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1.  Making sense of complex data: a mapping process for analyzing findings of a realist review on guideline implementability 
Background
Realist reviews offer a rigorous method to analyze heterogeneous data emerging from multiple disciplines as a means to develop new concepts, understand the relationships between them, and identify the evidentiary base underpinning them. However, emerging synthesis methods such as the Realist Review are not well operationalized and may be difficult for the novice researcher to grasp. The objective of this paper is to describe the development of an analytic process to organize and synthesize data from a realist review.
Methods
Clinical practice guidelines have had an inconsistent and modest impact on clinical practice, which may in part be due to limitations in their design. This study illustrates the development of a transparent method for organizing and analyzing a complex data set informed by a Realist Review on guideline implementability to better understand the characteristics of guidelines that affect their uptake in practice (e.g., clarity, format). The data organization method consisted of 4 levels of refinement: 1) extraction and 2) organization of data; 3) creation of a conceptual map of guideline implementability; and 4) the development of a codebook of definitions.
Results
This new method is comprised of four steps: data extraction, data organization, development of a conceptual map, and operationalization vis-a-vis a codebook. Applying this method, we extracted 1736 guideline attributes from 278 articles into a consensus-based set of categories, and collapsed them into 5 core conceptual domains for our guideline implementability map: Language, Format, Rigor of development, Feasibility, Decision-making.
Conclusions
This study advances analysis methods by offering a systematic approach to analyzing complex data sets where the goals are to condense, organize and identify relationships.
doi:10.1186/1471-2288-13-112
PMCID: PMC3848005  PMID: 24028286
2.  The development of a guideline implementability tool (GUIDE-IT): a qualitative study of family physician perspectives 
BMC Family Practice  2014;15:19.
Background
The potential of clinical practice guidelines has not been realized due to inconsistent adoption in clinical practice. Optimising intrinsic characteristics of guidelines (e.g., its wording and format) that are associated with uptake (as perceived by their end users) may have potential. Using findings from a realist review on guideline uptake and consultation with experts in guideline development, we designed a conceptual version of a future tool called Guideline Implementability Tool (GUIDE-IT). The tool will aim to involve family physicians in the guideline development process by providing a process to assess draft guideline recommendations. This feedback will then be given back to developers to consider when finalizing the recommendations. As guideline characteristics are best assessed by end-users, the objectives of the current study were to explore how family physicians perceive guideline implementability, and to determine what components should comprise the final GUIDE-IT prototype.
Methods
We conducted a qualitative study with family physicians inToronto, Ontario. Two experienced investigators conducted one-hour interviews with family physicians using a semi-structured interview guide to 1) elicit feedback on perceptions on guideline implementability; 2) to generate a discussion in response to three draft recommendations; and 3) to provide feedback on the conceptual GUIDE-IT. Sessions were audio taped and transcribed verbatim. Data collection and analysis were guided by content analyses.
Results
20 family physicians participated. They perceived guideline uptake according to facilitators and barriers across 6 categories of guideline implementability (format, content, language, usability, development, and the practice environment). Participants’ feedback on 3 draft guideline recommendations were grouped according to guideline perception, cognition, and agreement. When asked to comment on GUIDE-IT, most respondents believed that the tool would be useful, but urged to involve “regular” or community family physicians in the process, and suggested that an online system would be the most efficient way to deliver it.
Conclusions
Our study identified facilitators and barriers of guideline implementability from the perspective of community and academic family physicians that will be used to build our GUIDE-IT prototype. Our findings build on current knowledge by showing that family physicians perceive guideline uptake mostly according to factors that are in the control of guideline developers.
doi:10.1186/1471-2296-15-19
PMCID: PMC4016596  PMID: 24476491
Guideline implementability; Family practice; Knowledge translation; Qualitative
3.  A realistic evaluation: the case of protocol-based care 
Background
'Protocol based care' was envisioned by policy makers as a mechanism for delivering on the service improvement agenda in England. Realistic evaluation is an increasingly popular approach, but few published examples exist, particularly in implementation research. To fill this gap, within this paper we describe the application of a realistic evaluation approach to the study of protocol-based care, whilst sharing findings of relevance about standardising care through the use of protocols, guidelines, and pathways.
Methods
Situated between positivism and relativism, realistic evaluation is concerned with the identification of underlying causal mechanisms, how they work, and under what conditions. Fundamentally it focuses attention on finding out what works, for whom, how, and in what circumstances.
Results
In this research, we were interested in understanding the relationships between the type and nature of particular approaches to protocol-based care (mechanisms), within different clinical settings (context), and what impacts this resulted in (outcomes). An evidence review using the principles of realist synthesis resulted in a number of propositions, i.e., context, mechanism, and outcome threads (CMOs). These propositions were then 'tested' through multiple case studies, using multiple methods including non-participant observation, interviews, and document analysis through an iterative analysis process. The initial propositions (conjectured CMOs) only partially corresponded to the findings that emerged during analysis. From the iterative analysis process of scrutinising mechanisms, context, and outcomes we were able to draw out some theoretically generalisable features about what works, for whom, how, and what circumstances in relation to the use of standardised care approaches (refined CMOs).
Conclusions
As one of the first studies to apply realistic evaluation in implementation research, it was a good fit, particularly given the growing emphasis on understanding how context influences evidence-based practice. The strengths and limitations of the approach are considered, including how to operationalise it and some of the challenges. This approach provided a useful interpretive framework with which to make sense of the multiple factors that were simultaneously at play and being observed through various data sources, and for developing explanatory theory about using standardised care approaches in practice.
doi:10.1186/1748-5908-5-38
PMCID: PMC2889857  PMID: 20504293
4.  A realist review of educational interventions to improve the delivery of nutrition care by doctors and future doctors 
Systematic Reviews  2014;3:148.
Background
Dietary interventions are considered an important aspect of clinical practice, more so in the face of the rising prevalence of obesity, diabetes and cardiovascular diseases globally. Routinely, most doctors do not provide such intervention to their patients, and several barriers, present during both training and clinical practice, have been identified. Educational interventions to improve nutrition care competencies and delivery have been implemented but with variable success, probably, due to the complex nature of such interventions. Using traditional methods only to investigate whether interventions are effective or not could not provide appropriate lessons. It is therefore pertinent to conduct a realist review that investigates how the interventions work. This realist review aims at determining what sort of educational interventions work, how, for whom, and in what circumstances, to improve the delivery of nutrition care by doctors and future doctors.
Methods/design
This realist review will be conducted according to Pawson’s five practical steps for conducting a realist review: (1) clarifying the scope of the review, (2) determining the search strategy, including adopting broad inclusion/exclusion criteria and purposive snowballing techniques, (3) ensuring proper article selection and study quality assessment using multiple methods, (4) extracting and organising data through the process of note taking, annotation and conceptualization and (5) synthesising the evidence and drawing conclusions through a process of reasoning. This realist review protocol has not been registered in any database before now.
Discussion
Findings will be reported according to the publication criteria outlined by the realist and meta-narrative evidence synthesis (RAMESES) group.
doi:10.1186/2046-4053-3-148
PMCID: PMC4290450  PMID: 25528058
Realist review; Realist synthesis; Educational interventions; Nutrition care; Future doctors; Improve; Delivery
5.  Early years interventions to improve child health and wellbeing: what works, for whom and in what circumstances? Protocol for a realist review 
Systematic Reviews  2015;4:79.
Background
Child health and wellbeing is influenced by multiple factors, all of which can impact on early childhood development. Adverse early life experiences can have lasting effects across the life course, sustaining inequalities and resulting in negative consequences for the health and wellbeing of individuals and society. The potential to influence future outcomes via early intervention is widely accepted; there are numerous policy initiatives, programmes and interventions clustered around the early years theme, resulting in a broad and disparate evidence base. Existing reviews have addressed the effectiveness of early years interventions, yet there is a knowledge gap regarding the mechanisms underlying why interventions work in given contexts.
Methods/design
This realist review seeks to address the question ‘what works, for whom and in what circumstances?’ in terms of early years interventions to improve child health and wellbeing. The review will be conducted following Pawson’s five-stage iterative realist methodology: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions and (5) disseminate findings. The reviewers will work with stakeholders in the early stages to refine the focus of the review, create a review framework and build programme theory. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. A review collaboration group will oversee the review process.
Discussion
The review will demonstrate how early years interventions do or do not work in different contexts and with what outcomes and effects. Review findings will be written up following the RAMESES guidelines and will be disseminated via a report, presentations and peer-reviewed publications.
Systematic review registration
PROSPERO CRD42015017832
doi:10.1186/s13643-015-0068-5
PMCID: PMC4464136  PMID: 26047950
Realist review; Realist synthesis; Early years; Child health; Maternal health; Child development; Wellbeing; Health inequalities; Early intervention
6.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
7.  Understanding integrated care pathways in palliative care using realist evaluation: a mixed methods study protocol 
BMJ Open  2012;2(4):e001533.
Introduction
Policy- and evidence-based guidelines have highlighted the need for improved palliative and end-of-life care. However, there is still evidence of individuals dying undignified deaths with little pain control, therefore inflicting unnecessary suffering. New commissioning powers have enabled a 2-year pilot of an innovative integrated care pathway (ICP) designed to improve arrangements for individuals with life-limiting illnesses requiring palliative care. A novel feature of the ICP is its focus on palliative care over the last 6 months of life, aiming to intervene early to prepare for and ensure a good death. What is not known is if this pathway works, how it works and who it works for.
Methods and analysis
A realist evaluation and a complex analytical framework will investigate and discover context, mechanism and outcome conjectures and configurations of the ICP and thus facilitate exploration of how it works and who it works for. A mixed methods approach will be used with small sample sizes to capture the breadth of the ICP. Phase 1 will identify if the pathway works through analysis of NHS Morbidity Information Query and Export Syntax data, locality Death Audit data and the Quality of Dying and Death Questionnaire. Phase 2 employs soft systems methodology with data from focus groups with health professionals to identify how the pathway works. Phase 3 uses the Miller Behavioural Style Scale and interviews with palliative care patients and bereaved relatives to analyse communication in palliative care.
Ethics and dissemination
Ethical approval has been granted from the NHS local ethics committee (REC reference number: 11/NE/0318). Research & Development approval has been gained from four different trusts, and relevant voluntary organisations and the local council have been informed about the research. This protocol illustrates the complexity inherent in evaluating a palliative care ICP. Identification of whether the pathway works, how it works and who it works for will be beneficial to all practices and other care providers involved as it will give objective data on the impact of the ICP. Results will be disseminated throughout the study for continuous quality improvement of the ICP. Outcomes from each data collection phase will be disseminated separately if analysis warrants it; all data collection will be utilised in the realist evaluation. The research provides a potential for the dissemination of the pathway to other localities through the transferable knowledge it will generate, from its focus on the contexts that are crucial for successful implementation, the mechanisms that facilitate implementation and the outcomes achieved.
Article summary
Article focus
This article is a protocol of a realist evaluation of a palliative care ICP, which was developed in Primary Care by health practitioners. The ICP itself uses elements of long-term chronic illness care in order to provide holistic, supportive, high-quality palliative care. The focus of the article is to detail how the ICP will be evaluated, using a variety of data collection tools, which will identify contexts and mechanisms that lead to improved outcomes, thus taking the main focus away from just the outcomes alone. The identification of contexts and mechanisms for improved outcomes is known as realist evaluation and will provide a better knowledge of the essential conditions of effectiveness when the ICP is implemented in other localities.
Key messages
The key aim of this article is to detail the creation of a complex realist evaluation, which utilises a unique and varied methodological framework. It is hoped that through this article, others will understand the groundwork needed to set up and execute a realist evaluation.
Strengths and limitations of this study
The protocol details a complex evaluation of a unique palliative care ICP using a new and innovative methodology: realist evaluation.
Some may perceive the small sample sizes in the qualitative sections of the study as a weakness. However, the aim of the study is not to find a robust causal mechanism; this would be premature with an ICP in its infancy. The aim is to unpack the contexts and mechanisms that work in certain circumstances, from this conditions crucial for effectiveness can be highlighted, which are essential for implementation of the ICP in other localities.
The ICP involves 15 general practitioner practices, which collectively care for 80 300 patients. The study described will use Morbidity Information Query and Export Syntax and Death Audit data from all 15 practices and will conduct the other sections of research within selected practices, both rural and suburban.
Finally, palliative care is commonly misunderstood in the literature and in the field. This paper addresses this confusion and fills a gap in the literature.
doi:10.1136/bmjopen-2012-001533
PMCID: PMC3391371  PMID: 22761292
8.  Thou shalt versus thou shalt not: a meta-synthesis of GPs' attitudes to clinical practice guidelines 
Background
GPs' adherence to clinical practice guidelines is variable. Barriers to guideline implementation have been identified but qualitative studies have not been synthesised to explore what underpins these attitudes.
Aim
To explore and synthesise qualitative research on GPs' attitudes to and experiences with clinical practice guidelines.
Design of study
Systematic review and meta-synthesis of qualitative studies.
Method
PubMed, CINAHL, EMBASE, Social Science Citation Index, and Science Citation Index were used as data sources, and independent data extraction was carried out. Discrepancies were resolved by consensus. Initial thematic analysis was conducted, followed by interpretative synthesis.
Results
Seventeen studies met the inclusion criteria. Five were excluded following quality appraisal. Twelve papers were synthesised which reported research in the UK, US, Canada, and the Netherlands, and covered different clinical guideline topics. Six themes were identified: questioning the guidelines, GPs' experience, preserving the doctor–patient relationship, professional responsibility, practical issues, and guideline format. Comparative analysis and synthesis revealed that GPs' reasons for not following guidelines differed according to whether the guideline in question was prescriptive, in that it encouraged a certain type of behaviour or treatment, or proscriptive, in that it discouraged certain treatments or behaviours.
Conclusion
Previous analyses of guidelines have focused on professional attitudes and organisational barriers to adherence. This synthesis suggests that the purpose of the guideline, whether its aims are prescriptive or proscriptive, may influence if and how guidelines are received and implemented.
PMCID: PMC2084137  PMID: 18252073
attitudes of health personnel; general practice; guideline adherence; guidelines; meta-synthesis; qualitative research
9.  Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments 
PLoS Medicine  2013;10(7):e1001489.
Background
The vast majority of medical interventions introduced into clinical development prove unsafe or ineffective. One prominent explanation for the dismal success rate is flawed preclinical research. We conducted a systematic review of preclinical research guidelines and organized recommendations according to the type of validity threat (internal, construct, or external) or programmatic research activity they primarily address.
Methods and Findings
We searched MEDLINE, Google Scholar, Google, and the EQUATOR Network website for all preclinical guideline documents published up to April 9, 2013 that addressed the design and conduct of in vivo animal experiments aimed at supporting clinical translation. To be eligible, documents had to provide guidance on the design or execution of preclinical animal experiments and represent the aggregated consensus of four or more investigators. Data from included guidelines were independently extracted by two individuals for discrete recommendations on the design and implementation of preclinical efficacy studies. These recommendations were then organized according to the type of validity threat they addressed. A total of 2,029 citations were identified through our search strategy. From these, we identified 26 guidelines that met our eligibility criteria—most of which were directed at neurological or cerebrovascular drug development. Together, these guidelines offered 55 different recommendations. Some of the most common recommendations included performance of a power calculation to determine sample size, randomized treatment allocation, and characterization of disease phenotype in the animal model prior to experimentation.
Conclusions
By identifying the most recurrent recommendations among preclinical guidelines, we provide a starting point for developing preclinical guidelines in other disease domains. We also provide a basis for the study and evaluation of preclinical research practice.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The development process for new drugs is lengthy and complex. It begins in the laboratory, where scientists investigate the causes of diseases and identify potential new treatments. Next, promising interventions undergo preclinical research in cells and in animals (in vivo animal experiments) to test whether the intervention has the expected effect and to support the generalization (extension) of this treatment–effect relationship to patients. Drugs that pass these tests then enter clinical trials, where their safety and efficacy is tested in selected groups of patients under strictly controlled conditions. Finally, the government bodies responsible for drug approval review the results of the clinical trials, and successful drugs receive a marketing license, usually a decade or more after the initial laboratory work. Notably, only 11% of agents that enter clinical testing (investigational drugs) are ultimately licensed.
Why Was This Study Done?
The frequent failure of investigational drugs during clinical translation is potentially harmful to trial participants. Moreover, the costs of these failures are passed onto healthcare systems in the form of higher drug prices. It would be good, therefore, to reduce the attrition rate of investigational drugs. One possible explanation for the dismal success rate of clinical translation is that preclinical research, the key resource for justifying clinical development, is flawed. To address this possibility, several groups of preclinical researchers have issued guidelines intended to improve the design and execution of in vivo animal studies. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the authors identify the experimental practices that are commonly recommended in these guidelines and organize these recommendations according to the type of threat to validity (internal, construct, or external) that they address. Internal threats to validity are factors that confound reliable inferences about treatment–effect relationships in preclinical research. For example, experimenter expectation may bias outcome assessment. Construct threats to validity arise when researchers mischaracterize the relationship between an experimental system and the clinical disease it is intended to represent. For example, researchers may use an animal model for a complex multifaceted clinical disease that only includes one characteristic of the disease. External threats to validity are unseen factors that frustrate the transfer of treatment–effect relationships from animal models to patients.
What Did the Researchers Do and Find?
The researchers identified 26 preclinical guidelines that met their predefined eligibility criteria. Twelve guidelines addressed preclinical research for neurological and cerebrovascular drug development; other disorders covered by guidelines included cardiac and circulatory disorders, sepsis, pain, and arthritis. Together, the guidelines offered 55 different recommendations for the design and execution of preclinical in vivo animal studies. Nineteen recommendations addressed threats to internal validity. The most commonly included recommendations of this type called for the use of power calculations to ensure that sample sizes are large enough to yield statistically meaningful results, random allocation of animals to treatment groups, and “blinding” of researchers who assess outcomes to treatment allocation. Among the 25 recommendations that addressed threats to construct validity, the most commonly included recommendations called for characterization of the properties of the animal model before experimentation and matching of the animal model to the human manifestation of the disease. Finally, six recommendations addressed threats to external validity. The most commonly included of these recommendations suggested that preclinical research should be replicated in different models of the same disease and in different species, and should also be replicated independently.
What Do These Findings Mean?
This systematic review identifies a range of investigational recommendations that preclinical researchers believe address threats to the validity of preclinical efficacy studies. Many of these recommendations are not widely implemented in preclinical research at present. Whether the failure to implement them explains the frequent discordance between the results on drug safety and efficacy obtained in preclinical research and in clinical trials is currently unclear. These findings provide a starting point, however, for the improvement of existing preclinical research guidelines for specific diseases, and for the development of similar guidelines for other diseases. They also provide an evidence-based platform for the analysis of preclinical evidence and for the study and evaluation of preclinical research practice. These findings should, therefore, be considered by investigators, institutional review bodies, journals, and funding agents when designing, evaluating, and sponsoring translational research.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001489.
The US Food and Drug Administration provides information about drug approval in the US for consumers and for health professionals; its Patient Network provides a step-by-step description of the drug development process that includes information on preclinical research
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) provides information about all aspects of the scientific evaluation and approval of new medicines in the UK; its My Medicine: From Laboratory to Pharmacy Shelf web pages describe the drug development process from scientific discovery, through preclinical and clinical research, to licensing and ongoing monitoring
The STREAM website provides ongoing information about policy, ethics, and practices used in clinical translation of new drugs
The CAMARADES collaboration offers a “supporting framework for groups involved in the systematic review of animal studies” in stroke and other neurological diseases
doi:10.1371/journal.pmed.1001489
PMCID: PMC3720257  PMID: 23935460
10.  How equity is addressed in clinical practice guidelines: a content analysis 
BMJ Open  2014;4(12):e005660.
Objectives
Considering equity into guidelines presents methodological challenges. This study aims to qualitatively synthesise the methods for incorporating equity in clinical practice guidelines (CPGs).
Setting
Content analysis of methodological publications.
Eligibility criteria for selecting studies
Methodological publications were included if they provided checklists/frameworks on when, how and to what extent equity should be incorporated in CPGs.
Data sources
We electronically searched MEDLINE, retrieved references, and browsed guideline development organisation websites from inception to January 2013. After study selection by two authors, general characteristics and checklists items/framework components from included studies were extracted. Based on the questions or items from checklists/frameworks (unit of analysis), content analysis was conducted to identify themes and questions/items were grouped into these themes.
Primary outcomes
The primary outcomes were methodological themes and processes on how to address equity issues in guideline development.
Results
8 studies with 10 publications were included from 3405 citations. In total, a list of 87 questions/items was generated from 17 checklists/frameworks. After content analysis, questions were grouped into eight themes (‘scoping questions’, ‘searching relevant evidence’, ‘appraising evidence and recommendations’, ‘formulating recommendations’, ‘monitoring implementation’, ‘providing a flow chart to include equity in CPGs’, and ‘others: reporting of guidelines and comments from stakeholders’ for CPG developers and ‘assessing the quality of CPGs’ for CPG users). Four included studies covered more than five of these themes. We also summarised the process of guideline development based on the themes mentioned above.
Conclusions
For disadvantaged population-specific CPGs, eight important methodological issues identified in this review should be considered when including equity in CPGs under the guidance of a scientific guideline development manual.
doi:10.1136/bmjopen-2014-005660
PMCID: PMC4265087  PMID: 25479795
QUALITATIVE RESEARCH; PUBLIC HEALTH
11.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Background
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Conclusions
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001498.
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
doi:10.1371/journal.pmed.1001498
PMCID: PMC3742442  PMID: 23966839
12.  The barriers and facilitators to the implementation of clinical guidance in elective orthopaedic surgery: a qualitative study protocol 
Background
Clinical guidelines in orthopaedic surgery aim to improve the efficiency, quality and outcomes of patient care by ensuring that treatment recommendations are based on the best available evidence. The simple provision of guidelines, however, does not ensure fidelity or guarantee their uptake and use in surgical practice. Research exploring the factors that affect surgeons’ use of evidence and guidelines has focused on understanding what evidence exists for current clinical decisions. This narrowed scope emphasises the technical, educational and accessibility issues but overlooks wider factors that help explain how and why guidelines are not implemented and used in surgery. It is also important to understand how we can encourage the implementation processes in practice.
By taking a social science perspective to examine orthopaedic surgery, we move beyond the narrow focus and explore how and why clinical guidelines struggle to achieve full uptake. We aim to explore guideline uptake to discover the factors that contribute to, or complicate, appropriate implementation in this field. We need to go beyond traditional views and experimental methods to examine the barriers and facilitators of implementation in real-life NHS surgical practice. These could be multifactorial, linked to individual, organisational or contextual influences, which act on the guideline implementation process.
Methods/design
We will use ethnographic methods to conduct case studies in three English NHS hospitals. Within each case, we will conduct observations, interviews and analysis of key documents to understand experiences, complex processes and decisions made and the role of clinical guidance and other sources of evidence within orthopaedic surgery. The data will be transcribed and analysed thematically. Comparisons will be made within cases and across cases.
Discussion
Guidelines are a fundamental part of clinical practice, and various factors must be considered when preparing for their successful implementation into organisations. Understanding the views and experiences of a range of surgical, clerical and managerial staff across multiple orthopaedic departments will capture the complexity and variety of factors that can influence surgical decisions. The findings of our study will identify the specific features of orthopaedic practice to help guide the development of strategies to facilitate guideline uptake in everyday surgical work.
doi:10.1186/s13012-015-0273-6
PMCID: PMC4464880  PMID: 26033075
Guidelines; Orthopaedic surgery; Evidence-based medicine; Comparative case study; Barriers; Facilitators; Implementation
13.  Determinants of implementation of maternal health guidelines in Kosovo: mixed methods study 
Background
One of the challenges to implementing clinical practice guidelines is the need to adapt guidelines to the local context and identify barriers to their uptake. Several models of framework are available to consider for use in guideline adaptation.
Methods
We completed a multiphase study to explore the implementation of maternal health guidelines in Kosovo, focusing on determinants of uptake and methods to contextualize for local use. The study involved a survey, individual interviews, focus groups, and a consensus meeting with relevant stakeholders, including clinicians (obstetricians, midwives), managers, researchers, and policy makers from the national Ministry of Health and the World Health Organization office in Pristina, Kosovo.
Results
Participants identified several important barriers to implementation. First, lack of communication between clinicians and ministry representatives was seen as leading to duplication of effort in creating or adapting guidelines, as well as substantial mistrust between clinicians and policy makers. Second, there was a lack of communication across clinical groups that provide obstetric care and a lack of integration across the entire healthcare system, including rural and urban centers. This fragmentation was thought to have directly resulted from the war in 1998 – 1999. Third, the conflict substantially and adversely affected the healthcare infrastructure in Kosovo, which has resulted in an inability to monitor quality of care across the country. Furthermore, the impact on infrastructure has affected the ability to access required medications consistently and to smoothly transfer patients from rural to urban centers. Another issue raised during this project was the appropriateness of including guideline recommendations perceived to be ‘aspirational’.
Conclusions
Implementing clinical practice guidelines in low- and middle-income countries (LMICs) requires consideration of several specific barriers. Particularly pertinent to this study were the effects of recent conflict and the resulting fragmentation of healthcare and communication strategies among relevant stakeholders. However, as Kosovo rebuilds and invests in infrastructure after the conflict, there is a tremendous opportunity to create comprehensive, thoughtful strategies to monitor and improve quality of care. To avoid duplication of effort, it may be beneficial for LMICs to share information on assessing barriers as well as on guideline implementation strategies.
doi:10.1186/1748-5908-8-108
PMCID: PMC3846581  PMID: 24016149
Guideline implementation; Determinants of evidence uptake
14.  Following a natural experiment of guideline adaptation and early implementation: a mixed-methods study of facilitation 
Background
Facilitation is emerging as an important strategy in the uptake of evidence. However, it is not entirely clear from a practical perspective how facilitation occurs to help move research evidence into nursing practice. The Canadian Partnership Against Cancer, also known as the 'Partnership,' is a Pan-Canadian initiative supporting knowledge translation activity for improved care through guideline use. In this case-series study, five self-identified groups volunteered to use a systematic methodology to adapt existing clinical practice guidelines for Canadian use. With 'Partnership' support, local and external facilitators provided assistance for groups to begin the process by adapting the guidelines and planning for implementation.
Methods
To gain a more comprehensive understanding of the nature of facilitation, we conducted a mixed-methods study. Specifically, we examined the role and skills of individuals actively engaged in facilitation as well as the actual facilitation activities occurring within the 'Partnership.' The study was driven by and builds upon a focused literature review published in 2010 that examined facilitation as a role and process in achieving evidence-based practice in nursing. An audit tool outlining 46 discrete facilitation activities based on results of this review was used to examine the facilitation noted in the documents (emails, meeting minutes, field notes) of three nursing-related cases participating in the 'Partnership' case-series study. To further examine the concept, six facilitators were interviewed about their practical experiences. The case-audit data were analyzed through a simple content analysis and triangulated with participant responses from the focus group interview to understand what occurred as these cases undertook guideline adaptation.
Results
The analysis of the three cases revealed that almost all of the 46 discrete, practical facilitation activities from the literature were evidenced. Additionally, case documents exposed five other facilitation-related activities, and a combination of external and local facilitation was apparent. Individuals who were involved in the case or group adapting the guideline(s) also performed facilitation activities, both formally and informally, in conjunction with or in addition to appointed external and local facilitators.
Conclusions
Facilitation of evidence-based practice is a multifaceted process and a team effort. Communication and relationship-building are key components. The practical aspects of facilitation explicated in this study validate what has been previously noted in the literature and expand what is known about facilitation process and activity.
doi:10.1186/1748-5908-7-9
PMCID: PMC3296591  PMID: 22309743
facilitation; facilitator; evidence-based practice; nursing; guideline
15.  'How to know what you need to do': a cross-country comparison of maternal health guidelines in Burkina Faso, Ghana and Tanzania 
Background
Initiatives to raise the quality of care provided to mothers need to be given priority in Sub Saharan Africa (SSA). The promotion of clinical practice guidelines (CPGs) is a common strategy, but their implementation is often challenging, limiting their potential impact. Through a cross-country perspective, this study explored CPGs for maternal health in Burkina Faso, Ghana, and Tanzania. The objectives were to compare factors related to CPG use including their content compared with World Health Organization (WHO) guidelines, their format, and their development processes. Perceptions of their availability and use in practice were also explored. The overall purpose was to further the understanding of how to increase CPGs' potential to improve quality of care for mothers in SSA.
Methods
The study was a multiple case study design consisting of cross-country comparisons using document review and key informant interviews. A conceptual framework to aid analysis and discussion of results was developed, including selected domains related to guidelines' implementability and use by health workers in practice in terms of usability, applicability, and adaptability.
Results
The study revealed few significant differences in content between the national guidelines for maternal health and WHO recommendations. There were, however, marked variations in the format of CPGs between the three countries. Apart from the Ghanaian and one of the Tanzanian CPGs, the levels of both usability and applicability were assessed as low or medium. In all three countries, the use of CPGs by health workers in practice was perceived to be limited.
Conclusion
Our cross-country study suggests that it is not poor quality of content or lack of evidence base that constitute the major barrier for CPGs to positively impact on quality improvement in maternal care in SSA. It rather emphasises the need to prioritise the format of guidelines to increase their usability and applicability and to consider these attributes together with implementation strategies as integral to their development processes.
doi:10.1186/1748-5908-7-31
PMCID: PMC3372446  PMID: 22500744
CPGs; Health service delivery; Implementation; Information and communication technology (ICT); Maternal health; Quality improvement; Sub Saharan Africa; WHO
16.  Realist synthesis: illustrating the method for implementation research 
Background
Realist synthesis is an increasingly popular approach to the review and synthesis of evidence, which focuses on understanding the mechanisms by which an intervention works (or not). There are few published examples of realist synthesis. This paper therefore fills a gap by describing, in detail, the process used for a realist review and synthesis to answer the question ‘what interventions and strategies are effective in enabling evidence-informed healthcare?’ The strengths and challenges of conducting realist review are also considered.
Methods
The realist approach involves identifying underlying causal mechanisms and exploring how they work under what conditions. The stages of this review included: defining the scope of the review (concept mining and framework formulation); searching for and scrutinising the evidence; extracting and synthesising the evidence; and developing the narrative, including hypotheses.
Results
Based on key terms and concepts related to various interventions to promote evidence-informed healthcare, we developed an outcome-focused theoretical framework. Questions were tailored for each of four theory/intervention areas within the theoretical framework and were used to guide development of a review and data extraction process. The search for literature within our first theory area, change agency, was executed and the screening procedure resulted in inclusion of 52 papers. Using the questions relevant to this theory area, data were extracted by one reviewer and validated by a second reviewer. Synthesis involved organisation of extracted data into evidence tables, theming and formulation of chains of inference, linking between the chains of inference, and hypothesis formulation. The narrative was developed around the hypotheses generated within the change agency theory area.
Conclusions
Realist synthesis lends itself to the review of complex interventions because it accounts for context as well as outcomes in the process of systematically and transparently synthesising relevant literature. While realist synthesis demands flexible thinking and the ability to deal with complexity, the rewards include the potential for more pragmatic conclusions than alternative approaches to systematic reviewing. A separate publication will report the findings of the review.
doi:10.1186/1748-5908-7-33
PMCID: PMC3514310  PMID: 22515663
17.  Implementation of the Crisis Resolution Team model in adult mental health settings: a systematic review 
BMC Psychiatry  2015;15:74.
Background
Crisis Resolution Teams (CRTs) aim to offer an alternative to hospital admission during mental health crises, providing rapid assessment, home treatment, and facilitation of early discharge from hospital. CRTs were implemented nationally in England following the NHS Plan of 2000. Single centre studies suggest CRTs can reduce hospital admissions and increase service users’ satisfaction: however, there is also evidence that model implementation and outcomes vary considerably. Evidence on crucial characteristics of effective CRTs is needed to allow team functioning to be optimised. This review aims to establish what evidence, if any, is available regarding the characteristics of effective and acceptable CRTs.
Methods
A systematic review was conducted. MEDLINE, Embase, PsycINFO, CINAHL and Web of Science were searched to November 2013. A further web-based search was conducted for government and expert guidelines on CRTs. We analysed studies separately as: comparing CRTs to Treatment as Usual; comparing two or more CRT models; national or regional surveys of CRT services; qualitative studies of stakeholders’ views regarding best practice in CRTs; and guidelines from government and expert organisations regarding CRT service delivery. Quality assessment and narrative synthesis were conducted. Statistical meta-analysis was not feasible due to the variety of design of retrieved studies.
Results
Sixty-nine studies were included. Studies varied in quality and in the composition and activities of the clinical services studied. Quantitative studies suggested that longer opening hours and the presence of a psychiatrist in the team may increase CRTs’ ability to prevent hospital admissions. Stakeholders emphasised communication and integration with other local mental health services; provision of treatment at home; and limiting the number of different staff members visiting a service user. Existing guidelines prioritised 24-hour, seven-day-a-week CRT service provision (including psychiatrist and medical prescriber); and high quality of staff training.
Conclusions
We cannot draw confident conclusions about the critical components of CRTs from available quantitative evidence. Clearer definition of the CRT model is required, informed by stakeholders’ views and guidelines. Future studies examining the relationship of overall CRT model fidelity to outcomes, or evaluating the impact of key aspects of the CRT model, are desirable.
Trial registration
Prospero CRD42013006415.
Electronic supplementary material
The online version of this article (doi:10.1186/s12888-015-0441-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s12888-015-0441-x
PMCID: PMC4405828  PMID: 25879674
Crisis resolution team; Home treatment team; Crisis assessment and treatment team; Mental health; Service implementation; Good practice; Systematic review
18.  Barriers to accurate diagnosis and effective management of heart failure in primary care: qualitative study 
BMJ : British Medical Journal  2003;326(7382):196.
Objective
To ascertain the beliefs, current practices, and decision making of general practitioners in the diagnosis and management of suspected heart failure in primary care, with a view to identifying barriers to good care.
Design
A qualitative approach using focus groups with 30 general practitioners from four primary care groups. The sampling strategy was stratified and purposive. The contents of interviews were transcribed and analysed according to the principles of “pragmatic variant” grounded theory.
Setting
North east England.
Results
Three categories of difficulties contribute to variations in medical practice and to the reasons why general practitioners experience difficulties in diagnosing and managing heart failure. The first is uncertainty about clinical practice, including lack of confidence in establishing an accurate diagnosis and worries about using angiotensin converting enzyme inhibitors, β blockers, and spironolactone in patients who are often elderly and frail, with comorbidity and polypharmacy. The second is a lack of awareness of relevant research evidence in what was perceived to be a complex and rapidly changing therapeutic field. Doubts about the applicability of research findings in primary care, and fear of information overload also emerged. The third category consists of influences of individual preference and local organisational factors. Medical training, negative clinical experiences, and outside agencies influenced the behaviour of general practitioners and professional culture. Local factors included the availability of diagnostic services, resources (such as accessible cardiologists), and interactions between professionals in primary or secondary care, and they seemed to shape the practice and decision making processes in primary care.
Conclusions
The national service framework for coronary heart disease stresses that the substandard care of patients with heart failure is unacceptable. This study identified barriers to be overcome across primary and secondary care in implementation strategies that are specific to the locality and multifaceted. Single strategies—for example, the provision of guidelines—are unlikely to have an impact on clinical outcomes, and new, conjoint models of care need to be explored.
What is already known on this topicHeart failure is a common condition with a high morbidity and mortality and is largely managed in primary careAlthough modern management with accurate diagnosis and treatment improves prognosis considerably, unacceptable variations exist in the clinical application of current guidelines for heart failureWhat this study addsGeneral practitioners expressed a lack of confidence in establishing an accurate diagnosis of left ventricular systolic dysfunction, even if open access echocardiography was availableUncertainty about diagnosis led to poor uptake of evidence based treatment strategies for heart failure patients, and, despite awareness, reluctance to initiate modern treatmentLocal organisational factors around NHS provision of diagnostic services, resources, and interaction between primary and secondary care influence how general practitioners manage heart failureImplementation strategies for heart failure management across primary and secondary care are needed that are specific to their locality and multifaceted
PMCID: PMC140276  PMID: 12543836
19.  Understanding uptake of continuous quality improvement in Indigenous primary health care: lessons from a multi-site case study of the Audit and Best Practice for Chronic Disease project 
Background
Experimentation with continuous quality improvement (CQI) processes is well underway in Indigenous Australian primary health care. To date, little research into how health organizations take up, support, and embed these complex innovations is available on which services can draw to inform implementation. In this paper, we examine the practices and processes in the policy and organisational contexts, and aim to explore the ways in which they interact to support and/or hinder services' participation in a large scale Indigenous primary health care CQI program.
Methods
We took a theory-driven approach, drawing on literature on the theory and effectiveness of CQI systems and the Greenhalgh diffusion of innovation framework. Data included routinely collected regional and service profile data; uptake of tools and progress through the first CQI cycle, and data collected quarterly from hub coordinators on their perceptions of barriers and enablers. A total of 48 interviews were also conducted with key people involved in the development, dissemination, and implementation of the Audit and Best Practice for Chronic Disease (ABCD) project. We compiled the various data, conducted thematic analyses, and developed an in-depth narrative account of the processes of uptake and diffusion into services.
Results
Uptake of CQI was a complex and messy process that happened in fits and starts, was often characterised by conflicts and tensions, and was iterative, reactive, and transformational. Despite initial enthusiasm, the mixed successes during the first cycle were associated with the interaction of features of the environment, the service, the quality improvement process, and the stakeholders, which operated to produce a set of circumstances that either inhibited or enabled the process of change. Organisations had different levels of capacity to mobilize resources that could shift the balance toward supporting implementation. Different forms of leadership and organisational linkages were critical to success. The Greenhalgh framework provided a useful starting point for investigation, but we believe it is more a descriptive than explanatory model. As such, it has limitations in the extent to which it could assist us in understanding the interactions of the practices and processes that we observed at different levels of the system.
Summary
Taking up CQI involved engaging multiple stakeholders in new relationships that could support services to construct shared meaning and purpose, operationalise key concepts and tools, and develop and embed new practices into services systems and routines. Promoting quality improvement requires a system approach and organization-wide commitment. At the organization level, a formal high-level mandate, leadership at all levels, and resources to support implementation are needed. At the broader system level, governance arrangements that can fulfil a number of policy objectives related to articulating the linkages between CQI and other aspects of the regulatory, financing, and performance frameworks within the health system would help define a role and vision for quality improvement.
doi:10.1186/1748-5908-5-21
PMCID: PMC2847538  PMID: 20226066
20.  From policy to practice: implementation of physical activity and food policies in schools 
Purpose
Public policies targeting the school setting are increasingly being used to address childhood obesity; however, their effectiveness depends on their implementation. This study explores the factors which impeded or facilitated the implementation of publicly mandated school-based physical activity and nutrition guidelines in the province of British Columbia (BC), Canada.
Methods
Semi-structured interviews were conducted with 50 school informants (17 principals - 33 teacher/school informants) to examine the factors associated with the implementation of the mandated Daily Physical Activity (DPA) and Food and Beverage Sales in Schools (FBSS) guidelines. Coding used a constructivist grounded theory approach. The first five transcripts and every fifth transcript thereafter were coded by two independent coders with discrepancies reconciled by a third coder. Data was coded and analysed in the NVivo 9 software. Concept maps were developed and current theoretical perspectives were integrated in the later stages of analysis.
Results
The Diffusion of Innovations Model provided an organizing framework to present emergent themes. With the exception of triability (not relevant in the context of mandated guidelines/policies), the key attributes of the Diffusion of Innovations Model (relative advantage, compatibility, complexity, and observability) provided a robust framework for understanding themes associated with implementation of mandated guidelines. Specifically, implementation of the DPA and FBSS guidelines was facilitated by perceptions that they: were relatively advantageous compared to status quo; were compatible with school mandates and teaching philosophies; had observable positive impacts and impeded when perceived as complex to understand and implement. In addition, a number of contextual factors including availability of resources facilitated implementation.
Conclusions
The enactment of mandated policies/guidelines for schools is considered an essential step in improving physical activity and healthy eating. However, policy makers need to: monitor whether schools are able to implement the guidelines, support schools struggling with implementation, and document the impact of the guidelines on students’ behaviors. To facilitate the implementation of mandated guidelines/policies, the Diffusion of Innovations Model provides an organizational framework for planning interventions. Changing the school environment is a process which cannot be undertaken solely by passive means as we know that such approaches have not resulted in adequate implementation.
doi:10.1186/1479-5868-10-71
PMCID: PMC3681662  PMID: 23731803
Physical education; Physical activity; Nutrition; School policies; School guidelines; Implementation; Uptake; Barriers; Facilitators; Qualitative
21.  The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview 
PLoS Medicine  2011;8(1):e1000387.
Aziz Sheikh and colleagues report the findings of their systematic overview that assessed the impact of eHealth solutions on the quality and safety of health care.
Background
There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.
Methods and Findings
We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.
Conclusions
There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
There is considerable international interest in exploiting the potential of digital health care solutions, often referred to as eHealth—the use of information and communication technologies—to enhance the quality and safety of health care. Often accompanied by large costs, any large-scale expenditure on eHealth—such as electronic health records, picture archiving and communication systems, ePrescribing, associated computerized provider order entry systems, and computerized decision support systems—has tended to be justified on the grounds that these are efficient and cost-effective means for improving health care. In 2005, the World Health Assembly passed an eHealth resolution (WHA 58.28) that acknowledged, “eHealth is the cost-effective and secure use of information and communications technologies in support of health and health-related fields, including health-care services, health surveillance, health literature, and health education, knowledge and research,” and urged member states to develop and implement eHealth technologies. Since then, implementing eHealth technologies has become a main priority for many countries. For example, England has invested at least £12.8 billion in a National Programme for Information Technology for the National Health Service, and the Obama administration in the United States has committed to a US$38 billion eHealth investment in health care.
Why Was This Study Done?
Despite the wide endorsement of and support for eHealth, the scientific basis of its benefits—which are repeatedly made and often uncritically accepted—remains to be firmly established. A robust evidence-based perspective on the advantages on eHealth could help to suggest priority areas that have the greatest potential for benefit to patients and also to inform international eHealth deliberations on costs. Therefore, in order to better inform the international community, the authors systematically reviewed the published systematic review literature on eHealth technologies and evaluated the impact of these technologies on the quality and safety of health care delivery.
What Did the Researchers Do and Find?
The researchers divided eHealth technologies into three main categories: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. Then, implementing methods based on those developed by the Cochrane Collaboration and the NHS Service Delivery and Organisation Programme, the researchers used detailed search strategies and maps of health care quality, safety, and eHealth interventions to identify relevant systematic reviews (and related theoretical, methodological, and technical material) published between 1997 and 2010. Using these techniques, the researchers retrieved a total of 46,349 references from which they identified 108 reviews. The 53 reviews that the researchers finally selected (and critically reviewed) provided the main evidence base for assessing the impact of eHealth technologies in the three categories selected.
In their systematic review of systematic reviews, the researchers included electronic health records and picture archiving communications systems in their evaluation of category 1, computerized provider (or physician) order entry and e-prescribing in category 2, and all clinical information systems that, when used in the context of eHealth technologies, integrate clinical and demographic patient information to support clinician decision making in category 3.
The researchers found that many of the clinical claims made about the most commonly used eHealth technologies were not substantiated by empirical evidence. The evidence base in support of eHealth technologies was weak and inconsistent and importantly, there was insubstantial evidence to support the cost-effectiveness of these technologies. For example, the researchers only found limited evidence that some of the many presumed benefits could be realized; importantly, they also found some evidence that introducing these new technologies may on occasions also generate new risks such as prescribers becoming over-reliant on clinical decision support for e-prescribing, or overestimate its functionality, resulting in decreased practitioner performance.
What Do These Findings Mean?
The researchers found that despite the wide support for eHealth technologies and the frequently made claims by policy makers when constructing business cases to raise funds for large-scale eHealth projects, there is as yet relatively little empirical evidence to substantiate many of the claims made about eHealth technologies. In addition, even for the eHealth technology tools that have proven to be successful, there is little evidence to show that such tools would continue to be successful beyond the contexts in which they were originally developed. Therefore, in light of the lack of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, the authors say that future eHealth technologies should be evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle, and include socio-technical factors to maximize the likelihood of successful implementation and adoption in a given context. Furthermore, it is equally important that eHealth projects that have already been commissioned are subject to rigorous, multidisciplinary, and independent evaluation.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000387.
The authors' broader study is: Car J, Black A, Anandan C, Cresswell K, Pagliari C, McKinstry B, et al. (2008) The Impact of eHealth on the Quality and Safety of Healthcare. Available at: http://www.haps.bham.ac.uk/publichealth/cfhep/001.shtml
More information is available on the World Health Assembly eHealth resolution
The World Health Organization provides information at the Global Observatory on eHealth, as well as a global insight into eHealth developments
The European Commission provides Information on eHealth in Europe and some examples of good eHealth practice
More information is provided on NHS Connecting for Health
doi:10.1371/journal.pmed.1000387
PMCID: PMC3022523  PMID: 21267058
22.  Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm 
BMJ Open  2014;4(7):e005650.
Introduction
Little is understood about the role of quality improvement in enabling health organisations to survive and thrive in the contemporary context of financial and economic challenges. We will draw on the theoretical foundations of the ‘Resource Based View of the Firm’ (RBV) to develop insights into why health organisations engage in improvement work, how impacts are conceptualised, and ‘what works’ in delivering these impacts. Specifically, RBV theorises that the mix and use of resources across different organisations may explain differences in performance. Whether improvement work influences these resources is unclear.
Methods and analysis
Case study research will be conducted across health organisations participating in four approaches to improvement, including: a national improvement programme; a multiorganisational partnership around implementation; an organisational strategy for quality improvement; and a coproduction project designed to enhance the experience of a clinical service from the perspective of patients. Data will comprise in-depth interviews with key informants, observation of key events and documents; analysed within and then across cases. Adopting a realist perspective, the core tenets of RBV will be evaluated as a programme theory, focusing on the interplay between organisational conditions and behavioural or resource responses that are reported through engagement in improvement.
Ethics and dissemination
The study has been approved by Bangor University Ethics Committee. The investigation will not judge the relative merits of different approaches to healthcare quality improvement. Rather, we will develop unique insights into the organisational consequences, and dependencies of quality improvement, providing an opportunity to add to the explanatory potential of RBV in this and other contexts. In addition to scientific and lay reports of the study findings, research outputs will include a framework for constructing the economic impacts of quality improvement and practical guidance for health service managers that maximises the impacts of investment in quality improvement.
doi:10.1136/bmjopen-2014-005650
PMCID: PMC4120434  PMID: 25082421
QUALITATIVE RESEARCH
23.  The Guideline Implementability Decision Excellence Model (GUIDE-M): a mixed methods approach to create an international resource to advance the practice guideline field 
Background
Practice guideline (PG) implementability refers to PG features that promote their use. While there are tools and resources to promote PG implementability, none are based on an evidence-informed and multidisciplinary perspective. Our objectives were to (i) create a comprehensive and evidence-informed model of PG implementability, (ii) seek support for the model from the international PG community, (iii) map existing implementability tools on to the model, (iv) prioritize areas for further investigation, and (v) describe how the model can be used by PG developers, users, and researchers.
Methods
A mixed methods approach was used. Using our completed realist review of the literature of seven different disciplines as the foundation, an iterative consensus process was used to create the beta version of the model. This was followed by (i) a survey of international stakeholders (guideline developers and users) to gather feedback and to refine the model, (ii) a content analysis comparing the model to existing PG tools, and (iii) a strategy to prioritize areas of the model for further research by members of the research team.
Results
The Guideline Implementability for Decision Excellence Model (GUIDE-M) is comprised of 3 core tactics, 7 domains, 9 subdomains, 44 attributes, and 40 subattributes and elements. Feedback on the beta version was received from 248 stakeholders from 34 countries. The model was rated as logical, relevant, and appropriate. Seven PG tools were selected and compared to the GUIDE-M: very few tools targeted the Contextualization and Deliberations domain. Also, fewer of the tools addressed PG appraisal than PG development and reporting functions. These findings informed the research priorities identified by the team.
Conclusions
The GUIDE-M provides an evidence-informed international and multidisciplinary conceptualization of PG implementability. The model can be used by PG developers to help them create more implementable recommendations, by clinicians and other users to help them be better consumers of PGs, and by the research community to identify priorities for further investigation.
doi:10.1186/s13012-015-0225-1
PMCID: PMC4364563  PMID: 25885412
Clinical practice guidelines; Practice guidelines; Implementability; Implementation
24.  Attributes of clinical guidelines that influence use of guidelines in general practice: observational study 
BMJ : British Medical Journal  1998;317(7162):858-861.
Objective: To determine which attributes of clinical practice guidelines influence the use of guidelines in decision making in clinical practice.
Design: Observational study relating the use of 47 different recommendations from 10 national clinical guidelines to 12 different attributes of clinical guidelines—for example, evidence based, controversial, concrete.
Setting: General practice in the Netherlands.
Subjects: 61 general practitioners who made 12 880 decisions in their contacts with patients.
Main outcome measures: Compliance of decisions with clinical guidelines according to the attribute of the guideline.
Results: Recommendations were followed in, on average, 61% (7915/12 880) of the decisions. Controversial recommendations were followed in 35% (886/2497) of decisions and non-controversial recommendations in 68% (7029/10 383) of decisions. Vague and non-specific recommendations were followed in 36% (826/2280) of decisions and clear recommendations in 67% (7089/10 600) of decisions. Recommendations that demanded a change in existing practice routines were followed in 44% (1278/2912) of decisions and those that did not in 67% (6637/9968) of decisions. Evidence based recommendations were used more than recommendations for practice that were not based on research evidence (71% (2745/3841) v 57% (5170/9039)).
Conclusions: People and organisations setting evidence based clinical practice guidelines should take into account some of the other important attributes of effective recommendations for clinical practice.
Key messages Specific attributes of clinical practice guidelines determine whether they are used in practice Evidence based recommendations are better followed in practice than recommendations not based on scientific evidence Precise definitions of recommended performance improve the use of guidelines Testing the feasibility and acceptance of clinical guidelines among the target group is important for effective implementation People setting evidence based guidelines need to understand the attributes of effective guidelines
PMCID: PMC31096  PMID: 9748183
25.  A Holistic Framework to Improve the Uptake and Impact of eHealth Technologies 
Background
Many eHealth technologies are not successful in realizing sustainable innovations in health care practices. One of the reasons for this is that the current development of eHealth technology often disregards the interdependencies between technology, human characteristics, and the socioeconomic environment, resulting in technology that has a low impact in health care practices. To overcome the hurdles with eHealth design and implementation, a new, holistic approach to the development of eHealth technologies is needed, one that takes into account the complexity of health care and the rituals and habits of patients and other stakeholders.
Objective
The aim of this viewpoint paper is to improve the uptake and impact of eHealth technologies by advocating a holistic approach toward their development and eventual integration in the health sector.
Methods
To identify the potential and limitations of current eHealth frameworks (1999–2009), we carried out a literature search in the following electronic databases: PubMed, ScienceDirect, Web of Knowledge, PiCarta, and Google Scholar. Of the 60 papers that were identified, 44 were selected for full review. We excluded those papers that did not describe hands-on guidelines or quality criteria for the design, implementation, and evaluation of eHealth technologies (28 papers). From the results retrieved, we identified 16 eHealth frameworks that matched the inclusion criteria. The outcomes were used to posit strategies and principles for a holistic approach toward the development of eHealth technologies; these principles underpin our holistic eHealth framework.
Results
A total of 16 frameworks qualified for a final analysis, based on their theoretical backgrounds and visions on eHealth, and the strategies and conditions for the research and development of eHealth technologies. Despite their potential, the relationship between the visions on eHealth, proposed strategies, and research methods is obscure, perhaps due to a rather conceptual approach that focuses on the rationale behind the frameworks rather than on practical guidelines. In addition, the Web 2.0 technologies that call for a more stakeholder-driven approach are beyond the scope of current frameworks. To overcome these limitations, we composed a holistic framework based on a participatory development approach, persuasive design techniques, and business modeling.
Conclusions
To demonstrate the impact of eHealth technologies more effectively, a fresh way of thinking is required about how technology can be used to innovate health care. It also requires new concepts and instruments to develop and implement technologies in practice. The proposed framework serves as an evidence-based roadmap.
doi:10.2196/jmir.1672
PMCID: PMC3278097  PMID: 22155738
eHealth; design; participation; implementation; evaluation; multidisciplinary approach; Health 2.0; Wiki; e-collaboration

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