Mueller 2018.
Study characteristics | ||
Methods | Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): power not specified; study limitation: sample size was restricted to a group of 36 physical therapy students in 1 programme Imputation of missing data: information received from authors: per‐protocol analysis with Time 2 and Time 3 following the completion of the intervention by both groups | |
Participants |
Country: USA
Setting: online, self‐guided intervention
Age: mean = 26.83 (SD = 3.31) years
Sample size (randomised): 37
Sex: 25% women, 75% men
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: entry‐level doctor of physical therapy (DPT) students Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): 1 withdrawal in IG (immediate group) Reasons for missing data: for 1 withdrawal in IG: pregnancy‐related delay in internships |
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Interventions |
Intervention: “Called to Care” curriculum (immediate group) (n = 19)
Control: wait‐list control (n = 18)
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Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (after completion of intervention and 1. internship); 3) 10‐week follow‐up in IG (i.e. 10 weeks post‐intervention and after 2. internship) and post‐intervention in CG; for review only 1) and 2) relevant as the wait‐list control had also received the intervention at 3) Adverse events: not specified |
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Notes |
Contact with authors: We contacted the authors for information about the number of participants analysed for the outcomes reported in Table 2 and 3 (i.e. per‐protocol analysis with 36 participants at T2 and T3 and without 1 withdrawal). We also asked for more details about the intervention content (Mueller 2019 [pers comm]). Study start/end date: not specified; Called to Care curriculum provided to all participants at the end of spring 2015 semester Funding source: The authors report no funding or conflicts of interest related to this study Declaration of interest: no funding or conflicts of interest related to this study reported Ethical approval needed/obtained for study: approved by the Northern Arizona University IRB (case 729441‐1) Comments by study authors: not relevant Miscellaneous outcomes by the review authors: additional information about intervention content and number of participants analysed received from authors Correspondence: Dr Karen Mueller; Department of Physical Therapy and Athletic Training, Northern Arizona University, 208 E Pine Knoll Dr, PO Box 15105, Flagstaff, AZ 86011, USA; Karen.mueller@nau.edu |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "participants were randomly assigned (via a blinded shuffle of cards) to an immediate intervention group or a delayed intervention group. The deck included only the numbered cards (to ensure an even 50/50 split) and group assignment based on evens or odds." Quote: "There were no significant differences in age or gender distribution, and no significant differences between the baseline outcome measures of the immediate and delayed intervention groups, suggesting that the randomization worked appropriately." Judgement comment: investigators describe a random component in the sequence‐generation process (shuffling cards); verified baseline comparability of groups for sociodemographic characteristics (all Ps > 0.055) and outcomes of interest on the basis of analysis (see Table 1; Ps > 0.213) |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomly assigned (via a blinded shuffle of cards) to an immediate intervention group or a delayed intervention group." Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ ("blinded shuffle of cards"; method of allocation concealment is not described in sufficient detail) |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote: "The participants were informed of their designation into the immediate or delayed intervention group." Judgement comment: online, self‐guided intervention; no blinding of participants and probably no blinding of personnel (monitored discussion board postings); 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 to permit judgment of ‘Low risk’ or ‘High risk’ (in part electronic assessments); but due to 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 | Low risk | Quote: "37 students volunteered to participate in the Called to Care study. Of the 37 students, 1 withdrew from the project due to a pregnancy‐ related delay in her internships. Thirty‐six students completed the project." Quote: "FIGURE 1. Study design flowchart." Judgement comment: reasons for missing data unlikely to be related to true outcome (only 1 withdrawal in IG due to pregnancy); information received from authors: "We did perform a per‐protocol analysis with T2 and T3 following the completion of the intervention by both groups." |
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 |