Background
Methods
Identifying trials with qualitative research
Defining a ‘good’ proposal in this context
Data extraction and analysis
Results
Description of studies
Stated aim and rationale of the qualitative research
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
|
Rationale | Summarised statements from proposals and protocols |
---|---|
Patient voice or engagement (1) | Engage service users in driving research process. Giving users a ‘voice’ in the evaluation of a health technology of which they will be the recipients |
Optimise the trial process / Develop the best processes to maximise the success of the trial (4) | Optimise overall trial process |
Phase 1: Develop qualitative model to understand perceptions and inform strategies for full trial | |
Phase 2: Modify trial procedures and documentation in feasibility phase | |
Improve recruitment and consent procedures for main trial (2) | Development of training programme with individual feedback for staff involved in recruitment. Recommend recruitment strategies most likely to promote recruitment into the main trial |
To pilot and develop trial procedures including modeling consent procedures for main trial | |
Generate theories and models to guide intervention development (2) | Build conceptual model of [] preferences that will be explored in a subgroup of randomised [participants] |
Gain an insider’s perspective from which a theoretical framework regarding subjective experience of service users can be developed | |
Generate theories to guide the trial and health community (1) | Develop theoretical model of HTA practice / Develop a critical understanding of social processes and practices implicated in development, implementation and dissemination of a RCT in the field of HTA |
Optimise implementation into clinical practice (6) | Inform future development of services of this intervention |
Process evaluation will provide important generalizable information for wider health community about acceptability [in service] | |
Inform the roll out of the intervention to the wider community | |
Inform commissioners and service providers to contribute to maximisation of quality and uptake of [intervention] | |
Assess the feasibility of delivering [intervention] in NHS | |
Interpret trial findings (especially unexpected findings) (5) | Understand and explain any differences in outcome between intervention sites |
Insight into possible explanations for differential success of intervention | |
Interpret trial results to understand why intervention did work / work to further interpret and illuminate the findings from the trial itself | |
Influence the interpretation of the outcome data / identify unanticipated outcomes and barriers to change | |
Other (5) | Understand, as well as quantify, the process and outcome of care |
Bring together the views of different research participants | |
Explore range of resource use for economic analysis | |
Provide new insights into patients’ views and experiences of [intervention] and usual care | |
Provide a richer understanding of patient and carer perceptions to complement quantitative data |
The presentation of qualitative research in proposals
Space allocated to the qualitative research
Methods
Expertise and resources
Language describing the relationship of the qualitative research to the trial
Discussion
Limitations of the research
Guidance for researchers and commissioners
Aim | Describe the aim of the qualitative research. Where appropriate identify aims specific to the trial e.g. ‘to explore patient views on adherence to the trial intervention’ rather than using general aims e.g. ‘to explore patient experiences’. |
Rationale | Describe the rationale for including qualitative research; identify areas of uncertainty to be explored. Include a statement addressing the ways in which the aims of the qualitative research will ‘add value’ to the trial. |
Methods | Provide a clear account of the proposed methods of data collection including the location and timing of data collection, and the skills and seniority of the person who will undertake data collection. |
Describe the sample frame, sampling method(s), and sample size. Where the sample frame is trial participants, specify whether intervention, control or both will be included. | |
Describe and reference the proposed approach to analysis. A rationale for the approach to be taken may be included. | |
Identify the qualitative research skills and seniority of the person who will undertake the analysis and write-up. | |
Integration with trial | Outline suggestions for integrating and synthesising qualitative data / findings with the trial results. |
Costs | Describe the full costs of the qualitative research and highlight any dedicated equipment, software, staff, and transcription costs. |
Leadership | Identify which of the co-applicants will take overall responsibility for the qualitative research and describe their role in the design, data collection, analysis and write-up of the study. |