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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.

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

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.

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 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