Involving seldom-heard groups in a PPI process to inform the design of a proposed trial on the use of probiotics to prevent preterm birth: a case study

Background Patient and public involvement (PPI) is an important tool in approaching research challenges. However, involvement of socially and ethnically diverse populations remains limited and practitioners need effective methods of involving a broad section of the population in planning and designing research. Methods In preparation for the development of a pilot randomised controlled trial (RCT) on the use of probiotics to prevent preterm birth, we conducted a public consultation exercise in a socially disadvantaged and ethnically diverse community. The consultation aimed to meet and engage local service users in considering the acceptability of the proposed protocol, and to encourage their participation in future and ongoing patient and public involvement activities. Four discussion groups were held in the community with mothers of young children within the proposed trial region, using an inclusive approach that incorporated a modified version of the Nominal Group Technique (NGT). Bringing the consultation to the community supported the involvement of often seldom-heard participants, such as those from minority ethnic groups. Results The women involved expressed a number of concerns about the proposed protocol, including adherence to the probiotic supplement regimen and randomisation. The proposal for the RCT in itself was perceived as confirmation that probiotic supplements had potentially beneficial effects, but also that they had potentially harmful side-effects. The complexity of the women’s responses provided greater insights into the challenges of even quite simple trial designs and enabled the research team to take these concerns into account while planning the pilot trial. Conclusions The use of the NGT method allowed for a consultation of a population traditionally less likely to participate in medical research. A carefully facilitated PPI exercise can allow members to express unanticipated concerns that may not have been elicited by a survey method. Findings from such exercises can be utilised to improve clinical trial design, provide insight into the feasibility of trials, and enable engagement of often excluded population groups

Health Education through Analogies: Preparation of a Community for Clinical Trials of a Vaccine against Hookworm in an Endemic Area of Brazil

Conducting clinical trials of new vaccines in rural, resource-limited areas can be challenging since the people living in these areas often have high levels of illiteracy, little experience with clinical research, and limited access to routine health care. Especially difficult is obtaining informed consent for participation in this type of research and ensuring that potential participants adequately understand the potential risks and benefits of participation. The researchers have been preparing a remote field site in the northeastern part of the state of Minas Gerais, Brazil, for clinical trials of experimental hookworm vaccines. A special educational video was designed based on the method of analogies to introduce new scientific concepts related to the researchers' work and to improve knowledge of hookworm, a disease that is highly prevalent in their community. A questionnaire was administered both before and after the video was shown to a group of adults at the field site, which demonstrated the effectiveness of the video in disseminating knowledge about hookworm infection and about the vaccine being developed. Therefore, even in a rural, resource-limited area, educational tools can be specially designed that significantly improve understanding and therefore the likelihood of obtaining truly informed consent for participation in clinical research

Symplasmic transport and phloem loading in gymnosperm leaves

Despite more than 130 years of research, phloem loading is far from being understood in gymnosperms. In part this is due to the special architecture of their leaves. They differ from angiosperm leaves among others by having a transfusion tissue between bundle sheath and the axial vascular elements. This article reviews the somewhat inaccessible and/or neglected literature and identifies the key points for pre-phloem transport and loading of photoassimilates. The pre-phloem pathway of assimilates is structurally characterized by a high number of plasmodesmata between all cell types starting in the mesophyll and continuing via bundle sheath, transfusion parenchyma, Strasburger cells up to the sieve elements. Occurrence of median cavities and branching indicates that primary plasmodesmata get secondarily modified and multiplied during expansion growth. Only functional tests can elucidate whether this symplasmic pathway is indeed continuous for assimilates, and if phloem loading in gymnosperms is comparable with the symplasmic loading mode in many angiosperm trees. In contrast to angiosperms, the bundle sheath has properties of an endodermis and is equipped with Casparian strips or other wall modifications that form a domain border for any apoplasmic transport. It constitutes a key point of control for nutrient transport, where the opposing flow of mineral nutrients and photoassimilates has to be accommodated in each single cell, bringing to mind the principle of a revolving door. The review lists a number of experiments needed to elucidate the mode of phloem loading in gymnosperms

Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children : a systematic review

Background Randomised controlled trials (RCTs) are recommended as the ‘gold standard’ in evaluating health care interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. Aim To identify predictors of recruitment and retention in RCTs involving children. Methods A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0–12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. Results Twenty-eight studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socioeconomic status (SES)) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. Conclusion Parent characteristics may predict participation of children and their families to RCTs; however, there was a lack of consensus. Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention