Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

BACKGROUND: The tissue origin of low back pain (LBP) or referred lower extremity symptoms (LES) may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. METHODS: We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC) statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. RESULTS: In a sample of chronic LBP patients (n = 216) with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement (PCC) was estimated at 13%. "Exact" agreement between clinical and reference standard diagnoses was 32% and "clinical agreement" 51%. For six pathoanatomic categories (disc, facet joint, sacroiliac joint, hip joint, nerve root and spinal stenosis), PCC was 33% with actual agreement 56%. There was no overlap of 95% confidence intervals on any comparison. Diagnostic agreement on the six most common patho-anatomic categories produced a kappa of 0.31. CONCLUSION: Clinical diagnoses agree with reference standards diagnoses more often than chance. Using available reference standards, most patients can have a tissue source of pain identified

Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (−45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (−73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time

A Comparison of Cobb Angle : Standing Versus Supine Images of Late-Onset Idiopathic Scoliosis

Background: Scoliosis is traditionally evaluated by measuring the Cobb angle in radiograph images taken while the patient is standing. However, low-dose computed tomography (CT) images, which are taken while the patient is in a supine position, provide new opportunities to evaluate scoliosis. Few studies have investigated how the patient's position, standing or supine, affects measurements. The purpose of this study was to compare the Cobb angle in images from patients while standing versus supine.less thanbr /greater thanMaterial/methods: A total of 128 consecutive patients (97 females and 21 males; mean age 15.5 [11-26] years) with late-onset scoliosis requiring corrective surgery were enrolled. One observer evaluated the type of curve (Lenke classification) and measured the Cobb angle in whole-spine radiography (standing) and scout images from low-dose CT (supine) were taken on the same day.less thanbr /greater thanResults: For all primary curves, the mean Cobb angle was 59 (SD 12) while standing and 48 (SD 12) while in the supine position, with a mean difference of 11 (SD 5). The correlation between primary standing and supine images had an r value of 0.899 (95% CI 0.860-0.928) and an intra-class correlation coefficient value of 0.969. The correlation between the difference in standing and supine images from primary and secondary curves had an r value of 0.340 (95% CI 0.177-0.484).less thanbr /greater thanConclusions: We found a strong correlation between the Cobb angle in images obtained while the patient was standing versus supine for primary and secondary curves. This study is only applicable for patients with severe curves requiring surgical treatment. It enables additional studies based on low-dose CT

What can we learn from patient claims? : Analysing of patient injuries following orthopaedic surgery

Background: Objective data on the incidence and pattern of adverse events after orthopaedic surgical procedures remain scarce, secondary to the reluctance for encompassing reporting of surgical complications. The aim of this study was to analyze the nature of adverse events after orthopaedic surgery reported to a national database for patient claims in Sweden. Methods: In this retrospective review data from two Swedish national databases during a 4-year period were analyzed. We used the "County Councils' Mutual Insurance Company", a national no-fault insurance system for patient claims, and the "National Patient Register at the National Board of Health and Welfare". Results: A total of 6,029 patient claims filed after orthopaedic surgery were assessed during the study period. Of those, 3,336 (55%) were determined to be adverse events, which received financial compensation. Hospital-acquired infections and sepsis were the most common causes of adverse events (n = 741; 22%). The surgical procedure that caused the highest rate of adverse events was "decompression of spinal cord and nerve roots" (code ABC**), with 168 adverse events of 17,507 hospitals discharges (1%). One in five (36 of 168; 21.4%) injured patient was seriously disabled or died. Conclusions: We conclude that patients undergoing spinal surgery run the highest risk of being severely injured and that these patients also experienced a high degree of serious disability. The most common adverse event was related to hospital acquired infections. Claims data obtained in a no-fault system have a high potential for identifying adverse events and learning from them.On the day of the defence date the status of this article was "Manuscript".</p

F.E.M. Stress-Investigation of Scolios Apex

In scoliosis, kypholordos and wedge properties of the vertebrae should be involved in determining how stress is distributed in the vertebral column. The impact is logically expected to be maximal at the apex

Fully automatic measurements of axial vertebral rotation for assessment of spinal deformity in idiopathic scoliosis

Reliable measurements of spinal deformities in idiopathic scoliosis are vital, since they are used for assessing the degree of scoliosis, deciding upon treatment and monitoring the progression of the disease. However, commonly used two dimensional methods (e.g. the Cobb angle) do not fully capture the three dimensional deformity at hand in scoliosis, of which axial vertebral rotation (AVR) is considered to be of great importance. There are manual methods for measuring the AVR, but they are often time-consuming and related with a high intra- and inter-observer variability. In this paper, we present a fully automatic method for estimating the AVR in images from computed tomography. The proposed method is evaluated on four scoliotic patients with 17 vertebrae each and compared with manual measurements performed by three observers using the standard method by Aaro-Dahlborn. The comparison shows that the difference in measured AVR between automatic and manual measurements are on the same level as the inter-observer difference. This is further supported by a high intraclass correlation coefficient (0.971-0.979), obtained when comparing the automatic measurements with the manual measurements of each observer. Hence, the provided results and the computational performance, only requiring approximately 10 to 15 s for processing an entire volume, demonstrate the potential clinical value of the proposed method