Objective Nebuliser Adherence Data as "Proof" of Adherence in the Management of Cystic Fibrosis: A Qualitative Interview Study.

Purpose: Low adherence to medication via nebulisers is linked to poor clinical outcomes for people with Cystic Fibrosis (PWCF). Advances in technology allow electronic monitoring of nebuliser usage and feedback of objective adherence data to PWCF and clinical teams caring for them. CFHealthHub is a new intervention that collects and displays objective adherence data in easy-to-read formats with the aim of improving nebuliser adherence and health. There is little understanding of how objective adherence data is perceived by PWCF and healthcare professionals (HCPs). Patients and Methods: A qualitative study using semi-structured interviews with 22 PWCF and 31 HCPs who had used the CFHealthHub intervention. Results: Objective adherence data was welcomed by the majority of PWCF in the sample, and HCP delivering the intervention, because the data allowed PWCF to reflect on patterns of adherence or non-adherence. Ease of use and characteristics of data display were important, particularly the use of a "traffic light" system to allow PWCF to easily see if they were meeting their adherence targets. For PWCF objective adherence data was used as "proof to self", offering reassurance to high adherers, and a wake-up call to those with lower levels of adherence. It could also provide 'proof to others' where PWCF had higher levels of adherence than HCP or family members believed. The data could sometimes change HCP perceptions of PWCF's identities as poor adherers. Where adherence was not high, data was used to facilitate honest discussions between PWCF and HCPs about how to increase adherence. HCPs perceived that it was important to use the data positively to motivate, rather than criticise, PWCF. Conclusion: Objective nebuliser adherence data in CFHealthHub can offer proof of adherence to PWCF and HCPs. It is important to use it constructively to facilitate discussions on how to improve adherence.

Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial.

INTRODUCTION: Recurrent pulmonary exacerbations lead to progressive lung damage in cystic fibrosis (CF). Inhaled medications (mucoactive agents and antibiotics) help prevent exacerbations, but objectively measured adherence is low. We investigated whether a multi-component (complex) self-management intervention to support adherence would reduce exacerbation rates over 12 months. METHODS: Between October 2017 and May 2018, adults with CF (aged ≥16 years; 19 UK centres) were randomised to the intervention (data-logging nebulisers, a digital platform and behavioural change sessions with trained clinical interventionists) or usual care (data-logging nebulisers). Outcomes included pulmonary exacerbations (primary outcome), objectively measured adherence, body mass index (BMI), lung function (FEV1) and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Analyses were by intent to treat over 12 months. RESULTS: Among intervention (n=304) and usual care (n=303) participants (51% female, median age 31 years), 88% completed 12-month follow-up. Mean exacerbation rate was 1.63/year with intervention and 1.77/year with usual care (adjusted ratio 0.96; 95% CI 0.83 to 1.12; p=0.64). Adjusted mean differences (95% CI) were in favour of the intervention versus usual care for objectively measured adherence (9.5% (8.6% to 10.4%)) and BMI (0.3 (0.1 to 0.6) kg/m2), with no difference for %FEV1 (1.4 (-0.2 to 3.0)). Seven CFQ-R subscales showed no between-group difference, but treatment burden reduced for the intervention (3.9 (1.2 to 6.7) points). No intervention-related serious adverse events occurred. CONCLUSIONS: While pulmonary exacerbations and FEV1 did not show statistically significant differences, the intervention achieved higher objectively measured adherence versus usual care. The adherence difference might be inadequate to influence exacerbations, though higher BMI and lower perceived CF treatment burden were observed.

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation.

OBJECTIVES: To undertake a process evaluation of an adherence support intervention for people with cystic fibrosis (PWCF), to assess its feasibility and acceptability. SETTING: Two UK cystic fibrosis (CF) units. PARTICIPANTS: Fourteen adult PWCF; three professionals delivering adherence support ('interventionists'); five multi-disciplinary CF team members. INTERVENTIONS: Nebuliser with data recording and transfer capability, linked to a software platform, and strategies to support adherence to nebulised treatments facilitated by interventionists over 5 months (± 1 month). PRIMARY AND SECONDARY MEASURES: Feasibility and acceptability of the intervention, assessed through semistructured interviews, questionnaires, fidelity assessments and click analytics. RESULTS: Interventionists were complimentary about the intervention and training. Key barriers to intervention feasibility and acceptability were identified. Interventionists had difficulty finding clinic space and time in normal working hours to conduct review visits. As a result, fewer than expected intervention visits were conducted and interviews indicated this may explain low adherence in some intervention arm participants. Adherence levels appeared to be >100% for some patients, due to inaccurate prescription data, particularly in patients with complex treatment regimens. Flatlines in adherence data at the start of the study were linked to device connectivity problems. Content and delivery quality fidelity were 100% and 60%-92%, respectively, indicating that interventionists needed to focus more on intervention 'active ingredients' during sessions. CONCLUSIONS: The process evaluation led to 14 key changes to intervention procedures to overcome barriers to intervention success. With the identified changes, it is feasible and acceptable to support medication adherence with this intervention. TRIAL REGISTRATION NUMBER: ISRCTN13076797; Results.

How do third sector organisations or charities providing health and well-being services in England implement patient-reported outcome measures (PROMs)? A qualitative interview study.

OBJECTIVES: To identify the facilitators and barriers to implementing patient-reported outcome measures (PROMs) in third sector organisations (TSOs) delivering health and well-being services. DESIGN: A qualitative interview study. Participants were recruited using purposive, opportunistic and snowballing methods. Framework analysis was used. SETTING: TSOs including charities, community groups and not-for-profit organisations in England, UK. PARTICIPANTS: Thirty interviewees including service users, TSO front-line workers and managers, commissioners of TSOs and other stakeholders such as academic researchers. RESULTS: TSOs primarily used PROMs because of pressures arising from the external funding context. However, organisations often struggled to implement PROMs, rarely getting the process right first time. Facilitators for implementation included having an implementation lead committed to making it work, investing resources in data management systems and support staff and taking a collaborative approach to designing the PROMs process. The latter helped to ensure an appropriate PROMs process for the specific TSO including choosing a suitable measure and planning how data would be collected, processed and used. There was a dilemma about whether TSOs should use standardised well-being measures (eg, the Warwick-Edinburgh Mental Well-being Scale) or design their own PROM. Not all TSOs sustained the collection and reporting of PROMs over time because this required a change in organisational culture to view PROMs as beneficial for the TSO and PROMs becoming part of front-line workers' job specifications. CONCLUSIONS: TSOs are trying to use PROMs because they feel they have no choice but often struggle with implementation. Having an implementation lead, designing an appropriate process, investing resources, training staff and taking mitigating action to address potential barriers can facilitate implementation. Some of the findings are consistent with the experiences of more clinical services so appear relevant to the implementation of PROMs irrespective of the specific context.

Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study.

BACKGROUND: Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence. OBJECTIVE: This study aims to explore the mechanisms of action underpinning the intervention. METHODS: A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis. RESULTS: The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer. CONCLUSIONS: The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797.

When Is Forgetting Not Forgetting? A Discursive Analysis of Differences in Forgetting Talk Between Adults With Cystic Fibrosis With Different Levels of Adherence to Nebulizer Treatments.

Forgetting is often cited as a reason why people struggle to adhere to treatments for chronic conditions. Interventions have tried to improve forgetting behavior using reminders. We used a discursive psychological approach to explore differences in how high and low adherers constructed forgetting their nebulizer treatments for cystic fibrosis. Interviews were conducted with 18 adults from a cystic fibrosis center in the United Kingdom. High adherers constructed forgetting treatments as occasional lapses in automaticity and temporary lapses in memory that they found easy to repair. Low adherers utilized forgetting to normalize more consistent nonadherence to treatments. However, it is important to contextualize forgetting as a discursive resource that helped these participants to negotiate moral discourses around adherence to treatment that reminder interventions cannot address; we therefore recommend a more behavioral, patient-focused, theory-driven approach to intervention development.

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques. METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews. PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers. INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32). OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5). RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised. CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible. TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

Adherence to medication in adults with Cystic Fibrosis: An investigation using objective adherence data and the Theoretical Domains Framework.

OBJECTIVES: Adherence to nebulizer treatment in adults with Cystic Fibrosis (CF) is poor, and interventions are needed. This research aimed to identify the factors affecting nebulizer adherence using the Theoretical Domains Framework (TDF) and to compare these for participants with different levels of adherence. DESIGN: Data-prompted interviews using the TDF. METHODS: Eighteen semi-structured interviews were conducted with adults with CF during which objectively measured adherence data were discussed. Framework analysis was used to code the data into TDF domains, and inductive qualitative content analysis was used to code different beliefs and experiences. Aspects of the TDF that differed between participants with different adherence levels were explored. RESULTS: Factors influencing adherence to treatment included all 14 domains of the TDF, 10 of which appeared to vary by adherence level: Skills; Memory and decision-making; and Behavioural regulation; Environmental context and resources; Social influences; Beliefs about consequences; Beliefs about capability; Reinforcement; Social role and identify; Intentions; Optimism; and Emotions. CONCLUSIONS: This study is the first to use objectively measured adherence data in a data-prompted interview using the TDF framework to systematically assess the full range of factors potentially influencing adherence. The results highlighted that interventions need to consider issues of capability, opportunity, and motivation. Interventions that challenge dysfunctional beliefs about adherence and which support the development of routines or habits and problem-solving may be particularly useful for adults with CF. Statement of contribution What is already known? Adherence to medication in adults with cystic fibrosis is poor. Previous research has identified a range of contributing factors in relation to subjective reports of adherence. There is a wide discrepancy between self-reported adherence and objectively measured adherence. What this study adds A data-prompted interview using objectively measured adherence data enabled the systematic assessment of potential factors that could be targeted in an intervention to increase adherence. There were some differences in the factors that were identified by high and low adherers. There is not one-size fits all intervention for adherence to medication in cystic fibrosis.

Exploring variation in how ambulance services address non-conveyance: a qualitative interview study.

OBJECTIVES: There is considerable variation in non-conveyance rates between ambulance services in England. The aim was to explore variation in how each ambulance service addressed non-conveyance for calls ending in telephone advice and discharge at scene. DESIGN: A qualitative interview study. SETTING: Ten large regional ambulance services covering 99% of the population in England. PARTICIPANTS: Between four and seven interviewees from each ambulance service including managers, paramedics and healthcare commissioners, totalling 49 interviews. METHODS: Telephone semistructured interviews. RESULTS: The way interviewees in each ambulance service discussed non-conveyance within their organisation varied for three broad themes. First, ambulance service senior management appeared to set the culture around non-conveyance within an organisation, viewing it either as an opportunity or as a risky endeavour. Although motivation levels to undertake non-conveyance did not appear to be directly affected by the stability of an ambulance service in terms of continuity of leadership and externally assessed quality, this stability could affect the ability of the organisation to innovate to increase non-conveyance rates. Second, descriptions of workforce configuration differed between ambulance services, as well as how this workforce was used, trained and valued. Third, interviewees in each ambulance service described health and social care in the wider emergency and urgent care system differently in terms of availability of services that could facilitate non-conveyance, the amount of collaborative working between health and social care services and the ambulance service and complexity related to the numbers of services and healthcare commissioners with whom they had to work. CONCLUSIONS: This study suggests that factors within and outside the control of ambulance services may contribute to variation in non-conveyance rates. These findings can be tested in a quantitative analysis of factors affecting variation in non-conveyance rates between ambulance services in England.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial.

OBJECTIVE:  To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. DESIGN:  Pragmatic, multicentre, randomised controlled trial. SETTING:  42 general practices in three areas of England. PARTICIPANTS:  Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. INTERVENTIONS:  Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. MAIN OUTCOME MEASURES:  The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. RESULTS:  50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic -2.7 mm Hg (95% confidence interval -4.7 to -0.6 mm Hg), mean diastolic -2.8 (-4.0 to -1.6 mm Hg); weight -1.0 kg (-1.8 to -0.3 kg), and body mass index -0.4 ( -0.6 to -0.1) but not cholesterol -0.1 (-0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (-0.4, -1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure. CONCLUSIONS:  This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care.Trial registration Current Controlled Trials ISRCTN 27508731.

Factors affecting mortality in older trauma patients-A systematic review and meta-analysis.

INTRODUCTION: Major trauma in older people is a significant health burden in the developed world. The aging of the population has resulted in larger numbers of older patients suffering serious injury. Older trauma patients are at greater risk of death from major trauma, but the reasons for this are less well understood. The aim of this review was to identify the factors affecting mortality in older patients suffering major injury. MATERIALS AND METHODS: A systematic review of Medline, Cinhal and the Cochrane database, supplemented by a manual search of relevant papers was undertaken, with meta-analysis. Multi-centre cohort studies of existing trauma registries that reported risk-adjusted mortality (adjusted odds ratios, AOR) in their outcomes and which analysed patients aged 65 and older as a separate cohort were included in the review. RESULTS: 3609 papers were identified from the electronic databases, and 28 from manual searches. Of these, 15 papers fulfilled the inclusion criteria. Demographic variables (age and gender), pre-existing conditions (comorbidities and medication), and injury-related factors (injury severity, pattern and mechanism) were found to affect mortality. The 'oldest old', aged 75 and older, had higher mortality rates than younger patients, aged 65-74 years. Older men had a significantly higher mortality rate than women (cumulative odds ratio 1.51, 95% CI 1.37-1.66). Three papers reported a higher risk of death in patients with pre-existing conditions. Two studies reported increased mortality in patients on warfarin (cumulative odds ratio 1.32, 95% CI 1.05-1.66). Higher mortality was seen in patients with lower Glasgow coma scores and systolic blood pressures. Mortality increased with increased injury severity and number of injuries sustained. Low level falls were associated with higher mortality than motor vehicle collisions (cumulative odds ratio 2.88, 95% CI 1.26-6.60). CONCLUSIONS: Multiple factors contribute to mortality risk in older trauma patients. The relation between these factors and mortality is complex, and a fuller understanding of the contribution of each factor is needed to develop a better predictive model for trauma outcomes in older people. More research is required to identify patient and process factors affecting mortality in older patients.

Equity of access to health care. Evidence from NHS Direct in the UK.

In the UK National Health Service (NHS), NHS Direct, the national 24-h telephone helpline, has been available in England and Wales since 2000 and has been termed a 'single gateway' to health care. We conducted a population survey of 15,004 people in areas covered by the service, which included questions about NHS Direct use and socio-economic characteristics. After removing undeliverable questionnaires, the survey response rate was 60% (8750/14,516). In all, a quarter of respondents had ever used NHS Direct (26%, 95% confidence interval 25-27), ranging from 32% of the population in Preston/Chorley (888/2,794) and Newcastle and North Tyneside (515/1,621) to 17% (2,215/8,536) in Sheffield, which had introduced the service 20 months later. Logistic regression showed that those from poorer socioeconomic groups or with communication difficulties were less likely to have used the service than others. Overcoming this apparent bias against those likely to have the greatest need is an unsolved problem not confined to telemedicine.

Male callers to NHS Direct: the assertive carer, the new dad and the reluctant patient.

It has been suggested in the light of mortality and morbidity rates, and men's reluctance to seek medical help and advice, that there is a crisis in men's health. Little is known about men's experiences of using health care services, despite an emergent UK men's health movement. NHS Direct, the new telephone advice line, was designed to be more accessible, convenient and responsive to the public's needs for health care. In-depth interviews with male callers to the service, aged between 29 and 59, reveal that they sought help in their roles as fathers, partners and on their own behalf. Having used it once, they anticipated doing so again. Their learning about health matters, from both the formal structure and the informal agenda of the telephone consultation, suggests the potential of men's use of this service for 'normalizing' help seeking by men, and thereby for longer-term improvements in men's health.