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IntroductionAlcohol consumption is a leading global risk factor for ill-health and premature death. Alcohol screening and brief interventions (SBI) delivered in primary care is effective at reducing alcohol consumption, but routine implementation remains problematic. Screening all patients for excessive drinking (universal screening) is resource-intensive and may be at odds with general practitioners' (GPs') perceived professional role. This study aimed to develop a tailored, theory-based training intervention to strengthen GPs' ability to address alcohol and to manage alcohol-related health problems through a pragmatic approach based on clinical relevance.MethodsA qualitative study design involving focus group interviews and a structured questionnaire for free text replies with GPs in Norway. Behavioral analysis assessed factors influencing delivery of SBI according to the ‘capability, opportunity, motivation and behavior' (COM-B) model to inform intervention development using the Behavior Change Wheel. Qualitative data were analyzed using framework analysis and an iterative approach was adopted to develop the training.ResultsA purposive sample of GPs attended the focus groups (n = 25) and completed the questionnaire (n = 55). Four areas required additional support including: understanding the link between alcohol use and health problems; opening up the conversation on alcohol use; addressing alcohol and dealing with obstacles; and following-up and maintaining change. Findings informed the development of a four-session interactive training intervention and a digital intervention for providing support for patients between consultations to address the identified needs.ConclusionThis work highlights the value of pragmatic, relevance-based clinical strategies, as opposed to universal screening approaches to addressing alcohol in primary care. A pragmatic approach is more in line with GPs existing sclinical skill set and holds the potential to improve widespread uptake and implementation of SBI in routine primary care.

Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions.We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed. This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software.We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated.

BACKGROUND Internet-based Cognitive Behaviour Therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for effective strategies to improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective and tailored implementation is considered as a promising approach. The self-guided ‘Integrated Theory-based Framework for Implementation Tailoring Strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves (1) identifying local barriers, (2) matching selected barriers to implementation strategies, (3) developing an actionable work plan, and (4) applying, monitoring, and adapting where necessary. OBJECTIVE We compared the effectiveness of the ItFits-toolkit with Implementation-As-Usual (IAU) in implementing iCBT in twelve routine mental health care organisations in nine countries. METHODS A stepped-wedge cluster randomised trial design with repeated measures was applied. The total trial period was 30 months. The primary outcome was normalisation of iCBT delivery by service providers (therapists, referrers, IT developers, administrators) measured with the NoMAD as a proxy for implementation success. Three-level linear mixed-effects modelling was applied to estimate the effects. iCBT uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. Perceived satisfaction (CSQ-3), usability (SUS), and impact of the ItFits-toolkit by implementers was assessed to assesses the acceptability of the ItFits-toolkit. RESULTS In total, 456 mental health service providers were included in the study. Compared to IAU, the ItFits-toolkit had a small significant positive effect on normalisation levels in service providers (M=0.09, SD=0.04, p=0.02, Cohen’s d=0.12). Uptake of iCBT by patients was on par with IAU. Compared to IAU, implementers did not spent more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS The ItFits-toolkit performed better than usual implementation activities in implementing iCBT services in routine practice. However, the effect on normalization levels in mental health service providers was very small. There lies practical utility in the ItFits-toolkit for supporting implementers to develop and apply effective tailored implementation strategies. However, these findings warrant modesty about the effectiveness of self-guided tailored implementation in implementing iCBT services in routine practice. CLINICALTRIAL ClinicalTrials.gov (No. NCT03652883) INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-020-04686-4

Funding Information: This research was supported by the Health Foundation Improvement Science Award (grant number: GIFTS ID 7223 awarded to Sebastian Potthoff). Tracy Finch, Tim Rapley, Sebastian Potthoff, Tom Saunders and Luke Vale are members of the NIHR Applied Research Collaboration North East and North Cumbria ( NIHR200173 ). Luke Vale is also a member of the NIHR Newcastle In Vitro Diagnostics Co-operative, NIHR School for Public Health Research, and Fuse, the Centre for Translational Research in Public Health . The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care . Jeremy M. Grimshaw holds a Canada Research Chair in Health Knowledge Transfer and Uptake. Dominika Kwasnicka’s work is carried out within the HOMING program of the Foundation for Polish Science co-financed by the European Union under the European Regional Development Fund ; grant number POIR.04.04.00-00-5CF3/18-00 ; HOMING 5/2018. We would also like to thank Lauren Basey for optimising the design of our included figure. Funding Information: This research was supported by the Health Foundation Improvement Science Award (grant number: GIFTS ID 7223 awarded to Sebastian Potthoff). Tracy Finch, Tim Rapley, Sebastian Potthoff, Tom Saunders and Luke Vale are members of the NIHR Applied Research Collaboration North East and North Cumbria (NIHR200173). Luke Vale is also a member of the NIHR Newcastle In Vitro Diagnostics Co-operative, NIHR School for Public Health Research, and Fuse, the Centre for Translational Research in Public Health. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Jeremy M. Grimshaw holds a Canada Research Chair in Health Knowledge Transfer and Uptake. Dominika Kwasnicka's work is carried out within the HOMING program of the Foundation for Polish Science co-financed by the European Union under the European Regional Development Fund; grant number POIR.04.04.00-00-5CF3/18-00; HOMING 5/2018. We would also like to thank Lauren Basey for optimising the design of our included figure. Publisher Copyright: © 2022 Rationale: Translating research evidence into clinical practice to improve care involves healthcare professionals adopting new behaviours and changing or stopping their existing behaviours. However, changing healthcare professional behaviour can be difficult, particularly when it involves changing repetitive, ingrained ways of providing care. There is an increasing focus on understanding healthcare professional behaviour in terms of non-reflective processes, such as habits and routines, in addition to the more often studied deliberative processes. Theories of habit and routine provide two complementary lenses for understanding healthcare professional behaviour, although to date, each perspective has only been applied in isolation. Objectives: To combine theories of habit and routine to generate a broader understanding of healthcare professional behaviour and how it might be changed. Methods: Sixteen experts met for a two-day multidisciplinary workshop on how to advance implementation science by developing greater understanding of non-reflective processes. Results: From a psychological perspective ‘habit’ is understood as a process that maintains ingrained behaviour through a learned link between contextual cues and behaviours that have become associated with those cues. Theories of habit are useful for understanding the individual's role in developing and maintaining specific ways of working. Theories of routine add to this perspective by describing how clinical practices are formed, adapted, reinforced and discontinued in and through interactions with colleagues, systems and organisational procedures. We suggest a selection of theory-based strategies to advance understanding of healthcare professionals' habits and routines and how to change them. Conclusion: Combining theories of habit and routines has the potential to advance implementation science by providing a fuller understanding of the range of factors, operating at multiple levels of analysis, which can impact on the behaviours of healthcare professionals, and so quality of care provision. publishersversion published

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020-2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19-20th August 2021).

OBJECTIVE: Habitual behaviours are triggered automatically, with little conscious forethought. Theory suggests that making healthy behaviours habitual, and breaking the habits that underpin many ingrained unhealthy behaviours, promotes long-term behaviour change. This has prompted interest in incorporating habit formation and disruption strategies into behaviour change interventions. Yet, notable research gaps limit understanding of how to harness habit to change real-world behaviours. METHODS: Discussions among health psychology researchers and practitioners, at the 2019 European Health Psychology Society 'Synergy Expert Meeting', generated pertinent questions to guide further research into habit and health behaviour. RESULTS: In line with the four topics discussed at the meeting, 21 questions were identified, concerning: how habit manifests in health behaviour (3 questions); how to form healthy habits (5 questions); how to break unhealthy habits (4 questions); and how to develop and evaluate habit-based behaviour change interventions (9 questions). CONCLUSIONS: While our questions transcend research contexts, accumulating knowledge across studies of specific health behaviours, settings, and populations will build a broader understanding of habit change principles and how they may be embedded into interventions. We encourage researchers and practitioners to prioritise these questions, to further theory and evidence around how to create long-lasting health behaviour change. publishedVersion

Background. Qualitative studies, especially those conducted by teams of researchers, may benefit from clearly structured, parsimonious, coding manuals. The process of creating rigorous and robust coding manuals for individual studies is rarely described, and generalizable coding manuals are rare. Normalization Process Theory (NPT) provides conceptual tools to facilitate understanding of the dynamics of adoption, implementation, and sustainment of socio-technical and organizational innovations. As a widely used theory, a generalizable coding manual would be of utility to implementation researchersObjectives. To make the application of NPT simple for the user, to describe the development of a coding manual for qualitative content analytic studies using NPT, and present this for wider use.Method. Concept Selection and Structuring. Qualitative Content Analysis of selected published papers and interview transcripts. Results. All identifiable theoretical concepts (n=149) embedded in papers and chapters that developed NPT between 2006 and 2020 were identified and extracted from their texts. Overlapping, ambiguous, and duplicate versions of concepts were eliminated, as were concepts derived from other theories. This left 38 core concept definitions. These were piloted in coding of qualitative transcripts collected in two implementation studies, and by collaboratively coding papers collected for a systematic review of implementation studies. At the end of this process, a further process of elimination of overlapping or ambiguous concepts was undertaken leaving 12 primary NPT concepts. Conclusion. The process of coding manual resulted in the presentation of NPT concepts according to the Context-Mechanism-Outcomes configuration of realist evaluation research. A coding manual for NPT that is in accordance with realistic evaluation research was successfully produced and is now freely available to researchers who wish to use NPT in primary and secondary research that employs qualitative methods.

Summary Background Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. Methods In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , NCT02649426 . Findings Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg [IQR –16·4 to 0·0] vs –3·0 mm Hg [–10·3 to 1·8]; median between-group difference –4·5 mm Hg [95% CI –8·5 to –0·3]; adjusted p=0·022); the median between-group difference was –5·8 mm Hg (95% CI –9·7 to –1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Interpretation Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. Funding ReCor Medical.

Atomic-force-microscopy-based single-molecule force spectroscopy (AFM-SMFS) has become an important technique as the basis of novel, label-free biosensing strategies. In this work, we explored the possibility of using AFM-SMFS to detect the specific peptide cleavage activity by thrombin proteases. To achieve this aim, an oligopeptide with a sequence that is recognized and cleaved by thrombin was spanned between an AFM tip and a solid surface via a PEG-based linker system including the stable biotin–streptavidin receptor/ligand complex. We found that force spectral signatures associated with the biotin–streptavidin unbinding in the absence of thrombin can be clearly distinguished from the signatures of spectra collected after thrombin-induced peptide cleavage. However, this is possible only in a well-defined window of peak force and tip–sample separation distance values, in which specific streptavidin–biotin interactions do not overlap with non-specific interactions among all the other system components. The results were employed to engineer a sensing architecture capable of detecting the presence of thrombin at concentrations higher than about 0.2 μM.

In their efforts to provide evidence-based care, health care professionals engage in a range of clinical behaviours. Their clinical actions are characteristically performed repeatedly, in the same physical locations with the same colleagues and patients, under constant time pressure and competing demands. This repetition under pressure in a stable setting provides ideal circumstances for creating contingencies between physical and social cues and clinical actions. Health care professional behaviour provides an ideal setting in which to advance theory, methods and interventions to better understand habit formation and habit reversal. Contemporary theoretical and methodological development in the psychology of habit has begun to be applied to understand and promote forming, breaking and replacing habitual behaviour among health care professionals. This chapter highlights key theoretical approaches, methods and intervention techniques that have been applied to conceptualize, measure, develop and break habit and automaticity in health care professionals. These insights have the potential to synergistically contribute novel perspectives to the wider habit literature.

People with rheumatic conditions face many challenges. These include coping with the emotional impact of debilitating chronic disease, overcoming physical symptoms, such as pain and fatigue, to carry out activities of daily living, and undertaking the self-management behaviours necessary to prevent disease progression and to limit symptoms (e.g., medication adherence, maintaining a physically active lifestyle) [1]. Each of these areas concerns the field of health psychology, which has generated a wealth of research findings on the patient-centred processes and clinical actions that can help patients to achieve positive outcomes.

Background Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union’s Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. Methods A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. Discussion The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. Trial registration ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018

The interaction of silica (SiO2) with biological systems is complex and contradictory. On the one hand, silica is at the basis of several biomineralization processes (e.g., in sponges). On the other hand, silica nanoparticles and dust may lead to silicosis and, at the cellular level, hemolysis. These toxic responses are strongly dependent on the silica polymorph and their root causes are still under debate. Both silica biomineralization and silica-induced nanotoxicity could be related to similar mechanisms of molecular recognition between the cellular membranes and the surface of the SiO2 particles. On the basis of this hypothesis, we employed classical molecular dynamics simulations, coupled to advanced sampling techniques, to achieve an atomistic picture of the interactions between different types of silica nanoparticles and the membrane of erythrocytes. Our predicted free-energy profiles associated with membrane crossing give no evidence for segregation of nanoparticles at the membrane/water interface,...

Background The implementation of new medical interventions into routine care involves healthcare professionals adopting new clinical behaviours and changing existing ones. Whilst theory-based approaches can help understand healthcare professionals’ behaviours, such approaches often focus on a single behaviour and conceptualise its performance in terms of an underlying reflective process. Such approaches fail to consider the impact of non-reflective influences (e.g. habit and automaticity) and how the myriad of competing demands for their time may influence uptake. The current study aimed to apply a dual process theoretical approach to account for reflective and automatic determinants of healthcare professional behaviour while integrating a multiple behaviour approach to understanding the implementation and use of a new self-management tool by healthcare professionals in the context of diabetes care. Methods Following Diabetes UK’s national release of the ‘Information Prescription’ (DUK IP; a self-management tool targeting the management of cholesterol, blood pressure and HbA1c) in January 2015, we conducted semi-structured interviews with 13 healthcare professionals (general practitioners and nurses) who had started to use the DUK IP during consultations to provide self-management advice to people with type 2 diabetes. A theory-based topic guide included pre-specified constructs from a previously developed logic model. We elicited healthcare professionals’ views on reflective processes (outcome expectations, self-efficacy, intention, action and coping planning), automatic processes (habit), and multiple behaviour processes (goal priority, goal conflict and goal facilitation). All interviews were audio recorded and transcribed verbatim and all transcripts were independently double coded and analysed using content analysis. Results The majority of healthcare professionals interviewed reported strong intentions to use the DUK IP and having formed a habit of using them after a minimum of one month continuous use. Pop-up cues in the electronic patient records were perceived to facilitate the use of the tool. Factors that conflicted with the use of the DUK IP included existing pathways of providing self-management advice. Conclusion Data suggests that constructs from dual process and multiple behaviour approaches are useful to provide supplemental understanding of the implementation of new self-management tools such as the DUK IP and may help to advance behavioural approaches to implementation science. Electronic supplementary material The online version of this article (10.1186/s12911-019-0744-9) contains supplementary material, which is available to authorized users.

Theories of behaviour used to understand healthcare professional behaviour often focus on the deliberative processes that drive their behaviour; however, less is known about the role that implicit processes such as habit have on healthcare professional behaviour. This systematic review aimed to critically appraise and synthesise research evidence investigating the association between habit and healthcare professional behaviour. A search of five databases (PsycINFO, EMBASE, Scopus and CINAHL) was conducted up until 29 February 2016 to identify studies reporting correlations between habit and healthcare professional behaviours. Meta-analyses were conducted to assess the overall habit-behaviour association across all behaviours. A subgroup analysis assessed whether the habit-behaviour relationship differed depending on whether the behaviour was objectively measured or assessed by self-report. We identified nine eligible studies involving 1975 healthcare professionals that included 28 habit-behaviour correlations. A combined mean r+ of 0.35 (medium effect) was observed between habit and healthcare professional behaviour. The habit-behaviour correlation was not affected by whether behaviour was measured objectively or by self-report. This review suggests that habit plays a significant role in healthcare professional behaviour. Findings may have implications for considering health professionals’ habit when promoting the provision of evidence-based health care, and for breaking existing habit when de-implementing outdated, non-evidence-based practices.

Use of cognitive emotion regulation strategies in response to stressful life events varies by country, though research has been limited to comparisons between American and Asian cultures. This study aimed to compare six European countries to investigate cross-cultural differences in the use of cognitive strategies and test if the relationship between specific strategies and psychopathology varies across countries. Data arrays were collected from the Netherlands, Hungary, Spain, Italy, Portugal and Germany (N = 1553) and cross-cultural measures of cognitive emotion regulation using the Cognitive Emotion Regulation Questionnaire (CERQ) were included. Measures of depression and anxiety were also included. Results showed significant differences on all the subscales of the CERQ. Most notably, there were differences on strategies that have been linked to symptoms of psychopathology; overall northern European countries (Germany and Netherlands) made less use of strategies such as rumination, catastrophizing, and other-blame, when compared to southern and eastern European countries (Spain, Italy, Portugal, and Hungary). The direction of the relationships between specific strategies and symptoms of psychopathology was consistent across countries. Although there were cross-cultural differences in the use of cognitive strategies, the consistent relationship between strategies and psychopathology across countries supports the idea of a trans-cultural approach to treat psychopathology.

Healthcare professionals (HCPs) prescribe, provide advice, conduct examinations, perform surgical procedures, and engage in a range of clinical behaviours. Their clinical actions are characteristically performed repeatedly—sometimes multiple times per day—in the same physical locations with the same colleagues and patients, under constant time pressure, and competing demands. This repetition under pressure in a stable setting provides ideal circumstances for creating contingencies between physical and social cues and clinical actions. HCP behaviour provides an ideal setting in which to advance theory, methods, and interventions to better understand habit formation and habit reversal. Contemporary theoretical and methodological development in the psychology of habit has begun to be applied to understand and promote the formation, breaking, and replacement of habitual behaviour in HCPs. This chapter highlights key theoretical approaches, methods, and intervention techniques that have been applied to conceptualize, measure, develop, and break habit and automaticity in HCPs. These insights have the potential to synergistically contribute novel perspectives to the wider habit literature.

Background Gaps in the quality of care provided to people with type 2 diabetes are regularly identified. Healthcare professionals often have a strong intention to follow practice guidelines during consultations with people with type 2 diabetes; however, this intention does not always translate into action. Action planning (planning when, where and how to act) and coping planning (planning how to overcome pre-identified barriers) have been hypothesised to help with the enactment of intentions by creating mental cue-response links that promote habit formation. This study aimed to investigate whether habit helps to better understand how action and coping planning relate to clinical behaviour in the context of type 2 diabetes care. Methods The study utilised a prospective correlational design with six nested sub-studies. General practitioners and practice nurses (n = 427 from 99 UK primary care practices) completed measures of action planning, coping planning and habit at baseline and then self-reported their enactment of guideline-recommended advising, prescribing and examining behaviours 12 months later. Bootstrapped mediation analyses were used to test the indirect effect of action and coping planning on healthcare professionals’ clinical behaviour via their relationship with habit. Results Healthcare professionals who reported higher degrees of action or coping planning for performing six guideline recommended behaviours in the context of type 2 diabetes care were more likely to report performing these behaviours in clinical practice. All 12 bootstrapped mediation analyses showed that the positive relationship between planning (action and coping planning) and healthcare professionals’ clinical behaviour operated indirectly through habit. Conclusions These findings suggest that habit mediates the relationship between planning (action and coping planning) and healthcare professional behaviour. Promoting careful action and coping planning may support routinised uptake of guideline-recommended care by healthcare professionals in the primary care setting. Given the competing demands on healthcare professionals, exploring the behavioural processes involved in promoting more routinisation of behaviours where possible and appropriate could free up cognitive capacity for clinical behaviours that rely on more deliberation. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0551-6) contains supplementary material, which is available to authorized users.

Background Azilsartan medoxomil (AZL-M), has been demonstrated to be more effective than the other sartans currently in use; however, there is insufficient information available comparing it with ACE-inhibitors. Therefore, we aimed to compare the efficacy, safety, and tolerability of AZL-M with that of ACE-inhibitors in a real life clinical setting. Methods The EARLY registry is a prospective, observational, national, multicentre registry with a follow-up period of 12 months. There were two principal objectives: 1) documentation of the achievement of target BP values set according to recent national and international guidelines, and 2) description of the safety profile of AZL-M. Results A total of 3 849 patients with essential arterial hypertension were recruited from primary care offices in Germany. Patients who initiated monotherapy at baseline comprising either AZL-M or an ACE-inhibitor were included at a ratio of seven to three. Results demonstrated that a blood pressure target of

Background Patient characteristics and blood pressure-related outcomes in randomized clinical trials (RCTs) differ from clinical practice because of stringent selection criteria. The present study aimed to explore the relationship between clinical trials and clinical practice. We analyzed data from patients enrolled in the “Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy” (EARLY) registry comparing blood pressure (BP) effects of the angiotensin receptor blocker (ARB) azilsartan medoxomil (AZL-M) with the angiotensin-converting enzyme (ACE) inhibitor ramipril between patients who met the eligibility criteria of a previous RCT and those who did not. Methods Patients with primary arterial hypertension were consecutively enrolled from primary care offices in Germany into the EARLY registry in a 7:3 ratio for treatment with AZL-M or an ACE inhibitor, provided that they met the following criteria at baseline: 1) no antihypertensive treatment prior to inclusion or a non-renin-angiotensin system (RAS) based monotherapy; 2) initiation of treatment with either AZL-M or an ACE inhibitor alone. Analyses were performed to evaluate BP effects for patients in the EARLY registry who met the selection criteria of a prior RCT (RCT+) versus those who did not (RCT-). Results Out of 3,698 patients considered, 1,644 complied with the RCT criteria (RCT+) while 2,054 did not (RCT-). RCT- patients (55.5 %) displayed a higher risk profile in terms of age and comorbidities, and a wider spectrum of BP values at baseline, as highlighted by the grades of hypertension and mean BP values. The proportion of patients who achieved target blood pressure control in the RCT+ group was significantly higher for AZL-M versus ramipril (64.1 versus 56.1 %; P