standard deviations, from a recent study using the Transcendental Meditation (TM) technique as an intervention and measuring burnout with the MBI (Elder 2014). Applying Cohen’s power tables for P < 0.05 to this effect size, means the number of participants needed per group is 12; recruiting 20 participants per group allows for 20% attrition Imputation of missing data: no imputation of missing data; available‐case analysis (i.e. only participants who completed post‐intervention assessments)
Participants	Country: USA Setting: conducted at a medical school hospital and affiliated VA hospital Age: mean = 45.1 (SD = 10.51) years Sample size (randomised): 40 Sex: 23 women, 17 men Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified; burnout and depression values at pre‐intervention not reported Population description: academic physicians working at a medical school and hospital in a large midwestern metropolitan area Inclusion criteria: 1) being an academic attending physician at the Loyola Chicago School of Medicine or VA hospital; 2) commitment to attend all required sessions for learning the TM programme (intervention) and monthly follow‐ups; 3) agreeing to practice it twice daily for 20 minutes and to complete both pre‐and post‐testing (at 1 month and 4 months), including both the entry and exit interviews; additional criterion in trial registration = having a medical doctor degree Exclusion criteria: see trial registration; 1) current suicidal ideation (adverse event of suicidal ideation reporting excluded from study until such time event was resolved); 2) previous instruction in the TM technique Attrition (withdrawals and exclusions): 7 lost to follow‐up (i.e. did not complete post‐test/post‐test non‐compliance; IG = 6, CG = 1) Reasons for missing data: not specified
Interventions	Intervention: TM technique (n = 21) delivery: INSTRUCTION: face‐to‐face group setting (classes) + face‐to‐face individual instruction; DAILY PRACTICE OF TM TECHNIQUE: individual providers: instruction in TM technique conducted by experienced certified instructors from the area; after instruction: self‐guided practice duration of treatment period and timing: total treatment duration: 4 months; INSTRUCTION: 5 initial class instructions in TM technique (approximately 5 hours 40 minutes) followed by 6 additional classes (Follow‐up sessions) of 20 ‐ 60 minutes each over 4‐month period; DAILY PRACTICE: 2 x daily for 20 minutes description: TM technique = simple mental procedure; allows the mind and body to experience a unique state of restful alertness categorised in the automatic self‐transcending category of meditation practices: automatic in that it does not involve any concentration or control allows the mental activity to settle down in a spontaneous and natural manner during a process called transcending, or going beyond, until it reaches a state beyond conscious thinking correspondingly, the body settles down to a deep state of rest which allows stress to dissolve and the nervous system to rejuvenate a) INSTRUCTION: 1) information session (1 hour); 2) personal interview with a certified instructor (5 ‐ 10 minutes); 3) personal instruction – individual session with certified instructor (1½ hours); 4) group instruction – verifying the correctness of the practice and further instruction (1 hour); 5) group instruction – understanding the mechanics of the TM technique from personal experiences (1 hour); 6) group instruction – understanding the growth of higher stages of development through the regular practice of the TM technique (1 hour); 7) follow‐up sessions (20 ‐ 60 minutes) offered each month and participants reminded to attend by email or phone call, or both b) DAILY PRACTICE: participants asked to practice 2/day for 20 minutes compliance: n = 21/21 received allocated intervention; researcher oversaw all test administration and tracking of participant compliance COMPLIANCE: participants asked for twice‐daily practice of TM technique: 1) 1‐month assessment: number of participants practising the technique 2/day on average was 10 (67%); 1/day: 5 (33%); total compliance based on at least 1 session a day: 15 (100%) 2) 4‐month assessment: 6 (40%) reported practising 2/day, 8 (53%) 1/day and 1(6%) not practising; total compliance based on at least 1 session a day: 14 (93%) Time and scheduling conflicts most often reasons cited for less than twice a day practice integrity of delivery: not specified economic information: not specified theoretical basis: categorised in automatic self‐transcending category of meditation practices Control: wait‐list control (n = 19) description: asked to maintain a usual routine and not add any self‐development programmes during the test period compliance: n = 19/19 received allocated intervention; researcher oversaw all test administration and tracking of participant compliance
Outcomes	Outcomes collected and reported: burnout ‐ MBI – subscale for health professionals depression ‐ BDI‐II perceived stress ‐ PSS insomnia ‐ ISI resilience ‐ Brief Resilience Scale Time points measured and reported: 1) pre‐intervention; 2) during intervention (1‐month post‐test of 4‐month intervention period); 3) post‐intervention (4‐month post‐test; i.e. at the end of 4‐month intervention period) Adverse events: if adverse event reported through testing/interviews, reported to principal investigator who would speak to this study participant and recommend that they be seen in Employee Health; in case of suicidal ideation as adverse event, participant would be excluded from study until event was resolved; no adverse events reported during the study period
Notes	Contact with authors: We contacted the authors to ask for the unadjusted means and SDs for all outcomes at 1‐ and 4‐month assessment for both groups, but received no response to 2 inquiries. Study start/end date: see trial registration: August 2015 to September 2016 Funding source: not specified Declaration of interest: not specified Ethical approval needed/obtained for study: approved by IRB at Maharishi University of Management in March 2015; followed by IRB for the chosen medical school approval in July 2015 Comments by study authors: trial registration: NCT03714204 Miscellaneous outcomes by the review authors: dissertation Correspondence: Marie Ellen Loiselle; principal investigator of study (NCT03714204): Carla L Brown, PhD, Strich School of Medicine; Gregory Gruener, MD (study director), Loyola University Medical Center, 2160 S. First Ave; Maywood, IL 60153
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Random assignment was to the experimental (TM) group (n=21) or the wait‐list control group (n=19)." Quote: "Forty academic physicians completed their informed consent, baseline testing and entry interview and were randomly assigned to either the TM (experimental) group (immediate intervention start; n=21) or control group (delayed intervention start; n=19)." Quote: "Analysis of the data did not show any significant difference between the experimental or control groups in either their baseline testing or demographics (all p values >.05)." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; RCT and verified baseline comparability of groups for sociodemographic characteristics (see Table 1; all Ps > 0.123) and outcomes (i.e. baseline testing) on the basis of analysis (see Table 1)
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 (questionnaires administered in person by the researcher or as online survey); 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: "Six of the TM group and one of the control group subjects dropped out of the study before the one‐ month posttest." Quote: "A total of 33 physicians completed both the 1‐month and 4‐month posttests (TM = 15; control = 18)." Judgement comment: reasons for missing data likely to be related to true outcome with imbalance in amount of missing data between groups (lost to follow‐up: IG: n = 6; CG: n = 1, i.e. did not complete post‐test); available‐case analysis (only participants for whom outcomes were obtained at all assessments)
Selective reporting (reporting bias)	Low risk	Judgement comment: trial registration available (NCT03714204); and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way