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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

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
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