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Objective To understand the barriers and facilitators to single instillation of intravesical chemotherapy (SI-IVC) use following resection of non-muscle-invasive bladder cancer (NMIBC) in Scotland and England using a behavioural theory-informed approach. Materials 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 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 operation pro-forma (four hospitals). Performance targets (with audit and feedback) within a national governance framework was 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 Mitomycin C (MMC), following NMIBC resection reduces recurrences. This evidence underpins international guidance. Numbers 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.

Despite its importance, underreporting of the active content of experimental and comparator interventions in published literature has not been previously examined for behavioural trials. We assessed completeness and variability in reporting in 142 randomised controlled trials of behavioural interventions for smoking cessation published between 1/1996 and 11/2015. Two coders reliably identified the potential active components of experimental and comparator interventions (activities targeting behaviours key to smoking cessation and qualifying as behaviour change techniques, BCTs) in published, and in unpublished materials obtained from study authors directly. Unpublished materials were obtained for 129/204 (63%) experimental and 93/142 (65%) comparator groups. For those, only 35% (1200/3403) of experimental and 26% (491/1891) of comparator BCTs could be identified in published materials. Reporting quality (#published BCTs/#total BCTs) varied considerably between trials and between groups within trials. Experimental (vs. comparator) interventions were better reported (B(SE) = 0.34 (0.11), p

Background Many global health challenges may be targeted by changing people’s behaviour. Behaviours including cigarette smoking, physical inactivity and alcohol misuse, as well as certain dietary behaviours, contribute to deaths and disability by increasing the risk of cancers, cardiovascular diseases and diabetes. Interventions have been designed to change these health behaviours with a view to reducing these health risks. However, the effectiveness of these interventions has been quite variable and further information is needed to enhance their success. More information is needed about the specific processes that underlie the effectiveness of intervention strategies. Aim Researchers have developed a taxonomy of 93 behaviour change techniques (i.e. the active components of an intervention that bring about behavioural change), but little is known regarding their potential mechanisms of action (i.e. the processes through which a behaviour change technique affects behaviour). We therefore aimed to examine links between behaviour change techniques and mechanisms of action. Method First, we conducted a literature synthesis study of 277 behaviour change intervention studies, from which we extracted information on links, described by authors, between behaviour change techniques and mechanisms of action, and identified an average of 10 links per intervention report. Second, behaviour change experts (n = 105) were engaged in a three-round consensus study in which they discussed and rated their confidence in the presence/absence of ‘links’ and ‘non-links’ between commonly used behaviour change techniques (n = 61) and a set of mechanisms of action (n = 26). Ninety links and 460 ‘non-links’ reached the pre-set threshold of 80% agreement. To enhance the validity of these results, a third study was conducted that triangulated the findings of the first two studies. Discrepancies and uncertainties between the studies were included in a reconciliation consensus study with a new group of experts (n = 25). The final results identified 92 definite behaviour change technique–mechanism of action links and 465 definite non-links. In a fourth study, we examined whether or not groups of behaviour change techniques used together frequently across interventions revealed shared theoretical underpinnings. We found that experts agreed on the underlying theory for three groups of behaviour change techniques. Results Our results are potentially useful to policy-makers and practitioners in selecting behaviour change techniques to include in behaviour change interventions. However, our data do not demonstrate that the behaviour change techniques are effective in targeting the mechanism of action; rather, the links identified may be the ‘best bets’ for interventions that are effective in changing mechanisms of action, and the non-links are unlikely to be effective. Researchers examining effectiveness of interventions in either primary studies or evidence syntheses may consider these links for further investigation. Conclusion To make our results usable by researchers, practitioners and policy-makers, they are available in an online interactive tool, which enables discussion and collaboration (https://theoryandtechniquetool.humanbehaviourchange.org/); accessed 1 March 2020. This work, building on previous work to develop the behaviour change technique taxonomy, is part of an ongoing programme of work: the Human Behaviour Change Project (www.humanbehaviourchange.org/; accessed 1 March 2020). Funding This project was funded by the Medical Research Council via its Methodology Panel: ‘Developing methodology for designing and evaluating theory-based complex interventions: an ontology for linking behaviour change techniques to theory’ (reference MR/L011115/1).

Contains fulltext : 238651.pdf (Publisher’s version ) (Open Access) BACKGROUND: Individuals' perceptions of back pain may shape what they do in response to manage their pain, for example, self-care, medication and seeking healthcare. Illness perceptions encompass a variety of beliefs such as how long pain is expected to last and whether treatments are perceived to control pain. Whether these beliefs meaningfully cluster and whether these clusters are associated with how people manage their back pain are currently unknown. METHODS: 1,343 individuals with back pain from a general population sample completed the brief Illness Perceptions Questionnaire and measures about their pain and illness behaviours. Using a two-stage cluster analysis, we identified four distinct clusters of individuals. Logistic regression was used to investigate relationships between cluster membership and illness behaviours. RESULTS: After adjustment for socio-demographic characteristics, pain severity, interference and duration, relative to a low threat illness perception cluster, a high threat cluster was more likely to have contacted a general practitioner (OR: 3.03, 95% CI: 1.75, 5.23) and a moderate threat-high treatment control cluster was more likely to have consulted a physical therapist (OR: 2.21, 95% CI: 1.26, 3.87). Both the moderate threat-high treatment control cluster and high threat cluster were also less likely to have reported self-care (OR: 0.64, 95% CI: 0.43, 0.95; OR: 0.53, 95% CI: 0.34, 0.83, respectively). CONCLUSIONS: The cluster analysis provided a meaningful classification of individuals based on their cognitive illness perceptions of their back pain, as these clusters were associated with different illness behaviours. Interventions which modify clusters of illness perceptions may be effective in influencing how individuals respond to back pain. SIGNIFICANCE: Within a general population setting, we identified four clearly distinct groups of people based on the perceptions they held about their back pain. These groupings seemed to reflect meaningful characterisations as they differed based on the characteristics of their pain (e.g., severity and duration) and, after adjustment for these characteristics, were associated with different ways of managing pain. Interventions which focus on targeting the sets of illness perceptions that people hold may be effective in influencing how individuals manage back pain.

Contains fulltext : 229562.pdf (Publisher’s version ) (Open Access) AIMS: To estimate the strengths of associations between use of behaviour change techniques (BCTs) and clusters of BCTs in behavioural smoking cessation interventions and comparators with smoking cessation rates. METHOD: Systematic review and meta-regression of biochemically verified smoking cessation rates on BCTs in interventions and comparators in randomized controlled trials, adjusting for a priori-defined potential confounding variables, together with moderation analyses. Studies were drawn from the Cochrane Tobacco Addiction Group Specialised Register. Data were extracted from published and unpublished (i.e. obtained from study authors) study materials by two independent coders. Adequately described intervention (k = 143) and comparator (k = 92) groups were included in the analyses (n = 43 992 participants). Using bivariate mixed-effects meta-regressions, while controlling for key a priori confounders, we regressed smoking cessation on (a) three BCT groupings consistent with dual-process theory (i.e. associative, reflective motivational and self-regulatory), (b) 17 expert-derived BCT groupings (i.e. BCT taxonomy version 1 clusters) and (c) individual BCTs from the BCT taxonomy version 1. RESULTS: Among person-delivered interventions, higher smoking cessation rates were predicted by BCTs targeting associative and self-regulatory processes (B = 0.034, 0.041, P

Aims: To examine variability and effectiveness of interventions provided to comparator (control) groups in smoking cessation trials. Methods: Systematic review with meta‐analysis of randomized controlled trials (RCTs) of behavioral interventions for smoking cessation, with or without stop‐smoking medication. We searched the Cochrane Tobacco Addiction Group Specialized Register for RCTs with objective outcomes measured at ≥6months. Study authors were contacted to obtain comprehensive descriptions of their comparator interventions. Meta‐regression analyses examined the relationships of smoking cessation rates with stop‐smoking medication and behavior change techniques. Results: One hundred and four of 142 eligible comparator groups (n=23 706) had complete data and were included in analyses. There was considerable variability in the number of behavior change techniques delivered [mean=15.97, standard deviation (SD)=13.54, range=0–45] and the provision of smoking cessation medication (43% of groups received medication) throughout and within categories of comparator groups (e.g. usual care, brief advice). Higher smoking cessation rates were predicted by provision of medication [B=0.334, 95% confidence interval (CI)=0.030–0.638,P=0.031] and number of behavior change techniques included (B=0.020, 95% CI=0.008–0.032,P Conclusions: Interventions delivered to comparator groups in smoking cessation randomized controlled trials vary considerably in content, and cessation rates are strongly predicted by stop‐smoking medication and number of behavior change techniques delivered.

Background: Highly effective direct-acting antiviral drugs provide the opportunity to eliminate hepatitis C virus (HCV) infection, but established pathways can be ineffective. We aimed to examine whether a community pharmacy care pathway increased treatment uptake, treatment completion, and cure rates for people receiving opioid substitution therapy, compared with conventional care. Methods: This cluster-randomised trial was done in Scottish community pharmacies. Before participants were recruited, pharmacies were randomly assigned (1:1) to refer patients with evidence of HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care). Pharmacies were stratified by location. All pharmacies were trained to offer dried blood spot testing. All eligible participants had received opioid substitution therapy for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration. Neither pharmacists nor patients were masked to treatment allocation. In both groups, assessment blood samples were taken, infection with HCV was confirmed, and daily oral ledipasvir–sofosbuvir (90 mg ledipasivir plus 400 mg sofosbuvir) for 8 weeks for genotype 1 or daily oral sofosbuvir (400 mg) plus oral daclatasvir (60 mg) for 12 weeks for genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group). In the conventional care group, the patient received care at a treatment centre. Once prescribed, medication in both groups was delivered as daily modified directly observed therapy alongside opioid substitution therapy in the participants' pharmacy where treatment was observed on 6 days per week. The primary outcome was the number of patients with sustained virological response 12 weeks after completion of treatment (SVR12) as a proportion of the number of people receiving opioid substitution therapy at participating pharmacies. Participants were monitored at each visit for nausea and fatigue; other adverse events were recorded as free text. Secondary outcomes compared key points on treatment pathway between the two groups. These key points were the proportion of patients having dry blood spot testing, the proportion of patients initiating HCV treatment, the proportion of patients completing the 8 or 12 week HCV course of treatment, and the proportion of patients with sustained virological response at 12 months. This study is registered with ClinicalTrials.gov, NCT02706223. Findings: 56 pharmacies were randomly assigned (28 to each group; one pharmacy withdrew from the conventional care group). The 55 participating pharmacies included 2718 patients receiving opioid substitution therapy (1365 in the pharmacist-led care group and 1353 in the conventional care group). More patients met the primary endpoint of SVR12 in the pharmacist-led care group (98 [7%] of 1365) than in the conventional care group (43 [3%] of 1353; odds ratio 2·375, 95% CI 1·555–3·628, p

Contains fulltext : 251351.pdf (Publisher’s version ) (Open Access) Most countries in the world have recommended or mandated face masks in some or all public places during the COVID-19 pandemic. However, mask use has been thought to increase people's face-touching frequency and thus risk of self-inoculation. Across two studies, we video-observed the face-touching behaviour of members of the public in Amsterdam and Rotterdam (the Netherlands) during the first wave of the pandemic. Study 1 (n = 383) yielded evidence in favour of the absence of an association between mask-wearing and face-touching (defined as touches of face or mask), and Study 2 (n = 421) replicated this result. Secondary outcome analysis of the two studies-analysed separately and with pooled data sets-evidenced a negative association between mask-wearing and hand contact with the face and its t-zone (i.e. eyes, nose and mouth). In sum, the current findings alleviate the concern that mask-wearing has an adverse face-touching effect.

Contains fulltext : 202226.pdf (Publisher’s version ) (Closed access) 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 euro549 per reduction in log10 viral load and euro1659 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 euro27759 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.

ObjectivesTo describe the early impact of COVID-19 and associated control measures on the sexual behaviour of pre-exposure prophylaxis (PrEP) users in Wales.MethodsData 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.ResultsData 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, pConclusionsThe 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.

Contains fulltext : 243553.pdf (Publisher’s version ) (Open Access) Researchers, practitioners, and policymakers develop interventions to change behavior based on their understanding of how behavior change techniques (BCTs) impact the determinants of behavior. A transparent, systematic, and accessible method of linking BCTs with the processes through which they change behavior (i.e., their mechanisms of action [MoAs]) would advance the understanding of intervention effects and improve theory and intervention development. The purpose of this study is to triangulate evidence for hypothesized BCT-MoA links obtained in two previous studies and present the results in an interactive, online tool. Two previous studies generated evidence on links between 56 BCTs and 26 MoAs based on their frequency in literature synthesis and on expert consensus. Concordance between the findings of the two studies was examined using multilevel modeling. Uncertainties and differences between the two studies were reconciled by 16 behavior change experts using consensus development methods. The resulting evidence was used to generate an online tool. The two studies showed concordance for 25 of the 26 MoAs and agreement for 37 links and for 460 "nonlinks." A further 55 links were resolved by consensus (total of 92 [37 + 55] hypothesized BCT-MoA links). Full data on 1,456 possible links was incorporated into the online interactive Theory and Technique Tool (https://theoryandtechniquetool.humanbehaviourchange.org/). This triangulation of two distinct sources of evidence provides guidance on how BCTs may affect the mechanisms that change behavior and is available as a resource for behavior change intervention designers, researchers and theorists, supporting intervention design, research synthesis, and collaborative research.

Rationale Although women in low- and middle-income countries are increasingly encouraged to give birth at facilities, healthcare-associated infection of both the mother and newborn remain common. An important cause of infection is poor hand hygiene. There is a need to understand how environmental, behavioural, and organisational factors influence hygiene practice. Objective To understand variations between facilities and between people in hygiene behaviour and to explore potential intervention targets in four labour wards in Zanzibar. Methods Site visits including observation of deliveries and of day-to-day workings of the facilities. Thirty-three semi-structured interviews, totalling more than 46 hours, with birth attendants, orderlies, managerial staff and mothers. Transcribed interviews and observation notes were read and coded by two authors. Themes were developed and analysed in light of existing research. Results The physical preconditions for hand hygiene were met more regularly in the two highvolume facilities, where soap, water, gloves were almost always available. However, in all of the facilities, hand hygiene appeared impeded by poor ergonomics, like, for example, physical distance between water taps, gloves, or delivery beds. Recontamination of gloved hands following good hand hygiene was commonly observed, a pattern that the birth attendants attributed to high and unpredictable workload and equipment shortages. Interviews and focus groups suggested that birth attendants typically understood when and why hand hygiene should be implemented, and that they were aware of low handwashing rates among co-workers. In poorer performing facilities, managers were less inclined to visit wards and more likely to perceive hand hygiene as beyond their influence. Conclusions Observations and interviews suggest improvements in the ergonomic design of delivery rooms, including convenient availability of sinks, soap, hand gel, hand towels and gloves, may be a low-cost way to reduce the infection burden from poor hand hygiene., Highlights • We ran a mixed-methods study on clean birth practices in Zanzibar. • We interviewed 34 staff, observed 15 births, and spent 15 days in four facilities. • While gloves, soap, and handgel are often present, they are rarely convenient. • Midwives realise hygiene is low among colleagues not prioritised by management. • Improved ergonomics and norm change may help improve infection control.

Contains fulltext : 218860.pdf (Publisher’s version ) (Closed access) BACKGROUND: In asthma, short- and long-acting beta-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.

Recent research calls for distinguishing whether the failure to comply with World Health Organisation hand hygiene guidelines is driven by omitting to rub/wash hands, or subsequently recontamination of clean hands or gloves prior to a procedure. This study examined the determinants of these two behaviours. Across the 10 highest-volume labour wards in Zanzibar, we observed 103 birth attendants across 779 hand hygiene opportunities before aseptic procedures (time-and-motion methods). They were then interviewed using a structured cross-sectional survey. We used mixed-effect multivariable logistic regressions to investigate the independent association of candidate determinants with hand rubbing/washing and avoiding glove recontamination. After controlling for confounders, we found that availability of single-use material to dry hands (OR:2.9, CI:1.58&ndash, 5.14), a higher workload (OR:29.4, CI:12.9&ndash, 67.0), more knowledge about hand hygiene (OR:1.89, CI:1.02&ndash, 3.49), and an environment with more reminders from colleagues (OR:1.20, CI:0.98&ndash, 1.46) were associated with more hand rubbing/washing. Only the length of time elapsed since donning gloves (OR:4.5, CI:2.5&ndash, 8.0) was associated with avoiding glove recontamination. We identified multiple determinants of hand washing/rubbing. Only time elapsed since washing/rubbing was reliably associated with avoiding glove recontamination. In this setting, these two behaviours require different interventions. Future studies should measure them separately.

Background Understanding links between behaviour change techniques (BCTs) and mechanisms of action (the processes through which they affect behaviour) helps inform the systematic development of behaviour change interventions. Purpose This research aims to develop and test a methodology for linking BCTs to their mechanisms of action. Methods Study 1 (published explicit links): Hypothesised links between 93 BCTs (from the 93-item BCT taxonomy, BCTTv1) and mechanisms of action will be identified from published interventions and their frequency, explicitness and precision documented. Study 2 (expert-agreed explicit links): Behaviour change experts will identify links between 61 BCTs and 26 mechanisms of action in a formal consensus study. Study 3 (integrated matrix of explicit links): Agreement between studies 1 and 2 will be evaluated and a new group of experts will discuss discrepancies. An integrated matrix of BCT-mechanism of action links, annotated to indicate strength of evidence, will be generated. Study 4 (published implicit links): To determine whether groups of co-occurring BCTs can be linked to theories, we will identify groups of BCTs that are used together from the study 1 literature. A consensus exercise will be used to rate strength of links between groups of BCT and theories. Conclusions A formal methodology for linking BCTs to their hypothesised mechanisms of action can contribute to the development and evaluation of behaviour change interventions. This research is a step towards developing a behaviour change ‘ontology’, specifying relations between BCTs, mechanisms of action, modes of delivery, populations, settings and types of behaviour., The development of a formal method to link behaviour change techniques with mechanisms of action to support investigators as they design and evaluate behavioural interventions.

Objectives: Combination antiretroviral therapy (cART) for HIV is widely available in sub-Saharan Africa. Adherence is crucial to successful treatment. This study aimed to apply an extended Theory of Planned Behaviour (TPB) model to predict objectively measured adherence to cART in Tanzania. Design: Prospective observational study (n=158) where patients completed questionnaires on demographics (Month0), socio-cognitive variables including intentions (Month1), and action planning and self-regulatory processes hypothesised to mediate the intention-behaviour relationship (Month3), to predict adherence (Month5). Main Outcome Measures: Taking adherence was measured objectively using the Medication Events Monitoring System (MEMS) caps. Model tests were conducted using regression and bootstrap mediation analyses. Results: Perceived behavioural control (PBC) was positively (β=.767, p

Objective: This study presents the development and validation of MIS-A (Medication Intake Survey-Asthma), a new self-report instrument measuring key adherence properties during long-term asthma treatment. Design: Within a longitudinal asthma cohort study in France and the United Kingdom, adult patients and caregivers of children responded to computer-assisted telephone interviews. Main outcome measures: Scores for distinct adherence properties (taking adherence, correct dosing, therapeutic coverage, drug holidays, overuse) and composite measures were computed for several time intervals. We examined distributions, longitudinal variation, associations between adherence scores and concordance with adherence calculated from medication prescribing or dispensing records. Results: Nine hundred and two participants reported on adherence to 4481 medications on 4140 occasions. About 59.47 and 70.36% revealed < 100% taking adherence in the last week and month; 42.76% had a drug holiday of > 1 week in the last 4 months. Adherence varied within patients during the follow-up (intra-class correlation = . 41–.71). Correlations between adherence scores were moderate to strong (ρ = .51–.85, p ≤ .001), except medication overuse (ρ = .04–.19, p ≤.05). Four-month taking adherence was associated with dispensing adherence, but not with prescribing adherence (ρ = .33, p < .001; and .12, p = .26). Conclusion: MIS-A is a promising, easy-to-use self-report tool that can capture accurately different adherence properties over a long time period.

Background The behavior change technique (BCT) taxonomy v1 is often used in systematic reviews for identifying active components of interventions. Its utility could be enhanced by linking BCTs to specific target behaviors and qualifying BCT delivery style.Purpose To determine whether behavioral targets and delivery styles of BCTs can be coded reliably and to determine the utility of coding these characteristics.Methods As part of a large systematic review of 142 smoking cessation trials, two researchers independently coded publicly and privately held intervention and comparator group materials, specifying the behavioral target (quitting, abstinence, medication adherence, or treatment engagement) and delivery style (tailored vs. not tailored; active participation vs. passive receipt) of each BCT.Results Researchers coded 3,843 BCTs, which were reliably attributed to behavioral targets (AC(1) = 0.92, PABAK = 0.91). Tailoring (AC(1) = 0.80, PABAK = 0.74) and participation (AC(1) = 0.71, PABAK = 0.64) were also coded reliably. There was considerable variability between groups in quitting and abstinence BCTs (ranges: 0-41; 0-18) and in tailoring and participation (ranges: 0-20; 0-32), but less variability for medication adherence and treatment engagement (ranges: 0-6; 0-7).Conclusions Behavioral targets and delivery styles of BCTs can be reliably identified and occur with sufficient frequency in smoking cessation trials for inclusion in quantitative syntheses (e.g., meta-regression analyses). Systematic reviewers could consider adopting these methods to evaluate the impact of intervention components targeting different behaviors, as well as the benefits of different BCT delivery styles.In behavioral smoking cessation trials, the targeted behavior and delivery style of specific intervention content were identified reliably by two independent coders.

BACKGROUND: The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure the health-related quality of life (HRQoL) and considered suitable for patients with asthma. In 2009, the EuroQol Group developed a new EQ-5D version to overcome limitations related to its consistently reported high ceiling effect. To enhance the sensitivity for assessing the HRQoL in further patient populations, the number of responses of EQ-5D was increased from 3 to 5 levels (EQ-5D-5L). Moreover, the availability of well-defined requirements for its Web-based administration allows EQ-5D-5L use to monitor the HRQoL in electronic health (eHealth) programs. No study has evaluated the metric properties of the new EQ-5D-5L in patients with asthma yet. OBJECTIVE: This study aims to examine the distribution, construct validity, and reliability of the new EQ-5D-5L questionnaire administered online to adults with asthma. METHODS: We evaluated patients with asthma (age: 18-40 years) from a primary care setting in France and England, who self-completed the EQ-5D-5L questionnaire online. The inclusion criteria were persistent asthma defined as >6 months of prescribed inhaled corticosteroids and long-acting beta-agonists or inhaled corticosteroids alone during the 12 months prior to inclusion. The EQ-5D index was obtained by applying the English preference value set for the new EQ-5D-5L and the French 3L-5L crosswalk value set. Both value sets produced single preference-based indices ranging from 1 (best health state) to negative values (health states valued as worse than death), where 0=death, allowing the calculation of quality-adjusted life years. Responses to dimensions and index distribution, including ceiling and floor effects, were examined. The construct validity was assessed by comparing the means of known groups by analyses of variance and calculation of effect sizes. RESULTS: Of 312 patients answering the baseline Web-based survey, 290 completed the EQ-5D-5L (93%). The floor effect was null, and the ceiling effect was 26.5% (74/279). The mean EQ-5D-5L index was 0.88 (SD 0.14) with the English value set and 0.83 (SD 0.19) with the French 3L-5L crosswalk value set. In both indices, large effect sizes were observed for known groups defined by the Asthma Control Questionnaire (1.06 and 1.04, P

Exposure to second-hand smoke (SHS) is associated with various ill-health outcomes for children and adults. Barriers to creating a smoke-free home (SFH) are well-documented. Feasible and effective interventions to create smoke-free homes for disadvantaged households are lacking. Interventions that include providing parents with objective information about the impact of smoking on air quality in their home may be particularly effective. This study describes the development of a novel, theory- and evidence-based smoke-free homes intervention using objectively-assessed air quality feedback. The intervention was developed using the six-step Intervention Mapping (IM) protocol. Findings from literature reviews, focus groups with parents, interviews with health/care professionals, and expert panel discussions shaped intervention content and materials. Findings highlighted the importance of parents receiving personalised information on second-hand smoke levels in their home. Professionals considered the use of non-judgemental language essential in developed materials. Previous literature highlighted the need to address home smoking behaviour at a household rather than individual level. The AFRESH intervention is modular and designed to be delivered face-to-face by healthcare professionals. It includes up to five meetings with parents, two sets of five days’ air quality monitoring and personalised feedback, and the option to involve other household members in creating a smoke-free home using educational, motivational, and goal setting techniques. Further research is needed to evaluate the acceptability and effectiveness of the AFRESH intervention and which specific groups of parents this intervention will most likely benefit. IM was a useful framework for developing this complex intervention. This paper does not present evaluation findings.

Highlights • To our knowledge, this is the first study to systematically examine recontamination after hand hygiene in a low- and middle-income country. • Hand hygiene compliance before aseptic procedures was low (9.6%) among birth attendants in Zanzibar. • Birth attendants did not avoid recontamination half of the time after hand rubbing/washing or glove donning. • Recontamination should be investigated further to inform better behavior-change strategies., Background Our primary objective was to assess hand hygiene (HH) compliance before aseptic procedures among birth attendants in the 10 highest-volume facilities in Zanzibar. We also examined the extent to which recontamination contributes to poor HH. Recording exact recontamination occurrences is not possible using the existing World Health Organization HH audit tool. Methods In this time-and-motion study, 3 trained coders used WOMBATv2 software to record the hand actions of all birth attendants present in the study sites. The percentage compliance and 95% confidence intervals (CIs) for individual behaviors (hand washing/rubbing, avoiding recontamination and glove use) and for behavioral sequences during labor and delivery were calculated. Results We observed 104 birth attendants and 781 HH opportunities before aseptic procedures. Compliance with hand rubbing/washing was 24.6% (95% CI, 21.6-27.8). Only 9.6% (95% CI, 7.6-11.9) of birth attendants also donned gloves and avoided recontamination. Half of the time when rubbing/washing or glove donning was performed, hands were recontaminated prior to the aseptic procedure. Conclusions In this study, HH compliance by birth attendants before aseptic procedures was poor. To our knowledge, this is the first study in a low- to middle-income country to show the large contribution to poor HH compliance from hand and glove recontamination before the procedure. Recontamination is an important driver of infection risk from poor HH. It should be understood for the purposes of improvement and therefore included in HH monitoring and interventions.

Background Adults with severe obesity [body mass index (BMI) of ≥ 35 kg/m2] have an increased risk of comorbidities and psychological, social and economic consequences. Objectives Systematically review bariatric surgery, weight-management programmes (WMPs) and orlistat pharmacotherapy for adults with severe obesity, and evaluate the feasibility, acceptability, clinical effectiveness and cost-effectiveness of treatment. Data sources Electronic databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials and the NHS Economic Evaluation Database were searched (last searched in May 2017). Review methods Four systematic reviews evaluated clinical effectiveness, cost-effectiveness and qualitative evidence for adults with a BMI of ≥ 35 kg/m2. Data from meta-analyses populated a microsimulation model predicting costs, outcomes and cost-effectiveness of Roux-en-Y gastric bypass (RYGB) surgery and the most effective lifestyle WMPs over a 30-year time horizon from a NHS perspective, compared with current UK population obesity trends. Interventions were cost-effective if the additional cost of achieving a quality-adjusted life-year is Results A total of 131 randomised controlled trials (RCTs), 26 UK studies, 33 qualitative studies and 46 cost-effectiveness studies were included. From RCTs, RYGB produced the greatest long-term weight change [–20.23 kg, 95% confidence interval (CI) –23.75 to –16.71 kg, at 60 months]. WMPs with very low-calorie diets (VLCDs) produced the greatest weight loss at 12 months compared with no WMPs. Adding a VLCD to a WMP gave an additional mean weight change of –4.41 kg (95% CI –5.93 to –2.88 kg) at 12 months. The intensive Look AHEAD WMP produced mean long-term weight loss of 6% in people with type 2 diabetes mellitus (at a median of 9.6 years). The microsimulation model found that WMPs were generally cost-effective compared with population obesity trends. Long-term WMP weight regain was very uncertain, apart from Look AHEAD. The addition of a VLCD to a WMP was not cost-effective compared with a WMP alone. RYGB was cost-effective compared with no surgery and WMPs, but the model did not replicate long-term cost savings found in previous studies. Qualitative data suggested that participants could be attracted to take part in WMPs through endorsement by their health-care provider or through perceiving innovative activities, with WMPs being delivered to groups. Features improving long-term weight loss included having group support, additional behavioural support, a physical activity programme to attend, a prescribed calorie diet or a calorie deficit. Limitations Reviewed studies often lacked generalisability to UK settings in terms of participants and resources for implementation, and usually lacked long-term follow-up (particularly for complications for surgery), leading to unrealistic weight regain assumptions. The views of potential and actual users of services were rarely reported to contribute to service design. This study may have failed to identify unpublished UK evaluations. Dual, blinded numerical data extraction was not undertaken. Conclusions Roux-en-Y gastric bypass was costly to deliver, but it was the most cost-effective intervention. Adding a VLCD to a WMP was not cost-effective compared with a WMP alone. Most WMPs were cost-effective compared with current population obesity trends. Future work Improved reporting of WMPs is needed to allow replication, translation and further research. Qualitative research is needed with adults who are potential users of, or who fail to engage with or drop out from, WMPs. RCTs and economic evaluations in UK settings (e.g. Tier 3, commercial programmes or primary care) should evaluate VLCDs with long-term follow-up (≥ 5 years). Decision models should incorporate relevant costs, disease states and evidence-based weight regain assumptions. Study registration This study is registered as PROSPERO CRD42016040190. Funding The National Institute for Health Research Health Technology Assessment programme. The Health Services Research Unit and Health Economics Research Unit are core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.

Contains fulltext : 200314.pdf (Publisher’s version ) (Open Access) BACKGROUND: This review focuses on non-dispensing services from pharmacists, i.e. pharmacists in community, primary or ambulatory-care settings, to non-hospitalised patients, and is an update of a previously-published Cochrane Review. OBJECTIVES: To examine the effect of pharmacists' non-dispensing services on non-hospitalised patient outcomes. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, two other databases and two trial registers in March 2015, together with reference checking and contact with study authors to identify additional studies. We included non-English language publications. We ran top-up searches in January 2018 and have added potentially eligible studies to 'Studies awaiting classification'. SELECTION CRITERIA: Randomised trials of pharmacist services compared with the delivery of usual care or equivalent/similar services with the same objective delivered by other health professionals. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures of Cochrane and the Effective Practice and Organisation of Care Group. Two review authors independently checked studies for inclusion, extracted data and assessed risks of bias. We evaluated the overall certainty of evidence using GRADE. MAIN RESULTS: We included 116 trials comprising 111 trials (39,729 participants) comparing pharmacist interventions with usual care and five trials (2122 participants) comparing pharmacist services with services from other healthcare professionals. Of the 116 trials, 76 were included in meta-analyses. The 40 remaining trials were not included in the meta-analyses because they each reported unique outcome measures which could not be combined. Most trials targeted chronic conditions and were conducted in a range of settings, mostly community pharmacies and hospital outpatient clinics, and were mainly but not exclusively conducted in high-income countries. Most trials had a low risk of reporting bias and about 25%-30% were at high risk of bias for performance, detection, and attrition. Selection bias was unclear for about half of the included studies.Compared with usual care, we are uncertain whether pharmacist services reduce the percentage of patients outside the glycated haemoglobin target range (5 trials, N = 558, odds ratio (OR) 0.29, 95% confidence interval (CI) 0.04 to 2.22; very low-certainty evidence). Pharmacist services may reduce the percentage of patients whose blood pressure is outside the target range (18 trials, N = 4107, OR 0.40, 95% CI 0.29 to 0.55; low-certainty evidence) and probably lead to little or no difference in hospital attendance or admissions (14 trials, N = 3631, OR 0.85, 95% CI 0.65 to 1.11; moderate-certainty evidence). Pharmacist services may make little or no difference to adverse drug effects (3 trials, N = 590, OR 1.65, 95% CI 0.84 to 3.24) and may slightly improve physical functioning (7 trials, N = 1329, mean difference (MD) 5.84, 95% CI 1.21 to 10.48; low-certainty evidence). Pharmacist services may make little or no difference to mortality (9 trials, N = 1980, OR 0.79, 95% CI 0.56 to 1.12, low-certaintly evidence).Of the five studies that compared services delivered by pharmacists with other health professionals, no studies evaluated the impact of the intervention on the percentage of patients outside blood pressure or glycated haemoglobin target range, hospital attendance and admission, adverse drug effects, or physical functioning. AUTHORS' CONCLUSIONS: The results demonstrate that pharmacist services have varying effects on patient outcomes compared with usual care. We found no studies comparing services delivered by pharmacists with other healthcare professionals that evaluated the impact of the intervention on the six main outcome measures. The results need to be interpreted cautiously because there was major heterogeneity in study populations, types of interventions delivered and reported outcomes.There was considerable heterogeneity within many of the meta-analyses, as well as considerable variation in the risks of bias.

ObjectivesPain remains a problem for people with cancer despite effective treatments being available. We aimed to explore current pain management strategies used by patients, caregivers and professionals and to investigate opportunities for digital technologies to enhance cancer pain management.MethodsA qualitative study comprising semistructured interviews and focus groups. Patients with cancer pain, their caregivers and health professionals from Northeast Scotland were recruited from a purposive sample of general practices. Professionals were recruited from regional networks.ResultsFifty one participants took part in 33 interviews (eight patients alone, six patient/caregiver dyads and 19 professionals) and two focus groups (12 professionals). Living with cancer was hard work for patients and caregivers and comparable to a ‘full-time job’. Patients had personal goals which involved controlling pain intensity and balancing this with analgesic use, side effects, overall symptom burden and social/physical activities.Digital technologies were embraced by most patients, and made living life with advanced cancer easier and richer (eg, video calls with family). Technology was underutilised for pain and symptom management. There were suggestions that technology could support self-monitoring and communicating problems to professionals, but patients and professionals were concerned about technological monitoring adding to the work of managing illness.ConclusionsCancer pain management takes place in the context of multiple, sometimes competing personal goals. It is possible that technology could be used to help patients share individual symptom experiences and goals, thus enhancing tailored care. The challenge is for digital solutions to add value without adding undue burden.

Summary Background No high-quality trials have provided evidence of effectiveness and cost-effectiveness of HIV treatment adherence intervention strategies. We therefore examined the effectiveness and cost-effectiveness of the Adherence Improving self-Management Strategy (AIMS) compared with treatment as usual. Methods We did a pragmatic, multicentre, open-label, randomised controlled trial in seven HIV clinics at academic and non-academic hospitals in the Netherlands. Eligible participants were patients with HIV who were either treatment experienced (ie, with ≥9 months on combination antiretroviral therapy [ART] and at risk of viral rebound) or treatment-naive patients initiating their first combination ART regimen. We randomly assigned participants (1:1) to either AIMS or treatment as usual (ie, containing a range of common adherence intervention strategies) using a computer-generated randomisation table. Randomisation was stratified by treatment experience (experienced vs naive) and included block randomisation at nurse level with randomly ordered blocks of size four, six, and eight. 21 HIV nurses from the participating clinics received three training sessions of 6 h each (18 h in total) on AIMS and a 1·5 h booster training session at the clinic (two to three nurses per session) after each nurse had seen two to three patients. AIMS was delivered by nurses during routine clinic visits. We did mixed-effects, intent-to-treat analyses to examine treatment effects on the primary outcome of log 10 viral load collected at months 5, 10, and 15. The viral load results were exponentiated (with base 10) for easier interpretation. Using cohort data from 7347 Dutch patients with HIV to calculate the natural course of illness, we developed a lifetime Markov model to estimate the primary economic outcome of lifetime societal costs per quality-adjusted life-years (QALYs) gained. This trial is registered at ClinicalTrials.gov (number NCT01429142). Findings We recruited participants between Sept 1, 2011, and April 2, 2013; the last patient completed the study on June 16, 2014. The intent-to-treat sample comprised 221 patients; 109 assigned to AIMS and 112 to treatment as usual. Across the three timepoints (months 5, 10, and 15), log viral load was 1·26 times higher (95% CI 1·04–1·52) in the treatment-as-usual group (estimated marginal mean 44·5 copies per mL [95% CI 35·5–55·9]) than in the AIMS group (estimated marginal mean 35·4 copies per mL [29·9–42·0]). Additionally, AIMS was cost-effective (ie, dominant: cheaper and more effective) since it reduced lifetime societal costs by €592 per patient and increased QALYs by 0·034 per patient. Interpretation Findings from preparatory studies have shown that AIMS is acceptable, feasible to deliver in routine care, and has reproducible effects on medication adherence. In this study, AIMS reduced viral load, increased QALYs, and saved resources. Implementation of AIMS in routine clinical HIV care is therefore recommended. Funding Netherlands Organisation for Health Research and Development.

Introduction Few interventions to reduce second-hand smoke in homes where children are present have been successful. A novel intervention was developed that included personal airquality feedback. This study aimed to evaluate the feasibility and acceptability of delivering this theory-based intervention through small third-sector organisations in deprived areas within Scotland. Material and Methods The setting was third-sector organisations in Scotland. Support workers used air quality monitors to give information on smoke-free homes to parents. This advice was structured around computer generated reports, co-developed with workers and target-group members. Participants received a monitor then received a report, which was discussed with a support worker. Two weeks later, the monitor was reinstalled and another report produced to evaluate success. Three participants and one support worker were interviewed afterwards to explore their experiences. Results One centre out of six that were approached agreed to deliver the intervention. Four participants took part. All participants saw a decline in average concentrations of PM2.5 in their homes. In interviews, the participants and the support worker indicated that the intervention was acceptable and useful. The centres that declined to participate in the study cited a range of reasons, including a lack of staff time and perceived difficulties in recruiting members of the target population. Conclusions This intervention was acceptable for the target population tested, and may help participants to create smoke-free homes, although it is not possible to generalise the results of this small study. However, the resources required for the delivery of AFRESH do not match with the resources available in third-sector organisations, despite smoke-free homes being a policy priority

Background A previous study evaluating the psychometric properties of the traditional EQ-5D in asthmatic patients showed a high ceiling effect (59% of patients with perfect health) questioning its usefulness in these patients. Therefore, the EuroQol Group developed a new EQ-5D version increasing the number of responses from 3 to 5 levels. This new version, the EQ-5D-5L, has never been tested in asthmatic patients. The aim of this study is to examine the distribution and construct validity of the new EQ-5D-5L in a European cohort of asthmatic adolescents and adults.

Since the introduction of cART (combination antiretroviral therapy), HIV has evolved into a chronic disease such that it requires lifelong medical treatment to which patients must adhere. Communication with health care providers is pivotal in supporting patients to adapt to having HIV and adhering to treatment, in order to maintain health and quality of life. Previous research indicates that communication is optimal when it matches patient preferences for information exchange, relationship establishment, and involvement in treatment decisions. The aim of the present study is to explore HIV patient communication preferences as well as patient experiences with their providers (not) matching their preferences. A second aim is to explore provider beliefs about patient preferences and provider views on optimal communication. Data were collected through interviews with 28 patients and 11 providers from two academic hospitals. Results indicate that patient preferences reflect their cognitive, emotional, and practical needs such that patients look to increase their sense of control over their HIV. Patients aim to further increase their sense of control (by proxy) through their relationship with their providers and through their decisional involvement preferences. Providers are well aware of patient communication preferences but do not explicate underlying control needs. Implications for clinical practice are discussed.

Adequate medication adherence is key for optimal benefit of pharmacological treatments. A wealth of research has been conducted to understand and identify opportunities to intervene to improve medication adherence, but variations in adherence definitions within prior research have led to ambiguity in study findings. The lack of a standard taxonomy hinders the development of cumulative science in adherence research. This article reviews the newly established Ascertaining Barriers to Compliance (ABC) taxonomy for medication adherence with a particular focus on its relevance and applicability within the context of asthma and chronic obstructive pulmonary disease management. Building on traditional definitions and concepts within medication adherence, the ABC taxonomy considers the temporal sequence of steps a patient must undertake to be defined as " adherent to treatment": (A) initiation, (B) implementation, and (C) persistence. We explain the clinical and research relevance of differentiating between these phases, point to differences in its applicability in observational and experimental research, review strengths and limitations of available measures, and highlight recent findings on specific determinants of these behaviors. Finally, we provide recommendations for research and practice with a view to supporting and sign posting opportunities to improve future respiratory medication adherence and associated research. (C) 2016 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY-NC-ND license.

Contains fulltext : 200097.pdf (Publisher’s version ) (Closed access) BACKGROUND: The quality of asthma primary care may vary between countries, health care practices, and health care professionals (HCPs). Identifying and explaining such differences is critical for health services improvement. OBJECTIVES: To examine the quality of asthma primary care in France and United Kingdom, and identify within-country and between-country predictors amenable to intervention. METHODS: An online questionnaire to capture asthma medical care and self-management support, practice characteristics, and psychosocial determinants was completed by 276 HCPs. Mokken scaling analyses were used to examine item structure and consistency. Hierarchical regression analyses were used to identify predictors of the amount (number of asthma care activities HCPs delivered) and consistency (the degree to which HCPs deliver similar care) of asthma medical care and self-management support. RESULTS: On average, HCPs reported delivering 74.2% of guideline-recommended care. Consistency of medical care and self-management support was lower among HCPs delivering a lower amount of care (r = 0.58 and r = 0.57, P < .001). UK HCPs provided more and more consistent asthma self-management support-but not medical care-than French HCPs, which was explained by the presence of practice nurses in the United Kingdom. More training, positive social norms, and higher behavioral control explained better quality of care across all HCPs. CONCLUSIONS: Using carefully developed questionnaires and advanced psychometric analyses, this study suggests that involving practice nurses, making social expectations visible, and providing more training to enhance skills and confidence in asthma care delivery could enhance the amount and consistency of asthma primary care. This needs to be corroborated in a future intervention trial.

Purpose Cancer pain is a distressing and complex experience. It is feasible that the systematic collection and feedback of patient-reported outcome measurements (PROMs) relating to pain could enhance cancer pain management. We aimed to conduct a systematic review of interventions in which patient-reported pain data were collected and fed back to patients and/or professionals in order to improve cancer pain control. Methods MEDLINE, EMBASE and CINAHL databases were searched for randomised and non-randomised controlled trials in which patient-reported data were collected and fed back with the intention of improving pain management by adult patients or professionals. We conducted a narrative synthesis. We also conducted a meta-analysis of studies reporting pain intensity. Results 29 reports from 22 trials of 20 interventions were included. PROM measures were used to alert physicians to poorly controlled pain, to target pain education and to link treatment to management algorithms. Few interventions were underpinned by explicit behavioural theories. Interventions were inconsistently applied or infrequently led to changes in treatment. Narrative synthesis suggested that feedback of PROM data tended to increase discussions between patients and professionals about pain and/or symptoms overall. Meta-analysis of 12 studies showed a reduction in average pain intensity in intervention group participants compared with controls (mean difference=−0.59 (95% CI −0.87 to −0.30)). Conclusions Interventions that assess and feedback cancer pain data to patients and/or professionals have so far led to modest reductions in cancer pain intensity. Suggestions are given to inform and enhance future PROM feedback interventions.

Background Medication adherence is a dynamic process and may vary depending on life circumstances and treatment regimens, particularly in health conditions with variable symptoms such as asthma. Yet, adherence is commonly operationalized in observational studies as a single average score, which ignores its dynamic nature. Moreover, current self-report measures often do not assess behaviour nor capture relevant distinct properties of adherence, which reduces their accuracy and usefulness compared to, for example, electronic monitoring. Within a 2-year cohort study on asthma (ASTRO-LAB), we developed a new 6-item self-report tool for assessing adherence to daily inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) which used only items that capture the different relevant properties of adherence behaviours. We tested its ability to capture suboptimal adherence and variability in adherence for different types of inhaler and in different time intervals.

BackgroundThe concept of demand characteristics, which involves research participants being aware of what the researcher is investigating, is well known and widely used within psychology, particularly in laboratory-based studies. Studies of this phenomenon may make a useful contribution to broader consideration of the effects of taking part in research on participant behaviour. This systematic review seeks to summarise data from studies of the effects of demand characteristics on participant behaviours in non-laboratory settings.Methodology/Principal FindingsElectronic databases were searched to identify eligible studies. These had to be purposely designed to evaluate possible effects of demand characteristics on at least one behavioural outcome under the autonomous control of the participants and use longitudinal study designs. Only 7 studies were included, 6 providing observational data and 1 experimental study, with 5 studies involving examination of possible effects on health behaviours. Although studies provided some evidence of effects of demand characteristics on participant behaviour, heterogeneous operationalisation of the construct, the limited number of studies and poor quality of study designs made synthesis and interpretation of study findings challenging.Conclusions/SignificanceAlthough widely accepted as important in psychology, there have been few dedicated studies of the effects of demand characteristics on research participant behaviours outside laboratory settings. This body of literature does not currently contribute to the wider study of research participation effects. A systematic review of data from laboratory-based studies is needed, as are high-quality primary studies in non-laboratory settings. We suggest that unqualified use of the term demand characteristics should be abandoned.

BACKGROUND: Whether people with asthma gain and maintain control over their condition depends not only on the availability of effective drugs, but also on multiple patient and health care professional (HCP) behaviors. Research in asthma rarely considers how these behaviors interact with each other and drug effectiveness to determine health outcomes, which may limit real-life applicability of findings.OBJECTIVE: The objective of this study was to develop a logic process model (Asthma Care Model; ACM) that explains how patient and HCP behaviors impact on the asthma care process.METHODS: Within a European research project on asthma (ASTRO-LAB), we reviewed asthma care guidelines and empirical literature, and conducted qualitative interviews with patients and HCPs. Findings were discussed with the project team and respiratory care experts and integrated in a causal model.RESULTS: The model outlines a causal sequence of treatment events, from diagnosis and assessment to treatment prescription, drug exposure, and health outcomes. The relationships between these components are moderated by patient behaviors (medication adherence, symptom monitoring, managing triggers, and exacerbations) and HCP behaviors (medical care and self-management support). Modifiable and nonmodifiable behavioral determinants influence the behaviors of patients and HCPs. The model is dynamic as it includes feedback loops of behavioral and clinical outcomes, which influence future patient and HCP decision making. Key evidence for each relationship is summarized to derive research priorities and clinical recommendations.CONCLUSIONS: The ACM model is of interest to both researchers and practitioners, and intended as a first version (ACM-v1) of a common framework for generating and translating research evidence in asthma care.

Contains fulltext : 200171.pdf (Publisher’s version ) (Open Access) BACKGROUND: The aim was to evaluate the impact of asthma on patients' Health-Related Quality of Life (HRQoL) by comparing asthmatic women and men with reference norms, to examine the factors which contributed to an impaired HRQoL, and to identify groups at higher risk. METHODS: Cross-sectional evaluation of 222 primary care patients with persistent asthma (18-40 years old). HRQoL impact was estimated with the EuroQol-5 Dimensions (EQ-5D), which allows calculating Quality-Adjusted Life-Years (QALYs) by applying society preferences. Participants self-completed the EQ-5D questionnaire online. Telephonic interviews collected information on medication and adherence, and administered the Asthma Control Questionnaire. Severity markers included asthma-related comorbidity, previous oral corticosteroids course prescription, and inhaled corticosteroids daily dose. After bivariate analyses, multiple linear regression models were constructed to examine the relations between HRQoL asthma impact and socio-demographic and clinical variables, using as dependent variable the deviation from general population-based EQ-5D reference norms. RESULTS: Deviation from the EQ-5D index norms was moderate in most age/gender groups (-0.1, which corresponds to 0.6 standard deviations), while it was large in women aged 18-24 years (-0.18, corresponding to 1.1 standard deviations). In regression models, a poor asthma control was the only factor independently associated to HRQoL impact in both women and men: beta -0.18 (p

Contains fulltext : 249002.pdf (Publisher’s version ) (Open Access) AIM: To investigate predictors of participant eligibility, recruitment and retention in behavioural randomized controlled trials (RCTs) for smoking cessation. METHOD: Systematic review and pre-specified meta-regression analysis of behavioural RCTs for smoking cessation including adult (≥ 18-year-old) smokers. The pre-specified predictors were identified through a literature review and experts' consultation and included participant, trial and intervention characteristics and recruitment and retention strategies. Outcome measures included eligibility rates (proportion of people eligible for the trials), recruitment rates, retention rates and differential retention rates. RESULTS: A total of 172 RCTs with 89 639 participants. Eligibility [median 57.6%; interquartile range (IQR) = 34.7-83.7], recruitment (median 66.4%; IQR = 42.7-85.2) and retention rates (median 80.5%; IQR = 68.5-89.5) varied considerably across studies. For eligibility rates, the recruitment strategy appeared not to be associated with eligibility rates. For recruitment rates, use of indirect recruitment strategies (e.g. public announcements) [odds ratio (OR) = 0.30, 95% confidence interval (CI) = 0.11-0.82] and self-help interventions (OR = 0.14, 95% CI = 0.03-0.67) were associated with lower recruitment rates. For retention rates, higher retention was seen if the sample had ongoing physical health condition/s (OR = 1.66, 95% CI = 1.04-2.63), whereas lower retention was seen amongst primarily female samples (OR = 0.83, 95% CI = 0.71-0.98) and those motivated to quit smoking (OR = 0.74, 95% CI = 0.55-0.99) when indirect recruitment methods were used (OR = 0.60, 95% CI = 0.38-0.97) and at longer follow-up assessments (OR = 0.83, 95% CI = 0.79-0.87). For differential retention, higher retention in the intervention group occurred when the intervention but not comparator group received financial incentives for smoking cessation (OR = 1.35, 95% CI = 1.02-1.77). CONCLUSIONS: In randomized controlled trials of behavioural smoking cessation interventions, recruitment and retention rates appear to be higher for smoking cessation interventions that include a person-to-person rather than at-a-distance contact; male participants, smokers with chronic conditions, smokers not initially motivated to quit and shorter follow-up assessments seems to be associated with improved retention; financial incentive interventions improve retention in groups receiving them relative to comparison groups.