Clinical quality management: putting the pieces together.
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Biomedical subjects
Publications and source records attributed to G Stucki.
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We describe the favourable long-term outcome after late total knee joint prosthesis infection in an elderly RA patient. Peptostreptococcus micros and Propionibacterium acnes were cultured from the synovial fluid, and the finding of a coexistent abscess at the root of a wisdom tooth suggested a dental origin to the joint infection. Long-term antibiotics in conjunction with aspiration/irrigation resulted in salvage of the implant and an excellent functional outcome.
The objective of this study was to analyze the problem of interpreting change scores of ordinal health status measures for clinical research or practice. Methods used included exploration of the generation of change scores in the physical ability scale of the SF-36, one of the most widely used generic health status instruments. Resulting data are presented as the ranking of items according to baseline score; a percentage of patients with severe difficulty and Rasch analysis provided the same rank order of item difficulty. On the interval scale provided by the Rasch model a concentration of items reflecting moderate difficulty occurred. This "inflates" numerical gains for patients with moderate disability compared to patients with very severe or minor physical disability. Calibration of change scores using patient perception of the level of change in function showed important variation of numerical gains with baseline. We conclude that numerically equal gains may differ in their meaning depending on baseline health status. It is recommended that distribution of baseline health status measures and distribution of responders by baseline status be reported in evaluative studies.
The aim of this study was to evaluate the interobserver reliability of parametric and non-parametric variables in the clinical assessment of hip and knee osteoarthritis (OA). Three rheumatologists examined 49 patients with different radiological stages of OA using different assessment tools such as a tape measure, a goniometer, a plurimeter and a hand-held pull gauge. The reliabilities of parametric variables calculated by analysis of variance (ANOVA) showed much higher values than the non-parametric ones calculated by Kendall's tau beta. The highest levels of correlation in hip OA between clinical functional tests and radiological changes were found for hip extension (r = 0.57; P < 0.01) and the Patrick sign (r = 0.54; P < 0.01) while in knee OA the highest correlations were found for knee circumference (r = 0.5; P < 0.01) and knee flexion (r = 0.035; P < 0.02). Knee muscle strength, as measured with a hand-held pull gauge, showed a high level of interobserver agreement (r = 0.79), but correlated poorly with radiological changes. In conclusion parametric variables of joint morphology as knee circumference of parametric variables of function as the Patrick sign should be preferred for assessing secondary endpoints in OA clinical trials.
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OBJECTIVE: To examine the association among the BILAG disease activity index components and their relations with global assessments, health status, and laboratory tests with regard to the validity of the BILAG index. METHODS: A cross sectional study of consecutive patients with systemic lupus erythematosus (SLE) attending a specialist lupus outpatient clinic between July 1994 and February 1995. The internal consistency of the British Isles Lupus Assessment Group (BILAG) index-a disease activity assessment system for SLE patients, based on the principle of the physician's intention to treat-was examined using Cronbach's coefficient alpha. The association of the components of the BILAG index with health status as measured with the MOS Short Form 20 (SF-20), with patients' and doctors' global assessments of patient wellbeing and with laboratory tests was analysed with Spearman rank correlations. RESULTS: 133 female and eight male patients, age 20.1 to 88.7 years (mean 41.1, SD 12.5), were included. With few exceptions, the components of the BILAG index which reflect disease activity in different organ systems were not associated with each other. With the exception of the mucocutaneous component, we found a significant relation between all components of BILAG and global assessment of patient wellbeing, health status, erythrocyte sedimentation rate, or serum C3 level. CONCLUSIONS: The study confirms the validity of all but the mucocutaneous component of the BILAG index. However, disease activity in different organ systems in SLE does not follow a common pattern. Thus the individual BILAG components should be used rather than the total BILAG score as a primary endpoint in clinical and epidemiological studies. To capture the total effect of SLE on an individual measures of disease activity, damage, and health status are all needed.
Misoprostol is a prostaglandin E1 analogue which reduces both gastric ulcerations and clinically important bleeding in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). Economic evaluations of prophylactic use of misoprostol with NSAIDs differ in their conclusions mainly because of different assumptions regarding the absolute risk reduction of symptomatic ulcers. Assuming a conservative estimate of the absolute risk reduction based on new effectiveness data, all studies would have concluded that misoprostol prophylaxis results in net costs in the general population of NSAID users. However, in the elderly with a clearly increased risk of gastrointestinal (GI) lesions and ulcer complications, and an increased hospitalisation rate, misoprostol may be cost saving. Also, in the elderly the gain in quality of life seems to offset the uncertain reduction in quality of life due to the adverse effects of misoprostol. However, the suggestion that misoprostol prophylaxis in the elderly is cost effective or cost saving needs to be confirmed in further studies.
OBJECTIVE: In rheumatoid arthritis (RA) serum creatine kinase (CK) is reduced in association with inflammatory response variables. Our objective was to examine whether low CK is associated with muscle weakness and to what extent the hypothesized relationship between CK and muscle weakness can be explained by anthropometric and sociodemographic variables and/or disease variables. METHODS: Cross sectional and longitudinal retrospective analyses of clinical, radiological, and biochemical data of a prospective cohort of consecutive patients with RA. Isometric muscle strength was measured with a validated muscle strength index (MSI); CK was measured with an enzymatic assay (N-acetyl-cysteine, 37 degrees C). RESULTS: 65 patients were enrolled in the study and we obtained complete one year followup data from 47. In cross sectional analysis, CK was a significant, moderate correlate of the MSI (r = 0.43, p < 0.01). CK remained a significant explanatory variable of the MSI in multivariate models that controlled for demographic variables and lean body mass, corticosteroid use, and biochemical, clinical, and radiological disease variables. In longitudinal dichotomous analyses, worsening in CK was weakly but significantly associated with decreased muscle strength, whereas in linear analyses the association did not reach significance. CONCLUSION: In patients with RA, low CK activity is associated with muscle weakness. Demographic, anthropometric, and disease variables related to muscle mass or muscle atrophy explain only part of this association. Our findings support the hypothesis that muscle weakness may be partly caused by a disease related reduction of CK activity independent of muscle atrophy.
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Osteoarthritis of the knee joint is the most prevalent cause of disability in older patients. Isolated medial tibio-femoral compartment disease is by far the most common localization among the various combinations within the knee joint that is affected by osteoarthritis. Interestingly, the risk factors for the disease process in the medial tibio-femoral compartment are not the same for the femoropatellar disease. The diagnosis is not only based on the history and the clinical examination of the knee joint cartilage and bone, but it also includes the clinical assessment of periarticular structures of the knee. Standard radiographic examination should be performed in most cases to confirm the diagnosis. Unfortunately, so far no specific therapy is available that halts or cures the disease process in osteoarthritis. One probable exception are the corrective osteotomies. Conservative treatment strategies include prevention, therapy of established early and late end-stage disease. A proper combination of nonpharmacologic treatment and drug therapy is, together with the seldom indicated joint lavage, the key for satisfied patients. Information and assurance of the patients and their families prevents them from unjustified fears and frustration and is a strong promoter for an excellent compliance in successful programs to improve muscle strength.
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Longterm follow-up of patients with rheumatoid arthritis requires systematic measurement of all relevant disease dimensions. The disease process can be measured reliably with the disease activity score (DAS) which integrates the erythrocyte sedimentation rate and the number of swollen and the number of tender joints out of 28 defined joints. Cumulatively the disease process may result in joint damage which can be measured with a radiological score averaging the level of destruction of 10 key joints. Synovitis and/or joint damage lead to reduced joint mobility and muscle strength which may be quantified using a muscle strength index (MSI) which integrates the information of isometric muscle strength of knee and elbow extension and flexion. The most important outcome dimensions are symptoms and physical functional disability, which can be measured comprehensively with a symptom-oriented rheumatoid arthritis disease activity index (RADAI) and the health assessment questionnaire (HAQ). Reduction of a wide range of information to a few valid indices representing all relevant disease dimensions allows interpretable but comprehensive evaluation of the disease course.
Crystal-associated destructive arthropathy of the shoulder is most commonly observed in elderly women. Functional impairment and social impact define its importance especially in this group. Clinical features include pain at rest and on use, large cool effusion and instability. Radiographs show attrition of bone and cartilage with a paucity of reparative changes. Synovial fluids are viscous, with low cell counts, and stain positively for the presence of apatite-containing particles and often also for calcium-pyrophosphate crystals.
OBJECTIVE: To examine the psychometric properties and construct validity of a self-administered Rheumatoid Arthritis Disease Activity Index (RADAI). METHODS: Five items of the Rapid Assessment of Disease Activity in Rheumatology (RADAR) questionnaire were aggregated into the RADAI and assessed for their factor loading, internal consistency, and construct validity. RESULTS: In 55 patients with RA, the RADAI had a high internal consistency (Cronbach's alpha = 0.91) and correlated with physician's assessment of disease activity (r = 0.54, P < 0.01), the swollen joint count (r = 0.54, P < 0.01), and the C-reactive protein value (r = 0.43, P < 0.01). CONCLUSION: The RADAI is a highly reliable and valid self-administered measure of disease activity for clinical, health services, and epidemiologic research. Its sensitivity to change in longitudinal studies needs further study.
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OBJECTIVE: To assess the value of the history and physical examination findings in the diagnosis of symptomatic degenerative lumbar spinal stenosis (LSS). METHODS: The study was performed in 3 specialty clinics, and included patients with low back pain who were at least age 40. Findings from a standardized history and physical examination were compared with the diagnostic impression of expert attending clinicians. Imaging studies were available in 88% of those with LSS, and the findings further supported the diagnosis of LSS in each case. The sensitivity, specificity, and likelihood ratio associated with each history and physical examination finding were calculated in bivariate analyses, and independent correlates of LSS were identified with multivariate analyses. RESULTS: Ninety-three patients were evaluated. History findings most strongly associated with the diagnosis of LSS (likelihood ratio > or = 2) were greater age, severe lower-extremity pain, and absence of pain when seated. Physical examination findings most strongly associated with the diagnosis were wide-based gait, abnormal Romberg test result, thigh pain following 30 seconds of lumbar extension, and neuromuscular deficits. Independent correlates of LSS included advanced age (P = 0.0001), absence of pain when seated (P = 0.006), wide-based gait (P = 0.013), and thigh pain following 30 seconds of lumbar extension (P = 0.002). CONCLUSION: Specific history and physical examination findings are useful in the diagnosis of LSS and should be ascertained routinely in older patients with low back pain.
OBJECTIVE: To assess the comparative usefulness of the Short Form-36 (SF-36) and the Sickness Impact Profile, (SIP) as generic health status measures in total hip arthroplasty. METHODS: Analysis of preoperative and 3-month data of 54 consecutive patients undergoing total hip replacement for osteoarthritis or rheumatoid arthritis. Instruments were mailed to patients preoperatively and 3 months postoperatively. RESULTS: In 10 of the 12 SIP subscales, but just 1 of the 8 SF-36 subscales, more than 40% of the patients had scores of zero. On a 100-point scale, the median global SIP was 12 (range 0-40) whereas the median global SF-36 was 50 (range 10-85). This indicates that many items of the SIP were not germane to patients undergoing joint arthroplasty. The global and, particularly, the physical dimensions of the SF-36 were more responsive than their SIP counterparts, as measured both by the standardized response mean (1.26 and 0.88, respectively) and the correlation with self-perceived improvement in quality of life (r = 0.37 and 0.26, respectively). The SF-36, but not the SIP, discriminated between patients with relatively good physical performance at 3 months with respect to their ability to work, to play sports, or to garden. CONCLUSION: The SF-36 is briefer, more relevant, and more responsive than the SIP and is preferable as a generic health status measure in patients undergoing elective hip arthroplasty. The SF-36 should be tested in other populations as well as other conditions to determine whether it is a superior generic health status instrument for evaluative research in orthopedic surgery.
The objective of this study was to compare the relative responsiveness of a condition-specific spinal stenosis measure and two generic health status measures for outcome assessment of surgery for degenerative lumbar spinal stenosis, and to examine whether responsiveness statistics and measures of the ability to distinguish clinically important improvement rank the instruments consistently. Physical function and symptom severity scales of the spinal stenosis measure were compared to the Sickness Impact Profile (SIP) and the Roland scale, which is derived from the SIP. Responsiveness was calculated with the standardized response mean, the effect size, and Guyatt's responsiveness statistic. The discriminative ability of the instruments to distinguish patients who improved from those who did not was assessed using satisfaction with surgery as an external criterion. Minimal clinically relevant improvement was estimated using patient satisfaction as the external criterion. All responsiveness statistics revealed the same order of responsiveness; the physical function scale (SRM = 1.07) and symptom severity scales (SRM = 0.96) were more responsive than the Roland scale (SRM = 0.77) which was only slightly more responsive than the SIP (SRM = 0.69). Strikingly, the physical dimension of the SIP (SRM = 0.62) was even less responsive than the global SIP. The shape of and the area under the ROC curves showed that the physical function and symptom severity scales discriminate better between satisfied and unsatisfied patients than the Roland scale and SIP. The sensitivity to detect clinically important changes was somewhat lower at the ends of the scales, especially for the SIP and the Roland scale. Statistical approaches that assess the ability to distinguish clinically important changes and overall responsiveness statistics ranked the measures consistently. On the basis of these findings, we suggest that a condition-specific spinal stenosis measure is preferable as the primary end point in evaluative studies of degenerative lumbar spinal stenosis.