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Evaluating the quality of clinical practice guidelines
Abstract
To review and identify established methods for evaluating the quality of practice guidelines and to use a selected assessment tool to assess 2 chiropractic practice guideline documents.
A search of the medical literature was performed to identify current methods and procedures for practice guideline evaluation. Two chiropractic practice guideline documents, Vertebral Subluxation in Chiropractic Practice (CCP) and Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy) were then independently evaluated for validity by 10 appraisers using the identified appraisal tool. The appraisal scores were tabulated, and consensus appraisals were generated for the CCP and Mercy guideline documents.
The "Appraisal Instrument for Clinical Guidelines" (Cluzeau instrument) was identified as a reliable and valid method of guideline evaluation. The result of the application of this appraisal tool in the assessment of the CCP and Mercy guideline documents was that the former scored notably lower than the latter. On the basis of the results of the guideline appraisals, the CCP document is not recommended, and its guidelines are not considered suitable for application in chiropractic practice. The Mercy guidelines are recommended for application in chiropractic practice, with the proviso that new scientific data should be considered.
The literature reviewed suggests that professional organizations or groups should undertake a critical review of guidelines using available critical guideline appraisal tools. Guideline validity appraisal should be done before acceptance by the chiropractic profession. To avoid unwarranted utilization of poorly constructed guidelines, it is strongly recommended that all future guidelines be reviewed for validity and scientific accuracy with the findings published in a medically indexed journal before they are adopted by the chiropractic community.
... Thus, the field of guidelines development is a complex and confusing arena with high expectations, competing organizations, conflicting philosophies, and ill-defined or incompatible objectives (7,(22)(23)(24)(25)(26)(59)(60)(61)(62)(63)77,80,97,158,(172)(173)(174). The field of guidelines suffers from imperfect and incomplete scientific knowledge, as well as imperfect and uneven means of applying that knowledge. ...
... Despite the good intentions of many involved organizations and parties, guidelines development continues to lack clearly articulated goals, coherent structure, and credible mechanisms for evaluating, improving, and coordinating guidelines development to meet social needs for high quality, affordable health care. Substantial guidance has been provided for the critical appraisal of evidence to prepare guidelines (172,(175)(176)(177)(178). Standardized approaches have also been developed to evaluate the development and validity of guidelines (148,173,. However, the results of evaluations of various guidelines have been less than optimal (60-63,179). ...
... The literature available in assisting guideline preparation is extensive (3,173,179,182,(184)(185)(186)190,196,(241)(242)(243)(244). Table 10 illustrates the essential components required for guideline development which has been derived from various commonly used evaluation instruments (AGREE, AMA, IOM, and Shaneyfelt et al's criteria) (3,179,190,196). ...
Practice guidelines are systematically developed statements to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances. Clinical practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatment. In November 1989, Congress mandated the creation of the Agency for Healthcare Policy and Research (AHCPR). AHCPR was given broad responsibility for supporting research, data development, and related activities. Associated with this mandate, the National Academy of Sciences published a document indicating that guidelines are expected to enhance the quality, appropriateness, and effectiveness of health care services. Guidelines as a whole have been characterized by multiple conflicts in terminology and technique. These conflicts are notable for the confusion they create and for what they reflect about differences in values, experiences, and interest among different parties. Despite this confusion, public and private development of guidelines is growing exponentially. There are only limited means to coordinate these guidelines in order to resolve inconsistencies, fill in gaps, track applications and results, and assess the soundness of individual guidelines. Significant diversity exists in clinical practice guidelines. The inconsistency amongst guidelines arises from variations in values, tolerance for risks, preferences, expertise, and conflicts of interest. In 2000, the American Society of Interventional Pain Physicians (ASIPP) first created treatment guidelines to help practitioners. There have been 4 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance, dispel misconceptions among providers and patients, manage patient expectations reasonably, and form the basis of a therapeutic partnership between the patient, the provider, and payors. The ASIPP guidelines are based on evidence-based medicine (EBM). EBM is in turn based on 4 basic contingencies: the recognition of the patient’s problem and the construction of a structured clinical question; the ability to efficiently and effectively search the medical literature to retrieve the best available evidence to answer the clinical question; clinical appraisal of the evidence; and integration of the evidence with all aspects of the individual patient’s decision-making to determine the best clinical care of the patient. Evidence synthesis for guidelines includes the review of all relevant systematic reviews and individual articles, grading them for relevance, methodologic quality, consistency, and recommendations. Key words: Evidence-based medicine, clinical practice guidelines, critical appraisal, guideline development, interventional pain management, interventional techniques, evidence synthesis, clinical relevance, grading recommendations, systematic reviews
... Systematic reviews, such as Cochrane reviews, provide such summaries of the medical literature (45,46). Clinical guidelines go one step farther, providing recommendations for care based on the evidence summarized in systematic reviews (40,45,47,48). According to Cape and Barkham (41, p. 290), "guidelines set out the specific clinical processes that will lead to optimal outcomes for the specific circumstances." ...
... The development of clinical practice guidelines is a significant undertaking in terms of both time and money (41,(51)(52)(53); one report showed development costs of $200,000 per guideline in the United States (54). Historically, guidelines were developed based on expert opinion (48,54); however guideline development has evolved into a process that is based on systematic reviews of evidence reported in the medical literature (41,48,54). Guidelines typically include practice recommendations based on both scientific evidence and expert opinion when there are not formal studies available (47,55). ...
... The development of clinical practice guidelines is a significant undertaking in terms of both time and money (41,(51)(52)(53); one report showed development costs of $200,000 per guideline in the United States (54). Historically, guidelines were developed based on expert opinion (48,54); however guideline development has evolved into a process that is based on systematic reviews of evidence reported in the medical literature (41,48,54). Guidelines typically include practice recommendations based on both scientific evidence and expert opinion when there are not formal studies available (47,55). ...
... The field of guidelines development is a complex and confusing arena with high expectations, competing organizations, conflicting philosophies, and illdefined or incompatible objectives (1,(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27). Further, the field of guidelines suffers from imperfect and incomplete scientific knowledge as well as imperfect and uneven means of applying that knowledge. ...
... The American Medical Association (AMA), the Institute of Medicine (IOM), Canadian Medical Association (CMA), and Agency for Healthcare Research and Quality (AHRQ) have all formulated methodology for developing scientifically sound guidelines. Standardized approaches have also been developed to evaluate the development and validity of guidelines (24,25,(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41). In fact, the results of evaluation of various guidelines have been less than optimal. ...
... For domain 1, scope and purpose, the ACOEM guidelines chronic pain chapter (4) received a total score of 69.44%, whereas it was 77.78% for the low back pain chapter (3) with an average score of 73.61%. These scores were similar to Cates et al (24) with a mean domain score of 79.63%. All the appraisers agreed that the overall objectives of the guidelines, clinical questions covered by the guidelines, and to whom the guidelines were meant to apply, were described, with some ambiguity. ...
Today, with the growing interest of the medical community and others in practice guidelines, there is greater emphasis on formal procedures and methods for arriving at a widely scrutinized and endorsed consensus than ever before. Conflicts in terminology and technique are notable for the confusion that guidelines create and for what they reflect about differences in values, experiences, and interests among different parties. While public and private development activities continue to multiply, the means for coordinating these efforts to resolve inconsistencies, fill in gaps, track applications and results, and assess the soundness of particular guidelines continue to be limited. In this era of widespread guideline development by private organizations, the American College of Occupational and Environment Medicine (ACOEM) has developed guidelines that evaluate areas of clinical practice well beyond the scope of occupational medicine and yet fail to properly involve physicians expert in these, especially those in the field of interventional pain management. As the field of guidelines suffers from imperfect and incomplete scientific knowledge as well as imperfect and uneven means of applying that knowledge without a single or correct way to develop guidelines, ACOEM guidelines have been alleged to hinder patient care, reduce access to interventional pain management procedures, and transfer patients into a system of disability, Medicare, and Medicaid.
To critically appraise occupational medicine practice guidelines for interventional pain management by an independent review utilizing the Appraisal of Guidelines for Research and Evaluation (AGREE), American Medical Association (AMA), Institute of Medicine (IOM), and other commonly utilized criteria.
Revised chapters of ACOEM guidelines, low back pain and chronic pain, developed in 2007 and 2008 are evaluated, utilizing AGREE, AMA, IOM instruments, and Shaneyfelt et al's criteria, were independently reviewed by 4 appraisers.
Critical appraisal utilizing the AGREE instrument found that both chapters scored less than 10% in 3 of the 6 domains, less than 20% in one domain, over 30% in one domain, and over 70% in one domain. Global assessment also scored below 30% with a recommendation from AGREE, "not recommended or suitable for use in practice." Based on AMA key attributes, both chapters of ACOEM guidelines met only one of the 6 key attributes, only 3 of the 8 attributes were met by IOM criteria, and based on the criteria described by Shaneyfelt et al, overall only 28% of criteria were met.
Both the low back pain and chronic pain chapters of the ACOEM guidelines may not be ideal for clinical use based on the assessment by the AGREE instrument, AMA attributes, and criteria established by Shaneyfelt et al. They also scored low on IOM criteria (37.5%). These guidelines may not be applicable for clinical use.
... Thus, the field of guidelines development is a complex and confusing arena with high expectations, competing organizations, conflicting philosophies, and ill-defined or incompatible objectives (7,(22)(23)(24)(25)(26)(59)(60)(61)(62)(63)77,80,97,158,(172)(173)(174). The field of guidelines suffers from imperfect and incomplete scientific knowledge, as well as imperfect and uneven means of applying that knowledge. ...
... Despite the good intentions of many involved organizations and parties, guidelines development continues to lack clearly articulated goals, coherent structure, and credible mechanisms for evaluating, improving, and coordinating guidelines development to meet social needs for high quality, affordable health care. Substantial guidance has been provided for the critical appraisal of evidence to prepare guidelines (172,(175)(176)(177)(178). Standardized approaches have also been developed to evaluate the development and validity of guidelines (148,173,. However, the results of evaluations of various guidelines have been less than optimal (60-63,179). ...
... The literature available in assisting guideline preparation is extensive (3,173,179,182,(184)(185)(186)190,196,(241)(242)(243)(244). Table 10 illustrates the essential components required for guideline development which has been derived from various commonly used evaluation instruments (AGREE, AMA, IOM, and Shaneyfelt et al's criteria) (3,179,190,196). ...
Practice guidelines are systematically developed statements to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances. Clinical practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatment. In November 1989, Congress mandated the creation of the Agency for Healthcare Policy and Research (AHCPR). AHCPR was given broad responsibility for supporting research, data development, and related activities. Associated with this mandate, the National Academy of Sciences published a document indicating that guidelines are expected to enhance the quality, appropriateness, and effectiveness of health care services. Guidelines as a whole have been characterized by multiple conflicts in terminology and technique. These conflicts are notable for the confusion they create and for what they reflect about differences in values, experiences, and interest among different parties. Despite this confusion, public and private development of guidelines is growing exponentially. There are only limited means to coordinate these guidelines in order to resolve inconsistencies, fill in gaps, track applications and results, and assess the soundness of individual guidelines. Significant diversity exists in clinical practice guidelines. The inconsistency amongst guidelines arises from variations in values, tolerance for risks, preferences, expertise, and conflicts of interest. In 2000, the American Society of Interventional Pain Physicians (ASIPP) first created treatment guidelines to help practitioners. There have been 4 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance, dispel misconceptions among providers and patients, manage patient expectations reasonably, and form the basis of a therapeutic partnership between the patient, the provider, and payors. The ASIPP guidelines are based on evidence-based medicine (EBM). EBM is in turn based on 4 basic contingencies: the recognition of the patient's problem and the construction of a structured clinical question; the ability to efficiently and effectively search the medical literature to retrieve the best available evidence to answer the clinical question; clinical appraisal of the evidence; and integration of the evidence with all aspects of the individual patient's decision-making to determine the best clinical care of the patient. Evidence synthesis for guidelines includes the review of all relevant systematic reviews and individual articles, grading them for relevance, methodologic quality, consistency, and recommendations.
... 4 In recent years, the creation of various clinical guidelines for different topics has grown a lot. 5 So that currently these CPGs exist in almost all aspects of clinical practice and health policy. In fact, the main goal of these clinical guidelines is to increase the practical use of the results obtained from the research. ...
... 6 Due to the large number of clinical guides in different subjects, medical doctors and researchers who intend to use these clinical guides will be lost in choosing a good clinical guideline. 5 On the other hand, venous thromboembolism (VTE), which consists of two components, deep vein thrombosis and pulmonary embolism, is a life-threatening complication after surgeries and the most common cause of death during the first 30 days after surgeries. 7 Considering that the risk of VTE occurrence can be reduced through medical and clinical prophylaxis, 8 the way of management and the importance of using prophylaxis of VTE in urological surgeries are noticable. ...
Background and Aims
Venous thromboembolism (VTE) is the most common cause of death during the first 30 days after surgery. There is not any study which critically evaluated clinical guidelines related to VTE prophylaxis in urological surgeries. Therefore, in this study, we decided to evaluate related clinical guidelines using the AGREE II instrument to take a positive step towards improving the care of these patients.
Methods
The latest version of all available clinical guidelines related to the topic of VTE prophylaxis in urological surgeries until 2021 was searched. Four appraisers, including one urologist, one cardiologist, one epidemiologist, and one MD who had prior knowledge of working with the AGREE II tool and international articles in this field appraised selected clinical guidelines. Using the AGREE II review tool, clinical guidelines were critically evaluated. Then, the score of six domains of AGREE II for each guideline was calculated and compared with each other, and the relationship between the domains was measured by Kendall's correlation test. To determine the reliability of the test, interclass correlation coefficients were calculated for all indicators.
Results
Items were rated on a 7‐point scale from 1 (strongly disagree) to 7 (strongly agree). NICE, CHEST, and EAU guidelines obtained the highest scores from the Overall Assessment criteria by scoring 6, 5.75, and 5.25, respectively. There was only a correlation between the score of Overall Assessment criterion with “Applicability” domain, with Kendall's correlation coefficient of 0.867 and p = 0.015. The domains of “Clarity and presentation” and “Scope and purpose” obtained the highest standardized scores by getting 84.49% and 75.69%, respectively, and “Applicability” with 30.04% obtained the lowest standardized score.
Conclusion
In this study, NICE, CHEST, and EAU guidelines are suggested as clinical guidelines by obtaining the highest scores from Overall Assessment criterion.
... For the selection, particularly, we constructed an evaluation framework of all the selected abstracts as a type of applied active research [57], starting from the text analysis [58]. The text analysis of the abstracts was run by two different evaluators providing double-blind scoring (adapted from [59,60]) about aspects deductively and logically identified on the four main themes of the research: (i) CVD, (ii) physical activities, (iii) m-health, and (iv) co-production. The two evaluators scored, separately, all the documents, giving, for each theme, a score from 1 (low adherence) to 5 (high adherence), according to the relevance of the presence of the evaluated thematic within the abstract [61,62]. ...
... A last limitation concerns the internal coding we adopted in the double-blind scoring of the assessment of abstracts for the inclusion of documents for the conceptual analysis. Although based on a rigorous scoring process (extracted by the adaptation of previous research [59,60] and agreeing upon common grading rules [61,62]), this method is, in some sense, original and designed for our research aims; thus, it has not been tested in any previous research. ...
Background
Cardiovascular disease (CVD) is the first cause of death globally, with huge costs worldwide. Most cases of CVD could be prevented by addressing behavioural risk factors. Among these factors, there is physical and amateur sports activity (PASA), which has a linear negative correlation with the risk of CVD. Nevertheless, attempts to encourage PASA, as exercise prescription programmes, achieved little impact at the community-wide level. A new frontier to promote PASA is represented by mobile health tools, such as exergaming, mobile device apps, health wearables, GPS/GIS and virtual reality. Nevertheless, there has not yet been any evident turnabout in patient active involvement towards CVD prevention, and inactivity rates are even increasing. This study aims at framing the state of the art of the literature about the use of m-health in supporting PASA, as a user-centric innovation strategy, to promote co-production health policies aiming at CVD prevention.
Methods
A mixed-method systematic literature review was conducted in the fields of health and healthcare management to highlight the intersections between PASA promotion and m-health tools in fostering co-produced services focused on CVD prevention. The literature has been extracted by the PRISMA logic application. The resulting sample has been first statistically described by a bibliometric approach and then further investigated with a conceptual analysis of the most relevant contributions, which have been qualitatively analysed.
Results
We identified 2,295 studies, on which we ran the bibliometric analysis. After narrowing the research around the co-production field, we found 10 papers relevant for the concept analysis of contents. The interest about the theme has increased in the last two decades, with a high prevalence of contributions from higher income countries and those with higher CVD incidence. The field of research is highly multi-disciplinary; most of documents belong to the medical field, with only a few interconnections with the technology and health policy spheres. Although the involvement of patients is recognized as fundamental for CVD prevention through PASA, co-design schemes are still lacking at the public management level.
Conclusions
While the link between the subjects of motor activity, medicine and technology is clear, the involvement of citizens in the service delivery process is still underinvestigated, especially the issue concerning how “value co-creation” could effectively be applied by public agencies. In synthesis, the analysis of the role of co-production as a system coordination method, which is so important in designing and implementing preventive care, is still lacking.
... This creates the need to internationally define acknowledged criteria for their assessment 14 . This has led to standardized instruments for assessing the development and validity of clinical guidelines 15,16,17,18 , including the Appraisal of Guidelines for Research & Evaluation (AGREE II) instrument 16 . ...
... Domain (4), "clarity of presentation", assesses whether the different options for approaching the health condition or problem are clearly presented, and more specifically whether the recommendations are clear, unambiguous, and easily identifiable. This domain has three items (15)(16)(17) and maximum score per appraiser is 21. Domain (5), "applicability", discusses facilitators and barriers for implementation of recommendations, strategies to improve application, and the necessary resources for such. ...
There are various guidelines for the treatment of obesity, and thus the quality of these clinical guidelines has become a matter of concern. The objective was to describe and assess the quality of clinical guidelines for treatment of obesity in adults. We collected several studies, dated from 1998 to 2016, produced by different countries. The literature search included the National Guideline Clearinghouse (NGC), Guidelines International Network (GIN), PubMed (MEDLINE), Scopus, Web of Science, webpages of health institutions from different countries, and search sites, with the criterion: "clinical guidelines for treatment of obesity in adults and published until the 2016". The guidelines were assessed with the Appraisal of Guidelines for Research & Evaluation (AGREE II), according to the domains of the instrument. The search identified 21 guidelines: nine from Europe, six from North America, three from Latin America, and one each from Asia and Oceania and a transnational association. The Australian guideline had the best assessment. Of the six guidelines with the highest scores, five had been elaborated by the government sector responsible for the country's health. The domains "scope and purpose" and "clarity of presentation" had the highest score. Except for the Canadian guideline, the three guidelines drafted before the elaboration of AGREE II had the worst quality. In the domain "stakeholder involvement", only four guidelines (Australia, Scotland, France, and England) mentioned patient participation. Guideline development and quality enhancement are ongoing processes requiring systematic appraisal of the guideline production process and existing guidelines.
... These are all the limitations of this study. . Of all these instruments, a study showed that The Cluzeau instrument was the most well developed and had been tested and described as a reliable and valid method of guideline evaluation [12]. ...
... Based on the Cluzeau instrument, AGREE instrument was developed [12]. Up to now, it is the only guidelines instrument to have undergone extensive international validity assessment [13]. ...
The work of developing clinical practice guidelines began just a little more than ten years ago in China. Up to now, there have been few studies about them.
To review and analyze the status of Chinese clinical practice guidelines in 1997–2007.
All Chinese guidelines from 1997–2007 were collected, and made a regression analysis, and a citation analysis for evaluating the impact of guidelines. To analyze the developing quality, the most influential guidelines were evaluated with AGREE instrument, and each guideline was evaluated to check for any updating. In order to analyze the objective and target population, all guidelines were classified and counted separately according to disease/symptom center, and whether towards specialists or general practitioners.
143 guidelines were collected. An exponential function equation was established for the trend in the number of guidelines. The immediacy index in every year was very low while the average citation rate was not. Both the percentages of highly cited and never cited were high. For the evaluation with AGREE, only the average score of clarity and presentation was high (89.9%); the remaining were much lower. Editorial independence scored 0. Only 27 (18.9%) of 143 guidelines, were found to be evidence-based. Only a few had ever been updated, with an average updating interval of 5.2 years. Only 2.1% were symptom-centered, and only 4.2% were aimed at general practitioners.
Much progress has been obtained for Chinese guidelines development. However, there were still defects, and greater efforts should be made in the future.
... The AGREE Instrument is a generic tool developed by the AGREE Collaboration in 1998. It has been previously assessed as being reliable and valid for the purpose of guideline evaluation, and has been subjected to extensive evaluation (AGREE Collaboration, 2010;Cates et al., 2001;Goergen et al., 2010;Hannes et al., 2005;Leach & Segal, 2010). ...
The management of invasive fungal disease (IFD) in the haemato-oncology setting remains a challenge. This article reviews recent guidelines relating to IFD for their similarities and differences, as well as applying the Appraisal of Guidelines Research and Evaluation (AGREE) criteria. The guidelines' recommendations on antifungal prophylaxis, empirical and definitive treatment of candidiasis and aspergillosis are summarized; also, minimum standards for diagnosis and follow-up are discussed. This critique of the reviewed guidelines is a practical guide to physicians and commissioners in making local policies for IFD management.
... In response, the straights have developed their own guidelines, known as the "Wyndham Guidelines." Despite this, an independent review recently validated the process and recommended that the Mercy Guidelines be applied, with the proviso that new scientific data should be considered, as the Guidelines themselves recommend (Cates et al. 2001). The controversy that these various guidelines has caused is indicative of the challenges that the profession faces in presenting a credible face to the public. ...
Chiropractic is the best established of the alternative health care professions. Although marginalized for much of the 20th century, it has entered the mainstream of health care, gaining both legitimacy and access to third-party payers. However, the profession's efforts to validate the effectiveness of spinal manipulative therapy, its principal modality, have yielded only modest and often contrary results. At the same time, reimbursement is shrinking, the number of practitioners is growing, and competition from other healing professions is increasing. The profession's efforts to establish a role in primary care are meeting resistance, and its attempts to broaden its activities in alternative medicine have inherent limitations. Although patients express a high level of satisfaction with chiropractic treatment and politicians are sympathetic to it, this may not be enough as our nation grapples to define the health care system that it can afford.
... 169 Independent assessment of 3 of these chiropractic guidelines concluded that neither the CCP nor the ICA alternatives were suitable for utilization in chiropractic practice, whereas the Mercy guidelines were recommended for application in chiropractic practice, with the provision that new scientific data should be considered. 170,171 The different premises on which chiropractic guidelines are established may derive from a longstanding ideological debate among chiropractors regarding the identity of chiropractic. [172][173][174][175] Mootz 176 proposes that chiropractic institutions and organizations focus on an evidence-based and best practice-oriented research priority, constructive engagement of the greater health care system, and successful ethical business models. ...
Imaging technology can improve patient outcomes by allowing greater precision in diagnosing and treating patients. However, there is evidence that overuse, underuse, and misuse of imaging services occur. The purpose of this project was to develop evidence-based diagnostic imaging practice guidelines for musculoskeletal complaints for use by doctors of chiropractic and other primary health care professionals.
An electronic search of the English and French language literature (phase 1) was conducted on several databases. Cross references, and references provided by clinicians, were also used. Independent assessment of the quality of the citations used to support recommendations in the guidelines was performed using the QUADAS, the AGREE,and the SPREAD evaluation tools. A first draft of a diagnostic imaging practice guideline was produced, using the European Commission's Referral Guidelines for Imaging document as a template. Results were sent to 12 chiropractic specialists for a first external review. A modified Delphi process, including 149 international experts, was used to generate consensus on recommendations for diagnostic imaging studies. The reliability of proposed recommendations was further tested on field chiropractors and on a group of specialists both in chiropractic and in medicine in both Canada and the United States. All recommendations were graded according to the strength of the evidence.
The research procedure resulted in the recommendations for diagnostic imaging guidelines of adult extremity and spine disorders supported by more than 685 primary and secondary citations. High levels of agreement among Delphi panelists were reached for all proposed recommendations. Comments received by specialists were generally very favorable and reflected high levels of agreement with the proposed recommendations, perceived ease of use of guidelines, and implementation feasibility.
These evidence-based diagnostic imaging practice guidelines are intended to assist chiropractors and other primary care providers in decision making on the appropriate use of diagnostic imaging for specific clinical presentations. In all cases, the guidelines are intended to be used in conjunction with sound clinical judgment and experience. Application of these guidelines should help avoid unnecessary radiographs, increase examination precision,and decrease health care costs without compromising the quality of care. All guidelines are documents to be refined and modified regularly with new information and experience.
Background and Purpose. Osteoarthritis (OA) affects a large and growing proportion of the population. The purpose of this project was to create guidelines for the use of therapeutic exercises and manual therapy in the management of adult patients (> 18 years of age) with a diagnosis of CIA. All stages of the disease were included in the analysis, and studies of patients who had recent surgery or other rheumatologic, musculoskeletal, or spinal problems or of subjects without known pathology or impairments Were excluded. Methods: The Ottawa Methods Group used Cochrane Collaboration methods to find and synthesize evidence from comparative controlled trials and then asked stakeholder groups to nominate representatives to serve on a panel of experts. The Ottawa Panel agreed on criteria for grading the strength of the recommendations and their supporting evidence. Of the 609 potential articles on therapeutic exercises for CIA that were identified, 113 were considered potentially relevant, and 26 randomized controlled trials and controlled clinical trials were ultimately used. Results. Sixteen positive recommendations of clinical benefit were developed fortherapeutic exercises, especially strengthening exercises and general physical activity, particularly for the management of pain and improvement of functional status. Manual therapy combined with exercises also is recommended in the management of patients with OA. Discussion and Conclusion. The Ottawa Panel recommends the use of therapeutic exercises alone, or combined with manual therapy, for managing patients with CIA. There were a total of 16 positive recommendations: 13 grade A and 3 grade C+. The Ottawa Panel recommends the use of therapeutic exercises because of the strong evidence (grades A, B, and C+) in the literature.
Les guides sont considérés comme un outil important au niveau du transfert des connaissances. Ils permettent une organisation et une mise en forme opérationnelle des connaissances pour que les milieux puissent se les approprier. Les guides sont un outil de relais, par ailleurs ciblés par l'axe en transfert de connaissances du Réseau de recherche en santé et sécurité au travail du Québec en tant qu'enjeu important voire central en SST. À cet égard, le sujet d'intérêt particulier est l'utilisation et l'appropriation des guides. D'après l'enquête de Laroche (2009), menée auprès de chercheurs canadiens en santé et sécurité au travail (SST), le tiers avait été impliqué au cours des cinq dernières années dans l'élaboration d'un guide.
C'est dans ce contexte qu'a surgi au sein de cette équipe une première question simple : Sait-on ce qu'est un bon guide et comment l'évaluer? Existe-t-il une grille ou des critères d'évaluation qui nous permettraient de poser un premier diagnostic sur un guide ? Les questions corollaires étaient : Que sait-on sur leur utilisation et leur appropriation ? Ont-ils les impacts escomptés ?
Les guides en SST ayant été l'objet de peu de recherches, notre bilan de connaissances s'est rapidement orienté vers d'autres domaines, où rapidement, l'importance des travaux menés en santé s'est imposée. En effet, tant la production de guides de pratique clinique que le nombre de recherches menées sur le sujet ont crû de façon spectaculaire au cours des deux dernières décennies. Nous nous y sommes donc arrêtés, avec pour objectif d'en saisir autant la logique que la cohérence, afin de mieux en comprendre les développements et les questionnements.
Cependant, faire une revue exhaustive des écrits, vu leur ampleur, était irréaliste. Nous avons plutôt opté pour une démarche visant à dégager des points de repère qui pourraient être utiles aux acteurs en SST quant au développement des guides, à leur évaluation et à leur implantation. Deux grands axes de recherche et de développement s'y côtoient et s'entremêlent. Le premier axe est centré sur l'objet lui-même, le guide : comment les développer, les évaluer, les implanter? Le second axe est centré sur son utilisateur : Quel usage en fait-il ? Qu'en pense-t-il? Que recherche-t-il ?
Suite à cette revue des écrits, un premier constat a été l'importance de l'implication des organisations publiques, voire des États, dans le développement des guides, ces derniers voyant les guides de pratique comme une pierre angulaire des politiques de santé. Les guides pourraient en améliorer la performance en favorisant l'implantation de ce qu'on appelle evidence-based medicine, une médecine fondée sur des preuves obtenues de façon rigoureuse. Dans les années qui ont suivi le début de l'élaboration de guides de pratique en santé, des groupes de travail nationaux ont été mis en place - essentiellement dans les pays anglophones - pour statuer et élaborer des règles de développement dont le coeur est le tri et l'évaluation des preuves. En fait, fondamentalement, les guides de pratique sont des regroupements d'énoncés, de directives. En anglais, on parle de clinical pratical guidelines. Cela est compréhensible en santé, mais sans doute moins approprié en SST, où les guides de pratique (et pratiques) ont un sens plus large. Certains organismes internationaux, comme le Bureau International du Travail, commencent cependant à adopter cette perspective de guidelines.
Globalement, le développement des guides de pratique est abordé de façon très méthodologique dans le domaine de la santé, le déroulement de chaque étape étant soigneusement défini.
Cependant, nous n'avons pas trouvé – c'est une critique qui leur est adressée aussi – d'études montrant que les guides de pratique ainsi conçus sont de meilleure qualité. Les études de suivi menées auprès des développeurs de guides de pratique montrent aussi que les règles préconisées ne sont que bien partiellement adoptées, les procédures étant considérées trop lourdes et trop coûteuses à mettre en place. Les guides sont aussi avant tout développés par des professionnels qui en font une spécialité. Cette approche professionnalisante ne nous apparaît pas convenir à la SST.
Quant aux outils d'évaluation des guides développés en santé, ils suivent en fait la même logique ; ils évaluent essentiellement le processus de développement du guide, ou du moins, sa description. L'application de ces outils montre que les guides développés n'y satisfont que bien partiellement. Le reproche précédent signalé demeure : les outils évaluent le processus de développement, ce qui en est décrit en fait, et non la qualité elle-même. Nous n'avons donc pas trouvé de réponse satisfaisante à notre première question : si on ouvre un guide, y a-t-il un instrument qui permette d'évaluer son contenu, sa structure, son organisation, etc ? Ceci dit, les questions posées par ces recherches et les résultats obtenus sont riches d'enseignements pour la SST ; ils nous ont aidés à situer nos propres enjeux et perspectives, qui sont progressivement exposés dans ce rapport.
De façon générale, nos travaux ont révélé que trois grandes critiques sont adressées aux guides (directives) : ils ne prennent pas suffisamment en compte l'ensemble des éléments (ne sont pas suffisamment systémiques) ; ils ne collent pas suffisamment au processus de décision du praticien (ils sont construits sur une logique de résolution de problèmes); ils ne cadrent pas suffisamment avec le fait que chaque patient est une entité spécifique (et non un ensemble ou un patient moyen). Ces critiques remettent en partie en question le processus d'élaboration des connaissances. Les questions soulevées et leurs débats sont tout à fait pertinents au domaine de la SST.
D'autre part, les études menées auprès des utilisateurs montrent que ces derniers souscrivent aux efforts de rationalisation, mais les suivis d'utilisation montrent que les recommandations ne sont pas appliquées au niveau attendu. La raison première n'est pas que les gens n'y adhèrent pas, ni qu'ils les méconnaissent. Ce serait plutôt que les conditions d'application, les contextes et les efforts à investir y font obstacle. Les utilisateurs redoutent aussi toute approche coercitive qui pourrait se substituer à leur jugement. Au vu des efforts investis, ces résultats sont considérés comme décevants. Les études d'impact confirment par ailleurs que les effets attendus n'ont pas été au rendez-vous.
Ceci a amené les chercheurs à se pencher plus sur la question de l'implantation et à chercher à mieux comprendre ce qui fait obstacle ou au contraire favorise l'utilisation des guides de pratique, reconnaissant que trop peu d'efforts avaient été consacrés à cette question. Nous en retenons trois résultats clés: la possibilité de voir (ex. quelqu'un utiliser le guide, ce que cela donne, les bénéfices), de disposer de conditions adéquates (ex. ressources humaines et matérielles, organisation, support) et l'effort à consentir.
Enfin, au niveau de l'implantation, l'ensemble des études menées montre que les moyens passifs comme la diffusion de matériel sont peu efficaces et qu'il faut élaborer un plan d'implantation combinant des moyens. Cependant, aucune des synthèses effectuées sur la question ne met en évidence de moyens ou combinaisons foncièrement efficaces. Les impacts demeurent au mieux modestes. Nous en concluons qu'aucune stratégie d'implantation n'aura de succès si le contenu des guides ne correspond pas suffisamment à leurs conditions d'application.
Il nous apparaît ainsi central d'intégrer les questions d'implantation au processus de développement lui-même, non pas comme une étape finale, mais tout au long du processus. Et bien que l'ensemble des résultats mentionnés montre que statuer sur une méthode d'élaboration ne soit pas un gage de succès, le processus de développement demeure quant à nous une clé importante. Dans ce processus, le coeur devrait cependant en être moins celui de l'identification des preuves à traduire en directives que celui de l'identification des personnes porteuses d'un savoir pertinent aux questions d'implantation. Le rôle déterminant des contextes qui ressort des études nous convainc qu'il doit demeurer au coeur des développements.
In the modern day environment, workers' compensation costs continue to be a challenge, with a need to balance costs, benefits, and quality of medical care. The cost of workers' compensation care affects all stakeholders including workers, employers, providers, regulators, legislators, and insurers. Consequently, a continued commitment to quality, accessibility to care, and cost containment will help ensure that workers are afforded accessible, high quality, and cost-effective care. In 2004, workers' compensation programs in all 50 states, the District of Columbia, and federal programs in the United States combined received an income of 56 billion in medical and cash benefits with $31.4 billion or 37% in administrative expenses and profit. Occupational diseases represented only 8% of the workers' compensation claims and 29% of the cost. The American College of Occupational and Environmental Medicine (ACOEM) has published several guidelines; though widely adopted by WCPs, these guidelines evaluate the practice of medicine of multiple specialties without adequate expertise and expert input from the concerned specialties, including interventional pain management. An assessment of the ACOEM guidelines utilizing Appraisal of Guidelines for Research and Evaluation (AGREE) criteria, the criteria developed by the American Medical Association (AMA), the Institute of Medicine (IOM), and other significantly accepted criteria, consistently showed very low scores (< 30%) in most aspects of the these guidelines. The ACOEM recommendations do not appear to have been based on a careful review of the literature, overall quality of evidence, standard of care, or expert consensus. Based on the evaluation utilizing appropriate and current evidence-based medicine (EBM) principles, the evidence ratings for diagnostic techniques of lumbar discography; cervical, thoracic, and lumbar facet joint nerve blocks and sacroiliac joint nerve blocks; therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis; cervical interlaminar epidural steroid injections, caudal epidural steroid injections, and lumbar transforaminal epidural injections; caudal percutaneous adhesiolysis; abd spinal cord stimulation were found to be moderate with strong recommendation applying for most patients in most circumstances. The evidence ratings for intradiscal electrothermal therapy (IDET), an automated percutaneous disc decompression and also deserve further scrutiny and analysis. In conclusion, these ACOEM guidelines for interventional pain management have no applicability in modern patient care due to lack of expertise by the developing organization (ACOEM), lack of utilization of appropriate and current EBM principles, and lack of significant involvement of experts in these techniques resulting in a lack of clinical relevance. Thus, they may result in reduced medical quality of care; may severely hinder access to appropriate, medically needed and essential medical care; and finally, they may increase costs for injured workers, third party payors, and the government by transferring the injured worker into a non-productive disability system.
Guidelines for occupational physicians are increasing in number. Their quality and content is varied and they may even provide conflicting recommendations. Earlier studies show that guidelines directed at professionals in occupational health use scientific evidence unsystematically or inadequately. This article assesses the guidelines of the Finnish Institute of Occupational Health (FIOH). We selected a random sample of 29 guidelines from all those published by FIOH, which were assessed by four people individually using the AGREE instrument. The items were scored in six domains: scope and purpose of the guideline, stakeholder involvement, rigour of guideline development, clarity and presentation, application, and editorial independence. Mean domain scores were calculated according to AGREE instructions. The guidelines presented their scope and purpose well; the mean domain score was 62%. Their clarity and presentation was fairly good, mean domain score 47%. The stakeholder involvement's mean domain score was 33%. The other domains scored low: applicability domain, 15%, rigour of guideline development, 9%, and editorial independence, 7% only. The rigour and reporting of guideline development seems to be the main challenge for future guideline production in FIOH. A common structure for guideline preparation is needed.
The use of consensus recommendations and clinical guidelines is now widespread in industrialized countries and is becoming more common in developing countries. As guidance documents have become more influential, their methodological rigor has come under closer scrutiny. Using two independently developed scales, we assessed the methodological quality of an important set of guidelines developed by the World Health Organization (WHO). The consensus recommendation document called Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria for Contraceptive Use has become the basis for national guidelines in dozens of countries. We compared the quality of the WHO guidelines to that of over 300 previously assessed, published guidelines. In most categories of quality, the WHO document exceeded the mean scores for other published guidelines. We discuss these comparisons, as well as the strengths and weaknesses of the WHO guidelines.
Evidence on the use of clinical practice guidelines to aid in the legal determination of negligence is increasing, specifically where they affect determinations of the standard of care and causation. So too is evidence that some clinical practice guidelines are of poor quality. An action alleging the negligent failure to diagnose and treat gestational diabetes in 1988, in which the neonate suffered permanent brachial plexus injury, entered into evidence a 1984 clinical practice guideline authored by the Society of Obstetricians and Gynaecologists of Canada. No "experts" were called to adjudicate the quality of this guideline, which cited no evidence or rationale in support of its recommendations. The standard as laid out in the guideline was judged by the court to reflect a prevailing standard of care, and a finding of negligence was rendered. As the courts pay increased attention to clinical practice guidelines, critical appraisal by the professional organizations developing these documents must occur to assure methodological rigour. Further, the quality of clinical practice guidelines should receive critical scrutiny by the courts if they are to be relied upon, even partially, to assist with legal determinations of the standard of care or issues under causation.
To evaluate the quality of Recommended Clinical Protocols and Guidelines for the Practice of Chiropractic (ICA guidelines) published by the International Chiropractors Association (ICA), August, 2000.
The Appraisal Instrument for Clinical Guidelines (Cluzeau instrument) was applied to the ICA guidelines by 10 independent experienced evaluators. An independent, global assessment was also made by each evaluator.
Mean scores (with 95% confidence limit) for each of the instrument's 3 dimensions were Rigor of Development, 27% (5.1); Context and Content, 18.3% (9.4); and Application, 2% (3.9). The unanimous global assessment was "not recommended as suitable for utilization in practice." Comparison of the ICA guideline scores with the Council on Chiropractic Practice's Clinical Practice Guideline No. 1, Vertebral Subluxation in Chiropractic Practice (CCP guidelines) scores and Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy guidelines) Cluzeau instrument-based scores revealed that the ICA guidelines received slightly higher scores than the CCP guidelines but substantially lower scores than the Mercy guidelines for all dimensions.
The ICA guidelines were assessed as not suitable for utilization in chiropractic practice.
Clinical guidelines (CGs) are widely used in community hospitals. The advantages and limitations of CGs are well understood by nurses and therapists. There are effective human dissemination routes using local training of link nurses and cascade learning. Practice development nurses are a useful resource for locating CGs. However there is a universal lack of awareness of Internet based national CGs in this sample of ward nurses and therapists. Access to these national CGs via the Internet would make local adaptation of CGs more effective and efficient. Access to Internet PCs on the wards backed up with staff training was recommended, and is ongoing.
To describe the chiropractic care of a patient with a pelvic ring fracture and concomitant subluxations of multiple segments of the spinal column.
A 23-year-old male, after falling down a flight of stairs, was initially hospitalized for fractures of the pelvis. Five weeks posthospitalization, the patient initiated chiropractic care with complaints of severe low back pain with lower extremity involvement. He also complained of neck pain and occipital headache. The patient had several positive low back orthopedic tests with bilaterally absent Achilles deep tendon reflexes. The anteroposterior radiographic view revealed ununited fractures at the left superior and inferior pubic ramus, noted as a type I Malgaigne fracture. Subluxations were detected at the left innominate (ie, fracture-subluxation) and at the patient's lumbar, thoracic, and cervical spine.
The patient was cared for with contact-specific, high-velocity, low-amplitude adjustments to sites of vertebral and sacroiliac subluxations. The patient's response to care was positive, receiving great pain relief. Less than 3 months after initiating care, the patient returned to work on regular duty.
There are indications that patients suffering from the injuries described above may derive benefits from chiropractic care. The practitioner must pay careful attention to issues of biomechanical and vascular stability and adjustment modifications in these types of patients.
A large number of practice guidelines are being produced by numerous organizations. Health-care professionals need to critically evaluate these practice guidelines to understand whether they are well constructed and representative of the preponderance of evidence. The guideline development process should be precise and rigorous to ensure that the results are reproducible and not vague.
To evaluate the quality of the second edition of the practice guidelines published by the American College of Occupational and Environmental Medicine (ACOEM Guidelines).
Four appraisers used the AGREE (Appraisal of Guidelines Research and Evaluation) guideline evaluation instrument to evaluate the ACOEM Guidelines.
The Guidelines were evaluated with the AGREE guideline evaluation instrument. The AGREE instrument has been widely adopted around the world, and the authors recommended that it be adopted as the standard of guideline construction process evaluation in the United States. The instrument standardizes the quantitative assessment of quality for a guideline's development process across six domains that include: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, application, and editorial independence. Scores from four assessors were collected and interpreted. Additionally, each evaluator selected one of four global assessment choices: "strongly recommended for use in practice," "recommended for use with some modification or proviso," "not recommended as suitable for use in practice," or "unsure".
The ACOEM Guidelines scored highest in the dimensions that evaluated reporting of the guideline's scope and purpose (79.63) as well as clarity and presentation (86.81). The guideline scored much lower in the remaining areas that included stakeholder involvement (46.06), rigor of development (26.59), application (31.48), and editorial independence (19.17). The global assessment was unanimous with all four evaluators assessing the guideline as recommend with proviso.
Many of the Guidelines recommendations were consistent with current literature and guidelines; however, the AGREE assessment instrument evaluates the guideline development process and not the content. All the evaluators thought the content of the guidelines was substantially better than the documentation of the guideline construction process. The ACOEM Guidelines appear to have content consistent with their stated objectives, but the reporting of the guidelines construction process, particularly the rigor of recommendation development, is flawed, and the recommendations may not be valid owing to possible evidence selection deficiencies. The reader should consider these flaws and limitations when using the guideline. The reader should consider utilizing guidelines of higher quality when possible. Future guidelines should incorporate better reporting and give closer attention to guideline construction.
This project updates a previous effort to inventory health services research conducted on chiropractic and makes recommendations for a subsequent research agenda. A qualitative review of social sciences, medical, chiropractic, and health services research literature regarding chiropractic was done with emphasis on research published since the initial health services research agenda effort in 1995. This work informed development of updated health services research recommendations.
Literature was gathered through searches of electronic health care database retrieval systems and citation tracking. In addition to general collecting of new studies, the authors considered to what extent the 1995 research recommendations had been addressed in the new literature. A seed set of refined recommendations was formulated and initially distributed expert review and revision. The recommendations were made available for public comment and hearing at the 10th Annual Research Agenda Conference for Chiropractic in March 2005.
The past 10 years have seen numerous health service research studies related to chiropractic; however, nearly all of the research priorities identified in 1995 remain unaddressed and remain as important priorities. Thus, recommendations were reprioritized and revised to submit for open comment and hearing.
A smaller number of more concise recommendations with more specific action steps are proposed for clinical quality improvement, performing cost analyses, and assessing use barriers for chiropractic.
Evidence-based medicine, systematic reviews, and guidelines are part of modern interventional pain management. As in other specialties in the United States, evidence-based medicine appears to motivate the search for answers to numerous questions related to costs and quality of health care as well as access to care. Scientific, relevant evidence is essential in clinical care, policy-making, dispute resolution, and law. Consequently, evidence based practice brings together pertinent, trustworthy information by systematically acquiring, analyzing, and transferring research findings into clinical, management, and policy arenas. In the United States, researchers, clinicians, professional organizations, and government are looking for a sensible approach to health care with practical evidence-based medicine. All modes of evidence-based practice, either in the form of evidence-based medicine, systematic reviews, meta-analysis, or guidelines, evolve through a methodological, rational accumulation, analysis, and understanding of the evidentiary knowledge that can be applied in clinical settings. Historically, evidence-based medicine is traceable to the 1700s, even though it was not explicitly defined and advanced until the late 1970s and early 1980s. Evidence-based medicine was initially called "critical appraisal" to describe the application of basic rules of evidence as they evolve into application in daily practices. Evidence-based medicine is defined as a conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Evidence-based practice is defined based on 4 basic and important contingencies, which include recognition of the patient's problem and construction of a structured clinical question, thorough search of medical literature to retrieve the best available evidence to answer the question, critical appraisal of all available evidence, and integration of the evidence with all aspects and contexts of the clinical circumstances. Systematic reviews provide the application of scientific strategies that limit bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. While systematic reviews are close to meta-analysis, they are vastly different from narrative reviews and health technology assessments. Clinical practice guidelines are systematically developed statements that aim to help physicians and patients reach the best health care decisions. Appropriately developed guidelines incorporate validity, reliability, reproducibility, clinical applicability and flexibility, clarity, development through a multidisciplinary process, scheduled reviews, and documentation. Thus, evidence-based clinical practice guidelines represent statements developed to improve the quality of care, patient access, treatment outcomes, appropriateness of care, efficiency and effectiveness and achieve cost containment by improving the cost benefit ratio. Part 1 of this series in evidence-based medicine, systematic reviews, and guidelines in interventional pain management provides an introduction and general considerations of these 3 aspects in interventional pain management.
CLINICAL SCENARIO
You are relieved to find that the last patient in your busy primary care clinic is a previously well 48-year-old woman with acute dysuria. There has been no polydipsia, fever, or hematuria; the physical examination reveals suprapubic tenderness; and urinalysis shows pyuria but no casts. You arrange cultures and antibiotic treatment for a lower urinary tract infection. On her way out the door, your patient observes that her friend has just started taking "female hormones," and she wonders whether she should too. Her menstrual periods stopped 6 months ago and she has never had cervical, ovarian, uterine, breast, or cardiovascular problems, but her mother had a mastectomy at age 57 for postmenopausal breast cancer. You give the same general advice you have offered similar patients in the past, but suggest that the matter be discussed at greater length when she returns after completing the antibiotic treatment. Later, as
This is the first in a series of four articles on issues in the development and use of clinical guidelines
Over the past decade, clinical guidelines have increasingly become a familiar part of clinical practice. Every day, clinical decisions at the bedside, rules of operation at hospitals and clinics, and health spending by governments and insurers are being influenced by guidelines. As defined by the Institute of Medicine, clinical guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”1 They may offer concise instructions on which diagnostic or screening tests to order, how to provide medical or surgical services, how long patients should stay in hospital, or other details of clinical practice
The broad interest in clinical guidelines that is stretching across Europe, North America, Australia, New Zealand, and Africa (box) has its origin in issues that most healthcare systems face: rising healthcare costs, fueled by increased demand for care, more expensive technologies, and an ageing population; variations in service delivery among providers, hospitals, and geographical regions and the presumption that at least some of this variation stems from inappropriate care, either overuse or underuse of services; and the intrinsic desire of healthcare professionals to offer, and of patients to receive, the best care possible. Clinicians, policy makers, and payers see guidelines as a tool for making care more consistent and efficient and for closing the gap between what clinicians do and what scientific evidence supports.
As guidelines diffuse into medicine, there are important lessons to learn from the firsthand experience of those who develop, evaluate, and use them.3 This article, the first of a four part series to reflect on these lessons, examines the potential benefits, limitations, and harms of clinical guidelines. Future articles will review lessons learned …
This is the last in a series of four articles on issues in the development and use of clinical guidelinesIn this series we have discussed the advantages and disadvantages of clinical guidelines, methods of guideline development, and the legal, political, and emotional aspects of guidelines. Assuming that the overriding purpose of clinical guidelines is to improve the quality of care for patients, in this final article we discuss how healthcare organisations (hospitals, general practices, etc) and individual clinicians can use clinical guidelines to improve clinical effectiveness.The development of good guidelines does not ensure their use in practice. Systematic reviews of strategies for changing professional behaviour show that relatively passive methods of disseminating and implementing guidelines—by publication in professional journals or mailing to targeted healthcare professionals—rarely lead to changes in professional behaviour. 1 2 Lomas observed that the failure of passive dissemination strategies is unsurprising given that many factors influence healthcare professionals‘ behaviour,3 and this has led to increased recognition of factors that help or hinder implementation at various levels: the organisation, peer group, and individual clinician. Therefore, to maximise the likelihood of a clinical guideline being used we need coherent dissemination and implementation strategies to capitalise on known positive factors and to deal with obstacles to implementation that have already been identified.
Summary points
The implementation of clinical guidelines within a clinical governance setting requires time, enthusiasm, and resources
Local groups should adopt pre-existing valid guidelines
Implementation activity should draw on the available evidence
Clinical guidelines can also be used within continuing medical education or to answer specific clinical questions
Using clinical guidelines within healthcare organisations
In the same way as topics for guideline development need to be prioritised,4 organisations need a process by which they can set and pursue their clinical priorities. These can reflect national priorities or can be set at a …
This is the second in a series of four articles on issues in the development and use of clinical guidelinesThe methods of guideline development should ensure that treating patients according to the guidelines will achieve the outcomes that are desired. This article presents a combination of the literature about guideline development and the results of our combined experience in guideline development in North America and Britain. It considers the five steps in the initial development of an evidence based guideline. The dissemination, implementation, and evaluation of practice guidelines will be discussed in the final article in this series.1
Summary points
Identifying and refining the subject area is the first step in developing a guidelineConvening and running guideline development groups is the next stepOn the basis of systematic reviews, the group assesses the evidence about the clinical question or conditionThis evidence is then translated into a recommendation within a clinical practice guidelineThe last step in guideline development is external review of the guideline
Identifying and refining the subject area of a guideline
Prioritising topics
Guidelines can be developed for a wide range of subjects. Clinical areas can be concerned with conditions (abnormal uterine bleeding, coronary artery disease) or procedures (hysterectomy, coronary artery bypass surgery). Given the large number of potential areas, some priority setting is needed to select an area for guideline development. Potential areas can emerge from an assessment of the major causes of morbidity and mortality for a given population, uncertainty about the appropriateness of healthcare processes or evidence that they are effective in improving patient outcomes, or the need to conserve resources in providing care.
Refining the subject area
The topic for guideline development will usually need to be refined before the evidence can be assessed in order to answer exact questions. The usual way of refining the topic is by a dialogue among clinicians, patients, and the potential …
The implementation of clinical guidelines within a clinical governance setting requires time, enthusiasm, and resources. Local groups should adopt pre-existing valid guidelines. Implementation activity should draw on the available evidence. Clinical guidelines can also be used within continuing medical education or to answer specific clinical questions.
Despite clinical guidelines penetrating every aspect of clinical practice and health policy, doubts persist over their ability to improve patient care. We have designed and tested a generic critical appraisal instrument, that assesses whether developers have minimized the biases inherent in creating guidelines, and addressed the requirements for effective implementation.
Thirty-seven items describing suggested predictors of guideline quality were grouped into three dimensions covering the rigour of development, clarity of presentation (including the context and content) and implementation issues. The ease of use, reliability and validity of the instrument was tested on a national sample of guidelines for the management of asthma, breast cancer, depression and coronary heart disease, with 120 appraisers. A numerical score was derived to allow comparison of guidelines within and between diseases.
The instrument has acceptable reliability (Cronbach's alpha coefficient, 0.68-0.84; intra-class correlation coefficient, (0.82-0.90)). The results provided some evidence of validity (Pearson's correlation coefficient between appraisers' dimension scores and their global assessment was 0.49 for dimension one, 0.63 for dimension two and 0.40 for dimension three). The instrument could differentiate between national and local guidelines and was easy to apply. There was variation in the performance of guidelines with most not achieving a majority of criteria in each dimension.
Use of this instrument should encourage developers to create guidelines that reflect relevant research evidence more accurately. Potential users or groups adapting guidelines for local use could apply the instrument to help decide which one to follow. The National Health Service Executive is using the instrument to assist in deciding which guidelines to recommend to the UK National Health Service. This methodology forms the basis of a common approach to assessing guideline quality in Europe.
Clinical practice guidelines and protocols are a seductive way of trying to improve the standard of clinical practice. If these are to be most effective, they must evaluate rigorously the evidence supporting a particular management strategy and make appropriate recommendations based on this information. This process needs to be objective, should engage and obtain endorsement from the disciplines that are involved in providing the care, and be accompanied by appropriate implementation strategies. Subsequently, the impact of these strategies should be measured. Existing guidelines for the management of lumbosacral pain largely conform to criteria for guidelines development. It can therefore be expected that they will benefit practitioners and the community.
• There is growing interest in the use of practice guidelines for physicians as a means of reducing inappropriate care, controlling geographic variations in practice patterns, and making more effective use of health care resources. Recent developments at the national health policy level suggest that practice guidelines will play an increasingly prominent role in the practice of medicine. The federal government has created a new US Public Health Service agency with responsibility for practice guidelines. Guidelines have been developed by more than 35 physician organizations and specialty societies. The American Medical Association and the Council of Medical Specialty Societies have endorsed practice guidelines and are organizing specialty societies to set policy on the subject. Academic medical centers have formed a research consortium on practice guidelines. Independent research centers (eg, the RAND Corporation and the Institute of Medicine) are developing methods for assessing appropriateness and setting guidelines. Other groups, such as hospitals, insurers, managed care plans, and private enterprises, are also directly involved. The implications of these developments are far reaching.
(Arch Intern Med. 1990;150:1811-1818)
When the Omnibus Budget Reconciliation Act of 1989 created a new agency in the U.S. Public Health Service to foster the development of practice guidelines and outcomes and effectiveness research, the Institute of Medicine was engaged to develop the criteria for guideline development and medical review. The new agency--the Agency for Health Care Policy and Research (AHCPR)--has used those criteria to develop and disseminate its first three commissioned guidelines, released this spring. Those criteria are elaborated in the IOM's 1990 book. In a second book, released this summer, the IOM Committee on Clinical Practice Guidelines reviews the constructive expectations for guidelines and the conditions needed to ensure rigor in their development, application, evaluation, and revision to help realize these expectations. Key recommendations for action are development of an instrument to assess guidelines and establishment of an organization to carry out the assessment of guidelines. In an appendix, the report offers "A Provisional Instrument for Assessing Clinical Practice Guidelines." While asking that organizations undertake more field testing and revision of the instrument, the Committee on Clinical Practice Guidelines believes that the provisional instrument will be useful as an educational tool for those beginning to develop guidelines, a self-assessment tool that developers of guidelines can use to check their work, and a tool for external groups to use in judging whether a set of guidelines should or should not be recommended or adopted.
Current methods for developing practice guidelines include informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development. Informal consensus development is the oldest and most common approach, but guidelines produced in this manner are often of poor quality and lack adequate documentation of methods. Formal consensus development uses a systematic approach to assess expert opinion and to reach agreement on recommendations. Evidence-based guideline development links recommendations directly to scientific evidence of effectiveness; rules of evidence are emphasized over expert opinion in making recommendations. Explicit guideline development clarifies the rationale by specifying the potential benefits, harms, and costs of available interventions; estimating the possibility of the outcomes; and comparing the desirability of the outcomes based on patient preferences. Steps in the development of practice guidelines include introductory decisions (selection of topic and panel members, clarification of purpose); assessments of clinical appropriateness (review of scientific evidence and expert opinion); assessment of public policy issues (resource limitations, feasibility issues); and guideline document development and evaluation (drafting of document, peer review, and pretesting).
(Arch Intern Med. 1992;152:946-952)
There is growing interest in the use of practice guidelines for physicians as a means of reducing inappropriate care, controlling geographic variations in practice patterns, and making more effective use of health care resources. Recent developments at the national health policy level suggest that practice guidelines will play an increasingly prominent role in the practice of medicine. The federal government has created a new US Public Health Service agency with responsibility for practice guidelines. Guidelines have been developed by more than 35 physician organizations and specialty societies. The American Medical Association and the Council of Medical Specialty Societies have endorsed practice guidelines and are organizing specialty societies to set policy on the subject. Academic medical centers have formed a research consortium on practice guidelines. Independent research centers (eg, the RAND Corporation and the Institute of Medicine) are developing methods for assessing appropriateness and setting guidelines. Other groups, such as hospitals, insurers, managed care plans, and private enterprises, are also directly involved. The implications of these developments are far reaching.
Although interest in clinical guidelines has never been greater, uncertainty persists about whether they are effective. The debate has been hampered by the lack of a rigorous overview. We have identified 59 published evaluations of clinical guidelines that met defined criteria for scientific rigour; 24 investigated guidelines for specific clinical conditions, 27 studied preventive care, and 8 looked at guidelines for prescribing or for support services. All but 4 of these studies detected significant improvements in the process of care after the introduction of guidelines and all but 2 of the 11 studies that assessed the outcome of care reported significant improvements. We conclude that explicit guidelines do improve clinical practice, when introduced in the context of rigorous evaluations. However, the size of the improvements in performance varied considerably.
Although more than 1,000 medical practice guidelines have been developed, there have been few evaluations of their use in clinical practice or information to judge whether practice guidelines can be used to reduce health care costs. For this reason, the authors conducted a prospective controlled clinical trial with an alternating-month design at a large teaching community hospital to study the use of a practice guideline to promote early transfer of patients admitted to a hospital with congestive heart failure (CHF) from the coronary care unit (CCU) and intermediate care unit to unmonitored beds. The practice guideline was supported by locally derived risk information and recommended consideration of early "step-down" transfer of low-risk patients with CHF 24 hours after hospital admission. Physicians caring for patients identified as "low risk" received concurrent personalized written and verbal reminders concerning the guideline recommendation. Study subjects were patients admitted to a hospital CCU and intermediate care unit between November 1, 1991 and April 30, 1993 with a diagnosis of CHF or pulmonary edema. Ninety patients with CHF were identified as low risk according to the guideline during the study period. Feedback of the practice guideline recommendation was not associated with a significant increase in physician adoption of the guideline or shorter lengths of stay in the CCU or intermediate care unit. Physicians may have compensated for statistically insignificant reductions in monitored lengths of stay by increasing the length of stay in unmonitored beds (1.80 +/- 2.32 to 4.02 +/- 4.09 days, P = .002) and the total length of stay (4.73 +/- 2.43 to 6.71 +/- 5.44 days, P = .03). Quality of patient care, patient outcomes, and patient satisfaction were not affected by the guideline. Our study results suggest that implementation of a locally derived practice guideline for patients with CHF did not result in adoption of the guideline by physicians. The complexity of implementing the guideline, changes in physician practice before the study, and the failure of the guideline to address the continuum of patient care across monitored and unmonitored beds may have accounted for rejection of the guideline. Our experience demonstrates that practice guidelines, whenever possible, should be evaluated in prospective trials before they should be disseminated for widespread use.
A method for developing diagnostic practice guidelines is presented in which a team of experts used a semiquantitative scoring system to reach consensus on a standard procedure for SPECT cerebral perfusion imaging.
An expert panel generated a list of elements that they thought were important for the optimal performance of cerebral perfusion imaging as the first phase of a modified Delphi panel technique. Panel members then scored each statement to indicate the importance of that statement for the performance of cerebral perfusion imaging. The scores were recorded for each statement and the average score, s.d. and variance for each statement were determined for each successive panel round. A total of three panel rounds were conducted. The change in average s.d. between scoring rounds was analyzed for significance using both parametric and nonparametric tests.
The average s.d. decreased by 35% from 2.1 to 1.32 between the first and final panel round. This change in average s.d., which indicated enhanced consensus, was significant at p < 0.0001. Following consensus, all statements were grouped into four categories based on average score: critical elements, important elements, less important elements and elements of uncertain importance. This grouping formed the basis for a guideline summary narrative. Results were generated in 3 mo, at low cost and with clear documentation of rationale.
Through simple adaptations of this methodology, expert panels that develop practice guidelines can replace informal discussion with systematic scoring methods to rate the quality of evidence, generalizability to practice conditions, appropriate indications and strength of recommendations.
Recommendations are proposed for preparing more informative abstracts of articles describing clinical practice guidelines. Information about the development and content of guidelines should be summarized with the following structure.
a succinct statement of the objective of the guideline, including the targeted health problem, the targeted patients and providers, and the main reason for developing recommendations concerning this problem for this population.
principal practice options that were considered in formulating the guideline.
significant health and economic outcomes identified as potential consequences of the practice options.
Methods used to gather, select, and synthesize evidence, and the date of the most recent evidence obtained.
persons and methods used to assign values (relative importance) to potential outcomes of alternative practice options.
the type and magnitude of the main benefits, harms, and costs that are expected to result from guideline implementation.
a brief and specific list of key recommendations.
the results of any external review, comparison with guidelines developed by other groups, or clinical testing of guideline use.
key persons or groups that developed, funded, or endorsed the guideline. Abstracts adhering to these recommendations could enhance readers' ability to appraise the applicability, importance, and validity of guidelines for specific providers, patients, and settings. More informative abstracts could also promote the use of more explicit methods of guideline development, more consistent reporting of guideline documents, and the more appropriate use of guidelines by clinicians.
The US Preventive Services Task Force is an expert panel established by the federal government in 1984 to develop evidence-based practice guidelines on screening tests and other preventive services. Its recommendations are published elsewhere. This article explores the lessons learned in the process of developing and disseminating the recommendations. Topics include project organization (analytic philosophy, project sponsorship, panel composition, topic selection); the review of evidence (selecting outcome measures for judging effectiveness, constructing "causal pathways," searching the literature, rating the evidence, synthesizing the results); crafting recommendations (extrapolation, assessing magnitude, balancing risks and benefits, addressing costs, dealing with insufficient data, separating science from policy); peer review; collaboration with other groups; evaluating impact on clinicians' knowledge, attitudes, and behavior; updating recommendations; and defining a research agenda. The lessons learned suggest potential refinements in the future work of the task force and other groups engaged in guideline development.
Clinical guidelines are a very hot topic. Many guidelines are being published, but many concerns about guidelines still exist. Guidelines may be able to increase the quality of health care while eliminating unnecessary or inappropriate care. Critics wonder if the process will instead lead to poorer care and a waste of time and effort. Although guidelines are targeted on providers of care, those with other roles will use guidelines for optimizing patient care and outcomes, assuring quality, cutting costs and tracking liability and risk management. Examination of guidelines and their impact suggest that the process and product are imperfect and that the impact is difficult to measure. The chiropractic profession will continue in its guideline efforts. The direct effects of guidelines will be on certain aspects of doctor knowledge, attitude, belief and behavior. The indirect effects will be largely attitudinal in nature at first but will eventually lead to action. The profession will embrace the need to (a) develop a more comprehensive and useful research database and (b) to develop sophisticated means for obtaining profession-wide consensus on fundamental clinical issues.
Clinical practice guidelines and protocols are a seductive way of trying to improve the standard of clinical practice. If these are to be most effective, they must evaluate rigorously the evidence supporting a particular management strategy and make appropriate recommendations based on this information. This process needs to be objective, should engage and obtain endorsement from the disciplines that are involved in providing the care, and be accompanied by appropriate implementation strategies. Subsequently, the impact of these strategies should be measured. Existing guidelines for the management of lumbosacral pain largely conform to criteria for guidelines development. It can therefore be expected that they will benefit practitioners and the community.
Valid guidelines, when appropriately disseminated and implemented, can lead to changes in clinical practice and improvements in patient outcome. Guidelines are more likely to be valid if they are developed using systematic reviews, national or regional guideline development groups (including representatives of key disciplines) and explicit links between recommendations and scientific evidence. This paper discusses the practical implications of adopting this approach for guideline development and the role of peer review guidelines as another element of the process to ensure validity. Considerable resources are required to develop evidence-linked guidelines, but this investment can be recouped by relatively small changes in the process or outcome of care. Good leadership and technical support are required for the successful development of clinically valid guidelines, which is dependent upon the small-group processes of guideline development panels and the translation of evidence into recommendations. Future guideline developers need to gain expertise in these areas. Research priorities are identified.
Reports critiquing
the validity of randomized trials,1
meta-analyses,2 diagnostic test studies,3 and
economic evaluations4 have challenged researchers to
improve the conduct of their studies and have encouraged readers to
interpret them carefully. The study by Shaneyfelt and
colleagues5 in this issue of THE
JOURNAL tackles the clinical practice guideline industry,
asking fundamental questions about how well they measure up to
contemporary standards. Most guidelines outlined their rationale,
specified the benefits and harms of health practices, and cited their
evidentiary sources. However, guidelines much less often described how
the evidence was found, how its worth was judged, and how diverse
sources of evidence were combined to formulate recommendations.
To identify and compare clinical practice guideline appraisal instruments.
Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966-99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments.
Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated.
A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.
rJournal of Manipulative and Physiological Therapeutics Volume 24 • Number 3 • March/April 2001 Evaluating Guidelines • Cates et al 176 Haynes RB. More informative abstracts of articles describing clinical practice guidelines
- Rs Hayward
- Wilson
- Mc
- Sr Tunis
- Eb Bass
- Rubin
Hayward RS, Wilson MC, Tunis SR, Bass EB, Rubin HR, rJournal of Manipulative and Physiological Therapeutics Volume 24 • Number 3 • March/April 2001 Evaluating Guidelines • Cates et al 176 Haynes RB. More informative abstracts of articles describing clinical practice guidelines. Ann Intern Med 1993;118:731-7
Practice guidelines, clinical pathways and technology assessments in chiropractic
- Mootz
Mootz RD, Shekelle PG. Practice guidelines, clinical path-ways, and technology assessments in chiropractic. In: Cherkin D, Mootz R, editors. Chiropractic in the United States, prac-tice, and research. Washington:Agency for Health Care Policy and Research; 1997. p. 72-96
A provisional instrument for assessing clinical practice guidelines
- Lohr
Development and application of a generic methodology to assess the quality of clinical guidelines.
- Cluzeau F
- Littlejohns P
- Grimshaw J
- Feder G
- Morgan S
US)Committee to Advise the Public Health Service on Clinical Practice GuidelinesUnited States Department of Health and Human Services
- Field MJ
- Lohr KN
Guidelines for guideline development.
- Royal H
- Pierson Jr, R
- Fletcher J
- Dillehay G
Guidelines for guideline development
- Royal