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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 ...

Over the last quarter century, non‐medical prescribing in the UK has grown significantly; eight non‐medical professional groups now have authority to prescribe a wide range of medicines, suggesting it could be a potent driver of pharmaceuticalisation. In this article, we present data from a case study of physiotherapists' prescribing practices. UK physiotherapists have had legal rights to prescribe medicines since 2005, but relatively little is known about the contribution they make to expanding patient access to medicines. We approached our study through a lens of governmentality to capture the mentalities and micro‐practices governing physiotherapist non‐medical prescribing. Ethnographic methods were used to gather data from an outpatient orthopaedic service in an NHS Trust in England employing physiotherapist prescribers. From the data, we identified a grid of intelligibility – an organising framework formulated by powerful discourses and technologies of government through which physiotherapist prescribing was acted into being. A primary effect of this grid was the constitution of new physiotherapist subjectivities, mostly as non‐prescribers of medicines contrary to policy intentions, underpinned by a familiar and enduring template of medical professionalism.

This paper explores the early implementation of an organisational innovation in the UK National Health Service (NHS) - Treatment Centres (TCs) - designed to dramatically reduce waiting lists for elective care. The paper draws on case studies of eight TCs (each at varying stages of their development) and aims to explore how meanings about TCs are created and evolve, and how these meanings impact upon the development of the organisational innovation. Research on organisational meanings needs to take greater account of the fact that modern organisations like the NHS are complex multi-level phenomena, comprising layers of interlacing networks. To understand the pace, direction and impact of organisational innovation and change we need to study the interconnections between meanings across different organisational levels. The data presented in this paper show how the apparently simple, relatively unformed, concept of a TC framed by central government, is translated and transmuted by subsequent layers in the health service administration, and by players in local health economies and, ultimately in the TCs themselves, picking up new rationales, meanings, and significance as it goes. The developmental histories of TCs reveal a range of significant re-workings of macro policy with the result that there is considerable diversity and variation between local TC schemes. The picture is of important disconnections between meanings, that in many ways mirror Weick's (1976) 'loosely coupled systems'. The emergent meanings and the direction of micro-level development of TCs appear more strongly determined by interactions within the local TC environment, notably between what we identify as groups of 'idealists', 'pragmatists', 'opportunists' and 'sceptics' than by the framing (Goffman 1974) provided by macro and meso organisational levels. While this illustrates the limitations of top down and policy-driven attempts at change, and highlights the crucial importance of the front-line local 'micro-systems' (Donaldson & Mohr, 2000) in the overall scheme of implementing organisational innovations, the space or headroom provided by frames at the macro and meso levels can enable local change, albeit at variable speed and with uncertain outcomes.

Establishing and running remote consultation services is challenging politically (interest groups may gain or lose), organizationally (remote consulting requires implementation work and new roles and workflows), economically (costs and benefits are unevenly distributed across the system), technically (excellent care needs dependable links and high-quality audio and images), relationally (interpersonal interactions are altered), and clinically (patients are unique, some examinations require contact, and clinicians have deeply-held habits, dispositions and norms). Many of these challenges have an under-examined ethical dimension. In this paper, we present a novel framework, Planning and Evaluating Remote Consultation Services (PERCS), built from a literature review and ongoing research. PERCS has 7 domains—the reason for consulting, the patient, the clinical relationship, the home and family, technologies, staff, the healthcare organization, and the wider system—and considers how these domains interact and evolve over time as a complex system. It focuses attention on the organization's digital maturity and digital inclusion efforts. We have found that both during and beyond the pandemic, policymakers envisaged an efficient, safe and accessible remote consultation service delivered through state-of-the art digital technologies and implemented via rational allocation criteria and quality standards. In contrast, our empirical data reveal that strategic decisions about establishing remote consultation services, allocation decisions for appointment type (phone, video, e-, face-to-face), and clinical decisions when consulting remotely are fraught with contradictions and tensions—for example, between demand management and patient choice—leading to both large- and small-scale ethical dilemmas for managers, support staff, and clinicians. These dilemmas cannot be resolved by standard operating procedures or algorithms. Rather, they must be managed by attending to here-and-now practicalities and emergent narratives, drawing ...

This is the final version. Available from Wiley via the DOI in this record. ; Aims: The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. Background: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality. Design: The eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes. Methods: The study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. Findings: Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. Conclusion: The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology. ; NIHR ; DECIPHer, a UKCRC Public Health Research Centre of Excellence: British Heart Foundation ; Cancer Research UK ; Economic and Social Research Council ; Medical Research Council ; Welsh Government ; Wellcome Trust

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 Improving survival and extending the longevity of life for all populations requires timely, robust evidence on local mortality levels and trends. The Global Burden of Disease 2015 Study (GBD 2015) provides a comprehensive assessment of all-cause and cause-specific mortality for 249 causes in 195 countries and territories from 1980 to 2015. These results informed an in-depth investigation of observed and expected mortality patterns based on sociodemographic measures. Methods We estimated all-cause mortality by age, sex, geography, and year using an improved analytical approach originally developed for GBD 2013 and GBD 2010. Improvements included refinements to the estimation of child and adult mortality and corresponding uncertainty, parameter selection for under-5 mortality synthesis by spatiotemporal Gaussian process regression, and sibling history data processing. We also expanded the database of vital registration, survey, and census data to 14 294 geography–year datapoints. For GBD 2015, eight causes, including Ebola virus disease, were added to the previous GBD cause list for mortality. We used six modelling approaches to assess cause-specific mortality, with the Cause of Death Ensemble Model (CODEm) generating estimates for most causes. We used a series of novel analyses to systematically quantify the drivers of trends in mortality across geographies. First, we assessed observed and expected levels and trends of cause-specific mortality as they relate to the Socio-demographic Index (SDI), a summary indicator derived from measures of income per capita, educational attainment, and fertility. Second, we examined factors affecting total mortality patterns through a series of counterfactual scenarios, testing the magnitude by which population growth, population age structures, and epidemiological changes contributed to shifts in mortality. Finally, we attributed changes in life expectancy to changes in cause of death. We documented each step of the GBD 2015 estimation processes, as well as data sources, in accordance with Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER). Findings Globally, life expectancy from birth increased from 61·7 years (95% uncertainty interval 61·4–61·9) in 1980 to 71·8 years (71·5–72·2) in 2015. Several countries in sub-Saharan Africa had very large gains in life expectancy from 2005 to 2015, rebounding from an era of exceedingly high loss of life due to HIV/AIDS. At the same time, many geographies saw life expectancy stagnate or decline, particularly for men and in countries with rising mortality from war or interpersonal violence. From 2005 to 2015, male life expectancy in Syria dropped by 11·3 years (3·7–17·4), to 62·6 years (56·5–70·2). Total deaths increased by 4·1% (2·6–5·6) from 2005 to 2015, rising to 55·8 million (54·9 million to 56·6 million) in 2015, but age-standardised death rates fell by 17·0% (15·8–18·1) during this time, underscoring changes in population growth and shifts in global age structures. The result was similar for non-communicable diseases (NCDs), with total deaths from these causes increasing by 14·1% (12·6–16·0) to 39·8 million (39·2 million to 40·5 million) in 2015, whereas age-standardised rates decreased by 13·1% (11·9–14·3). Globally, this mortality pattern emerged for several NCDs, including several types of cancer, ischaemic heart disease, cirrhosis, and Alzheimer's disease and other dementias. By contrast, both total deaths and age-standardised death rates due to communicable, maternal, neonatal, and nutritional conditions significantly declined from 2005 to 2015, gains largely attributable to decreases in mortality rates due to HIV/AIDS (42·1%, 39·1–44·6), malaria (43·1%, 34·7–51·8), neonatal preterm birth complications (29·8%, 24·8–34·9), and maternal disorders (29·1%, 19·3–37·1). Progress was slower for several causes, such as lower respiratory infections and nutritional deficiencies, whereas deaths increased for others, including dengue and drug use disorders. Age-standardised death rates due to injuries significantly declined from 2005 to 2015, yet interpersonal violence and war claimed increasingly more lives in some regions, particularly in the Middle East. In 2015, rotaviral enteritis (rotavirus) was the leading cause of under-5 deaths due to diarrhoea (146 000 deaths, 118 000–183 000) and pneumococcal pneumonia was the leading cause of under-5 deaths due to lower respiratory infections (393 000 deaths, 228 000–532 000), although pathogen-specific mortality varied by region. Globally, the effects of population growth, ageing, and changes in age-standardised death rates substantially differed by cause. Our analyses on the expected associations between cause-specific mortality and SDI show the regular shifts in cause of death composition and population age structure with rising SDI. Country patterns of premature mortality (measured as years of life lost [YLLs]) and how they differ from the level expected on the basis of SDI alone revealed distinct but highly heterogeneous patterns by region and country or territory. Ischaemic heart disease, stroke, and diabetes were among the leading causes of YLLs in most regions, but in many cases, intraregional results sharply diverged for ratios of observed and expected YLLs based on SDI. Communicable, maternal, neonatal, and nutritional diseases caused the most YLLs throughout sub-Saharan Africa, with observed YLLs far exceeding expected YLLs for countries in which malaria or HIV/AIDS remained the leading causes of early death. Interpretation At the global scale, age-specific mortality has steadily improved over the past 35 years; this pattern of general progress continued in the past decade. Progress has been faster in most countries than expected on the basis of development measured by the SDI. Against this background of progress, some countries have seen falls in life expectancy, and age-standardised death rates for some causes are increasing. Despite progress in reducing age-standardised death rates, population growth and ageing mean that the number of deaths from most non-communicable causes are increasing in most countries, putting increased demands on health systems. Funding Bill & Melinda Gates Foundation. ; We thank the countless individuals who have contributed to the Global Burden of Disease Study 2015 in various capacities. The data reported here have been supplied by the United States Renal Data System (USRDS). Data for this research was provided by MEASURE Evaluation, funded by the United States Agency for International Development (USAID). Collection of these data was made possible by USAID under the terms of cooperative agreement GPO-A-00-08-000_D3-00. Views expressed do not necessarily reflect those of USAID, the US Government, or MEASURE Evaluation. Parts of this material are based on data and information provided by the Canadian institute for Health Information. However, the analyses, conclusions, opinions and statements expressed herein are those of the author and not those of the Canadian Institute for Health information. The Palestinian Central Bureau of Statistics granted the researchers access to relevant data in accordance with licence number SLN2014-3-170, after subjecting data to processing aiming to preserve the confidentiality of individual data in accordance with the General Statistics Law–2000. The researchers are solely responsible for the conclusions and inferences drawn upon available data. The following individuals acknowledge various forms of institutional support. Simon I Hay is funded by a Senior Research Fellowship from the Wellcome Trust (#095066), and grants from the Bill & Melinda Gates Foundation (OPP1119467, OPP1093011, OPP1106023 and OPP1132415). Panniyammakal Jeemon is supported by a Clinical and Public Health Intermediate Fellowship from the Wellcome Trust-DBT India Alliance (2015–20). Luciano A Sposato is partly supported by the Edward and Alma Saraydar Neurosciences Fund, London Health Sciences Foundation, London, ON, Canada. George A Mensah notes that the views expressed in this Article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, National Institutes of Health, or the United States Department of Health and Human Services. Boris Bikbov acknowledges that work related to this paper has been done on the behalf of the GBD Genitourinary Disease Expert Group supported by the International Society of Nephrology (ISN). Ana Maria Nogales Vasconcelos acknowledges that her team in Brazil received funding from Ministry of Health (process number 25000192049/2014-14). Rodrigo Sarmiento-Suarez receives institutional support from Universidad de Ciencias Aplicadas y Ambientales, UDCA, Bogotá, Colombia. Ulrich O Mueller and Andrea Werdecker gratefully acknowledge funding by the German National Cohort BMBF (grant number OIER 1301/22). Peter James was supported by the National Cancer Institute of the National Institutes of Health (Award K99CA201542). Brett M Kissela would like to acknowledge NIH/NINDS R-01 30678. Louisa Degenhardt is supported by an Australian National Health and Medical Research Council Principal Research fellowship. Daisy M X Abreu received institutional support from the Brazilian Ministry of Health (Proc number 25000192049/2014-14). Jennifer H MacLachlan receives funding support from the Australian Government Department of Health and Royal Melbourne Hospital Research Funding Program. Miriam Levi acknowledges institutional support received from CeRIMP, Regional Centre for Occupational Diseases and Injuries, Tuscany Region, Florence, Italy. Tea Lallukka reports funding from The Academy of Finland (grant 287488). No individuals acknowledged received additional compensation for their efforts. ; Peer-reviewed ; Publisher Version