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

Thomas 2016.

Study characteristics
Methods Randomised trial, Canada
Participants 54 families
Interventions This trial’s purpose is to: (1) compare identification rates of developmental problems by GPs/family physicians using four evidence‐based tools with non‐evidence based screening, and (2) ascertain whether the four tools can be completed in 10‐min pre‐visit on a computer.
 
Intervention features
Single complex feedback (multiple PROMs at a single time) 
PROM(s) used as intervention: Parents’ Evaluation of Developmental Status (PEDS), the PEDS‐Developmental Milestones (PEDS‐DM), the Modified Checklist for Autism in Toddlers (M‐CHAT) and PHQ9 (maternal depression)
Constructs measured: Symptoms, Functioning
Instrument categories/domains: Domain/Disease specific (child development, autism, mental health)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) 
How administered: Self‐administered
Format of PROMs questionnaire(s): Electronic
 
Feedback features
Format of PROMs feedback: Electronic
How often information fed back: Once
Who information fed back to: Clinicians, Patients
Information fed back: Scores
Outcomes Main outcomes: Parents’ Evaluation of Developmental Status (PEDS), PEDS‐Developmental Milestones (PEDS‐DM), Modified Checklist for Autism in Toddlers (M‐CHAT), maternal depression (PHQ9).
Notes Funding not disclosed. The study period was not reported. Conflicts of interest were not reported. 
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated method.
Allocation concealment (selection bias) Low risk Allocation was done by research assistant by computer to ‘usual care’ or evidence‐based screening.
Blinding of participants and personnel (performance bias)
All outcomes High risk Neither the participants nor family physicians could be blinded due to the nature of the intervention.
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 Unclear risk Not clearly reported.
Baseline characteristics similar High risk The usual care and evidence based care groups were very similar in gestational age at birth and age at screening (17.84 and 17.59 months). They differed markedly in female gender (40%, 62%)
Incomplete outcome data (attrition bias)
All outcomes High risk In the ‘usual care’ group four (16%) and in the evidence‐based tools group 18 (62%) were identified as having a possible developmental problem.
Was study protected against contamination High risk As the physician or research associate were aware that the patient was a participant in the study.
Selective reporting (reporting bias) Low risk All relevant outcomes in the methods section are reported in the results section.