Chen 2018a.
| Study characteristics | ||
| Methods | Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): not specified in conference abstract Imputation of missing data: probably no imputation of missing data; only 9 did not withdraw and completed all surveys, i.e. yielding an analytic sample of 9 (due to small sample size, no analysis of hypotheses) | |
| Participants | Country: USASetting: not specifiedAge: not specified Sample size (randomised): 22Sex: not specifiedComorbidity (mean(SD) of respective measures in indicated, if available) at baseline: not specified Population description: fall and spring first‐semester baccalaureate students in nursing (BSNs) Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): n = 9/22 withdrawals (not specified which group); 9 of 13 remaining participants completed all surveys (not specified which group), i.e. 4 with incomplete surveys Withdrawals and exclusions: 9/22 withdrawals (not specified which group); 9 of 13 remaining participants completed all surveys (not specified which group), i.e. 4 with incomplete surveys | |
| Interventions | Intervention: Brief Mindfulness‐based Compassion (MSC) (n randomised not specified) 
 Control: wait‐list control (n randomised not specified) 
 | |
| Outcomes | Outcomes collected and reported: 
 Time points measured and reported: 1) pre‐intervention; 2) post‐intervention; 3) 1‐month follow‐up (at 8 weeks after baseline, i.e. 4 weeks after 4‐week intervention); time points reported not specified Adverse events: not specified | |
| Notes | Contact with authors: We contacted the authors to see if the study was already published (Kelleher 2019 [pers comm]). Study start/end date: not specified Funding source: not specified Declaration of interest: not specified Ethical approval needed/obtained for study: not specifiedComments by study authors: not relevantMiscellaneous outcomes by the review authors: not relevantCorrespondence: Catherine Kelleher; University of Maryland, School of Nursing; kelleher@umaryland.edu | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement | 
| Random sequence generation (selection bias) | Unclear risk | Quote (see conference abstract): "During year 1, participants were randomized to MBSR and MSC programs as originally planned but enrollment was low. During year 2, the randomized design was modified to drop the MBSR arm, focus only on the MSC program, and use a control group in which participants would get the MSC program in a consolidated half‐day program at the beginning of the following semester. The simplified design permitted testing student interest in signing up for an MSC study and the impact on enrollment if there was no uncertainty about being randomized to 1 of 2 programs which met at different times." Judgement comment: based on conference abstract, insufficient information about random‐sequence generation to permit judgement of 'Low risk' or 'High risk'; no judgement on baseline comparability possible | 
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: based on conference abstract, 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: based on conference abstract, blinding of participants 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: based on conference abstract, insufficient information about blinding of outcome assessment; but 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 the intervention they received) | 
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote (see conference abstract): "In year 2, total recruitment=22, total withdrawal=9, and 9 of the 13 participants completed all surveys, yielding an analytic sample=9. Due to small sample size, analysis for both pilot years was limited to descriptive statistics, and hypotheses could not be tested" Judgement comment: unclear if reasons for missing data likely to be related to true outcome (number of participants randomised to each group and number of dropouts in each group not stated); probably per‐protocol analysis and available‐case analysis (analyses restricted to descriptive statistics and no testing of hypotheses due to withdrawals and incomplete surveys; i.e. only 9 participants who did not withdrew and completed the surveys were considered) | 
| Selective reporting (reporting bias) | Unclear risk | Judgement comment: no judgement possible based on conference abstract |