Rapid reviews methods series: guidance on rapid qualitative evidence synthesis.

This paper forms part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group and addresses rapid qualitative evidence syntheses (QESs), which use modified systematic, transparent and reproducible methodsu to accelerate the synthesis of qualitative evidence when faced with resource constraints. This guidance covers the review process as it relates to synthesis of qualitative research. 'Rapid' or 'resource-constrained' QES require use of templates and targeted knowledge user involvement. Clear definition of perspectives and decisions on indirect evidence, sampling and use of existing QES help in targeting eligibility criteria. Involvement of an information specialist, especially in prioritising databases, targeting grey literature and planning supplemental searches, can prove invaluable. Use of templates and frameworks in study selection and data extraction can be accompanied by quality assurance procedures targeting areas of likely weakness. Current Cochrane guidance informs selection of tools for quality assessment and of synthesis method. Thematic and framework synthesis facilitate efficient synthesis of large numbers of studies or plentiful data. Finally, judicious use of Grading of Recommendations Assessment, Development and Evaluation approach for assessing the Confidence of Evidence from Reviews of Qualitative research assessments and of software as appropriate help to achieve a timely and useful review product.

Factors that impact on recruitment to vaccine trials in the context of a pandemic or epidemic: a qualitative evidence synthesis.

BACKGROUND: The World Health Organization declared the COVID-19 pandemic on 11 March 2020. Vaccine development and deployment were swiftly prioritised as a method to manage and control disease spread. The development of an effective vaccine relies on people's participation in randomised trials. Recruitment to vaccine trials is particularly challenging as it involves healthy volunteers who may have concerns around the potential risks and benefits associated with rapidly developed vaccines. OBJECTIVES: To explore the factors that influence a person's decision to participate in a vaccine trial in the context of a pandemic or epidemic. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was June 2021. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored the perspectives of adults aged 18 years or older who were invited to take part in vaccine trials in the context of a pandemic or epidemic. DATA COLLECTION AND ANALYSIS: We assessed the title, abstracts and full texts identified by the search. We used a sampling frame to identify data-rich studies that represented a range of diseases and geographical spread. We used QSR NVivo to manage extracted data. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool for qualitative studies. We used the 'best-fit framework approach' to analyse and synthesise the evidence from our included studies. We then used the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) assessment to assess our confidence in each finding and develop implications for practice. MAIN RESULTS: We included 34 studies in our review. Most studies related to HIV vaccine trials. The other studies related to Ebola virus, tuberculosis, Zika virus and COVID-19. We developed 20 key findings, under three broad themes (with seven subthemes), that described the factors that people consider when deciding whether to take part in a vaccine trial for a pandemic or epidemic disease. Our GRADE-CERQual confidence was high in nine of the key findings, moderate in 10 key findings and low in one key finding. The main reason for downgrading review findings were concerns regarding the relevance and adequacy of the underlying data. As a result of the over-representation of HIV studies, our GRADE-CERQual assessment of some findings was downgraded in terms of relevance because the views described may not reflect those of people regarding vaccine trials for other pandemic or epidemic diseases. Adequacy relates to the degree of richness and quantity of data supporting a review finding. Moderate concerns about adequacy resulted in a downgrading of some review findings. Some factors were considered to be under the control of the trial team. These included how trial information was communicated and the inclusion of people in the community to help with trial information dissemination. Aspects of trial design were also considered under control of the trial team and included convenience of participation, provision of financial incentives and access to additional support services for those taking part in the trial. Other factors influencing people's decision to take part could be personal, from family, friends or wider society. From a personal perceptive, people had concerns about vaccine side effects, vaccine efficacy and possible impact on their daily lives (carer responsibilities, work, etc.). People were also influenced by their families, and the impact participation may have on relationships. The fear of stigma from society influenced the decision to take part. Also, from a societal perspective, the level of trust in governments' involvement in research and trial may influence a person's decision. Finally, the perceived rewards, both personal and societal, were influencing factors on the decision to participate. Personal rewards included access to a vaccine, improved health and improved disease knowledge, and a return to normality in the context of a pandemic or epidemic. Potential societal rewards included helping the community and contributing to science, often motivated by the memories of family and friends who had died from the disease. AUTHORS' CONCLUSIONS: This review identifies many of the factors that influence a person's decision to take part in a vaccine trial, and these reflect findings from reviews that examine trials more broadly. However, we also recognise some factors that become more important in connection with a vaccine trial in the context of a pandemic or epidemic. These factors include the potential stigma of taking part, the possible adverse effects of a vaccine, the added motivation for helping society, the role of community leaders in trial dissemination, and the level of trust placed in governments and companies developing vaccines. These specific influences need to be considered by trial teams when designing, and communicating about, vaccine trials in the context of a pandemic or epidemic.

Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ' Understanding and experiences of the potential benefits of sharing qualitative data from trials', 'Concerns about qualitative data sharing', and ' Future guidance and funding'. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.

Perceptions and experiences of nursing students communicating with people living with dementia: The validation, emotion, reassure, activity (VERA) communication skills framework.

BACKGROUND: There is an increased risk with advancing age that degenerative conditions such as dementia will affect a person's capacity to communicate. Thus, there is increased possibility that nursing students will be caring for this client group and will need to have the skills to communicate effectively. The Validation, Emotion, Reassure, Activity (VERA) framework is a communication tool developed for this purpose. OBJECTIVES: This pilot study explored nursing students' perceptions and experiences of communicating with people with dementia incorporating the VERA communication skills framework. METHODS: Using a descriptive qualitative approach, second year undergraduate general nursing students were eligible for inclusion if they were assigned to complete their 4-week clinical placement in the designated research site and were willing to participate. Students allocated to the designated research site (n = 6) in semester 1 received standard communication skills as part of the undergraduate programme and students allocated (n = 10) in semester 2 received 2.5 h of additional communication skills based on the VERA framework. Data were analysed using framework analysis as described by Ritchie & Spencer. RESULTS: The findings showed that students in both groups had initial reservations about communicating with people living with dementia. They employed several strategies including nonverbal techniques, distraction, reminiscence and life story work. However, students who received the VERA communication training felt more prepared to engage in these strategies because of the VERA training. CONCLUSION: With increasing numbers of people with dementia accessing health care, it is crucial that future nursing staff are equipped to meet the specific care needs of this population; which includes effective communication. The VERA framework can be useful to structure communication for nursing students. IMPLICATION FOR PRACTICE: The VERA training may be considered a useful framework for increasing undergraduate nursing students' knowledge and confidence in advance of clinical placements in older person's services. Nursing staff should continue to support students on clinical placements which involve caring for people with dementia and be cognisant of the trepidation students may have when first meeting this client group.

Healthcare professionals' experiences and perceptions of providing support for mental health during the period from pregnancy to two years postpartum.

OBJECTIVE: Mental health issues in the perinatal period are common, and can have negative consequences for maternal and child health. Healthcare professionals (HCPs) who provide women with perinatal care are well-placed to detect mental health issues and provide support. This study therefore examines HCPs' experiences and perceptions of providing mental health support during the perinatal period, including during the COVID-19 pandemic. DESIGN: An exploratory realist qualitative study was conducted. SETTING: Republic of Ireland PARTICIPANTS: A purposive sampling strategy was employed to recruit HCPs (e.g., general practitioners, midwives, public health nurses, practice nurses, doulas, and breastfeeding counsellors), via professional bodies in Ireland. An invitation to participate was also circulated via Twitter. A total of 18 HCPs participated in semi-structured interviews conducted between 18/8/2020 and 24/5/2021. MEASUREMENTS AND FINDINGS: Semi-structured interviews were conducted according to a topic guide designed by a multidisciplinary team. Data were analysed using thematic analysis. Four themes were developed: 'Supporting women in healthcare settings,' 'Skills and capacity to provide adequate care,' 'Structural barriers to care provision,' and 'The impact of the COVID-19 pandemic on stress support.' KEY CONCLUSIONS: HCPs reported providing emotional support and advocacy, but highlighted challenges, including limited capacity to address women's concerns, clinical culture and hierarchy, insufficient organisational investment, and social inequities in support access. Some HCPs felt these barriers could lead to additional psychological harm. HCPs also reported that the pandemic had introduced novel stressors and changed the nature of the mental health support they provided. IMPLICATIONS FOR PRACTICE: Interventions incorporating education and physical resources for HCPs, increased investment in specialist perinatal mental health services, increased investment in holistic supports, and changes to address cultural challenges in care environments, may facilitate - or enhance - support for women.

Scope of professional roles for genetic counsellors and clinical geneticists in the United Kingdom : Position on behalf of the Association of Genetic Nurses and Counsellors and the Clinical Genetics Society.

This document is written on behalf of the two professional bodies in the United Kingdom that represent genetic counsellors (the Association of Genetic Nurses and Counsellors) and clinical geneticists (the Clinical Genetics Society) and aims to support multidisciplinary working of these professional groups highlighting within a quick-reference format, areas of shared practice and the distinctions between role profiles for a Consultant Clinical Geneticist, Principal/Consultant Genetic Counsellor and the new support role that we have termed 'Genomic Associate', see AGNC career structure [1]. This builds on published documents that articulate the scope of practice of the clinical genetics workforce [2] and specifically the genetic counsellor [3] and clinical geneticist [4] roles.

Key Stakeholders' Experiences and Perceptions of Virtual Reality for Older Adults Living With Dementia: Systematic Review and Thematic Synthesis.

BACKGROUND: Technology is increasingly being used and evolving in the dementia care landscape. One such technology that has gained traction over the last decade is virtual reality (VR). VR is being applied in many areas of dementia care, including cognitive assessment and training, reminiscence therapy, music therapy, and other recreational VR applications. Despite the plethora of applications, they are often not shaped by the experiences and perceptions of older adults living with dementia. Currently, there is no qualitative evidence synthesis (QES) to explore this area. This review aimed to provide qualitative evidence supporting existing systematic reviews in this area. OBJECTIVE: The aim of this QES was to explore key stakeholders' experiences and perceptions of VR for older adults living with dementia. It aimed to explore the barriers and facilitators to VR use and provide recommendations for future design and implementation. METHODS: QES was used, which involved a systematic search of 6 databases to identify studies that qualitatively explored key stakeholders' experiences and perceptions of VR for older adults living with dementia. Thematic synthesis was used to integrate the findings of 14 studies (from 15 reports). The Critical Appraisal Skills Programme tool was used to assess the methodological quality of the included studies. The confidence placed in the review findings was assessed using the GRADE-CERQUAL (Confidence in the Evidence from Reviews of Qualitative research). RESULTS: A total of 15 reports from 14 studies were included in the review, consisting of a range of levels of VR immersion, stages of dementia, and care contexts. Three analytical themes were generated: stepping into virtuality, a virtual world, and returning to reality. The results indicate the importance of sensitively designing and introducing VR to this population, as older adults living with dementia often have no prior experience of using this technology. VR can be a positive experience for older adults living with dementia and can provide meaningful interactions, positive expressions, and long-term impacts on everyday functioning. However, it should be acknowledged that some negative associations must be accounted for before, during, and after use. CONCLUSIONS: This review highlights the positive implications as well as negative associations of VR use. It emphasizes the need for VR design and implementation driven by the needs and views of older adults living with dementia as well as with other key stakeholders. Future research needs to explore the vital role that older adults living with dementia can play in the design process and how they can be empowered to meaningfully design and use this technology.

Understanding the perspectives of recruiters is key to improving randomised controlled trial enrolment: a qualitative evidence synthesis.

BACKGROUND: Recruiting patients to randomised controlled trials (RCTs) is often reported to be challenging, and the evidence base for effective interventions that could be used by staff (recruiters) undertaking recruitment is lacking. Although the experiences and perspectives of recruiters have been widely reported, an evidence synthesis is required in order to inform the development of future interventions. This paper aims to address this by systematically searching and synthesising the evidence on recruiters' perspectives and experiences of recruiting patients into RCTs.  METHODS: A qualitative evidence synthesis (QES) following Thomas and Harden's approach to thematic synthesis was conducted. The Ovid MEDLINE, CINAHL, EMBASE, PsycInfo, Cochrane Central Register of Controlled Trials, ORRCA and Web of Science electronic databases were searched. Studies were sampled to ensure that the focus of the research was aligned with the phenomena of interest of the QES, their methodological relevance to the QES question, and to include variation across the clinical areas of the studies. The GRADE CERQual framework was used to assess confidence in the review findings. RESULTS: In total, 9316 studies were identified for screening, which resulted in 128 eligible papers. The application of the QES sampling strategy resulted in 30 papers being included in the final analysis. Five overlapping themes were identified which highlighted the complex manner in which recruiters experience RCT recruitment: (1) recruiting to RCTs in a clinical environment, (2) enthusiasm for the RCT, (3) making judgements about whether to approach a patient, (4) communication challenges, (5) interplay between recruiter and professional roles. CONCLUSIONS: This QES identified factors which contribute to the complexities that recruiters can face in day-to-day clinical settings, and the influence recruiters and non-recruiting healthcare professionals have on opportunities afforded to patients for RCT participation. It has reinforced the importance of considering the clinical setting in its entirety when planning future RCTs and indicated the need to better normalise and support research if it is to become part of day-to-day practice. TRIAL REGISTRATION: PROSPERO CRD42020141297 (registered 11/02/2020).

Priority III: top 10 rapid review methodology research priorities identified using a James Lind Alliance Priority Setting Partnership.

OBJECTIVES: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research. STUDY DESIGN AND SETTING: A modified James Lind Alliance Priority Setting Partnership approach was adopted. This approach used two online surveys and a virtual prioritization workshop with patients and the public, reviewers, researchers, clinicians, policymakers, and funders to identify and prioritize unanswered questions. RESULTS: Patients and the public, researchers, reviewers, clinicians, policymakers, and funders identified and prioritized the top 10 unanswered research questions about rapid review methodology. Priorities were identified throughout the entire review process, from stakeholder involvement and formulating the question, to the methods of a systematic review that are appropriate to use, through to the dissemination of results. CONCLUSION: The results of the Priority III study will inform the future research agenda on rapid review methodology. We hope this will enhance the quality of evidence produced by rapid reviews, which will ultimately inform decision-making in the context of healthcare.

The experiences and perceptions of young people and older people living with dementia of participating in intergenerational programmes: A qualitative evidence synthesis.

BACKGROUND: Intergenerational programmes are formal activities bringing different generations together and have been identified as a way to help people living with dementia to stay socially connected. While there is some evidence from individual studies as to their benefits, there is no overall coherent account as to the perceptions and experiences of participants who engage in such programmes. This review synthesises qualitative evidence of the experiences and perceptions of young people and older people living with dementia of participating in such programmes. METHODS: We searched EBSCO CINAHL, OVID Medline, Embase, Ovid PsycINFO, the Web of Science, Epistemonikos and grey literature sources. We used thematic synthesis to analyse and synthesise the evidence in to four themes, with 11 key findings. We assessed our confidence in each of these findings using the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach. FINDINGS: Our review highlights the potential enjoyment for young people and older people living with dementia when participating in Intergenerational programmes, despite some initial trepidation. These programmes provide an opportunity to establish and develop relationships and for young people to learn about dementia, ageing and how to interact with older people living with dementia. However, it is important to have staff facilitators present to provide reassurance to both groups. It is also important to take the personal preferences of participants into account and to be considerate of noise levels and other aspects of programme delivery that may inhibit engagement. CONCLUSION: This is the first qualitative evidence synthesis specifically exploring Intergenerational programmes aimed at older people living with dementia. We provide insights into the perspectives of those who have participated in Intergenerational programmes. It is important to consider these views, together with other evidence of effectiveness, when planning Intergenerational programmes. While our review is limited by a small number of studies from only a few countries, we have moderate to high confidence in our findings. Further research into the development of Intergenerational programmes specifically tailored for people living with dementia is needed. The findings also provide guidance for people planning to deliver or design future Intergenerational programmes.

Study protocol: navigating access to gender care in Ireland-a mixed-method study on the experiences of transgender and non-binary youth.

INTRODUCTION: There has been a global increase in demand for gender-specific healthcare services and a recognition that healthcare access is complex and convoluted, even in countries with well-developed healthcare services. Despite evidence in Ireland supporting the improvement in physical and mental health following access to gender care, little is known about the local healthcare navigation challenges. Internationally, research focuses primarily on the experience of service users and omits the perspective of other potential key stakeholders. Youth experiences are a particularly seldom-heard group. METHODS AND ANALYSIS: This study will use a sequential exploratory mixed-methods design with a participatory social justice approach. The qualitative phase will explore factors that help and hinder access to gender care for young people in Ireland. This will be explored from multiple stakeholders' perspectives, namely, young people, caregivers and specialist healthcare providers. Framework analysis will be used to identify priorities for action and the qualitative findings used to build a survey tool for the quantitative phase. The quantitative phase will then measure the burden of the identified factors on healthcare navigation across different age categories and gender identities (transmasculine vs transfeminine vs non-binary). ETHICS AND DISSEMINATION: This study has been approved by St Vincent's Hospital Research Ethics Committee (RS21-019), University College Dublin Ethics Committee (LS-21-14Kearns-OShea) and the Transgender Equality Network Ireland's Internal Ethics Committee (TIECSK). We aim to disseminate the findings through international conferences, peer-review journals and by utilisation of expert panel members and strategic partners.

A qualitative evidence synthesis of users' experience of mobile health applications in the self-management of type 2 diabetes.

AIM: The aim of this qualitative evidence synthesis was to identify and synthesise qualitative research relating to experiences of using mobile health (mHealth) applications to aid self-management of Type 2 Diabetes. METHODS: Using a systematic search strategy, 11 databases were searched (Medline, CINAHL, PsychInfo, PubMed, Web of Science, Embase, Cochrane Library, Scopus, ProQuest A&1, ProQuest UK & Ireland, Mednar). "Best fit" framework synthesis was used guided by the Health Information Technology Acceptance Model (HITAM). Assessment of methodological limitations was conducted using Critical Appraisal Skills Programme (CASP) and confidence in the review findings were guided by GRADE-CERQual. RESULTS: Fourteen eligible studies were included in the synthesis (7 qualitative and 5 mixed methods). Key themes identified under the health, information and technology zones of the HITAM revealed the benefits of mHealth apps, barriers to their use, their perceived usefulness and ease of use. DISCUSSION: Most people used the apps for feedback on their self-management and found them helpful in their communication with health care providers. Some embraced the technology and found it easy to use while others found mHealth apps to be counterintuitive.

Women's experiences and perceptions of anxiety and stress during the perinatal period: a systematic review and qualitative evidence synthesis.

BACKGROUND: The perinatal period, from pregnancy to the first year postpartum, is a transitional period that can result in anxiety and stress for some women. Perinatal anxiety and stress can adversely impact the physical and psychological health of women and children. Understanding women's lived experiences of perinatal anxiety and stress is essential to better support women. The aim of this qualitative evidence synthesis was to examine women's experiences and perceptions of, and barriers and facilitators to coping with, perinatal anxiety and stress. METHODS: Databases CINAHL, EMBASE, MEDLINE, PsycINFO and Maternity and Infant Care were searched from inception to June 2020. Eligible studies included women who were pregnant or up to one year postpartum and examined women's experiences of anxiety and/or stress during the perinatal period. Data were synthesised using thematic synthesis. RESULTS: Of 20,318 identified articles, 13 studies met inclusion criteria and were included in this review. Five key themes emerged: Social support, women's experiences of healthcare, social norms and expectations, factors that impact on coping and mother and baby's health. CONCLUSION: This review provided a comprehensive synthesis of perinatal anxiety and stress. Findings indicate that increased support for perinatal mental health in antenatal and postpartum care is needed. Addressing unrealistic expectations and conceptualisations of motherhood is also important to better support women. Enhancing women's social support networks and provision of clear and consistent information are also essential to support women and minimise stress and anxiety in the perinatal period.

What are the most important unanswered research questions on rapid review methodology? A James Lind Alliance research methodology Priority Setting Partnership: the Priority III study protocol.

Background: The value of rapid reviews in informing health care decisions is more evident since the onset of the coronavirus disease 2019 (COVID-19) pandemic. While systematic reviews can be completed rapidly, rapid reviews are usually a type of evidence synthesis in which components of the systematic review process may be simplified or omitted to produce information more efficiently within constraints of time, expertise, funding or any combination thereof. There is an absence of high-quality evidence underpinning some decisions about how we plan, do and share rapid reviews. We will conduct a modified James Lind Alliance Priority Setting Partnership to determine the top 10 unanswered research questions about how we plan, do and share rapid reviews in collaboration with patients, public, reviewers, researchers, clinicians, policymakers and funders. Methods: An international steering group consisting of key stakeholder perspectives (patients, the public, reviewers, researchers, clinicians, policymakers and funders) will facilitate broad reach, recruitment and participation across stakeholder groups. An initial online survey will identify stakeholders' perceptions of research uncertainties about how we plan, do and share rapid reviews. Responses will be categorised to generate a long list of questions. The list will be checked against systematic reviews published within the past three years to identify if the question is unanswered. A second online stakeholder survey will rank the long list in order of priority. Finally, a virtual consensus workshop of key stakeholders will agree on the top 10 unanswered questions. Discussion: Research prioritisation is an important means for minimising research waste and ensuring that research resources are targeted towards answering the most important questions. Identifying the top 10 rapid review methodology research priorities will help target research to improve how we plan, do and share rapid reviews and ultimately enhance the use of high-quality synthesised evidence to inform health care policy and practice.

Recruiters' perspectives and experiences of trial recruitment processes: a qualitative evidence synthesis protocol.

INTRODUCTION: Recruitment to randomised trials (RCTs) is often challenging. Reviews of interventions to improve recruitment have highlighted a paucity of effective interventions aimed at recruiters and the need for further research in this area. Understanding the perspectives and experiences of those involved in RCT recruitment can help to identify barriers and facilitators to recruitment, and subsequently inform future interventions to support recruitment. This protocol describes methods for a proposed qualitative evidence synthesis (QES) of recruiters' perspectives and experiences relating to RCT recruitment. METHODS AND ANALYSIS: The proposed review will synthesise studies reporting clinical and non-clinical recruiters' perspectives and experiences of recruiting to RCTs. The following databases will be searched: Ovid MEDLINE, CINAHL, EMBASE, PsycInfo, Cochrane Central Register of Controlled Trials, ORRCA and Web of Science. A thematic synthesis approach to analysing the data will be used. An assessment of methodological limitations of each study will be performed using the Critical Appraisal Skills Programme tool. Assessing the confidence in the review findings will be evaluated using the GRADE Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) tool. ETHICS AND DISSEMINATION: The proposed QES will not require ethical approval as it includes only published literature. The results of the synthesis will be published in a peer-reviewed journal and publicised using social media. The results will be considered alongside other work addressing factors affecting recruitment in order to inform future development and refinement of recruitment interventions. PROSPERO REGISTRATION NUMBER: CRD42020141297.

Factors Influencing Fidelity to a Calorie Posting Policy in Public Hospitals: A Mixed Methods Study.

Background: Labelling menus with nutrition information has increasingly become an important obesity policy option. While much research to-date has focused on determining its effectiveness, few studies report the extent to which menu labelling is implemented as designed. The aim of this study was to explore factors influencing fidelity to a calorie posting policy in Irish acute public hospitals. Methods: A mixed methods sequential explanatory study design was employed, with a nested case study for the qualitative component. Quantitative data on implementation fidelity at hospitals were analysed first and informed case sampling in the follow-on qualitative phase. Maximum variation sampling was used to select four hospitals with high and low levels of implementation and variation in terms of geographic location, hospital size, complexity of care provided and hospital type. Data were collected using structured observations, unstructured non-participant observations and in-depth semi-structured interviews. The Consolidated Framework for Implementation Research guided qualitative data collection and analysis. Using framework analysis, factors influencing implementation were identified. A triangulation protocol was used to integrate fidelity findings from multiple sources. Data on influencing factors and fidelity were then combined using joint displays for within and cross-case analysis. Results: Quantitative fidelity data showed seven hospitals were categorised as low implementers and 28 hospitals were high implementers of the policy. Across the four hospitals selected as cases, qualitative analysis revealed factors influencing implementation and fidelity were multiple, and operated independently and in combination. Factors were related to the internal hospital environment (e.g., leadership support, access to knowledge and information, perceived importance of calorie posting implementation), external hospital environment (e.g., national policy, monitoring), features of the calorie posting policy (e.g., availability of supporting materials), and the implementation process (e.g., engaging relevant stakeholders). Integrated analysis of fidelity indicated a pattern of partial adherence to the calorie posting policy across the four hospitals. Across all hospitals, there was a consistent pattern of low adherence to calorie posting across all menu items on sale, low adherence to calorie information displayed per standard portion or per meal, low adherence to standardised recipes/portions, and inaccurate calorie information. Conclusion: Efforts to maximise fidelity require multi-level, multi-component strategies in order to reduce or mitigate barriers and to leverage facilitators. Future research should examine the relative importance of calorie posting determinants and the association between implementation strategies and shifts in fidelity to intervention core components.

A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

Background: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. Methods: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. Conclusions: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable data.

A Qualitative Evidence Synthesis of Parental Experiences and Perceptions of Parent-Child Interaction Therapy for Preschool Children With Communication Difficulties.

Purpose Parent-child interaction therapy refers to a number of interventions mediated by trained parents to treat developmental difficulties, including speech, language, and communication. Understanding the experiences of parents who take part in parent-child interaction therapy is a key aspect of determining how this intervention can be implemented successfully. However, to date, there has been limited work on synthesizing parental views of this intervention. Method We used qualitative evidence synthesis that involved searching the literature for qualitative studies addressing the experiences and perceptions of parent-child interaction therapy for parents of preschool children with communication difficulties. We identified 27 studies (from 32 publications) and synthesized the data using thematic synthesis. We appraised the quality of included studies using Critical Appraisal Skills Programme (CASP) and assessed our confidence in the review findings using GRADE Confidence in the Evidence from Reviews of Qualitative research (CERQual). Results At the beginning of this intervention, parents may have competing demands and varied expectations about the intervention. Their engagement is facilitated when the intervention is tailored to their individual family, their preferences for learning, and when they have a trusting relationship with the clinician. At the end of the intervention, although most parents perceive an improvement in their child's communication and feel empowered to facilitate this, they have concerns about their child's future needs. Conclusions It is important that clinicians explore parents' readiness for this intervention by discussing their needs and preferences openly, and that they facilitate their engagement through a supportive relationship. They also need to consider how parents will transition out of the intervention and continue to support their child's language development. Supplemental Material https://doi.org/10.23641/asha.14978454.