Overarching Priorities for Health and Care Research in the United Kingdom: A Coproduced Synthesis of James Lind Alliance 'Top 10s'.

INTRODUCTION: James Lind Alliance (JLA) Priority Setting Partnerships (PSPs) produce 'Top 10' lists of health and care research priorities through a structured, shared decision-making process with patients or service users, carers and health or care professionals who identify questions that are most important to them. To date, over 150 PSPs in different areas of health and care have published research priorities. Some PSPs share similar priorities, which could be combined, promoted and addressed through collaborative research to increase value and reduce research waste. AIM: The aim of this study was to identify overarching themes common to JLA PSP priorities across different areas of health and care. METHODS: Our analysis included 'Top 10' research priorities produced by UK-based JLA PSPs between 2016 and 2020. The priorities were coded deductively by the Health Research Classification System (HRCS) health category and research activity. We then carried out online workshops with patients, service users and carers to generate new codes not already captured by this framework. Within each code, multistakeholder inductive thematic analysis was used to identify overarching themes, defined as encompassing priorities from three or more PSPs covering two or more health categories. We used codesign methods to produce an interactive tool for end users to navigate the overarching themes. RESULTS: Five hundred and fifteen research priorities from 51 PSPs were included in our analysis. The priorities together encompassed 20 of 21 HRCS health categories, the most common being 'generic health relevance' (22%), 'mental health' (18%) and 'musculoskeletal' (14%). We identified 89 overarching themes and subthemes, which we organised into a hierarchy with seven top-level themes: quality of life, caregivers and families, causes and prevention, screening and diagnosis, treatment and management, services and systems and social influences and impacts. CONCLUSION: There are many overarching themes common to research priorities across multiple areas of health and care. To facilitate new research and research funding, we have developed an interactive tool to help researchers, funders and patients or service users to explore these priority topics. This is freely available to download online. PATIENT OR PUBLIC CONTRIBUTION: Patients or service users and carers were involved throughout the study, including deciding the aims, designing the study, analysing priorities to identify themes, interpreting and reporting the findings.

Is it worth it? Patient and public views on the impact of their involvement in health research and its assessment: a UK-based qualitative interview study.

BACKGROUND: There are mounting calls for robust, critical evaluation of the impact of patient and public involvement (PPI) in health research. However, questions remain about how to assess its impact, and whether it should be assessed at all. The debate has thus far been dominated by professionals. OBJECTIVE: To explore the views of PPI contributors involved in health research regarding the impact of PPI on research, whether and how it should be assessed. DESIGN: Qualitative interview study. SETTING AND PARTICIPANTS: Thirty-eight PPI contributors involved in health research across the UK. RESULTS: Participants felt that PPI has a beneficial impact on health research. They described various impactful roles, which we conceptualize as the 'expert in lived experience', the 'creative outsider', the 'free challenger', the 'bridger', the 'motivator' and the 'passive presence'. Participants generally supported assessing the impact of PPI, while acknowledging the challenges and concerns about the appropriateness and feasibility of measurement. They expressed a range of views about what impacts should be assessed, by whom and how. Individual feedback on impact was seen as an important driver of improved impact and motivation to stay involved. CONCLUSIONS: While there appears to be widespread support for PPI impact assessment among PPI contributors, their views on what to assess and how are diverse. PPI contributors should be involved as equal partners in debates and decisions about these issues. Individual feedback on impact may increase PPI contributors' potential impact and their motivation to stay involved.

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

BACKGROUND: Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. OBJECTIVE: To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. DESIGN: A modified Delphi process including a two round online survey and a stakeholder consensus meeting. PARTICIPANTS: In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. RESULTS: Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. CONCLUSIONS: The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Inviting parents to take part in paediatric palliative care research: a mixed-methods examination of selection bias.

BACKGROUND: Recruitment to paediatric palliative care research is challenging, with high rates of non-invitation of eligible families by clinicians. The impact on sample characteristics is unknown. AIM: To investigate, using mixed methods, non-invitation of eligible families and ensuing selection bias in an interview study about parents' experiences of advance care planning (ACP). DESIGN: We examined differences between eligible families invited and not invited to participate by clinicians using (1) field notes of discussions with clinicians during the invitation phase and (2) anonymised information from the service's clinical database. SETTING: Families were eligible for the ACP study if their child was receiving care from a UK-based tertiary palliative care service (Group A; N = 519) or had died 6-10 months previously having received care from the service (Group B; N = 73). RESULTS: Rates of non-invitation to the ACP study were high. A total of 28 (5.4%) Group A families and 21 (28.8%) Group B families (p < 0.0005) were invited. Family-clinician relationship appeared to be a key factor associated qualitatively with invitation in both groups. In Group A, out-of-hours contact with family was statistically associated with invitation (adjusted odds ratio 5.46 (95% confidence interval 2.13-14.00); p < 0.0005). Qualitative findings also indicated that clinicians' perceptions of families' wellbeing, circumstances, characteristics, engagement with clinicians and anticipated reaction to invitation influenced invitation. CONCLUSION: We found evidence of selective invitation practices that could bias research findings. Non-invitation and selection bias should be considered, assessed and reported in palliative care studies.

Paediatric pneumonia or empyema and prior antibiotic use in primary care: a case-control study.

OBJECTIVES: To investigate the association between hospital presentation for paediatric pneumonia or empyema and prior antibiotic use for respiratory tract infection (RTI). METHODS: Case-control study of children aged 6 months to 16 years presenting to hospital with radiographic evidence of pneumonia or empyema and a history of general practitioner (GP) consultation for the index illness. Cases were recruited from seven hospitals in South Wales between October 2008 and December 2009. Controls were children from the same age group who were diagnosed with an uncomplicated RTI in general practice in the same area and at a similar time of year. Primary data were collected from carers by a self-complete questionnaire, with a subsample compared against general practice records. RESULTS: We recruited 89 eligible cases and 166 eligible controls. Cases were less likely than controls to have been prescribed antibiotics at the first GP consultation for the index illness [odds ratio (OR) 0.53; 95% confidence interval (95% CI) 0.31-0.90]. Stratified analyses revealed that this association was limited to children who consulted a GP <3 days after illness onset (OR 0.23; 95% CI 0.10-0.50). Cases were also less likely to have taken antibiotics before the date of index hospital presentation, but this finding was not statistically significant after adjustment for confounding factors (adjusted OR 0.84; 95% CI 0.47-1.49). CONCLUSIONS: Antibiotics prescribed at the first GP consultation for an RTI may protect against subsequent hospital presentation for pneumonia or empyema in some children. Given the strong rationale against unnecessary antibiotic prescribing, further research is needed to identify which children are most likely to benefit from early antibiotic treatment.

Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study.

BACKGROUND: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. METHODS: A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society's (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. RESULTS: The BESS surgeons' survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. CONCLUSIONS: Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

Patch augmentation surgery for rotator cuff repair: the PARCS mixed-methods feasibility study.

BACKGROUND: A rotator cuff tear is a common, disabling shoulder problem. Symptoms may include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a need to improve the outcome of rotator cuff surgery, and the use of patch augmentation (on-lay or bridging) to provide support to the healing process and improve patient outcomes holds promise. Patches have been made using different materials (e.g. human/animal skin or tissue and synthetic materials) and processes (e.g. woven or mesh). OBJECTIVES: The aim of the Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study was to determine the design of a definitive randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. DESIGN: A mixed-methods feasibility study of a randomised controlled trial. DATA SOURCES: MEDLINE, EMBASE and the Cochrane Library databases were searched between April 2006 and August 2018. METHODS: The project involved six stages: a systematic review of clinical evidence, a survey of the British Elbow and Shoulder Society's surgical membership, a survey of surgeon triallists, focus groups and interviews with stakeholders, a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The various stakeholders (including patients, surgeons and industry representatives) were involved in stages 2-6. RESULTS: The systematic review comprised 52 studies; only 15 were comparative and, of these, 11 were observational (search conducted in August 2018). These studies were typically small (median number of participants 26, range 5-152 participants). There was some evidence to support the use of patches, although most comparative studies were at a serious risk of bias. Little to no published clinical evidence was available for a number of patches in clinical use. The membership survey of British Elbow and Shoulder surgeons [105 (21%) responses received] identified a variety of patches in use. Twenty-four surgeons (77%) completed the triallist survey relating to trial design. Four focus groups were conducted, involving 24 stakeholders. Differing views were held on a number of aspects of trial design, including the appropriate patient population (e.g. patient age) to participate. Agreement on the key research questions and the outline of two potential randomised controlled trials were achieved through the Delphi study [29 (67%)] and the consensus meeting that 22 participants attended. LIMITATIONS: The main limitation was that the findings were influenced by the participants, who are not necessarily representative of the views of the relevant stakeholder groups. CONCLUSION: The need for further clinical studies was clear, particularly given the range and number of different patches available. FUTURE WORK: Randomised comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study. STUDY REGISTRATION: The systematic review is registered as PROSPERO CRD42017057908. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 13. See the NIHR Journals Library website for further project information.

Shoulder muscles and tendons allow us to move our arms to carry out daily activities, work and play sports. Disease and injury of these tendons can cause significant long-term disability. Early treatment of these tendon problems usually involves painkillers, injections and physiotherapy. However, many patients whose symptoms do not improve may need surgery to repair these tendons. Unfortunately, around 40% of surgical tendon repairs fail within 12 months. As such, these operations need to be improved. A promising approach is to use a patch to support the repair while the tendon heals; this patch is often used in a similar way to a plaster. However, it is not yet clear whether or not using a patch improves patient health and, if so, whether or not it makes enough of a difference to justify the additional cost to the NHS. A scientific study called a randomised controlled trial is needed to fairly assess the value of surgery with a patch in people requiring a tendon repair. This study must be carefully designed so that it is acceptable to patients and surgeons, among others, and feasible to run. We conducted a multistage study to explore whether or not a potential trial design could be achieved. We searched the scientific literature for previous research that had studied using patches for repairing shoulder tendons. We surveyed shoulder surgeons, including those who had previously been involved shoulder randomised controlled trials. We conducted four focus groups with stakeholders. Initial agreement on the best way to run a randomised controlled trial of patches in shoulder surgery was achieved using online questionnaires. Finally, we held a 2-day meeting to scrutinise the study findings and the relevant issues. Two potential studies were recommended, as was the need for closer monitoring of patch safety.

What happens after James Lind Alliance Priority Setting Partnerships? A qualitative study of contexts, processes and impacts.

BACKGROUND: The James Lind Alliance (JLA) supports priority setting partnerships (PSPs) in which patients, carers and health professionals collaborate to identify a Top 10 list of research priorities. Few studies have examined how partnerships plan for the post-prioritisation phase, or how context and post-PSP processes influence the fortunes of priorities. This evaluation aimed to explore these questions. METHODS: We selected a diverse sample of 20 interviewees who had knowledge of 25 PSPs. Thirteen interviewees had led a PSP, either from a university, patient organisation or charity. Three were patients who had taken part in a PSP workshop. Four others, three researchers and one funder, had worked with JLA PSP priorities to develop research proposals. We analysed the data thematically, exploring how success was understood and achieved. RESULTS: The JLA PSPs had different histories, funding sources, goals and stakeholders. Whilst their focus was on generating priority research topics, PSPs' wider impacts included enhanced status and greater confidence for individuals, as well as relationship-building and network strengthening for the organisations involved. To follow through on a Top 10, additional work was needed to refine broad priority topics into research questions and match them with appropriate funding sources. Commitment to post-PSP action from partners appeared to increase the chance that priority topics would be followed through to funded studies. Academic publications could alert researchers to a PSP's outputs, but not all PSPs had the capacity to produce them. A Top 10 list potentially influences funding decisions through direct funding, themed calls or as a prompt in open calls. Influence on funders appears to depend on alignment between a priority and the funder's remit, culture and values. CONCLUSION: The history and context of a JLA PSP have a major influence on its impact. Our findings suggest that there is no universal formula for success, but that greater resource and attention should be given to what happens after prioritisation. Further research is needed on what works best in what circumstances. Overall, we conclude that a wider cultural change in the research world is needed for JLA PSPs to achieve their goal of shaping the research agenda.

Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences.

BACKGROUND AND AIMS: Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We aimed to identify and describe current PPI practice in surgical trials in the United Kingdom, and to explore the views and experiences of surgical trial staff and patient or public contributors in relation to these practices. This was part of a larger study to inform development of a robust PPI intervention aimed at improving recruitment and retention in surgical trials. METHODS: Our study had two stages: 1) an online survey to identify current PPI practice in active UK-led, adult surgical trials; and 2) focus groups and interviews with key stakeholders (surgical trial investigators, administrators, and patient or public contributors) to explore their views and experiences of PPI. RESULTS: Of 129 eligible surgical trial teams identified, 71 (55%) took part in the survey. In addition, 54 stakeholders subsequently took part in focus groups or interviews. Sixty-five (92%) survey respondents reported some kind of PPI, most commonly at the design and dissemination stages and in oversight or advisory roles. The single most common PPI activity was developing participant information sheets (72%). Participants reported mixed practice and views on a variety of issues including the involvement of patients versus lay members of the public, recruitment methods, use of role descriptions and payment for the time of PPI contributors. They suggested some solutions, including the use of written role descriptions and databases of potential PPI contributors to aid recruitment. CONCLUSIONS: UK surgical trials involve patients and members of the public in a variety of different ways, most commonly at the beginning and end of the trial lifecycle and in oversight or advisory roles. These are not without challenges and there remain uncertainties about who best to involve, why, and how. Future research should aim to address these issues.

Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis.

OBJECTIVE: To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries. ELIGIBILITY CRITERIA: Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement). DATA EXTRACTION AND ANALYSIS: Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses. RESULTS: 26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14 v 1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis). CONCLUSIONS: These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016043808.

Patch-augmented rotator cuff surgery (PARCS) study-protocol for a feasibility study.

BACKGROUND: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery and the use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Patches have been made using different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh). However, clinical evidence on their use is limited. The aim of the patch-augmented rotator cuff surgery (PARCS) feasibility study is to determine, using a mixed method approach, the design of a definitive randomised trial assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. METHODS: The objectives of this six-stage mixed methods feasibility study are to determine current practice, evidence and views about patch use; achieve consensus on the design of a randomised trial to evaluate patch-augmented rotator cuff surgery; and assess the acceptability and feasibility of the proposed design. The six stages will involve a systematic review of clinical evidence, two surveys of surgeons, focus groups and interviews with stakeholders, a Delphi study and a consensus meeting. The various stakeholders (including patients, surgeons, and representatives from industry, the NHS and regulatory bodies) will be involved across the six stages. DISCUSSION: The PARCS feasibility study will inform the feasibility and acceptability of a randomised trial of the effectiveness and cost-effectiveness of a patch-augmented rotator cuff surgery. Consensus opinion on the basic design of a randomised trial will be sought. TRIAL REGISTRATION: Not applicable.

Why some children hospitalized for pneumonia do not consult with a general practitioner before the day of hospitalization.

BACKGROUND: Early consultation in primary care may provide an opportunity for early intervention in children developing pneumonia, but little is known about why some children do not consult a general practitioner (GP) before hospitalization. OBJECTIVES: To identify differences between children who consulted a GP and children who did not consult a GP before the day of hospital presentation with pneumonia or empyema. METHODS: Carers of children aged six months to 16 years presenting to hospital with pneumonia or empyema completed a questionnaire, with a subset participating in an interview to identify physical, organizational and psychological barriers to consultation. Responses from those who had consulted a GP before the day of hospital presentation were compared with those who had not on a range of medical, social and environmental variables. RESULTS: Fifty seven (38%) of 151 participants had not consulted a GP before the day of hospital presentation. On multivariate analysis, illness duration ≥ 3 days (odds ratio [OR] 4.36, 95% confidence interval [CI]: 1.67-11.39), prior antibiotic use (OR: 10.35, 95% CI: 2.16-49.55) and home ownership (OR: 3.17, 95% CI: 1.07-9.37) were significantly associated with early GP consultation (P < 0.05). Interviews with 28 carers whose children had not seen a GP before the day of presentation revealed that most had not considered it and/or did not think their child's initial symptoms were serious or unusual; 11 (39.3%) had considered consulting a GP but reported barriers to access. CONCLUSION: Lack of early GP consultation was strongly associated with rapid evolution of pneumonia.

Carers' perspectives on the presentation of community-acquired pneumonia and empyema in children: a case series.

OBJECTIVE: To describe carers' perceptions of the development and presentation of community-acquired pneumonia or empyema in their children. DESIGN: Case series. SETTING: Seven hospitals with paediatric inpatient units in South Wales, UK. PARTICIPANTS: Carers of 79 children aged 6 months to 16 years assessed in hospital between October 2008 and September 2009 with radiographic, community-acquired pneumonia or empyema. METHODS: Carers were recruited in hospital and participated in a structured face-to-face or telephone interview about the history and presenting features of their children's illnesses. Responses to open questions were initially coded very finely and then grouped into common themes. Cases were classified into two age groups: 3 or more years and under 3 years. RESULTS: The reported median duration of illness from onset until the index hospital presentation was 4 days (IQR 2-9 days). Pain in the torso was reported in 84% of cases aged 3 or more years and was the most common cause for carer concern in this age group. According to carer accounts, clinicians sometimes misjudged the origin of this pain. Almost all carers reported something unusual about the index illness that had particularly concerned them-mostly non-specific physical symptoms and behavioural changes. CONCLUSIONS: Pain in the torso and carer concerns about unusual symptoms in their child may provide valuable additional information in a clinician's assessment of the risk of pneumonia in primary care. Further research is needed to confirm the diagnostic value of these features.

Missed opportunities for earlier treatment? A qualitative interview study with parents of children admitted to hospital with serious respiratory tract infections.

OBJECTIVE: To identify potential opportunities for earlier intervention among children who develop a complicated respiratory tract infection (RTI). DESIGN: Qualitative, face-to-face, individual interview study, either in hospital or at home, with parents of children admitted to hospital with a complicated RTI. SETTING: Participants were recruited from a large UK teaching hospital, and described events (largely) prior to hospital admission. PARTICIPANTS: Parents of 22 children (12 with empyema, 8 with pneumonia, 1 with peritonsillar abscess and 1 with mastoiditis). RESULTS: Parents' accounts revealed missed opportunities for timely treatment resulting from parental and health service associated factors. Themes relating to parental factors included problems assessing the severity of the illness (5 parents), beliefs about accessing health services (10 parents; including fear of appearing 'neurotic', belief that their concerns would not be taken seriously, and belief that their child would not be prescribed antibiotics or would be prescribed antibiotics too readily) and feeling powerless to challenge clinical authority (7 parents). Health service associated factors included perceived problems accessing healthcare services (13 parents; including inadequate primary care triage, barriers to accessing timely consultations and past experience of problems accessing healthcare leading to failure to consult) and perceived poor quality clinical encounters (11 parents; including inadequate assessment and communication). CONCLUSION: Addressing, where appropriate, these parental (skills, fears and beliefs) and health service (access and consultation quality) associated factors may lead to more prompt care for seriously ill children.