From autonomy to accountability: the role of clinical practice guidelines in professional power

Evidence-based medicine (EBM) aims to address the persistent problem of clinical practice variation with the help of various tools, including standardized practice guidelines. Based on a systematic evaluation of the available scientific evidence, these guidelines offer recommendations for clinicians about details of patient care and clinical decision making. Because clinical practice guidelines specify how health care should be performed, they could be considered a threat to clinical and professional autonomy. Inspired by the theory of countervailing powers, this article explores how clinical practice guidelines have shifted the focus of professional power from autonomy to accountability. Professional organizations develop clinical practice guidelines as a service to their members but do not require strict adherence to the guidelines. Indeed, implementation studies show at best a modest change in clinical behavior. Such non-adherence might render a profession vulnerable, however, when third parties seize upon guidelines and offer financial incentives to keep clinicians accountable for delivering optimal patient care.     

Financial Relationships between Organizations That Produce Clinical Practice Guidelines and the Biomedical Industry: A Cross-Sectional Study

BackgroundFinancial relationships between organizations that produce clinical practice guidelines and biomedical companies are vulnerable to conflicts of interest. We sought to determine whether organizations that produce clinical practice guidelines have financial relationships with biomedical companies and whether there are associations between organizations’ conflict of interest policies and recommendations and disclosures provided in guidelines.ConclusionsFinancial relationships between organizations that produce clinical practice guidelines and biomedical companies are common and infrequently disclosed in guidelines. Our study highlights the need for an effective policy to manage organizational conflicts of interest and disclosure of financial relationships.     

Clinical Practice Guidelines and Consensus Statements in Oncology – An Assessment of Their Methodological Quality

BackgroundConsensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine’s standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.MethodsConsensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine''s standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.FindingsThirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal’s consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases.ConclusionGuidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor’s product to enhance transparency.     

Ethical considerations for clinical photography in the global South

Clinical photography is an important tool for teaching practitioners and field workers about the clinical manifestations of famine and undernutrition, particularly with respect to the Global South. Current international guidelines for clinical photography are not consistently applied or enforced, which has led to violations of privacy and rights, particularly for patients and victims of disaster in the Global South. Combining existing clinical photography guidelines from the North with ongoing clinical ethics debates in the South, this paper explores approaches to establishing photography guidelines throughout the world that will be sensitive to the privacy and dignities of all patients and victims of emergencies.     

Clinical guidelines contribute to the health inequities experienced by individuals with intellectual disabilities

ABSTRACT: BACKGROUND: Clinical practice guidelines are developed to improve the quality of healthcare. However, clinical guidelines may contribute to health inequities experienced by disadvantaged groups. This study uses an equity lens developed by the International Clinical Epidemiology Network (INCLEN) to examine how well clinical guidelines address inequities experienced by individuals with intellectual disabilities. METHODS: Nine health problems relevant to the health inequities experienced by persons with intellectual disabilities were selected. Clinical guidelines on these disorders were identified from across the world. The INCLEN equity lens was used as the basis for a purposedesigned, semistructured data collection tool. Two raters independently examined each guideline and completed the data collection tool. The data extracted by each rater were discussed at a research group consensus conference and agreement was reached on a final equity lens rating for each guideline. RESULTS: Thirty-six guidelines were identified, one of which (2.8%) explicitly excluded persons with intellectual disabilities. Of the remaining 35, six (17.1%) met the first criterion of the equity lens, identifying persons with intellectual disabilities at high risk for the specific health problem. Eight guidelines (22.9%) contained any content on intellectual disabilities. Six guidelines addressed the fourth equity lens criterion, by giving specific consideration to the barriers to implementation of the guideline in disadvantaged populations. There were no guidelines that addressed the second, third, and fifth equity lens criteria. CONCLUSIONS: The equity lens is a useful tool to systematically examine whether clinical guidelines address the health needs and inequities experienced by disadvantaged groups. Clinical guidelines are likely to further widen the health inequities experienced by persons with intellectual disabilities, and other disadvantaged groups, by being preferentially advantageous to the general population. There is a need to systematically incorporate methods to consider disadvantaged population groups into the processes used to develop clinical guidelines.     

One hundred years ago : Fashion and medicine

Objective: To determine which attributes of clinical practice guidelines influence the use of guidelines in decision making in clinical practice. Design: Observational study relating the use of 47 different recommendations from 10 national clinical guidelines to 12 different attributes of clinical guidelines—for example, evidence based, controversial, concrete. Setting: General practice in the Netherlands. Subjects: 61 general practitioners who made 12 880 decisions in their contacts with patients. Main outcome measures: Compliance of decisions with clinical guidelines according to the attribute of the guideline. Results: Recommendations were followed in, on average, 61% (7915/12 880) of the decisions. Controversial recommendations were followed in 35% (886/2497) of decisions and non-controversial recommendations in 68% (7029/10 383) of decisions. Vague and non-specific recommendations were followed in 36% (826/2280) of decisions and clear recommendations in 67% (7089/10 600) of decisions. Recommendations that demanded a change in existing practice routines were followed in 44% (1278/2912) of decisions and those that did not in 67% (6637/9968) of decisions. Evidence based recommendations were used more than recommendations for practice that were not based on research evidence (71% (2745/3841) v 57% (5170/9039)). Conclusions: People and organisations setting evidence based clinical practice guidelines should take into account some of the other important attributes of effective recommendations for clinical practice.

Key messages

• Specific attributes of clinical practice guidelines determine whether they are used in practice
• Evidence based recommendations are better followed in practice than recommendations not based on scientific evidence
• Precise definitions of recommended performance improve the use of guidelines
• Testing the feasibility and acceptance of clinical guidelines among the target group is important for effective implementation
• People setting evidence based guidelines need to understand the attributes of effective guidelines

     

Evaluating "payback" on biomedical research from papers cited in clinical guidelines: applied bibliometric study

ObjectivesTo develop a methodology for evaluating the impact of research on health care, and to characterise the papers cited on clinical guidelines.DesignThe bibliographic details of the papers cited in 15 clinical guidelines, developed in and for the United Kingdom, were collated and analysed with applied bibliometric techniques.ResultsThe median age of papers cited in clinical guidelines was eight years; most papers were published by authors living in either the United States (36%) or the United Kingdom (25%)—this is two and a half times more than expected as about 10% of all biomedical outputs are published in the United Kingdom; and clinical guidelines do not cite basic research papers.ConclusionAnalysis of the evidence base of clinical guidelines may be one way of tracking the flow of knowledge from the laboratory to the clinic. Moreover, such analysis provides a useful, clinically relevant method for evaluating research outcomes and different strategies in research and development.     

Self-monitoring of blood glucose in patients with diabetes who do not use insulin-are guidelines evidence-based?

Diabet. Med. 29, 1226-1236 (2012) ABSTRACT: Aims To evaluate if clinical practice guideline recommendations regarding self-monitoring of blood glucose in patients with diabetes not using insulin follow the principles of evidence-based medicine. Methods After a search from 1999 to 2011, 18 clinical practice guidelines were included. Recommendations regarding self-monitoring of blood glucose were graded on a scale from one (strongly against self-monitoring) to four (strongly in favour of self-monitoring) and compared with the similarly graded conclusions of systematic reviews that were cited by the clinical practice guidelines. We also investigated how clinical practice guideline characteristics, for example funding sources, and quality of references cited could be related to the guideline recommendations. Results The clinical practice guidelines cited in total 15 systematic reviews, 14 randomized controlled trials, 33 non-randomized controlled trials papers and 18 clinical practice guidelines or position statements. The clinical practice guideline recommendations had an average grade of 3.4 (range 2.0-4.0). Higher grades were seen for clinical practice guidelines that acknowledged industry funding (mean value 4.0) or were issued by organizations depending on private funding (mean value 3.6 vs. 3.0 for governmental funding). The conclusions of the 15 systematic reviews had a mean grade of 2.2 (range 1.0-3.8). Systematic reviews with low grades were less cited. In total, 21 randomized controlled trials were included in the systematic reviews. Approximately half of these evaluated an educational intervention where the effect of self-monitoring of blood glucose could not be clearly isolated. Conclusions Clinical practice guidelines were more in favour of self-monitoring use than the systematic reviews that were cited. The citation practice was non-systematic and industry funding seemingly led to a more positive attitude towards use of self-monitoring of blood glucose.     

Challenges of disseminating clinical practice guidelines in a weak health system: the case of HIV and infant feeding recommendations in Tanzania

Background

Clinical guidelines aim to improve patient outcomes by providing recommendations on appropriate healthcare for specific clinical conditions. Scientific evidence produced over time leads to change in clinical guidelines, and a serious challenge may emerge in the process of communicating the changes to healthcare practitioners and getting new practices adopted. There is very little information on the major barriers to implementing clinical guidelines in low-income settings. Looking at how continual updates to clinical guidelines within a particular health intervention are communicated may shed light on the processes at work. The aim of this paper is to explore how the content of a series of diverging infant feeding guidelines have been communicated to managers in the Prevention of Mother to Child Transmission of HIV Programme (PMTCT) with the aim of generating knowledge about both barriers and facilitating factors in the dissemination of new and updated knowledge in clinical guidelines in the context of weak healthcare systems.

Methods

A total of 22 in-depth interviews and two focus group discussions were conducted in 2011. All informants were linked to the PMTCT programme in Tanzania. The informants included managers at regional and district levels and health workers at health facility level.

Results

The informants demonstrated partial and incomplete knowledge about the recommendations. There was lack of scientific reasoning behind various infant feeding recommendations. The greatest challenges to the successful communication of the infant feeding guidelines were related to slowness of communication, inaccessible jargon-ridden English language in the manuals, lack of summaries, lack of supportive supervision to make the guidelines comprehensible, and the absence of a reading culture.

Conclusion

The study encountered substantial gaps in knowledge about the diverse HIV and infant feeding policies. These gaps were partly related to the challenges of communicating the clinical guidelines. There is a need for caution in assuming that important changes in guidelines for clinical practice can easily be translated to and implemented in local programme settings, not least in the context of weak healthcare systems.

     

Breaking new ground: challenging existing asthma guidelines

Background

While we have international guidelines and various national guidelines for asthma diagnosis and management, asthma remains poorly controlled in many children and adults. In this paper we review the limitations of current asthma guidelines and describe important issues and remaining questions regarding asthma guidelines for use, particularly in primary care.

Discussion

Clinical practice guidelines based on evidence from randomized controlled trials are considered the most rigorous and accurate. Current evidence-based guidelines are written predominantly from the perspective of the patient with a clear-cut asthma diagnosis, however, and tend not to consider the heterogeneity of asthma or to accommodate individual patient variations in response to treatment or their needs, differences in practice settings, or local differences in availability and cost of therapies. The results of randomized controlled trials, which are designed to establish efficacy of treatment under ideal conditions, may not apply to 'real-world' clinical practice, where patients are unselected, monitoring is less frequent, and effectiveness – the benefit of treatment in routine clinical practice – is the most relevant outcome. Moreover, most guidelines see asthma in isolation rather than considering other factors that may impact on asthma and response to asthma therapy, particularly age, allergic rhinitis, cigarette smoking, adherence, and genetic factors. When these links are recognized, guidelines rarely provide practical recommendations for treatment in these scenarios. Finally, there is some evidence that general practitioners are not convinced of the applicability of asthma guidelines to their practice settings, especially when those writing the guidelines principally work in specialist practice.

Conclusion

Developing country-specific guidelines or, ideally, local guidelines could provide more practical solutions for asthma care and could account for regional factors that influence patient choice and adherence to therapy. Pragmatic clinical trials and well-designed observational trials are needed in addition to randomized controlled trials to assess real-world effectiveness of therapies, and such evidence needs also to be considered by guideline writers. Finally, practical tools to facilitate the diagnosis and assessment of asthma and factors responsible for poor control, such as associated allergic rhinitis, limited adherence, and smoking behavior, are needed to supplement treatment information provided in clinical practice guidelines for asthma.

     

Evaluation of clinical practice guidelines.

Compared with the current focus on the development of clinical practice guidelines the effort devoted to their evaluation is meagre. Yet the ultimate success of guidelines depends on routine evaluation. Three types of evaluation are identified: evaluation of guidelines under development and before dissemination and implementation, evaluation of health care programs in which guidelines play a central role, and scientific evaluation, through studies that provide the scientific knowledge base for further evolution of guidelines. Identification of evaluation and program goals, evaluation design and a framework for evaluation planning are discussed.     

Clinical utility of ICD‐11 diagnostic guidelines for high‐burden mental disorders: results from mental health settings in 13 countries

In this paper we report the clinical utility of the diagnostic guidelines for ICD‐11 mental, behavioural and neurodevelopmental disorders as assessed by 339 clinicians in 1,806 patients in 28 mental health settings in 13 countries. Clinician raters applied the guidelines for schizophrenia and other primary psychotic disorders, mood disorders (depressive and bipolar disorders), anxiety and fear‐related disorders, and disorders specifically associated with stress. Clinician ratings of the clinical utility of the proposed ICD‐11 diagnostic guidelines were very positive overall. The guidelines were perceived as easy to use, corresponding accurately to patients’ presentations (i.e., goodness of fit), clear and understandable, providing an appropriate level of detail, taking about the same or less time than clinicians’ usual practice, and providing useful guidance about distinguishing disorder from normality and from other disorders. Clinicians evaluated the guidelines as less useful for treatment selection and assessing prognosis than for communicating with other health professionals, though the former ratings were still positive overall. Field studies that assess perceived clinical utility of the proposed ICD‐11 diagnostic guidelines among their intended users have very important implications. Classification is the interface between health encounters and health information; if clinicians do not find that a new diagnostic system provides clinically useful information, they are unlikely to apply it consistently and faithfully. This would have a major impact on the validity of aggregated health encounter data used for health policy and decision making. Overall, the results of this study provide considerable reason to be optimistic about the perceived clinical utility of the ICD‐11 among global clinicians.     

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines

OBJECTIVE: To assess Canadian physicians'' confidence in, attitudes about and preferences regarding clinical practice guidelines. DESIGN: Cross-sectional, self-administered mailed survey. PARTICIPANTS: Stratified random sample of 3000 Canadian physicians; 1878 (62.6%) responded. SETTING: Canada. OUTCOME MEASURES: Physicians'' use of various information sources; familiarity with and confidence in guidelines; attitudes about guidelines and their effect on medical care; rating of importance of guidelines and other sources of information in clinical decision-making; rating of importance of various considerations in deciding whether to adopt a set of guidelines; and rating of usefulness of different formats for presenting guidelines. MAIN RESULTS: In all, 52% of the respondents reported using guidelines at least monthly, substantially less frequently than traditional information sources. Most of the respondents expressed confidence in guidelines issued by various physician organizations, but 51% to 77% were not confident in guidelines issued by federal or provincial health ministries or by health insurance plans. The respondents were generally positive about guidelines (e.g., over 50% strongly agreed that they are a convenient source of advice and good educational tools); however, 22% to 26% had concerns about loss of autonomy, the rigidity of guidelines and decreased satisfaction with medical practice. Endorsement by respected colleagues or major organizations was identified as very important by 78% and 62% of the respondents respectively in deciding whether to adopt a set of guidelines in their practice. User friendliness of the guidelines format was thought to be very important by 62%; short pamphlets, manuals summarizing a number of guidelines, journal articles and pocket cards summarizing guidelines were the preferred formats (identified as most useful by 50% to 62% of the respondents). CONCLUSIONS: Canadian physicians, although generally positive about guidelines and confident in those developed by clinicians, have not yet integrated the use of guidelines into their practices to a large extent. Our results suggest that respected organizations and opinion leaders should be involved in the development of guidelines and that the acceptability of any proposed format and medium for guidelines presentation should be pretested.     

A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis

Clinical practice guidelines are important tools to assist clinical decision-making. Recently, several guidelines addressing the management of osteoarthritis (OA) have been published. Clinicians treating patients with OA must ensure that these guidelines are developed with consistency and methodological rigour. We undertook a qualitative summary and critical appraisal of six medical treatment guidelines for the management of lower-limb OA published in the medical literature within the past 5 years. A review of these six guidelines revealed that each possesses strengths and weakness. While most described the scope and intended patient populations, the guidelines varied considerably in the rigour of their development, coverage of implementation issues, and disclosure of conflicts of interest.     

A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis

Clinical practice guidelines are important tools to assist clinical decision-making. Recently, several guidelines addressing the management of osteoarthritis (OA) have been published. Clinicians treating patients with OA must ensure that these guidelines are developed with consistency and methodological rigour. We undertook a qualitative summary and critical appraisal of six medical treatment guidelines for the management of lower-limb OA published in the medical literature within the past 5 years. A review of these six guidelines revealed that each possesses strengths and weakness. While most described the scope and intended patient populations, the guidelines varied considerably in the rigour of their development, coverage of implementation issues, and disclosure of conflicts of interest.     

Working to Improve Care of Hospital Hyperglycemia Through Statewide Collaboration: The Georgia Hospital Association Diabetes Special Interest Group

ObjectiveTo review the efforts of the Georgia Hospital Association Diabetes Special Interest Group (DSIG) to develop and disseminate sample clinical guidelines on management of inpatient hyperglycemia.MethodsBeginning in February 2003, a consortium of physicians and allied health professionals from throughout the state of Georgia began meeting on a frequent basis to formulate a plan to enhance the care of hospitalized patients with hyperglycemia. The immediate goals of the DSIG were the identification and organization of interested stakeholders, the development of consensus sample clinical guidelines, and the dissemination of information.ResultsSince its inception, the DSIG has accomplished the following: development of 7 consensus sample clinical guidelines, construction of a Web site that posts these clinical guidelines and other useful related information and educational materials, and sponsorship of workshops throughout the state of Georgia.ConclusionAs the importance of glucose control in the hospital setting has become increasingly recognized, institutions must find ways of applying results of clinical trials to “real-world” hospital environments. The DSIG is an example of a successful collaboration that could serve as a model for other state hospital organizations that wish to develop programs to enhance the care of inpatients with hyperglycemia. (Endocr Pract. 2007;13:45-50)     

The effects of clinical practice guidelines on patient outcomes in primary care: a systematic review

OBJECTIVE: To assess the evidence for the effectiveness of clinical practice guidelines (CPGs) in improving patient outcomes in primary care. DATA SOURCES: A search of the MEDLINE, HEALTHPLAN, CINAHL and FAMLI databases was conducted to identify studies published between Jan. 1, 1980, and Dec. 31, 1995, concerning the use of guidelines in primary medical care. The keywords used in the search were "clinical guidelines," "primary care," "clinical care," "intervention," "randomized controlled trial" and "effectiveness." STUDY SELECTION: Studies of the use of CPGs were selected if they involved a randomized experimental or quasi-experimental method, concerned primary care, were related to clinical care and examined patient outcomes. Of 91 trials of CPGs identified through the search, 13 met the criteria for inclusion in the critical appraisal. DATA EXTRACTION: The following data were extracted, when possible, from the 13 trials: country and setting, number of physicians, number of patients (and the proportion followed to completion), length of follow-up, study method (including random assignment method), type of intervention, medical condition treated and effect on patient outcomes (including clinical and statistical significance, with confidence intervals). DATA SYNTHESIS: The most common conditions studied were hypertension (7 studies), asthma (2 studies) and cigarette smoking (2 studies). Four of the studies followed nationally developed guidelines, and 9 used locally developed guidelines. Six studies involved computerized or automated reminder systems, whereas the others relied on small-group workshops and education sessions. Only 5 of the 13 trials (38%) produced statistically significant results. CONCLUSION: There is very little evidence that the use of CPGs improves patient outcomes in primary medical care, but most studies published to date have used older guidelines and methods, which may have been insensitive to small changes in outcomes. Research is needed to determine whether the newer, evidence-based CPGs have an effect on patient outcomes.     

Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface

ObjectiveTo investigate the effect of clinical guidelines on the management of infertility across the primary care-secondary care interface.DesignCluster randomised controlled trial.SettingGeneral practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area.ParticipantsAll 221 general practices in Glasgow; 214 completed the trial.InterventionGeneral practices in the intervention arm received clinical guidelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings.ResultsData on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were referred inappropriately early. Referrals from intervention practices were significantly more likely to have all relevant investigations carried out (odds ratio 1.32, 95% confidence interval 1.00 to 1.75, P=0.025). 70% of measurements of serum progesterone concentrations during the midluteal phase and 34% of semen analyses were repeated at least once in hospital, despite having been recorded as normal when checked in general practice. No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan. NHS costs were not significantly affected.ConclusionsDissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice, but there are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care tended to fail to respond to changes in referral practice by doctors. Guidelines that aim to improve the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary care.

What is already known on this topic

Most previous research into clinical guidelines has focused on their development and implementationEvidence is lacking about the outcomes and costs associated with the use of clinical guidelines

What this study adds

Clinical guidelines that may alter the balance of care between general practice and hospital settings require more intensive implementation than guidelines aimed at either setting on its ownThe cost effectiveness of clinical guidelines should not be assumed