The Infant KIdney Dialysis and Utrafiltration (I-KID) Study: A Stepped-Wedge Cluster-Randomized Study in Infants, Comparing Peritoneal Dialysis, Continuous Venovenous Hemofiltration, and Newcastle Infant Dialysis Ultrafiltration System, a Novel Infant Hemodialysis Device.

OBJECTIVES: Renal replacement therapy (RRT) options are limited for small babies because of lack of available technology. We investigated the precision of ultrafiltration, biochemical clearances, clinical efficacy, outcomes, and safety profile for a novel non-Conformité Européenne-marked hemodialysis device for babies under 8 kg, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with the current options of peritoneal dialysis (PD) or continuous venovenous hemofiltration (CVVH). DESIGN: Nonblinded cluster-randomized cross-sectional stepped-wedge design with four periods, three sequences, and two clusters per sequence. SETTING: Clusters were six U.K. PICUs. PATIENTS: Babies less than 8 kg requiring RRT for fluid overload or biochemical disturbance. INTERVENTIONS: In controls, RRT was delivered by PD or CVVH, and in interventions, NIDUS was used. The primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances. MEASUREMENTS AND MAIN RESULTS: At closure, 97 participants were recruited from the six PICUs (62 control and 35 intervention). The primary outcome, obtained from 62 control and 21 intervention patients, showed that ultrafiltration with NIDUS was closer to that prescribed than with control: sd controls, 18.75, intervention, 2.95 (mL/hr); adjusted ratio, 0.13; 95% CI, 0.03-0.71; p = 0.018. Creatinine clearance was smallest and least variable for PD (mean, sd ) = (0.08, 0.03) mL/min/kg, larger for NIDUS (0.46, 0.30), and largest for CVVH (1.20, 0.72). Adverse events were reported in all groups. In this critically ill population with multiple organ failure, mortality was lowest for PD and highest for CVVH, with NIDUS in between. CONCLUSIONS: NIDUS delivers accurate, controllable fluid removal and adequate clearances, indicating that it has important potential alongside other modalities for infant RRT.

A collaborative approach to develop an intervention to strengthen health visitors' role in prevention of excess weight gain in children.

BACKGROUND: The high prevalence of childhood obesity is a concern for public health policy and practitioners, leading to a focus on early prevention. UK health visitors (HVs) are well-positioned to prevent excessive weight gain trends in pre-school children but experience barriers to implementing guideline recommended practices. This research engaged with HVs to design an intervention to strengthen their role in prevention of early childhood obesity. METHODS: We describe the processes we used to develop a behaviour change intervention and measures to test its feasibility. We conducted a systematic review to identify factors associated with implementation of practices recommended for prevention of early childhood obesity. We carried out interactive workshops with HVs who deliver health visiting services in County Durham, England. Workshop format was informed by the behaviour change wheel framework for developing theory-based interventions and incorporated systematic review evidence. As intended recipients of the intervention, HVs provided their views of what is important and acceptable in the local context. The findings of the workshops were combined in an iterative process to inform the four steps of the Implementation Intervention development framework that was adapted as a practical guide for the development process. RESULTS: Theoretical analysis of the workshop findings revealed HVs' capabilities, opportunities and motivations related to prevention of excess weight in 0-2 year olds. Intervention strategies deemed most likely to support implementation (enablement, education, training, modelling, persuasion) were combined to design an interactive training intervention. Measures to test acceptability, feasibility, and fidelity of delivery of the proposed intervention were identified. CONCLUSIONS: An interactive training intervention has been designed, informed by theory, evidence, and expert knowledge of HVs, in an area of health promotion that is currently evolving. This research addresses an important evidence-practice gap in prevention of childhood obesity. The use of a systematic approach to the development process, identification of intervention contents and their hypothesised mechanisms of action provides an opportunity for this research to contribute to the body of literature on designing of implementation interventions using a collaborative approach. Future research should be directed to evaluate the acceptability and feasibility of the intervention.

Effect of Different Corticosteroid Dosing Regimens on Clinical Outcomes in Boys With Duchenne Muscular Dystrophy: A Randomized Clinical Trial.

Importance: Corticosteroids improve strength and function in boys with Duchenne muscular dystrophy. However, there is uncertainty regarding the optimum regimen and dosage. Objective: To compare efficacy and adverse effects of the 3 most frequently prescribed corticosteroid regimens in boys with Duchenne muscular dystrophy. Design, Setting, and Participants: Double-blind, parallel-group randomized clinical trial including 196 boys aged 4 to 7 years with Duchenne muscular dystrophy who had not previously been treated with corticosteroids; enrollment occurred between January 30, 2013, and September 17, 2016, at 32 clinic sites in 5 countries. The boys were assessed for 3 years (last participant visit on October 16, 2019). Interventions: Participants were randomized to daily prednisone (0.75 mg/kg) (n = 65), daily deflazacort (0.90 mg/kg) (n = 65), or intermittent prednisone (0.75 mg/kg for 10 days on and then 10 days off) (n = 66). Main Outcomes and Measures: The global primary outcome comprised 3 end points: rise from the floor velocity (in rise/seconds), forced vital capacity (in liters), and participant or parent global satisfaction with treatment measured by the Treatment Satisfaction Questionnaire for Medication (TSQM; score range, 0 to 100), each averaged across all study visits after baseline. Pairwise group comparisons used a Bonferroni-adjusted significance level of .017. Results: Among the 196 boys randomized (mean age, 5.8 years [SD, 1.0 years]), 164 (84%) completed the trial. Both daily prednisone and daily deflazacort were more effective than intermittent prednisone for the primary outcome (P < .001 for daily prednisone vs intermittent prednisone using a global test; P = .017 for daily deflazacort vs intermittent prednisone using a global test) and the daily regimens did not differ significantly (P = .38 for daily prednisone vs daily deflazacort using a global test). The between-group differences were principally attributable to rise from the floor velocity (0.06 rise/s [98.3% CI, 0.03 to 0.08 rise/s] for daily prednisone vs intermittent prednisone [P = .003]; 0.06 rise/s [98.3% CI, 0.03 to 0.09 rise/s] for daily deflazacort vs intermittent prednisone [P = .017]; and -0.004 rise/s [98.3% CI, -0.03 to 0.02 rise/s] for daily prednisone vs daily deflazacort [P = .75]). The pairwise comparisons for forced vital capacity and TSQM global satisfaction subscale score were not statistically significant. The most common adverse events were abnormal behavior (22 [34%] in the daily prednisone group, 25 [38%] in the daily deflazacort group, and 24 [36%] in the intermittent prednisone group), upper respiratory tract infection (24 [37%], 19 [29%], and 24 [36%], respectively), and vomiting (19 [29%], 17 [26%], and 15 [23%]). Conclusions and Relevance: Among patients with Duchenne muscular dystrophy, treatment with daily prednisone or daily deflazacort, compared with intermittent prednisone alternating 10 days on and 10 days off, resulted in significant improvement over 3 years in a composite outcome comprising measures of motor function, pulmonary function, and satisfaction with treatment; there was no significant difference between the 2 daily corticosteroid regimens. The findings support the use of a daily corticosteroid regimen over the intermittent prednisone regimen tested in this study as initial treatment for boys with Duchenne muscular dystrophy. Trial Registration: ClinicalTrials.gov Identifier: NCT01603407.

Interventions for tobacco cessation delivered by dental professionals.

BACKGROUND: Dental professionals are well placed to help their patients stop using tobacco products. Large proportions of the population visit the dentist regularly. In addition, the adverse effects of tobacco use on oral health provide a context that dental professionals can use to motivate a quit attempt. OBJECTIVES: To assess the effectiveness, adverse events and oral health effects of tobacco cessation interventions offered by dental professionals. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialised Register up to February 2020. SELECTION CRITERIA: We included randomised and quasi-randomised clinical trials assessing tobacco cessation interventions conducted by dental professionals in the dental practice or community setting, with at least six months of follow-up. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed abstracts for potential inclusion and extracted data from included trials. We resolved disagreements by consensus. The primary outcome was abstinence from all tobacco use (e.g. cigarettes, smokeless tobacco) at the longest follow-up, using the strictest definition of abstinence reported. Individual study effects and pooled effects were summarised as risk ratios (RR) and 95% confidence intervals (CI), using Mantel-Haenszel random-effects models to combine studies where appropriate. We assessed statistical heterogeneity with the I2 statistic. We summarised secondary outcomes narratively. MAIN RESULTS: Twenty clinical trials involving 14,897 participants met the criteria for inclusion in this review. Sixteen studies assessed the effectiveness of interventions for tobacco-use cessation in dental clinics and four assessed this in community (school or college) settings. Five studies included only smokeless tobacco users, and the remaining studies included either smoked tobacco users only, or a combination of both smoked and smokeless tobacco users. All studies employed behavioural interventions, with four offering nicotine treatment (nicotine replacement therapy (NRT) or e-cigarettes) as part of the intervention. We judged three studies to be at low risk of bias, one to be at unclear risk of bias, and the remaining 16 studies to be at high risk of bias. Compared with usual care, brief advice, very brief advice, or less active treatment, we found very low-certainty evidence of benefit from behavioural support provided by dental professionals, comprising either one session (RR 1.86, 95% CI 1.01 to 3.41; I2 = 66%; four studies, n = 6328), or more than one session (RR 1.90, 95% CI 1.17 to 3.11; I2 = 61%; seven studies, n = 2639), on abstinence from tobacco use at least six months from baseline. We found moderate-certainty evidence of benefit from behavioural interventions provided by dental professionals combined with the provision of NRT or e-cigarettes, compared with no intervention, usual care, brief, or very brief advice only (RR 2.76, 95% CI 1.58 to 4.82; I2 = 0%; four studies, n = 1221). We did not detect a benefit from multiple-session behavioural support provided by dental professionals delivered in a high school or college, instead of a dental setting (RR 1.51, 95% CI 0.86 to 2.65; I2 = 83%; three studies, n = 1020; very low-certainty evidence). Only one study reported adverse events or oral health outcomes, making it difficult to draw any conclusions. AUTHORS' CONCLUSIONS: There is very low-certainty evidence that quit rates increase when dental professionals offer behavioural support to promote tobacco cessation. There is moderate-certainty evidence that tobacco abstinence rates increase in cigarette smokers if dental professionals offer behavioural support combined with pharmacotherapy. Further evidence is required to be certain of the size of the benefit and whether adding pharmacological interventions is more effective than behavioural support alone. Future studies should use biochemical validation of abstinence so as to preclude the risk of detection bias. There is insufficient evidence on whether these interventions lead to adverse effects, but no reasons to suspect that these effects would be specific to interventions delivered by dental professionals. There was insufficient evidence that interventions affected oral health.

Describing pre-appointment written materials as an intervention in the context of children's NHS therapy services: A national survey.

CONTEXT: Pre-appointment written materials, including letters and leaflets, are commonly used by healthcare organisations to deliver professional-patient interactions. The written materials potentially change patients' knowledge and behaviour as part of a healthcare intervention but have received little investigation. OBJECTIVE: To describe the content of pre-appointment written materials through a behaviour change intervention perspective. DESIGN: Mixed methods study with an online questionnaire about pre-appointment written materials and an analysis of actual materials. Questionnaire data were analysed descriptively and pre-appointment materials by qualitative framework analysis. SETTING AND PARTICIPANTS: Children's community/outpatient occupational therapy, physiotherapy and/or speech and language therapy services across the UK. Service managers/clinical leads provided data. INTERVENTION: Pre-appointment written materials. RESULTS: Questionnaire responses were received from n = 110 managers/clinical leads from n = 58 NHS organisations. Written materials (n = 64) were received from n = 24 organisations. Current materials are used by therapy services as a conduit to convey the therapy service's expectations related to: accessing the service, decision-making about care and help-giving. The materials enrol the parent and child to the therapy services' expectations by behaviour change techniques. The materials configure the parent/child expectations, knowledge and behaviour towards the therapy services' operational procedures. CONCLUSION: Pre-appointment written materials configure patients to organisations' operational procedures. The written materials currently lack support for parent/child empowerment, shared decision-making and self-management to improve health. PATIENT CONTRIBUTION: Four parents of children accessing therapy services were involved in the study. The parents shared their experiences to highlight the importance of the topic and contributed to the final research design and methods.

Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial).

BACKGROUND: A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA). METHODS: Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%. RESULTS: A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P. CONCLUSIONS: The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%. TRIAL REGISTRATION: The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

Dental professionals' experiences of managing children with carious lesions in their primary teeth - a qualitative study within the FiCTION randomised controlled trial.

BACKGROUND: The lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry. METHODS: Overall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C + P), biological management of carious lesions and prevention (B + P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis. RESULTS: Participants discussed perceived effectiveness of, and familiarity with, the three techniques. The C + P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children. CONCLUSIONS: RCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials.

Children and parents' perspectives on the acceptability of three management strategies for dental caries in primary teeth within the 'Filling Children's Teeth: Indicated or Not' (FiCTION) randomised controlled trial - a qualitative study.

BACKGROUND: The Filling Children's Teeth: Indicated Or Not? (FiCTION) randomised controlled trial (RCT) aimed to explore the clinical- and cost-effectiveness of managing dental caries in children's primary teeth. The trial compared three management strategies: conventional caries management with best practice prevention (C + P), biological management with best practice prevention (B + P) and best practice prevention alone (PA)-based approaches. Recently, the concept of treatment acceptability has gained attention and attempts have been made to provide a conceptual definition, however this has mainly focused on adults. Recognising the importance of evaluating the acceptability of interventions in addition to their effectiveness, particularly for multi-component complex interventions, the trial design included a qualitative component. The aim of this component was to explore the acceptability of the three strategies from the perspectives of the child participants and their parents. METHODS: Qualitative exploration, based on the concept of acceptability. Participants were children already taking part in the FiCTION trial and their parents. Children were identified through purposive maximum variation sampling. The sample included children from the three management strategy arms who had been treated and followed up; median (IQR) follow-up was at 33.8 (23.8, 36.7) months. Semi-structured interviews with thirteen child-parent dyads. Interviews were transcribed verbatim and analysed using a framework approach. RESULTS: Data saturation was reached after thirteen interviews. Each child-parent dyad took part in one interview together. The participants were eight girls and five boys aged 5-11 years and their parents. The children's distribution across the trial arms was: C + P n = 4; B + P n = 5; PA n = 4. Three key factors influenced the acceptability of caries management in primary teeth to children and parents: i) experiences of specific procedures within management strategies; ii) experiences of anticipatory dental anxiety and; iii) perceptions of effectiveness (particularly whether pain was reduced). These factors were underpinned by a fourth key factor: the notion of trust in the dental professionals - this was pervasive across all arms. CONCLUSIONS: Overall children and parents found each of the three strategies for the management of dental caries in primary teeth acceptable, with trust in the dental professional playing an important role.

Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: A randomised controlled trial in the UK (NULevel Trial).

BACKGROUND: Scalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice. METHODS AND FINDINGS: The NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed. CONCLUSIONS: There was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

Understanding frames: A qualitative exploration of standing frame use for young people with cerebral palsy in educational settings.

BACKGROUND: Consensus opinion supports standing frame use as part of postural management for nonambulant young people with cerebral palsy. Most young people with cerebral palsy in the United Kingdom, who use standing frames, use them at nursery or school, rather than at home. In this paper we report professionals' and parents' experiences and views of standing frame use specifically in educational settings. This research was conducted as part of a large mixed methods study to determine the acceptability and inform the design of a future trial of standing frames. METHODS: Qualitative methods were used: focus groups with educational professionals, parents and clinicians (paediatricians, physiotherapists and occupational therapists) were convened. Data were analysed thematically using framework analysis. RESULTS: Five focus groups were conducted. The overarching theme "flexibility" encompassed four subordinate themes: (i) "balancing education and therapy," which described the way education professionals had to juggle different priorities from health professionals within a multi-disciplinary team; (ii) "young people's autonomy," which highlighted participants' belief that standing frame use should be centred on the individual young person and their needs; (iii) "working within logistical boundaries," which demonstrated that "ideal" standing frame use was not always possible due to logistical issues (e.g., staffing and standing frame availability); and (iv) "competence and confidence," which highlighted that educational professionals felt that they lacked the training to confidently position young people in their standing frame. CONCLUSIONS: This paper highlights the complexity of standing frame use in the educational setting. If a standing frame programme is prescribed to be delivered in an educational setting, strong multidisciplinary and interagency communication is essential to balance therapy versus education. Training is required to ensure staff are competent in using the standing frame with the young person understanding their individual requirements. A flexible approach-inclusive of the young person's needs, logistical demands and resource-is necessary.

Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

BACKGROUND: Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants. METHODS: An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument. RESULTS: We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items. CONCLUSION: The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.

Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

INTRODUCTION: Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated. METHODS: Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample. RESULTS: We obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89). CONCLUSIONS: The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

Alcohol Screening and Brief Intervention in Police Custody Suites: Pilot Cluster Randomised Controlled Trial (AcCePT).

AIMS: There is a clear association between alcohol use and offending behaviour and significant police time is spent on alcohol-related incidents. This study aimed to test the feasibility of a trial of screening and brief intervention in police custody suites to reduce heavy drinking and re-offending behaviour. SHORT SUMMARY: We achieved target recruitment and high brief intervention delivery if this occurred immediately after screening. Low rates of return for counselling and retention at follow-up were challenges for a definitive trial. Conversely, high consent rates for access to police data suggested at least some outcomes could be measured remotely. METHODS: A three-armed pilot Cluster Randomised Controlled Trial with an embedded qualitative interview-based process evaluation to explore acceptability issues in six police custody suites (north east and south west of the UK). Interventions included: 1. Screening only (Controls), 2. 10 min Brief Advice 3. Brief Advice plus 20 min of brief Counselling. RESULTS: Of 3330 arrestees approached: 2228 were eligible for screening (67%) and 720 consented (32%); 386 (54%) scored 8+ on AUDIT; and 205 (53%) were enroled (79 controls, 65 brief advice and 61 brief counselling). Follow-up rates at 6 and 12 months were 29% and 26%, respectively. However, routinely collected re-offending data were obtained for 193 (94%) participants. Indices of deprivation data were calculated for 184 (90%) participants; 37.6% of these resided in the 20% most deprived areas of UK. Qualitative data showed that all arrestees reported awareness that participation was voluntary, that the trial was separate from police work, and the majority said trial procedures were acceptable. CONCLUSION: Despite hitting target recruitment and same-day brief intervention delivery, a future trial of alcohol screening and brief intervention in a police custody setting would only be feasible if routinely collected re-offending and health data were used for outcome measurement. TRIAL REGISTRATION: ISRCTN number: 89291046.

Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial.

BACKGROUND: Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. METHODS: The Quality of Life after Treatment for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK and three Australian centres. NSCLC patients with brain metastases unsuitable for surgical resection or stereotactic radiotherapy were randomly assigned (1:1) to optimal supportive care (OSC) including dexamethasone plus WBRT (20 Gy in five daily fractions) or OSC alone (including dexamethasone). The dose of dexamethasone was determined by the patients' symptoms and titrated downwards if symptoms improved. Allocation to treatment group was done by a phone call from the hospital to the Medical Research Council Clinical Trials Unit at University College London using a minimisation programme with a random element and stratification by centre, Karnofsky Performance Status (KPS), gender, status of brain metastases, and the status of primary lung cancer. The primary outcome measure was quality-adjusted life-years (QALYs). QALYs were generated from overall survival and patients' weekly completion of the EQ-5D questionnaire. Treatment with OSC alone was considered non-inferior if it was no more than 7 QALY days worse than treatment with WBRT plus OSC, which required 534 patients (80% power, 5% [one-sided] significance level). Analysis was done by intention to treat for all randomly assigned patients. The trial is registered with ISRCTN, number ISRCTN3826061. FINDINGS: Between March 2, 2007, and Aug 29, 2014, 538 patients were recruited from 69 UK and three Australian centres, and were randomly assigned to receive either OSC plus WBRT (269) or OSC alone (269). Baseline characteristics were balanced between groups, and the median age of participants was 66 years (range 38-85). Significantly more episodes of drowsiness, hair loss, nausea, and dry or itchy scalp were reported while patients were receiving WBRT, although there was no evidence of a difference in the rate of serious adverse events between the two groups. There was no evidence of a difference in overall survival (hazard ratio 1·06, 95% CI 0·90-1·26), overall quality of life, or dexamethasone use between the two groups. The difference between the mean QALYs was 4·7 days (46·4 QALY days for the OSC plus WBRT group vs 41·7 QALY days for the OSC group), with two-sided 90% CI of -12·7 to 3·3. INTERPRETATION: Although the primary outcome measure result includes the prespecified non-inferiority margin, the combination of the small difference in QALYs and the absence of a difference in survival and quality of life between the two groups suggests that WBRT provides little additional clinically significant benefit for this patient group. FUNDING: Cancer Research UK, Medical Research Council Clinical Trials Unit at University College London, and the National Health and Medical Research Council in Australia.

Trial participation as avoidance strategy: a qualitative study.

BACKGROUND: Trial participation decisions are often influenced by expectations of potential benefit. Attention has focused on trial participation as a means of securing something seen as desirable, such as experimental treatment. In contrast, we consider a case in which one trial arm involved receiving less than usual care. We explore how this influenced participants' decisions to participate. METHODS: Semi-structured interviews with 29 women participating in a pilot trial comparing invasive urodynamic testing (typically normal care) to basic clinical assessment with non-invasive tests, prior to surgical treatment for stress urinary incontinence. Analysis was based on the constant comparative method. RESULTS: Invasive tests were something many were aware of and worried about. Participants understood that trial participation meant they might avoid having these tests, and for about one-third, this was the primary factor motivating participation. A further third mentioned they were not looking forward to tests (if allocated to them) or were lucky to have missed them (if allocated to basic clinical assessment). None of the women appeared to have discussed their desire to avoid having invasive tests with their clinicians. CONCLUSIONS: In contrast to cases in which trial participation is motivated by the wish to secure an intervention not otherwise available, this study reports the opposite - trial participation as an opportunity to avoid having something regarded as undesirable. The option to decline a particular intervention should always be available, and care must be taken to ensure that potential participants are aware that trial participation is not the only possible means of avoidance.

Acceptability of financial incentives for health behaviour change to public health policymakers: a qualitative study.

BACKGROUND: Providing financial incentives contingent on healthy behaviours is one way to encourage healthy behaviours. However, there remains substantial concerns with the acceptability of health promoting financial incentives (HPFI). Previous research has studied acceptability of HPFI to the public, recipients and practitioners. We are not aware of any previous work that has focused particularly on the views of public health policymakers. Our aim was to explore the views of public health policymakers on whether or not HPFI are acceptable; and what, if anything, could be done to maximise acceptability of HPFI. METHODS: We recruited 21 local, regional and national policymakers working in England via gatekeepers and snowballing. We conducted semi-structured in-depth interviews with participants exploring experiences of, and attitudes towards, HPFI. We analysed data using the Framework approach. RESULTS: Public health policymakers working in England acknowledged that HPFI could be a useful behaviour change tool, but were not overwhelmingly supportive of them. In particular, they raised concerns about effectiveness and cost-effectiveness, potential 'gaming', and whether or not HPFI address the underlying causes of unhealthy behaviours. Shopping voucher rewards, of smaller value, targeted at deprived groups were particularly acceptable to policymakers. Participants were particularly concerned about the response of other stakeholders to HPFI - including the public, potential recipients, politicians and the media. Overall, the interviews reflected three tensions. Firstly, a tension between wanting to trust individuals and promote responsibility; and distrust around the potential for 'gaming the system'. Secondly, a tension between participants' own views about HPFI; and their concerns about the possible views of other stakeholders. Thirdly, a tension between participants' personal distaste of HPFI; and their professional view that they could be a valuable behaviour change tool. CONCLUSIONS: There are aspects of design that influence acceptability of financial incentive interventions to public health policymakers. However, it is not clear that even interventions designed to maximise acceptability would be acceptable enough to be recommended for implementation. Further work may be required to help policymakers understand the potential responses of other stakeholder groups to financial incentive interventions.

Acceptability of financial incentives for encouraging uptake of healthy behaviours: A critical review using systematic methods.

OBJECTIVE: Financial incentives are effective in encouraging healthy behaviours, yet concerns about acceptability remain. We conducted a systematic review exploring acceptability of financial incentives for encouraging healthy behaviours. METHODS: Database, reference, and citation searches were conducted from the earliest available date to October 2014, to identify empirical studies and scholarly writing that: had an English language title, were published in a peer-reviewed journal, and explored acceptability of financial incentives for healthy behaviours in members of the public, potential recipients, potential practitioners or policy makers. Data was analysed using thematic analysis. RESULTS: Eighty one papers were included: 59 pieces of scholarly writing and 22 empirical studies, primarily exploring acceptability to the public. Five themes were identified: fair exchange, design and delivery, effectiveness and cost-effectiveness, recipients, and impact on individuals and wider society. Although there was consensus that if financial incentives are effective and cost effective they are likely to be considered acceptable, a number of other factors also influenced acceptability. CONCLUSIONS: Financial incentives tend to be acceptable to the public when they are effective and cost-effective. Programmes that benefit recipients and wider society; are considered fair; and are delivered to individuals deemed appropriate are likely to be considered more acceptable.

Head and neck cancer patients' perceptions of swallowing following chemoradiotherapy.

PURPOSE: The study aims to describe patients' experiences of swallowing difficulties following (chemo)radiotherapy for head and neck cancer and to explore any changes over time. METHODS: A purposive sample of patients with swallowing difficulties was selected at a range of time points, from 3 to 18 months following treatment. Ethnographic observations of 12 patients were conducted in their own homes, over a mealtime situation. Nine new patients were interviewed about changes to their eating and drinking from pre- to post-treatment. Thematic analysis was used to code and analyse the data. RESULTS: Patients' reports of swallowing function were divided into four time zones: pre-treatment, during radiotherapy, early (0-3 months) and late (6-18 months) time points following treatment. The majority reported minimal problems at diagnosis, but marked impairment during and after radiotherapy, without a return to pre-treatment functioning. The focus was on severe physical side effects and changes to food preparation during radiotherapy and in the early phase of recovery. By 6 months, side effects began to subside, but swallowing was still difficult, leading to major changes to family life, socialisation and lifestyle. CONCLUSIONS: Swallowing problems after (chemo)radiotherapy are multi-faceted and highly individualised and restrict lives in the long term. Swallowing ability may improve in time, but does not appear to return to pre-treatment function. Further work is required to find ways of being able to best support patients living with this long-term condition.

Acceptability of financial incentives for breastfeeding: thematic analysis of readers' comments to UK online news reports.

BACKGROUND: Whilst it is recommended that babies are breastfed exclusively for the first six months, many mothers do not maintain breastfeeding for this length of time. Previous research confirms that women and midwives value financial incentives for breastfeeding, but limited research has explored the wider acceptability of these interventions to the general public. This paper examines opinion towards financial incentives for breastfeeding using reader responses to UK on-line media coverage of a study undertaken in this area. METHODS: This study used netnography to undertake a thematic analysis of 3,373 reader comments posted in response to thirteen articles, published in November 2013, which reported findings from a feasibility study of financial incentives for breastfeeding. All articles were published on one of six UK news websites that achieved a monthly audience of at least five million viewers across laptop and desktop computers and mobile devices during April-May 2013. RESULTS: Nine analytical themes were identified, with a majority view that financial incentives for breastfeeding are unacceptable. These themes cover a range of opinions: from negligent parents unable to take responsibility for their own actions; through to psychologically vulnerable members of society who should be protected from coercion and manipulation; to capable and responsible women who can, and should be allowed to, make their own decisions. Many views focused on the immediate costs of the intervention, concluding that this was something that was currently unaffordable to fund (e.g. by the NHS). Others contrasted the value of the incentive against other 'costs' of breastfeeding. There was some consideration of the issue of cost-effectiveness and cost-saving, where the potential future benefit from initial investment was identified. Many commenters identified that financial incentives do not address the many structural and cultural barriers to breastfeeding. CONCLUSIONS: Overall, those commenting on the on-line UK news articles viewed financial incentives for breastfeeding as unacceptable and that alternative, structural, interventions were likely to be more effective. Further consideration of how best to conduct internet-based qualitative research to elicit opinion towards public health issues is required.