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Diagnosis of Fracture

Date: May 16, 2012
Result type: Resources

Indication Overview

Bone fracture or break is the result of stress on the bone. Fracture can result from a variety of reasons, but the most common types include traumatic fracture, insufficiency fracture, and stress fracture. Traumatic fractures are the most common and result from accidental causes (e.g., severe fall, motor vehicle accident) or non-accidental or intentional causes (i.e., abuse). Insufficiency fractures occur when the quality of bone is insufficient to handle the normal stress of weight bearing (e.g., osteoporosis). Stress (or fatigue) fractures are associated with repetitive load-bearing stress to a normally healthy bone, common among athletes (e.g., gymnasts, dancers, long-distance runners) and military personnel.1,2

Imaging of suspected fracture usually begins with plain radiography (x-ray). Although x-ray will reveal most fractures, subtle fractures, including those in skeletally immature children, and some stress fractures may not be visible immediately on x-ray. If symptoms of fracture persist, an occult (or hidden) fracture is suspected. Follow-up x-rays may show a fracture due to loss of bone around the fracture site during the healing process. However, if plain x-rays continue to be negative but clinical suspicion remains, further imaging tests (i.e., bone scintigraphy, magnetic resonance imaging [MRI], or computed tomography [CT]) are warranted.

Population: Adults with suspected osteoporotic fracture or stress fracture.

Note: although not identified as a population of interest for this indication, relevant fracture data relating to children are presented in Appendix 5.

Intervention: Radionuclide bone scintigraphy (bone scan) using technetium-99m (99mTc)-labelled pharmaceuticals.

Bone scintigraphy is one of the most frequently performed nuclear medicine procedures for the detection of bone disorders.4,5 Canadian 2006 data indicate that 17% of the supply of 99mTc was used in bone scintigraphy.6 Although protocols may vary between institutions, the most common method of administering bone scintigraphy is the three-phase radionuclide examination. Prior to these phases, approximately 25 millicurie (mCi) of 99mTc-labelled radiopharmaceutical is injected into the patient who is positioned under a gamma camera. Images are then obtained through the following three phases:7

  • Phase 1: Blood flow/dynamic phase: This phase occurs almost immediately after the administration of the 99mTc radiopharmaceutical and is obtained over the area being examined.
  • Phase 2: Blood pool phase: occurs five to 10 minutes after the blood flow phase. Images are acquired by a gamma camera. Note: uptake of radiotracer within bone is influenced by blood flow and rate of new bone formation.4,8
  • Phase 3: Delayed images: occurs 1.5 to five hours after injection of radiopharmaceutical (time varies according to age).

The gamma camera images reflect osteoblast (bone cells involved in new bone formation) cell activity in the bones. The delay between injection and imaging allows clearance of the radiotracer from the soft tissues, resulting in a higher target-to-background ratio and improved visualization of bone.9 Areas that absorb little or no amount of tracer appear as "cold" spots, which can indicate a lack of blood supply to the bone (bone infarction) or the presence of certain types of cancer. Areas of rapid bone growth or repair absorb increased amounts of the tracer and show up as "hot" spots in the pictures. Hot spots can indicate the presence of a fracture, tumour, or an infection. Although most skeletal trauma is evaluated by radiography, some injuries are occult, and bone scintigraphy can detect changes as early as a few hours after injury.10 Hence, bone scintigraphy often has a complementary role to radiography in fracture assessment, most notably in children younger than two years with suspected non-accidental fracture11 or occult osteoporotic fractures.5

Comparators: For this report, the following diagnostic tests are considered as alternatives to bone scintigraphy:

  • Computed Tomography (CT): CT (also known as computed-assisted tomography or CAT) creates three-dimensional images of body tissues and organs using x-ray images processed by a computer.12
  • Magnetic Resonance Imaging (MRI): MRI uses three components to generate detailed images of internal organs and tissues — hydrogen atoms in the tissues, a powerful cylindrical external magnet to generate a magnetic field around the subject, and radiofrequency coils to generate intermittent radio waves.12 In a strong magnetic field, atoms tend to line up like iron filings around a bar magnet. A pulse of radiofrequency radiation (like that used in a microwave oven) disturbs that alignment. When the atoms return to their former state, they emit the energy from the radiation that reveals their molecular environment and spatial location. MRI imaging techniques can be enhanced by injection of contrast agents such as gadolinium (Gd).12
  • Positron Emission Tomography (PET): PET is a nuclear medicine exam used to create images of the inside of the body by measuring the metabolic activity of the soft tissue adjacent to a fracture site.12 A radiotracer used in PET scanning of the bone is 18F-labelled sodium fluoride (Na18F, referred to as 18F-PET herein).

Outcomes: Eleven outcomes (referred to as criteria) are considered in this report:

  • Criterion 1: Size of the affected population
  • Criterion 2: Timeliness and urgency of test results in planning patient management
  • Criterion 3: Impact of not performing a diagnostic imaging test on mortality related to the underlying condition
  • Criterion 4: Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition
  • Criterion 5: Relative impact on health disparities
  • Criterion 6: Relative acceptability of the test to patients
  • Criterion 7: Relative diagnostic accuracy of the test
  • Criterion 8: Relative risks associated with the test
  • Criterion 9: Relative availability of personnel with expertise and experience required for the test
  • Criterion 10: Accessibility of alternative tests (equipment and wait times)
  • Criterion 11: Relative cost of the test.

Definitions of the criteria are in Appendix 1.

Methods

The literature search was performed by an information specialist using a peer-reviewed search strategy.

Published literature was identified by searching the following bibliographic databases: MEDLINE with In-Process records and daily updates via Ovid; The Cochrane Library (2011, Issue 2) via Ovid; and PubMed. The search strategy consisted of both controlled vocabulary, such as the National Library of Medicine's MeSH (Medical Subject Headings), and keywords. The main search concepts were radionuclide imaging and fracture.

Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, and non-randomized studies, including diagnostic accuracy studies. The search was also limited to English language documents, with no publication date limits. Regular alerts were established to update the search until October 2011. Detailed search strategies are located in Appendix 2.

Grey literature (literature that is not commercially published) was identified by searching relevant sections of the CADTH Grey Matters checklist. Google was used to search for additional web-based materials. The searches were supplemented by reviewing the bibliographies of key papers. See Appendix 2 for more information on the grey literature search strategy.

Targeted searches were done as required for the criteria, using the aforementioned databases and Internet search engines. When no literature was identified that addressed specific criteria, experts were consulted.

Search Results

The database/literature search identified 785 citations, from which 44 articles underwent full-text screening. Of these, 29 were included in the final report. No HTAs were identified through the literature review. Two relevant systematic reviews and meta-analyses were identified: one relevant to criteria 2, 3, and 4 was identified through the grey literature search,13 and the other pertaining to the diagnostic accuracy of bone scintigraphy compared with CT and MRI.14 No systematic reviews comparing bone scintigraphy and 18F-PET were identified. Six primary studies reporting on diagnostic accuracy were included.

The remaining articles identified through the search, along with articles found through searching the grey literature and from reference lists, were used to abstract information on the rest of the criteria.

Summary table

Table 1: Summary of Criterion Evidence

Domain 1: Criteria Related to the Underlying Health Condition
Criterion Synthesized Information
1 Size of the affected population Osteoporotic fracture
There are an estimated 138,600 osteoporosis-associated fractures each year in Canada.15

Stress fracture
The incidence of stress fracture is less than 1% in the general population.16

Based on this available information, it is estimated that the size of the affected population is:
  • more than 1 in 1,000 (0.1%) and less than or equal to 1 in 100 (1%) for osteoporosis-associated fracture
  • more than 1 in 1,000 (0.1%) and less than or equal to 1 in 100 (1%) for stress fracture.
2 Timeliness and urgency of test results in planning patient management Osteoporotic fracture
Delayed recognition of osteoporotic fractures, particularly in the elderly, can result in progression to complete fracture, resulting in considerable long-term residual disability and mortality. A 2007 study on wait times for fracture management at the MUHC reported that hip fractures should be corrected within 24 hours.13

Stress fracture
Delay in diagnosis of stress fractures may result in progression to complete fracture, non-union, delayed union, and need for operative intervention or refracture.17,18

Based on this information, the target time frame for performing the 99mTc-based test is:
  • between 2 and 7 days, and obtaining the 99mTc-based test results in the appropriate timely manner for the underlying condition has a significant impact on the management of the condition or the effective use of heath care resources in adults with suspected osteoporotic fracture
  • between 8 and 30 days, and obtaining the test results in the appropriate timely manner for the underlying condition has moderate impact on the management of the condition or the effective use of heath care resources in patients with suspected stress fracture.
3 Impact of not performing a diagnostic imaging test on mortality related to the underlying condition Osteoporotic fracture
No data on the effect of missed or delayed diagnosis of osteoporosis-related fractures on mortality were identified. However, untreated occult fractures can proceed to a complete fracture, which may affect mortality. A 5-year observational study of Canadians older than 50 years found that compared with participants without fracture, those with hip or vertebral fractures were more likely to die during the 5 years of follow-up.19 Fractures of the forearm or wrist and ribs had no impact on mortality.19

Stress fracture
Stress fracture is not associated with increased risk of death in otherwise healthy adults.

Based on the available evidence, it is assumed that diagnostic imaging test results can have:
  • a moderate impact on the mortality of patients suspected of having osteoporotic fractures
  • no impact on mortality in cases of suspected stress fracture.
4 Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition Osteoporotic fracture
Fractures resulting from osteoporosis are associated with clinically important functional decline and reduced quality of life. The site of fracture, particularly in the elderly, will affect morbidity. According to the MUHC, early fixation of hip fracture results in reduced pain and disability, easier surgical fixation, reduced OR time, and shorter post-operative stay.13 Likewise, wrist fractures can affect activities of daily living, such as meal preparation, and cause loss of functional independence.20

Stress fracture
Undiagnosed and untreated stress fracture can progress to complete fracture, potentially resulting in significant morbidity and reduced quality of life.21
Based on the available evidence, it is assumed that diagnostic imaging test results can have a:
  • significant impact on morbidity or quality of life of patients suspected of having osteoporotic fracture
  • moderate impact on morbidity or quality of life of patients suspected of having stress fracture.

 

Domain 2: Criteria Comparing 99mTc with an Alternative or Comparing Between Clinical Uses
Criterion Synthesized Information
5 Relative impact on health disparities To be scored locally.
6 Relative acceptability of the test to patients Bone scintigraphy
Patients, or parents of patients, may have concerns about radiation exposure and the intravenous injection of radiopharmaceutical agent and potential need for sedation.22

CT
Patients, or parents of patients, may have concerns about radiation exposure and may also feel claustrophobic while in the scanner, although this may be less of a problem with new CT scanners (MIIMAC expert opinion).

MRI
Patients may experience feelings of claustrophobia or apprehension and be bothered by the noise, although this may be less of a problem with new MRI machines (MIIMAC expert opinion). Some patients may have difficulty remaining still during the scan, and children may require sedation.23 Patients are not exposed to radiation during a MRI scan, which may be more acceptable to some.

18F-PET
Patients, or parents of patients, may have concerns about radiation exposure and the intravenous injection of radiopharmaceutical agent.

Overall, bone scintigraphy with 99mTc-labelled radiotracers:
  • has similar acceptability to CT
  • is minimally less acceptable than MRI
  • is minimally less acceptable than 18F-PET.
7 Relative diagnostic accuracy of the test

A 2010 systematic review compared the diagnostic accuracy of bone scintigraphy with CT and MRI.14

Pooled Estimates of Sensitivity and Specificity14
Imaging Modality Number of Studies (N) Sensitivity (95% CI) Specificity
(95% CI)
Bone scintigraphy 15 (N = 1,102) 97% (93% to 99%) 89% (83% to 94%)
CT 6 (N = 211) 93% (83% to 98%) 99% (96% to 100%)
MRI 10 (N = 513) 96% (91% to 99%) 99% (96% to 100%)

CI = confidence interval; CT = computed tomography; MRI = magnetic resonance imaging; N = number of patients.

Five primary studies compared the diagnostic accuracy of bone scintigraphy with MRI for detection of stress fracture.24-28 Two primary studies compared bone scintigraphy with CT (findings from one study were reported in two separate publications).29,30 Sensitivity and specificity values were consistent with those reported in the systematic review.

No studies were identified that compared 99mTc-based imaging with 18F-PET.

Based on the available evidence, the diagnostic accuracy of bone scintigraphy with 99mTc-labelled radiotracers is:

  • similar to CT
  • minimally lower than MRI
  • similar to 18F-PET.
8 Relative risks associated with the test

Non–radiation-related Risks

Bone scintigraphy
Rare, mild adverse reactions with 99mTc-labelled tracers (e.g., skin reactions) have been reported.31-33 Although the MDP radionuclide clears faster in young children with normal kidney function, no additional dosing is generally needed.34

CT
Patients may experience an allergic reaction to the contrast agent (if required), which may worsen with repeated exposure.35 According to the American College of Radiology Manual on Contrast Media,36 the frequency of severe, life-threatening reactions with Gd is extremely rare (0.001% to 0.01%). Moderate reactions resembling an allergic response (i.e., rash, hives, urticaria) are also very unusual and range in frequency from 0.004% to 0.7%.36

MRI
MRI is contraindicated in patients with metallic implants, including pacemakers and, potentially, hearing aids.37 Moderate AEs resembling an allergic reaction to the contrast media (if required) are possible.36 The frequency of severe, life-threatening reactions with Gd is extremely rare (0.001% to 0.01%) and the frequency of moderate reactions is also rare (0.004% to 0.7%).36

PET
The Pharmacopeia Committee of the SNM conducted a 4-year prospective evaluation of PET and reported no AEs among the 33,925 scans conducted in 22 participating PET centres in the United States.38

Radiation-related Risks

Patients undergoing bone scintigraphy, CT, and 18F-PET are exposed to ionizing radiation.

Table 3: Effective Doses of Radiation

Procedure Average Dose (mSv)
99mTc-labelled tracers bone scan 6.339,40
CT 6 to 2541,42
MRI 039
Whole body PET* 14.141
Average background dose of radiation per year 1 to 3.043-45

CT = computed tomography; MRI = magnetic resonance imaging; mSv = millisievert; PET = positron emission tomography; 99mTC = technetium-99m.

*Estimate higher than what people would be exposed to for a single site.

Overall, bone scintigraphy with 99mTc-labelled radiotracers:

  • has a similar safety profile to that of CT
  • is minimally less safe than MRI
  • has a similar safety profile to that of 18F-PET.
9 Relative availability of personnel with expertise and experience required for the test

Bone scintigraphy
In Canada, physicians involved in the performance, supervision, and interpretation of bone scintigraphy should be nuclear medicine physicians or diagnostic radiologists with training or expertise in nuclear imaging.46 Technologists must be certified by the Canadian Association of Medical Radiation Technologists (CAMRT) or an equivalent licensing body.

CT
Medical radiation technologists who are certified by CAMRT, or an equivalent licensing body recognized by CAMRT, are required. Training of technologists specifically engaged in CT should meet the applicable and valid national and provincial specialty qualifications.

MRI
MRI medical technologists must have CAMRT certification in magnetic resonance or be certified by an equivalent licensing body recognized by the CAMRT.

PET
In Canada, physicians involved in the performance, supervision, and interpretation of PET scans should be nuclear medicine physicians or diagnostic radiologists with training/expertise in nuclear imaging. Technologists must be certified by CAMRT or an equivalent licensing body.

Assuming the necessary equipment is available, if bone scintigraphy with 99mTc-based imaging is not available, it is estimated that:

  • more than 95% of the procedures can be performed in a timely manner using CT
  • 75% to 94% of the procedures can be performed in a timely manner using MRI
  • fewer than 25% of the procedures can be performed in a timely manner using PET.
10 Accessibility of alternative tests (equipment and wait times)

Bone scintigraphy
Nuclear medicine facilities with gamma cameras (including SPECT) are required. No nuclear medicine cameras are available in the Yukon, Northwest Territories, or Nunavut.47

CT
There are no CT scanners available in Nunavut.47 For CT scanners, the average weekly use ranged from 40 hours in Prince Edward Island to 69 hours in Ontario, with a national average of 60 hours.12 In 2010, the average wait time for a CT scan in Canada is 4.2 weeks.48

MRI
There are no MRI scanners available in the Yukon, Northwest Territories, or Nunavut.47 According to CIHI's National Survey of Selected Medical Imaging Equipment database, the average number of hours of operation per week for MRI scanners in 2006-2007 ranged from 40 hours in Prince Edward Island to 99 hours in Ontario, with a national average of 71 hours.12 In 2010, the average wait time for MR imaging in Canada was 9.8 weeks.48

PET
A 2010 Environmental Scan published by CADTH reported that there are approximately 31 Canadian centres equipped to perform PET scans.49 These centres are located in the provinces of British Columbia, Alberta, Manitoba, Ontario, Quebec, New Brunswick, and Nova Scotia.49 There are 36 PET or PET/CT scanners, 4 of which are used for research purposes only.49

Assuming the availability of personnel with the necessary expertise and experience, if 99mTc-based bone scintigraphy is not available, it is estimated that:

  • more than 95% of the procedures can be performed in a timely manner using CT
  • 75% to 94% of the procedures can be performed in a timely manner using MRI
  • fewer than 25% of the procedures can be performed in a timely manner using PET.
11 Relative cost of the test

According to our estimates, the cost of a bone scan with 99mTc-based radioisotopes is $335.55. CT and MRI are minimally more costly alternatives and 18F-PET is a significantly more costly alternative.

Relative costs
Test Total costs ($) Cost of test relative to 99mTc-based test ($)
Bone scan 335.55 Reference
CT 262.56 –72.99
MRI 501.90 +166.35
18F-PET 850.00 +514.45

 

AE = adverse events; CI = confidence interval; CIHI = Canadian Institute for Health Information; CT = computed tomography; 18FDG = 18F-fluorodeoxyglucose; Gd = gadolinium; MDP = methylene diphosphonate; MR = magnetic resonance; MRI = magnetic resonance imaging; MUHC = McGill University Health Centre; OR = operating room;; PET = positron emission tomography; SNM = Society of Nuclear Medicine; SPECT = single-photon emission computer tomography; 99mTc = technetium-99.

Criterion 1: Size of affected population (link to definition)

The potential adult population requiring bone scintigraphy is primarily Canadians with stress fractures and elderly persons with osteoporosis (most common cause of fracture in the elderly).50

Osteoporotic fracture
Osteoporosis is a skeletal disease characterized by low bone mass and deterioration of bone tissue, leading to increased susceptibility to fracture.50,51 Although diagnosis is usually made with standard x-ray, fracture may not be apparent on radiography, and occult fractures are estimated to occur in 2% to 9% of patients.52

There are an estimated 138,600 osteoporosis-associated fractures each year in Canada.15 Estimates from Saskatchewan indicate that 8.5 per 1,000 women and 4.4 per 1,000 men between the ages of 75 and 84 break their hip. Over the age of 85 years, this increases to 22.5 per 1,000 for women and 14.1 per 1,000 for men.53

Stress fracture
The available literature suggests that stress fractures are common injuries in athletes (professional and recreational), dancers, and military recruits. Track and field athletes have the highest reported incidence of stress fractures compared with other athletes.2 The most common affected bones for stress fractures are in the lower extremity (tibia, metatarsals, and fibula)2 and hip (e.g., femoral neck);54 however, they can also occur in non–weight-bearing bones such as ribs, upper extremities, or pelvis.55

In the military, stress fractures of the calcaneus bone are also reported to be common.2 Epidemiological research demonstrates that risk factors for stress fracture include prior stress fracture, status of physical fitness, physical activity, and gender.16

Women are at a greater risk of stress fractures, with a reported relative risk ranging from 1.2 to 10.16 Tibial fractures are most common in athletes and military recruits (38.2% to 51.2%), followed by femoral neck fractures (29.8%) and fractures of the foot (i.e., tarsal or tarsal navicular fracture [11.8% to 25.3%]).16 Stress fractures within the metatarsals (8.8% to 20.6%) and femur (7.2% to 20.6%) occur at similar rates.54,56

In general, stress fractures occur in less than 1% of the general population.16 In a civilian athletic population, 10% of injuries experienced are stress fractures,54,57,58 while female and male athletes report having stress fractures at 13% and 8%, respectively.54 Military recruits have reported incidence of fracture from as low as 1% to as high as 31%, depending on the number of weeks within training.55

Return to Summary Table

Criterion 2: Timeliness and urgency of test results in planning patient management (link to definition)

Failure to diagnose occult or hidden fracture, including stress fracture, can result in progression to complete fracture of a previously non-displaced fracture, which can lead to subsequent long-term residual disability and morbidity. Potential complications, including non-union, avascular necrosis, and osteoarthritis, are made more likely by a delay in diagnosis and treatment. Hence, prompt identification and treatment of occult fractures are critical for improving outcomes.

Osteoporotic fracture
In the elderly, delayed recognition of osteoporotic fractures can result in considerable long-term residual disability and mortality. This is especially true as occurrence of fragility fracture increases the risk of further fractures, highlighting the need for prompt detection of fracture and appropriate therapy to decrease the risk of future fractures.59 When hip fracture is detected early, appropriate treatment can minimize morbidity and mortality and prevent the rapid decline in quality of life that is often associated with this injury.60 A 2007 systematic review on wait times for fracture management at the McGill University Health Centre (MUHC) reported that expert opinion and guidelines unanimously concluded that hip fractures should be corrected within 24 hours in the absence of medical contraindications.13 Early fixation results in reduced pain and disability, easier surgical fixation, reduced operating room (OR) time, and shorter post-operative stay.13

Stress fracture
A delay in the diagnosis of high-risk stress fractures may result in progression to a complete fracture, non-union, delayed union, need for operative intervention, or refracture.17,18 For example, early diagnosis is quite important for fractures of the tarsal navicular, as complications are high, and early recognition of partial fracture damage can be confined to the dorsal portion to prevent complete fracture.61 Therefore, early diagnosis of stress fractures assists in reducing morbidity.7,18

Return to Summary Table

Criterion 3: Impact of not performing a diagnostic imaging test on mortality related to the underlying condition (link to definition)

Osteoporotic fracture
Persons with hip or vertebral fractures have substantially increased risk of death after fracture.62 Osteoporosis Canada reports that up to 30% of cases of hip fracture induced by osteoporosis result in death, and an estimated 23% of patients with hip fracture die in less than year.50 Although men are less likely than women to have osteoporosis, they have higher post-fracture mortality and institutionalization rates than women.62

A recent report by Ioannidis et al. reported on the relation between fractures and mortality in the Canadian Multicentre Osteoporosis Study.19 The five-year observational study compared incidence of fracture and mortality in a cohort of 7,753 people (2,187 men and 5,566 women) aged 50 years and older in Canada. Results demonstrated that compared with participants without fracture, those with hip or vertebral fractures were more likely to die during the five years of follow-up (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.1 to 6.6 for vertebral fracture; HR 3.2, 95% CI 1.4 to 7.4 for hip fracture). Fractures of the forearm or wrist and ribs had no impact on mortality.19

Stress fracture
It is not likely that accidental occult skeletal fracture alone will affect mortality in otherwise healthy adults.

Return to Summary Table

Criterion 4: Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition (link to definition)

Osteoporotic fracture
Fractures, particularly in the elderly, are associated with significant morbidity and reduced quality of life. Recent evidence-based guidelines report that delay in hip fracture treatment results in increased length of hospital stay and more complications, including pressure sores, pneumonia, and confusion.63 A 2007 systematic review by MUHC concluded that early fixation of hip fracture results in reduced pain and disability, easier surgical fixation, reduced OR time, and shorter post-operative stay.13

Wrist fractures are associated with clinically important functional decline and reduced quality of life in older women with respect to activities of daily living, such as meal preparation, and may cause loss of functional independence.20

Stress fracture
Stress fractures, if not diagnosed and treated promptly, can progress to complete fracture, potentially resulting in significant morbidity. Potential complications include delayed union, need for operative intervention, refracture, avascular necrosis, and osteoarthritis,17,18 which may impede the patient's return to activity.21

Return to Summary Table

Criterion 5: Relative impact on health disparities (link to definition)

To be scored locally.

No information was found on the potential health disparities relating specifically to the detection of osteoporotic or stress fracture.

Women are at greater risk for stress- and osteoporosis-induced fracture. Risk of osteoporosis and, subsequently, fracture increases with age, regardless of ethnicity.59,64 Wrist fractures are more common in women younger than 75 years, whereas hip fractures become more common in women older than 75 years.20 Although osteoporosis is less common in men than in women, elderly men account for almost 30% of hip fracture cases. Men also have higher post-fracture mortality and institutionalization rates than women.62

A Saskatchewan study found that in Manitoba First Nations elderly, the rate of osteoporotic fracture at all sites was nearly double that of age- and sex-matched non-Aboriginal controls (6.3 versus 3.0 per 1,000 person years), regardless of diabetes diagnosis.65

Return to Summary Table

Criterion 6: Relative acceptability of the test to patients (link to definition)

Bone scintigraphy
Limited information was identified on the acceptability of bone scintigraphy to patients. A retrospective study on the use of bone scintigraphy in children with osteosarcoma or Ewing sarcoma suggested that any test, including a bone scintigraphy, causes psychological strain on the children and the parents.66 Patients, or parents of patients, may have concerns about radiation exposure and the intravenous injection of radiopharmaceutical agent.

CT
Patients undergoing CT scan may have concerns about radiation exposure and may also feel claustrophobic while in the scanner. This may be less of a problem with new CT scanners, if available (MIIMAC expert opinion). Patients may also be required to hold their breath for a substantial period of time, which is seen as "uncomfortable" and "difficult."67

MRI
Because of the closed space of an MRI, patients may experience feelings of claustrophobia, as well as be bothered by the noise. This may be less of a problem with new MRI machines, if available (MIIMAC expert opinion). It has been reported that up to 30% of patients experience apprehension and 5% to 10% endure some severe psychological distress, panic, or claustrophobia.68,69 Some patients may have difficulty remaining still during the scan. Patients are not exposed to radiation during an MRI scan, which may be more acceptable to some.

PET
Patients may have concerns about radiation exposure and the intravenous injection of radiopharmaceutical agent.

Return to Summary Table

Criterion 7: Relative diagnostic accuracy of the test (link to definition)

A literature search was conducted to evaluate the diagnostic accuracy of bone scintigraphy relative to the alternative diagnostic tests. One relevant systematic review/meta-analysis14 and seven primary studies not included in the systematic review compared the diagnostic performance and accuracy of bone scintigraphy with MRI, CT, or PET for diagnosis of fractures. The primary studies were heterogeneous in terms of study design, target population, site of fracture, comparators, and reported outcome measures. The identified studies are described below and the results of each study are summarized in Appendix 4. No studies were identified that compared 99mTc-based imaging with 18F-PET.

Systematic reviews

Bone scintigraphy versus CT
One 2010 systematic review and meta-analysis compared the diagnostic performance and accuracy of bone scintigraphy, MRI, and CT for diagnosis of suspected scaphoid fractures.14 Twenty-six studies were identified between January 1966 and October 2008. Pooled sensitivity, specificity, the diagnostic odds ratio (DOR), were calculated and presented in Table 2. There was no difference in DOR between CT and bone scintigraphy (P = 0.12). The positive and negative likelihood ratios derived from the pooled sensitivities and specificities were 93 and 0.07, respectively, for CT, compared with 8.82 and 0.03 for bone scintigraphy. As a general rule, positive likelihood ratios greater than 10 and negative likelihood ratios less than 0.1 are considered to provide strong evidence to rule in or rule out diagnoses.14 The authors conclude that additional studies are needed to assess the diagnostic performance of CT compared with bone scintigraphy.14

Table 2: Pooled Estimates of Sensitivity, Specificity, and DOR14

Imaging Modality Number of Studies (N) Sensitivity (95% CI) Specificity (95% CI) DOR (95% CI)
Bone scintigraphy 15 (N = 1,102) 97% (93% to 99%) 89% (83% to 94%) 4.78 (4.02 to 5.54)
CT 6 (N = 211) 93% (83% to 98%) 99% (96% to 100%) 6.11 (4.56 to 7.76)
MRI 10 (N = 513) 96% (91% to 99%) 99% (96% to 100%) 6.60 (5.43 to 7.76)

CI = confidence interval; DOR = diagnostic odds ratio; MRI = magnetic resonance imaging;14 N = number of patients.

Bone scintigraphy versus MRI
The Yin et al. systematic review and meta-analysis compared the diagnostic accuracy of bone scintigraphy with MRI for diagnosing scaphoid fracture (Table 2).14 Pooled sensitivity, specificity, and DOR for bone scintigraphy and MRI are presented in Table 2. The positive likelihood ratios of MRI were greater than 90 (i.e., 96) and negative likelihood ratio less than 0.1 (i.e., 0.04). The authors conclude that bone scintigraphy and MRI have equally high sensitivity and high diagnostic value for excluding scaphoid fracture; however, MRI is more specific and better for confirming scaphoid fracture.14

In 2005, Foex and colleagues70 published results of a "shortcut review" to establish whether MRI or bone scintigraphy is better at identifying scaphoid fractures not apparent on plain x-rays. They identified four applicable studies dated from 1966 to March 2005, which included 145 patients and compared the two imaging modalities. Although the sensitivity and specificity were not calculated, the results suggested that MRI is slightly superior to bone scintigraphy in the diagnosis of occult scaphoid fractures. MRI also allows for accurate diagnosis of clinically significant soft tissue injuries, which might otherwise be missed. MRI was also quicker to perform than bone scintigraphy. The authors concluded that (1) MRI is the investigation of choice in clinically suspected scaphoid fracture after negative initial and 10- to 14-day follow-up x-rays, and (2) bone scintigraphy is a reasonable alternative in patients with claustrophobia.70

Primary studies

Bone scintigraphy versus multiple alternatives

Gaeta et al.24

In this prospective study (January 2001 to November 2003), the diagnostic accuracy of MRI, CT, and bone scintigraphy were compared in 42 recreational athletes with suspected tibial stress injury (mean age: 28.2 years, range: 16 to 37 years) and 10 asymptomatic controls. All patients underwent initial radiography that was negative for injury. Sensitivity of MRI, CT, and bone scintigraphy was 88%, 42%, and 74%, respectively. Specificity, accuracy, and positive and negative predictive values were 100%, 90%, 100%, and 62%, respectively, for MRI and 100%, 52%, 100%, and 26%, respectively, for CT. Significant difference in detection of early tibial stress injuries was found between MRI and both CT and bone scintigraphy (McNemar test; P < 0.001; P = 0.008, respectively). The authors conclude that MRI is the single best technique to assess patients with suspected tibial stress injury; CT can detect osteopenia in some patients with negative MRI findings.

Bone scintigraphy versus CT

Groves et al.29,30 (findings from one study were reported in two separate publications)

In this prospective study, 16-detector CT was compared with bone scintigraphy in 26 patients with suspected stress fracture (a total of 33 suspected fractures). Bone scintigraphy identified 13 of 33 cases of stress fracture, whereas CT identified only four cases. There were eight "scintigraphy positive–CT negative" discordant cases. CT demonstrated more details of bone cortex and trabecular compared with bone scintigraphy. The authors concluded that multi-section CT cannot be recommended as a first-line diagnostic tool for stress fractures. They suggested that CT should be reserved for special circumstances, such as uncertain result of bone scintigraphy or to rule out other differential diagnoses.

Bone scintigraphy versus MRI

Ishibashi et al.26

In this prospective study, radiography, scintigraphy, and MRI were compared in 31 patients with suspected stress injuries of the bone. Even with negative initial radiographic findings, initial scintigraphy and MRI indicated stress injury, although MRI showed more diagnostic information (e.g., fracture line and periosteal edema) compared with bone scintigraphy. The authors conclude that compared with bone scintigraphy, MRI is less invasive and provides more information and is recommended for initial diagnosis of suspected stress injury to bone.

Kiuru et al.27

In this retrospective chart review, the accuracy of radiography and MRI was compared with bone scintigraphy, as a gold standard, in 50 military trainees with stress-related pain in the pelvis or lower extremities. Bone scintigraphy was performed within an average of 14 days from the radiography, and MRI performed within two days after bone scintigraphy. Sensitivity, specificity, and positive and negative predictive values were reported to be 56%, 94%, 95%, and 48%, respectively, for radiography (accuracy 67%) and 100%, 86%, 93%, and 100%, respectively, for MRI (accuracy 95%). The authors suggested that MRI is more sensitive than bone scintigraphy and this technique should be used as the standard of reference in the assessment of stress injuries of bone.

Hodler et al.25

In this study, the diagnostic accuracy of MRI was compared with that of bone scintigraphy in 16 patients with normal radiography results and typical bone scintigraphy results suggestive of stress-related bone injuries. Standard of reference consisted of a combination of clinical and scintigraphic findings and clinical follow-up. Bone scintigraphy was reported to correctly identify all normal and abnormal findings. The accuracy measurements reported by two independent readers differed (intra-observer agreement = 0.62). For MRI, the two readers reported the sensitivity, specificity, and positive and negative predictive values to be 69%/63%, 100%/80%, 100%/91%, and 50%/40%, respectively. The authors concluded that bone scintigraphy should be considered as the initial imaging modality in patients with clinically suspected stress-related injuries for whom the probability of other active bone diseases, such as infection or cancer, is low.

Shin et al.28

In this prospective study, the accuracy of MRI and bone scintigraphy was compared in differentiating the cause of hip pain. Nineteen military members who were engaged in endurance training and had hip pain (a total of 22 hips) were included. The patients underwent bone scintigraphy (imaged in plantar and SPECT modes). MRI of both hips was also performed for the patients who had bone scintigraphy results suggestive of femoral neck stress fracture. The diagnosis was confirmed with a follow-up x-ray examination and clinical evaluation six weeks after the MRI scan. Bone scintigraphy had an accuracy of 68% for detection of femoral neck stress fractures, whereas MRI was 100% accurate. The authors concluded that MRI was superior to bone scintigraphy in differentiating the causes of hip pain in endurance athletes.

Bone scintigraphy versus PET

18F-PET is increasingly being used for evaluation of skeletal trauma;71 however, no studies were identified that compared the diagnostic accuracy of 18F-PET with bone scintigraphy for this indication.

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Criterion 8: Relative risks associated with the test (link to definition)

Non–radiation-related Risks

Bone scintigraphy
Several studies31-33,72 reported mild adverse events with 99mTc-labelled tracers (e.g., skin reactions) and one case report published in 1985 reported a patient who experienced a rash following two bone scintigraphy procedures with 99mTc-MDP, one in 1983 and one the following year.73 The authors concluded that this patient had an allergic reaction to MDP on both occasions. This case report references an older study that reported 22 adverse reactions to 99mTc-MDP, in which 20 of the reactions were either "probably" or "possibly" caused by MDP.

CT
Some patients may experience an allergic reaction to the contrast agent (if required), which may worsen with repeated exposure.35 In addition, patients may experience mild side effects from the contrast agent, such as nausea, vomiting, or hives. A 2009 retrospective review of all intravascular doses of low-osmolar iodinated and Gd contrast materials administered at the Mayo Clinic between 2002 and 2006 (456,930 doses) found 0.15% of patients given CT contrast material experienced side effects, most of which were mild. A serious side effect was experienced by 0.005% of patients.74 CT is contraindicated in patients with elevated heart rate, hypercalcemia, and impaired renal function. Specifically, Gd is contraindicated in patients with renal failure or end-stage renal disease, as they are at risk of nephrogenic systemic fibrosis. According to the American College of Radiology Manual on Contrast Media,36 the frequency of severe, life-threatening reactions with Gd is extremely rare (0.001% to 0.01%). Moderate reactions resembling an allergic response (i.e., rash, hives, urticaria) are also very unusual and range in frequency from 0.004% to 0.7%.36

MRI
MRI is contraindicated in patients with metallic implants, including pacemakers.37 MRI is often used in conjunction with the contrast agent Gd. Some patients may experience an allergic reaction to the contrast agent (if required), which may worsen with repeated exposure.35 Side effects of Gd include headaches, nausea, and metallic taste. Gd is contraindicated in patients with renal failure or end-stage renal disease, as they are at risk of nephrogenic systemic fibrosis. According to the American College of Radiology Manual on Contrast Media,36 the frequency of severe, life-threatening reactions with Gd is extremely rare (0.001% to 0.01%). Moderate reactions resembling an allergic response (i.e., rash, hives, urticaria) are also very unusual and range in frequency from 0.004% to 0.7%.36

PET
The Pharmacopeia Committee of the Society of Nuclear Medicine conducted a four-year prospective evaluation of adverse reactions to PET and reported no adverse reactions among the 33,925 scans conducted in 22 participating PET centres in the United States.38

Radiation-related Risks

Among the modalities to diagnose fractures, bone scintigraphy and 18F-PET expose the patient to ionizing radiation. The average effective dose of radiation delivered with each of these procedures can be found in Table 3. It should be noted that the estimate for PET is higher than what a patient would be exposed to for a single site scan.

Table 3: Effective Doses of Radiation41,42

Procedure Average Effective Dose (mSv)
99mTc-labelled tracers bone scan 6.3
CT 6 to 25
Whole body PET 14.1
MRI 0
Average background dose of radiation per year 1 to 3.043-45

CT = computed tomography; MRI = magnetic resonance imaging; mSv = millisievert, PET = positron emission tomography; 99mTc = technetium-99m.

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Criterion 9: Relative availability of personnel with expertise and experience required for the test (link to definition)

The personnel required for the performance of the imaging tests to diagnose occult fractures are presented by imaging modality. A summary of the availability of personnel required to diagnose fractures, by bone scintigraphy or any of the alternative imaging modalities, is provided in Table 4.

Bone scintigraphy
In Canada, physicians involved in the performance, supervision, and interpretation of bone scintigraphy should be nuclear medicine physicians or diagnostic radiologists with training or expertise in nuclear imaging.46 Physicians should have a Fellowship of Certification in Nuclear Medicine or Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Nuclear medicine technologists are required to conduct bone scans. Technologists must be certified by the Canadian Association of Medical Radiation Technologists (CAMRT) or an equivalent licensing body.

All alternative imaging modalities
In Canada, physicians involved in the performance, supervision, and interpretation of diagnostic CT scans, MRI, and ultrasound should be diagnostic radiologists12 and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Foreign-trained radiologists also are qualified if they are certified by a recognized certifying body and hold a valid provincial license.46

Medical radiation technologists (MRTs) must be certified by CAMRT or an equivalent licensing body.

Service engineers are needed for system installation, calibration, and preventive maintenance of the imaging equipment at regularly scheduled intervals. The service engineer's qualification will be ensured by the corporation responsible for service and the manufacturer of the equipment used at the site.

Qualified medical physicists (on-site or contracted part-time) should be available for the installation, testing, and ongoing quality control of CT scanners, MR scanners, and nuclear medicine equipment.46

CT
For the performance of CT scan, MRTs who are certified by CAMRT, or an equivalent licensing body recognized by CAMRT, are required. The training of technologists specifically engaged in CT should meet the applicable and valid national and provincial specialty qualifications.

MRI
For the performance of MRI, medical technologists must have CAMRT certification in magnetic resonance or be certified by an equivalent licensing body recognized by CAMRT.

PET
In Canada, physicians involved in the performance, supervision, and interpretation of PET scans should be nuclear medicine physicians or diagnostic radiologists with training or expertise in nuclear imaging. Physicians should have a Fellowship of Certification in Nuclear Medicine or Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Technologists must be certified by CAMRT or an equivalent licensing body.

Table 4: Medical Imaging Professionals in Canada12

Jurisdiction Diagnostic Radiology Physicians Nuclear Medicine Physicians Medical Radiation Technologists Nuclear Medicine Technologists Sonographers Medical Physicists
NL 46 3 263 15 NR NR
NS 71 5 403 71 NR NR
NB 47 3 387 55 NR NR
PEI 7 0 57 3 NR 0
QC 522 90 3,342 460 NR NR
ON 754 69 4,336 693 NR NR
MB 58 8 501 42 NR NR
SK 61 4 359 36 NR NR
AB 227 18 1,229 193 NR NR
BC 241 21 1,352 212 NR NR
YT 0 0 0 0 NR 0
NT 0 0 26 1 NR 0
NU 0 0 0 0 NR 0
Total 2,034 221 12,255 1,781 2,900* 322*

AB = Alberta; BC = British Columbia; MB = Manitoba; NB = New Brunswick; NL = Newfoundland and Labrador; NR = not reported by jurisdictions; NS = Nova Scotia; NT = Northwest Territories; NU = Nunavut; ON = Ontario; PEI= Prince Edward Island; QC = Quebec; YT = Yukon.

*This represents a total for all of the jurisdictions.

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Criterion 10: Accessibility of alternative tests (equipment and wait times) (link to definition)

There are notable variations in the availability of medical imaging technologies across Canada. Table 5 provides an overview of the availability of equipment required to diagnose fracture. Data for nuclear medicine cameras (including SPECT) are current to January 1, 2007. The number of CT, MRI, and SPECT/CT scanners is current to January 1, 2010. Information on the availability of PET and PET/CT scanners is current to November 30, 2010.

Table 5: Diagnostic Imaging Equipment in Canada12,47,49

  Nuclear Medicine Cameras CT Scanners MRI Scanners SPECT/CT Scanners PET or PET/CT scanners
Number of devices 60312 46047 21847 9647 3649
Average number of hours of operation per week (2006-2007) 40 60 71 n/a n/a
Provinces and Territories with no devices available YT, NT, NU NU YT, NT, NU PEI, YT, NT, NU NL, PEI, SK, YT, NT, NU

CT = computed tomography; MRI = magnetic resonance imaging; n/a = not applicable; NL = Newfoundland and Labrador; NU = Nunavut; NT = Northwest Territories; PEI = Prince Edward Island; PET = positron emission tomography; SK = Saskatchewan; SPECT = single-photon emission computed tomography; YT = Yukon.

Bone scintigraphy
For bone scintigraphy, nuclear medicine facilities with gamma cameras (including SPECT) are required. Three jurisdictions, the Yukon, the Northwest Territories, and Nunavut, do not have any nuclear medicine equipment.12

CT
No CT scanners are available in Nunavut.12 The average weekly use of CT scanners ranged from 40 hours in Prince Edward Island to 69 hours in Ontario, with a national average of 60 hours.12 In 2010, the average wait time for a CT scan in Canada is 4.2 weeks.48

MRI
No MRI scanners are available in the Yukon, Northwest Territories, or Nunavut.12 According to the Canadian Institute for Health Information's National Survey of Selected Medical Imaging Equipment database, the average number of hours of operation per week for MRI scanners in 2006-2007 ranged from 40 hours in Prince Edward Island to 99 hours in Ontario, with a national average of 71 hours.12 In 2010, the average wait time for MR imaging in Canada was 9.8 weeks.48

PET
A 2010 Environmental Scan published by CADTH reported that approximately 31 Canadian centres are equipped to perform PET scans.49 These centres are located in the provinces of: British Columbia, Alberta, Manitoba, Ontario, Quebec, New Brunswick, and Nova Scotia.49 There are 36 PET or PET/CT scanners, four of which are used for research purposes only.49

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Criterion 11: Relative cost of the test (link to definition)

Fee codes from the Ontario Schedule of Benefits were used to estimate the relative costs of bone scanning and its alternatives. Technical fees are intended to cover costs incurred by the hospital (i.e., radiopharmaceutical costs, medical and surgical supplies, and non-physician salaries). Maintenance fees are not billed to OHIP — estimates here were provided by St. Michael's Hospital in Toronto. Certain procedures (i.e., PET scan, CT scan, MRI scan) are paid for, in part, out of the hospital's global budget; these estimates were provided by The Ottawa Hospital. It is understood that the relative costs of imaging will vary from one institution to the next.

According to our estimates (Table 6), the cost of a bone scan with 99mTc-based radioisotopes is $335.55. CT and MRI are minimally more costly alternatives and 18F-PET is a significantly more costly alternative.

Table 6: Cost Estimates Based on the Ontario Schedule of Benefits for Physician Services Under the Health Insurance Act (September 2011)75

Fee Code Description Tech. Fees ($) Prof. Fees ($) Total Costs ($)
Bone scan
J867 Blood flow and pool imaging 58.75 29.30 88.05
J851 Bone scintigraphy — single site 87.00 50.95 137.95
J866 Application of tomography (SPECT) 44.60 31.10 75.70
Maintenance fees — global budget 33.85   33.85
TOTAL 224.20 111.35 335.55
CT
X231 CT — pelvis — without IV contrast   91.15 91.15
Technical cost — from global budget 150.00   150.00
Maintenance fees — from global budget 21.41   21.41
TOTAL 171.41 91.15 262.56
MRI
X471C Multislice sequence, one extremity and/or one joint   66.10 66.10
X475C (×3) Repeat (another plane, different pulse sequence; to a maximum of 3 repeats)   33.10 (×3) = 99.30 99.30
Technical cost — from global budget 300.00   300.00
Maintenance fees — from global budget 36.50   36.50
TOTAL 336.50 165.40 501.90
18F-PET
Professional fee for PET   250.00 250.00
Technical cost — from global budget 600.00   600.00
TOTAL 800.00 250.00 850.00

CT = computed tomography; 18F-PET = 18F-labelled fluoride position emission tomography; IV = intravenous; MRI = magnetic resonance imaging; prof. = professional; SPECT = single-photon emission computed tomography; tech. = technical.

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Appendix 1: Multi-Criteria Decision Analysis Definitions

Domain 1: Criteria Related to the Underlying Health Condition
Criterion Definition
1. Size of the affected population The estimated size of the patient population that is affected by the underlying health condition and that may potentially undergo the test. The ideal measure is point prevalence, or information on how rare or common the health condition is.
2. Timeliness and urgency of test results in planning patient management The timeliness and urgency of obtaining the test results in terms of their impact on the management of the condition and the effective use of health care resources.
3. Impact of not performing a diagnostic imaging test on mortality related to the underlying condition Impact of not performing the test, in whatever way, on the expected mortality of the underlying condition. Measures could include survival curves showing survival over time, and/or survival at specific time intervals with and without the test.
4. Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition Impact of not performing the test, in whatever way, on the expected morbidity or on the quality of life reduction of the underlying condition. Measures of impact may include natural morbidity outcome measures such as events or disease severity, or might be expressed using generic or disease-specific quality of life rating scales with and without the test.
Domain 2: Criteria Comparing 99mTc with an Alternative, or Comparing between Clinical Uses
Criterion Definition
5. Relative impact on health disparities Health disparities are defined as situations where there is a disproportionate burden (e.g., incidence, prevalence, morbidity, or mortality) amongst particular population groups (e.g., gender, age, ethnicity, geography, disability, sexual orientation, socioeconomic status, and special health care needs). Impact on health disparities is assessed by estimating the proportion of current clients of the technetium-99m (99mTc)-based test that are in population groups with disproportionate burdens. (Explanatory note: The implication of this definition is that, everything else being the same, it is preferable to prioritize those clinical uses that have the greatest proportion of clients in groups with disproportionate burdens.)
6. Relative acceptability of the test to patients Acceptability of the 99mTc-based test from the patient's perspective compared with alternatives. Patient acceptability considerations include discomfort associated with the administration of the test, out-of-pocket expenses or travel costs, factors that may cause great inconvenience to patients, as well as other burdens. This criterion does not include risks of adverse events but is about everything related to the experience of undergoing the test.
7. Relative diagnostic accuracy of the test Ability of the test to correctly diagnose the patients who have the condition (sensitivity) and patients who do not have the condition (specificity) compared with alternatives.
8. Relative risks associated with the test Risks associated with the test (e.g., radiation exposure, side effects, adverse events) compared with alternatives. Risks could include immediate safety concerns from a specific test or long-term cumulative safety concerns from repeat testing or exposure.
9. Relative availability of personnel with expertise and experience required for the test Availability of personnel with the appropriate expertise and experience required to proficiently conduct the test and/or interpret the test findings compared with alternatives.
10. Accessibility of alternatives (equipment and wait times) Availability (supply) of equipment and wait times for alternative tests within the geographic area. Includes consideration of the capacity of the system to accommodate increased demand for the alternatives. Excludes any limitation on accessibility related to human resources considerations.
11. Relative cost of the test Operating cost of test (e.g., consumables, health care professional reimbursement) compared with alternatives.

Appendix 2: Literature Search Strategy

OVERVIEW
Interface: Ovid
Databases: Database(s): EBM Reviews - ACP Journal Club 1991 to February 2011

EBM Reviews - Cochrane Central Register of Controlled Trials 1st Quarter 2011

EBM Reviews - Cochrane Database of Systematic Reviews 2005 to February 2011

EBM Reviews - Cochrane Methodology Register 1st Quarter 2011

EBM Reviews - Database of Abstracts of Reviews of Effects 1st Quarter 2011

EBM Reviews - Health Technology Assessment 1st Quarter 2011

Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) 1946 to March 16, 2011

Note: Duplicates between databases were removed in Ovid.
Date of Search: March 16, 2011
Alerts: Monthly search updates began January 14, 2011 and ran until October 2011.
Study Types: Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non-randomized studies, and diagnostic accuracy studies.
Limits: English language

2001-2011 for primary studies

Human limit for primary studies
SYNTAX GUIDE
/ At the end of a phrase, searches the phrase as a subject heading
MeSH Medical subject heading
.fs Floating subheading
exp Explode a subject heading
* Before a word, indicates that the marked subject heading is a primary topic; or, after a word, a truncation symbol (wildcard) to retrieve plurals or varying endings
? Truncation symbol for one or no characters only
ADJ Requires words are adjacent to each other (in any order)
ADJ# Adjacency within # number of words (in any order)
.ti Title
.ab Abstract
.hw Heading word: usually includes subject headings and controlled vocabulary
.tw Text word: searches title, abstract, captions, and full text
.mp Keyword search: includes title, abstract, name of substance word, subject heading word and other text fields
.pt Publication type
.nm Name of substance word: used to search portions of chemical names and includes words from the CAS Registry/EC Number/Name (RN) fields
.jw Journal words: searches words from journal names
/du Diagnostic use
/ri Radionuclide imaging

 

Ovid MEDLINE Strategy
Line # Search Strategy
1 exp Fractures, Bone/
2 Fractur*.ti,ab.
3 ((bone or bones or bony or boney or scull or limb or skeleton* or skeletal* or arm or arms or leg or legs or jaw or jaws or joint or joints or spine* or spinal or rib or ribs or pelvis or pelvic or foot or feet or ankle* or clavicle* or shoulder* or hip or hips or femur* or femoral* or humeral* or humerus or hand or hands or finger* or nose or nasal or wrist* or knee or knees or face or occipital or tibia or ulna or intra-articular* or intraarticular* or osteoporotic* or peri-prosthetic* or periprosthetic* or maxilla* or mandibular or skull or cranial or metacarpal or metatarsal or sternal or scapular or vertebral) adj2 (broken or break or breakage or crack*)).ti,ab.
4 or/1-3
5 Technetium/ or exp Technetium Compounds/ or exp Organotechnetium Compounds/ or exp Radiopharmaceuticals/
6 (Technetium* or Tc-99 or Tc99 or Tc-99m or Tc99m or 99mTc or 99m-Tc).tw,nm.
7 Radionuclide Imaging/ or Perfusion Imaging/
8 radionuclide imaging.fs.
9 radioisotope*.mp.
10 ((radionucl* or nuclear or radiotracer*) adj2 (imag* or scan* or test* or diagnos*)).ti,ab.
11 Tomography, Emission-Computed, Single-Photon/
12 (single-photon adj2 emission*).ti,ab.
13 (SPECT or scintigraph* or scintigram* or scintiphotograph*).ti,ab.
14 (medronate or methyl diphosphonate).ti,ab.
15 exp Child abuse/ri
16 exp "Bone and Bones"/ri
17 or/5-16
18 4 and 17
19 (fracture* adj2 (scan* or imag*)).ti,ab.
20 18 or 19
21 (child or children or infant* or baby or babies or newborn* or neonate or neonates or neonatal or preemie or preemies or paediatric* or pediatric* or toddler* or girl or girls or boy or boys or kid or kids).ti,ab.
22 (abuse or abusive or abused).ti,ab.
23 17 and 21 and 22
24 20 or 23
25 meta-analysis.pt.
26 meta-analysis/ or systematic review/ or meta-analysis as topic/ or exp technology assessment, biomedical/
27 ((systematic* adj3 (review* or overview*)) or (methodologic* adj3 (review* or overview*))).ti,ab.
28 ((quantitative adj3 (review* or overview* or synthes*)) or (research adj3 (integrati* or overview*))).ti,ab.
29 ((integrative adj3 (review* or overview*)) or (collaborative adj3 (review* or overview*)) or (pool* adj3 analy*)).ti,ab.
30 (data synthes* or data extraction* or data abstraction*).ti,ab.
31 (handsearch* or hand search*).ti,ab.
32 (mantel haenszel or peto or der simonian or dersimonian or fixed effect* or latin square*).ti,ab.
33 (met analy* or metanaly* or health technology assessment* or HTA or HTAs).ti,ab.
34 (meta regression* or metaregression* or mega regression*).ti,ab.
35 (meta-analy* or metaanaly* or systematic review* or biomedical technology assessment* or bio-medical technology assessment*).mp,hw.
36 (medline or Cochrane or pubmed or medlars).ti,ab,hw.
37 (cochrane or health technology assessment or evidence report).jw.
38 (meta-analysis or systematic review).md.
39 or/25-38
40 24 and 39
41 exp "Sensitivity and Specificity"/
42 False Positive Reactions/
43 False Negative Reactions/
44 du.fs.
45 sensitivit*.tw.
46 (distinguish* or differentiat* or enhancement or identif* or detect* or diagnos* or accura* or comparison*).ti,ab.
47 (predictive adj4 value*).tw.
48 Comparative Study.pt.
49 (Validation Studies or Evaluation Studies).pt.
50 Randomized Controlled Trial.pt.
51 Controlled Clinical Trial.pt.
52 (Clinical Trial or Clinical Trial, Phase II or Clinical Trial, Phase III or Clinical Trial, Phase IV).pt.
53 Multicenter Study.pt.
54 (random* or sham or placebo*).ti.
55 ((singl* or doubl*) adj (blind* or dumm* or mask*)).ti.
56 ((tripl* or trebl*) adj (blind* or dumm* or mask*)).ti.
57 (control* adj3 (study or studies or trial*)).ti.
58 (non-random* or nonrandom* or quasi-random* or quasirandom*).ti.
59 (allocated adj "to").ti.
60 Cohort Studies/
61 Longitudinal Studies/
62 Prospective Studies/
63 Follow-Up Studies/
64 Retrospective Studies/
65 Case-Control Studies/
66 Cross-Sectional Study/
67 (observational adj3 (study or studies or design or analysis or analyses)).ti.
68 cohort.ti.
69 (prospective adj7 (study or studies or design or analysis or analyses or cohort)).ti.
70 ((follow up or followup) adj7 (study or studies or design or analysis or analyses)).ti.
71 ((longitudinal or longterm or (long adj term)) adj7 (study or studies or design or analysis or analyses or data or cohort)).ti.
72 (retrospective adj7 (study or studies or design or analysis or analyses or cohort or data or review)).ti.
73 ((case adj control) or (case adj comparison) or (case adj controlled)).ti.
74 (case-referent adj3 (study or studies or design or analysis or analyses)).ti.
75 (population adj3 (study or studies or analysis or analyses)).ti.
76 (cross adj sectional adj7 (study or studies or design or research or analysis or analyses or survey or findings)).ti.
77 or/41-76
78 77 not case reports.pt.
79 24 and 78
80 exp animals/
81 exp animal experimentation/
82 exp models animal/
83 exp animal experiment/
84 nonhuman/
85 exp vertebrate/
86 animal.po.
87 or/80-86
88 exp humans/
89 exp human experiment/
90 human.po.
91 or/88-90
92 87 not 91
93 79 not 92

 

OTHER DATABASES
PubMed Same MeSH, keywords, limits, and study types used as per MEDLINE search, with appropriate syntax used.

 

GREY LITERATURE SEARCHING
Dates for Search: March 2011
Keywords: Fractures (including child abuse) and radionuclide imaging.
Limits: English language

Human limits for primary studies

The following sections of the CADTH grey literature checklist, "Grey matters: a practical tool for evidence-based medicine" were searched:

  • Health Technology Assessment Agencies (selected)
  • Clinical Practice Guidelines
  • Databases (free)
  • Internet Search.

 

Appendix 3: Definitions

Diaphysis: The main or midsection (shaft) of a long bone. It is made up of cortical bone and usually contains bone marrow and adipose tissue (fat).

Occult: A fracture that does not appear in x-rays, although the bone shows new bone formation within three or four weeks of fracture.

 

Appendix 4: Diagnostic Accuracy

Table 7: Diagnostic Accuracy of Bone Scintigraphy and Alternative Tests

Author(s), Year, Country Study Design Population/ Condition Diagnostic Accuracy of Tests (%) Standard of Reference
Bone Scintigraphy CT MRI PET

Systematic review/Meta-analysis

Yin et al. 200914

China
Systematic review and meta-analysis 26 studies (N = 1,826) assessing the diagnostic performance of bone scintigraphy, CT, and MRI for detection of scaphoid fracture (age range, 22 to 44 years) included. Sens: 97% (95% CI, 93 to 99)

Spec: 89% (95% CI, 83 to 94)
Sens: 93% (95% CI, 83 to 98)

Spec: 99% (95% CI, 96 to 100)
Sens: 96% (95% CI, 91 to 99)

Spec: 99% (95% CI, 96 to 100)
  Follow-up images (radiographs, CT, MRI, or bone scintigraphy) or clinical follow-up and/or combined images
Primary studies
Gaeta et al. 200524

Italy
Prospective observational 42 athletes (mean age: 28.2 years; age range 16 to 37 years) with occult tibial stress injury Sens: 74%

Spec: NR

PPV: NR

NPV: NR
Sens: 42%

Spec: 100%

PPV: 52%

NPV: 100%
Sens: 88%

Spec: 100%

PPV: 90%

NPV: 100%
  Review of clinical findings, physical exam, and detailed history by 3 sports medicine physicians
Groves et al. 200529,30

UK
Prospective observational Military recruits with lower limb stress-related symptoms (33 suspected stress fractures in 26 patients) (mean age: 25 years, range,16 to 67 years)   Sens: 31%

Spec: 100%

PPV: 52%

NPV: 100%
    Bone scintigraphy
Hodler et al. 199825

Switzerland
Prospective observational 16 consecutive patients with stress-related injuries Sens: 100%

Spec: 100%

PPV: NR

NPV: NR
  Sens: 63% to 69%

Spec: NR

PPV: 91% to 100%

NPV: 40% to 50%
  Clinical and scintigraphic findings plus clinical follow-up
Ishibashi et al. 200227

Japan
Prospective observational Stress injuries (36 extremities) in 31 athletes (mean age: 14.9 years, range 12 to 21 years) Sens: 86%       MRI
Kiur et al. 200227

Finland
Retrospective observational Military trainees with 41 stress injuries of pelvis or lower extremity in 26 patients     Sens: 100%

Spec: 86%

PPV: 93%

NPV: 100%

Acc: 95%
  Bone scintigraphy

Kappa value for MRI and bone scintigraphy = 0.89
Shin et al. 199628

USA
Prospective observational 19 military trainees with hip pain with positive bone scintigraphy Sens: 100%

Spec: NR

PPV: 68%

NPV: NR
      MRI

Acc = accuracy; CI = confidence interval; CT = computed tomography; MRI = magnetic resonance imaging; NPV = negative predictive value; NR = not reported; 18F-PET = sodium fluoride positron emission tomography; PPV = positive predictive value; Sens = sensitivity; Spec = specificity.

 

Appendix 5: Accidental Fractures in Children

Patient population: Children with accidental fracture.

Comparators: CT, MRI.

Criterion 1: Size of affected population (link to definition)

Occult accidental pediatric fracture can result from a myriad of reasons, including accidental fall or stress fracture resulting from participation in a recreational activity.

An estimate of the potential pediatric population requiring bone scintigraphy to diagnose occult fracture was derived from a 2009 Canadian prospective study that reported that there were 44 playground-related fractures in 15,074 elementary students attending Toronto schools in 2008.76 In 2008, Sankor et al. reported that 18% of acute ankle trauma cases in children presenting to the emergency room of a large tertiary care children's hospital in California were occult fractures.76

Considering these studies, and assuming the situation is similar in Canada, we estimate the size of the Canadian pediatric population requiring bone scintigraphy for detection of accidental occult fracture to be eight (18% × 44) per 15,074 children (0.05%).

Criterion 2: Timeliness and urgency of test results in planning patient management (link to definition)

Prompt diagnosis of fracture in children can prevent onset of potential complications, including non-union, avascular necrosis, and osteoarthritis.

Criterion 3: Impact of not performing a diagnostic imaging test on mortality related to the underlying condition (link to definition)

It is unlikely that accidental occult skeletal fracture alone will affect mortality in children.

Criterion 4: Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition (link to definition)

Unidentified fractures in children can cause prolonged disability, including limited physical mobility and persistent pain. If untreated, unidentified fracture can progress to complete fracture, potentially having an impact on morbidity and quality of life in affected children.

Criterion 5: Relative impact on health disparities (link to definition)

No information was found on the potential health disparities relating to the detection of occult accidental fracture in children.

CriteriA 6–11

PET is not considered an alternate imaging test for diagnosing accidental fracture in children. Additional articles specific to accidental fracture in children were not identified. Hence, Criteria 6 to 11 are as reported for adults.