Mache 2017.

Study characteristics
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): statistical power analysis performed and showed that a sample size of 80 would provide statistical power (2‐tailed, α = 0.05) of > 85%; therefore, size of the included study groups was considered sufficient for this pilot study, after weighing statistical considerations along with logistical and resource constraints Imputation of missing data: no imputation of missing data; per‐protocol analysis (i.e. without 2 participants in IG who participated in < 80% of training sessions) and available‐case analysis (i.e. only participants for whom outcomes were obtained at follow‐up assessments)
Participants	Country: Germany Setting: junior physicians in gynaecology and obstetrics; exact training setting not specified (training sessions performed off duty) Age: mean = 27.5 (SD = 2.2) years Sample size (randomised): 80 Sex: 54 women, 26 men Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: emotional exhaustion (subscale of MBI): IG = 4.10 (0.63), CG = 4.19 (0.71) Population description: junior physicians in gynaecology and obstetrics Included criteria: 1) employment in gynaecology/obstetrics; 2) being employed full‐time; 3) a maximum of 2 years of work experience in gynaecology or obstetrics; 4) participation in the study during the next 9 months; 5) access to the internet and e‐mail Excluded criteria: not specified Attrition (withdrawals and exclusions): exclusions (from follow‐up analyses): n = 2 in IG; withdrawals (losses to follow‐up at follow‐ups 1 to 3): follow‐up 1: 6 (IG: 1, CG: 5); follow‐up 2: 5 further losses to follow‐up (IG: 4, CG: 1); follow‐up 3: 7 further losses to follow‐up (IG: 2, CG: 5) Reasons for missing data: for 2 exclusions: participation in < 80% of training sessions; reasons for losses to follow‐up at assessments in 2 groups not specified
Interventions	Intervention: coping skills training/psychosocial skills training (n = 40) delivery: face‐to‐face group setting; modules of training sessions: psycho‐education, theoretical input, watching videos, group discussions, experiential exercises, role plays providers: certified occupational health psychologists with expertise in several stress management techniques, cognitive behavioural therapy as well as solution‐focused training duration of treatment period and timing: 12 weekly 1½‐hour sessions over 3 months; sessions performed off duty description: performed to promote job performance and well‐being in physicians and to reduce perceived distress METHODOLOGICAL ELEMENTS: discussion groups organised around a curriculum including elements of reflection, shared experience, and small‐group learning among the physicians; training modules enclosed well‐established problem‐solving and emotion regulation strategies according to Lazarus’ transactional model of stress; training modules mainly focused on situations and problems experienced at work; practical implication including coping strategies (cognitive, emotional, external, support systems, etc.) were integrated SESSIONS: each session with a special work‐related topic: (1) introduction: opening and discussion on the theme '‘working as a gynaecologist in the clinical setting' (2) and (3) experienced work‐related problems (4) and (5) coping skills training (cognitive strategies, emotion regulation, and stress management techniques, self‐awareness and resilience (6) and (7) conflict management, analysing conflict types and conflict handling in daily work routines (8) receiving and giving feedback, asking for supervision and feedback (9) communication training (10) learning from mistakes, reporting, dealing with consequences, organisational hospital culture (11) handling difficult medical decisions, creating a support system, how to speak up to supervisors and senior physicians (12) overall training evaluation compliance: 38 of 40 in IG participated in ≥ 80% of training sessions; overall training satisfaction (range: 1 ‐ 5) mean = 4.58; satisfaction with training design: mean = 4.34; atmosphere during training: mean = 4.21; gynaecologists would recommend skills training programme (mean = 4.58); 4 levels of Kirkpatrick’s training criteria demonstrated to be fulfilled integrity of delivery: not specified economic information: not specified; training sessions were performed off duty theoretical basis: based on Lazarus’ transactional model of stress (Malouff 2007); problem‐ and emotion‐focused coping skills and cognitive behavioural as well as solution‐focused counselling Control: no intervention (n = 40) description: CG received neither coping‐skills training nor any other comparable intervention (i.e. any other psychosocial‐skills training, counselling or therapy)
Outcomes	Outcomes collected and reported: perceived stress ‐ PSQ emotional exhaustion ‐ emotional exhaustion subscale of MBI emotion regulation skills, comprehension ‐ Emotion Regulation Skills Questionnaire (ERSQ‐27) emotion regulation skills, acceptance ‐ ERSQ‐27 emotion regulation skills, self‐support ‐ ERSQ‐27 resilience ‐ BRCS job satisfaction ‐ job satisfaction scale of CPQ Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (after final session of training; follow‐up 1); 3) 3‐month follow‐up (3 months after final session of training; follow‐up 2); 4) 6‐month follow‐up (6 months after final session of training; follow‐up 3) Adverse events: not specified
Notes	Contact with authors: We contacted the authors to ask whether they performed available‐case analysis with participants for whom outcomes were obtained at follow‐up assessments (Mache 2019b [pers comm]). Study start/end date: not specified Funding source: not specified Declaration of interest: no conflict of interest declared Ethical approval needed/obtained for study: approved by IRB of the Free University Berlin Comments by study authors: not specified Miscellaneous outcomes by the review authors: information received from authors (Mache 2019b [pers comm]): correct that available‐case analysis only with participants for whom outcomes were obtained at follow‐up assessments for outcomes reported in Table 2 of the publication (e.g. assessment II: n = 37 in IG and n = 35 in CG) Correspondence: Stefanie Mache; Institute for Occupational and Maritime Medicine (ZfAM), University Medical Center Hamburg‐Eppendorf, Seewartenstrasse 10, 20459 Hamburg, Germany; Institute of Occupational Medicine, Social Medicine and Environmental Medicine, Goethe‐University, Theodor‐SternKai 7, 60590 Frankfurt Am Main, Germany; s.mache@uke.de
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "In a two‐arm randomized controlled trial junior physicians working in clinic departments of Gynecology and Obstetrics were divided into two groups: (1) intervention group (IG) and (2) control group (CG)." Quote: "second the participants were randomized into two groups (intervention and control group). This procedure was supported by a computer generated list of numbers." Quote: "The demographic variables including gender, age, years of working experiences are shown in Table 1. 69 % of the physicians in the intervention group were women (n = 26) and 31 % were men (n = 12). The comparison group include 70 % female physicians (n = 28) and 30 % male physicians (n = 12). The average age in the intervention group was 27 years (SD 2.1) with an average time of working experience as a physician of 1 year (SD 1.8). All the gynecologists were employed full‐ time. Comparing both groups (IG and CG) baseline data on socio‐demographic differences indicate insignificant differences." Judgement comment: The investigators describe a random component in the sequence‐generation process (computer‐generated list of numbers)and there is verified baseline comparability of groups for sociodemographic characteristics (age, gender, relationship status, work characteristics, place of work); baseline comparability for outcome variables (see T0 in Table 2) unclear (i.e. statistical significance not specified)
Allocation concealment (selection bias)	Unclear risk	Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ (method of concealment is not described)
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 surveys); 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: "Fig. 1 Flow chart of the study design" Quote: "Of the 80 junior physicians enrolled, all completed the baseline measures. Two physicians of the IG were excluded for the follow‐up analyses because they participated in less than 80 % of the training sessions." Quote: "As illustrated in Fig. 1, during follow‐up 1, 37 of the participants in the IG (98 %) gave responses, and 33 (n = 87 %) gave responses for follow‐up 2. Finally, 31 physicians of the IG (82 %) answered the last survey (follow‐up 3). Participants who failed to complete the follow‐up surveys did not differ in their baseline responses from those who complied with the study protocol." Judgement comment: reasons for missing data likely to be related to true outcome with slight imbalance in missing data between groups (n = 2 excluded in IG due to < 80% participation in training sessions; follow‐up 1: IG: n = 1, CG: n = 5; follow‐up 2: IG: n = 5, CG: n = 6; follow‐up 3: IG: n = 7, CG: n = 11); per‐protocol analysis (i.e. exclusion of physicians participating in < 80% of training sessions); available‐case analysis (only participants for whom outcomes were obtained at follow‐up assessments)
Selective reporting (reporting bias)	Low risk	Judgement comment: no study protocol or trial registration available but it is clear that the published reports include all expected outcomes, including those that were prespecified