Table 2. GRADE-CERQual summary of qualitative findings.
| Summary of Review Finding | Studies Contributing to the Review Finding | CERQual Assessment of Confidence in the Evidence | Explanation of CERQual Assessment |
|---|---|---|---|
| Theme 1: Recruitment through a clinician’s lens | |||
| 1. Recruiters in the maternity care setting were predominately clinicians. Primarily identifying as clinicians, recruiters prioritised clinical care over recruitment responsibilities. | [31–35] | Moderate confidence | Minor methodological concerns with four studies as reflexivity is not addressed. Moderate concerns about the fit with data in the primary studies. Minor concerns about adequacy as studies 2 & 3 based on same participants. |
| 2. The duality of the clinician/recruiter role meant that recruiters were already busy juggling a high clinical workload, which allowed little time for the task of recruitment. In contrast, recruiters employed purely in a research capacity, experienced recruitment as unhurried and complementary to the women’s care experience | [31, 32, 34] | High confidence | Only minor methodological concerns with all three studies as reflexivity is not addressed. |
| 3. Recruiters made judgements, and assumptions, about pregnant women’s mental capacity and their ability to comprehend what trial participation involved. Recruiters regarded pregnant women as vulnerable and as such they believed women needed to be protected from research and therefore were less inclined to recruit them to trial. | [31, 33–35] | High confidence | Only minor methodological concerns with all four studies as reflexivity is not addressed. |
| 4. Recruiters made assumptions of knowledge regarding how receptive pregnant women would be towards the trial, and also demonstrated an ‘ownership’ of women through the language they used. | [34, 35] | Moderate confidence | Minor methodological concerns with both studies as reflexivity is not addressed. Moderate concerns regarding coherence and adequacy, however, both studies offered rich data. |
| Theme 2: The recruiter’s judgement of acceptability | |||
| 5. Recruiters made a judgement on the clinical relevance and aim of the trial. Concordance between the recruiter’s values and beliefs, and the research goals, promoted their willingness to engage in recruitment. Whilst discordance, in turn, dissuaded recruitment. | [32–35] | Moderate confidence | Minor methodological concerns with four studies as reflexivity is not addressed. Moderate concerns regarding coherence and minor concerns about adequacy as studies 2 & 3 based on same participants. |
| 6. It was important to recruiters that recruitment processes and protocols were pragmatic and an efficient use of the resources available. | [33, 34] | Moderate confidence | Minor methodological concerns with both studies as reflexivity is not addressed. Moderate concerns about adequacy as two studies with moderately rich data. |
| 7. Recruiters formed an opinion around the acceptability of the trial intervention based on its utility, potential benefits for stakeholders (women, clinicians, and the organisation of care), and potential to ultimately improve the current standard of care. | [32–35] | High confidence | Only minor methodological concerns with all four studies as reflexivity is not addressed. |
| 8. Recruiters expressed optimism and hope for a successful trial outcome. Their engagement triggered a cyclical process where the recruiters ‘buy in’ to the trial generated recruitment, leading to a sense of achievement, which in turn provided positive reinforcement for their efforts and generated further recruitment. However, the cycle could also be reversed when declining recruitment rates lead to disengagement. | [32–34] | Moderate confidence | Minor methodological concerns with all three studies as reflexivity is not addressed. Moderate concerns about coherence and adequacy as studies 2 & 3 based on same participants. |
| 9. Recruiters had strong ties with established clinical practice and were uncomfortable recruiting for a trial that moved away from their routine. | [34, 35] | Low confidence | Minor methodological concerns with both studies as reflexivity is not addressed. Very minor concerns about coherence. Serious concerns about adequacy as both studies offered thin data. |
| 10. The recruiter’s perception of risk (associated with the intervention) was fundamental in their judgement of acceptability, and therefore a key determinant in their willingness to engage in recruitment. Recruiters were more comfortable recruiting to a trial they considered to be low risk. | [31, 32, 34, 35] | High confidence | Minor methodological concerns with four studies as reflexivity not addressed. Only minor concerns with coherence and adequacy. |
| Theme 3: From protocol to recruiter’s lived experience | |||
| 11. Recruiters were also gatekeepers to potential participants and assumed the role of a protective advocate of women. Recruiters were paternalistic in the role and were seen to withhold trial information and steer women towards decision making which was aligned with their own views. Gatekeeping could also include protecting the interests of the trial | [31–35] | High confidence | Minor methodological concerns with five studies as reflexivity is not addressed. Only minor concerns with coherence and adequacy. |
| 12. An additional layer of gatekeeping existed between midwife recruiters and recruiters from other professional backgrounds. In what was apparently a culturally appointed hierarchy, recruiters sought permission from the midwife (recruiter) to approach a potential participant. | [31, 34] | Low confidence | Minor methodological concerns with both studies as reflexivity is not addressed. Serious concerns about adequacy as only two studies offered thin data. |
| 13. Recruitment frequently involved a team approach, with often more than one recruiter over several encounters. Recruiters often engaged in an ‘exit’ encounter, post-trial, which appeared to bring closure to the trial recruitment process for both women and recruiters. | [31–33] | Moderate confidence | Minor methodological concerns with three studies as reflexivity is not addressed. Minor concerns about coherence and moderate concerns about adequacy as two studies offered moderately rich data. |
| 14. There was no consensus reached amongst recruiters regarding either, the best method for communicating trial information to potential participants or at what time point the information should be given. | [31, 33] | Moderate confidence | Minor methodological concerns with both studies as reflexivity is not addressed. Minor concerns about coherence and moderate concerns about adequacy as both studies offered thin data. |
| Theme 4: Framing recruitment in context | |||
| 15. Recruiting pregnant women during an emergency or in a time-critical situation challenged recruiters to communicate effectively in a highly pressured time constrained environment. Recruiters were not comfortable with the task of obtaining informed consent in this environment. | [31, 33] | Moderate | Minor methodological concerns with both studies as reflexivity is not addressed. Minor concerns with both coherence and adequacy as moderately rich data offered. |
| 16. Training in methodological aspects of the trial and recruitment protocols provides recruiters with the knowledge and confidence to perform their recruitment task well. Recruiters recognised the need for regular structured multidisciplinary recruitment training, both initially, and throughout life of trial | [31, 32, 34, 35] | High confidence | Only minor methodological concerns with four studies as reflexivity is not addressed and minor concerns with adequacy as one study offered moderately rich data. |
Table format from Lewin et al., 2018 [36]