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.