OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited.

BACKGROUND: The OARSI Standing Committee for Clinical Trials Response Criteria Initiative had developed two sets of responder criteria to present the results of changes after treatment in three symptomatic domains (pain, function, and patient's global assessment) as a single variable for clinical trials (1). For each domain, a response was defined by both a relative and an absolute change, with different cut-offs with regard to the drug, the route of administration and the OA localization. OBJECTIVE: To propose a simplified set of responder criteria with a similar cut-off, whatever the drug, the route or the OA localization. METHODS: Data driven approach: (1) Two databases were considered: the "elaboration" database with which the formal OARSI sets of responder criteria were elaborated, and the "revisit" database. (2) Six different scenarios were evaluated: The two formal OARSI sets of criteria; Four proposed scenarios of simplified sets of criteria. Data from clinical randomized blinded placebo controlled trials were used to evaluate the performances of the two formal scenarios with two different databases ("elaboration" versus "revisit") and those of the four proposed simplified scenarios within the "revisit" database. The placebo effect, active effect, treatment effect, and the required sample arm size to obtain the placebo effect and the active treatment effect observed were the performances evaluated for each of the six scenarios. Experts' opinion approach: Results were discussed among the participants of the OMERACT VI meeting, who voted to select the definite OMERACT-OARSI set of criteria (one of the six evaluated scenarios). RESULTS: Data driven approach: Fourteen trials totaling 1886 OA patients and fifteen studies involving 8164 OA patients were evaluated in the "elaboration"and the "revisit" databases respectively. The variability of the performances observed in the "revisit" database when using the different simplified scenarios was similar to that observed between the two databases ("elaboration" versus "revisit") when using the formal scenarios. The treatment effect and the required sample arm size were similar for each set of criteria. Experts' opinion approach: According to the experts, these two previous performances were the most important of an optimal set of responder criteria. They chose the set of criteria considering both pain and function as evaluation domain and requiring an absolute change and a relative change from baseline to define a response, with similar cut-offs whatever the drug, the route of administration or the OA localization. CONCLUSION: This data driven and experts' opinion approach is the basis for proposing an optimal simplified set of responder criteria for OA clinical trials. Other studies, using other sets of OA patients, are required in order to further validate this proposed OMERACT-OARSI set of criteria.

Report of the American Medical Association (AMA) Council on Scientific Affairs and AMA recommendations to medical professional staff on the use of wireless radio-frequency equipment in hospitals.

In lieu of a comprehensive technical assessment, this report of the American Medical Association (AMA) Council on Scientific Affairs reviews the issue of electromagnetic interference (EMI) with medical devices caused by the use of wireless radio-frequency (RF) equipment such as cellular telephones, 2-way radios, and pagers. It identifies medical device EMI problems that have been reported and guidance that has been published to assist hospital personnel in assessing and minimizing the potential for EMI in the hospital and in making informed risk management decisions. For more-detailed information on this subject, readers are encouraged to consult publications from various scientific and health care organizations.

Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative.

BACKGROUND: The domains of pain, function and patient's global assessment are identified as core variables and frequently measured in clinical trials of patients with osteoarthritis (OA) of the hip and knee. OBJECTIVE: To develop response criteria for OA of hip and knee based on the domains of pain, function and patient's global assessment. METHODS: A methodology was developed by an interaction of the Osteoarthritis Research Society International Standing Committee on Clinical Trials, biostatisticians, pharmaceutical company representatives and health agency representatives. Data from previously conducted placebo-controlled clinical trials were normalized and collated. Data were subset by location of OA (knee, hip), active agent used in the clinical trial (non-steroidal anti-inflammatory drug, other agent) and route of administration (oral, intra-articular). Statistical analysis identified response criteria which best discriminate active agent from placebo. RESULTS: Based on the analysis of data from 14 studies (totaling 1886 patients) and consensus opinion, the optimal responder criteria set differed for location of OA, active agent to be used, and route of administration. Because of nearly identical statistical results, two sets of responder criteria are proposed: (1) 'high' pain response or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment; (2) 'high' response for either pain or function or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment. The sensitivity (i.e., the percentage of responders in the active group) ranged from 52 to 96% and the specificity (i.e., the percentage of nonresponders in the control group) from 47 to 73%. CONCLUSION: Based on data from clinical trials, two sets of responder criteria have been developed that can categorize an individual's responses to treatment in a clinical trial. These responder criteria require validation in additional datasets.

Radiographic assessment of progression in osteoarthritis.

We evaluated methods of grading radiologic progression of osteoarthritis (OA). Sets of radiographs were assessed separately by 8 readers who were blinded to the time sequence. Included were radiographs of patients with OA of the hands (24 pairs), hips (40 pairs), and knees (32 pairs). Most films were taken 12-60 months apart. The relative contribution of individual joints (such as particular interphalangeal joints), of observations (such as narrowing or spurs), and of a single joint compartment (such as the medial or lateral compartment of the knee) toward evidence of OA progression was evaluated, as well as the reliability and concordance of scoring, and the sensitivity in detecting change. In assessing OA of the hand, the greatest sensitivity was achieved by reading a single posteroanterior bilateral hand radiograph for narrowing, spurs, and erosions, and scoring 10 joints (second and third distal interphalangeal, second and third proximal interphalangeal, and trapeziometacarpal joints, bilaterally), using a scale of 0-3. In OA of the hip, a single anteroposterior radiograph assessed for joint space narrowing and cyst formation yielded the greatest sensitivity. In OA of the knee, an anteroposterior radiograph, with weight-bearing, assessed for narrowing, spurs, and sclerosis in both the medial and lateral compartments yielded the greatest sensitivity. These techniques will be useful to the investigator in designing experimental studies and to the clinician in determining the rate of disease progression in an individual patient.

Method for calculating costs of steam sterilization devised.

Through a study at 10 hospitals located throughout the United States, a method for determining the costs of operating steam sterilization equipment was devised and tested. Any hospital central sterile supply manager can use this method to monitor his sterilizers' cost per hour of operation and cost per load.