Controversies Surrounding the BMD Reporting Standard for the Determination of 10-Year Absolute Fracture Risk: A Canadian Perspective.

The Canadian Association of Radiologists and Osteoporosis Canada currently endorse a fracture risk prediction tool called CAROC. It has been used in Canada since 2005 with an update in 2010. It is an integral part of bone mineral densitometry reporting across the country. New osteoporosis guidelines from Osteoporosis Canada (OC) are expected in the near future. There has been pressure on radiologists to report fracture risk using an alternative fracture risk prediction platform called FRAX. In addition, OC collaborated in the development of the Canadian FRAX model and has been copromoting both FRAX and CAROC, raising the prospect that new guidelines may seek to replace CAROC with FRAX for fracture risk determination. A number of concerns have been raised about FRAX, including: (1) FRAX has not released its algorithms to the public domain with the consequence that it is impossible to verify results for an individual patient; (2) FRAX has incorrectly claimed that it was developed by the World Health Organization (WHO) and has used this affiliation to promote itself until recently ordered by the WHO to desist; (3) FRAX requires collection of additional clinical information beyond that needed for CAROC, and this patient-reported medical data is prone to substantial error; and (4) despite claims to the contrary, there are no valid studies comparing FRAX to CAROC. We believe it is important that radiologists be aware of these issues in order to provide input into future Technical Standards for Bone Mineral Densitometry Reporting of the Canadian Association of Radiologists.

Recommendations for bone mineral density reporting in Canada: a shift to absolute fracture risk assessment.

In June 2005, new Canadian recommendations for bone mineral density (BMD) reporting in postmenopausal women and older men were published by Osteoporosis Canada (formerly the Osteoporosis Society of Canada) and the Canadian Association of Radiologists. The recommendations were developed by a multidisciplinary working group that included the Canadian Panel of the International Society for Clinical Densitometry and were reviewed and endorsed by multiple stakeholders. Previous Canadian osteoporosis guidelines advised intervention based on an individual's World Health Organization category (normal, osteopenia, or osteoporosis) as a marker of relative fracture risk. In the new approach, an individual's 10-yr absolute fracture risk, rather than BMD alone, is used for fracture risk categorization. Absolute fracture risk is determined using not only BMD results, but also age, sex, fragility fracture history, and glucocorticoid use. A procedure is presented for estimating absolute 10-yr fracture risk in untreated individuals, leading to assigning an individual to 1 of 3 absolute fracture risk categories: low risk (<10% 10-yr fracture risk), moderate risk (10-20%), and high risk (>20%). We propose that an individual's absolute fracture risk category should be the basis for deciding on treatment and frequency of BMD monitoring.

Recognizing and reporting vertebral fractures: reducing the risk of future osteoporotic fractures.

OBJECTIVE: Given the increasing evidence that vertebral fractures are underdiagnosed and not acted on, Osteoporosis Canada and the Canadian Association of Radiologists initiated a project to develop and publish a set of recommendations to promote and facilitate the diagnosis and reporting of vertebral fractures. OPTIONS: The identification of spinal fractures is not uniform. More than 65% of vertebral fractures cause no symptoms. It is also apparent that vertebral fractures are inadequately recognized when the opportunity for diagnosis arises fortuitously. It is to patients' benefit that radiologists report vertebral fractures evident on a chest or other radiograph, no matter how incidental to the immediate clinical indication for the examination. OUTCOMES: The present recommendations can help to close the gap in care in recognizing and treating vertebral fractures, to prevent future fractures and thus reduce the burden of osteoporosis-related morbidity and mortality, as well as fracture-related costs to the health care system. EVIDENCE: Several studies indicate that a gap exists in regard to the diagnosis of vertebral fractures and the clinical response following such diagnosis. All recommendations presented here are based on consensus. VALUES: These recommendations were developed by a multidisciplinary working group under the auspices of the Scientific Advisory Council of Osteoporosis Canada and the Canadian Association of Radiologists. BENEFITS, HARM, AND COSTS: Prevalent vertebral fractures have important clinical implications in terms of future fracture risk. Recognizing and reporting fractures incidental to radiologic examinations done for other reasons has the potential to reduce health care costs by initiating further steps in osteoporosis diagnosis and appropriate therapy. RECOMMENDATIONS: Physicians should be aware of the importance of vertebral fracture diagnosis in assessing future osteoporotic fracture risk. Vertebral fractures incidental to radiologic examinations done for other reasons should be identified and reported. Vertebral fractures should be assessed from lateral spinal or chest radiographs according to the semiquantitative method of Genant and colleagues. Grade II and Grade III fractures as classified by this method should be given the greatest emphasis. Semiquantitative fracture recognition should include the recognition of changes such as loss of vertebral end-plate parallelism, cortical interruptions, and quantitative changes in the anterior, midbody, and posterior heights of vertebral bodies. When spine radiographs are performed to assess the presence of vertebral fractures, anteroposterior examinations may assist in the initial evaluation. The standard follow-up need only consist of single lateral views of the thoracic and lumbar spine that include T4 to L4 vertebrae. The radiographic technique described in this paper, or a technique of comparable efficacy, should be used. Dual X-ray absorptiometry examinations that include lateral spinal morphological assessments (vertebral fracture assessment) may contribute to fracture recognition. Educational material about the clinical importance of vertebral fracture recognition as a potential indicator of future osteoporotic fracture risk with its associated morbidity and mortality should be directed to all physicians. VALIDATION: Recommendations were based on consensus opinion.

Relationship among initial serum prostate specific antigen, prostate specific antigen progression and prostate cancer detection at repeat screening visits.

PURPOSE: We evaluated the probability of positive serum PSA (3 ng/ml or greater) and CaP detection at annual followup visits in men with negative initial PSA (less than 3 ng/ml) to optimize the re-screening schedule. MATERIALS AND METHODS: Data on 5,387 men 45 to 80 years old with negative PSA and no CaP diagnosis at the first screening visit were obtained from the Laval University Prostate Cancer Screening Program database. Accelerated failure time regressions were fitted to time from baseline to positive PSA and to time from positive PSA to CaP detection. The models were combined to estimate the cumulative probability of positive PSA followed by CaP detection at re-screening. RESULTS: The 5-year cumulative probability of detecting CaP at annual visits in men with baseline PSA up to 1.5 ng/ml remained below 0.8%, while it was 1.3%, 4.8% and 8.3% in men with PSA 1.5 to less than 2, 2 to less than 2.5 and 2.5 to less than 3 ng/ml, respectively. Time to positive PSA significantly decreased with increasing baseline PSA and age, while the time between positive PSA and CaP detection depended only on age. Men with PSA below 1.0 ng/ml could wait for 4 to 5 years before being re-tested, while men with PSA between 1.0 and 1.5 ng/ml should be screened every second year and men with PSA 1.5 ng/ml or greater should be screened every year. CONCLUSIONS: The proposed retesting schedule using current PSA and age decreases the number of visits by 38.1%, while delaying the detection of only 2.4% of CaPs that would have been detected using annual PSA testing.

Recommendations for bone mineral density reporting in Canada.

OBJECTIVE: To propose a set of recommendations for optimal bone mineral density (BMD) reporting in postmenopausal women and older men and to provide clinicians with both a BMD diagnostic category and a useful tool to assess an individual's risk of osteoporotic fracture. OPTIONS: The current methods of BMD reporting were reviewed. In this document, we propose that an individual's 10-year absolute fracture risk, rather than BMD alone, be used for fracture risk categorization. Consequently, age, sex, BMD, fragility fracture history, and glucocorticoid use are the basis for the approach outlined in this document. OUTCOMES: An optimal BMD report as proposed in this document will provide clinicians with both a BMD diagnostic category and a useful tool to assess an individual's risk of osteoporotic fracture. A BMD report format, a checklist, and a patient questionnaire are meant to further encourage its use. EVIDENCE: All recommendations were developed using a consensus from clinicians and experts in the field of BMD testing and a standard method for the evaluation and citation of the supporting evidence. VALUES: These recommendations were developed by a multidisciplinary working group under the auspices of the Scientific Advisory Council of the Osteoporosis Society of Canada and the Canadian Association of Radiologists. BENEFITS, HARM, AND COSTS: Optimal BMD reports help the practitioner to assess an individual's risk for osteoporotic fracture and to decide whether medical therapy is warranted. RECOMMENDATIONS: The BMD report should include: patient identifiers. Dual-energy X-ray absorptiometry (DXA) scanner identifier. BMD results expressed in absolute values (g/cm2; 3 decimal places) and T-score (1 decimal place) for lumbar spine; proximal femur (total hip, femoral neck, and trochanter); and an alternate site (forearm BMD preferred: 1/3 radius, 33% radius or proximal radius) if either hip or spine is not valid. A statement about any limitations due to artifacts, if present. The fracture risk category (low, moderate, or high) as determined by using Tables 3 and 4 and by including major clinical factors that modify absolute fracture risk probability (with an indication of the corresponding absolute 10-year fracture risk of <10%, 10-20%, or >20%). A statement as to whether the change is statistically significant or not for serial measurements. The BMD centre's least significant change for each skeletal site (in g/cm2) should be included. VALIDATION: Recommendations were based on consensus opinion. Since these are the first Canadian recommendations integrating clinical risk factors in a quantitative fracture risk assessment, it is anticipated that these "Recommendations for BMD Reporting in Canada" will be a work in progress and will be updated periodically to accommodate advances in this field.

Screening decreases prostate cancer mortality: 11-year follow-up of the 1988 Quebec prospective randomized controlled trial.

PURPOSE: This clinical trial is aimed at evaluating the impact of prostate cancer screening on cancer-specific mortality. SUBJECTS AND METHODS: Forty-six thousand four hundred and eighty-six (46,486) men aged 45-80 years registered in the electoral roll of the Quebec city area were randomized in 1988 between screening and no screening. Screening included measurement of serum prostatic specific antigen (PSA) using 3.0 ng/ml as upper limit of normal and digital rectal examination (DRE) at first visit. At follow-up visits, serum PSA only was used. RESULTS: Seventy-four (74) deaths from prostate cancer occurred in the 14,231 unscreened controls while 10 deaths were observed in the screened group of 7,348 men during the first 11 years following randomization. Median follow-up of screened men was 7.93 years. A Cox proportional hazards model of the age at death from prostate cancer shows a 62% reduction (P < 0.002, Fisher's exact test) of cause-specific mortality in the screened men (P = 0.005). These results are in agreement with the continuous decrease of prostate cancer mortality observed in North America.

Impact of Levovist ultrasonographic contrast agent on the diagnosis and management of hypertensive patients with suspected renal artery stenosis: a Canadian multicentre pilot study.

OBJECTIVES: To compare the diagnoses obtained with unenhanced ultrasonography (US), contrast-enhanced US and captopril-enhanced renal scintigraphy and to determine whether use of a contrast agent improves ability to assess the renal arteries with duplex Doppler US. SUBJECTS AND METHODS: The study was an open-label controlled trial involving 78 patients with hypertension suspected to have a renovascular cause. The patients underwent captopril-enhanced scintigraphy or routine unenhanced US (the usual diagnostic methods at the centres where the study was conducted) and contrast-enhanced US (with Levovist, Berlex Canada, Lachine, Que.). The patients were followed for 3 months after the diagnostic tests were performed. RESULTS: Enhanced US yielded a diagnosis for a significantly greater proportion of patients than did unenhanced US (77 [99%] v. 64 [82%] of 78 patients; p = 0.002) or captopril-enhanced scintigraphy (71 [99%] v. 58 [81%] of 72 patients; p = 0.002). Diagnosis was possible with both enhanced and unenhanced duplex Doppler US in only 64 (82%) of the 78 patients, and the diagnosis was the same with both methods for 63 (98%) of these 64 patients. In contrast, diagnosis was possible for only 58 (81%) of the 72 patients who underwent both enhanced US and captopril-enhanced scintigraphy; the same diagnosis was reported in 53 (91%) of these 58 cases. During follow-up, 11 patients (21 kidneys) underwent angiography. Significant stenosis was detected in 6 (55%) of the patients (8 [38%] of the kidneys). Both the enhanced and unenhanced US results agreed more often with angiography than did captopril-enhanced scintigraphy (9 [82%] v. 8 [73%] of the 11 patients). The proportion of patients in whom the left and right renal artery could be assessed by duplex Doppler US increased significantly (by 58% and 43%, respectively) with use of the contrast agent. CONCLUSION: Enhanced US had a higher rate of successful diagnosis than unenhanced US and captopril-enhanced renal scintigraphy. Enhanced US might therefore be suitable as a screening method for hypertensive patients with suspected renal artery stenosis.

Economic impact of an ultrasonographic contrast agent on the diagnosis and initial management of patients with suspected renal artery stenosis.

OBJECTIVES: To determine resource use in the diagnosis and management of Canadian hypertensive patients with suspected renal artery stenosis and to estimate the impact of diagnosis with contrast-enhanced duplex Doppler ultrasonography (US) on resource use. SUBJECTS AND METHODS: Seventy-eight patients with suspected renal artery stenosis underwent usual diagnostic tests (captopril-enhanced renal scintigraphy or duplex Doppler US) and contrast-enhanced US. A management pathway ("planned") describing the medical resources required for further patient care was outlined on the basis of results from each test (separately), and a modified management pathway ("recommended"), which considered data from both diagnostic methods, was also outlined. Medical resources and productivity losses were assessed prospectively for a 3-month period after patients underwent both tests ("actual" management pathway). RESULTS: With usual diagnostic methods, 14 (18%) of the tests were inconclusive, whereas only 1 (1%) of the enhanced US examinations was inconclusive; the cost-efficacy ratio was $422 and $343 per successful diagnosis, respectively. Further management costs for patients with an inconclusive diagnosis were estimated at $6370 after the usual diagnostic tests, but only $1278 with enhanced US. Although the costs of the planned and recommended management pathways were similar ($227 and $294 per patient respectively), the proportion of patients requiring further resources was lower with enhanced US (56% v. 46%). Three-month actual management costs ranged from $121 to $1605 per patient (mean $360). Diagnostic tests and surgical procedures were the major cost drivers in all pathways, and costs were highest for patients in whom stenosis was diagnosed. CONCLUSIONS: For patients with suspected renal artery stenosis, contrast-enhanced US had a higher diagnostic success rate than usual diagnostic methods and afforded savings through lower administrative costs and lower medical resource consumption for patients whose diagnosis was unclear after usual diagnostic tests.