Table 2

Description of themes, subthemes and quality ratings with examples

ThemeSubthemeDescription of ratingExamples of data supporting ratingRating
Preparatory work Need for the study Multiple sources of evidence of need for the study, for example, recent systematic review, guidelines, high level reports, commissioned research, national auditInternational task force highlighted lack of evidence and need for evaluation. Cochrane review drew similar conclusions. Graphic
Single source of evidence/non-systematic review to support need for studyOld systematic review indicates paucity of high quality research. Graphic
Lack of clarity or underpinning evidence regarding need for studyPoor justification for the study. Evidence cited does not support the need for this particular study. Graphic
Theoretical underpinning Theoretical underpinning describedPhysiological and psychological theories underpinning the intervention described in detail. Graphic
Lacks clear theoretical underpinningNo information provided regarding the theoretical basis for the intervention provided. Graphic
Co-design Good PPI and expert clinical inputPatients and clinicians helped develop the intervention. Graphic
Good PPI but weak or no expert clinical input/Good clinical input but unclear or no PPIClinicians contributed to the intervention development but no indication of service user involvement. Graphic
No co-designNo co-design was undertaken to develop the intervention. Graphic
Contextual considerations Context consideredThe use of different professionals in delivering the intervention reflected the real-world situation of how this would occur in practice. Graphic
Context not adequately consideredThere was a lack of understanding of relevant context and factors needed for intervention development and delivery. Graphic
Piloting of intervention Pilot conducted, evaluated and findings addressed for main evaluationThe pilot data helped refine the intervention for evaluation in the main trial. Graphic
Pilot conducted but findings not clearly addressed in intervention for main evaluationThe pilot work led to a modification of the control intervention but unclear as to whether this also happened for the novel intervention. Graphic
No pilot reportedNo piloting of intervention reported Graphic
Intervention and control Content and dose Intervention components and dose clearly describedThe content and the dose of the exercise programme were described in detail. Graphic
Intervention components clearly described but dose was not standardisedThe content of the programme was well described but no specific dose was prescribed. Graphic
Intervention not replicable from description of components and doseIntervention was based on usual practice and had no protocol or guidance on minimum dose. Graphic
Tailoring Formalised assessment to inform tailoringAn assessment tool was used to determine the individuals level of exercise intensity Graphic
Clinical judgement only used to inform tailoringTherapists used their clinical judgement to individually tailor programmes. Graphic
Not adequately reportedIntervention individually tailored but no information as to how this was undertaken. Graphic
Adherence support strategies Explicit strategies to support adherence to the intervention clearly reportedSpecific adherence strategies described as part of the intervention. Graphic
No clear information regarding adherence support strategiesNo information reported regarding adherence strategies. Graphic
Supporting adherence is not relevant to the interventionThe intervention was passive and adherence strategies not relevant.NA
Intervention training Standardised training in intervention received +/- additional/ongoing support or trainingStaff attended a 1.5-day training session and had an additional support session with ongoing contact from research team. Graphic
No standardised intervention training received but staff delivering described to be experienced in the intervention or training of staff unclear/not reportedStaff have postgraduate training in the intervention but no study-specific training reported. Graphic
Control description Active control/attention control/usual care with some standardised componentsControl was an active intervention that differed from intervention only in terms of delivery setting. Graphic
Usual care had no standardised componentsControl was usual care and was not standardised between sites. Graphic
  • Key: Graphic High quality Graphic Some/Unclear quality Graphic Limited quality.

  • PPI, Patient and Public Involvement.