Waddell 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; not specified if attrition from intervention or lost to assessments; probably per‐protocol analysis (only participants who took part in allocated intervention) and available‐case analysis (only participants for whom outcomes were obtained) |
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Participants |
Country: Canada Setting: collaborative baccalaureate nursing degree programme at academic sites (2 colleges, 1 university site) Age: range = 18 ‐ 22 years Sample size (randomised): 142 (recruited in 2 cohorts in year 1, n = 120, and beginning of year 3, n = 22) Sex: not specified; most of analysed sample was female Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: nursing students in a collaborative baccalaureate degree program Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): probably attrition of n = 70 participants over study course (not specified which group) Reasons for missing data: CG: probably information about assignment to control group; IG: probably due to time commitment; most students withdrew in year 2,which is considered by students and faculty to be most demanding and difficult |
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Interventions |
Intervention: career planning and development (CPD) programme (n not specified; for 72 participants analysed: n = 33)
Control: TAU (standard undergraduate curriculum group) (n not specified; for 72 participants analysed: n = 39)
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Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention (year 2 of baccalaureate programme, prior to randomisation); 2) during intervention, year 3 of baccalaureate programme; 3) post‐intervention, year 4 of baccalaureate programme; and 4) 12‐month follow‐up (12 months post‐intervention/after baccalaureate programme); 4) presented in 2nd report Adverse events: not specified |
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Notes |
Contact with authors: We contacted the authors for the number of participants randomised to each group and whether there were 70 missing, but they had not responded at the time of writing this review Study start/end date: not specified Funding source: funding support by Social Sciences and Humanities Council Declaration of interest: not specified Ethical approval needed/obtained for study: research ethics board approval Comments by authors: not relevant Miscellaneous outcomes by the review authors: Waddell 2015 is the first of 3 reports on this study; besides this 1st report on the undergraduate student outcomes of the programme, 2nd paper will examine graduate nurses’ experiences at 12 months post‐graduation, 3rd paper will explore faculty outcomes for those participating in the programme Correspondence: Janice Waddell; Department of Nursing, Ryerson University, 350 Victoria Street, Toronto, Ontario M5B 2K3, Canada; jwaddell@ryerson.ca |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Eligible students who consented to participate were randomly assigned by means of a random numbers chart with allocation concealment, to one of two conditions: (a) a 4‐year CPD group (intervention) or (b) a 4‐year standard undergraduate curriculum group (control)." Quote: "There were no significant group differences in terms of marital status (majority were single), number of children (majority were childless), registration with the Registered Nurses Association of Ontario (majority were not members), or employment status. Finally, there were no significant group differences in terms of previous CPD training/ involvement outside of this study (most respondents reported no previous engagement in CPD activities)." Quote: "Mean career scores, including total scores (p = 0.002) and subscale scores, were higher for all intervention participants except at Time 1 (when baseline scores for the initial 142 participants were gathered prior to randomization where there were no significant between group differences)." Judgement comment: investigators describe a random component in the sequence‐generation process (random‐numbers chart); verified baseline comparability of groups for sociodemographic characteristics and outcome variables on the basis of analysis (mean career scores refers to total score of CPD activities and self‐efficacy as well as subscales in Table 1) |
Allocation concealment (selection bias) | Unclear risk | Quote: "Eligible students who consented to participate were randomly assigned by means of a random numbers chart with allocation concealment, to one of two conditions: (a) a 4‐year CPD group (intervention) or (b) a 4‐year standard undergraduate curriculum group (control)." Judgement comment: insufficient information about allocation concealment to permit judgement of 'Low risk' or 'High risk'; unclear if random‐sequence generation was concealed from personnel or participants, or both; exact method not described |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote: "A large number of those randomized into the control group dropped out of the study after completing the pre‐study measures and being informed of their assignment to the control group." Judgement comment: no blinding of participants and personnel (face‐to‐face intervention; CG participants were informed of being in the control group) 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; 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 | High risk | Quote: "One hundred and twenty students in their first year in the program consented to participate (Cohort # 1). Due to participant attrition in Year 2 of the program, a second recruitment phase was undertaken as the Year 2 cohort was beginning the third year of their program." Quote: "A final sample size, after accounting for attrition, was an additional 22 participants (Cohort # 2) for a total of 142 participants entering the third year of the program." Quote: "The final sample for quantitative data analysis consisted of 50 participants from Cohort #1 (Intervention = 29, Control = 21) and 22 participants from Cohort #2 (Intervention = 4, Control = 18) for a total of 72 participants, 33 of whom were in the intervention group and 39 in the control group." Quote: "large number of those randomized into the control group dropped out of the study after completing the pre‐study measures and being informed of their assignment to the control group." Quote: "The time commitment involved may have been a major factor that contributed to attrition in the intervention group. These participants were required to attend one 3‐hour CPD workshop per term, per program year. The majority of students who withdrew from the study during its first year were in Year 2, which is considered by students and faculty to be the most demanding and difficult, as students’ clinical hours increase to 11 per week in addition to five classroom or online courses per term." Judgement comment: insufficient information about attrition/exclusions (number of participants randomised to each group not stated; number of attrition per group not specified; not specified if attrition from intervention or lost to assessments); probably per‐protocol analysis (only participants who took part in allocated intervention) and available‐case analysis (only participants for whom outcomes were obtained) since only 72 participants were analysed |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no study protocol available; published report seems to include all expected outcomes, including those that were prespecified; unclear if Time 4 refers to 12‐month follow‐up since not further specified in text |