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.
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.
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.
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.
Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.
This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.
This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.
Australian New Zealand Clinical Trials Registry ACTRN012606000098538 (date registered 14/03/2006).
Clinical practice guidelines are not uniformly successful in influencing clinicians' behaviour toward best practices. Implementability refers to a set of characteristics that predict ease of (and obstacles to) guideline implementation. Our objective is to develop and validate a tool for appraisal of implementability of clinical guidelines.
Indicators of implementability were identified from the literature and used to create items and dimensions of the GuideLine Implementability Appraisal (GLIA). GLIA consists of 31 items, arranged into 10 dimensions. Questions from 9 of the 10 dimensions are applied individually to each recommendation of the guideline. Decidability and Executability are critical dimensions. Other dimensions are Global, Presentation and Formatting, Measurable Outcomes, Apparent Validity, Flexibility, Effect on Process of Care, Novelty/Innovation, and Computability. We conducted a series of validation activities, including validation of the construct of implementability, expert review of content for clarity, relevance, and comprehensiveness, and assessment of construct validity of the instrument. Finally, GLIA was applied to a draft guideline under development by national professional societies.
Evidence of content validity and preliminary support for construct validity were obtained. The GLIA proved to be useful in identifying barriers to implementation in the draft guideline and the guideline was revised accordingly.
GLIA may be useful to guideline developers who can apply the results to remedy defects in their guidelines. Likewise, guideline implementers may use GLIA to select implementable recommendations and to devise implementation strategies that address identified barriers. By aiding the design and operationalization of highly implementable guidelines, our goal is that application of GLIA may help to improve health outcomes, but further evaluation will be required to support this potential benefit.
Translating scientific evidence into daily practice is complex. Clinical guidelines can improve health care delivery, but there are a number of challenges in guideline adoption and implementation. Factors influencing the effective implementation of guidelines remain poorly understood. Understanding of barriers and facilitators is important for development of effective implementation strategies. The aim of this study was to determine perceived facilitators and barriers to guideline implementation and clinical compliance to guidelines for depression in psychiatric care.
This qualitative study was conducted at two psychiatric clinics in Stockholm, Sweden. The implementation activities at one of the clinics included local implementation teams, seminars, regular feedback and academic detailing. The other clinic served as a control and only received guidelines by post. Data were collected from three focus groups and 28 individual, semi-structured interviews. Content analysis was used to identify themes emerging from the interview data.
The identified barriers to, and facilitators of, the implementation of guidelines could be classified into three major categories: (1) organizational resources, (2) health care professionals' individual characteristics and (3) perception of guidelines and implementation strategies. The practitioners in the implementation team and at control clinics differed in three main areas: (1) concerns about control over professional practice, (2) beliefs about evidence-based practice and (3) suspicions about financial motives for guideline introduction.
Identifying the barriers to, and facilitators of, the adoption of recommendations is an important way of achieving efficient implementation strategies. The findings of this study suggest that the adoption of guidelines may be improved if local health professionals actively participate in an ongoing implementation process and identify efficient strategies to overcome barriers on an organizational and individual level. Getting evidence into practice and implementing clinical guidelines are dependent upon more than practitioners' motivation. There are factors in the local context, e.g. culture and leadership, evaluation, feedback on performance and facilitation, -that are likely to be equally influential.
Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions.
Documentation of unexplained geographic variations in medical practices and use of inappropriate interventions has led to the proliferation of clinical practice guidelines. With increased enthusiasm for guidelines, evidence exists that clinical practice guidelines often influence clinical practices or health outcomes. Their successful implementation may improve the quality of care by decreasing in appropriate variation and expediting the application of effective advances to healthcare practices. In Korea, physicians and healthcare professionals have begun to take interests in clinical practice guidelines. Currently, over 50 practice guidelines have been developed through professional academic organizations or via other routes; however, the quality of the guidelines is unsatisfactory, implementation in clinical settings is incomplete, and there is insufficient infrastructure to develop clinical practice guidelines. Korea must develop policies and invest resources to enhance the development and implementation of clinical practice guidelines.
Clinical Practice Guidelines; Evidence-Based Medicine; Healthcare Quality; Health Policy; Clinical Practice Guideline Development; Korea
Background: Heterogeneity in aspects of development, structure and context of oncology guidelines was not evaluated. We analysed and critically examined its implications.
Materials and methods: Nine cancer clinical practice guidelines were selected on the basis of popularity among oncologists. The relevant Web sites and publications on three tumours were examined and characteristics grouped in the data domains: producing organisation, methodology, guideline structure and content, implementation and evaluation and scientific agreement.
Results: ASCO, ESMO, NICE, SIGN, START, NHMRC, NCI, NCCN and CCO guidelines were examined. Development was initiated by stakeholders or authorised bodies, run by task forces with varying degrees of multidisciplinarity, with rare endorsement of external guidelines. Recommendation formulation was on the basis of evidence, shaped via interactive processes of expert review and public consultation-based modifications. Guidelines varied in comprehensiveness per tumour type, number, size, format, grading of evidence, update and legal issues. Orientation for clinic use or as reference document, end-users and binding or elective nature also varied. Standard dissemination strategies were used, though evaluation of adoption and of impact on health outcomes was implemented with considerable heterogeneity.
Conclusions: Heterogeneity in development, structure, user and end points of guidelines is evident, though necessary in order to meet divergent demands. Crucial for their effectiveness are adherence to methodological standards, a clear definition of what the guideline intends to do for whom and a systematic evaluation of their impact on health care.
cancer; clinical practice; guidelines; oncology
Clinical practice guidelines are important evidence-based resources to guide complex clinical decision making. However, it is challenging for health professionals to keep abreast available guidelines and to know how and where to access relevant guidelines. This review examines currently available guidelines for lung cancer published in the English language. Important key features are listed for each identified guideline. The methodology, approaches to dissemination and implementation, and associated resources are summarised. General challenges in the area of guideline development are highlighted. The potential to collaborate more widely across lung cancer guideline developers by sharing literature searches and assessments is discussed.
Clinical practice guidelines; clinical practice guideline development; evidence-based medicine; lung neoplasms; non-small cell lung carcinoma; small cell lung carcinoma
Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition.
This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP.
The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation.
Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009)
Important efforts have been invested in the past few years in the development of quality clinical guidelines. However, the means for the effective dissemination of guidelines to practicing physicians have not been determined. Several studies have examined the possibilities offered by the World Wide Web (the Web), but studies examining the implementation of clinical guidelines in actual practice are clearly lacking.
This study assessed the potential of the Web to implement clinical practice guidelines in actual clinical settings. It also documents the obstacles perceived by the physicians in their use of guidelines on the Internet to determine the role that the Web can play in the implementation of guidelines in practice.
Two guidelines were developed using a standardized panel method and made available via the Web. One concerned indications for low-back surgery and the other dealt with indications for upper and lower digestive endoscopies. To identify obstacles to their use in clinical practice, 20 physicians were asked to consult the guidelines during consultations with patients. Answers were collected using 3 different questionnaires.
Questionnaires were completed for consultations involving 213 patients. Less than 50% of the physicians have direct access to the Internet in their examination room. For 75%, the use of the guidelines was easy and the time required to consult them acceptable (3.4 minutes on average, or 12% of the time spent with the patient). The fear that use of such guidelines might interfere with the physician-patient relationship was mentioned as a reason for not consulting the guidelines for 27 consultations. Taking into account their experience with the Web, 75% of the physicians considered that the Web has a great or very-great potential for the dissemination of guidelines and 78% indicated that they would use such guidelines if they became generally available for clinical questions that concerned them. Only 3 physicians had consulted guidelines on the Web prior to this study.
The acceptance of use of clinical practice guidelines via the Web is high. The main limits to further use of such Web-based guidelines seem to be the lack of a computer connection in the physician's office or examining room and the fear that use of such guidelines might interfere with the physician-patient relationship. Though most participants appreciate the considerable potential of the Web for disseminating guidelines, only a small handful regularly use guidelines available on the Web. There are still numerous obstacles to the regular use of guidelines in clinical practice, some related to the physicians, others to the guidelines themselves.
Practice guidelines; Internet; decision support systems, clinical; appropriateness of care; quality of health care; back pain; laminectomy; endoscopy
In recent years the development of clinical guidelines has received increasing attention from medical educators and those involved in standard setting, and has been initiated at both central and local levels. This review article outlines the current state of knowledge with regard to clinical guideline implementation in medical practice. It deals with the main aspects of the current guideline debate, such as, clinical freedom and doctor autonomy, the importance of ownership in guideline implementation, the effectiveness of guidelines in changing practice and, in particular, the strategies needed to implement clinical guidelines in general practice. Mechanisms of behavioural change that have been recognized as being important for implementation are also discussed. If implementation strategies are not treated as an integral part of the development process then clinical guidelines may fail to achieve their potential in changing clinical practice.
The uptake of guideline recommendations in general practice can potentially be improved by designing implementation interventions that are tailored to prospectively identify barriers. However, there is insufficient evidence regarding the most effective and efficient approaches to tailoring. Our study provides an insight into the usefulness of tailored interventions to prospectively identified barriers affecting the uptake of guideline recommendations for anxiety and depressive disorders experienced by general practitioners (GPs) in their local context.
A qualitative study was conducted, in which 23 GPs gave informed consent and 14 finally participated. To explore the barriers affecting the uptake of guideline recommendations, a face-to-face interview was conducted with each GP to generate a personalised list. In response to this list, interventions were tailored to remove the barriers experienced by the GPs. To examine the perceived usefulness of the tailored interventions, telephone interviews were conducted after one year and coded through thematic coding. The analysis was descriptive in nature.
The most frequently perceived barriers were: a lack of knowledge and skills, no agreement on guideline recommendations, negative outcome expectancy, low self-efficacy, no consensus with patients, and a lack of information about treatments provided by mental health professionals, together with waiting lists. The tailored interventions ‘peer group supervision’ and ‘individualised telephone consultations’ were perceived as useful by most GPs. Besides the tailored interventions, a perceived benefit of using a self-rating scale, measuring depressive and anxiety symptoms, and the idea of delivering better patient care, were supportive in the uptake of guideline recommendations.
Our findings suggest that tailoring interventions to prospectively identified barriers, affecting the uptake of guideline recommendations for anxiety and depressive disorders, as perceived by GPs, may enhance the implementation of these guideline recommendations.
Anxiety disorders; Depressive disorders; Primary care; Implementation; Tailored interventions; Guidelines; Qualitative research
Chiropractic quality assurance involves development of both clinical guidelines and standards. Confusion generated by poor differentiation of guidelines from standards contributes to mistrust of the guideline development process. Guidelines are considered to be recommendations that allow for flexibility and individual patient differences. Standards are more binding and require a high level of supporting evidence. While guidelines serve as educational tools to improve the quality of practice, standards that outline minimum competency are used more as administrative tools on which to base policy. Barriers to development of clinical guidelines and standards include fear that they will create prescriptive “cookbook” practice, and the distrust that guidelines are developed primarily for cost containment. Clinicians also criticize guidelines developed by academics that don't relate to practice, and those based on evidence that lacks clinical relevance. Conflicting guidelines perceived to be based on strong bias or conflict of interest are also suspect. To reduce barriers to acceptance and implementation, guidelines should be inclusive, patient-centered, and based on a variety of evidence and clinical experience.
chiropractic; quality assurance; guidelines; standards; evidence-based; patient-centered; informed consent
Although considerable efforts are directed at developing international guidelines to improve clinical management in low-income settings they appear to influence practice rarely. This study aimed to explore barriers to guideline implementation in the early phase of an intervention study in four district hospitals in Kenya.
We developed a simple interview guide based on a simple characterisation of the intervention informed by review of major theories on barriers to uptake of guidelines. In-depth interviews, non-participatory observation, and informal discussions were then used to explore perceived barriers to guideline introduction and general improvements in paediatric and newborn care. Data were collected four to five months after in-service training in the hospitals. Data were transcribed, themes explored, and revised in two rounds of coding and analysis using NVivo 7 software, subjected to a layered analysis, reviewed, and revised after discussion with four hospital staff who acted as within-hospital facilitators.
A total of 29 health workers were interviewed. Ten major themes preventing guideline uptake were identified: incomplete training coverage; inadequacies in local standard setting and leadership; lack of recognition and appreciation of good work; poor communication and teamwork; organizational constraints and limited resources; counterproductive health worker norms; absence of perceived benefits linked to adoption of new practices; difficulties accepting change; lack of motivation; and conflicting attitudes and beliefs.
While the barriers identified are broadly similar in theme to those reported from high-income settings, their specific nature often differs. For example, at an institutional level there is an almost complete lack of systems to introduce or reinforce guidelines, poor teamwork across different cadres of health worker, and failure to confront poor practice. At an individual level, lack of interest in the evidence supporting guidelines, feelings that they erode professionalism, and expectations that people should be paid to change practice threaten successful implementation.
The study objective was to develop and evaluate a template for evidence-informed symptom protocols for use by nurses over the telephone for the assessment, triage, and management of patients experiencing cancer treatment-related symptoms. Guided by the CAN-IMPLEMENT© methodology, symptom protocols were developed by, conducting a systematic review of the literature to identify clinical practice guidelines and systematic reviews, appraising their quality, reaching consensus on the protocol template, and evaluating the two symptom protocols for acceptability and usability. After excluding one guideline due to poor overall quality, the symptom protocols were developed using 12 clinical practice guidelines (8 for diarrhea and 4 for fever). AGREE Instrument (Appraisal of Guidelines for Research and Evaluation) rigour domain subscale ratings ranged from 8% to 86% (median 60.1 diarrhea; 40.5 fever). Included guidelines were used to inform the protocols along with the Edmonton Symptom Assessment System questionnaire to assess symptom severity. Acceptability and usability testing of the symptom populated template with 12 practicing oncology nurses revealed high readability (n = 12), just the right amount of information (n = 10), appropriate terms (n = 10), fit with clinical work flow (n = 8), and being self-evident for how to complete (n = 5). Five nurses made suggestions and 11 rated patient self-management strategies the highest for usefulness. This new template for symptom protocols can be populated with symptom-specific evidence that nurses can use when assessing, triaging, documenting, and guiding patients to manage their-cancer treatment-related symptoms.
Accurate diagnosis is a fundamental aspect of appropriate healthcare. However, clinicians need guidance when implementing diagnostic tests given the number of tests available and resource constraints in healthcare. Practitioners of health often feel compelled to implement recommendations in guidelines, including recommendations about the use of diagnostic tests. However, the understanding about diagnostic tests by guideline panels and the methodology for developing recommendations is far from completely explored. Therefore, we evaluated the factors that guideline developers and users need to consider for the development of implementable recommendations about diagnostic tests.
Using a critical analysis of the process, we present the results of a case study using the Grading of Recommendations Applicability, Development and Evaluation (GRADE) approach to develop a clinical practice guideline for the diagnosis of Cow Milk Allergy with the World Allergy Organization.
To ensure that guideline panels can develop informed recommendations about diagnostic tests, it appears that more emphasis needs to be placed on group processes, including question formulation, defining patient-important outcomes for diagnostic tests, and summarizing evidence. Explicit consideration of concepts of diagnosis from evidence-based medicine, such as pre-test probability and treatment threshold, is required to facilitate the work of a guideline panel and to formulate implementable recommendations.
This case study provides useful guidance for guideline developers and clinicians about what they ought to demand from clinical practice guidelines to facilitate implementation and strengthen confidence in recommendations about diagnostic tests. Applying a structured framework like the GRADE approach with its requirement for transparency in the description of the evidence and factors that influence recommendations facilitates laying out the process and decision factors that are required for the development, interpretation, and implementation of recommendations about diagnostic tests.
Beneficial effects of clinical practice guidelines (CPGs) have not yet reached expectations due to limited routine adoption. Electronic distribution and reminder systems have the potential to overcome implementation barriers. Existing electronic CPG repositories like the National Guideline Clearinghouse (NGC) provide individual access but lack standardized computer-readable interfaces necessary for automated guideline retrieval. The aim of this paper was to facilitate automated context-based selection and presentation of CPGs. Using attributes from the NGC classification scheme, an XML-based metadata repository was successfully implemented, providing document storage, classification and retrieval functionality. Semi-automated extraction of attributes was implemented for the import of XML guideline documents using XPath. A hospital information system interface was exemplarily implemented for diagnosis-based guideline invocation. Limitations of the implemented system are discussed and possible future work is outlined. Integration of standardized computer-readable search interfaces into existing CPG repositories is proposed.
Practice guidelines can improve health care delivery and outcomes but several issues challenge guideline adoption, including their intrinsic attributes, and whether and how they are implemented. It appears that guideline format may influence accessibility and ease of use, which may overcome attitudinal barriers of guideline adoption, and appear to be important to all stakeholders. Guideline content may facilitate various forms of decision making about guideline adoption relevant to different stakeholders. Knowledge and attitudes about, and incentives and capacity for implementation on the part of guideline sponsors may influence whether and how they develop guidelines containing these features, and undertake implementation. Examination of these issues may yield opportunities to improve guideline adoption.
The attributes hypothesized to facilitate adoption will be expanded by thematic analysis, and quantitative and qualitative summary of the content of international guidelines for two primary care (diabetes, hypertension) and institutional care (chronic ulcer, chronic heart failure) topics. Factors that influence whether and how guidelines are implemented will be explored by qualitative analysis of interviews with individuals affiliated with guideline sponsoring agencies.
Previous research examined guideline implementation by measuring rates of compliance with recommendations or associated outcomes, but this produced little insight on how the products themselves, or their implementation, could be improved. This research will establish a theoretical basis upon which to conduct experimental studies to compare the cost-effectiveness of interventions that enhance guideline development and implementation capacity. Such studies could first examine short-term outcomes predictive of guideline utilization, such as recall, attitude toward, confidence in, and adoption intention. If successful, then long-term objective outcomes reflecting the adoption of processes and associated patient care outcomes could be evaluated.
Computer-interpretable clinical guidelines (CIGs) aim to eliminate clinician errors, reduce practice variation, and promote best medical practices by delivering patient-specific advice during patient encounters. Clinical guidelines are being regularly updated and revised to handle expanding clinical knowledge. When revising CIGs, much effort can be saved by specifying changes among versions instead of encoding revised guidelines from scratch. A representation of differences between versions could focus the process of re-implementing CIGs in a clinical environment and help users understand and embrace changes. Guideline versioning has not been adequately dealt with by existing CIG formalisms. We present three approaches for CIG versioning. Focusing on one approach, we developed a versioning tool based on version 3 of the GuideLine Interchange Format (GLIF3), and used it to represent two guideline versions for management of community-acquired pneumonia (CAP) and the changes between them.
The current clinical guidelines for the management of infertility as presented by the American Urologic Association and European Association of Urology represent consensus opinions for the management of male-factor infertility. The goal of the present study is to define the currently available guidelines for male-factor infertility, provide a rationale for why guidelines should be implemented, and review concerns and shortcomings towards their incorporation into clinical practice. Successfully integrating guidelines into clinical practice offers the potential benefit of creating a standardized, efficient, and cost-effective algorithm for the evaluation of infertility and facilitates future research. Despite their availability and ease of use, many clinicians fail to adopt clinical guidelines for numerous reasons including decreased awareness of available guidelines, insufficient time, lack of interest, and personal financial considerations. The current guidelines are limited by the inability to generalize recommendations to a heterogeneous patient sample, the lack of interdisciplinary adoption of guidelines, and the need for additional emphasis on prevention and lifestyle modifications. Future direction for the current guidelines will likely incorporate a multidisciplinary approach with increasing utilization of genetic analysis and novel treatment strategies. As the field of infertility continues to expand, the utility of guidelines combined with physician clinical judgment will remain prominent in the treatment of male-factor infertility.
Consensus; semen analysis; standard
In March of 1994, the National Institutes of Health (NIH) released guidelines mandating the inclusion of women and minorities in clinical research. Four years later, the NIH released similar guidelines mandating the inclusion of children. These “inclusion guidelines” were created to increase the representation of women, minorities and children in clinical research to address potential harms (real and perceived) created by their exclusion or omission. As designated in the guidelines, Institutional Review Board (IRB), NIH Scientific Review Groups (SRG) and NIH program staff all have responsibility for the evaluation of Principal Investigator (PI) adherence to the inclusion guidelines. The purpose of this survey was to assess the experience with and attitudes of NIH Scientific Review Group (SRG) members with the implementation of these justice-based policy recommendations.
The results of the survey identify one clear measure of success regarding the implementation of the NIH guidelines; SRG members indicate the guidelines are in part responsible for their attention to the inclusion of women, minorities and children in clinical research. In addition, SRG members believe that gender and race are important factors when assessing the diversity of study samples and that the current NIH guidelines are adequate for encouraging their inclusion. As a proxy measure of success, SRG members believe that PIs responsible for protocols reviewed by their study group are generally compliant with the inclusion guidelines. Future research ought to explore whether IRB members and NIH program officers find PIs to be compliant as their projects get underway. In addition, more research ought to be conducted to assess the downstream effects of this important social policy.
NIH Inclusion Policy; Study Section Members; Attitudes and Opinions about Implementation
Enhancing CPG acceptance and implementation can play a major role in the development and establishment of emergency medicine as a specialty in many parts of the world. A Guideline International Network special interest group established to support collaboration to improve uptake of clinical practice guidelines (CPGs) across the emergency care sector conducted an international survey to identify attributes of guideline likely to enhance their use.
A Web-based survey was undertaken to determine how CPGs were accessed, the preferred formats and attributes of guidelines, and familiarity with GRADE. The criteria used to identify preferred attributes of guidelines were adapted from the AGREE II Tool.
Two hundred six responses were received from 31 countries, 74/206 (36%) from the US, 28/206 (16%) from Canada, 17/206 (8%) from Australia and 15/206 (7%) from the UK. The majority of responses were from physicians (176/206, 85%) with 15/206 (7%) of responses from nurses and 9/206 (4%) from pre-hospital emergency services personnel. The preferred format for guidelines was clinical protocols that incorporated recommendations into workflow, and the most preferred attribute of guidelines was the clear identification of key recommendations. The results also identified that within the group that responded to the question related to GRADE, 66% were unfamiliar with this system for summarizing evidence in relationship to recommendations.
The findings provide the basis for further research to explore the most appropriate formats for guidelines or guidelines resources tailored to the needs of the emergency care providers.
The development and publication of clinical practice guidelines for acute low-back pain has resulted in evidence-based recommendations that have the potential to improve the quality and safety of care for acute low-back pain. Development and dissemination of guidelines may not, however, be sufficient to produce improvements in clinical practice; further investment in active implementation of guideline recommendations may be required. Further research is required to quantify the trade-off between the additional upfront cost of active implementation of guideline recommendations for low-back pain and any resulting improvements in clinical practice.
Cost-effectiveness analysis alongside the IMPLEMENT trial from a health sector perspective to compare active implementation of guideline recommendations via the IMPLEMENT intervention (plus standard dissemination) against standard dissemination alone.
The base-case analysis suggests that delivery of the IMPLEMENT intervention dominates standard dissemination (less costly and more effective), yielding savings of $135 per x-ray referral avoided (-$462.93/3.43). However, confidence intervals around point estimates for the primary outcome suggest that – irrespective of willingness to pay (WTP) – we cannot be at least 95% confident that the IMPLEMENT intervention differs in value from standard dissemination.
Our findings demonstrate that moving beyond development and dissemination to active implementation entails a significant additional upfront investment that may not be offset by health gains and/or reductions in health service utilization of sufficient magnitude to render active implementation cost-effective.
Health care practice based on research evidence requires that evidence is synthesised, and that recommendations based on this evidence are implemented. It also requires an intermediate step: translating synthesised evidence into practice recommendations. There is considerable literature on evidence synthesis and implementation, but little on how guideline development groups (GDGs) produce recommendations. This is a complex process, with many influences on communication and decision-making, e.g., the quality of evidence, methods of presentation, practical/resource constraints, individual values, professional and scientific interests, social and psychological processes. To make this process more transparent and potentially effective, we need to understand these influences. Psychological theories of decision-making and social influence provide a framework for this understanding.
This study aims to investigate the processes by which GDGs formulate recommendations, drawing on psychological theories of decision-making and social influence. The findings will potentially inform the further evolution of GDG methods, such as choice of members and procedures for presenting evidence, conducting discussion and formulating recommendations.
Longitudinal observation of the meetings of three National Institute of Health and Clinical Excellence (NICE) GDGs, one from each of acute, mental health and public health, will be tape recorded and transcribed. Interviews with a sample of GDG members at the beginning, middle, and end of the GDG's work will be recorded and transcribed. Site documents including relevant e-mail interchanges, GDG meeting minutes, and stakeholders' responses to the drafts of the recommendations will be collected. Data will be selected for analysis if they refer to either evidence or recommendations; the focus is on "hot spots", e.g., dilemmas, conflicts, and uncertainty. Data will be analysed thematically and by content analysis, drawing on psychological theories of decision-making and social influence.
The Clinical Pharmacogenetics Implementation Consortium (CPIC) publishes genotype-based drug guidelines to help
clinicians understand how available genetic test results could be used to optimize drug therapy. CPIC has focused initially on well-known
examples of pharmacogenomic associations that have been implemented in selected clinical settings, publishing nine to date. Each CPIC
guideline adheres to a standardized format and includes a standard system for grading levels of evidence linking genotypes to phenotypes
and assigning a level of strength to each prescribing recommendation. CPIC guidelines contain the necessary information to help
clinicians translate patient-specific diplotypes for each gene into clinical phenotypes or drug dosing groups. This paper reviews the
development process of the CPIC guidelines and compares this process to the Institute of Medicine’s Standards for Developing Trustworthy
Clinical Practice Guidelines.
Clinical practice guideline; guideline; pharmacogenetics; pharmacogenomics.