Context Matters: Patterns in Physical Distancing Behavior Across Situations and Over Time During the Covid-19 Pandemic in the Netherlands.

BACKGROUND: Physical distancing is an effective preventative measure during respiratory infectious disease outbreaks. Prior studies on distancing behaviors have largely ignored context characteristics (physical, social) and time. PURPOSE: We investigated patterns in physical distancing over time and across situations, as well as sociodemographic variation herein. METHODS: We employed data from five rounds of a cohort study conducted throughout the pandemic by the Dutch public health institute (RIVM; N ≈ 50.000 per round). We conducted Latent Class Analyses to investigate patterns of physical distancing in a range of situations, followed by regression models to investigate associations between distancing behavior and sociodemographic and context characteristics. RESULTS: Participants differed in their general tendency to adhere to distancing guidelines across situations, but there were also substantial differences in distancing behavior between situations, particularly at work, with friends and family and outdoors. Distancing at work was strongly associated with work environment characteristics. Younger age groups reported less distancing behavior, particularly with close relations (friends or family) and at work. In periods when the pandemic situation was most severe, people adhered more strongly to distancing guidelines and age differences were most pronounced during these periods. CONCLUSIONS: Physical and social context matters for physical distancing, highlighting the importance of developing strategies for pandemic preparedness that improve opportunities for physical distancing (e.g., reducing crowding, one-way traffic) and accommodate young people to safely meet even in times of high pandemic severity and lockdowns. Future studies should account for the physical and social context in which distancing behavior is observed.

Physical distancing helps reduce the transmission of infectious diseases, but people's opportunities and willingness to keep distance from others can vary between situations. In a survey conducted at various time points during the Covid-19 pandemic, The Dutch National Public Health Institute asked people about their distancing behavior in various such situations, such as at work, when grocery shopping or when visiting with friends and family. We found that people mainly differed in their general tendency to keep distance from others: some individuals were more likely to keep distance than others in all situations. However, there were also substantial differences in distancing behavior at work, with friends and family and outdoors. Differences in distancing at work resulted from the specific work context and activities people had to perform. Younger age groups reported less distancing behavior in social situations such as when meeting with friends and family or with colleagues. In periods when the pandemic situation was most severe, people were more likely to keep their distance from others and there were larger age differences in distancing behavior. These results highlight the importance of improving people's opportunities to keep their distance from others and safely meet in times of a severe pandemic.

A cardiac-rehab behaviour intervention to reduce sedentary time in coronary artery disease patients: the SIT LESS randomized controlled trial.

BACKGROUND: High sedentary times (ST) is highly prevalent in patients with coronary artery disease (CAD), highlighting the need for behavioural change interventions that effectively reduce ST. We examined the immediate and medium-term effect of the SIT LESS intervention on changes in ST among CAD patients enrolled in cardiac rehabilitation (CR). METHODS: CAD patients participating in CR at 2 regional hospitals were included in this randomized controlled trial (1:1, stratified for gender and hospital). The control group received CR, whereas SIT LESS participants additionally received a 12-week hybrid behaviour change intervention. The primary outcome was the change in accelerometer-derived ST from pre-CR to post-CR and 3 months post-CR. Secondary outcomes included changes in ST and physical activity characteristics, subjective outcomes, and cardiovascular risk factors. A baseline constrained linear mixed-model was used. RESULTS: Participants (23% female; SIT LESS: n = 108, control: n = 104) were 63 ± 10 years. Greater ST reductions were found for SIT LESS compared to control post-CR (-1.7 (95% confidence interval (CI): -2.0; -1.4) versus - 1.1 (95% CI: -1.4; -0.8) h/day, pinteraction=0.009), but not at 3 months post-CR (pinteraction=0.61). Besides, larger light-intensity physical activity (LIPA) increases were found for SIT LESS compared to control post-CR (+ 1.4 (95% CI: +1.2; +1.6) versus + 1.0 (95% CI: +0.8; +1.3) h/day, pinteraction=0.020). Changes in other secondary outcomes did not differ among groups. CONCLUSION: SIT LESS transiently reduced ST and increased LIPA, but group differences were no longer significant 3 months post-CR. These findings highlight the challenge to induce sustainable behaviour changes in CAD patients without any continued support. TRIAL REGISTRATION: Netherlands Trial Register: NL9263. Registration Date: 24 February 2021.

Mobile vaccination units to increase COVID-19 vaccination uptake in areas with lower coverage: a within-neighbourhood analysis using national registration data, the Netherlands, September-December 2021.

BackgroundVaccine uptake differs between social groups. Mobile vaccination units (MV-units) were deployed in the Netherlands by municipal health services in neighbourhoods with low uptake of COVID-19 vaccines.AimWe aimed to evaluate the impact of MV-units on vaccine uptake in neighbourhoods with low vaccine uptake.MethodsWe used the Dutch national-level registry of COVID-19 vaccinations (CIMS) and MV-unit deployment registrations containing observations in 253 neighbourhoods where MV-units were deployed and 890 contiguous neighbourhoods (total observations: 88,543 neighbourhood-days). A negative binomial regression with neighbourhood-specific temporal effects using splines was used to study the effect.ResultsDuring deployment, the increase in daily vaccination rate in targeted neighbourhoods ranged from a factor 2.0 (95% confidence interval (CI): 1.8-2.2) in urbanised neighbourhoods to 14.5 (95% CI: 11.6-18.0) in rural neighbourhoods. The effects were larger in neighbourhoods with more voters for the Dutch conservative Reformed Christian party but smaller in neighbourhoods with a higher proportion of people with non-western migration backgrounds. The absolute increase in uptake over the complete intervention period ranged from 0.22 percentage points (95% CI: 0.18-0.26) in the most urbanised neighbourhoods to 0.33 percentage point (95% CI: 0.28-0.37) in rural neighbourhoods.ConclusionDeployment of MV-units increased daily vaccination rate, particularly in rural neighbourhoods, with longer travel distance to permanent vaccination locations. This public health intervention shows promise to reduce geographic and social health inequalities, but more proactive and long-term deployment is required to identify its potential to substantially contribute to overall vaccination rates at country level.

Design of a Multiple-Behavior Change Intervention for Supporting Self-management in Patients With Chronic Heart Failure: An Intervention Mapping Approach.

BACKGROUND: Nonadherence to medication and low physical activity contribute to morbidity, mortality, and decreased quality of life among patients with chronic heart failure (CHF). Effective interventions that can be delivered during routine clinical care are lacking. OBJECTIVE: We aimed to adapt the feasible and cost-effective Adherence Improving self-Management Strategy (AIMS) for patients with human immunodeficiency virus (HIV) to CHF treatment. Subsequently, we determined its acceptability and feasibility. METHODS: Adherence Improving self-Management Strategy is a systematic, nurse-delivered counseling intervention blended with eHealth to facilitate patient self-management. We used the intervention mapping framework to systematically adapt AIMS-HIV to AIMS-CHF, while preserving essential intervention elements. Therefore, we systematically consulted the scientific literature, patients with CHF and nurses, and pretested intervention materials. RESULTS: Adherence Improving self-Management Strategy-HIV was modified to AIMS-CHF: a multiple-behavior change intervention, focused on medication adherence and physical activity. Key self-management determinants (such as attitudes, self-efficacy, and self-regulatory skills) and organization of care (such as specialized nurses delivering AIMS) were similar for HIV and heart failure care. The AIMS protocol, as well as material content and design, was systematically adapted to CHF. Preliminary testing suggests that AIMS-CHF is likely feasible and acceptable to patients with CHF and care providers. CONCLUSION: Using the intervention mapping protocol, AIMS-HIV could be systematically adapted to AIMS-CHF and seems acceptable and feasible. Evidence from the literature, behavioral theory, and input from nurses and patients were essential in this process. Adherence Improving self-Management Strategy-CHF should now be tested for feasibility and effectiveness in routine care.

Between- and Within-Individual Sociodemographic and Psychological Determinants of PrEP Adherence Among Men Who have Sex with Men Prescribed a Daily PrEP Regimen in Wales.

We investigated the determinants of daily PrEP use and coverage of condomless anal sex (CAS) by PrEP among men who have sex with men in Wales, UK. We measured PrEP use by electronic monitors and CAS by secure online surveys. We defined PrEP use based on daily medication cap openings and coverage as CAS episodes preceded by ≥ 3 days of PrEP use and followed by ≥ 2 days of PrEP use. We included 57 participants (5463 observations). An STI diagnosis was associated with lower PrEP use but also lower PrEP coverage. Older adults had higher PrEP use. A belief that other PrEP users took PrEP as prescribed was associated with lower PrEP coverage. An STI diagnosis is an important cue for an intervention, reflecting episodes of high-risk sexual behaviour and low PrEP coverage. Other results provide a basis for the development of an evidence-informed intervention for promoting coverage of PrEP.

Psychometric Properties of an Adapted Stigma Scale and Experiences of Stigma Associated with HIV Pre-exposure Prophylaxis Use Among Men Who have Sex with Men: A Mixed Methods Study.

Stigma may influence the use of HIV pre-exposure prophylaxis (PrEP). However, there is an absence of robust measures for PrEP-related stigma. We describe an adaptation of a HIV stigma scale for use in PrEP users and experiences of PrEP users in Wales (UK) with regards to PrEP-related stigma. A mixed methods study was conducted where PrEP users completed questionnaire items about PrEP-related stigma and a subset were interviewed about their experiences of taking PrEP. We adapted items from the HIV stigma scale and assessed construct validity and internal consistency. We analysed interview data using a framework approach, with themes focussing on enacted and anticipated stigma in order to identify areas for scale refinement. Our measure had good psychometric properties but additional items may be useful (e.g. specific instances of enacted stigma, concerns around homonegativity). Further work is needed to develop this scale and validate it in a larger sample.

Experiences of men who have sex with men when initiating, implementing and persisting with HIV pre-exposure prophylaxis.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) involves the use of antiretroviral medication in HIV-negative individuals considered to be at risk of acquiring HIV. It has been shown to prevent HIV and has been available in Wales since July 2017. Measuring and understanding adherence to PrEP is complex as it relies on the simultaneous understanding of both PrEP use and sexual activity. We aimed to understand the experiences of men who have sex with men (MSM) living in Wales initiating, implementing and persisting with HIV PrEP. METHODS: We conducted semistructured interviews with MSM PrEP users in Wales who participated in a cohort study of PrEP use and sexual behaviour. Following completion of the cohort study, participants were invited to take part in a semistructured interview about their experiences of taking PrEP. We aimed to include both individuals who had persisted with and discontinued PrEP during the study. The interview topic guide was informed by the ABC taxonomy for medication adherence and the theory of planned behaviour. We analysed our data using reflexive thematic analysis. RESULTS: Twenty-one participants were interviewed, five having discontinued PrEP during the cohort study. The developed themes focused on triggers for initiating PrEP, habitual behaviour, drivers for discontinuation and engagement with sexual health services. Stigma surrounding both PrEP and HIV permeated most topics, acting as a driver for initiating PrEP, an opportunity to reduce discrimination against people living with HIV, but also a concern around the perception of PrEP users. CONCLUSION: This is the first study to investigate PrEP-taking experiences incorporating established medication adherence taxonomy. We highlight key experiences regarding the initiation, implementation and persistence with PrEP and describe how taking PrEP may promote positive engagement with sexual health services. These findings may be useful for informing PrEP rollout programmes and need to be explored in other key populations. PATIENT AND PUBLIC CONTRIBUTION: PrEP users, in addition to PrEP providers and representatives of HIV advocacy and policy, were involved in developing the topic guide for this study.

Systematic adaptation of the adherence improving self-management strategy to support breast cancer survivors' adherence to adjuvant endocrine therapy: An intervention mapping approach.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) for breast cancer leads to increased recurrence and mortality risk and healthcare costs. Evidence on feasible, effective AET adherence interventions is scarce. This paper describes the systematic adaptation of the cost-effective adherence improving self-management strategy (AIMS) for patients with HIV to AET for women after breast cancer treatment. METHODS: We followed the intervention mapping protocol for adapting interventions by conducting a needs assessment, reviewing target behaviours and determinants, reassessing behaviour change methods and adapting programme content. Therefore, we performed a literature review, consulted behavioural theory and organised nine advisory board meetings with patients and healthcare professionals. RESULTS: Non-adherence occurs frequently among AET users. Compared to HIV treatment, AET is less effective, and AET side effects are more burdensome. This drives AET treatment discontinuation. However, the key determinants of non-adherence are largely similar to HIV treatment (e.g. motivation, self-regulation and patient-provider relationship); therefore, most strategies in AIMS-HIV also seem suitable for AIMS-AET. Modifications were required, however, regarding supporting patients with coping with side effects and sustaining treatment motivation. CONCLUSION: AIMS seems to be a suitable framework for adherence self-management across conditions and treatments. Intervention mapping offered a transparent, systematic approach to adapting AIMS-HIV to AET.

Habit formation of preventive behaviours during the COVID-19 pandemic: a longitudinal study of physical distancing and hand washing.

BACKGROUND: Since the outbreak of the COVID-19 pandemic, physical distancing and hand washing have been used as effective means to reduce virus transmission in the Netherlands. However, these measures pose a societal challenge as they require people to change their customary behaviours in various contexts. The science of habit formation is potentially useful for informing policy-making in public health, but the current literature largely overlooked the role of habit in predicting and explaining these preventive behaviours. Our research aimed to describe habit formation processes of physical distancing and hand washing and to estimate the influences of habit strength and intention on behavioural adherence. METHODS: A longitudinal survey was conducted between July and November 2020 on a representative Dutch sample (n = 800). Respondents reported their intentions, habit strengths, and adherence regarding six context-specific preventive behaviours on a weekly basis. Temporal developments of the measured variables were visualized, quantified, and mapped onto five distinct phases of the pandemic. Regression models were used to test the effects of intention, habit strength, and their interaction on behavioural adherence. RESULTS: Dutch respondents generally had strong intentions to adhere to all preventive measures and their adherence rates were between 70% and 90%. They also self-reported to experience their behaviours as more automatic over time, and this increasing trend in habit strength was more evident for physical-distancing than for hand washing behaviours. For all six behaviours, both intention and habit strength predicted subsequent adherence (all ps < 2e-16). In addition, the predictive power of intention decreased over time and was weaker for respondents with strong habits for physical distancing when visiting supermarkets (B = -0.63, p <.0001) and having guests at home (B = -0.54, p <.0001) in the later phases of the study, but not for hand washing. CONCLUSIONS: People's adaptations to physical-distancing and hand washing measures involve both intentional and habitual processes. For public health management, our findings highlight the importance of using contextual cues to promote habit formation, especially for maintaining physical-distancing practices. For habit theories, our study provides a unique dataset that covers multiple health behaviours in a critical real-world setting.

Public health measures during the COVID-19 pandemic through the lens of community organisations and networks in the Netherlands (2020-2021): five lessons for pandemic decision-making.

BackgroundDuring the coronavirus disease (COVID-19) pandemic, key persons who were formally or informally active in community organisations and networks, such as sports clubs or cultural, educational, day care and healthcare facilities, occupied a key position between governments and citizens. However, their experiences, the dilemmas they faced and the solutions they generated when implementing COVID-19 measures in their respective settings are understudied.AimWe aimed to understand how key persons in different community organisations and networks experienced and responded to the COVID-19 measures in the Netherlands.MethodsBetween October 2020 and December 2021, the Corona Behavioural Unit at the Dutch national public health institute, conducted qualitative research based on narratives derived from 65 in-depth interviews with 95 key persons from 32 organisations and networks in eight different sectors.ResultsFirstly, key persons enhanced adherence and supported the resilience and well-being of people involved in their settings. Secondly, adherence was negatively affected where COVID-19 measures conflicted with important organisational goals and values. Thirdly, small changes and ambiguities in COVID-19 policy had substantial consequences, depending on the context. Fourthly, problem-solving was achieved through trial-and-error, peer support, co-creation and transparent communication. Lastly, the COVID-19 pandemic and measures highlighted inequalities in access to resources.ConclusionPandemic preparedness requires organisational and community preparedness and a multidisciplinary public health approach. Structural engagement of governments with key persons in community organisations and networks is key to enhance public trust and adherence to pandemic measures and contributes to health equity and the well-being of the people involved.

Behavioural insights and the evolving COVID-19 pandemic.

Behavioural sciences have complemented medical and epidemiological sciences in the response to the SARS-CoV-2 pandemic. As vaccination uptake continues to increase across the EU/EEA - including booster vaccinations - behavioural science research remains important for both pandemic policy, planning of services and communication. From a behavioural perspective, the following three areas are key as the pandemic progresses: (i) attaining and maintaining high levels of vaccination including booster doses across all groups in society, including socially vulnerable populations, (ii) informing sustainable pandemic policies and ensuring adherence to basic prevention measures to protect the most vulnerable population, and (iii) facilitating population preparedness and willingness to support and adhere to the reimposition of restrictions locally or regionally whenever outbreaks may occur. Based on mixed-methods research, expert consultations, and engagement with communities, behavioural data and interventions can thus be important to prevent and effectively respond to local or regional outbreaks, and to minimise socioeconomic and health disparities. In this Perspective, we briefly outline these topics from a European viewpoint, while recognising the importance of considering the specific context in individual countries.

Early impact of COVID-19 social distancing measures on reported sexual behaviour of HIV pre-exposure prophylaxis users in Wales.

OBJECTIVES: To describe the early impact of COVID-19 and associated control measures on the sexual behaviour of pre-exposure prophylaxis (PrEP) users in Wales. METHODS: Data were obtained from an ecological momentary assessment study of PrEP use and sexual behaviour. Participants were individuals accessing PrEP through the National Health Service (NHS) sexual health clinics across four health boards in Wales. Weekly data documenting condomless sex in the preceding week were analysed between 03/02/2020 and 10/05/2020. The introduction of social distancing measures and changes to sexual health clinics in Wales occurred on the week starting 16/03/2020. Two-level logistic regression models were fitted to condomless sex (yes/no) over time, included an indicator for the week starting 16/03/2020, and were extended to explore differential associations by relationship status and sexual health clinic. RESULTS: Data were available from 56 participants and included 697 person-weeks (89% of the maximum number that could have been obtained). On average, 42% of participants reported condomless sex in the period prior to the introduction of social distancing measures and 20% reported condomless sex after (OR=0.16, 95% CI 0.07 to 0.37, p<0.001). There was some evidence to suggest that this association was moderated by relationship status (OR for single participants=0.09, 95% CI 0.06 to 0.23; OR for not single participants=0.46, 95% CI 0.16 to 1.25). CONCLUSIONS: The introduction of social distancing measures and changes to PrEP services across Wales was associated with a marked reduction in reported instances of condomless sexual intercourse among respondents, with a larger reduction in those who were single compared with those who were not. The long-term impact of COVID-19 and associated control measures on this population's physical and mental health and well-being requires close examination.

What influences adherence to guidance for postoperative instillation of intravesical chemotherapy to patients with bladder cancer?

OBJECTIVE: To understand the barriers and facilitators to single instillation of intravesical chemotherapy (SI-IVC) use after resection of non-muscle-invasive bladder cancer (NMIBC) in Scotland and England using a behavioural theory-informed approach. SUBJECTS AND METHODS: In a cross-sectional descriptive study of practices at seven hospitals, we investigated care pathways, policies, and interviewed 30 urology staff responsible for SI-IVC. We used the Theoretical Domains Framework (TDF) to organise our investigation and conducted deductive thematic analyses, while inductively coding emergent beliefs. RESULTS: Barriers to SI-IVC were present at different organisational levels and professional roles. In four hospitals, there was a policy to not instil SI-IVC in theatre. Six hospitals' staff reported delays in mitomycin C (MMC) ordering and/or local storage. Lack of training, skills and perceived workload affected motivation. Facilitators included access to modern instilling devices (four hospitals) and incorporating reminders in operation proforma (four hospitals). Performance targets (with audit and feedback) within a national governance framework were present in Scotland but not England. Differences in coordinated leadership, sharing best practices, and disliking being perceived as underperforming, were evident in Scotland. CONCLUSIONS: High-certainty evidence shows that SI-IVC, such as MMC, after NMIBC resection reduces recurrences. This evidence underpins international guidance. The number of eligible patients receiving SI-IVC is variable indicating suboptimal practice. Improving SI-IVC adherence requires modifications to theatre instilling policies, delivery and storage of MMC, staff training, and documentation. Centralising care, with bladder cancer expert leadership and best practices sharing with performance targets, likely led to improvements in Scotland. National quality improvement, incorporating audit and feedback, with additional implementation strategies targeted to professional role could improve adherence and patient outcomes elsewhere. This process should be controlled to clarify implementation intervention effectiveness.

Can-Pain-a digital intervention to optimise cancer pain control in the community: development and feasibility testing.

PURPOSE: To develop a novel digital intervention to optimise cancer pain control in the community. This paper describes intervention development, content/rationale and initial feasibility testing. METHODS: Determinants of suboptimal cancer pain management were characterised through two systematic reviews; patient, caregiver and healthcare professional (HCP) interviews (n = 39); and two HCP focus groups (n = 12). Intervention mapping was used to translate results into theory-based content, creating the app "Can-Pain". Patients with/without a linked caregiver, their general practitioners and community palliative care nurses were recruited to feasibility test Can-Pain over 4 weeks. RESULTS: Patients on strong opioids described challenges balancing pain levels with opioid intake, side effects and activities and communicating about pain management problems with HCPs. Can-Pain addresses these challenges through educational resources, contemporaneous short-acting opioid tracking and weekly patient-reported outcome monitoring. Novel aspects of Can-Pain include the use of contemporaneous breakthrough analgesic reports as a surrogate measure of pain control and measuring the level at which pain becomes bothersome to the individual. Patients were unwell due to advanced cancer, making recruitment to feasibility testing difficult. Two patients and one caregiver used Can-Pain for 4 weeks, sharing weekly reports with four HCPs. Can-Pain highlighted unrecognised problems, promoted shared understanding about symptoms between patients and HCPs and supported shared decision-making. CONCLUSIONS: Preliminary testing suggests that Can-Pain is feasible and could promote patient-centred pain management. We will conduct further small-scale evaluations to inform a future randomised, stepped-wedge trial. TRIAL REGISTRATION: Qualitative research: ClinicalTrials.gov , reference NCT02341846 Feasibility study: NIHR CPMS database ID 34172.

Understanding a national increase in COVID-19 vaccination intention, the Netherlands, November 2020-March 2021.

The intention to get the COVID-19 vaccine increased from 48% (November 2020) to 75% (March 2021) as national campaigning in the Netherlands commenced. Using a mixed method approach we identified six vaccination beliefs and two contextual factors informing this increase. Analysis of a national survey confirmed that shifting intentions were a function of shifting beliefs: people with stronger intention to vaccinate were most motivated by protecting others and reopening society; those reluctant were most concerned about side effects.

Do Combinations of Behavior Change Techniques That Occur Frequently in Interventions Reflect Underlying Theory?

BACKGROUND: Behavioral interventions typically include multiple behavior change techniques (BCTs). The theory informing the selection of BCTs for an intervention may be stated explicitly or remain unreported, thus impeding the identification of links between theory and behavior change outcomes. PURPOSE: This study aimed to identify groups of BCTs commonly occurring together in behavior change interventions and examine whether behavior change theories underlying these groups could be identified. METHODS: The study involved three phases: (a) a factor analysis to identify groups of co-occurring BCTs from 277 behavior change intervention reports; (b) examining expert consensus (n = 25) about links between BCT groups and behavioral theories; (c) a comparison of the expert-linked theories with theories explicitly mentioned by authors of the 277 intervention reports. RESULTS: Five groups of co-occurring BCTs (range: 3-13 BCTs per group) were identified through factor analysis. Experts agreed on five links (≥80% of experts), comprising three BCT groups and five behavior change theories. Four of the five BCT group-theory links agreed by experts were also stated by study authors in intervention reports using similar groups of BCTs. CONCLUSIONS: It is possible to identify groups of BCTs frequently used together in interventions. Experts made shared inferences about behavior change theory underlying these BCT groups, suggesting that it may be possible to propose a theoretical basis for interventions where authors do not explicitly put forward a theory. These results advance our understanding of theory use in multicomponent interventions and build the evidence base for further understanding theory-based intervention development and evaluation.

Effects of short- and long-acting beta-agonists on asthma exacerbations: a prospective cohort.

BACKGROUND: In asthma, short- and long-acting ß-agonists (SABAs and LABAs) should be used together with inhaled corticosteroids (ICS), and regular use is inappropriate. OBJECTIVE: To assess the relationship between patterns of use of therapy and asthma exacerbations (AEx). METHODS: Patients with asthma (6-40 years) were enrolled in France and the United Kingdom. Prescribing data, computer-assisted telephone interviews (CATIs), and text messages assessed medication use and AEx over a maximum period of 24 months. Generalized linear mixed models provided AEx risks associated with therapy. RESULTS: Among the 908 patients (median age: 20.0 years, 46.6% women, 24.5% children) answering a total of 4248 CATIs over 486 (±235) days, regular (ie, daily) use was more frequent for single LABAs and fixed dose combinations (FDCs) than for single ICS (75.6%, 70.1%, and 65.4% of investigated periods of use, respectively). Regular (ie, daily or almost daily) SABA use was observed for 21.1% of periods of use. Altogether, 265 patients (29.2%) experienced 1 or more AEx. The ORs for AEx risk related to regular vs no use of FDCs, single ICS, and single LABAs were 0.98 (95% CI = [0.73-1.33]), 0.90 (95% CI = [0.61-1.33]), and 1.29 (95% CI = [0.76-2.17]), respectively, after adjustment for cotherapy, sociodemographic, and disease characteristics. The OR was 2.09 (95% CI = [1.36-3.21]) in regular SABA users. CONCLUSION: Inhaled corticosteroids and FDCs were often used intermittently, whereas SABAs and LABAs could be used regularly, and exacerbations were frequent. Compared with non-users, the risk of exacerbation increased moderately under regular use of single LABAs, whereas it doubled, significantly, in regular SABA users, likely in relationship with poor overall asthma control.

Cost-effectiveness and Cost-utility of the Adherence Improving Self-management Strategy in Human Immunodeficiency Virus Care: A Trial-based Economic Evaluation.

Background: Several promising human immunodeficiency virus (HIV) treatment adherence interventions have been identified, but data about their cost-effectiveness are lacking. This study examines the trial-based cost-effectiveness and cost-utility of the proven-effective Adherence Improving Self-Management Strategy (AIMS), from a societal perspective, with a 15-month time horizon. Methods: Treatment-naive and treatment-experienced patients at risk for viral rebound were randomized to treatment as usual (TAU) or AIMS in a multicenter randomized controlled trial in the Netherlands. AIMS is a nurse-led, 1-on-1 self-management intervention incorporating feedback from electronic medication monitors, delivered during routine clinical visits. Main outcomes were costs per reduction in log10 viral load, treatment failure (2 consecutive detectable viral loads), and quality-adjusted life-years (QALYs). Results: Two hundred twenty-three patients were randomized. From a societal perspective, AIMS was slightly more expensive than TAU but also more effective, resulting in an incremental cost-effectiveness ratio (ICER) of €549 per reduction in log10 viral load and €1659 per percentage decrease in treatment failure. In terms of QALYs, AIMS resulted in higher costs but more QALYs compared to TAU, which resulted in an ICER of €27759 per QALY gained. From a healthcare perspective, AIMS dominated TAU. Additional sensitivity analyses addressing key limitations of the base case analyses also suggested that AIMS dominates TAU. Conclusions: Base case analyses suggests that over a period of 15 months, AIMS may be costlier, but also more effective than TAU. All additional analyses suggest that AIMS is cheaper and more effective than TAU. This trial-based economic evaluation confirms and complements a model-based economic evaluation with a lifetime horizon showing that AIMS is cost-effective. Clinical Trials Registration: NCT01429142.

Does adherence to inhaled corticosteroids predict asthma-related outcomes over time? A cohort study.

Inhaled corticosteroids (ICS) adherence is important for asthma management. Current evidence on the impact of ICS adherence on outcomes is mostly based on correlational analyses of between-person data. Although it is widely acknowledged that asthma outcomes fluctuate over time, evidence on predictors of within-person change is scarce. We aimed to quantify these fluctuations and the longitudinal relationships between ICS adherence and outcomes at both between- and within-person levels.A prospective cohort of persistent asthma patients in France and the UK (n=847, age 6-40 years) provided 3756 reports over up to 2 years via computer-assisted telephone interviews and text messages on ICS adherence, asthma control, reliever medication use and exacerbations. We examined adherence-outcome relationships via longitudinal models, controlling for confounders, including severity.Considerable within-person variability was found for exacerbations (91%), asthma control (59%) and reliever use (52%); 431 (11.5%) reports signalled exacerbations and 2046 (54.5%) poor control. At between-person level, patients with higher average adherence were more likely to report asthma control (OR 1.25, 95% CI 1.06-1.47), but not asthma exacerbations (OR 0.99, 95% CI 0.87-1.12) or lower reliever use (b -0.0004, 95% CI -0.089-0.088). At within-person level, higher-than-usual adherence was associated with higher concomitant reliever use (b 0.092, 95% CI 0.053-0.131) and lower subsequent reliever use (b -0.047, 95% CI -0.005- -0.088); it was unrelated to asthma control (OR 0.93, 95% CI 0.84-1.02) or exacerbations (OR 1.04, 95% CI 0.94-1.16).Patients maintaining high ICS adherence over time have better asthma control. Temporarily increasing ICS adherence tends to be simultaneous to higher reliever use and reduces reliever use later on. Causes of within-person variation in outcomes require more investigation.

Links Between Behavior Change Techniques and Mechanisms of Action: An Expert Consensus Study.

BACKGROUND: Understanding the mechanisms through which behavior change techniques (BCTs) can modify behavior is important for the development and evaluation of effective behavioral interventions. To advance the field, we require a shared knowledge of the mechanisms of action (MoAs) through which BCTs may operate when influencing behavior. PURPOSE: To elicit expert consensus on links between BCTs and MoAs. METHODS: In a modified Nominal Group Technique study, 105 international behavior change experts rated, discussed, and rerated links between 61 frequently used BCTs and 26 MoAs. The criterion for consensus was that at least 80 per cent of experts reached agreement about a link. Heat maps were used to present the data relating to all possible links. RESULTS: Of 1,586 possible links (61 BCTs × 26 MoAs), 51 of 61 (83.6 per cent) BCTs had a definite link to one or more MoAs (mean [SD] = 1.44 [0.96], range = 1-4), and 20 of 26 (76.9 per cent) MoAs had a definite link to one or more BCTs (mean [SD] = 3.27 [2.91], range = 9). Ninety (5.7 per cent) were identified as "definite" links, 464 (29.2 per cent) as "definitely not" links, and 1,032 (65.1 per cent) as "possible" or "unsure" links. No "definite" links were identified for 10 BCTs (e.g., "Action Planning" and "Behavioural Substitution") and for six MoAs (e.g., "Needs" and "Optimism"). CONCLUSIONS: The matrix of links between BCTs and MoAs provides a basis for those developing and synthesizing behavioral interventions. These links also provide a framework for specifying empirical tests in future studies.