Description of themes, subthemes and quality ratings with examples
Theme | Subtheme | Description of rating | Examples of data supporting rating | Rating |
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 audit | International task force highlighted lack of evidence and need for evaluation. Cochrane review drew similar conclusions. |
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Single source of evidence/non-systematic review to support need for study | Old systematic review indicates paucity of high quality research. |
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Lack of clarity or underpinning evidence regarding need for study | Poor justification for the study. Evidence cited does not support the need for this particular study. |
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Theoretical underpinning | Theoretical underpinning described | Physiological and psychological theories underpinning the intervention described in detail. |
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Lacks clear theoretical underpinning | No information provided regarding the theoretical basis for the intervention provided. |
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Co-design | Good PPI and expert clinical input | Patients and clinicians helped develop the intervention. |
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Good PPI but weak or no expert clinical input/Good clinical input but unclear or no PPI | Clinicians contributed to the intervention development but no indication of service user involvement. |
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No co-design | No co-design was undertaken to develop the intervention. |
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Contextual considerations | Context considered | The use of different professionals in delivering the intervention reflected the real-world situation of how this would occur in practice. |
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Context not adequately considered | There was a lack of understanding of relevant context and factors needed for intervention development and delivery. |
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Piloting of intervention | Pilot conducted, evaluated and findings addressed for main evaluation | The pilot data helped refine the intervention for evaluation in the main trial. |
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Pilot conducted but findings not clearly addressed in intervention for main evaluation | The pilot work led to a modification of the control intervention but unclear as to whether this also happened for the novel intervention. |
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No pilot reported | No piloting of intervention reported |
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Intervention and control | Content and dose | Intervention components and dose clearly described | The content and the dose of the exercise programme were described in detail. |
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Intervention components clearly described but dose was not standardised | The content of the programme was well described but no specific dose was prescribed. |
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Intervention not replicable from description of components and dose | Intervention was based on usual practice and had no protocol or guidance on minimum dose. |
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Tailoring | Formalised assessment to inform tailoring | An assessment tool was used to determine the individuals level of exercise intensity |
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Clinical judgement only used to inform tailoring | Therapists used their clinical judgement to individually tailor programmes. |
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Not adequately reported | Intervention individually tailored but no information as to how this was undertaken. |
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Adherence support strategies | Explicit strategies to support adherence to the intervention clearly reported | Specific adherence strategies described as part of the intervention. |
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No clear information regarding adherence support strategies | No information reported regarding adherence strategies. |
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Supporting adherence is not relevant to the intervention | The intervention was passive and adherence strategies not relevant. | NA | ||
Intervention training | Standardised training in intervention received +/- additional/ongoing support or training | Staff attended a 1.5-day training session and had an additional support session with ongoing contact from research team. |
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No standardised intervention training received but staff delivering described to be experienced in the intervention or training of staff unclear/not reported | Staff have postgraduate training in the intervention but no study-specific training reported. |
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Control description | Active control/attention control/usual care with some standardised components | Control was an active intervention that differed from intervention only in terms of delivery setting. |
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Usual care had no standardised components | Control was usual care and was not standardised between sites. |
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Key: High quality
Some/Unclear quality
Limited quality.
PPI, Patient and Public Involvement.