Consultations about randomised controlled trials are shorter and less in-depth for socioeconomically disadvantaged patients compared to socioeconomically advantaged patients: qualitative analysis across three trials.

BACKGROUND: Patients from socioeconomically disadvantaged backgrounds are underserved in randomised controlled trials, yet they experience a much greater burden of disease compared with patients from socioeconomically advantaged areas. It is crucial to make trials more inclusive to ensure that treatments and interventions are safe and effective in real-world contexts. Improving how information about trials is verbally communicated is an unexplored strategy to make trials more inclusive. This study examined how trials are communicated verbally, comparing consultations involving patients from the most and least socioeconomically disadvantaged areas. METHODS: Secondary qualitative analysis of 55 trial consultation transcripts from 41 patients, sampled from 3 qualitative studies embedded in their respective UK multi-site, cancer-related randomised controlled trials. Patients living in the most and least socioeconomically disadvantaged areas, defined using English Indices of Multiple Deprivation decile scores, were purposively sampled. Analysis was largely thematic and drew on the constant comparison method. RESULTS: Recruiters communicated clinical uncertainty in a similar way for patients living in different socioeconomic areas. Consultations with disadvantaged patients were, on average, half the duration of those with advantaged patients, and tended to involve recruiters providing less in-depth explanations of trial concepts, used phrasing that softened trial arm risks, and described trial processes (e.g. randomisation) using informal or metaphorical phrasing. Disadvantaged and advantaged patients differed in the concerns they expressed; disadvantaged patients voiced fewer concerns and asked fewer questions but were also less likely to be invited to do so by recruiters. CONCLUSION: Interactions about trials unfolded in different ways between patients living in different socioeconomic areas, likely due to both patient- and recruiter-related factors. We present considerations for recruiters when discussing trials with patients from socioeconomically disadvantaged backgrounds, aimed at enhancing trial communication. Future research should examine disadvantaged patients' and recruiters' experiences of verbal trial communication to inform guidance that addresses the needs and preferences of underserved groups.

Development of a head and neck lymphoedema specific quality of life tool: The Comprehensive Assessment of Lymphoedema Impact in the Head and Neck.

PURPOSE: To develop a head and neck lymphoedema (HNL) specific quality of life (QoL) instrument to assess physical, functional, and social/emotional impacts of HNL. METHODS: Instrument candidate items were reviewed by patients with HNL and clinicians and rated for importance, clarity, and invasiveness. The Content Validity Ratio was applied for item reduction. Three-step cognitive interviews were conducted with HNL patients to validate the items, survey format, and instructions. RESULTS: Initially, 130 candidate questions were developed. Following item reduction, 52 items progressed to three-step cognitive interviews. Following cognitive interviews, the Comprehensive Assessment of Lymphoedema Impact in Head and Neck (CALI-HaN) included 33 items; 1 global, 10 physical, 7 functional, and 15 emotional. CONCLUSIONS: Physical, functional, and socioemotional effects need to be considered when measuring QoL in patients with HNL. This study describes initial development of the CALI-HaN, an instrument that shows promise for clinical and research applications following future validation.

Assessment of Measures of Head and Neck Lymphedema Following Head and Neck Cancer Treatment: A Systematic Review.

Purpose: Head and neck lymphedema is a common condition following head and neck cancer (HNC) treatment, with substantial functional morbidity. This systematic review aimed to (1) identify tools used to assess head and neck lymphedema in HNC patients and (2) determine their validity and reliability. Methods: Electronic and hand searches of Prospero, MEDLINE, Cochrane Library, and Embase were searched from their inception until April 2021, and hand searches were independently screened by two reviewers. Studies were included if they were available in English and measured lymphedema in adult HNC patients (aged ≥18 years). Data including psychometric characteristics were extracted and synthesized narratively, with the Quality Assessment of Diagnostic Accuracy Studies-2 and the COnsensus-based Standards for the selection of health Measurement INstruments checklists used to assess risk of bias. Results: Thirty-three studies, reporting 38 assessment tools, were included. Assessments included clinician rating scales, symptom inventories, size measures, measures of internal edema, radiographic and ultrasonographic measures, and quality-of-life measures. Of the 38 measures cited, only 11 had any degree of validation and reliability testing. Risk of bias varied among the different assessment tools. Conclusion: While many tools are used in the assessment of head and neck lymphedema, the majority of these tools lack validation and reliability data. Only one tool, the Head and Neck Lymphedema and Fibrosis Symptom Inventory, met criteria for strong quality assessment. Further efforts to establish a core set of metrics for this complex condition are warranted.

Assessing the effectiveness of social network interventions for adults with a diagnosis of mental health problems: a systematic review and narrative synthesis of impact.

BACKGROUND: Social connections have been linked to the genesis and amelioration of mental health problems and thus have potential therapeutic value. PURPOSE: To identify the current evidence base, assess risk of bias and synthesise findings on the effectiveness of social network interventions for people with mental health problems. METHODS: Electronic databases (MEDLINE, Embase, PsycINFO, CINAHL, Cochrane Library, Web of Science, Scopus) and grey literature databases were systematically searched from inception to October 2021 using free text syntax combining synonyms for 'mental health problems' and 'social network interventions'. Articles were eligible for inclusion if they reported data from randomised controlled trials on the effectiveness of interventions designed to improve social networks for adults (18+) with mental health problems. Papers were independently reviewed for inclusion with conflicts resolved through consensus. Included papers were quality assessed and data extracted and synthesized narratively. Risk of bias was assessed using the Cochrane Risk of Bias Tool. RESULTS: Nine studies randomising 2226 participants were included. Four focused on those with a diagnosis of schizophrenia or psychosis, one on major depressive disorder and four included all types of mental health diagnoses. The current evidence base is of unclear quality. However, interventions which focused on supporting social activities appear to hold the most promise for enhancing social networks. Data on cost-effectiveness and research acceptability were limited, but suggest the potential economic feasibility of and acceptability for evaluating these interventions. CONCLUSION: There is emerging evidence that social network interventions can be effective in improving social connections for people with mental health problems. However, further evaluations with robust methodological approaches are required to inform evidence-based recommendations for health services.

Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT.

BACKGROUND: Although non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, randomised trial data comparing important outcomes of non-operative treatment with those of appendicectomy are lacking. OBJECTIVES: The objectives were to ascertain the feasibility of conducting a multicentre randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of a non-operative treatment pathway with appendicectomy for the treatment of uncomplicated acute appendicitis in children. DESIGN: This was a mixed-methods study, which included a feasibility randomised controlled trial, embedded and parallel qualitative and survey studies, a parallel health economic feasibility study and the development of a core outcome set. SETTING: This study was set in three specialist NHS paediatric surgical units in England. PARTICIPANTS: Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility randomised controlled trial. Children, their families, recruiting clinicians and other health-care professionals involved in caring for children with appendicitis took part in the qualitative study. UK specialist paediatric surgeons took part in the survey. Specialist paediatric surgeons, adult general surgeons who treat children, and children and young people who previously had appendicitis, along with their families, took part in the development of the core outcome set. INTERVENTIONS: Participants in the feasibility randomised controlled trial were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of eligible patients recruited to the feasibility trial. DATA SOURCES: Data were sourced from NHS case notes, questionnaire responses, transcribed audio-recordings of recruitment discussions and qualitative interviews. RESULTS: Overall, 50% (95% confidence interval 40% to 59%) of 115 eligible patients approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow-up rates of 89%, 85% and 85% at 6 weeks, 3 months and 6 months, respectively). More participants had perforated appendicitis than had been anticipated. Qualitative work enabled us to communicate about the trial effectively with patients and families, to design and deliver bespoke training to optimise recruitment and to understand how to optimise the design and delivery of a future trial. The health economic study indicated that the main cost drivers are the ward stay cost and the cost of the operation; it has also informed quality-of-life assessment methods for future work. A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes. There is adequate surgeon interest to justify proceeding to an effectiveness trial, with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol. LIMITATIONS: Because the feasibility randomised controlled trial was performed in only three centres, successful recruitment across a larger number of sites cannot be guaranteed. However, the qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have changed over time. CONCLUSIONS: A future effectiveness trial is feasible, following limited additional preparation, to establish appropriate outcome measures and case identification. It is recommended to include a limited package of qualitative work to optimise recruitment, in particular at new centres. FUTURE WORK: Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15830435. 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. 10. See the NIHR Journals Library website for further project information.

Appendicitis is usually treated with an operation to remove the appendix. But we have learned, from other research, that some children with appendicitis may not need an operation, and could be treated with antibiotics instead. To find out how these two different treatments compare with one another, we need to do a big study. First, though, we need to see if doing that kind of study would even be possible (or 'feasible'). We carried out a feasibility study that had several parts. First, we did a small study with children who had appendicitis, whereby children were randomly allocated to have either antibiotics or an operation, with an equal chance of having either treatment. Second, we asked parents and health-care staff about why they wanted, or did not want, to take part in that small study. This helped us to understand how to make a bigger future study as acceptable as possible to children, families and surgeons. Third, we asked parents, patients and surgeons what they think are the most important things ­ or 'outcomes' ­ we should look at in future research on children who have appendicitis. From that, we developed a list of outcomes that should be included in our future big study, so we can be certain that the research we do is likely to help parents and surgeons. Overall, we established that a future big study is feasible and we have plenty of information to help us with how to plan it best, so that it has the greatest possible chance of success. We were also guided in all of these steps of the research by a group of parents, children and young people, some of whom had appendicitis and some of whom did not.

Heterogeneity in outcome assessment for inflammatory bowel disease in routine clinical practice: a mixed-methods study in a sample of English hospitals.

OBJECTIVES: Knowledge of the extent of variation in outcome assessment for inflammatory bowel disease (IBD) in routine practice is limited. We aimed to describe and quantify variation in outcome coverage and to explore patient, clinician and practitioner factors associated with it. DESIGN: Prospective exploratory mixed-methods study. SETTING: IBD clinics at six hospitals in North West England with differing electronic health record (EHR) systems. METHODS: Mixed-methods study comprising: (a) structured observations of outcomes elicited during consultations (102 patients consulting 24 clinicians); (b) retrospective analysis of outcomes recorded in the EHR (909 consultations; 127 clinicians) and (c) semistructured interviews with the 24 observed clinicians. We determined whether specific outcome 'sets' were elicited or recorded, including: (1) a minimum set of symptom pairs ('PRO-2'); (2) symptom sets from disease activity indices and (3) a reference list of 37 symptoms, signs and impacts. Factors associated with variation were explored in univariate and multivariate binary logistic regression analyses and from clinician interviews. RESULTS: PRO-2 coverage was not invariable (elicited during 81% of observed consultations; recorded in 56% of EHR) and infrequent for complete activity indices (all domains from Harvey-Bradshaw Index: elicited, 18%; recorded, 5%). The median number of outcomes from the reference list elicited per consultation was 12 (13-fold variation) and recorded in EHR was 7 (>20-fold variation). Symptom quantification (PRO-2) seldom adhered closely to standardised descriptors and an explicit timeframe was defined rarely. PRO-2 recording in EHR was associated with a diagnosis of ulcerative colitis (OR: 2.09 (95% CI 1.15 to 3.80)) and nurse-led consultations (OR: 6.98 (95% CI 3.28 to 14.83)) and a three-way model suggested 26% of total variability lay between clinicians, 17% between patients but the remainder was unexplained. Most clinicians expressed preference for individualised health status evaluations versus standardised outcome assessments. CONCLUSIONS: There was little evidence for standardised assessment and recording of IBD outcomes and substantial intra-clinician and inter-clinician variation from one consultation to another. Nurses demonstrated a greater tendency to standardised practice.

Different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis: the SIRJIA mixed-methods feasibility study.

BACKGROUND: In the UK, juvenile idiopathic arthritis is the most common inflammatory disorder in childhood, affecting 10 : 100,000 children and young people aged < 16 years each year, with a population prevalence of around 1 : 1000. Corticosteroids are commonly used to treat juvenile idiopathic arthritis; however, there is currently a lack of consensus as to which corticosteroid induction regimen should be used with various disease subtypes and severities of juvenile idiopathic arthritis. OBJECTIVE: The main study objective was to determine the feasibility of conducting a randomised controlled trial to compare the different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis. DESIGN: This was a mixed-methods study. Work packages included a literature review; qualitative interviews with children and young people with juvenile idiopathic arthritis and their families; a questionnaire survey and screening log to establish current UK practice; a consensus meeting with health-care professionals, children and young people with juvenile idiopathic arthritis, and their families to establish the primary outcome; a feasibility study to pilot data capture and to collect data for future sample size calculations; and a final consensus meeting to establish the final protocol. SETTING: The setting was rheumatology clinics across the UK. PARTICIPANTS: Children, young people and their families who attended clinics and health-care professionals took part in this mixed-methods study. INTERVENTIONS: This study observed methods of prescribing corticosteroids across the UK. MAIN OUTCOME MEASURES: The main study outcomes were the acceptability of a future trial for children, young people, their families and health-care professionals, and the feasibility of delivering such a trial. RESULTS: Qualitative interviews identified differences in the views of children, young people and their families on a randomised controlled trial and potential barriers to recruitment. A total of 297 participants were screened from 13 centres in just less than 6 months. In practice, all routes of corticosteroid administration were used, and in all subtypes of juvenile idiopathic arthritis. Intra-articular corticosteroid injection was the most common treatment. The questionnaire surveys showed the varying clinical practice across the UK, but established intra-articular corticosteroids as the treatment control for a future trial. The primary outcome of choice for children, young people, their families and health-care professionals was the Juvenile Arthritis Disease Activity Score, 71-joint count. However, results from the feasibility study showed that, owing to missing blood test data, the clinical Juvenile Arthritis Disease Activity Score should be used. The Juvenile Arthritis Disease Activity Score, 71-joint count, and the clinical Juvenile Arthritis Disease Activity Score are composite disease activity scoring systems for juvenile arthritis. Two final trial protocols were established for a future randomised controlled trial. LIMITATIONS: Fewer clinics were included in this feasibility study than originally planned, limiting the ability to draw strong conclusions about these units to take part in future research. CONCLUSIONS: A definitive randomised controlled trial is likely to be feasible based on the findings from this study; however, important recommendations should be taken into account when planning such a trial. FUTURE WORK: This mixed-methods study has laid down the foundations to develop the evidence base in this area and conducting a randomised control trial to compare different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis is likely to be feasible. STUDY REGISTRATION: Current Controlled Trials ISRCTN16649996. 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. 24, No. 36. See the NIHR Journals Library website for further project information.

ABOUT JUVENILE IDIOPATHIC ARTHRITIS: Juvenile idiopathic arthritis refers to a group of conditions that cause inflammation and damage of the joints, starting in children and young people aged < 16 years. Treatments include anti-inflammatory medicines, disease-modifying/biologic medicines and corticosteroids. Young people often require corticosteroids at the start of their treatment, or in a flare with worsening inflammation, to get their juvenile idiopathic arthritis under control. A short course of corticosteroids can help and can be given by injection into the joint, through a drip into a vein, by injection into the muscle or in the form of tablets or liquid to be taken orally. Although they have been used for decades, there is no research to show the best way(s) of giving corticosteroids. STUDY AIMS: The study aimed to (1) agree on what corticosteroid treatments to compare in a treatment trial and the best way to measure changes in juvenile idiopathic arthritis to evaluate a quick-acting treatment and (2) find out if there are enough young people with active juvenile idiopathic arthritis in the UK to be included in such a study. METHODS: Published research on corticosteroids in juvenile idiopathic arthritis was reviewed. Health-care professionals were asked how they choose which corticosteroids to use and which method of administration to use. Interviews were carried out with children and young people and their families to (1) consider the design of a study comparing corticosteroid routes, (2) identify outcomes important to them and (3) determine whether or not they would be willing to take part in a future study. A 3-month feasibility study was carried out to collect details of children and young people with active juvenile idiopathic arthritis before and after corticosteroid treatment to measure improvements in juvenile idiopathic arthritis activity, and to see whether or not a larger study would be possible. FINDINGS: This study showed that corticosteroids are used in different ways across the UK. The views of children, young people and their families must be taken into account when designing a future study. This study calculated the number of young people who would be needed to take part in the future, showing that it would be possible to do a larger study that compared different corticosteroid treatments, which would help everyone to understand the best way to use corticosteroids.

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence.

BACKGROUND: Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT. METHODS: We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool. RESULTS: We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention. CONCLUSIONS: Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention. REVIEW REGISTRATION: PROSPERO CRD42018098994.

Overcoming Barriers to Mobilizing Collective Intelligence in Research: Qualitative Study of Researchers With Experience of Collective Intelligence.

BACKGROUND: Innovative ways of planning and conducting research have emerged recently, based on the concept of collective intelligence. Collective intelligence is defined as shared intelligence emerging when people are mobilized within or outside an organization to work on a specific task that could result in more innovative outcomes than those when individuals work alone. Crowdsourcing is defined as "the act of taking a job traditionally performed by a designated agent and outsourcing it to an undefined, generally large group of people in the form of an open call." OBJECTIVE: This qualitative study aimed to identify the barriers to mobilizing collective intelligence and ways to overcome these barriers and provide good practice advice for planning and conducting collective intelligence projects across different research disciplines. METHODS: We conducted a multinational online open-ended question survey and semistructured audio-recorded interviews with a purposive sample of researchers who had experience in running collective intelligence projects. The questionnaires had an interactive component, enabling respondents to rate and comment on the advice of their fellow respondents. Data were analyzed thematically, drawing on the framework method. RESULTS: A total of 82 respondents from various research fields participated in the survey (n=65) or interview (n=17). The main barriers identified were the lack of evidence-based guidelines for implementing collective intelligence, complexity in recruiting and engaging the community, and difficulties in disseminating the results of collective intelligence projects. We drew on respondents' experience to provide tips and good practice advice for governance, planning, and conducting collective intelligence projects. Respondents particularly suggested establishing a diverse coordination team to plan and manage collective intelligence projects and setting up common rules of governance for participants in projects. In project planning, respondents provided advice on identifying research problems that could be answered by collective intelligence and identifying communities of participants. They shared tips on preparing the task and interface and organizing communication activities to recruit and engage participants. CONCLUSIONS: Mobilizing collective intelligence through crowdsourcing is an innovative method to increase research efficiency, although there are several barriers to its implementation. We present good practice advice from researchers with experience of collective intelligence across different disciplines to overcome barriers to mobilizing collective intelligence.

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

BACKGROUND: Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. METHODS/DESIGN: The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery. DISCUSSION: In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design. TRIAL REGISTRATION: ISRCTN15830435 . Registered on 8 February 2017.

GPs' experiences of children with anxiety disorders in primary care: a qualitative study.

BACKGROUND: Anxiety disorders have a median age of onset of 11 years and are the most common emotional disorders in childhood; however, a significant proportion of those affected do not access professional support. In the UK, GPs are often the first medical professional that families see so are in a prime position to support children with anxiety disorders; however, currently there is little research available on GPs' perspectives on and experiences of supporting children with these disorders. AIM: To explore the experiences of GPs in relation to identification, management, and access to specialist services for children (<12 years) with anxiety disorders. DESIGN AND SETTING: Twenty semi-structured interviews were conducted with GPs in primary care throughout England. METHOD: GPs reflected a diverse group in relation to the ethnic and socioeconomic profile of registered patients, GP age, sex, professional status, previous engagement with research, and practice size and location. Purposive sampling was used to recruit GPs until theoretical saturation was reached. Data were analysed using a constant comparative method of thematic analysis. RESULTS: Data from 20 semi-structured interviews were organised into three themes: decision making, responsibility, and emotional response, with an overarching theme of GPs feeling ill equipped. These themes were retrospectively analysed to illustrate their role at different stages in the primary care process (identification, management, and access to specialist services). CONCLUSION: GPs feel ill equipped to manage and support childhood anxiety disorders, demonstrating a need for medical training to include greater emphasis on children's mental health, as well as potential for greater collaboration between primary and specialist services.

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial.

BACKGROUND: Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants. METHODS: This is a cluster trial, embedded within a host trial ('EQUIP') recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation. RESULTS: Thirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes. CONCLUSION: To our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research. TRIAL REGISTRATION NUMBERS: ISRCTN, ISRCTN16488358 . Registered on 14 May 2014. Study Within A Trial, SWAT-26 . Registered on 21 January 2016.

The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial.

BACKGROUND: Atypical meningiomas are an intermediate grade brain tumour with a recurrence rate of 39-58 %. It is not known whether early adjuvant radiotherapy reduces the risk of tumour recurrence and whether the potential side-effects are justified. An alternative management strategy is to perform active monitoring with magnetic resonance imaging (MRI) and to treat at recurrence. There are no randomised controlled trials comparing these two approaches. METHODS/DESIGN: A total of 190 patients will be recruited from neurosurgical/neuro-oncology centres across the United Kingdom, Ireland and mainland Europe. Adult patients undergoing gross total resection of intracranial atypical meningioma are eligible. Patients with multiple meningioma, optic nerve sheath meningioma, previous intracranial tumour, previous cranial radiotherapy and neurofibromatosis will be excluded. Informed consent will be obtained from patients. This is a two-stage trial (both stages will run in parallel): Stage 1 (qualitative study) is designed to maximise patient and clinician acceptability, thereby optimising recruitment and retention. Patients wishing to continue will proceed to randomisation. Stage 2 (randomisation) patients will be randomised to receive either early adjuvant radiotherapy for 6 weeks (60 Gy in 30 fractions) or active monitoring. The primary outcome measure is time to MRI evidence of tumour recurrence (progression-free survival (PFS)). Secondary outcome measures include assessing the toxicity of the radiotherapy, the quality of life, neurocognitive function, time to second line treatment, time to death (overall survival (OS)) and incremental cost per quality-adjusted life year (QALY) gained. DISCUSSION: ROAM/EORTC-1308 is the first multi-centre randomised controlled trial designed to determine whether early adjuvant radiotherapy reduces the risk of tumour recurrence following complete surgical resection of atypical meningioma. The results of this study will be used to inform current neurosurgery and neuro-oncology practice worldwide. TRIAL REGISTRATION: ISRCTN71502099 on 19 May 2014.

From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.

UNLABELLED: : Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited. OBJECTIVE: Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams. METHODS: We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers' and PPI contributors' interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique. RESULTS: Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors' lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding 'the right' PPI contributors, and advised caution when involving investigators' current patients. CONCLUSIONS: Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised.

Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

BACKGROUND: Randomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions. OBJECTIVE: To increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders. METHODS: Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006-2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded. RESULTS: 110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI. CONCLUSIONS: Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed.

Incorporating children's and their parents' perspectives into condition-specific quality-of-life instruments for children with cerebral palsy: a qualitative study.

OBJECTIVES: This study investigated the extent of agreement between children with cerebral palsy (CP) and their parents concerning their views on what contributed to the children's quality of life. It also investigated how well an Australian condition-specific health-related quality of life self-report measure for children with CP, the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child), mapped to the views of UK children and parents. METHODS: UK children with CP aged 8 to 13 years and their parents participated in qualitative interviews about their perspectives on the child's quality of life. RESULTS: The interviews with 28 children and 35 parents showed considerable overlap but also some divergence. For example, both parties considered social relationships to be important, but children described how they enjoyed being on their own at times whereas parents tended not to value time spent alone for children. The CP QOL-Child covered most themes considered to be important to the children's quality of life. Omissions included relationships with extended family members, restful recreational activities and associated possessions, relaxing, tiredness, negative emotions, and safety. CONCLUSIONS: Both children's and parents' views are required for the development of child health-related quality of life instruments. The CP QOL-Child has good coverage of many aspects discussed in the interviews. Cultural differences may account for its omission of some topics considered important by UK children and parents. Rewording of many of the CP QOL-Child's items and further work on item content would optimize its suitability for UK children and possibly for children elsewhere.

Parenting in a crisis: conceptualising mothers of children with cancer.

Much research on the experiences of parents of children with cancer has been conducted within a discourse of psycho-pathology, or has tended to see parents mostly as a proxy source of information on the well-being of their children. Using empirical data from semi-structured interviews with 20 mothers of a child with cancer, in one area of the UK, we draw on sociological literatures on motherhood, childhood, caring, and chronic illness to suggest a more helpful and informative way of understanding their experiences. We suggest that mothers, although not ill themselves, experience many of the consequences of chronic illness. Biographical disruption begins for them when they first notice something wrong with their child, and intensifies with diagnosis, altering their sense of self and their social identity. The diagnosis brings with it a set of new responsibilities and role expectations, including an obligation of 'proximity'-being physically close to their child at all times to provide 'comfort' and 'keep-watch'. For mothers, caring evokes an intense emotional interdependence with their sick child, and involves a range of technical tasks and emotional work, including acting as 'brokers' of information for their child and managing their cooperation with treatment. Managing these obligations was achieved at high cost to the mothers themselves, and resulted in severe role strain by compromising their ability to function in other roles, including their role as the mother of their other children. Against the backdrop of a severe and life-threatening illness, everyday concerns about their child's diet or appropriate discipline take on a new significance and carry a heightened potential for generating conflict and distress for mothers. In presenting their accounts, mothers draw on prevailing cultural discourses about motherhood, childhood and cancer, and these clearly influence the context in which they care for their child, and shape their reflexive constructions of their experiences. Caring for a child with cancer had many adverse implications for the quality of life of the women we studied. Mothers of a child with cancer warrant study in their own right, and such study benefits from interpretive perspectives.