A RCT to explore the effectiveness of supporting adherence to nebuliser medication in adults with cystic fibrosis: fidelity assessment of study interventions.

BACKGROUND: A multi-component self-management intervention 'CFHealthHub' was developed to reduce pulmonary exacerbations in adults with Cystic Fibrosis (CF) by supporting adherence to nebuliser medication. It was evaluated in a randomized controlled trial (RCT) involving 19 CF centres, with 32 interventionists, 305 participants in the intervention group, and 303 participants in the standard care arm. Ensuring treatment fidelity of intervention delivery was crucial to ensure that the intervention produced the expected outcomes. METHODS: Fidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform. RESULTS: Design: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant. CONCLUSIONS: The study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care. TRIAL REGISTRATION: ISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).

Adapting evidence-informed population health interventions for new contexts: a scoping review of current practice.

BACKGROUND: Implementing evidence-informed population health interventions in new contexts often requires adaptations. While the need to adapt interventions to better fit new contexts is recognised, uncertainties remain regarding why and when to adapt (or not), and how to assess the benefits (or not) of adaptation. The ADAPT Study aims to develop comprehensive guidance on adaptation. This scoping review informs guidance development by mapping and exploring how adaptation has been undertaken in practice, in public health and health services research. METHODS: We searched seven databases from January 2000 and October 2018 to identify eligible studies for this scoping review and a related systematic review of adaptation guidance. We mapped the studies of adaptation by coding data from all eligible studies describing the methods, contexts, and interventions considered for adaptation. From this map, we selected a sample of studies for in-depth examination. Two reviewers extracted data independently into seven categories: description, key concepts, types, rationale, processes, evaluation methods, evaluation justification, and accounts of failures and successes. RESULTS: We retrieved 6694 unique records. From 429 records screened at full text, we identified 298 eligible studies for mapping and selected 28 studies for in-depth examination. The majority of studies in our map focused on micro- (i.e., individual-) level interventions (84%), related to transferring an intervention to a new population group within the same country (62%) and did not report using guidance (73%). Studies covered a range of topic areas, including health behaviour (24%), mental health (19%), sexual health (16%), and parenting and family-centred interventions (15%). Our in-depth analysis showed that adaptation is seen to save costs and time relative to developing a new intervention, and to enhance contextual relevance and cultural compatibility. It commonly follows a structured process and involves stakeholders to help with decisions on what to adapt, when, and how. CONCLUSIONS: Adaptation has been undertaken on a range of health topics and largely in line with existing guidance. Significant gaps relate to adaptation of macro- (e.g., national-) level interventions, consideration of programme theories, mechanisms and contexts (i.e., a functional view of interventions), nuances around stakeholder involvement, and evaluation of the adapted interventions. Registration Open Science Framework, 2019, osf.io/udzma.

Interventions to improve the management of pain in emergency departments: systematic review and narrative synthesis.

INTRODUCTION: Pain management in emergency departments (ED) is often inadequate despite the availability of effective analgesia, with many patients receiving insufficient and untimely analgesia. We conducted a systematic literature review to identify interventions that could improve pain management in the ED. METHODS: We systematically searched seven databases for studies reporting pain management outcomes after intervention to change professional practice to improve pain management in the ED, compared with pain management before or without intervention. Data was synthesised using principles of narrative synthesis. RESULTS: We identified 43 relevant studies, including 40 uncontrolled before-and-after studies. Interventions included implementation of guidelines and protocols, educational interventions, pain scoring tools and changes in nursing roles, with many multifaceted interventions incorporating two or more of these elements. Interventions aimed to improve assessment and documentation of pain, knowledge and awareness of pain management and reduce time to analgesia. Due to the high probability of bias in study design and significant variation between studies, it was not possible to estimate the overall effectiveness of interventions, or identify which had the greatest impact. Intervention to improve pain management was reported to have some positive impact in most studies, but these findings may be explained by limitations in study design. CONCLUSIONS: Many interventions reported improvements in pain management, but current evidence is insufficient to recommend any for widespread adoption. In order to improve pain management we need to understand more about the theory underlying interventions, the context in which interventions work, and develop interventions based on this stronger theoretical understanding.

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub.

BACKGROUND: Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. METHODS: Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. RESULTS: Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. CONCLUSIONS: The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

Adapting evidence-informed complex population health interventions for new contexts: a systematic review of guidance.

BACKGROUND: Adapting interventions that have worked elsewhere can save resources associated with developing new interventions for each specific context. While a developing body of evidence shows benefits of adapted interventions compared with interventions transported without adaptation, there are also examples of interventions which have been extensively adapted, yet have not worked in the new context. Decisions on when, to what extent, and how to adapt interventions therefore are not straightforward, particularly when conceptualising intervention effects as contingent upon contextual interactions in complex systems. No guidance currently addresses these questions comprehensively. To inform development of an overarching guidance on adaptation of complex population health interventions, this systematic review synthesises the content of the existing guidance papers. METHODS: We searched for papers published between January 2000 and October 2018 in 7 bibliographic databases. We used citation tracking and contacted authors and experts to locate further papers. We double screened all the identified records. We extracted data into the following categories: descriptive information, key concepts and definitions, rationale for adaptation, aspects of adaptation, process of adaptation, evaluating and reporting adapted interventions. Data extraction was conducted independently by two reviewers, and retrieved data were synthesised thematically within pre-specified and emergent categories. RESULTS: We retrieved 6694 unique records. Thirty-eight papers were included in the review representing 35 sources of guidance. Most papers were developed in the USA in the context of implementing evidence-informed interventions among different population groups within the country, such as minority populations. We found much agreement on how the papers defined key concepts, aims, and procedures of adaptation, including involvement of key stakeholders, but also identified gaps in scope, conceptualisation, and operationalisation in several categories. CONCLUSIONS: Our review found limitations that should be addressed in future guidance on adaptation. Specifically, future guidance needs to be reflective of adaptations in the context of transferring interventions across countries, including macro- (e.g. national-) level interventions, better theorise the role of intervention mechanisms and contextual interactions in the replicability of effects and accordingly conceptualise key concepts, such as fidelity to intervention functions, and finally, suggest evidence-informed strategies for adaptation re-evaluation and reporting. TRIAL REGISTRATION: PROSPERO 2018, CRD42018112714.

Effect of a national urgent care telephone triage service on population perceptions of urgent care provision: controlled before and after study.

OBJECTIVE: To measure the effect of an urgent care telephone service NHS 111 on population perceptions of urgent care. DESIGN: Controlled before and after population survey, using quota sampling to identify 2000 respondents reflective of the age/sex profile of the general population. SETTING: England. 4 areas where NHS 111 was introduced, and 3 control areas where NHS 111 had yet to be introduced. PARTICIPANTS: 28 071 members of the general population, including 2237 recent users of urgent care. INTERVENTION: NHS 111 offers advice to members of the general population seeking urgent care, recommending the best service to use or self-management. Policymakers introduced NHS 111 to improve access to urgent care. OUTCOMES MEASURES: The primary outcome was change in satisfaction with recent urgent care use 9 months after the launch of NHS 111. Secondary outcomes were change in satisfaction with urgent care generally and with the national health service. RESULTS: The overall response rate was 28% (28 071/100 408). 8% (2237/28 071) had used urgent care in the previous 3 months. Of the 652 recent users of urgent care in the NHS 111 intervention areas, 9% (60/652) reported calling NHS 111 in the 'after' period. There was no evidence that the introduction of NHS 111 was associated with a changed perception of recent urgent care. For example, the percentage rating their experience as excellent remained at 43% (OR 0.97, 95% CI 0.69 to 1.37). Similarly, there was no change in population perceptions of urgent care generally (1.06, 95% CI 0.95 to 1.17) or the NHS (0.94, 95% CI 0.85 to 1.05) following the introduction of NHS 111. CONCLUSIONS: A new telephone triage service did not improve perceptions of urgent care or the health service. This could be explained by the small amount of NHS 111 activity in a large emergency and urgent care system.

Rationing in the emergency department: the good, the bad, and the unacceptable.

OBJECTIVES: Waiting times in emergency departments (EDs) are an important government priority. Although substantial efforts are currently being made to reduce waiting times, little attention has been paid to the patients' view. We used qualitative methods to explore patients' perspectives on waiting times and other approaches to rationing and prioritisation. METHODS: Face to face, in depth, qualitative interviews (n = 11) explored how patients valued waiting times for non-urgent ED care. The framework approach (identifying a thematic framework through repeated re-reading) was used to analyse transcripts. RESULTS: Interviewees found some forms of rationing and prioritisation acceptable. They expected rationing by delay, but required explanations or information on the reason for their wait. They valued prioritisation by triage (rationing by selection) and thought that this role could be expanded for the re-direction of non-urgent patients elsewhere (rationing by deflection). Interviewees were mainly unwilling or unable to engage in prioritisation of different types of patients, openly prioritising only those with obvious clinical need, and children. However, some interviewees were willing to ration implicitly, labelling some attenders as inappropriate, such as those causing a nuisance. Others felt it was unacceptable to blame "inappropriate" attenders, as their attendance may relate to lack of information or awareness of service use. Explicit rationing between services was not acceptable, although some believed there were more important priorities for NHS resources than ED waiting times. Interviewees disagreed with the hypothetical notion of paying to be seen more quickly in the ED (rationing by charging). CONCLUSIONS: Interviewees expected to wait and accepted the need for prioritisation, although they were reluctant to engage in judgements regarding prioritisation. They supported the re-direction of patients with certain non-urgent complaints. However, they perceived a need for more explanation and information about their wait, the system, and alternative services.

Social and psychosocial factors associated with high-risk sexual behaviour among university students in the United Kingdom: a web-survey.

In the UK there are limited data about university students' risky sexual behaviour. A cross-sectional web-survey was conducted to investigate factors associated with high-risk sex among students at two UK universities. High-risk sex was reported by 25% of 1108. High personal sexually transmitted infection (STI) risk perception and permissive attitudes towards casual sex were associated with high-risk sex for both men (odds ratio [OR]: 12.12; 95% confidence interval [CI]: 4.10-35.81; OR: 2.49; 95%CI: 1.11-5.56, respectively) and women (OR: 22.31; 95% CI: 9.34-53.26; OR: 3.02; 95% CI: 1.82-5.01, respectively). For men, drinking alcohol (OR: 17.67; 95% CI: 1.90-164.23) and for women age and frequent drinking (OR: 2.02; 95% CI: 1.05-3.89; OR: 1.89; 95% CI: 1.08-3.31, respectively) were associated with high-risk sex. However, perceiving an average student as more likely to contract STIs (men, OR: 0.34; 95% CI: 0.16-0.75) or HIV (men, OR: 0.44; 95% CI: 0.20-0.96; women, OR: 0.42; 95% CI: 0.28-0.63) and finding it difficult to discuss sexual matters (women, OR: 0.60; 95% CI: 0.39-0.91) were negatively associated with high-risk sex. Most of the factors found were similar to other populations, but some psychosocial factors showed complex patterns of association that require further investigation.

Feasibility of new prognostic classification for rectal cancer.

Sixty slides from 60 blocks taken from 30 colonic carcinomas were circulated twice to six histopathologists of varying experience. Five of the six pathologists showed a good to excellent intraobserver agreement for assessment of the character of the invasive margin (0.44 less than kappa less than 0.82), which was not significantly affected by sampling (0.40 less than kappa less than 0.56, comparing both slides from each tumour) or observer (five of six pathologists agreeing on 46 of 60 slides). Pathologists were unreliable in assessing peritumoural lymphocytic infiltrates, with only two pathologists achieving moderate levels of intraobserver agreement (-0.03 less than kappa less than 0.52). The interobserver agreement for peritumoural lymphocytic infiltrates was also low (kappa less than 0.29) between the three most experienced pathologists. The assessment of peritumoural lymphocytic infiltrates was significantly affected by sampling, the two pathologists with the lowest intraobserver variation achieving kappa values of 0.21 and 0.10 between the 30 paired slides from each tumour. The character of the invasive margin was reliably assessed, was not dependent on sample, and added useful prognostic information, but peritumoural lymphocytic infiltration is not a reproducible observation and may therefore not add useful prognostic information in routine use.

Epidemiology of babies dying at different ages from the sudden infant death syndrome.

An analysis of data from the United Kingdom multicentre study of postneonatal mortality has been made to assess whether there are causally distinct groups of babies dying from the Sudden Infant Death Syndrome (SIDS), and to develop explicit risk factor profiles for the subgroups. The 303 SIDS babies in the multicentre study were divided into four subgroups by age at death: weeks 1-7, 8-15, 16-23, and 24 or more weeks. Contrasts between these subgroups with respect to 28 epidemiological characteristics and to pathology findings were investigated. Significant contrasts in the number of previous pregnancies, duration of the 2nd stage of labour, gestational length, family finances and repair of housing were found. Overall, very strong evidence of epidemiological differences was found (chi 2(9) = 29.3, p less than 0.001), and of contrasts in the nature and degree of any acquired terminal disease. It is concluded that there are different causes of SIDS with different distributions according to age at death.