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Table 3 Eight coding items used to form a scale of efficacy-effectiveness (or clinical representativeness) (adapted from Kaner et al.[8])

From: The efficacy-effectiveness distinction in trials of alcohol brief intervention

Patients and problems Therapeutic flexibility
2 = clinically representative subjects initially present with a typically wide range of problems via self-referral or invitation for a health check. 1 = clinically representativeness allows professional judgement in how an intervention is delivered (e.g., freedom to focus on particular issues according to patient need).
0 = research representative subjects may be paid patients, researcher-solicited volunteers (e.g., via advertisement) or referrals from specialist services. 0 = research representativeness would be strict adherence to a prescribed protocol or script that does not allow for variability in practice.
Practice context Pre-therapy training
2 = clinically representative is a community-based setting in which a range of clinical services are usually provided to patients. 1 = clinically representative training in intervention procedures occurs according to typical CPD/CME procedures (e.g., outreach visits, seminars, one-off training days).
0 = research representative is a setting in which the research function clearly dominates any clinical one (e.g., clinic at a university or hospital). 0 = research representative training is unusually intensive or requiring of atypical levels of interest or motivation (e.g., prolonged or intensive courses, formal qualification).
Practitioners and therapists Intervention support
2 = clinically representative practitioners are practising doctors, nurses, and qualified therapists who earn their main living by providing health services in primary care. 1 = clinically representative support occurs within standard practice resources (e.g., colleague assistance with screening, IT flagging).
0 = research representative practitioners are nonclinicians or clinicians in training who are contracted to deliver interventions for the purposes of the study. 0 = research representative support would not typically be available (e.g., researcher help to flag notes, extra staff for period of the trial).
Intervention content Intervention monitoring
2 = clinically representative intervention fits with current practice in terms of timing, content or style (e.g., 5–15 minutes for a GP; 20–30 minutes for a nurse or initial screening accompanied by a return visit for brief intervention). 1 = clinically representative monitoring of intervention delivery does not interfere with practitioners’ behaviour or their relationship with patients.
0 = research representative treatment would not normally occur in routine practice (e.g., unusually long consultations). 0 = research representative monitoring would be direct observation of therapist behaviour or ongoing/immediate feedback to practitioners after each session.