Incorporating parent, former patient, and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition

Background: Comparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition. Methods: We used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis. Results: We identified support for the trial’s methodology and vision, and elicited themes illustrating parents’ emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views. Conclusions: The early involvement of parents and former patients identified the centrality of parents’ emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation

Parental qualitative feedback on participating in the COSYBABY study – A preliminary randomised controlled trial to improve physiological stability of very preterm babies

Background: Preterm babies born below 32 weeks gestational age are placed in incubators, therefore deprived of exposure to maternal heartbeat sounds and breathing rhythms. The Babybe is a unique soft-robotics device which replicates these via the Babybe mattress in the incubator. Aims: Obtain data on the experience of mothers who participated in COSYBABY in relation to using the device and learn what, if any, value this device has to parents in the neonatal unit setting. Methods: We used qualitative focus groups conducted by our Patient and Public Involvement (PPI) leads and interviews with parents. We conducted framework analysis. Findings: Resulting themes included: willingness to try anything, Babybe supporting mothers, scepticism and searching for causality, limitations of the Babybe, and beyond the intervention. Conclusions: The Babybe provides socioemotional benefits to mothers of neonatal babies, even though health benefits to their baby are uncertain

Patient perspectives on the benefits and risks of percutaneous coronary interventions: a qualitative study

Background: Growing evidence for coronary stents in patients with stable coronary artery disease (CAD) suggests that the benefits of stents are uncertain. The goal of this study was to assess patients’ informational needs and how patients react to information about the uncertain benefit of stents to CAD patients. Methods: Semi-structured qualitative interviews (N=20) were conducted with patients with stable CAD who received a recent stent. Data were coded and analyzed using a mixed inductive-deductive approach. Results: Some patients mistakenly believed that the purpose of their stent was to prevent a future heart attack, and few were previously aware of the uncertain benefit. Nearly all patients perceived positive outcomes from their procedure, even if their symptoms persisted. Some patients had difficulty accepting evidence that stents may not reduce the risk of heart attack or reliably improve symptoms. Nonetheless, patients still expressed a desire to receive new information about the uncertain benefits of stents and wanted to have received this information early in their care. Conclusion: Many patients with stable CAD do not understand the intended benefit of coronary stents and want to be informed of the evidence of uncertain benefit of coronary stents, even if this would not change their decision. Improved communication and patient education tools are needed to better inform patients. An intervention providing patients with this information early has the potential to solve these problems

More than words: Parent, Patient and Public Involvement perspectives on language used by clinical researchers in neonatal care

In this qualitative study exploring parent views of information about research studies, we found they accepted uncertainty as justification, and that three key aspects of language - words, tone, and pace - influence parents' decision about their baby's inclusion. We recommend parents are routinely involved in developing information materials

DataSheet_1_Association of Chlamydia trachomatis burden with the vaginal microbiota, bacterial vaginosis, and metronidazole treatment.docx

Bacterial vaginosis (BV), a dysbiosis of the vaginal microbiota, is a common coinfection with Chlamydia trachomatis (Ct), and BV-associated bacteria (BVAB) and their products have been implicated in aiding Ct evade natural immunity. Here, we determined if a non-optimal vaginal microbiota was associated with a higher genital Ct burden and if metronidazole, a standard treatment for BV, would reduce Ct burden or aid in natural clearance of Ct infection. Cervicovaginal samples were collected from women at enrollment and, if testing positive for Ct infection, at a follow-up visit approximately one week later. Cervical Ct burden was assessed by inclusion forming units (IFU) and Ct genome copy number (GCN), and 16S rRNA gene sequencing was used to determine the composition of the vaginal microbiota. We observed a six-log spectrum of IFU and an eight-log spectrum of GCN in our study participants at their enrollment visit, but BV, as indicated by Amsel’s criteria, Nugent scoring, or VALENCIA community state typing, did not predict infectious and total Ct burden, although IFU : GCN increased with Amsel and Nugent scores and in BV-like community state types. Ct burden was, however, associated with the abundance of bacterial species in the vaginal microbiota, negatively with Lactobacillus crispatus and positively with Prevotella bivia. Women diagnosed with BV were treated with metronidazole, and Ct burden was significantly reduced in those who resolved BV with treatment. A subset of women naturally cleared Ct infection in the interim, typified by low Ct burden at enrollment and resolution of BV. Abundance of many BVAB decreased, and Lactobacillus increased, in response to metronidazole treatment, but no changes in abundances of specific vaginal bacteria were unique to women who spontaneously cleared Ct infection.</p