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.     

No magic bullets: a systematic review of 102 trials of interventions to improve professional practice.

OBJECTIVE: To determine the effectiveness of different types of interventions in improving health professional performance and health outcomes. DATA SOURCES: MEDLINE, SCISEARCH, CINAHL and the Research and Development Resource Base in CME were searched for trials of educational interventions in the health care professions published between 1970 and 1993 inclusive. STUDY SELECTION: Studies were selected if they provided objective measurements of health professional performance or health outcomes and employed random or quasi-random allocation methods in their study designs to assign individual subjects or groups. Interventions included such activities as conferences, outreach visits, the use of local opinion leaders, audit and feedback, and reminder systems. DATA EXTRACTION: Details extracted from the studies included the study design; the unit of allocation (e.g., patient, provider, practice, hospital); the characteristics of the targeted health care professionals, educational interventions and patients (when appropriate); and the main outcome measure. DATA SYNTHESIS: The inclusion criteria were met by 102 trials. Areas of behaviour change included general patient management, preventive services, prescribing practices, treatment of specific conditions such as hypertension or diabetes, and diagnostic service or hospital utilization. Dissemination-only strategies, such as conferences or the mailing of unsolicited materials, demonstrated little or no changes in health professional behaviour or health outcome when used alone. More complex interventions, such as the use of outreach visits or local opinion leaders, ranged from ineffective to highly effective but were most often moderately effective (resulting in reductions of 20% to 50% in the incidence of inappropriate performance). CONCLUSION: There are no "magic bullets" for improving the quality of health care, but there are a wide range of interventions available that, if used appropriately, could lead to important improvements in professional practice and patient outcomes.     

Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis

Background

Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.

Methods and Findings

To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs'' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.

Conclusions

Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines. Please see later in the article for the Editors'' Summary     

A Systematic Review of Recent Clinical Practice Guidelines on the Diagnosis,Assessment and Management of Hypertension

Background

Despite the availability of clinical practice guidelines (CPGs), optimal hypertension control is not achieved in many parts of the world; one of the challenges is the volume of guidelines on this topic and their variable quality. To systematically review the quality, methodology, and consistency of recommendations of recently-developed national CPGs on the diagnosis, assessment and the management of hypertension.

Methodology/Principal Findings

MEDLINE, EMBASE, guidelines'' websites and Google were searched for CPGs written in English on the general management of hypertension in any clinical setting published between January 2006 and September 2011. Four raters independently appraised each CPG using the AGREE-II instrument and 2 reviewers independently extracted the data. Conflicts were resolved by discussion or the involvement of an additional reviewer. Eleven CPGs were identified. The overall quality ranged from 2.5 to 6 out of 7 on the AGREE-II tool. The highest scores were for “clarity of presentation” (44.4% −88.9%) and the lowest were for “rigour of development” (8.3%–30% for 9 CGPs). None of them clearly reported being newly developed or adapted. Only one reported having a patient representative in its development team. Systematic reviews were not consistently used and only 2 up-to-date Cochrane reviews were cited. Two CPGs graded some recommendations and related that to levels (but not quality) of evidence. The CPGs'' recommendations on assessment and non-pharmacological management were fairly consistent. Guidelines varied in the selection of first-line treatment, adjustment of therapy and drug combinations. Important specific aspects of care (e.g. resistant hypertension) were ignored by 6/11 CPGs. The CPGs varied in methodological quality, suggesting that their implementation might not result in less variation of care or in better health-related outcomes.

Conclusions/Significance

More efforts are needed to promote the realistic approach of localization or local adaptation of existing high-quality CPGs to the national context.     

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.     

A Systematic Critical Appraisal for Non-Pharmacological Management of Osteoarthritis Using the Appraisal of Guidelines Research and Evaluation II Instrument

Clinical practice CPGs (CPGs) have been developed to summarize evidence related to the management of osteoarthritis (OA). CPGs facilitate uptake of evidence-based knowledge by consumers, health professionals, health administrators and policy makers. The objectives of the present review were: 1) to assess the quality of the CPGs on non-pharmacological management of OA; using a standardized and validated instrument - the Appraisal of Guidelines Research and Evaluation (AGREE II) tool - by three pairs of trained appraisers; and 2) to summarize the recommendations based on only high-quality existing CPGs. Scientific literature databases from 2001 to 2013 were systematically searched for the state of evidence, with 17 CPGs for OA being identified. Most CPGs effectively addressed only a minority of AGREE II domains. Scope and purpose was effectively addressed in 10 CPGs on the management of OA, stakeholder involvement in 12 CPGs, rigour of development in 10 CPGs, clarity/presentation in 17 CPGs, editorial independence in 2 CPGs, and applicability in none of the OA CPGs. The overall quality of the included CPGs, according to the 7-point AGREE II scoring system, is 4.8±0.41 for OA. Therapeutic exercises, patient education, transcutaneous electrical nerve stimulation, acupuncture, orthoses and insoles, heat and cryotherapy, patellar tapping, and weight control are commonly recommended for the non-pharmacological management of OA by the high-quality CPGs. The general clinical management recommendations tended to be similar among high-quality CPGs, although interventions addressed varied. Non-pharmacological management interventions were superficially addressed in more than half of the selected CPGs. For CPGs to be standardized uniform creators should use the AGREE II criteria when developing CPGs. Innovative and effective methods of CPG implementation to users are needed to ultimately enhance the quality of life of arthritic individuals.     

Overview of the VA Quality Enhancement Research Initiative (QUERI) and QUERI theme articles: QUERI Series

Background

The recent development and publication of evidence-based clinical practice guidelines (CPGs) for acute low back pain (LBP) has resulted in evidence-based recommendations that, if implemented, have the potential to improve the quality and safety of care for acute LBP. While a strategy has been specified for dissemination of the CPG for acute LBP in Australia, there is no accompanying plan for active implementation. Evidence regarding the cost-effectiveness of active implementation of CPGs for acute LBP is sparse. The IMPLEMENT study will consider the incremental benefits and costs of progressing beyond development and dissemination to implementation.

Methods/design

Cost-effectiveness and cost-utility analyses alongside the IMPLEMENT cluster randomised controlled trial (CRCT) from a societal perspective to quantify the additional costs (savings) and health gains associated with a targeted implementation strategy as compared with access to the CPG via dissemination only.

Discussion

The protocol provided here registers our intent to conduct an economic evaluation alongside the IMPLEMENT study, facilitates peer-review of proposed methods and provides a transparent statement of planned analyses.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN012606000098538     

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.     

Performance of health workers in the management of seriously sick children at a kenyan tertiary hospital: before and after a training intervention

Background

Implementation of WHO case management guidelines for serious common childhood illnesses remains a challenge in hospitals in low-income countries. The impact of locally adapted clinical practice guidelines (CPGs) on the quality-of-care of patients in tertiary hospitals has rarely been evaluated.

Methods and Findings

We conducted, in Kenyatta National Hospital, an uncontrolled before and after study with an attempt to explore intervention dose-effect relationships, as CPGs were disseminated and training was progressively implemented. The emergency triage, assessment and treatment plus admission care (ETAT+) training and locally adapted CPGs targeted common, serious childhood illnesses. We compared performance in the pre-intervention (2005) and post-intervention periods (2009) using quality indicators for three diseases: pneumonia, dehydration and severe malnutrition. The indicators spanned four domains in the continuum of care namely assessment, classification, treatment, and follow-up care in the initial 48 hours of admission. In the pre-intervention period patients'' care was largely inconsistent with the guidelines, with nine of the 15 key indicators having performance of below 10%. The intervention produced a marked improvement in guideline adherence with an absolute effect size of over 20% observed in seven of the 15 key indicators; three of which had an effect size of over 50%. However, for all the five indicators that required sustained team effort performance continued to be poor, at less than 10%, in the post-intervention period. Data from the five-year period (2005–09) suggest some dose dependency though the adoption rate of the best-practices varied across diseases and over time.

Conclusion

Active dissemination of locally adapted clinical guidelines for common serious childhood illnesses can achieve a significant impact on documented clinical practices, particularly for tasks that rely on competence of individual clinicians. However, more attention must be given to broader implementation strategies that also target institutional and organisational aspects of service delivery to further enhance quality-of-care.     

Evidence-Based Medicine,Clinical Practice Guidelines,and Common Sense in the Management of Osteoporosis

ObjectiveTo evaluate the benefits and limitations of randomized controlled trials (RCTs), clinical practice guidelines (CPGs), and clinical judgment in the management of osteoporosis.MethodsA review was conducted of the English-language literature on the origins and applications of RCTs, CPGs, evidence-based medicine, and clinical judgment in the management of osteoporosis.ResultsEvidence-based medicine is use of the currently available best evidence in making clinical decisions for individual patients. CPGs are recommendations for making clinical decisions based on research evidence, sometimes with consideration of expert opinion, health care policy, and costs of care. The highest levels of medical evidence are usually thought to be RCTs and meta-analyses of high-quality RCTs. Although it is desirable and appropriate for clinicians to consider research evidence from RCTs and recommendations presented in CPGs in making clinical decisions, other factors—such as patient preference, comorbidities, affordability, and availability of care—are important for the actual implementation of evidence-based medicine.ConclusionDecisions about who to treat, which drug to use, how best to monitor, and how long to treat require clinical skills in addition to knowledge of medical research. The necessity of integrating common sense and clinical judgment is highlighted by the fact that many patients treated for osteoporosis in clinical practice would not qualify for participation in the pivotal clinical trials that demonstrated efficacy and safety of the drugs used to treat them. (Endocr Pract. 2009;15:573-579)     

Quality of Clinical Practice Guidelines for Glycemic Control in Type 2 Diabetes Mellitus

Background

Several studies have reported that clinical practice guidelines (CPGs) in a variety of clinical areas are of modest or variable quality. The objective of this study was to evaluate the quality of an international cohort of CPGs that provide recommendations on pharmaceutical management of glycemic control in patients with type 2 diabetes mellitus (DM2).

Methods and Findings

We searched the National Guideline Clearinghouse (NGC) on February 15th and June 4th, 2012 for CPGs meeting inclusion criteria. Two independent assessors rated the quality of each CPG using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument. Twenty-four guidelines were evaluated, and most had high scores for clarity and presentation. However, scope and purpose, stakeholder involvement, rigor of development, and applicability domains varied considerably. The majority of guidelines scored low on editorial independence, and only seven CPGs were based on an underlying systematic review of the evidence.

Conclusions

The overall quality of CPGs for glycemic control in DM2 is moderate, but there is substantial variability among quality domains within and across guidelines. Guideline users need to be aware of this variability and carefully appraise and select the guidelines that they apply to patient care.     

Conflict of Interest Disclosures for Clinical Practice Guidelines in the National Guideline Clearinghouse

Background

Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs) and high rates of COI among guideline authors have been reported in the past. Our objective was to report current rates of disclosure and specific author COI across a broad range of CPGs and to examine whether CPG characteristics were associated with the presence of disclosures and of conflicts.

Methods and Findings

We selected a random sample of 250 CPGs listed in the National Guideline Clearinghouse on November 22, 2010, representing approximately a 10% sample of guidelines listed in the NGC on that date. We abstracted information on author COI from each CPG and examined predictors of the disclosures and COI using a logistic generalized estimating equation regression model. 87% of organizations developing guidelines had a CPG-specific policy, however, 40% of CPGs did not indicate that they had collected disclosures from guideline authors. In addition, 42% of organizations that did collect author disclosures did not have those disclosures available in the public domain. Of CPGs where we had disclosures for all authors, 60% had one or more authors with a conflict. On average, 28% of the authors of CPGs with available disclosures had a COI. Guidelines that were published in journals with an impact factor greater than 5.0 were more likely to have one or more authors with a COI than guidelines not published in journals.

Conclusions

Rates of disclosure of author COI and the public availability of that information are unacceptably low, however rates of COI among guideline authors may have decreased in recent years. Continued efforts are needed to establish and enforce optimal COI policies in clinical practice guideline development in order to minimize the risk of bias associated with those conflicts.     

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.     

Proceedings of the 1994 Canadian Clinical Practice Guidelines Network Workshop

A workshop on the Clinical Practice Guidelines (CPG) Network was held in Ottawa on Oct. 31 and Nov. 1, 1994. Five plenary sessions focused on CPGs and the roles of organizations, priority setting, dissemination and implementation, evaluation, and establishment of a network of individuals and organizations active in the CPG field. In general, the participants identified consumers as important stakeholders in CPG processes and agreed that there was a role for national coordination and information gathering, however, local and regional bodies have a role in CPG development, dissemination and implementation. Burden of illness and likeliness that the guidelines would affect the burden were key criteria for setting priorities. Eighteen high-priority topics were identified for CPG development and dissemination. Methods to enhance the effectiveness of dissemination and implementation were identified: improved funding, enhanced research and decreased duplication of effort. Barriers to CPG evaluation were lack of funding and inadequate data sources. Voluntary self-audit was the preferred evaluation method. The participants agreed on three important functions of the network: facilitation, cooperation and communication, operation of a central CPG information centre, and provision of expertise in CPG processes. They also agreed to the use of an existing organization as a secretariat for the network, with a voluntary, informal membership of all those interested.     

Conflict of interest in clinical practice guideline development: a systematic review

Background

There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.

Methodology/Principal Findings

We searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6–80%); research support (4–78%); equity/stock ownership (2–17%); or any COI (56–87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs.

Conclusions/Significance

There are limited data describing the high prevalence of COI among CPG authors, and only case studies of the effect of COI on CPG recommendations. Further research is needed to explore this potential source of bias.     

A Systematic Critical Appraisal of Clinical Practice Guidelines in Juvenile Idiopathic Arthritis Using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) Instrument

Objectives

The objectives of this review are to: 1) appraise the methodological quality of clinical practice guidelines (CPGs) in juvenile idiopathic arthritis (JIA) providing pharmacological and/or non-pharmacological intervention recommendations, and 2) summarize the recommendations provided by the included CPGs and compare them where possible.

Methods

A systematic search was performed. Three trained appraisers independently evaluated the methodological quality of the CPGs using a validated and reliable instrument, the Appraisal of Guidelines in Research and Evaluation II. Six domains were considered: 1) score and purpose; 2) stakeholder involvement; 3) rigor of development; 4) clarity of presentation; 5) applicability; and 6) editorial independence. The domains consist of a total of 23 items each scored on a 7-point scale. High quality CPGs were identified if they had a domain score above 60% in rigor of development, and two other domains.

Results

Of the three included CPGs, the Royal Australian College of General Practitioners (RACGP) and American College of Rheumatology (ACR) CPGs were considered to be of high quality, but the German Society for Pediatric Rheumatology was of lower quality. Domains one to four had high domain scores across the guidelines (mean (standard deviation)): 72.76 (13.80); 66.67 (9.81); 64.67 (7.77); and 87.00 (9.64), respectively. Lower scores were obtained for applicability (14.00 (5.57)) and editorial independence (43.44 (7.02)). Recommendations varied across CPGs due to differences in context, target audience (general practitioners, rheumatologists, and other multidisciplinary healthcare professionals) and patients’ disease presentations. Despite this variability, progression of pharmacological treatment did not conflict between CPGs. Recommendations for non-pharmacological interventions were vague and the interventions considered varied between CPGs.

Conclusions

Overall, recommendations were based on a paucity of evidence and weak study designs. Further research is needed on interventions in JIA, as well as higher quality CPGs to facilitate implementation of the best evidence-based recommendations in clinical practice.     

Medical practice guidelines: lessons from the United States.

Clinical guidelines, or protocols, have been devised by many different groups, often with differing aims. Some aim to reduce variations in care by using guidelines, while others seek to improve outcomes. Guidelines have long been used in the United States to try to control the behaviour of the medical profession--and the cost of health care. The "effectiveness initiative," run by the Agency for Health Care Policy and Research spawned much activity among other groups, including the American Medical Association and the American College of Physicians. The experience of the Americans in analysing data to gauge effectiveness and then in disseminating good practice may help British moves in this direction. In particular, it is often hard to get guidelines adopted in practice; doctors have to be exposed to the same message in different forms. Also guidelines must not be unrealistic: those devised by senior doctors away from the realities of day to day practice are likely to fail.     

Setting priorities and selecting topics for clinical practice guidelines.

Setting priorities and selecting topics are important steps in guidelines development, but they have received relatively little attention to date. Responses from a survey of guidelines stakeholders in Canada suggest that the health burden of a clinical condition on the population is an important factor in priority setting. Economic considerations, cast as either costs of treatment to the health care system or the economic burden of illness to society, are given varying importance by different stakeholder groups. Drawing on the literature and the survey results, the authors propose a framework for priority setting. Important issues requiring consideration include the role of public and community participation, the need for and appropriate emphasis on quantitative data regarding current practice and its variation, and mechanisms to link guidelines to health-policy development and management of the health care system.