Hoekstra 2006.
Study characteristics | ||
Methods | Randomised trial, the Netherlands | |
Participants | 146 patients with cancer in the palliative phase | |
Interventions | Symptom reporting with a systematic symptom monitoring instrument (Symptom Monitor). Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: Symptom Monitor (assessing 10 symptoms) Constructs measured: Symptoms Instrument categories/domains: Domain/Disease specific (cancer) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Paper Feedback features Format of PROMs feedback: Paper How often information fed back: Weekly Who information fed back to: Clinicians Information fed back: Scores |
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Outcomes | Main outcome: prevalence and severity of symptoms (Symptom Monitor) | |
Notes | The study was funded by the Dutch Cancer Society (grant). The study recruited between January 2000 and June 2002. Conflicts of interest were not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block design (randomisation by GP practice) |
Allocation concealment (selection bias) | High risk | Patients knew their allocation and so did the therapist in the intervention group |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible due to study design. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention. |
Baseline outcome measurements similar | Low risk | Tables 2 and 3 compare the prevalence and symptom severity scores at baseline between groups which are similar |
Baseline characteristics similar | Low risk | Table is provided and paper states that the baseline characteristics were quote "distributed equally in terms of age and gender between the two groups". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The study group expected a high dropout rate due to death and analysis was done separately for complete datasets |
Was study protected against contamination | Low risk | Randomisation by GP practice. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether selective reporting took place |