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Clinical practice guidelines for osteoarthritis
Abstract
The movement towards evidence-based medicine has highlighted the importance of using the best possible evidence to inform the care of patients. However, healthcare practices are not always based on evidence, resulting in inconsistencies and gaps in the provision of care of many diseases, such as osteoarthritis [1,2]. Clinical practice guidelines have the potential to improve the consistency and quality of care within existing resources [3]. Clinical practice guidelines (CPGs) in the field of rheumatology have proliferated because rheumatic diseases, such as osteoarthritis (OA), have become more prevalent and are a leading cause of disability in most developed countries [4]. Several CPGs have appraised the evidence for the many treatments available and presented clinical recommendations for OA. This chapter will explain the strengths and limitations of CPGs. It will present different CPGs that have been developed to improve the care of patients with OA in the past 10 years. An appraisal of their methodological quality and a presentation of their results and dissemination procedures will follow. Finally, recommendations will be made to ensure that CPGs lead to the best care for patients with OA.
... In order to make optimal and accurate clinical decisions for their arthritic patients, health professionals should use high-quality CPGs. In previous systematic reviews [13][14][15][16], CPGs that considered non-pharmacological and pharmacological interventions have been appraised. However, the CPGs which targeted only non-pharmacological interventions have never been assessed with the Appraisal of Guidelines Research and Evaluation II (AGREE II) tool [14][15]. ...
... In previous systematic reviews [13][14][15][16], CPGs that considered non-pharmacological and pharmacological interventions have been appraised. However, the CPGs which targeted only non-pharmacological interventions have never been assessed with the Appraisal of Guidelines Research and Evaluation II (AGREE II) tool [14][15]. Our paper focused on the quality assessment of non-pharmacological interventions, especially in terms of rigour of development. ...
... In the past, OA CPGs have been evaluated with the AGREE I instrument [13][14]16,45]. To our knowledge, the AGREE II instrument has been used to appraise pharmacological and nonpharmacological CPGs for the management of OA; however, no quality scoring was presented in the literature [15]. Therefore, the results of this review can only be compared partially with previous literature for CPGs on non-pharmacological and pharmacological interventions. ...
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.
... Although CPGs still involve an expert panel, they are increasingly evidence based. Hence, CPGs have a growing influence on clinical practice due to a movement toward the use of evidence-based medicine in clinical decision making [1]. Increasing healthcare costs are also a driving influence for the development of CPGs for clinical decision making, as a tool for limiting healthcare expenditure on treatments not proven to be effective [2]. ...
... There has been a surge of CPG development on osteoarthritis (OA) treatment, perhaps reflecting the increasing prevalence of OA as a cause of disability, particularly in developed countries [1]. Several organizations developed their own CPGs for knee OA, and the quality of these guidelines is highly variable. ...
Clinical practice guidelines are of increasing importance in the decision making for the treatment of knee osteoarthritis. Inconsistent recommendations regarding the use of intra-articular hyaluronic acid for the treatment of knee osteoarthritis have led to confusion among treating physicians.
Literature search to identify clinical practice guidelines that provide recommendations regarding the use of intra-articular hyaluronic acid treatment for knee osteoarthritis was conducted. Included guidelines were appraised using the AGREE II instrument. Guideline development methodologies, how the results were assessed, the recommendation formation, and work group composition were summarized.
Overall, 10 clinical practice guidelines were identified that met our inclusion criteria. AGREE II domain scores were variable across the included guidelines. The methodology utilized across the guidelines was heterogeneous regarding the evidence inclusion criteria, analysis of evidence results, formulation of clinical practice recommendations, and work group composition. The recommendations provided by the guidelines for intra-articular hyaluronic acid treatment for knee osteoarthritis are highly inconsistent as a result of the variability in guideline methodology. Overall, 30% of the included guidelines recommended against the use of intra-articular hyaluronic acid in the treatment of knee osteoarthritis, while 30% deemed the treatment an appropriate intervention under certain scenarios. The remaining 40% of the guidelines provided either an uncertain recommendation or no recommendation at all, based on the high variability in reviewed evidence regarding efficacy and trial quality.
There is a need for a standard "appropriate methodology" that is agreed upon for osteoarthritis clinical practice guidelines in order to prevent the development of conflicting recommendations for intra-articular hyaluronic acid treatment for knee osteoarthritis, and to assure that treating physicians who are utilizing these guidelines are making their clinical decisions on the best available evidence. At present, the inconsistent recommendations provided for intra-articular hyaluronic acid treatment make it difficult for clinical professionals to determine its appropriateness when treating patients with knee osteoarthritis.
Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
... In the past, only one critical appraisal using AGREE I instrument has been conducted on CPGs available for the non-pharmacological management of RA [15]. Although the AGREE II instrument has been used to assess the quality of some CPGs for the management of osteoarthritis [10,[16][17], the quality of non-pharmacological CPGs for the management of RA have not been assessed with this updated instrument. Therefore, there is a need to appraise non-pharmacological CPGs for RA -so that health care providers can identify which CPGs in RA are high-quality and reliable to use in their practice. ...
Clinical practice guidelines (CPGs) have been developed to summarize evidence about the management of rheumatoid arthritis (RA) and facilitate the uptake of evidence-based knowledge by consumers, health professionals, health administrators and policy makers. The objectives of this review was to assess the quality of CPGS on non-pharmacological management of RA with a standardized and validated instrument - the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool and summarize the key recommendations from these CPGs. Scientific literature databases from 2001 to 2013 were systematically searched and a total of 13 CPGs for RA was identified. Only a minority of AGREE II domains were effectively addressed by the CPGS. Scope and purpose was effectively addressed in 10 out of 13 CPGs, stakeholder involvement in 11 CPGs, rigor of development in 6 CPGs, clarity/presentation in 9 CPGs, editorial independence in 1 CPGs, and applicability in none of the CPGs. The overall quality of the included CPGs according to the 7-point AGREE II scoring system was 4.8±1.04. Patient education/self-management, aerobic, dynamic and stretching exercises were the commonly recommended for the non-pharmacological management of RA by the high-quality CPGs. The general clinical management recommendations tended to be similar among high-quality CPGs. Non-pharmacological management interventions were superficially addressed in more than half of the selected CPGs. CPGs creators should use the AGREE II criteria when developing guidelines. Innovative and effective methods of CPGs implementation to users are needed to ultimately enhance the quality of life of arthritic individuals. In addition, it was difficult to establish between strongly recommended, recommended and weakly recommended, as there is no consensus between the strength of the recommendations between the appraised CPGs.
Objective:
To summarize changes in recommendations for injection treatments for knee osteoarthritis (OA) in current clinical practice guidelines (CPGs) and to assess whether these changes have affected public interest according to Google data and content in YouTube videos.
Design:
A literature search to identify CPGs revised since 2019 that provide recommendations regarding the five intra-articular injection treatments for knee OA (corticosteroid [CS], hyaluronic acid [HA], stem cell [SC], platelet-rich plasma [PRP], and botulinum toxin [BT]) was conducted to assess perspective changes for each treatment. Data from Google Trends were examined to identify changes in search volume from 2004 to 2021 using a join-point regression model. Relevant YouTube videos were divided into those uploaded before and after changes in CPGs and compared according to degrees of recommendation for each treatment to identify the effect of changes in CPGs on video production.
Results:
All eight identified CPGs released after 2019 recommended HA and CS use. Most CPGs were the first to state a neutral or opposing stance concerning the use of SC, PRP, or BT. Interestingly, relative searches on Google for SC, PRP, and BT has increased greater than those for CS and HA. YouTube videos produced after CPGs changed continue to recommend SC, PRP, and BT as much as those produced before CPGs were revised.
Conclusions:
Although knee OA CPGs have changed, public interest and healthcare information providers on YouTube have not reacted to this shift. Improved methods to propagate updates to CPGs warrant consideration.
The objective of this study was to observe the immediate effect of a knee brace with a patellar hole versus without a patellar hole on pain perception in patients with knee osteoarthritis. To accomplish this, a double-blind, randomized controlled trial enrolled 108 patients divided into two groups (knee brace with a patellar hole or without a patellar hole). Patients were evaluated by the Visual Analogue Scale (VAS) in order to measure their pain sensation, the Timed Up and Go (TUG) test was used to evaluate their ability to walk, and the 8-m walking test (8MWT) was used to estimate their walking speed. Both groups presented significant reduction in pain perception, higher function of the lower extremities, and greater mobility while wearing a knee brace. However, the patients who wore a knee brace without a patellar hole presented more favorable results than those who wore a knee brace with a patellar hole: a 1.6-point reduction was found versus 1.1 points in the VAS, the patients presented 0.7 s less time versus 0.4 s in the TUG, and the speed was reduced by 1.4 s versus 0.8 s in the 8MWT. Therefore, the knee brace without a patellar hole presented more favorable results when compared with the knee brace with a patellar hole.
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 …
Clinical guidelines have been the subject of much criticism in primary care literature partly due to potential conflicts in their implementation among patients with multiple chronic conditions. We assessed the relevance of selected Canadian clinical guidelines on chronic diseases for patients with comorbidity and examined their quality.
We selected 16 chronic medical conditions according to their frequency of occurrence, complexity of treatment, and pertinence to primary care. Recent Canadian clinical guidelines (2004 - 2009) on these conditions, published in English or French, were retrieved. We assessed guideline relevance to the care of patients with comorbidity with a tool developed by Boyd and colleagues. Quality was assessed using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument.
Regarding relevance, 56.2% of guidelines addressed treatment for patients with multiple chronic conditions and 18.8% addressed the issue for older patients. Fifteen guidelines (93.8%) included specific recommendations for patients with one concurrent condition; only three guidelines (18.8%) addressed specific recommendations for patients with two comorbid conditions and one for more than two concurrent comorbid conditions. Quality of the evaluated guidelines was good to very good in four out of the six domains measured using the AGREE instrument. The domains with lower mean scores were Stakeholder Involvement and Applicability.
The quality of the Canadian guidelines examined is generally good, yet their relevance for patients with two or more chronic conditions is very limited and there is room for improvement in this respect.
Guidelines continue to be underutilized, and a variety of strategies to improve their use have been suboptimal. Modifying guideline features represents an alternative, but untested way to promote their use. The purpose of this study was to identify and define features that facilitate guideline use, and examine whether and how they are included in current guidelines.
A guideline implementability framework was developed by reviewing the implementation science literature. We then examined whether guidelines included these, or additional implementability elements. Data were extracted from publicly available high quality guidelines reflecting primary and institutional care, reviewed independently by two individuals, who through discussion resolved conflicts, then by the research team.
The final implementability framework included 22 elements organized in the domains of adaptability, usability, validity, applicability, communicability, accommodation, implementation, and evaluation. Data were extracted from 20 guidelines on the management of diabetes, hypertension, leg ulcer, and heart failure. Most contained a large volume of graded, narrative evidence, and tables featuring complementary clinical information. Few contained additional features that could improve guideline use. These included alternate versions for different users and purposes, summaries of evidence and recommendations, information to facilitate interaction with and involvement of patients, details of resource implications, and instructions on how to locally promote and monitor guideline use. There were no consistent trends by guideline topic.
Numerous opportunities were identified by which guidelines could be modified to support various types of decision making by different users. New governance structures may be required to accommodate development of guidelines with these features. Further research is needed to validate the proposed framework of guideline implementability, develop methods for preparing this information, and evaluate how inclusion of this information influences guideline use.
To develop evidence based recommendations for the management of hip osteoarthritis (OA).
The multidisciplinary guideline development group comprised 18 rheumatologists, 4 orthopaedic surgeons, and 1 epidemiologist, representing 14 European countries. Each participant contributed up to 10 propositions describing key clinical aspects of hip OA management. Ten final recommendations were agreed using a Delphi consensus approach. Medline, Embase, CINAHL, Cochrane Library, and HTA reports were searched systematically to obtain research evidence for each proposition. Where possible, outcome data for efficacy, adverse effects, and cost effectiveness were abstracted. Effect size, rate ratio, number needed to treat, and incremental cost effectiveness ratio were calculated. The quality of evidence was categorised according to the evidence hierarchy. The strength of recommendation was assessed using the traditional A-D grading scale and a visual analogue scale.
Ten key treatment propositions were generated through three Delphi rounds. They included 21 interventions, such as paracetamol, NSAIDs, symptomatic slow acting disease modifying drugs, opioids, intra-articular steroids, non-pharmacological treatment, total hip replacement, osteotomy, and two general propositions. 461 studies were identified from the literature search for the proposed interventions of efficacy, side effects, and cost effectiveness. Research evidence supported 15 interventions in the treatment of hip OA. Evidence specific for the hip was strikingly lacking. Strength of recommendation varied according to category of research evidence and expert opinion.
Ten key recommendations for the treatment of hip OA were developed based on research evidence and expert consensus. The effectiveness and cost effectiveness of these recommendations were evaluated and the strength of recommendation was scored.
We undertook research to improve the AGREE instrument, a tool used to evaluate guidelines. We tested a new seven-point scale, evaluated the usefulness of the original items in the instrument, investigated evidence to support shorter, tailored versions of the tool, and identified areas for improvement.
We report on one component of a larger study that used a mixed design with four factors (user type, clinical topic, guideline and condition). For the analysis reported in this article, we asked participants to read a guideline and use the AGREE items to evaluate it based on a seven-point scale, to complete three outcome measures related to adoption of the guideline, and to provide feedback on the instrument's usefulness and how to improve it.
Guideline developers gave lower-quality ratings than did clinicians or policy-makers. Five of six domains were significant predictors of participants' outcome measures (p < 0.05). All domains and items were rated as useful by stakeholders (mean scores > 4.0) with no significant differences by user type (p > 0.05). Internal consistency ranged between 0.64 and 0.89. Inter-rater reliability was satisfactory. We received feedback on how to improve the instrument.
Quality ratings of the AGREE domains were significant predictors of outcome measures associated with guideline adoption: guideline endorsements, overall intentions to use guidelines, and overall quality of guidelines. All AGREE items were assessed as useful in determining whether a participant would use a guideline. No clusters of items were found more useful by some users than others. The measurement properties of the seven-point scale were promising. These data contributed to the refinements and release of the AGREE II.
We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user's manual in the beta version of the AGREE II.
We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user's manual and completed a survey assessing the manual.
In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the beta-AGREE II could be improved.
The validity of the items was established and the user's manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user's manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation.
To present a descriptive overview of the quality and recommendations of clinical practice guidelines (CPGs) on diagnosis or management of osteoarthritis (OA) of the hip and/or knee.
CPGs were identified from several research databases (MEDLINE, EMBASE and The Cochrane Library) and guideline-specific databases from 1966 to August 2005. GUIDELINE RETRIEVAL: Thirty-four relevant CPGs were identified.
Recommendations were extracted from CPGs and categorised into: assessment and diagnosis, pharmacological management, nonpharmacological management, complementary/alternative therapy, or surgery. The quality of the CPGs were assessed by two appraisers using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument.
Most recommendations for aspects of diagnosis and treatment of OA of the hip and/or knee were consistent among the CPGs included in this study. However, quality varied considerably, with few CPGs being "strongly recommended" according to the AGREE quality appraisal instrument.
Given the number of CPGs available relevant to OA, and the consistency of recommendations within them, and considering the time and resources required for CPG development, future efforts to guide management of OA of the hip and/or knee may be better directed towards adapting existing CPGs to the local context, implementing practices known to be effective, and facilitating research to answer important questions where there is little evidence.
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.
To update the EULAR recommendations for management of knee osteoarthritis (OA) by an evidence based medicine and expert opinion approach.
The literature search and guidelines were restricted to treatments for knee OA pertaining to clinical and/or radiological OA of any compartment of the knee. Papers for combined treatment of knee and other types of OA were excluded. Medline and Embase were searched using a combination of subject headings and key words. Searches for those treatments previously investigated were conducted for January 1999 to February 2002 and for those treatments not previously investigated for 1966 to February 2002. The level of evidence found for each treatment was documented. Quality scores were determined for each paper, an effect size comparing the treatment with placebo was calculated, where possible, and a toxicity profile was determined for each treatment modality.
497 new publications were identified by the search. Of these, 103 were intervention trials and included in the overall analysis, and 33 treatment modalities were identified. Previously identified publications which were not exclusively knee OA in the initial analysis were rejected. In total, 545 publications were included. Based on the results of the literature search and expert opinion, 10 recommendations for the treatment of knee OA were devised using a five stage Delphi technique. Based on expert opinion, a further set of 10 items was identified by a five stage Delphi technique as important for future research.
The updated recommendations support some of the previous propositions published in 2000 but also include modified statements and new propositions. Although a large number of treatment options for knee OA exist, the evidence based format of the EULAR Recommendations continues to identify key clinical questions that currently are unanswered.
The problems of getting people to act on evidence
based guidelines are widely recognised. An overview
of 41 systematic reviews found that the most promising
approach was to use a variety of interventions
including audit and feedback, reminders, and educational
outreach. The effective interventions often
involved complicated procedures and were always an
addition to the provision of guidelines. None of the
studies used the simplest intervention—that is, changing
the wording of the guidelines. We examine the
importance of precise behavioural recommendations
and suggest how some current guidelines could be
improved.
To undertake a systematic review of the effectiveness and costs of different guideline development, dissemination and implementation strategies. To estimate the resource implications of these strategies. To develop a framework for deciding when it is efficient to develop and introduce clinical guidelines.
MEDLINE, Healthstar, Cochrane Controlled Trial Register, EMBASE, SIGLE and the specialised register of the Cochrane Effective Practice and Organisation of Care (EPOC) group.
Single estimates of dichotomous process variables were derived for each study comparison based upon the primary end-point or the median measure across several reported end-points. Separate analyses were undertaken for comparisons of different types of intervention. The study also explored whether the effects of multifaceted interventions increased with the number of intervention components. Studies reporting economic data were also critically appraised. A survey to estimate the feasibility and likely resource requirements of guideline dissemination and implementation strategies in UK settings was carried out with key informants from primary and secondary care.
In total, 235 studies reporting 309 comparisons met the inclusion criteria; of these 73% of comparisons evaluated multifaceted interventions, although the maximum number of replications of a specific multifaceted intervention was 11 comparisons. Overall, the majority of comparisons reporting dichotomous process data observed improvements in care; however, there was considerable variation in the observed effects both within and across interventions. Commonly evaluated single interventions were reminders, dissemination of educational materials, and audit and feedback. There were 23 comparisons of multifaceted interventions involving educational outreach. The majority of interventions observed modest to moderate improvements in care. No relationship was found between the number of component interventions and the effects of multifaceted interventions. Only 29.4% of comparisons reported any economic data. The majority of studies only reported costs of treatment; only 25 studies reported data on the costs of guideline development or guideline dissemination and implementation. The majority of studies used process measures for their primary end-point, despite the fact that only three guidelines were explicitly evidence based (and may not have been efficient). Respondents to the key informant survey rarely identified existing budgets to support guideline dissemination and implementation strategies. In general, the respondents thought that only dissemination of educational materials and short (lunchtime) educational meetings were generally feasible within current resources.
There is an imperfect evidence base to support decisions about which guideline dissemination and implementation strategies are likely to be efficient under different circumstances. Decision makers need to use considerable judgement about how best to use the limited resources they have for clinical governance and related activities to maximise population benefits. They need to consider the potential clinical areas for clinical effectiveness activities, the likely benefits and costs required to introduce guidelines and the likely benefits and costs as a result of any changes in provider behaviour. Further research is required to: develop and validate a coherent theoretical framework of health professional and organisational behaviour and behaviour change to inform better the choice of interventions in research and service settings, and to estimate the efficiency of dissemination and implementation strategies in the presence of different barriers and effect modifiers.
Clinical practice guidelines (CPGs) have been developed to improve the quality of health care for many chronic conditions. Pay-for-performance initiatives assess physician adherence to interventions that may reflect CPG recommendations.
To evaluate the applicability of CPGs to the care of older individuals with several comorbid diseases.
The National Health Interview Survey and a nationally representative sample of Medicare beneficiaries (to identify the most prevalent chronic diseases in this population); the National Guideline Clearinghouse (for locating evidence-based CPGs for each chronic disease).
Of the 15 most common chronic diseases, we selected hypertension, chronic heart failure, stable angina, atrial fibrillation, hypercholesterolemia, diabetes mellitus, osteoarthritis, chronic obstructive pulmonary disease, and osteoporosis, which are usually managed in primary care, choosing CPGs promulgated by national and international medical organizations for each.
Two investigators independently assessed whether each CPG addressed older patients with multiple comorbid diseases, goals of treatment, interactions between recommendations, burden to patients and caregivers, patient preferences, life expectancy, and quality of life. Differences were resolved by consensus. For a hypothetical 79-year-old woman with chronic obstructive pulmonary disease, type 2 diabetes, osteoporosis, hypertension, and osteoarthritis, we aggregated the recommendations from the relevant CPGs.
Most CPGs did not modify or discuss the applicability of their recommendations for older patients with multiple comorbidities. Most also did not comment on burden, short- and long-term goals, and the quality of the underlying scientific evidence, nor give guidance for incorporating patient preferences into treatment plans. If the relevant CPGs were followed, the hypothetical patient would be prescribed 12 medications (costing her 406 dollars per month) and a complicated nonpharmacological regimen. Adverse interactions between drugs and diseases could result.
This review suggests that adhering to current CPGs in caring for an older person with several comorbidities may have undesirable effects. Basing standards for quality of care and pay for performance on existing CPGs could lead to inappropriate judgment of the care provided to older individuals with complex comorbidities and could create perverse incentives that emphasize the wrong aspects of care for this population and diminish the quality of their care. Developing measures of the quality of the care needed by older patients with complex comorbidities is critical to improving their care.
To develop evidence based recommendations for the management of hand osteoarthritis (OA).
The multidisciplinary guideline development group comprised 16 rheumatologists, one physiatrist, one orthopaedic surgeon, two allied health professionals, and one evidence based medicine expert, representing 15 different European countries. Each participant contributed up to 10 propositions describing key clinical points for management of hand OA. Final recommendations were agreed using a Delphi consensus approach. A systematic search of Medline, Embase, CINAHL, Science Citation Index, AMED, Cochrane Library, HTA, and NICE reports was used to identify the best available research evidence to support each proposition. Where possible, the effect size and number needed to treat were calculated for efficacy. Relative risk or odds ratio was estimated for safety, and incremental cost effectiveness ratio was used for cost effectiveness. The strength of recommendation was provided according to research evidence, clinical expertise, and perceived patient preference.
Eleven key propositions involving 17 treatment modalities were generated through three Delphi rounds. Treatment topics included general considerations (for example, clinical features, risk factors, comorbidities), non-pharmacological (for example, education plus exercise, local heat, and splint), pharmacological (for example, paracetamol, NSAIDs, NSAIDs plus gastroprotective agents, COX-2 inhibitors, systemic slow acting disease modifying drugs, intra-articular corticosteroids), and surgery. Of 17 treatment modalities, only six were supported by research evidence (education plus exercise, NSAIDs, COX-2 inhibitors, topical NSAIDs, topical capsaicin, and chondroitin sulphate). Others were supported either by evidence extrapolated from studies of OA affecting other joint sites or by expert opinion. Strength of recommendation varied according to level of evidence, benefits and harms/costs of the treatment, and clinical expertise.
Eleven key recommendations for treatment of hand OA were developed using a combination of research based evidence and expert consensus. The evidence was evaluated and the strength of recommendation was provided.
Clinical practice guidelines have been elaborated to summarize evidence related to the management of knee osteoarthritis and to facilitate uptake of evidence-based knowledge by clinicians. The objectives of the present review were summarizing the recommendations of existing guidelines on knee osteoarthritis, and assessing the quality of the guidelines using a standardized and validated instrument--the Appraisal of Guidelines Research and Evaluation (AGREE) tool. Internet medical literature databases from 2001 to 2006 were searched for guidelines, with six guidelines being identified. Thirteen clinician researchers participated in the review. Each reviewer was trained in the AGREE instrument. The guidelines were distributed to four groups of three or four reviewers, each group reviewing one guideline with the exception of one group that reviewed two guidelines. One independent evaluator reviewed all guidelines. All guidelines effectively addressed only a minority of AGREE domains. Clarity/presentation was effectively addressed in three out of six guidelines, scope/purpose and rigour of development in two guidelines, editorial independence in one guideline, and stakeholder involvement and applicability in none. The clinical management recommendation tended to be similar among guidelines, although interventions addressed varied. Acetaminophen was recommended for initial pain treatment, combined with exercise and education. Nonsteroidal anti-inflammatory drugs were recommended if acetaminophen failed to control pain, but cautiously because of gastrointestinal risks. Surgery was recommended in the presence of persistent pain and disability. Education and activity management interventions were superficially addressed in most guidelines. Guideline creators should use the AGREE criteria when developing guidelines. Innovative and effective methods of knowledge translation to health professionals are needed.
This study aims to contribute to the knowledge of the influence of comorbidity in OA. The objectives of the study were (i) to describe the prevalence of comorbidity and (ii) to describe the relationship between comorbidity (morbidity count, severity and the presence of specific diseases) and limitations in activities and pain in elderly patients with knee or hip OA using a comprehensive inventory of comorbidity.
A cross-sectional cohort study was conducted, in which 288 elderly patients with hip or knee osteoarthritis were included. Apart from demographic and clinical data, information about comorbidity, limitations in activities (WOMAC, SF-36 and timed walking test) and pain (VAS) was collected by questionnaires and tests. Statistical analyses included descriptive statistics, multivariate regression techniques, t-tests and one-way ANOVA.
Almost all patients suffered from at least one comorbid disease, with cardiac diseases, diseases of eye, ear, nose, throat and larynx, other urogenital diseases and endocrine/metabolic diseases being most prevalent. Morbidity count and severity index were associated with more limitations in activities and with more pain. The presence of most of the moderate or severe diseases and obesity was associated with limitations in activities or with pain.
The results of this study emphasize the importance of comorbidity in the rehabilitation of elderly patients with osteoarthritis of the hip or knee. Clinical practitioners should be aware of the relationship of comorbidity with functional problems in OA patients.
Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety. Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers. This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development.
Objective: To review the evidence from controlled trials of the effects of computer-based clinical decision support systems (CDSSs) on clinician performance and patient outcomes. Data Sources: The literature in the MEDLARS, EMBASE, SCISEARCH, and INSPEC databases was searched from 1974 to the present. Conference proceedings and reference lists of relevant articles were reviewed. Evaluators of CDSSs were asked to identify additional studies. Study Selection: 793 citations were examined, and 28 controlled trials that met predefined criteria were reviewed in detail. Data Extraction: Study quality was assessed, and data on setting, clinicians and patients, method of allocation, computer system, and outcomes were abstracted and verified using a structured form
Summary points
Summary pointsGuidelines are a way to support effective clinical practiceThere is a growing body of literature on the factors that influence the effectiveness of guidelinesReference to these factors will enhance the likelihood of achieving the objectives of guidelinesThe use of this series of reflective questions rooted in this literature will support the effective development, dissemination,implementation, and review of guidelines
The assessment of a health practice and the development of a policy for the use of that practice is the final step in a long process that begins with a research idea and ends in actual changes in people's health. All the accumulated research, development, and experience is converted into practical recommendations that largely determine what happens to a patient. In this pivotal position the design of a policy deserves whatever effort is required to ensure that all the proceeding work is put to the best effect1There is an explosion of interest in guidelines, reflected in a vivid debate ranging from “the best thing since sliced bread” to cries of “cookbook medicine” and fears of constraint on clinical freedom.2 3 4 5 6 7 8 Furthermore, the Department of Health has introduced an initiative to encourage the adoption of evidence based guidelines within purchaser-provider contracts,9 10 and a review of the effectiveness of clinical guidelines has recently been published.11The subject of guidelines is complex. Even for enthusiasts, ensuring that guidelines are effective by addressing each part of the complex chain of development, dissemination, implementation, and evaluation (fig 1) can be a daunting task. There are an increasing number of publications on the subject--for example, on the details of guideline development and effectiveness.1 12 13 14 15 16 In particular, the seminal work of Grimshaw and Russell has led to a …
Objective . To evaluate the nature, risks, and benefits of osteoarthritis (OA) management by primary care physicians and rheumatologists.
Methods . Subjects were 419 patients followed for symptoms of knee OA by either a specialist in family medicine (FM) or general internal medicine (GIM) or by a rheumatologist (RH). Management practices were characterized by in‐home documentation by a visiting nurse of drugs taken to relieve OA pain or to prevent gastrointestinal side effects of nonsteroidal anti‐inflammatory drugs (NSAIDs) and by patient report (self‐administered survey) of nonpharmacologic treatments. Changes in outcomes (knee pain and physical function) over 6 months were measured with the Western Ontario and McMaster Universities Osteoarthritis Index.
Results . Patients of RHs were 2‐3 years older (P = 0.035) and tended to exhibit greater radiographic severity of OA (P = 0.064) and poorer physical function (P = 0.076) at baseline than the other 2 groups. In all 3 groups, knee pain and physical function improved slightly over 6 months; however, between‐group differences were not significant. Compared to drug management of knee pain by FMs or RHs, that by the GIMs was distinguished by greater utilization of acetaminophen and nonacetylated salicylates (P = 0.008), lower prescribed doses of NSAIDs (P = 0.007), and, therefore, lower risk of iatrogenic gastroenteropathy (P < 0.001). In contrast, patients of RHs were more likely than those of FMs and GIMs to report that they had been instructed in use of isometric quadriceps and range‐of‐motion exercises (P ≦ 0.001), application of heat (P = 0.051) and cold (P < 0.001) packs, and in the principles of joint protection (P = 0.016). Neither physician specialty nor specific management practices accounted for variations in patient outcomes.
Conclusion . This observational study identified specialty‐related variability in key aspects of the management of knee OA in the community (i.e., frequency and dosing of NSAIDs, use of nonpharmacologic modalities) that bear strong implications for long‐term safety and cost. However, changes in knee pain and function over 6 months were unrelated to variations in management practices.
Reliable, comparable information about the main causes of disease and injury in populations, and how these are changing, is a critical input for debates about priorities in the health sector. Traditional sources of information about the descriptive epidemiology of diseases, injuries, and risk factors are generally incomplete, fragmented, and of uncertain reliability and comparability. The Global Burden of Disease (GBD) Study has provided a conceptual and methodological framework to quantify and compare the health of populations using a summary measure of both mortality and disability, the disability-adjusted life year (DALY). This article describes key features of the Global Burden of Disease analytic approach, the evolution of the GBD starting from the first study for the year 1990, and summarizes the methodological improvements incorporated into GBD revisions carried out by the World Health Organization. It also reviews controversies and criticisms, and examines priorities and issues for future GBD updates. © 2008
To update the American College of Rheumatology (ACR) 2000 recommendations for hip and knee osteoarthritis (OA) and develop new recommendations for hand OA.
A list of pharmacologic and nonpharmacologic modalities commonly used to manage knee, hip, and hand OA as well as clinical scenarios representing patients with symptomatic hand, hip, and knee OA were generated. Systematic evidence-based literature reviews were conducted by a working group at the Institute of Population Health, University of Ottawa, and updated by ACR staff to include additions to bibliographic databases through December 31, 2010. The Grading of Recommendations Assessment, Development and Evaluation approach, a formal process to rate scientific evidence and to develop recommendations that are as evidence based as possible, was used by a Technical Expert Panel comprised of various stakeholders to formulate the recommendations for the use of nonpharmacologic and pharmacologic modalities for OA of the hand, hip, and knee.
Both “strong” and “conditional” recommendations were made for OA management. Modalities conditionally recommended for the management of hand OA include instruction in joint protection techniques, provision of assistive devices, use of thermal modalities and trapeziometacarpal joint splints, and use of oral and topical nonsteroidal antiinflammatory drugs (NSAIDs), tramadol, and topical capsaicin. Nonpharmacologic modalities strongly recommended for the management of knee OA were aerobic, aquatic, and/or resistance exercises as well as weight loss for overweight patients. Nonpharmacologic modalities conditionally recommended for knee OA included medial wedge insoles for valgus knee OA, subtalar strapped lateral insoles for varus knee OA, medially directed patellar taping, manual therapy, walking aids, thermal agents, tai chi, self management programs, and psychosocial interventions. Pharmacologic modalities conditionally recommended for the initial management of patients with knee OA included acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid injections; intraarticular hyaluronate injections, duloxetine, and opioids were conditionally recommended in patients who had an inadequate response to initial therapy. Opioid analgesics were strongly recommended in patients who were either not willing to undergo or had contraindications for total joint arthroplasty after having failed medical therapy. Recommendations for hip OA were similar to those for the management of knee OA.
These recommendations are based on the consensus judgment of clinical experts from a wide range of disciplines, informed by available evidence, balancing the benefits and harms of both nonpharmacologic and pharmacologic modalities, and incorporating their preferences and values. It is hoped that these recommendations will be utilized by health care providers involved in the management of patients with OA.
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.
Many computer software developers and vendors claim that their systems can directly improve clinical decisions. As for other health care interventions, such claims should be based on careful trials that assess their effects on clinical performance and, preferably, patient outcomes.
To systematically review controlled clinical trials assessing the effects of computer-based clinical decision support systems (CDSSs) on physician performance and patient outcomes.
We updated earlier reviews covering 1974 to 1992 by searching the MEDLINE, EMBASE, INSPEC, SCISEARCH, and the Cochrane Library bibliographic databases from 1992 to March 1998. Reference lists and conference proceedings were reviewed and evaluators of CDSSs were contacted.
Studies were included if they involved the use of a CDSS in a clinical setting by a health care practitioner and assessed the effects of the system prospectively with a concurrent control.
The validity of each relevant study (scored from 0-10) was evaluated in duplicate. Data on setting, subjects, computer systems, and outcomes were abstracted and a power analysis was done on studies with negative findings.
A total of 68 controlled trials met our criteria, 40 of which were published since 1992. Quality scores ranged from 2 to 10, with more recent trials rating higher (mean, 7.7) than earlier studies (mean, 6.4) (P<.001). Effects on physician performance were assessed in 65 studies and 43 found a benefit (66%). These included 9 of 15 studies on drug dosing systems, 1 of 5 studies on diagnostic aids, 14 of 19 preventive care systems, and 19 of 26 studies evaluating CDSSs for other medical care. Six of 14 studies assessing patient outcomes found a benefit. Of the remaining 8 studies, only 3 had a power of greater than 80% to detect a clinically important effect.
Published studies of CDSSs are increasing rapidly, and their quality is improving. The CDSSs can enhance clinical performance for drug dosing, preventive care, and other aspects of medical care, but not convincingly for diagnosis. The effects of CDSSs on patient outcomes have been insufficiently studied.
As a prelude to developing updated, evidence-based, international consensus recommendations for the management of hip and knee osteoarthritis (OA), the Osteoarthritis Research Society International (OARSI) Treatment Guidelines Committee undertook a critical appraisal of published guidelines and a systematic review (SR) of more recent evidence for relevant therapies.
Sixteen experts from four medical disciplines (primary care two, rheumatology 11, orthopaedics one and evidence-based medicine two), two continents and six countries (USA, UK, France, Netherlands, Sweden and Canada) formed the guidelines development team. Three additional experts were invited to take part in the critical appraisal of existing guidelines in languages other than English. MEDLINE, EMBASE, Science Citation Index, CINAHL, AMED, Cochrane Library, seven Guidelines Websites and Google were searched systematically to identify guidelines for the management of hip and/or knee OA. Guidelines which met the inclusion/exclusion criteria were assigned to four groups of four appraisers. The quality of the guidelines was assessed using the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument and standardised percent scores (0-100%) for scope, stakeholder involvement, rigour, clarity, applicability and editorial independence, as well as overall quality, were calculated. Treatment modalities addressed and recommended by the guidelines were summarised. Agreement (%) was estimated and the best level of evidence to support each recommendation was extracted. Evidence for each treatment modality was updated from the date of the last SR in January 2002 to January 2006. The quality of evidence was evaluated using the Oxman and Guyatt, and Jadad scales for SRs and randomised controlled trials (RCTs), respectively. Where possible, effect size (ES), number needed to treat, relative risk (RR) or odds ratio and cost per quality-adjusted life year gained (QALY) were estimated.
Twenty-three of 1462 guidelines or consensus statements retrieved from the literature search met the inclusion/exclusion criteria. Six were predominantly based on expert opinion, five were primarily evidence based and 12 were based on both. Overall quality scores were 28%, 41% and 51% for opinion-based, evidence-based and hybrid guidelines, respectively (P=0.001). Scores for aspects of quality varied from 18% for applicability to 67% for scope. Thirteen guidelines had been developed for specific care settings including five for primary care (e.g., Prodigy Guidance), three for rheumatology (e.g., European League against Rheumatism recommendations), three for physiotherapy (e.g., Dutch clinical practice guidelines for physical therapy) and two for orthopaedics (e.g., National Institutes of Health consensus guidelines), whereas 10 did not specify the target users (e.g., Ontario guidelines for optimal therapy). Whilst 14 guidelines did not separate hip and knee, eight were specific for knee but only one for hip. Fifty-one different treatment modalities were addressed by these guidelines, but only 20 were universally recommended. Evidence to support these modalities ranged from Ia (meta-analysis/SR of RCTs) to IV (expert opinion). The efficacy of some modalities of therapy was confirmed by the results of RCTs published between January 2002 and 2006. These included exercise (strengthening ES 0.32, 95% confidence interval (CI) 0.23, 0.42, aerobic ES 0.52, 95% CI 0.34, 0.70 and water-based ES 0.25, 95% CI 0.02, 0.47) and nonsteroidal anti-inflammatory drugs (NSAIDs) (ES 0.32, 95% CI 0.24, 0.39). Examples of other treatment modalities where recent trials failed to confirm efficacy included ultrasound (ES 0.06, 95% CI -0.39, 0.52), massage (ES 0.10, 95% CI -0.23, 0.43) and heat/ice therapy (ES 0.69, 95% CI -0.07, 1.45). The updated evidence on adverse effects also varied from treatment to treatment. For example, while the evidence for gastrointestinal (GI) toxicity of non-selective NSAIDs (RR=5.36, 95% CI 1.79, 16.10) and for increased risk of myocardial infarction associated with rofecoxib (RR=2.24, 95% CI 1.24, 4.02) were reinforced, evidence for other potential drug related adverse events such as GI toxicity with acetaminophen or myocardial infarction with celecoxib remained inconclusive.
Twenty-three guidelines have been developed for the treatment of hip and/or knee OA, based on opinion alone, research evidence or both. Twenty of 51 modalities of therapy are universally recommended by these guidelines. Although this suggests that a core set of recommendations for treatment exists, critical appraisal shows that the overall quality of existing guidelines is sub-optimal, and consensus recommendations are not always supported by the best available evidence. Guidelines of optimal quality are most likely to be achieved by combining research evidence with expert consensus and by paying due attention to issues such as editorial independence, stakeholder involvement and applicability. This review of existing guidelines provides support for the development of new guidelines cognisant of the limitations in existing guidelines. Recommendations should be revised regularly following SR of new research evidence as this becomes available.
To develop concise, patient-focussed, up to date, evidence-based, expert consensus recommendations for the management of hip and knee osteoarthritis (OA), which are adaptable and designed to assist physicians and allied health care professionals in general and specialist practise throughout the world.
Sixteen experts from four medical disciplines (primary care, rheumatology, orthopaedics and evidence-based medicine), two continents and six countries (USA, UK, France, Netherlands, Sweden and Canada) formed the guidelines development team. A systematic review of existing guidelines for the management of hip and knee OA published between 1945 and January 2006 was undertaken using the validated appraisal of guidelines research and evaluation (AGREE) instrument. A core set of management modalities was generated based on the agreement between guidelines. Evidence before 2002 was based on a systematic review conducted by European League Against Rheumatism and evidence after 2002 was updated using MEDLINE, EMBASE, CINAHL, AMED, the Cochrane Library and HTA reports. The quality of evidence was evaluated, and where possible, effect size (ES), number needed to treat, relative risk or odds ratio and cost per quality-adjusted life years gained were estimated. Consensus recommendations were produced following a Delphi exercise and the strength of recommendation (SOR) for propositions relating to each modality was determined using a visual analogue scale.
Twenty-three treatment guidelines for the management of hip and knee OA were identified from the literature search, including six opinion-based, five evidence-based and 12 based on both expert opinion and research evidence. Twenty out of 51 treatment modalities addressed by these guidelines were universally recommended. ES for pain relief varied from treatment to treatment. Overall there was no statistically significant difference between non-pharmacological therapies [0.25, 95% confidence interval (CI) 0.16, 0.34] and pharmacological therapies (ES=0.39, 95% CI 0.31, 0.47). Following feedback from Osteoarthritis Research International members on the draft guidelines and six Delphi rounds consensus was reached on 25 carefully worded recommendations. Optimal management of patients with OA hip or knee requires a combination of non-pharmacological and pharmacological modalities of therapy. Recommendations cover the use of 12 non-pharmacological modalities: education and self-management, regular telephone contact, referral to a physical therapist, aerobic, muscle strengthening and water-based exercises, weight reduction, walking aids, knee braces, footwear and insoles, thermal modalities, transcutaneous electrical nerve stimulation and acupuncture. Eight recommendations cover pharmacological modalities of treatment including acetaminophen, cyclooxygenase-2 (COX-2) non-selective and selective oral non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs and capsaicin, intra-articular injections of corticosteroids and hyaluronates, glucosamine and/or chondroitin sulphate for symptom relief; glucosamine sulphate, chondroitin sulphate and diacerein for possible structure-modifying effects and the use of opioid analgesics for the treatment of refractory pain. There are recommendations covering five surgical modalities: total joint replacements, unicompartmental knee replacement, osteotomy and joint preserving surgical procedures; joint lavage and arthroscopic debridement in knee OA, and joint fusion as a salvage procedure when joint replacement had failed. Strengths of recommendation and 95% CIs are provided.
Twenty-five carefully worded recommendations have been generated based on a critical appraisal of existing guidelines, a systematic review of research evidence and the consensus opinions of an international, multidisciplinary group of experts. The recommendations may be adapted for use in different countries or regions according to the availability of treatment modalities and SOR for each modality of therapy. These recommendations will be revised regularly following systematic review of new research evidence as this becomes available.