Interest In Clinical Practice Guidelines Research Articles

Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review.

ObjectiveTo systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).MethodsIn this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.ResultsAmong the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.ConclusionThere are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.

Corrigendum to: "Conflicts of Interest in Clinical Practice Guidelines: Accelerating an Evolution. An Endocrine Society Consensus Statement".

Corrigendum to: "Conflicts of Interest in Clinical Practice Guidelines: Accelerating an Evolution. An Endocrine Society Consensus Statement".

Disclosures of conflicts of interest in clinical practice guidelines

Problem consideredDespite promotion for adequate declarations of conflicts of interests (COI), clinical practice guidelines (CPGs) continuously fail to provide suitable statements. It was our aim to investigate the frequency of COI reporting in Philippine CPGs and possible associations of COI disclosure and use of the Grading of Recommendations, Assessment, Development and Evaluation or GRADE methodology. MethodsEighty-seven CPGs developed in the Philippines before 2017 were appraised for adequate COI disclosures using Item-23 of the AGREE II instrument. Explanatory variables included indications of use of GRADE, professional organization that led the development of the CPG, and year of CPG completion. ResultsOnly 12 CPGs (13.8%) had a COI score above the base COI score, with a mean COI score of 5.5 (SD: 1.5). COI disclosure was not statistically different between CPGs that reported or did not report using GRADE (p = 0.2196). Similarly, there was no difference in COI reporting by surgical versus non-surgical organizations (p = 0.5264). The increase in the number of Philippine CPGs was strongly correlated with COI reporting (r = 0.82, p = 0.0001). There was a steady increase of COI reporting through the years, from 5.3% in 1999–2006 to 35.3% in 2016 (p = 0.03427). ConclusionDespite improving levels of compliance in reporting COIs in recent years, the overall number of disclosures remain low even when GRADE methodology was reportedly implemented. The findings indicate the need for better GRADE training, a clearinghouse for monitoring disclosures, and future studies on the impact of COI disclosures on quality of recommendations.

Conflicts of Interest in Clinical Practice Guidelines: Accelerating an Evolution. An Endocrine Society Consensus Statement*

An analysis of the Endocrine Society's clinical practice guidelines (CPGs) published from 2010 to 2017-presented by Irwig et al. in the current issue of The Journal of Endocrinology and Metabolism-suggested that the Endocrine Society met five of seven National Academy of Medicine (NAM) standards concerning financial conflicts of interest in CPGs. As current contributors to the Endocrine Society's CPG efforts, we offer additional context related to the 2011 NAM standards and the current environment concerning industry support in medicine, and we comment on the nature of industry support received by the Society's CPG authors according to Irwig and colleagues' analysis of the Centers for Medicare and Medicaid Services' Open Payments database. Perhaps most importantly, we outline the Society's recent and ongoing efforts to enhance the value of its CPGs. Such efforts include a 2016 revision of CPG author conflict of interest rules-a change that was invisible to the investigatory methods used by Irwig et al.-in addition to other processes designed to enhance CPG objectivity. We conclude our commentary by recognizing that good-faith attempts to enhance transparency and to reduce conflicts of interest (real or apparent) in CPGs will ultimately serve the best interests of patients and providers; we confirm the Endocrine Society's resolute commitment to providing high-quality, evidence-based clinical guidance via a CPG development process that faithfully accords with current CPG best practices.

Conflicts of Interest in Clinical Practice Guidelines

Conflicts of Interest in Clinical Practice Guidelines

Assessing the methodological quality of the Canadian Psychiatric Association's anxiety and depression clinical practice guidelines.

Clinical practice guidelines (CPGs) endeavour to incorporate the best available research evidence together with the clinically informed opinions of leading experts in order to guide clinical practice when dealing with a given condition. There has been increased interest in CPGs that are evidence based and that promote best practice, a central component of which is incorporating the best available research predicated on strong study designs. Despite this soaring interest, there remains heterogeneity in the methodological quality of many CPGs, which may have an effect on the quality of services that clinicians offer. In light of this, this study examined the quality of the methodology used to develop two CPGs of the Canadian Psychiatric Association (CPA). The CPA's guidelines for the management of anxiety disorders (2006) and for the treatment of depressive disorders (2001) were assessed by trained raters using the Appraisal of Guidelines for Research and Evaluation II Instrument scale. The blind ratings of three trained raters demonstrated that the anxiety and depression CPGs had a number of strengths and important weaknesses. Implications for the development of future CPGs on anxiety and depression, including recommendations to improve guideline quality in psychiatry in particular, are discussed.

Methodological quality of systematic reviews referenced in clinical practice guidelines for the treatment of opioid use disorder.

IntroductionWith efforts to combat opioid use disorder, there is an increased interest in clinical practice guidelines (CPGs) for opioid use disorder treatments. No literature exists examining the quality of systematic reviews used in opioid use disorder CPGs. This study aims to describe the methodological quality and reporting clarity of systematic reviews (SRs) used to create CPGs for opioid use disorder.MethodsFrom June to July 2016 guideline clearinghouses and medical literature databases were searched for relevant CPGs used in the treatment of opioid use disorder. Included CPGs must have been recognized by a national organization. SRs from the reference section of each CPG was scored by using AMSTAR (a measurement tool to assess the methodological quality of systematic reviews) tool and PRISMA (preferred reporting items for systematic reviews and meta-analyses) checklist.ResultsSeventeen CPGs from 2006–2016 were included in the review. From these, 57 unique SRs were extracted. SRS comprised 0.28% to 17.92% of all references found in the CPGs. All SRs obtained moderate or high methodological quality score on the AMSTAR tool. All reviews met at least 70% of PRISMA criteria. In PRISMA, underperforming areas included accurate title labeling, protocol registration, and risk of bias. Underperforming areas in AMSTAR included conflicts of interest, funding, and publication bias. A positive correlation was found between AMSTAR and PRISMA scores (r = .79).ConclusionAlthough the SRs in the CPGs were of good quality, there are still areas for improvement. Systematic reviewers should consult PRISMA and AMSTAR when conducting and reporting reviews. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations, recognizing that the quality of systematic reviews underpinning guidelines does not necessarily correspond to the quality of the guideline itself.

Reporting of financial conflicts of interest in clinical practice guidelines: a case study analysis of guidelines from the Canadian Medical Association Infobase.

BackgroundClinical practice guidelines are widely distributed by medical associations and relied upon by physicians for the best available clinical evidence. International findings report that financial conflicts of interest (FCOI) with drug companies may influence drug recommendations and are common among guideline authors. There is no comparable study on exclusively Canadian guidelines; therefore, we provide a case study of authors’ FCOI declarations in guidelines from the Canadian Medical Association (CMA) Infobase. We also assess the financial relationships between guideline-affiliated organizations and drug companies.MethodsUsing a population approach, we extracted first-line drug recommendations and authors’ FCOI disclosures in guidelines from the CMA Infobase. We contacted the corresponding authors on guidelines when FCOI disclosures were missing for some or all authors. We also extracted guideline-affiliated organizations and searched each of their websites to determine if they had financial relationships with drug companies.ResultsWe analyzed 350 authors from 28 guidelines. Authors were named on one, two, or three guidelines, yielding 400 FCOI statements. In 75.0 % of guidelines at least one author, and in 21.4 % of guidelines all authors, disclosed FCOI with drug companies. In 54.0 % of guidelines at least one author, and in 28.6 % of guidelines over half of the authors, disclosed FCOI with manufacturers of drugs that they recommended. Twenty of 48 authors on multiple guidelines reported different FCOI in their disclosures. Eight guidelines identified affiliated organizations with financial relationships with manufacturers of drugs recommended in those guidelines.ConclusionsThis is the first study to systematically describe FCOI disclosures by authors of Canadian guidelines and financial relationships between guideline-affiliated organizations and pharmaceutical companies. These financial relationships are common. Because authoritative value is assigned to guidelines distributed by medical associations, we encourage them to develop formal policies to limit the potential influence of FCOI on guideline recommendations.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1646-5) contains supplementary material, which is available to authorized users.

Underreporting of conflicts of interest in clinical practice guidelines: cross sectional study

BackgroundConflicts of interest affect recommendations in clinical guidelines and disclosure of such conflicts is important. However, not all conflicts of interest are disclosed. Using a public available disclosure list we determined the prevalence and underreporting of conflicts of interest among authors of clinical guidelines on drug treatments.MethodsWe included up to five guidelines published from July 2010 to March 2012 from each Danish clinical specialty society. Using the disclosure list of the Danish Health and Medicines Authority, we identified author conflicts of interest and compared them with the disclosures in the guidelines. For each guideline we extracted methodological characteristics of guideline development.ResultsForty-five guidelines from 14 specialty societies were included. Of 254 authors, 135 (53%) had conflicts of interest, corresponding to 43 of the 45 guidelines (96%) having one or more authors with a conflict of interest. Only one of the 45 guidelines (2%) disclosed author conflicts of interest. The most common type of conflict of interest (83 of the 135) was being a consultant, an advisory board member or a company employee. Only 10 guidelines (22%) described the methods used for guideline development, 27 (60%) used references in the text and 11 (24%) graded the types of evidence.ConclusionsConflicts of interest were common, but disclosures were very rare. Most guidelines did not describe how they were developed and many did not describe the evidence behind specific recommendations. Publicly available disclosure lists may assist guideline issuing bodies in ensuring that all conflicts are disclosed.

Guidelines always the right lines?

Over the past years, it has become mandatory for composers of Clinical Practice Guidelines to disclose industrial relationships. This is based on the premise that disclosure of these relationships ensures the independence and scientific integrity of those involved in guidelines. Clinical practice guidelines serve as standards of care in practice, quality improvement, and reimbursement. Individual physicians use clinical practice guidelines to establish which diagnostic tests and therapeutic strategies are most appropriate in patient care. Government and third-party payers use clinical practice guidelines to determine which procedures and drugs should receive reimbursement. Hospitals use these guidelines to decide when therapies justify a major investment. The government, the public and the media use these guidelines as reference standards in the evaluation of the quality of medical practice for both hospitals and individual physicians. Accordingly, maintaining the integrity and reliability of clinical practice guidelines is crucial to society and fundamental to the practice of evidence-based medicine. Recently, Mendelson et al. (1) described the extent of conflicts of interest in clinical practice guidelines. To this purpose, the authors examined the 17 most recent guidelines launched by American College of Cardiology/American Heart Association from 2004 through 2008. Using disclosure lists, conflicts of interests were evaluated for each participant. Conflicts of interest were described as 1) receiving a research grant, 2) being on a speaker’s bureau and/or receiving honoraria, 3) owning stock, or 4) being a consultant or member of an advisory board. Also the companies and institutions reported in each disclosure were documented. It was shown that more than half (56%) of the 498 individuals reported a conflict of interest. Being a consultant or member of an advisory board was the most common type. This implies that more than half of clinical practice guideline writers served as promotional speakers on behalf of industry. A substantial number held stock in companies affected by the clinical practice guidelines. In particular, one-third (!) of the writers of the percutaneous intervention guidelines actually owned stock in companies affected by the clinical practice guidelines. Interestingly, the study (1) also demonstrated that committee chairs (or first authors) of clinical practice guidelines are significantly more involved (81%) than committee members (55%). Such findings suggest that the decision-making process for selecting chairs for cardiovascular clinical practice guidelines is seriously affected. If the leadership of professional societies were to carefully examine such appointments, it is unimaginable that such a high percentage of first authors would have financial conflicts. In protecting such relationships, professional societies usually put forward that it is always necessary to include expert individuals in order to properly balance the underlying evidence. In my opinion, it is falsely argued that non-participants in industry-sponsored research lack the expertise to interpret the complex scientific data that must be reviewed when writing the guidelines. Such statements are self-fulfilling and far from convincing. By contrast, independent experts are very well capable to objectively judge the needed evidence (if not more than biased experts!). As noted by Mendelson et al. [1], if 44% of clinical practice guidelines writers were free of financial relationships with industry, there must be other independent experts. In an accompanying Editorial comment [2], Steve Nissen (Cleveland Clinic, USA) appropriately stated that ‘For Clinical practice guidelines to be truly independent and respected, even the appearance of impropriety must be avoided. For the public, congressional oversight committees, and the media, a promotional speaker and stockholder are inherently biased and should never be permitted to serve as a clinical practice guidelines writer’. For guidelines to become the right lines, our professional society should be highly aware of these facts and act accordingly. When we fail as a profession to govern the clinical practice guidelines process, the integrity of evidence-based medicine will be seriously damaged.

The Vexing Problem of Guidelines and Conflict of Interest: A Potential Solution

Issues of financial and intellectual conflict of interest in clinical practice guidelines have raised increasing concern. Professional organizations have responded by more rigorous regulation of conflict of interest. Nevertheless, tension remains between the competing goals of optimizing guideline quality by using the experience and insight of experts and ensuring that financial and intellectual conflicts of interest do not influence recommendations. The executive committee of the American College of Chest Physicians' Antithrombotic Guidelines has developed a strategy comprising 3 innovative aspects to address this tension: First, place equal emphasis on intellectual and financial conflicts and provide explicit criteria for both; second, a methodologist without important conflicts of interest should have primary responsibility for each chapter; and third, experts with important financial or intellectual conflicts of interest can collect and interpret evidence, but only panel members without important conflicts can be involved in developing the recommendation for a specific question. These strategies may help to achieve the benefits of expert input without conflicts of interest influencing recommendations.

Guías de práctica clínica (I): elaboración, implantación y evaluación

Clinical practice guidelines are defined as a set of systematically developed recommendations that aim to guide the decision-making process. In the last ten years, interest in clinical practice guidelines has grown steadily as they have enabled a point of encounter between research and clinical practice. Unlike classical protocols, usually based on consensus or opinion and a narrative review of the available scientific literature, clinical practice guidelines are developed by multidisciplinary teams, review the evidence exhaustively and systematically, evaluate the quality of the information, and propose specific recommendations in line with the quality and design of the studies available. The later stages of dissemination, implementation, and posterior evaluation of their impact complete the cycle for dynamic change in clinical practice.

Guías de práctica clínica basadas en la evidencia: desarrollo actual y perspectivas futuras

Because of interest in clinical practice guidelines (CPG) as instruments for improving clinical practice, the production of these documents has markedly increased. In Spain, multiple documents described as CPG are promoted by various institutions (health systems, scientific societies, industry, etc.). However, recent evaluations of their quality reveal a wide margin for improvement in their design. CPG should be developed through a systematic and structured process. The essence of a CPG is the formulation of recommendations responding to a list of questions in which the management of a problem in a specific context can be summarized. The response to the list of questions through evaluating and summarizing the evidence constitutes the nucleus of the CPG and is what distinguishes it from other document types that provide recommendations based mainly on “expert” opinion. Recommendations should be graded according to the quality of the evidence on which they are based. The highest level of evidence is provided by systematic reviews and consequently consultation of these studies should be a priority. There are several initiatives in Spain such as Guiasalud or Redeguias of the Red Temática de Investigación MBE (Thematic Network for Research on EBM) that work on this type of CPG design. An essential strategy is the coordination of parties interested in producing CPG (scientific societies, health systems, etc.). Lastly, for CPG to improve the population’s health, they must be disseminated and systematically implemented.

医学情報 診療ガイドライン

Clinical practice guidelines are commonly defined as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” The issues underlying the increasing interest in clinical practice guidelines are concerns over quality of care, marked variation in physician practice, and increasing costs. Many believe that guidelines can serve as a vehicle to address these problems. While clinical practice guidelines are produced by various organizations, such as medical societies or associations, in Japan, they are hardly ever accessible to the public. We at the Medical Media Center of Toho University are compiling relevant guideline information, and a list is available to the public on the Media Center Home Page. In this article I discuss the concept and prospects for the future development of guidelines, embracing the issue of the “EBM Health Care Information Service” as well as overseas counterparts.

Developing a Clinical Pathway in Depression: Sharing Our Experience

The Second National Mental Health Plan [ 1 ] has as one of its key themes, a focus on the quality and effectiveness of services with an emphasis on outcomes for consumers and carers. This focus on quality and outcomes results in an increasing interest in clinical practice guidelines, benchmarking of services and the development and evaluation of models of best practice. One way to progress these issues within clinical services is to develop clinical pathways for groups of patients with similar conditions.

Clinical practice guidelines in practice and education.

Clinical practice guidelines have been a fundamental component of medical practice since one physician first asked another how to manage a patient. A clinical practice guideline is formally defined as a preformed recommendation made for the purpose of influencing a decision about a health intervention.1 In practice, however, journal articles, editorials, algorithms, care maps, computerized reminders, textbook chapters, and advice from consultants are all clinical practice guidelines in the general form “if x, then y” on some clinical question. The terminology defining these decision rules is not standard. Physicians will find the terms practice policy, clinical guideline, practice parameter, clinical pathway, standard, algorithm, and many others used synonymously. This article uses the term clinical practice guideline. The recent surge of interest in clinical practice guidelines has several parents. First, medical history is littered with clinical practice guidelines that have been fatally incorrect, leading to interest in methods that promise better validity and reliability. Second, the physician's ability to keep up with the medical literature erodes with each year's burden of (literally) millions of medical articles published worldwide, leading to interest in methods that make sense out of the vast amount of information on a given clinical topic. Third, costly and unexplained variability in medical practice, documented everywhere one looks, leads to interest in developing more accountable approaches for those conditions for which the greatest variations in practice or cost occur (this parent is strongly driven by the shift to more managed care). Fourth, growing demand from patients for greater participation in medical decisions leads to searching for a process in which benefits and harms are linked to outcomes explicitly in terms that patients can understand. Driven by these four parent concerns, methods used to develop clinical practice guidelines have evolved rapidly in recent years. It is important to emphasize, however, that the modern “clinical practice guidelines movement” is too young to have demonstrated success in addressing any of the four concerns, although relevant research attempting to do so is under way in many centers. Beyond addressing the above concerns, clinical practice guidelines are used for many purposes, some of them competing. Well-formulated clinical practice guidelines can be used positively not only to guide practice, but also for education, quality assurance and improvement, and cost accountability, ends with which most physicians would agree. On the negative side, guidelines are also used in malpractice actions to justify or attack care provided in specific cases with adverse outcomes, and are used by groups of physicians in attempts to protect clinical turf. Poorly constructed clinical practice guidelines are justifiably attacked when used in any setting, but physicians who assist in developing well-designed evidence-based guidelines must be prepared to find the products used in all kinds of appropriate and inappropriate ways. Attentiveness to the integrity of the process used to generate clinical practice guidelines must be matched with vigilance to guard against inappropriate use. This article presents an overview of methods used to construct clinical guidelines, discusses an extended example—screening for prostate cancer—and concludes with a review of the use of clinical guidelines in practice and education.

Clinical Practice Guidelines: Policy Issues and Legal Implications

The growing interest in clinical practice guidelines is raising a number of complex legal questions that have yet to be widely examined. Could physicians be held liable if they disregard good medical judgement in favor of following cost containment guidelines? To what extent should developers and implementers of guidelines be granted civil immunity from liability? How will judges respond to guidelines as evidence, and how will they react when various guidelines conflict?