Chesak 2015.
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 Imputation of missing data: no imputation of missing data; per‐protocol analysis with participants who complied with allocated intervention and for whom outcomes were obtained |
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Participants |
Country: USA Setting: nurse orientation programme at Mayo Clinic Age: mean = 28.16 (SD = 8.29) years Sample size (randomised): 55 Sex: 38 women, 2 men (in analysed sample) Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: anxiety GAD‐7: IG = 3.11 (2.76), CG = 4.25 (2.77) Population description: nurses who were new to the institution or transitioning to a new unit or new role and who were undergoing new‐nurse orientation Inclusion criteria: 1) registered nurses (RN) who were enrolled in 1 of 2 designated nurse orientation classes; 2) RNs who were willing and able to participate in all aspects of the study; 3) RNs who were provided with, understood, and signed the informed consent Exclusion criteria: 1) if they reported currently or recently (within the past 6 months) experiencing a psychotic episode; 2) if they reported a clinically significant acute psychiatric event, or a physical illness Attrition (withdrawals and exclusions): 4 withdrawals before the intervention (IG = 2, CG = 2); total number of withdrawals: n = 15 (IG = 8/27 (29.6%), CG = 7/28 (25%)); i.e. 40 completed the study (IG = 19, CG = 21) Reasons for missing data: 4 withdrawals before the intervention: declined to participate in allocated group prior to first group session; not exactly specified for further withdrawals (nurse participants who voluntarily dropped out of the study: inability to make time for the programme) |
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Interventions |
Intervention: Stress Management and Resiliency Training (SMART) (n = 27)
Control: active control (n = 28)
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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) Adverse events: not specified |
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Notes |
Contact with authors: no correspondence required Study start/end date: not specified Funding source: not specified Declaration of interest: Dr Sood has a proprietary interest in a company that teaches resiliency programmes. The other authors have no financial or proprietary interest in the subject matter of this article. Ethical approval needed/obtained for study: IRB‐approved trial Comments by authors: not specified Miscellaneous outcomes by the review authors: not relevant Correspondence: Sherry S. Chesak, PhD, Department of Nursing, Mayo Clinic, 200 First St. SW Rochester, Minnesota 55905Tel: (507) 255‐3236; chesak.sherry@mayo.edu |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomized into either the intervention or control group through the use of a random number generator." Judgement comment: The investigators describe a random component in the sequence generation process (random‐number generator); no information about comparability of groups at baseline or respective analysis (statistical (non)significance of differences in demographic variables unclear; baseline comparability for outcome variables not specified |
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 (online questionnaires); 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: "55 consented and were randomized ‐ 27 into the intervention arm and 28 into the control arm. Prior to the first group session, 2 participants from each group declined to participate." Quote: "Analysis was restricted to participants who completed the study, including all follow‐up assessments." Quote: "Forty subjects (19 intervention, 21 control) completed the baseline and follow‐up assessments. Some subjects did not complete all scales at both time points. Data are presented only for those who completed the given scale at both baseline and follow‐up." Judgement comment: reasons for missing data unlikely to be related to true outcome with relative balance in missing data between groups (IG: n = 8, CG: n = 7); no reasons for missing data stated for each group; per‐protocol analysis with participants who complied with allocated intervention and for whom outcomes were obtained |
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 |