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Table 1 The stated aim of qualitative research described in proposals 1,2

From: Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis

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
  1. 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.
  2. 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.
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