Kutner 1999.
Methods | Cluster RCT ‐ with an intervention group (IG) and a control group (CG) | |
Participants | Cancer patients scheduled for a follow‐up visit in an ambulatory cancer clinic Country: USA Age: Physicians: IG: 41.7 ± 6.9, CG: 42.2 ± 6.3; Participants: IG: 51.5 ± 16.4, CG: 55.6 ± 13.3 Sex: Physicians: IG: 33% female, CG: 20% female; Participants: IG: 44% female, CG: 66% female Inclusion criteria
Exclusion criteria N randomised: Physicians: n = 11, IG: n = 6, CG: n = 5; Participants: n = 282, IG: n = 149, CG: n = 133 N in analysis: baseline: Physicians: n = 11, IG: n = 6, CG: n = 5; Participants: n = 282, IG: n = 149, CG: n = 133 |
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Interventions |
Content of screen:CARE NEEDS: Needs assessment questionnaire adapted from published instruments, exploring needs in 13 domains: intensive care, financial, self‐care, future, symptom relief, treatment, emotional, spiritual, test, prevention, diagnosis, referral, and advance directives Interventionist: No interventionist for screening act, self‐completion of screening tool Intervention procedure:Solitary SI: Participants completed a pre‐visit needs assessment questionnaire; completed forms were attached to the patient charts prior to the clinic visit. Physicians were aware of this information, but were not instructed in use of the information provided Conditions for implementation: A person or system that gives/sends the pre‐visit questionnaire to participants and attaches it to patient files Comparative condition: Usual care: not further specified Length of follow‐up: No follow‐up |
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Outcomes |
Primary outcomes
Secondary outcomes: / Outcome time points: only 1, postvisit |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear what method was used to randomise the physicians |
Allocation concealment (selection bias) | Unclear risk | Unclear which method was used to conceal the allocation to conditions |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of physicians or participants |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome data were collected with postvisit questionnaires in both conditions No extra person for outcome assessment aware of condition allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 outcome time point, so no potential for missing data due to loss in follow‐up. No indication for other missing data |
Selective reporting (reporting bias) | Low risk | Incomplete reporting of outcomes (only significant subscales reported for patient satisfaction, without a measure of the spread of the data) |
Other bias | High risk | Adjusted P values reported everywhere to adjust for clustering, but no information on how this adjustment was done It is clear that there is a huge difference in baseline characteristics, which is the result of clustering at the physician level, but this becomes non‐significant when "clustering is taken into account". Nevertheless, this remains problematic |