Table 1.
The stated aim of qualitative research described in proposals 1,2
| Aspect of trial 1 | Sub-category 1 | 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 |
1Numbers in brackets represent the number of incidences that this category or sub-category was mentioned in the proposals we analysed. All text in square brackets has been removed / summarized to maintain anonymity.
2The table is based on a framework developed from a systematic mapping review of articles reporting qualitative research undertaken with trials [6]. Categories in italics are additional categories identified in the proposals.