Aspect of trial1 | Sub-category1 | Examples of summarised stated aims of the qualitative research from proposals |
---|---|---|
Intervention content and delivery (40) | Intervention development (3) | To develop the [intervention] |
Focus group [] to identify the range of possible interventions | ||
Intervention components (3) | One of the subsidiary aims is to find out what “support as usual” means | |
Identify components of the intervention which contribute to its effectiveness | ||
Describe “usual care” for this patient group | ||
Models, mechanisms and underlying theory development (1) | To better understand women’s decisions regarding [intervention] | |
Feasibility and acceptability of intervention in practice (8) | Examine acceptability of [intervention] for those over 75 and to ascertain the views of various stakeholders | |
Treatment acceptability and usefulness of intervention | ||
Assess the acceptability of the intervention to patients and healthcare providers | ||
Explore factors associated with success or failure of the intervention: feasibility, acceptability of different models of [intervention] | ||
Intervention fidelity, reach & dose (3) | Identify patients’ reasons for completing or not completing [intervention] | |
Gain insights into reasons for poor uptake and lack of adherence | ||
Compliance with intervention | ||
Intervention implementation (2) | [Healthcare professionals]: experiences of learning and applying new [intervention], their impressions of the ‘climate’ within the group and the impact of the group on the wider service. Managers: Understanding of service policies and practices for [treatment group] – perceived influence that [this type of trial] have had on the clinical practice within each of the services | |
Assess the impact of the new [intervention] on the [] workforce, other ‘key’ stakeholders and national leads | ||
Generic acceptability / implementation (7) | Identify factors (organisational, professional and patient related) that influence successful implementation | |
Views of [healthcare professionals] concerning implementation of the service. Understand how the intervention worked in practice | ||
Experiences and views about the intervention (11) | Main trial – assess experience of receiving [intervention] | |
To qualitatively explore participants’ experiences of the two [interventions] | ||
Explore patients’ views and experiences of [intervention] | ||
Understand how patients make sense of their treatment and recovery and whether there are any differences in experience between the two treatment groups | ||
Service users: experiences of participating in [intervention] | ||
Patient experiences about the process and effects of [intervention] | ||
Unclear (2) | Identify additional factors influencing the uptake of [intervention] and the way it is used | |
Explore how [intervention] influences beliefs and behaviours | ||
Trial design, conduct and processes (14) | Recruitment and retention (3) | Development of training programme with individual feedback for staff involved in recruitment |
Start-up: assess parent and clinician attitudes to recruitment methods | ||
Reasons for rates of recruitment to the trial | ||
Trial participation (4) | To ascertain the impact of the trial on participants | |
Start-up: assess parent and clinician attitudes to participation | ||
Understand why some [participants] consent to randomisation or express strong preferences for a particular treatment | ||
Acceptability of trial in principle (1) | Explore attitudes towards a possible [] type of randomised trial; focus groups with patients to explore their attitudes towards the proposed trial | |
Acceptability of trial in practice (2) | Understand the reasons for acceptance or refusal of randomization | |
Ethical conduct (2) | Ethical and practical issues of consent and assent e.g., merits and problems associated with a number of models of consent, feasibility and acceptability of taking advance consent / assent for research trial procedures | |
Consent and assent | ||
Public and patient involvement (1) | Phase 1: engage service users and carers in driving the research process, and to elicit views of NHS services | |
Unclear (1) | The empirical investigation of the social organisation, production and effects of the RCT in practice | |
Outcomes (5) | Breadth of outcomes (2) | Ensure the most relevant [outcome] factors are assessed by the questionnaires |
To access important aspects of [] care not reflected in standardised measures of clinical outcomes | ||
Variation of outcomes (2) | To examine the perspectives of participant and professional stakeholders using qualitative methods. This is important to understand and explain any differences in outcome between intervention sites | |
Phase 2: Determine user's and carers' views on the process and effects of [intervention] compared with the views of those who received the attention control | ||
Unclear (1) | Start-up: assess parent and clinician attitudes to outcomes | |
Measures of process and outcome (2) | Completion of measures (1) | Ensure the feasibility of daily assessment |
Development of measures (1) | Look at ways of asking about [outcome measures]. Ensure that the most relevant [outcome measures] are assessed by the questionnaires | |
Target condition (3) | Experience of the disease, health behaviour and beliefs (3) | Main trial: explore parent and clinician attitudes and knowledge to [health behaviour] |
Explore issues related to [disease] | ||
Unclear (3) | Unclear (3) | Understanding of the processes underlying the changes in patients’ beliefs and attitudes |
A qualitative assessment of patient and carer perceptions | ||
Process evaluation: perceived impact of the intervention on outcomes |