Unit quiz: From trial to service: pragmatic fit, monitoring, fidelity and scale

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Question 1

A fictional service director reads a trial of a new therapy and says it proves the therapy does not work in real services, because the trial excluded people with comorbid substance use, used specially trained therapists with weekly supervision, and measured outcomes at twelve weeks by assessors who knew the allocation. Using lesson 86, how should this be characterised?The trial is explanatory rather than pragmatic on several PRECIS-2 domains (eligibility, organisation, flexibility of delivery, follow-up, and possibly outcome and analysis), so it estimates efficacy under favourable conditions; that bounds what it can say about routine delivery but does not show the therapy fails there.Exclusion criteria and intensive supervision are markers of low internal validity, so the trial cannot support efficacy either and should be disregarded.

Question 2

A fictional clinic now administers a symptom scale at every appointment and files the score in the record. Six months later, outcomes are unchanged and clinicians say the scale is administrative burden. Using lesson 87, what is the most likely explanation?The scale must be the wrong instrument, since a validated measure administered at every visit should improve outcomes by itself if it is specific to the condition.Measurement without a feedback rule is not measurement-based care: the trials that show benefit feed scores back to the treating clinician during the encounter, in time to change the plan, with a threshold or algorithm for acting on them.

Question 3

A fictional programme for early psychosis is rolled out from one well-supervised site to nine others. Twelve months later the pooled readmission reduction has halved. An evaluation finds that the new sites deliver the same number of sessions but shortened them, dropped the family component, and halved supervision. Using lesson 88, what is the correct reading?This is a fidelity and adaptation problem: adherence to content and dose, quality of delivery and the support system all degraded, and the implementation literature finds that level of implementation affects outcomes, so the attenuated effect is expected rather than evidence that the model does not work.The halving of effect is regression to the mean plus publication of an unusually strong first site, so the pooled figure is the truer estimate and nothing can be learned about delivery.

Question 4

A fictional commissioner is offered a mental health app supported by a six-week randomised trial against a waitlist, with a between-group effect of g = 0.28 on depressive symptoms and no follow-up beyond the trial end. Real-world data for comparable apps show median 15-day retention of about 4%. What is the soundest appraisal?The trial is randomised and the effect is statistically significant, so the app is an effective low-intensity intervention and the retention figure describes only people who were never motivated to engage.The effect is small and measured against an inactive comparator at the point of maximum novelty in a self-selected sample; with retention near 4% at 15 days, most users will not receive the dose the trial delivered, so the likely population impact is far below the trial effect.

Question 5

A fictional regional plan proposes to scale a successful pilot: the pilot showed a 40% reduction in admissions, so the plan sets a target of a 40% reduction regionally within two years and defines success as meeting that target. Using lesson 90, what is missing?The plan has imported a pilot effect as a production target without a theory of the denominator, the displaced activity, the workforce and supervision needed, or the fidelity conditions that produced the pilot result, and it has no pre-specified conditions under which the roll-out would be judged to have failed.The plan is sound because the pilot provides the effect size, and the only thing missing is a communication strategy for clinicians who are resistant to change.

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