Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts.

BACKGROUND/AIMS: The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University's Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration. METHODS: We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper. RESULTS: Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies. CONCLUSIONS: Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit's experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

Effectiveness of Mental Health and Wellbeing Interventions for Children and Young People in Foster, Kinship, and Residential Care: Systematic Review and Meta-Analysis.

The mental health and wellbeing of children and young people who have been in care, primarily foster care, kinship care or residential care, remains a public health priority. The Care-experienced cHildren and young people's Interventions to improve Mental health and wEll-being outcomes Systematic review (CHIMES) synthesized evidence for the effectiveness of interventions targeting: subjective wellbeing; mental, behavioral and neurodevelopmental disorders; and suicide-related outcomes. Searches were conducted in 16 bibliographic databases and 22 websites between 1990 and 2022. This was supplemented by citation tracking, screening of relevant systematic reviews, and expert recommendation. We identified 35 interventions, with 44 evaluations via randomized controlled trials. Through meta-analyses, we found that interventions have a small beneficial impact on a variety of mental health outcomes in the short term (0-6 months). Interventions improved total social, emotional, and behavioral problems (d = -0.15, 95% CI [-0.28, -0.02]), social-emotional functioning difficulties (d = -0.18, 95% CI [-0.31, -0.05]), externalizing problem behaviors (d = -0.30, 95% CI [-0.53, -0.08]), internalizing problem behaviors (d = -0.35, 95% CI [-0.61, -0.08]); and depression and anxiety (d = -0.26, 95% CI [-0.40, -0.13]). Interventions did not demonstrate any effectiveness for outcomes assessed in the longer term (>6 months). Certainty of effectiveness was limited by risk of bias and imprecision. There was limited available evidence for interventions targeting subjective wellbeing and suicide-related outcomes. Future intervention design and delivery must ensure that programs are sufficient to activate causal mechanisms and facilitate change. Evaluation research should use a robust methodology.PROSPERO Registration: CRD42020177478.

The impact of a specialist home-visiting intervention on the language outcomes of young mothers and their children: a pragmatic randomised controlled trial.

BACKGROUND: Young mothers are more likely to provide a suboptimal early language environment for their children who in turn show impairments in their language development, yet few studies have used observational methods to assess the effectiveness of home-visiting programmes in improving the language outcomes of young mothers and their children. The Family Nurse Partnership (FNP) is a licensed home-visiting intervention developed in the USA and introduced into practice in England. The intervention involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained Family Nurses. We assessed the effectiveness of FNP in improving the language outcomes of first-time teenage mothers and their infants. METHOD: We conducted a pragmatic, non-blinded, randomised controlled trial to test whether the FNP programme improved mothers' and children's language production at 24 months postpartum. Eligible participants were nulliparous, aged 19 years or younger, and were recruited at less than 25 weeks' gestation from community midwifery settings (Country). Pregnant young mothers were randomly assigned to FNP plus usual care (n = 243) or usual care alone (n = 233). At 24 months postpartum, mother-child dyads were observed during a standardised free-play task with their first-born child and features of their language production was coded. Data was analysed using multi-level modelling; linear or poisson/negative binomial regression models were used as appropriate. RESULTS: A small effect of FNP on mothers' productive language was detected, where mothers in the FNP group demonstrated higher mean length of utterances than mothers who received usual care alone, mean difference (adjusted by minimisation variables and by site, linear regression) = 0.10, p < .05, 95% CI (0.004-0.20), d = .18. No differences were detected between groups regarding other characteristics of maternal language or children's language outcomes. CONCLUSION: This observational study conducted within the context of a randomised-controlled trial suggests that the FNP home-visiting programme may have a small, but potentially important impact on young mothers' speech to their toddlers. Exploratory analyses identified family environment, maternal, and child related predictors of the language outcomes of young mothers and their offspring. Trial registration This trial is registered with ISRCTN, number ISRCTN23019866, 20/04/2009.

Recruitment and retention of participants from socioeconomically deprived communities: lessons from the Awareness and Beliefs About Cancer (ABACus3) Randomised Controlled Trial.

BACKGROUND: Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. METHODS: Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. RESULTS: The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n = 212) retention at 2-weeks and 85% (n = 199) at 6-months. Community settings yielded 75% (n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n = 148) were female, with 66% (n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. CONCLUSIONS: The ABACus3 trial achieved recruitment and high retention with a population that is often "hard to reach" or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement. This study adheres to CONSORT guidelines. TRIAL REGISTRATION: Retrospectively registered with ISRCTN ( http://www.isrctn.com/ISRCTN16872545 ) on 12.01.2018.

Do home visiting programmes improve children's language development? A systematic review.

OBJECTIVES: This review examines home visiting programmes that specifically provide home based support to vulnerable, socially disadvantaged women who are either pregnant or have recently become a new parent. Home visiting programmes often report multiple outcomes. The purpose of this review is to systematically summarise how effective home visiting programmes are at improving young children's language development. DATA SOURCES: A comprehensive search of four online databases (Embase, Emcare, Psycinfo and Medline) between 1990 and 2020 was conducted, as well as a hand search of the references of relevant studies. REVIEW METHOD: Studies were screened with N = 11 meeting the inclusion/exclusion criteria. The risk of bias of each study was assessed. To enable comparisons between home visiting programmes, relevant data was extracted using an adapted version of the Cochrane Public Health Group Data Extraction and Assessment Template. RESULTS: Most of the home visiting programmes had been established in America. Six of the eleven studies reported positive language outcomes for children. Where statistical data was reported, the magnitude of the difference between the intervention and control groups represented small effect sizes. Nine different language measures were used, reporting on varying domains of language development rendering comparisons across programmes difficult. Most studies failed to report the duration of home visits, though studies which started prenatally showed the most promise in improving children's language development. CONCLUSION: Home visiting programmes targeted at socially disadvantaged women and their children have the potential to positively influence the language development of the child. This review highlights that not all home visiting programmes measure the impact that the programme has on children's language development, and not all home visiting programmes achieve positive language outcomes. Initiating visits prenatally may help towards the improvement of children's language development. Future evaluations of home visiting programmes should explore this finding further, consider the language assessment tools selected, and improve on the reporting of their language results.

Assessing predictors of respiratory tract infections in infants born to teenage mothers: secondary analysis of the Building Blocks trial data.

BACKGROUND: Respiratory tract infections (RTIs) are estimated to account for 60% of infants' primary care visits. There is limited research into risk factors for infant RTIs in those born to teenage mothers. AIMS: To identify risk factors for primary and secondary care RTI attendances, in infants of teenage mothers, and to identify risk factors associated with high primary care RTI consultations. METHOD: Secondary analysis of a data set from the Building Blocks trial of special home visiting support in England containing 1510 infants born to teenage mothers recruited to the study. Maternally reported and routinely collected data were examined. Multivariable logistic regression models were performed to determine independent predictors. Primary care data analysis also focused on infant risk factors for RTI consultation. RESULTS: No independently predictive risk factors for infant RTI were identified in primary care. Lower maternal antenatal attendances (odds ratio = 0.96, 95% confidence interval = 0.92-0.99), infants born in autumn (vs. spring; 0.54, 0.36-0.80) and neonatal unit (NNU) admissions (0.51, 0.30-0.89) had increased odds of attending accidents and emergencies with an RTI. Male infants (1.52, 1.03-2.25), NNU admissions (3.21, 1.98-5.22) and birth season had increased odds of RTI-associated hospital admissions. High infant RTI primary care consulters were more likely to have an RTI-associated hospital admission (2.11, 1.17-3.81) and less likely to have breastfed (0.55, 0.38-0.78). CONCLUSION: Risk factors previously found to increase the risk of an RTI infant admission in the broader population have been identified here. This study is one of the first to identify modifiable risk factors of high primary care RTI consulters.

Implementation of the Family Nurse Partnership programme in England: experiences of key health professionals explored through trial parallel process evaluation.

BACKGROUND: The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context. The aim of the focus groups was to investigate views of key health professionals towards the integration and delivery of FNP programme in England. METHODS: Focus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011-2012. Transcripts from audio-recordings were analysed thematically. RESULTS: A total of 122 professionals participated in one of 19 focus groups. Family Nurses were confident in the effectiveness of FNP, although they experienced practical difficulties meeting programme fidelity targets and considered that programme goals did not sufficiently reflect client or community priorities. Health Visitors and Midwives regarded FNP as well-resourced and beneficial to clients, describing their own services as undervalued and struggling. They wished to work closely with Family Nurses, but felt excluded from doing so by practical barriers and programme protection. CONCLUSION: FNP was described as well-resourced and delivered by highly motivated and well supported Family Nurses. FNP eligibility, content and outcomes conflicted with individual client and community priorities. These factors may have restricted the potential effectiveness of a programme developed and previously tested in a different social milieu. Building Blocks ISRCTN23019866 Registered 20/04/2009.

Availability of breastfeeding peer support in the United Kingdom: A cross-sectional study.

Peer support is recommended by the World Health Organization for the initiation and continuation of breastfeeding, and this recommendation is included in United Kingdom (U.K.) guidance. There is a lack of information about how, when, and where breastfeeding peer support was provided in the U.K. We aimed to generate an overview of how peer support is delivered in the U.K. and to gain an understanding of challenges for implementation. We surveyed all U.K. infant feeding coordinators (n = 696) who were part of U.K.-based National Infant Feeding Networks, covering 177 National Health Service (NHS) organisations. We received 136 responses (individual response rate 19.5%), covering 102 U.K. NHS organisations (organisational response rate 58%). We also searched NHS organisation websites to obtain data on the presence of breastfeeding peer support. Breastfeeding peer support was available in 56% of areas. However, coverage within areas was variable. The provision of training and ongoing supervision, and peer-supporter roles, varied significantly between services. Around one third of respondents felt that breastfeeding peer-support services were not well integrated with NHS health services. Financial issues were commonly reported to have a negative impact on service provision. One quarter of respondents stated that breastfeeding peer support was not accessed by mothers from poorer social backgrounds. Overall, there was marked variation in the provision of peer-support services for breastfeeding in the U.K. A more robust evidence base is urgently needed to inform guidance on the structure and provision of breastfeeding peer-support services.

A novel peer-support intervention using motivational interviewing for breastfeeding maintenance: a UK feasibility study.

BACKGROUND: In total, 81% of women in the UK start breastfeeding, but fewer than half continue beyond 6 weeks. Peer support in the early postnatal period may encourage women to breastfeed for longer. OBJECTIVE: To develop a breastfeeding peer-support intervention based on motivational interviewing (MI) for breastfeeding maintenance and to test the feasibility of delivering it to mothers in areas with high levels of social deprivation. DESIGN: Intervention development and a non-randomised multisite feasibility study. SETTING: Community maternity services in three areas with high levels of social deprivation and low breastfeeding initiation rates in England and Wales. PARTICIPANTS: Pregnant women considering breastfeeding. Women who did not plan to breastfeed, who had a clinical reason that precluded breastfeeding continuation or who were unable to consent were excluded. INTERVENTION: The intervention Mam-Kind was informed by a survey of infant feeding co-ordinators, rapid literature review, focus groups with service users and peer supporters and interviews with health-care professionals and a Stakeholder Advisory Group. It consisted of face-to-face contact at 48 hours after birth and proactive one-to-one peer support from the Mam-Kind buddy for 2 weeks, followed by mother-led contact for a further 2-6 weeks. MAIN OUTCOME MEASURES: Recruitment and retention of Mam-Kind buddies, uptake of Mam-Kind by participants, feasibility of delivering Mam-Kind as specified and of data collection methods, and acceptability of Mam-Kind to mothers, buddies and health-care professionals. RESULTS: Nine buddies were recruited to deliver Mam-Kind to 70 participants (61% of eligible women who expressed an interest in taking part in the study). Participants were aged between 19 and 41 years and 94% of participants were white. Intervention uptake was 75% and did not vary according to age or parity. Most contacts (79%) were initiated by the buddy, demonstrating the intended proactive nature of the intervention and 73% (n = 51) of participants received a contact within 48 hours. Follow-up data were available for 78% of participants at 10 days and 64% at 8 weeks. Data collection methods were judged feasible and acceptable. Data completeness was > 80% for almost all variables. Interviews with participants, buddies and health service professionals showed that the intervention was acceptable. Buddies delivered the intervention content with fidelity (93% of intervention objectives were met), and, in some cases, developed certain MI skills to a competency level. However, they reported difficulties in changing from an information-giving role to a collaborative approach. These findings were used to refine the training and intervention specification to emphasise the focus of the intervention on providing mother-centric support. Health-care professionals were satisfied that the intervention could be integrated with existing services. CONCLUSIONS: The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial. The feasibility study highlighted the need to strengthen strategies for birth notification and retention of participants, and provided some insights on how this could be achieved in a full trial. LIMITATIONS: The response rate to the survey of infant feeding co-ordinators was low (19.5%). In addition, the women who were recruited may not be representative of the study sites. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Patient-reported measurement of time to diagnosis in cancer: development of the Cancer Symptom Interval Measure (C-SIM) and randomised controlled trial of method of delivery.

BACKGROUND: The duration between first symptom and a cancer diagnosis is important because, if shortened, may lead to earlier stage diagnosis and improved cancer outcomes. We have previously developed a tool to measure this duration in newly-diagnosed patients. In this two-phase study, we aimed further improve our tool and to conduct a trial comparing levels of anxiety between two modes of delivery: self-completed versus researcher-administered. METHODS: In phase 1, ten patients completed the modified tool and participated in cognitive debrief interviews. In phase 2, we undertook a Randomised Controlled Trial (RCT) of the revised tool (Cancer Symptom Interval Measure (C-SIM)) in three hospitals for 11 different cancers. Respondents were invited to provide either exact or estimated dates of first noticing symptoms and presenting them to primary care. The primary outcome was anxiety related to delivery mode, with completeness of recording as a secondary outcome. Dates from a subset of patients were compared with GP records. RESULTS: After analysis of phase 1 interviews, the wording and format were improved. In phase 2, 201 patients were randomised (93 self-complete and 108 researcher-complete). Anxiety scores were significantly lower in the researcher-completed group, with a mean rank of 83.5; compared with the self-completed group, with a mean rank of 104.0 (Mann-Whitney U = 3152, p = 0.007). Completeness of data was significantly better in the researcher-completed group, with no statistically significant difference in time taken to complete the tool between the two groups. When comparing the dates in the patient questionnaires with those in the GP records, there was evidence in the records of a consultation on the same date or within a proscribed time window for 32/37 (86%) consultations; for estimated dates there was evidence for 23/37 consultations (62%). CONCLUSIONS: We have developed and tested a tool for collecting patient-reported data relating to appraisal intervals, help-seeking intervals, and diagnostic intervals in the cancer diagnostic pathway for 11 separate cancers, and provided evidence of its acceptability, feasibility and validity. This is a useful tool to use in descriptive and epidemiological studies of cancer diagnostic journeys, and causes less anxiety if administered by a researcher.

Continuity of care in the transition from child to adult diabetes services: a realistic evaluation study.

OBJECTIVES: To identify the continuity mechanisms central to a smooth transition from child to adult diabetes care, the service components through which these can be achieved and their inter-relations in different contexts. METHODS: A realistic evaluation study of five models of transition in England comprising: organizational analysis (semi-structured interviews with 38 health care professionals and selected observations); case studies of 46 young people under-going transition and 39 carers (three qualitative interviews over a 12-18 month period, medical record review and clinical interviews); surveys of 82 (32% response rate at least once and 11% response rate at two time points) young people in the population approaching, undergoing or less than 12 months post-transition, and their carers (questionnaires included psychosocial outcome measures); and a costs and consequences analysis. RESULTS: Seven continuities contribute to smooth transition: relational, longitudinal, management, informational, flexible, developmental and cultural. Relational, longitudinal, flexible and cultural continuity are the most important. Models with high levels of relational, longitudinal, flexible and cultural continuity achieve smooth transition with relatively informal, low-cost informational and management continuity mechanisms. Models with low levels of relational and longitudinal continuity need to invest in more formal interventions to facilitate management, flexible and informational continuity so that smooth transition is not compromised. CONCLUSIONS: Focusing on continuity mechanisms, their inter-relations and the effectiveness of different constellations of service components in achieving smooth transition has furnished evidence to inform the development of innovative models which build on the logic of these findings but are sensitive to local context. Further studies are needed to confirm the quantitative findings from a broader range of services and patients.

The effect of the Talking Diabetes consulting skills intervention on glycaemic control and quality of life in children with type 1 diabetes: cluster randomised controlled trial (DEPICTED study).

OBJECTIVE: To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams. DESIGN: Pragmatic cluster randomised controlled trial. SETTING: 26 UK secondary and tertiary care paediatric diabetes services. PARTICIPANTS: 79 healthcare practitioners (13 teams) trained in the intervention (359 young people with type 1 diabetes aged 4-15 years and their main carers) and 13 teams allocated to the control group (334 children and their main carers). INTERVENTION: Talking Diabetes programme, which promotes shared agenda setting and guiding communication style, through flexible menu of consultation strategies to support patient led behaviour change. MAIN OUTCOME MEASURES: The primary outcome was glycated haemoglobin (HbA(1c)) level one year after training. Secondary outcomes were clinical measures (hypoglycaemic episodes, body mass index, insulin regimen), general and diabetes specific quality of life, self reported and proxy reported self care and enablement, perceptions of the diabetes team, self reported and carer reported importance of, and confidence in, undertaking diabetes self management measured over one year. Analysis was by intention to treat. An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training (intervention group) and at one year follow-up (intervention and control group). Two key domains of skill assessment were use of the guiding communication style and shared agenda setting. RESULTS: 660/693 patients (95.2%) provided blood samples at follow-up. Training diabetes care teams had no effect on HbA(1c) levels (intervention effect 0.01, 95% confidence interval -0.02 to 0.04, P=0.5), even after adjusting for age and sex of the participants. At follow-up, trained staff (n=29) were more capable than controls (n=29) in guiding (difference in means 1.14, P<0.001) and agenda setting (difference in proportions 0.45, 95% confidence interval 0.22 to 0.62). Although skills waned over time for the trained practitioners, the reduction was not significant for either guiding (difference in means -0.33, P=0.128) or use of agenda setting (difference in proportions -0.20, -0.42 to 0.05). 390 patients (56%) and 441 carers (64%) completed follow-up questionnaires. Some aspects of diabetes specific quality of life improved in controls: reduced problems with treatment barriers (mean difference -4.6, 95% confidence interval -8.5 to -0.6, P=0.03) and with treatment adherence (-3.1, -6.3 to -0.01, P=0.05). Short term ability to cope with diabetes increased in patients in intervention clinics (10.4, 0.5 to 20.4, P=0.04). Carers in the intervention arm reported greater excitement about clinic visits (1.9, 1.05 to 3.43, P=0.03) and improved continuity of care (0.2, 0.1 to 0.3, P=0.01). CONCLUSIONS: Improving glycaemic control in children attending specialist diabetes clinics may not be possible through brief, team-wide training in consultation skills. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.

Evaluating the family nurse partnership in England: the Building Blocks trial.

The Family Nurse Partnership (FNP) Programme is a structured intensive home visiting programme delivered by trained family nurses to nulliparous teenagers throughout pregnancy and until their child is two years old. Currently FNP is provided in over 60 primary healthcare sites in England with a planned capacity increase to 13,000 concurrent clients by 2015. Researchers from the South East Wales Trials Unit at Cardiff University are testing the effectiveness of FNP in England in the Building Blocks study--a randomised controlled trial funded by the Department of Health (DH). The trial team includes collaborators from the Universities of York, Bristol and Glamorgan.

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes.

BACKGROUND: Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. METHODS/DESIGN: Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. DISCUSSION: The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.

Managing long-term worklessness in primary care: a focus group study.

BACKGROUND: Evidence suggests that overall the benefits of work are greater than the harmful effects of long-term unemployment and prolonged sickness absence. General practitioners (GPs) often feel that work and health-related issues extend beyond their role. There is a paucity of research that focuses on GPs' attitudes to the management of long-term worklessness. AIMS: To explore GPs' perceptions of the management of individuals in receipt of long-term incapacity benefits and their attitudes to UK government funded return to work programmes such as the Want2Work scheme in Wales. METHODS: A qualitative study set in South Wales. Focus groups were conducted with GPs and explored the role of primary care and the challenges that GPs face when managing long-term worklessness and how the Want2Work programme might benefit GP practice. Data were analysed using the framework method of analysis. RESULTS: The main themes that emerged from the GP focus groups were role boundaries, responsibilities, negotiation and knowledge. A key finding was that many of the participants felt that their role in managing long-term worklessness was limited to providing support and management of health-related issues only. The perceived risk to their own personal safety in addressing these issues with some patients also impacted on GPs' decision making CONCLUSIONS: There seems to be a clear divide between managing patients' health concerns and their work-related activities. Some GPs recognized that patients became 'lost' in their system once receiving long-term benefits.

Predicting the clinical course of suspected acute viral upper respiratory tract infection in children.

BACKGROUND: Suspected acute viral upper respiratory tract infection (SAVURTI) is the commonest acute reason why children consult in general practice. The clinical course varies widely and about one in five children re-consult for the same SAVURTI episode. If clinicians had feasible tools for predicting which children are likely to suffer a prolonged course, then additional explanations and possibly treatments could be provided at the initial consultation that might enable carers to manage the condition without re-consulting. OBJECTIVE: To identify features available on the day of consulting that might predict a prolonged clinical course among children with SAVURTI. METHOD: Regression analysis using Canadian Respiratory Illness and Flu Scale (CARIFS) data from a randomized controlled trial cohort of children aged from 6 months to 12 years consulting in general practice with SAVURTI. RESULTS: Two variables from the clinician's records ('age' and 'cough') and two variables from the CARIFS completed by carers on the day of consulting ('fever' and 'low energy, tired') explained approximately 15% of the variation present in CARIFS scores on day seven. CONCLUSION: Children and carers may benefit from a clear account of the evidence that the clinical course of RTIs in children varies widely and may be longer that expected, and that prediction for individuals is difficult.

A qualitative evaluation of implementing a randomized controlled trial in general practice.

BACKGROUND: For findings of randomized controlled trials in primary care to be applicable, both the sample of clinicians implementing the trial and the recruited patients should be as representative as possible. The processes of conducting trials should be made "user-friendly" to clinician investigators in order to maximize their participation in research. Formal evaluations of trial implementation are unusual. This study reports clinicians' perspectives on acting as a clinician investigator in a randomized controlled trial (the SAVIT study) in general practice. OBJECTIVE: Our purpose was to explore clinicians' accounts of taking part in a randomized controlled trial in which subjects were recruited opportunistically during general practice consultations. METHOD: Individual semi-structured interviews were conducted with nine GPs and one practice nurse practising in the Bro Taf area of South Wales who recruited children into the SAVIT study. A structured interview guide was used and data were analysed using the qualitative method of pattern coding. RESULTS: Major emerging themes included recruitment difficulties and concerns about the safety of the study medication. Participants also outlined positive aspects of the study (clarity and simplicity of the study, potential benefits to clinicians and patients and study team follow-up of recruited patients). Recommendations for possible improvements in study implementation included the simplification and reduction of patient reading materials and improved presentation of study materials. CONCLUSIONS: Difficulty in recruiting patients was the most frequently mentioned problem by clinician investigators. Insufficient time in the consultation was perceived as the main barrier. Ingredients of successful trial implementation include good organization, simple documentation and study procedures, and the ability to allay concerns about patient safety. Findings from this evaluation may assist researchers in the design and implementation of future community-based randomized controlled trials.

Management of suspected acute viral upper respiratory tract infection in children with intranasal sodium cromoglicate: a randomised controlled trial.

BACKGROUND: Upper respiratory tract infection in children is one of the most frequent reasons for visiting a family doctor, and antibiotics are often prescribed inappropriately. Sodium cromoglicate inhibits the ICAM-1 molecule, which is the receptor for human rhinoviruses. We aimed to investigate whether intranasal cromoglicate shortens duration of infection of the upper respiratory tract. METHODS: We randomly assigned 290 children diagnosed with suspected acute viral upper respiratory tract infection by their family doctor (137 boys, 153 girls; mean age 5.2 years [SD 3.39]) either intranasal 4% sodium cromoglicate spray or intranasal normal saline spray. Follow-up was by daily symptom diary for 2 weeks and by telephone. Canadian Acute Respiratory Illness and Flu Scale (CARIFS) score was the primary outcome measure. FINDINGS: 195 patients returned symptom diaries, and 20 of these could not be included in the main analysis. 246 patients completed the telephone interview at week 1. There was no difference in recovery rate over the first week between the two groups, with the estimated difference in slope of log (CARIFS) being -0.01 (95% CI -0.05 to 0.03). There were no differences between the two groups in side-effects or re-consultation rates. 43 (17%) of 246 children with suspected acute viral upper respiratory tract infection went back to see their family doctor, and 220 (89%) of 246 were managed without prescription of antibiotics. INTERPRETATION: Intranasal sodium cromoglicate is not a useful additional treatment for this infection. Our results further clarify the role of prescribed drugs for children with these frequent illnesses.

General practitioners' use of magnetic resonance imaging: an open randomized trial comparing telephone and written requests and an open randomized controlled trial of different methods of local guideline dissemination.

AIM: To determine the impact and cost-effectiveness of telephone versus written access to magnetic resonance imaging (MRI), and of different strategies for disseminating locally produced guidelines, upon requests by general practitioners (GPs) for knee and lumbar spine investigation. MATERIAL AND METHODS: Two sequential pragmatic open cluster-randomized trials were conducted within 39 general practices. The outcome measure in each trial was concordance of request with local guidelines. Trial 1: practices requested MRI by telephone or in writing. Trial 2: all practices received guidelines, plus either: a practice-based seminar, practice-specific audit feedback, both seminar and feedback, or neither. RESULTS: A total of 414 requests were assessed in the two trials. Trial 1: telephone access cost pound4.86 more per request but rates of concordant requests were equivalent (65%/64%: telephone/written). Trial 2: compared to the control group, costs per practice were pound1911 higher in seminar group, pound1543 higher in feedback group and pound3578 higher for those receiving both. Concordance was greater following the intervention (74% vs 65%; P < 0.05), but there was no difference between the four study groups. CONCLUSIONS: Method of access did not affect concordance. Written access was more cost-effective. Seminars and feedback were no more effective in modifying practice than guidelines alone, which was thus the most cost-effective option.