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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.