Identifying interventions with Gypsies, Roma and Travellers to promote immunisation uptake: methodological approach and findings.

BACKGROUND: In the UK, Gypsy, Roma and Traveller (GRT) communities are generally considered to be at risk of low or variable immunisation uptake. Many strategies to increase uptake for the general population are relevant for GRT communities, however additional approaches may also be required, and importantly one cannot assume that "one size fits all". Robust methods are needed to identify content and methods of delivery that are likely to be acceptable, feasible, effective and cost effective. In this paper, we describe the approach taken to identify potential interventions to increase uptake of immunisations in six GRT communities in four UK cities; and present the list of prioritised interventions that emerged. METHODS: This work was conducted in three stages: (1) a modified intervention mapping process to identify ideas for potential interventions; (2) a two-step prioritisation activity at workshops with 51 GRTs and 25 Service Providers to agree a prioritised list of potentially feasible and acceptable interventions for each community; (3) cross-community synthesis to produce a final list of interventions. The theoretical framework underpinning the study was the Social Ecological Model. RESULTS: Five priority interventions were agreed across communities and Service Providers to improve the uptake of immunisation amongst GRTs who are housed or settled on an authorised site. These interventions are all at the Institutional (e.g. cultural competence training) and Policy (e.g. protected funding) levels of the Social Ecological Model. CONCLUSIONS: The "upstream" nature of the five interventions reinforces the key role of GP practices, frontline workers and wider NHS systems on improving immunisation uptake. All five interventions have potentially broader applicability than GRTs. We believe that their impact would be enhanced if delivered as a combined package. The robust intervention development and co-production methods described could usefully be applied to other communities where poor uptake of immunisation is a concern. STUDY REGISTRATION: Current Controlled Trials ISRCTN20019630, Date of registration 01-08-2013, Prospectively registered.

Needles, Jabs and Jags: a qualitative exploration of barriers and facilitators to child and adult immunisation uptake among Gypsies, Travellers and Roma.

BACKGROUND: Gypsies, Travellers and Roma (referred to as Travellers) are less likely to access health services including immunisation. To improve immunisation rates, it is necessary to understand what helps and hinders individuals in these communities in taking up immunisations. This study had two aims. 1. Investigate the views of Travellers in the UK on the barriers and facilitators to acceptability and uptake of immunisations and explore their ideas for improving immunisation uptake; 2. Examine whether and how these responses vary across and within communities, and for different vaccines (childhood and adult). METHODS: This was a qualitative, cross-sectional interview study informed by the Social Ecological Model. Semi-structured interviews were conducted with 174 Travellers from six communities: Romanian Roma, English Gypsy/Irish Travellers (Bristol), English Gypsy (York), Romanian/Slovakian Roma, Scottish Show people (Glasgow) and Irish Traveller (London). The focus was childhood and selected adult vaccines. Data were analysed using the Framework approach. RESULTS: Common accounts of barriers and facilitators were identified across all six Traveller communities, similar to those documented for the general population. All Roma communities experienced additional barriers of language and being in a new country. Men and women described similar barriers and facilitators although women spoke more of discrimination and low literacy. There was broad acceptance of childhood and adult immunisation across and within communities, with current parents perceived as more positive than their elders. A minority of English-speaking Travellers worried about multiple/combined childhood vaccines, adult flu and whooping cough and described barriers to booking and attending immunisation. Cultural concerns about antenatal vaccines and HPV vaccination were most evident in the Bristol English Gypsy/Irish Traveller community. Language, literacy, discrimination, poor school attendance, poverty and housing were identified as barriers across different communities. Trustful relationships with health professionals were important and continuity of care valued. CONCLUSIONS: The experience of many Travellers in this study, and the context through which they make health decisions, is changing. This large study identified key issues that should be considered when taking action to improve uptake of immunisations in Traveller families and reduce the persistent inequalities in coverage. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20019630 .

Mapping breastfeeding services: a method to inform effective implementation and evaluation of evidence-based policy in practice.

This paper aims to introduce a method for mapping local service provision to local demographic and health outcome data, to inform evidence-based policy and practice in public health. A mapping exercise was conducted in London, England with the aims of: (1) describing services provided for breastfeeding women in primary and tertiary health care sectors and government, voluntary and private sectors; and (2) linking this information with routine data on deprivation, breastfeeding rates and health outcomes. Quantitative data on local breastfeeding services were collected via an online questionnaire by a designated 'mapping lead' in each locality. Data were collected at the level of individual health care organisations on the provision, nature and management of breastfeeding services, and related organisational inputs such as leadership, staffing, accreditation and policy. Demographic and health outcome data were identified from existing routine national data collections. Ninety-one per cent of eligible acute and primary care organisations participated in the mapping exercise. A range of mapping tools and profile were developed and launched in 2009 (http://atlas.chimat.org.uk/IAS/dataviews/view?viewId=66). These tools can be used for descriptive analyses of service provision on the basis of local need. Comparative analyses on the impact of service provision on breastfeeding or health outcomes will be feasible from 18 months of data collection onwards. This case study has demonstrated the potential utility of this mapping method to inform effective implementation and evaluation of public health policy in practice consistent with the World Health Organisation framework. Formal evaluation of the utility of the tools is recommended.

Policy and public health recommendations to promote the initiation and duration of breast-feeding in developed country settings.

OBJECTIVE: To develop policy and public health recommendations for implementation at all levels by individuals and organisations working in, or related to, the field of breast-feeding promotion in developed country settings, where breast-feeding rates remain low. DESIGN: Two research phases, comprising (i) an assessment of the formal evidence base in developed country settings and (ii) a consultation with UK-based practitioners, service managers and commissioners, and representatives of service users. The evidence base included three systematic reviews and an Evidence Briefing. One hundred and ten studies evaluating an intervention in developed country settings were assessed for quality and awarded an overall quality rating. Studies with a poor quality rating were excluded. The resulting seventy studies examined twenty-five types of intervention for breast-feeding promotion. These formed the basis of the second consultation phase to develop the evidence-based interventions into recommendations for practice, which comprised (i) pilot consultation, (ii) electronic consultation, (iii) fieldwork meetings and (iv) workshops. Draft findings were synthesised for two rounds of stakeholder review conducted by the National Institute for Health and Clinical Excellence. RESULTS: Twenty-five recommendations emerged within three complementary and necessary categories, i.e. public health policy, mainstream clinical practice and local interventions. CONCLUSIONS: The need for national policy directives was clearly identified as a priority to address many of the barriers experienced by practitioners when trying to work across sectors, organisations and professional groups. Routine implementation of the WHO/UNICEF Baby Friendly Initiative across hospital and community services was recommended as core to breast-feeding promotion in the UK. A local mix of complementary interventions is also required.

Factors influencing the infant feeding decision for socioeconomically deprived pregnant teenagers: the moral dimension.

BACKGROUND: The importance of breastfeeding-related health outcomes in reducing inequalities in health has been recognized as a National Health Service target to increase initiation rates especially among disadvantaged groups in England. This study examined the psychosocial factors influencing infant feeding intention among pregnant teenagers expecting their first baby and living in deprived urban areas in England. METHODS: A mixed methods study, using a quantitative questionnaire based on the Theory of Planned Behaviour, was conducted in four English regions with predominantly white and Asian teenagers (n = 71). This method identified which of all known Theory of Planned Behaviour variables were the most important in influencing feeding intentions. Focus groups provided contextual insight into the meaning of these variables for white pregnant teenagers living in a northern English inner city (n = 17). RESULTS: Moral norms were identified as the most predictive variable influencing teenage intention to formula feed or breastfeed. The likelihood that breastfeeding "will be embarrassing" was the only attitudinal belief rated as significantly important in influencing teenage intention to breastfeed. Three overarching themes emerged from the focus group data: "moral norms,""sexuality of the breast," and "self-esteem," with concerns relating to breastfeeding in public cutting across all themes. CONCLUSIONS: Breastfeeding was viewed as a morally inappropriate behavior by most of these teenagers, with formula feeding being perceived as the appropriate behavior. Existing breastfeeding promotion activities are likely to continue to fail to reach teenagers experiencing deprivation in England in the absence of effective strategies to change the underlying negative moral norms toward breastfeeding.

Studying the infant feeding intentions of pregnant women experiencing material deprivation: methodology of the Looking at Infant Feeding Today (LIFT) study.

The Looking at Infant Feeding Today (LIFT) study examined the factors underlying the infant feeding choices of first-time mothers in the Leeds and Bradford areas of England experiencing material hardship, with a view to informing interventions aimed at increasing breastfeeding uptake amongst this group. This short report describes the novel methodology used to obtain data from a sample of pregnant women who are traditionally 'hard-to-reach' in deprived areas. This involved the use of trusted individuals such as midwives and multilingual health workers. A total of 449 women were approached; 441 (91.5%) agreed to participate and 303 returned completed questionnaires. Whilst 285 participants self-completed, 18 opted for interviewer assistance provided by a trained multilingual health worker. Feeding method up to 10 days after birth was obtained from the hospital records of 248 women (82.4% of eligible returns), and self-reported feeding method at six weeks was obtained from 273 women (90.7% of eligible returns). The study succeeded in obtaining data from a relatively deprived and hard-to-reach sample, with adequate numbers of participants in the subgroups of interest (teenage, left full time education age 16 or younger, household receiving income support or job seekers allowance, Asian or African-Caribbean).

Using an extended theory of planned behaviour to inform interventions aimed at increasing breastfeeding uptake in primiparas experiencing material deprivation.

OBJECTIVES: The theory of planned behaviour (TPB) was employed to investigate infant feeding intentions and subsequent behaviour in women from selected areas of economic hardship in the UK. Underlying beliefs were examined in order to inform future interventions aimed at increasing breastfeeding uptake among women living in such areas, which is associated with low rates of breastfeeding. DESIGN: Midwives recruited women from areas meeting study criteria. TPB measures were obtained from 303 primiparas via postal questionnaires completed during pregnancy, and feeding method was subsequently obtained from 286 of these women. RESULTS: A model containing age, education, deprivation, attitude, subjective norm (SN), and perceived behavioural control (PBC) predicted intention to breastfeed (R(2)=.44) and intention to formula feed (R(2)=.45). A model controlling for age, education and deprivation predicted ever having breastfed (86.1% correctly classified) and ever having formula fed (77.1% correctly classified). MANCOVAs differentiated those who intended to breastfeed and subsequently did (inclined actors), those who intended to breastfeed but did not (inclined abstainers), and those who did not intend to breastfeed and did not (disinclined abstainers). Differentiating outcome beliefs, normative beliefs, and control beliefs are presented. CONCLUSIONS: The TPB provided a useful framework with which to examine the factors underlying breastfeeding intentions and behaviour amongst primiparas. A grouping system based on the congruence between intentions and subsequent behaviour revealed important differences between beliefs of the three groups. Further research might usefully test the effectiveness of interventions targeting the beliefs identified here in increasing breastfeeding uptake and duration.

A systematic review of education and evidence-based practice interventions with health professionals and breast feeding counsellors on duration of breast feeding.

OBJECTIVE: to examine the effects of training, education and practice change interventions with health professionals and lay breast feeding educator/counsellors on duration of breast feeding. REVIEW METHODS: this was part of a series of reviews of interventions that affect duration of breast feeding. Full details of methods used, including search strategy, are reported separately. SELECTION CRITERIA FOR INCLUDED STUDIES: randomised controlled trials, non randomised controlled trials with concurrent controls and before after studies (cohort or cross-sectional), undertaken in a developed country, published between 1980 and 2003 in any language. The primary outcome was duration of breast feeding. Secondary and process outcomes, including attitude, knowledge and behaviour change of participants, were included from papers that also reported breast feeding duration outcomes. STUDY-QUALITY ASSESSMENT: inclusion and exclusion criteria were applied, data extracted and study quality assessments made by one reviewer and independently checked by another, with a third reviewer to resolve differences, as recommended by the NHS Centre for Reviews and Dissemination's guidance for reviews. FINDINGS: the search identified nine papers. All were before after studies that included the education of health professionals; no studies were identified that related to breast feeding counsellors. In six of the studies, the participants were working with mothers and babies in hospitals (three in the UK, two in Italy and one in France); in three studies, the participants were working in community settings (Canada, Spain and the USA). Two UK studies and two non-UK studies (Spain and USA) involved mothers living in disadvantaged areas. Most interventions aimed to increase knowledge and change professional practice in support of breast feeding. KEY CONCLUSIONS: many of the studies reviewed have methodological limitations. Study settings and contexts vary and lack comparability. Evidence from these studies was insufficient to draw conclusions about overall benefit or harm associated with the interventions. From the studies identified, there seems to be no single way that consistently achieves changes in breast feeding duration. From one of the methodologically more robust studies, it seems that UNICEF/WHO Baby Friendly Hospital Initiative (BFI) training might have the potential to influence breast feeding duration. RECOMMENDATIONS FOR FURTHER RESEARCH: further testing of the BFI initiative within a controlled design. Future research into the education of health-care professionals that relates to the support of breast feeding women should have appropriate theoretical underpinning, describe educational programmes and the context of care delivery comprehensively and use standardised time points in the assessment of the effect of interventions. Intermediate outcomes should also be reported, including those related to the effect on education and practice.

Developing evidence-based recommendations in public health--incorporating the views of practitioners, service users and user representatives.

BACKGROUND: Guidance based on a systematic assessment of the evidence base has become a fundamental tool in the cycle of evidence-based practice and policy internationally. The process of moving from the formal evidence base derived from research studies to the formation and agreement of recommendations is however acknowledged to be problematic, especially in public health; and the involvement of practitioners, service commissioners and service users in that process is both important and methodologically challenging. AIM: To test a structured process of developing evidence-based recommendations in public health while involving a broad constituency of practitioners, service commissioners and service user representatives. METHODS: As part of the development of national public health recommendations to promote and support breastfeeding in England, the methodological challenges of involving stakeholders were examined and addressed. There were three main stages: (i) an assessment of the formal evidence base (210 studies graded); (ii) electronic and fieldwork-based consultation with practitioners, service commissioners and service user representatives (563 participants), and an in-depth analytical consultation in three 'diagonal slice' workshops (89 participants); (iii) synthesis of the previous two stages. RESULTS AND CONCLUSIONS: The process resulted in widely agreed recommendations together with suggestions for implementation. It was very positively evaluated by participants and those likely to use the recommendations. Service users had a strong voice throughout and participated actively. This mix of methods allowed a transparent, accountable process for formulating recommendations based on scientific, theoretical, practical and expert evidence, with the added potential to enhance implementation.

The impact of lung function case-finding tests on smoking behaviour: A nested randomised trial within a case-finding cohort.

RATIONALE AIMS AND OBJECTIVES: Increasing awareness of people's lung health through the use of lung function tests or symptom-based questionnaires is a potential method to aid smoking cessation. We investigated the impact of case-finding lung function tests for chronic obstructive pulmonary disease on smoking behaviour. METHODS: Our trial used a novel waiting list randomised controlled trial design, nested within a case-finding cohort study. The cohort comprised current smokers aged 35 years or more, from general practices in Yorkshire and Humberside, who were randomised to receive lung function tests (spirometry, microspirometry, peak flow meter measurement, and a WheezoMeter) and case-finding questionnaires either immediately ("tests now") or later ("waiting list" control). Outcome measures included self-reported smoking cessation and number of cigarettes smoked at follow-up (at 2, 3, or 6 months after randomisation, depending on study site), with 409 participants included in the primary analysis. RESULTS: Six hundred seventy-four participants were randomised using stratified block randomisation to the 2 groups (340 to "tests now" and 334 to "waiting list"), with 409 included in the primary analysis (194 in "tests now" and 215 in "waiting list" groups). Smoking cessation at follow-up was very similar across groups (8.8% in the "tests now" group, compared with 9.2% in the "waiting list" group). Completing case-finding lung function tests did not significantly impact smoking cessation (OR 1.00, 95% CI, 0.57-1.77, adjusting for age, sex, baseline number of cigarettes smoked, and study site). A sensitivity analysis, assuming that participants with missing data were still smoking, gave similar results (OR 0.86, 95% CI, 0.47-1.56). Analysis of the number of cigarettes smoked at follow-up using negative binomial regression adjusting for the same factors above gave an incidence rate ratio of 0.95 (95% CI, 0.88-1.03). CONCLUSIONS: There is no evidence from this trial of an effect of lung function tests on smoking cessation among a population of smokers aged 35 years or over. Indeed, when assuming that those with missing data were smokers, a slightly lower odds of smoking cessation was observed in the "test now" group compared with the "waiting list" group.

Determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease: The DOC study.

RATIONALE, AIMS, AND OBJECTIVES: Early identification of chronic obstructive pulmonary disease (COPD) results in patients receiving appropriate management for their condition at an earlier stage in their disease. The determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease (DOC) study was a case-finding study to enhance early identification of COPD in primary care, which evaluated the diagnostic accuracy of a series of simple lung function tests and symptom-based case-finding questionnaires. METHODS: Current smokers aged 35 or more were invited to undertake a series of case-finding tools, which comprised lung function tests (specifically, spirometry, microspirometry, peak flow meter, and WheezoMeter) and several case-finding questionnaires. The effectiveness of these tests, individually or in combination, to identify small airways obstruction was evaluated against the gold standard of spirometry, with the quality of spirometry tests assessed by independent overreaders. The study was conducted with general practices in the Yorkshire and Humberside area, in the UK. RESULTS: Six hundred eighty-one individuals met the inclusion criteria, with 444 participants completing their study appointments. A total of 216 (49%) with good-quality spirometry readings were included in the analysis. The most effective case-finding tools were found to be the peak flow meter alone, the peak flow meter plus WheezoMeter, and microspirometry alone. In addition to the main analysis, where the severity of airflow obstruction was based on fixed ratios and percent of predicted values, sensitivity analyses were conducted by using lower limit of normal values. CONCLUSIONS: This research informs the choice of test for COPD identification; case-finding by use of the peak flow meter or microspirometer could be used routinely in primary care for suspected COPD patients. Only those testing positive to these tests would move on to full spirometry, thereby reducing unnecessary spirometric testing.

Identification of depression in women during pregnancy and the early postnatal period using the Whooley questions and the Edinburgh Postnatal Depression Scale: protocol for the Born and Bred in Yorkshire: PeriNatal Depression Diagnostic Accuracy (BaBY PaNDA) study.

INTRODUCTION: Perinatal depression is well recognised as a mental health condition but <50% of cases are identified by healthcare professionals in routine clinical practice. The Edinburgh Postnatal Depression Scale (EPDS) is often used to detect symptoms of postnatal depression in maternity and child services. The National Institute for Health and Care Excellence (NICE) recommends 2 'ultra-brief' case-finding questions (the Whooley questions) to aid identification of depression during the perinatal period, but this recommendation was made in the absence of any validation studies in a perinatal population. Limited research exists on the acceptability of these depression case-finding instruments and the cost-effectiveness of routine screening for perinatal depression. METHODS AND ANALYSIS: The diagnostic accuracy of the Whooley questions and the EPDS will be determined against a reference standard (the Client Interview Schedule-Revised) during pregnancy (around 20 weeks) and the early postnatal period (around 3-4 months post partum) in a sample of 379 women. Further outcome measures will assess a range of psychological comorbidities, health-related quality of life and resource utilisation. Women will be followed up 12 months postnatally. The sensitivity, specificity and predictive values of the Whooley questions and the EPDS will be calculated against the reference standard at 20 weeks pregnancy and 3-4 months post partum. Acceptability of the depression case-finding instruments to women and healthcare professionals will involve in-depth qualitative interviews. An existing decision analytic model will be adapted to determine the cost-effectiveness of routine screening for perinatal depression. ETHICS AND DISSEMINATION: This study is considered low risk for participants. Robust protocols will deal with cases where risk of depression, self-harm or suicide is identified. The protocol received favourable ethical opinion from the North East-York Research Ethics Committee (reference: 11/NE/0022). The study findings will be published in peer-reviewed journals and presented at relevant conferences.

UNderstanding uptake of Immunisations in TravellIng aNd Gypsy communities (UNITING): a qualitative interview study.

BACKGROUND: Gypsies, Travellers and Roma (referred to as Travellers) are less likely to access health services, including immunisation. To improve immunisation rates, we need to understand what helps and hinders individuals in these communities in taking up immunisations. AIMS: (1) Investigate the barriers to and facilitators of acceptability and uptake of immunisations among six Traveller communities across four UK cities; and (2) identify possible interventions to increase uptake of immunisations in these Traveller communities that could be tested in a subsequent feasibility study. METHODS: Three-phase qualitative study underpinned by the social ecological model. Phase 1: interviews with 174 Travellers from six communities: Romanian Roma (Bristol); English Gypsy/Irish Traveller (Bristol); English Gypsy (York); Romanian/Slovakian Roma (Glasgow); Scottish Showpeople (Glasgow); and Irish Traveller (London). Focus on childhood and adult vaccines. Phase 2: interviews with 39 service providers. Data were analysed using the framework approach. Interventions were identified using a modified intervention mapping approach. Phase 3: 51 Travellers and 25 service providers attended workshops and produced a prioritised list of potentially acceptable and feasible interventions. RESULTS: There were many common accounts of barriers and facilitators across communities, particularly across the English-speaking communities. Scottish Showpeople were the most similar to the general population. Roma communities experienced additional barriers of language and being in a new country. Men, women and service providers described similar barriers and facilitators. There was widespread acceptance of childhood and adult immunisation, with current parents perceived as more positive than their elders. A minority of English-speaking Travellers worried about multiple/combined childhood vaccines, adult flu and whooping cough. Cultural concerns about vaccines offered during pregnancy and about human papillomavirus were most evident in the Bristol English Gypsy/Irish Traveller community. Language, literacy, discrimination, poor school attendance, poverty and housing were identified by Travellers and service providers as barriers for some. Trustful relationships with health professionals were important and continuity of care was valued. A few English-speaking Travellers described problems of booking and attending for immunisation. Service providers tailored their approach to Travellers, particularly the Roma. Funding cuts, NHS reforms and poor monitoring challenged their work. Five 'top-priority' interventions were agreed across communities and service providers to improve the immunisation among Travellers who are housed or settled on an authorised site: (1) cultural competence training for health professionals and frontline staff; (2) identification of Travellers in health records to tailor support and monitor uptake; (3) provision of a named frontline person in general practitioner practices to provide respectful and supportive service; (4) flexible and diverse systems for booking appointments, recall and reminders; and (5) protected funding for health visitors specialising in Traveller health, including immunisation. LIMITATIONS: No Travellers living on the roadside or on unofficial encampments were interviewed. We should exert caution in generalising to these groups. FUTURE WORK: To include development, implementation and evaluation of a national policy plan (and practice guidance plan) to promote the uptake of immunisation among Traveller communities. STUDY REGISTRATION: Current Controlled Trials ISRCTN20019630 and UK Clinical Research Network Portfolio number 15182. 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. 20, No. 72. See the NIHR Journals Library website for further project information.

Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis.

BACKGROUND: Patients who have knee instability that is associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee-ankle-foot orthoses (KAFOs). OBJECTIVES: To assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devices prescribed in the UK NHS; and associated costs. METHODS: Qualitative study of views of orthoses users - a qualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed and an inductive approach was used to identify themes. Systematic review - 18 databases were searched up to November 2014: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, Recal Legacy, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and National Technical Information Service. Studies of adults using an orthosis for instability of the knee related to NMD or a CNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis - a web survey of orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed a costing analysis. RESULTS: Qualitative study - a total of 24 people participated. Potential for engagement in daily activities was of vital importance to patients; the extent to which their device enabled this was the yardstick by which it was measured. Patients' prime desired outcome was a reduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems and referral pathways. Systematic review - a total of 21 studies (478 participants) were included of people who had post-polio syndrome, inclusion body myositis, were post stroke or had spinal cord injury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hip KAFOs. All of the studies were at risk of bias and, in general, were poorly reported. Survey and costing analysis - in total, 238 health-care professionals responded. A range of orthoses is prescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence in mobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553. CONCLUSIONS: Various types of orthoses are used in the NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence on the effectiveness of the orthoses is limited, especially in relation to the outcomes that are important to orthoses users. LIMITATIONS: The population included was broad, limiting any in-depth consideration of specific conditions. The response rate to the survey was low, and the costing analysis was based on some assumptions that may not reflect the true costs of providing KAFOs. FUTURE WORK: Future work should include high-quality research on the effectiveness and cost-effectiveness of orthoses; development of a core set of outcome measures; further exploration of the views and experiences of patients; and the best models of service delivery. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Electronic prompts significantly increase response rates to postal questionnaires: a randomized trial within a randomized trial and meta-analysis.

OBJECTIVES: To assess the effectiveness of sending electronic prompts to randomized controlled trial participants to return study questionnaires. STUDY DESIGN AND SETTING: A "trial within a trial" embedded within a study determining the effectiveness of chronic obstructive pulmonary disease (DOC) screening on smoking cessation. Those participants taking part in DOC who provided a mobile phone number and/or an electronic mail address were randomized to either receive an electronic prompt or no electronic prompt to return a study questionnaire. The results were combined with two previous studies in a meta-analysis. RESULTS: A total of 437 participants were randomized: 226 to the electronic prompt group and 211 to the control group. A total of 285 (65.2%) participants returned the follow-up questionnaire: 157 (69.5%) in the electronic prompt group and 128 (60.7%) in the control group [difference 8.8%; 95% confidence interval (CI): -0.11%, 17.7%; P = 0.05]. The mean time to response was 23 days in the electronic prompt group and 33 days in the control group (hazard ratio = 1.27; 95% CI: 1.105, 1.47). The meta-analysis of all three studies showed an increase in response rate of 7.1% (95% CI: 0.8%, 13.3%). CONCLUSION: The use of electronic prompts increased response rates and reduces the time to response.

UNderstanding uptake of Immunisations in TravellIng aNd Gypsy communities (UNITING): protocol for an exploratory, qualitative study.

INTRODUCTION: Gypsies, Travellers and Roma (referred to here as Travellers) experience significantly poorer health and have shorter life expectancy than the general population. They are also less likely to access health services including immunisation. To improve immunisation rates, we need to understand what helps and hinders individuals in these communities in taking up immunisations. This study has two aims: (1) Investigate the barriers and facilitators to acceptability and uptake of immunisations among six Traveller communities in the UK; (2) Identify potential interventions to increase uptake in these Traveller communities. METHODS AND ANALYSIS: A three-phase qualitative study with six Traveller communities. PHASE 1: In each community, we will explore up to 45 Travellers' views about the influences on their immunisation behaviours and ideas for improving uptake in their community. PHASE 2: In each community, we will investigate 6-8 service providers' perspectives on barriers and facilitators to childhood and adult immunisations for Traveller communities with whom they work, and ideas to improve uptake. Interview data will be analysed using the Framework approach. PHASE 3: The findings will be discussed and interventions prioritised in six workshops, each with 10-12 phase 1 and 3-4 phase 2 participants. ETHICS AND DISSEMINATION: This research received approval from NRES Committee Yorkshire and The Humber-Leeds East (Ref. 13/YH/02). It will produce (1) findings on the barriers and facilitators to uptake of immunisations in six Traveller communities; (2) a prioritised list of potentially feasible and acceptable interventions for increasing uptake in these communities; and (3) methodological development in undertaking research with diverse Traveller communities. The study has the potential to inform new ways of delivering services to ensure high immunisation uptake. Findings will be disseminated to participants, relevant UK organisations with responsibility for the implementation of immunisation policy and Traveller health/welfare; and submitted for publication in academic journals. TRIAL REGISTRATION NUMBER: ISRCTN20019630.

Waiting list randomized controlled trial within a case-finding design: methodological considerations.

RATIONALE, AIMS AND OBJECTIVES: Randomized controlled trials (RCTs) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention. However, sometimes a study does not require an RCT in order to answer its primary objective; a case-finding design may be more appropriate. The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study. METHODS: An example of the new study design is the DOC Study, which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease. It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design. The first step of the study design is to obtain participants' consent. Individuals are then randomized to one of two groups; either the 'intervention now' group or the 'intervention later' group, that is, participants are placed on a waiting list. All participants receive the same intervention; the only difference between the groups is the timing of the intervention. RESULTS AND CONCLUSIONS: The design addresses patient preference issues and recruitment issues that can arise in other trial designs. Potential limitations include differential attrition between study groups and potential demoralization for the 'intervention later' group. The 'waiting list case-finding trial' design is a valuable method that could be applied to case-finding studies; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial.

Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial.

INTRODUCTION: The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). METHODS AND ANALYSIS: Adolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness. ETHICS AND DISSEMINATION: The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137). TRIAL REGISTRATION NUMBER: ISRCTN31219579.

The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.

BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants. DESIGN: Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. SETTING: Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. PARTICIPANTS: Retropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation. INTERVENTIONS: Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging. MAIN OUTCOME MEASURE: Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. DATA SOURCES: EHR research database. RESULTS: The governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0.9% respectively. The IT system allowed for complex eligibility criteria with central on and off control of recruitment and flagging at a practice. Good Clinical Practice guidelines, governance and consent procedures were found to have substantially affected the intended simple nature of the trials. One qualitative study of 13 clinicians found that clinicians were generally positive about the principle of computerised trial recruitment (flagging during consultation). However, trials which did not include patients with acute illness were favoured. The second qualitative process evaluation interviewed 27 GPs about their actual experiences, including declining, recruiting and non-recruiting GPs. Opportunistic patient recruitment during a routine GP consultation was found to be the most controversial element. The actual experiences of recruiting patients during unscheduled consultation were generally more positive than the hypothetical views of GPs. Several of the recruiting GPs reported the process took 5 minutes and was straightforward and feasible on most occasions. Almost all GPs expressed their strong support for the use of EHRs for trials. Ten eLung participants were interviewed, all of whom considered it acceptable to be recruited during a consultation and to use EHRs for trials. CONCLUSIONS: EHR point-of-care trials are feasible, although the recruitment of clinicians is a major challenge owing to the complexity of trial approvals. These trials will provide substantial evidence on clinical effectiveness only if trial interventions and participating clinicians and patients are typical of usual clinical care and trials are simple to initiate and conduct. Recommendations for research include the development of evidence and implementation of risk proportionality in trial governance and conduct. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33113202 and ISRCTN72035428. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and the Wellcome Trust and will be published in full in Health Technology Assessment; Vol. 18, No. 43. See the NIHR Journals Library website for further project information.