Search

ObjectiveTo establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.DesignRandomised controlled, open feasibility trial with embedded economic and process evaluations.SettingAudiology departments in two hospitals in two UK cities.ParticipantsTwelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.InterventionsConsenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.Secondary outcome measuresInternational Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.ResultsTwelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.ConclusionsWhile ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.Trial registration numberISRCTN28090877.

Background This article reports the results from a feasibility study of an intervention (‘E-PLAYS’) aimed at supporting children who experience difficulties with social communication. E-PLAYS is based around a dyadic computer game, which aims to develop collaborative and communication skills. A pilot study found that when E-PLAYS was delivered by researchers, improvements on communication test scores and on collaborative behaviours were observed. The aim of this study was to ascertain the feasibility of running a full-scale trial to test the effectiveness of E-PLAYS in a National Health Service (NHS) setting with delivery by speech and language therapists and teaching assistants. Methods The study was a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with a treatment as usual control arm. Data relating to recruitment and retention, treatment fidelity, acceptability to participants, suitability of outcomes and feasibility of collecting health economic measures and of determining cost-effectiveness were collected. Speech and language therapists selected suitable children (ages 4–7 years old) from their caseload. E-PLAYS intervention (experimental group) was then delivered by teaching assistants overseen by speech and language therapists. The control group received usual care. Assessments included blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and non-blinded parent-reported use of health and education resources and quality of life. Results Planned recruitment was for 70 children, in the event, 50 children were recruited which was sufficient for feasibility purposes. E-PLAYS was very highly rated by children, teaching assistants and speech and language therapists and treatment fidelity did not pose any issues. We were able to collect health economic data which suggests that E-PLAYS would be a low-cost intervention. Conclusion Based on recruitment, retention and adherence rates and our outcome measures, a full-scale randomised controlled trial estimated appears feasible and warranted to assess the effectiveness of E-PLAYS for use by the NHS and schools. Trial registration ISRCTN 14818949 (retrospectively registered).

Background Most surgical incisions heal by primary intention (i.e. wound edges are apposed with sutures, clips or glue); however, some heal by secondary intention (i.e. the wound is left open and heals by formation of granulation tissue). There is, however, a lack of evidence regarding the epidemiology, management and impact on patients’ quality of life of these surgical wounds healing by secondary intention, resulting in uncertainty regarding effective treatments and difficulty in planning care and research. Objectives To derive a better understanding of the nature, extent, costs, impact and outcomes of surgical wounds healing by secondary intention, effective treatments, and the value and nature of further research. Design Cross-sectional survey; inception cohort; cost-effectiveness and value of implementation analyses; qualitative interviews; and pilot, feasibility randomised controlled trial. Setting Acute and community care settings in Leeds and Hull, Yorkshire, UK. Participants Adults (or for qualitative interviews, patients or practitioners) with previous experience of a surgical wound healing by secondary intention. Inclusion criteria varied between the individual workstreams. Interventions The pilot, feasibility randomised controlled trial compared negative-pressure wound therapy – a device applying a controlled vacuum to a wound via a dressing – with usual care (no negative-pressure wound therapy). Results Survey data estimated that treated surgical wounds healing by secondary intention have a point prevalence of 4.1 per 10,000 population (95% confidence interval 3.5 to 4.7 per 10,000 population). Surgical wounds healing by secondary intention most frequently occurred following colorectal surgery (n = 80, 42.8% cross-sectional survey; n = 136, 39.7% inception cohort) and were often planned before surgery (n = 89, 47.6% cross-sectional survey; n = 236, 60.1% inception cohort). Wound care was frequently delivered in community settings (n = 109, 58.3%) and most patients (n = 184, 98.4%) received active wound treatment. Cohort data identified hydrofibre dressings (n = 259, 65.9%) as the most common treatment, although 29.3% (n = 115) of participants used negative-pressure wound therapy at some time during the study. Surgical wounds healing by secondary intention occurred in 81.4% (n = 320) of participants at a median of 86 days (95% confidence interval 75 to 103 days). Baseline wound area (p ≤ 0.01), surgical wound contamination (determined during surgery; p = 0.04) and wound infection at any time (p ≤ 0.01) (i.e. at baseline or postoperatively) were found to be predictors of prolonged healing. Econometric models, using observational, cohort study data, identified that, with little uncertainty, negative-pressure wound therapy treatment is more costly and less effective than standard dressing treatment for the healing of open surgical wounds. Model A (ordinary least squares with imputation) effectiveness: 73 days longer than those who did not receive negative-pressure wound therapy (95% credible interval 33.8 to 112.8 days longer). Model A cost-effectiveness (associated incremental quality-adjusted life-years): observables –0.012 (standard error 0.005) and unobservables –0.008 (standard error 0.011). Model B (two-stage model, logistic and linear regression) effectiveness: 46 days longer than those who did not receive negative-pressure wound therapy (95% credible interval 19.6 to 72.5 days longer). Model B cost-effectiveness (associated incremental quality-adjusted life-years): observables –0.007 (standard error 0.004) and unobservables –0.027 (standard error 0.017). Patient interviews (n = 20) identified initial reactions to surgical wounds healing by secondary intention of shock and disbelief. Impaired quality of life characterised the long healing process, with particular impact on daily living for patients with families or in paid employment. Patients were willing to try any treatment promising wound healing. Health professionals (n = 12) had variable knowledge of surgical wound healing by secondary intention treatments and, frequently, favoured negative-pressure wound therapy, despite the lack of robust evidence. The pilot feasibility randomised controlled trial screened 248 patients for eligibility and subsequently recruited and randomised 40 participants to receive negative-pressure wound therapy or usual care (no negative-pressure wound therapy). Data indicated that it was feasible to complete a full randomised controlled trial to provide definitive evidence for the clinical effectiveness and cost-effectiveness of negative-pressure wound therapy as a treatment for surgical wounds healing by secondary intention. Key elements and recommendations for a larger randomised controlled trial were identified. Limitations This research programme was conducted in a single geographical area (i.e. Yorkshire and the Humber, UK) and local guidelines and practices may have affected treatment availability, and so may not represent UK-wide treatment choices. A wide range of wound types were included; however, some wound types may be under-represented, meaning that this research may not represent the overall surgical wound healing by secondary intention population. The lack of randomised controlled trial data on the relative effects of negative-pressure wound therapy in surgical wounds healing by secondary intention resulted in much of the economic modelling being based on observational data. Observational data, even with extensive adjustment, do not negate the potential for unresolved confounding to affect the results, which can reduce confidence in conclusions drawn from observational data. Definitive evidence from a randomised controlled trial may be the only way to overcome this lack of confidence. Conclusions This research has provided new information regarding the nature, extent, costs, impacts and outcomes of surgical wounds healing by secondary intention, treatment effectiveness, and the value and nature of future research, while addressing previous uncertainties regarding the problem of surgical wounds healing by secondary intention. Aspects of our research indicate that negative-pressure wound therapy is more costly and less effective than standard dressing for the healing of open surgical wounds. However, because this conclusion is based solely on observational data, it may be affected by unresolved confounding. Should a future randomised controlled trial be considered necessary, its design should reflect careful consideration of the findings of this programme of research. Future work This research signals the importance of further research on surgical wound healing by secondary intention. Key research questions raised by this programme of research include (1) which treatments are clinically effective and cost-effective for surgical wound healing by secondary intention for all patients or for particular patient subgroups? (2) Can particular prognostic factors predict time to healing of surgical wound healing by secondary intention? And (3) do psychosocial interventions have the potential to improve quality of life in people with hard-to-heal surgical wound healing by secondary intention? Given that negative-pressure wound therapy has been widely adopted, with relatively little evidence to support its use, the design and outcomes of a randomised controlled trial would need to be carefully considered. We focused in this research on wound healing, and maintain, based on the findings of patient interviews, that this is a key outcome for future research. Impacts of negative-pressure wound therapy on outcomes such as infection and reoperation should also be considered, as should patients’ views of the treatment. The type of patient group recruited and the outcomes of interest will all influence the duration of follow-up of any planned study. The comparator in any future study will also need careful consideration. Trial registration Current Controlled Trials ISRCTN12761776. Funding This project was funded by the National Institute for Health Research Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 7. See the National Institute for Health Research Journals Library website for further project information.

Background Online psychotherapy has been successfully used as supportive treatment in many chronic illnesses. However, there is a lack of evidence on its role in the management of gastrointestinal (GI) diseases. Aims To examine whether online psychological interventions improve mental and physical outcomes in gastrointestinal diseases. Methods We searched CINAHL Plus, MEDLINE, EMBASE, Health Management Information Consortium, PsycINFO, British Nursing Index, Cochrane Library, a specialised register of the IBD/FBD Cochrane Group, MEDLINE (PubMed) WHO International Clinical Trial Registry, ClinicalTrials.gov, and reference lists of all papers included in the review. The Cochrane Risk of Bias Tool was used to assess internal validity. Where possible, data were pooled using random-effects meta-analysis. Results We identified 11 publications (encompassing nine studies) meeting inclusion criteria. One study had a high risk of selection bias (allocation concealment), all studies had a high risk of performance and detection bias. Eight studies were included in the meta-analyses (6 on irritable bowel syndrome [IBS] and two on inflammatory bowel disease [IBD]). Online cognitive behavioural therapy (CBT) was shown to significantly improve gastrointestinal symptom-specific anxiety (MD: -8.51, 95% CI -12.99 to -4.04, P = 0.0002) and lessen symptom-induced disability (MD: -2.78, 95% CI -5.43 to -0.12, P = 0.04) in IBS post intervention. There was no significant effect of online CBT on any other outcomes in IBS. No significant effect of online psychotherapy was demonstrated in IBD. Conclusion There is insufficient evidence to demonstrate the effectiveness of online CBT to manage mental and physical outcomes in gastrointestinal diseases.

PURPOSE: Previous research has shown atrophy of visual cortex can occur in retinotopic representations of retinal lesions resulting from eye disease. However, the time course of atrophy cannot be established from these cross-sectional studies, which included patients with longstanding disease of varying severity. Our aim, therefore, was to measure visual cortical structure over time in participants after onset of unilateral visual loss resulting from AMD. METHODS: Inclusion criteria were onset of acute unilateral neovascular AMD with bilateral dry AMD based on clinical examination. Therefore, substantial loss of unilateral visual input to cortex was relatively well-defined in time. Changes in cortical anatomy were assessed in the occipital lobe as a whole, and in cortical representations of the lesion and intact retina, the lesion and intact projection zones, respectively. Whole brain, T1-weighted magnetic resonance imaging was taken at diagnosis (before antiangiogenic treatment to stabilize the retina), during the 3- to 4-month initial treatment period, with a long-term follow-up approximately 5 (range 3.8-6.1 years) years later. RESULTS: Significant cortical atrophy was detected at long-term follow-up only, with a reduction in mean cortical volume across the whole occipital lobe. Importantly, this reduction was explained by cortical thinning of the lesion projection zone, which suggests additional changes to those associated with normal aging. Over the period of study, antiangiogenic treatment stabilized visual acuity and central retinal thickness, suggesting that the atrophy detected was most likely governed by long-term decreased visual input. CONCLUSIONS: Our results indicate that consequences of eye disease on visual cortex are atrophic and retinotopic. Our work also raises the potential to follow the status of visual cortex in individuals over time to inform on how best to treat patients, particularly with restorative techniques.

© 2019 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. Aims: Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost-effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo. Methods and results: Parallel group, double-blind, randomized, placebo-controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between-group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment-emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39–89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, −0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change-from-baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise-related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment-emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2. Conclusions: We could not answer our primary objectives due to inadequate power. However, we provide novel placebo-controlled medium-term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects.

IntroductionThe majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.Methods and analysisThis feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.Ethics and disseminationEthical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.Trial registration numberISRCTN15043643.

Objectives Evidence suggests that maternal psychological distress is an under-diagnosed condition that can have lasting impacts on child outcomes. Models based solely on maternal outcomes have not found screening to be cost-effective. This research explores the effects of self-reported maternal psychological distress on children’s language and behavioural development up to the age of 7. Methods Using longitudinal survey data from 10,893 families in the UK Millennium Cohort Study, multilevel models are used to explore the differential effects of maternal diagnosed and treated depression versus untreated maternal psychological distress during the postnatal year on longer-term child outcomes. Results Both diagnosed and treated depression and self-reported maternal psychological distress have detrimental effects on child behavioural development. Behavioural outcomes up to age 5 were better for children of women who received treatment for depression, compared with children those whose mothers’ psychological distress was untreated, but this was not maintained to age 7. Little or no evidence of a difference was found between maternal psychological distress and child language development. Conclusions for Practice This research highlights the lack of effectiveness of existing treatment for maternal psychological distress both to benefit child development and to provide long-term symptom remediation for women. Future research could aim to identify more effective treatments for both women and children.

A number of children experience difficulties with social communication and this has long-term deleterious effects on their mental health, social development and education. The proposal presented in this article describes a feasibility study for a trial to test an intervention (‘E-PLAYS’) aimed at supporting children with social communication impairments. E-PLAYS harnesses technology in the form of a novel computer game in order to develop collaborative and communication skills. Preliminary studies by the authors show that when E-PLAYS was administered by the research team, children with social communication impairments showed improvements on communication test scores and on observed collaborative behaviours. The study described here is a pragmatic trial to test the application of E-PLAYS delivered by NHS speech and language therapists together with schools. This protocol outlines a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with treatment as usual control arm, with randomisation at the level of the speech and language therapist. The aim of this study is to ascertain whether it will be feasible to progress to running a full-scale definitive trial to test the effectiveness of E-PLAYS in an NHS setting. Data relating to recruitment and retention, the appropriateness of outcomes and the acceptability of E-PLAYS to participants will be collected. Speech and language therapists will select suitable children (ages 4–7 years old) from their caseloads and deliver either the E-PLAYS intervention (experimental group) or treatment as usual (control group). Assessments will include blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and parent-reported use of resources and quality of life. There will also be a qualitative process evaluation. The findings of this study will inform the decision as to whether to progress to a full-scale definitive randomised controlled trial to test the effectiveness of E-PLAYS when delivered by speech and language therapists and teaching assistants within schools. The use of technology in game form is a novel approach in an area where there are currently few available interventions. ISRCTN 14818949 (retrospectively registered).

Background: Surgical wounds healing by secondary intention can be difficult and costly to manage and are profoundly under researched. This prospective inception, cohort study aimed to derive a better understanding of surgical wounds healing by secondary intention and to facilitate the design of future research investigating effective treatments. Objectives: To investigate the clinical characteristics of patients with surgical wounds healing by secondary intention and the surgeries that preceded their wounds; to clearly delineate the clinical outcomes of these patients, specifically focusing on time to wound healing and its determinants; to explore the types of treatments for surgical wounds healing by secondary intention; and to assess the impact surgical wounds healing by secondary intention have on patients’ quality of life. Design: Prospective, inception cohort study. Setting: Acute and community settings in eight sites across two large centres in the United Kingdom (Hull and Leeds, UK). Methods: Patients with a surgical wounds healing by secondary intention (an open wound, < 3 weeks’ duration, resulting from surgery), were recruited and followed up for at least 12 months. Key outcome events included: time to healing; treatment type; infection; hospital re-admission and further procedures; health-related quality of life and pain. Results: In total, 393 patients were recruited. Common co-morbidities were cardiovascular disease (38%), diabetes (26%) and peripheral vascular disease (14.5%). Baseline median SWHSI area was 6 cm2 (range 0.01-1200). Abdominal (n=132), foot (n=59), leg (n=58) and peri-anal (n=34) wounds were common. The majority of wounds (236, 60.1%) were intentionally left open following surgery; the remainder were mostly dehisced wounds. Healing was observed in 320 (81.4%) wounds with a median time to healing of 86 days (95% CI: 75-130). Factors associated with delayed healing included wound infection at any point and baseline wound area above the median. Health-related quality of life scores were low at baseline but improved with time and healing. Conclusions: This is the first inception cohort study in patients with surgical wounds healing by secondary intention. Patient characteristics have been clearly defined, with prolonged healing times and adverse events being common impacting on patient’s health-related quality of life. Areas for, and factors crucial to the design of, future research have been identified. Key Words: Surgical wounds, secondary intention, inception cohort, characteristics, clinical outcomes, treatments, quality of life.

ObjectivesTo determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot.DesignMulticentre parallel group feasibility RCT.SettingFive prosthetics centres in England recruiting from July 2018 to August 2019.ParticipantsAdults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot.InterventionParticipants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot.OutcomesFeasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire.ResultsFifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%–94%, and clinical assessments were 92%–95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively.ConclusionsThis feasibility trial recruited and retained participants who were categorised as having ‘limited community mobility’ following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery.Trial registration numberISRCTN15043643.

Summary Background Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. Methods We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation ( vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. Findings Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64–1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI −47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99–1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77–1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother–child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention. Interpretation Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge. Funding Department of Health Policy Research Programme.

Gypsies, Roma and Travellers (GRT) are socially excluded groups where evidence for improving health is weakest. Although GRT communities are diverse, and robust evidence of health needs is lacking, there is consensus that GRT in the UK have poorer health and lower life expectancy than the general population and other disadvantaged groups. Reasons why GRT are vulnerable to poor health outcomes include poor living conditions, high rates of homelessness, low educational achievement, social exclusion, widespread prejudice and discrimination and barriers to accessing healthcare. These multiple factors, alongside poor quality care that does not meet needs, may lead to low expectations and mistrust of health services. Trust in services and personnel is associated with increased utilisation of healthcare, improved health behaviours and quality of care. Community engagement strategies have the potential to enhance trust and ensure services are tailored to the needs of specific populations. This multi-component study aimed to strengthen evidence on how to improve uptake and delivery of health services and thereby reduce health inequalities for GRT.

Introduction Up to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service. Methods and analysis This will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews. Ethics and dissemination Ethical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins. Trial registration number ISRCTN28090877. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Background Gypsy, Roma and Traveller people represent the most disadvantaged minority groups in Europe, having the poorest health outcomes. This systematic review addressed the question of how Gypsy, Roma and Traveller people access healthcare and what are the best ways to enhance their engagement with health services. Methods Searches were conducted in 21 electronic databases complemented by a focussed Google search. Studies were included if they had sufficient focus on Gypsy, Roma or Traveller populations; reported data pertinent to healthcare service use or engagement and were published in English from 2000 to 2015. Study findings were analyzed thematically and a narrative synthesis reported. Results Ninety-nine studies from 32 countries were included, covering a range of health services. Nearly one-half of the presented findings related to primary healthcare services. Reported barriers to health service usage related to organisation of health systems, discrimination, culture and language, health literacy, service-user attributes and economic barriers. Promising engagement strategies included specialist roles, outreach services, dedicated services, raising health awareness, handheld records, training for staff and collaborative working. Conclusion This review provides evidence that Gypsy, Roma and Traveller populations across Europe struggle to exercise their right to healthcare on account of multiple barriers; and related to other determinants of disadvantage such as low literacy levels and experiences of discrimination. Some promising strategies to overcome barriers were reported but the evidence is weak; therefore, rigorous evaluations of interventions to improve access to and engagement with health services for Gypsy, Roma and Traveller people are needed.

Individual, social, and economic circumstances faced by teenage mothers can challenge a successful start for children and interrupt mothers' long-term socioeconomic stability. The Family-Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the United States and introduced into practice in England. Family-Nurse Partnership involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. This study aimed to assess the effectiveness of providing the program to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. A pragmatic, nonblinded, randomized controlled, parallel-group trial was conducted in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organizations in England. Eligible participants were nulliparous, aged 19 years or younger, living within the catchment area of a local FNP team, of less than 25 weeks' gestation, and able to provide consent and speak English. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and Web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimized by gestation (=16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Primary outcomes were tobacco use at late pregnancy (34–36 weeks' gestation), birth weight, emergency attendances, and hospital admissions for the infant within 24 months of birth, as well as the proportion of women with a second pregnancy within 24 months postpartum. Between 2009, and 2010, 3251 women were screened. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. The mean (SD) birth weight of 742 babies with mothers assigned to FNP was 3217.4 (618.0) g, whereas birth weight of 768 babies assigned to usual care was 3197.5 (581.5) g (adjusted mean difference, 20.75 g; 97.5% confidence interval [CI], -47.73 to 89.23). It was found that 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (adjusted odds ratio, 1.32; 97.5% CI, 0.99-1.76). The results of the study indicate that adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. The continuation of the program is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge.

Rational, aims, and objectives The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention developed in the United States. It has been provided in England by the Department of Health since 2006. The Building Blocks trial assessed the effectiveness and cost-effectiveness of FNP in England. Methods We performed a cost-utility analysis (National Health Service (NHS) perspective) alongside the Building Blocks trial (over 2.5 y). The analysis was conducted in accordance with National Institute for Health and Clinical Excellence (NICE) reference case standards. Health-related quality of life was elicited from mothers using the EQ-5D-3L. Resource-use data were collected from self-reported questionnaires, Hospital Episode Statistics, general practitioner records and the central Department of Health FNP database. Costs and quality-adjusted life years (QALYs) were discounted at 3.5%. The base case analysis used an intention to treat approach on the imputed dataset using multiple imputation. Results The FNP intervention costs on average £1812 more per participant compared to usual care (95% confidence interval: −£2700; £5744). Incremental adjusted mean QALYs are marginally higher for FNP (mean difference 0.0036, 95% confidence interval: −0.017; 0.025). The probability of FNP being cost-effective is less than 20% given the current NICE willingness to pay threshold of £20 000 per additional QALY. The results were robust to sensitivity analyses. Conclusion Given the absence of significant benefits of FNP in terms of the primary outcomes of the trial and only marginal maternal QALY gains, FNP does not represent a cost-effective intervention when compared with existing services already offered to young pregnant women.

Background: Verrucae are a common foot skin pathology which can in some cases persist for many years. Plantar verrucae can be unsightly and painful. There are a range of treatment options including needling. Objectives: The EVerT2 trial aimed to evaluate the clinical and cost effectiveness of the needling procedure for the treatment of plantar verrucae, relative to callus debridement. Methods: This single centre randomised controlled trial recruited 60 participants (aged 18 years and over with a plantar verruca). Participants were randomised 1:1 to the intervention group (needling) or the control group (debridement of the overlying callus). The primary outcome was clearance of the index verruca at 12 weeks after randomisation. Secondary outcomes include recurrence of the verruca; clearance of all verrucae; number of verrucae; size of the index verruca; pain; and participant satisfaction at 12 and 24 weeks. A cost-effectiveness analysis was carried out from the NHS perspective over 12 weeks. Results: Sixty eligible patients were randomised (needling group n=29, 48.3%; debridement group n=31, 51.7%) and 53 were included in the primary analysis (needling n=28, 96.6%; debridement n=25, 80.7%). Clearance of the index verruca occurred in 8 (15.1%) participants (needling n=4, 14.3%; debridement n=4, 16.0%, p=0.86). The needling intervention costs were on average £14.33 (95% CI 5.32 to 23.35) more per patient than debridement. Conclusions: There is no evidence that the needling technique is more clinically or cost effective than callus debridement. The results show a significant improvement in pain outcomes after needling compared to the debridement treatment alone. Trial registration number: Current Controlled Trials ISRCTN16429440

Background\ud Despite effective assessment methods and medications targeting osteoporosis and related fractures, screening for fracture risk is not currently advocated in the UK. We tested whether a community-based screening intervention could reduce fractures in older women.\ud \ud Methods\ud We did a two-arm randomised controlled trial in women aged 70–85 years to compare a screening programme using the Fracture Risk Assessment Tool (FRAX) with usual management. Women were recruited from 100 general practitioner (GP) practices in seven regions of the UK: Birmingham, Bristol, Manchester, Norwich, Sheffield, Southampton, and York. We excluded women who were currently on prescription anti-osteoporotic drugs and any individuals deemed to be unsuitable to enter a research study (eg, known dementia, terminally ill, or recently bereaved). The primary outcome was the proportion of individuals who had one or more osteoporosis-related fractures over a 5-year period. In the screening group, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. Prespecified secondary outcomes were the proportions of participants who had at least one hip fracture, any clinical fracture, or mortality; and the effect of screening on anxiety and health-related quality of life. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN 55814835.\ud \ud Findings\ud 12 483 eligible women were identified and participated in the trial, and 6233 women randomly assigned to the screening group between April 15, 2008, and July 2, 2009. Treatment was recommended in 898 (14%) of 6233 women. Use of osteoporosis medication was higher at the end of year 1 in the screening group compared with controls (15% vs 4%), with uptake particularly high (78% at 6 months) in the screening high-risk subgroup. Screening did not reduce the primary outcome of incidence of all osteoporosis-related fractures (hazard ratio [HR] 0·94, 95% CI 0·85–1·03, p=0·178), nor the overall incidence of all clinical fractures (0·94, 0·86–1·03, p=0·183), but screening reduced the incidence of hip fractures (0·72, 0·59–0·89, p=0·002). There was no evidence of differences in mortality, anxiety levels, or quality of life.\ud \ud Interpretation\ud Systematic, community-based screening programme of fracture risk in older women in the UK is feasible, and could be effective in reducing hip fractures.\ud \ud Funding\ud Arthritis Research UK and Medical Research Council.\ud \ud

Background Gypsy/Travellers have poor health and experience discrimination alongside structural and cultural barriers when accessing health services and consequently may mistrust those services. Our study aims to investigate which approaches to community engagement are most likely to be effective at enhancing trust between Gypsy/Travellers and mainstream health services. Methods This multi-method 30-month study, commenced in June 2015, and comprises four stages.Three related reviews: a) systematic review of Gypsy/Travellers’ access to health services; b) systematic review of reviews of how trust has been conceptualised within healthcare; c) realist synthesis of community engagement approaches to enhance trust and increase Gypsy/Travellers’ participation in health services. The reviews will consider any economic literature;Online consultation with health and social care practitioners, and civil society organisations on existing engagement activities, including perceptions of barriers and good practice;Four in-depth case studies of different Gypsy/Traveller communities, focusing on maternity, early years and child dental health services. The case studies include the views of 32–48 mothers of pre-school children, 32–40 healthcare providers and 8–12 informants from third sector organisations.Two stakeholder workshops exploring whether policy options are realistic, sustainable and replicable. Case study data will be analysed thematically informed by the evaluative framework derived from the realist synthesis in stage one. The main outputs will be: a) an evaluative framework of Gypsy/Travellers’ engagement with health services; b) recommendations for policy and practice; c) evidence on which to base future implementation strategies including estimation of costs. Discussion Our novel multi-method study seeks to provide recommendations for policy and practice that have potential to improve uptake and delivery of health services, and to reduce lifetime health inequalities for Gypsy/Travellers. The findings may have wider resonance for other marginalised populations. Strengths and limitations of the study are discussed. Trial registration Prospero registration for literature reviews: CRD42015021955 and CRD42015021950 UKCRN reference: 20036

Objectives To assess the effectiveness of including a pen in postal questionnaires on response rate, necessity of reminders, time to response, and completeness of response to the primary outcome question (POQ). Study Design and Setting A two-arm randomized controlled trial (RCT) embedded within the screening of older women for prevention of fracture trial (SCOOP). Women, aged 70–75 years, were randomized to receive a pen with their questionnaire (n = 3,826) or to receive the questionnaire alone (n = 3,829). The results were combined with another embedded RCT in a meta-analysis. Results A response rate of 92.4% was observed in the pen group compared with 91.3% in the control group (odds ratio [OR] = 1.16; 95% confidence interval [CI]: 0.98, 1.37; P = 0.08). There was a difference in reminders required (OR = 0.88; 95% CI: 0.79, 0.98; P = 0.02), time to response (hazard ratio = 1.06; 95% CI: 1.01, 1.11; P = 0.01) and some difference in the completeness of response to the POQ (OR = 1.18; 95% CI: 1.00, 1.39; P = 0.05). The pooled OR from the meta-analysis for response rate was 1.21 (95% CI: 1.05, 1.39; P = 0.01). Conclusion Inclusion of a pen with postal questionnaires potentially has a positive impact on response rates and the number of reminders required. There may be some reduction in time to response. Studies of different participant groups are needed to test the effectiveness over more diverse populations.

Introduction: Verrucae are extremely common, and are experienced by most people at some time during their lives. Although most verrucae will spontaneously disappear without treatment, many patients seek treatment, often because they have persisted for many years, are unsightly or painful or prevent them from doing sports or other activities. There are many different treatments available; including the Falknor’s needling procedure. To date, there has only been one small trial evaluating the clinical effectiveness of this treatment and no health economic analysis has been undertaken. The Effective Verruca Treatments (EVerT2) trial aims to evaluate the clinical and cost-effectiveness of the\ud needling procedure for the treatment of verrucae.\ud Methods and analysis: This single-centre randomised controlled trial will recruit 58 participants (aged 18 years and over with a plantar verruca) from Salford Podiatry Clinic patient lists and the surrounding area. If the participant presents with multiple verrucae, an ‘index’ verruca (largest and thickest lesion) will be identified and patients will be randomised 1:1 to the intervention group to receive the needling treatment or the control group to have the callus overlying the verruca debrided. The primary outcome is complete clearance of the index verruca at 12 weeks after randomisation. Secondary outcomes include clearance and recurrence of the treated verruca, clearance of all verrucae, number of verrucae remaining, change in size of the index verruca, pain, and participant satisfaction. A cost-effectiveness analysis of the needling versus callus debridement will be carried out from the perspective of health services over a time horizon of 12 weeks.\ud Ethics and dissemination: Ethical approval has been obtained from the University of Salford, Department of Health Sciences Ethical Approval Committee (HSCR15/24) and the University of York, Department of Health Sciences Research Governance Committee (HSRGC/2014/98/B). Findings will be disseminated through publication and conference presentations.\ud Trial registration number: ISRCTN16429440.

Economic evaluation alongside trials is often based on data collected through self-reported questionnaires. Consequently, there are consistent problems with incomplete (missing) data irrespective of how well data collection methods are designed. Missing data poses a significant problem when conducting economic analyses of clinical trials, potentially leading to incorrect conclusions being drawn concerning an interventions’ cost-effectiveness.