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Objective: To perform a cost effectiveness analysis of cyclosporine (CyA) in the treatment of rheumatoid arthritis (RA)., Methods: Five randomized controlled parallel group clinical trials were selected for metaanalysis. A fixed effects model was used to calculate the treatment effects among the studies. An incremental economic analysis was performed from both a societal perspective and the perspective of Ontario Ministry of Health (MOH). A placebo comparison and 2 head to head comparisons were performed. The total treatment cost was calculated for a typical patient based on a modified intent to treat approach modelled over a one year period., Results: CyA produced a 25% or greater improvement in tender joint account in 35% of the patients relative to 17% of patients receiving placebo. There was no significant difference in improvement between CyA and azathioprine (Aza) or D-penicillamine (D-Pen). From the perspective of the Ontario MOH, the annual incremental cost of achieving the same level of improvement between CyA and Aza was found to be $1,473, and between CyA and D-Pen, $1,618; the annual incremental cost effectiveness ratio per patient improved of adopting CyA over placebo was $11,547. From a societal perspective, the incremental cost of CyA was $2,886 and $3,731 between Aza and D-Pen, respectively. The annual incremental cost effectiveness ratio against placebo was $20,698., Conclusion: Given budgetary constraints on provincial drug plans, guidelines identifying patients in whom the cost effectiveness of CyA may be expected to be most favorable need to be explored. When CyA is the last option available to alleviate RA, whether it is "good value for money" depends upon the importance placed on patient improvement by the patients and/or by society, and on the alternative uses of the same scarce resources.

Objective: To obtain a better quantitative and qualitative estimate of the effect of tenoxicam (Tx) compared to piroxicam (Px), diclofenac (Dcl) and indomethacin (Ind) in the treatment of osteoarthritis (OA)., Methods: Relevant studies were identified using computerized Medline search, manual search of cited references and correspondence with investigators, colleagues and the manufacturer of Tx. Once the studies were selected and chosen on the basis of predetermined methodologic criteria, the required data were extracted by 2 authors, independently. Eighteen studies met the required eligibility criteria. Meta-analyses were undertaken on 12 studies of Tx vs Px, 3 studies of Tx vs Dcl, and 2 studies of Tx vs Ind. Efficacy was measured in 2 ways: (1) physician global rating scale and (2) pain scale. Safety was measured in 3 ways: (1) physician global rating scale, (2) number of patients with adverse events, and (3) dropouts due to adverse events., Results: The following findings of the meta-analysis were statistically significant: In Tx vs Px comparisons, efficacy-(1), safety-(1) and safety-(3) were all better with Tx; in Tx vs Ind comparisons, safety-(1) and safety-(2) were better with Tx. All other findings showed no statistically significant differences between Tx and the comparison drug., Conclusions: Compared to Px, Tx performs better on physician assessment of efficacy and tolerability, but the other comparisons remain inconclusive. Compared to Dcl, there appears not to be a difference. Compared to Ind, Tx is safer.

Because economic evaluations of health care services are being published with increasing frequency it is important to (a) evaluate them rigorously and (b) compare the net benefit of the application of one technology with that of others. Four "levels of evidence" that rate economic evaluations on the basis of their methodologic rigour are proposed. They are based on the quality of the methods used to estimate clinical effectiveness, quality of life and costs. With the use of the magnitude of the incremental net benefit of a technology, therapies can also be classified into five "grades of recommendation." A grade A technology is both more effective and cheaper than the existing one, whereas a grade E technology is less or equally effective and more costly. Those of grades B through D are more effective and more costly. A grade B technology costs less than $20,000 per quality-adjusted life-year (QALY), a grade C one $20,000 to $100,000/QALY and a grade D one more than $100,000/QALY. Many issues other than cost effectiveness, such as ethical and political considerations, affect the implementation of a new technology. However, it is hoped that these guidelines will provide a framework with which to interpret economic evaluations and to identify additional information that will be useful in making sound decisions on the adoption and utilization of health care services.

The prevalence of complaints of thoracic pain or stiffness in the past 6 months was assessed by examination, HLA typing and sacroiliac radiographs in 420 relatives of 275 B27+ probands with ankylosing spondylitis (AS). AS or sacroiliitis was found in 15 of 420 relatives (3.6%). The gender of the proband did not influence the probability of AS or sacroiliitis among the relatives. In the absence of sacroiliitis, B27+ relatives had chest pain more often (31 of 208, or 14.9%) than B27- relatives (13 of 197, or 6.6%) (p less than 0.01). Chest pain assessed by questionnaire was associated with pain on pressure at the costosternal junctions. The concept of AS as a combination of radiographic sacroiliitis plus clinical signs or symptoms may be too narrow.

While measurement of quality of life is a vital part of assessing the effect of treatment in many clinical trials, a measure that is responsive to clinically important change is often unavailable. Investigators are therefore faced with the challenge of constructing an index for a specific condition or even for a single trial. There are several stages in the development and testing of a quality-of-life measure: selecting an initial item pool, choosing the "best" items from that pool, deciding on questionnaire format, pretesting the instrument, and demonstrating the responsiveness and validity of the instrument. At each stage the investigator must choose between a rigorous, time-consuming approach to questionnaire construction that will establish the clinical relevance, responsiveness and validity of the instrument and a more efficient, less costly strategy that leaves reproducibility, responsiveness and validity untested. This article describes these options and outlines a pragmatic approach that yields consistently satisfactory disease-specific measures of quality of life.

Studies in which clinicians' therapeutic plans are determined before and after application of a new test offer an attractive alternative to randomized trials as a strategy for establishing the usefulness of diagnostic technologies. To maximize scientific credibility such studies should include a number of design features: specific clinical questions should be addressed; consecutive patients presenting with a clinical problem should be entered; the test's accuracy should be assessed; and changes in therapy should be described in sufficient detail to allow an estimate of the impact on patient outcome. Even with attention to these issues, the validity of before-after studies of therapeutic impact is limited by possible discrepancies between clinicians' stated plans and actual behavior, and by the often tenuous link between change in therapy and patient benefit. Before-after designs will be most useful in primary investigations which, if positive, should be followed by more rigorous studies to establish patient benefit.

Most new diagnostic technologies have not been adequately assessed to determine whether their application improves health. Comprehensive evaluation of diagnostic technologies includes establishing technologic capability and determining the range of possible uses, diagnostic accuracy, impact on the health care provider, therapeutic impact and impact on patient outcome. Guidelines to determine whether each of these criteria have been met adequately are presented. Diagnostic technologies should be disseminated only if they are less expensive, produce fewer untoward effects and are at least as accurate as existing methods, if they eliminate the need for other investigations without loss of accuracy, or if they lead to institution of effective therapy. Establishing patient benefit often requires a randomized controlled trial in which patients receive the new test or an alternative diagnostic strategy. Other study designs are logistically less difficult but may not provide accurate assessment of benefit. Rigorous assessment of diagnostic technologies is needed for efficient use of health care resources.