Multiple simultaneous fractures are associated with higher all-cause mortality: results from a province-wide fracture liaison service.

Mortality rates in our fracture liaison service ranged from 2.7% at year 1 to 14.8% at year 5 post-screening. Presentation with multiple simultaneous fractures at screening was associated with higher risk of death. This finding indicates the need for increased focus on this high-risk group. PURPOSE: To examine all-cause mortality rates in a provincial fracture liaison service (FLS) and the association between the index fracture type, particularly multiple simultaneous fractures, and the risk of death at follow-up. METHODS: This cohort study includes fragility fracture patients aged 50+, enrolled in a provincial FLS in Ontario, Canada, between 2007 and 2010. All-cause mortality was assessed using administrative data. Multivariable Cox proportional hazards model was used to examine the risk of death 5 years after screening. RESULTS: Crude mortality rates for 6543 fragility fracture patients were 2.7% at year 1, 5.6% at year 2, and 14.8% at year 5 after screening. After adjusting for age and sex, and relative to distal radius fracture, patients with multiple (simultaneous) fractures at screening had a higher risk of dying (HR = 1.8, 95%CI 1.3-2.4), followed by those with a hip fracture (HR = 1.5, 95%CI 1.3-1.8), a proximal humerus fracture (HR = 1.4, 95%CI 1.2-1.7), and other single fractures (HR = 1.4, 95%CI 1.1-1.7). Having an index ankle fracture was not associated with the risk of death over a distal radius fracture. As compared to the 50-65 age group, patients 66 years and older had a higher risk of death (for 66-70 age group: HR = 2.5, 95%CI 1.9-3.3; for 71-80: HR = 4.3, 95%CI 3.5-5.4; and for 81+: HR = 10.6, 95%CI 8.7-13.0). Females had a lower risk of death (HR = 0.5, 95%CI 0.5-0.6) than males. CONCLUSIONS: Presenting with multiple fractures was an indicator of higher risk of death relative to a distal radius fracture. This finding indicates the need for increased focus on this high-risk group.

Five-year refracture rates of a province-wide fracture liaison service.

We examined the 5-year refracture rate of 6543 patients and found an overall rate of 9.7%. Adjusted analysis showed that presenting with multiple fractures was an indicator of a higher refracture risk; while presenting with an ankle fracture was associated with a lower refracture risk. INTRODUCTION: To examine refractures among patients screened in a province-wide fracture liaison service (FLS). METHODS: We assessed the 5-year refracture rate of fragility fracture patients aged 50+ who were screened at 37 FLS fracture clinics in Ontario, Canada. Refracture was defined as a new hip, pelvis, spine, distal radius, or proximal humerus fracture. Kaplan-Meier curves and Cox proportional hazards model adjusting for age, sex, and index fracture type were used to examine refracture rates. RESULTS: The 5-year refracture rate of 6543 patients was 9.7%. Those presenting with multiple fractures at baseline (i.e., two or more fractures occurring simultaneously) had the highest refracture rate of 19.6%. As compared to the 50-65 age group, refracture risk increased monotonically with age group (66-70 years: HR = 1.3, CI 95%, 1.0-1.7; 71-80 years: HR = 1.7, CI 1.4-2.1; 81+ years: HR = 3.0, CI 2.4-3.7). Relative to distal radius, presenting with multiple fractures at screening was associated with a higher risk of refracture (HR = 2.3 CI 1.6-3.1), while presenting with an ankle fracture was associated with a lower risk of refracture (HR = 0.7 CI 0.6-0.9). Sex was not a statistically significant predictor of refracture risk in this cohort (HR = 1.2, CI 1.0-1.5). CONCLUSIONS: One in ten patients in our cohort refractured within 5 years after baseline. Presenting with multiple fractures was an indicator of a higher refracture risk, while presenting with an ankle fracture was associated with a lower refracture risk. A more targeted FLS approach may be appropriate for patients at a higher refracture risk.

The impact of fragility fractures on work and characteristics associated with time to return to work.

We examined the impact of fragility fractures on the work outcomes of employed patients. The majority successfully returned to their previous jobs in a short amount of time, and productivity loss at work was low. Our findings underscore the fast recovery rates of working fragility fracture patients. INTRODUCTION: The purpose of this study is to describe the impact of fragility fractures on the work outcomes of patients who were employed at the time of their fracture. METHODS: A self-report anonymous survey was mailed to fragility fracture patients over 50 who were screened as part of the quality assurance programs of fracture clinics across 35 hospitals in Ontario, Canada. Measures of return to work (RTW), at-work productivity loss (Work Limitations Questionnaire), and sociodemographic, fracture-related, and job characteristics were included in the survey. Kaplan-Meier estimates of the cumulative proportion of patients still off work were computed. Factors associated with RTW time following a fragility fracture were examined using Cox proportional hazards modeling. RESULTS: Of 275 participants, 242 (88 %) returned to work. Of these, the median RTW time was 20.5 days. About 86 % returned to the same job, duties, and hours as before their injury. Among full-time workers, the median number of lost hours due to presenteeism was 2.9 h (Q1-Q3 0.4-8.1 h). The median cost of presenteeism was $75.30 based on the month prior to survey completion. In multivariable analyses, female gender, needing surgery, and medium/heavy work requirements were associated with longer RTW time. Earlier RTW time was associated with elbow fracture and feeling completely better at time of survey completion. CONCLUSIONS: The majority of fragility fracture patients successfully returned to their previous jobs in a short amount of time, and productivity loss at work was low. Our findings underscore their fast recovery rates and give reason for optimism regarding the resilience of this population.

Addition of a fracture risk assessment to a coordinator's role improved treatment rates within 6 months of screening in a fragility fracture screening program.

We evaluated the impact of a more intensive version of an existing post-fracture coordinator-based fracture prevention program and found that the addition of a full-risk assessment improved treatment rates. These findings provide additional support for more intensive programs aimed at reducing the risk of re-fractures. INTRODUCTION: Evidence-based guidelines support coordinator-based programs to improve post-fracture osteoporosis guideline uptake, with more intensive programs including bone mineral density (BMD) testing and/or treatment being associated with better patient outcomes. The purpose of this study was to evaluate the impact of a more intensive version (BMD "fast track") of an existing provincial coordinator-based program. METHODS: We compared two versions of the program that screened treatment naïve fragility fracture patients (>50 years). Cases came from the BMD fast track program that included full fracture risk assessment and communication of relevant guidelines to the primary care provider (PCP). Matched controls were selected from the usual care program matching according to age, sex, fracture type, and date. Two matching techniques were used: traditional (hard) matching (TM) and propensity score matching (PS). The outcomes were treatment initiation with bone sparing medication, BMD testing rate, and the rate of returning to discuss the test results with a PCP. RESULTS: The program improvements led to a significant improvement in treatment initiation within 6 months from 16 % (controls based on PS) or 21 % (controls based on TM) to 32 % (cases). Ninety percent of patients in the BMD fast track program returned to their PCP to discuss bone health in the cases versus 60 % of the controls (for TM and PS). BMD testing occurred in 96 % of cases compared to the 66 (TM) or 65 % (PS) of the matched controls. CONCLUSIONS: Addition of a full-risk assessment to a coordinator-based program significantly improved treatment rates within 6 months of screening.

Equal treatment: no evidence of gender inequity in osteoporosis management in a coordinator-based fragility fracture screening program.

We evaluated gender imbalance in osteoporosis management in a provincial coordinator-based fracture prevention program and found no difference by gender in treatment of high-risk fragility fracture patients. This establishes that a systemic approach with interventions for all fragility fracture patients can eliminate the gender inequity that is often observed. INRODUCTION: The purpose of this study was to evaluate an Ontario-based fracture prevention program for its ability to address the well-documented gender imbalance in osteoporosis (OP) management, by incorporating its integrated fracture risk assessments within a needs-based evaluation of equity. METHODS: Fragility fracture patients (≥ 50 years) who were treatment naïve at screening and completed follow-up within 6 months of screening were studied. Patients who underwent bone mineral density (BMD) testing done in the year prior to their current fracture were excluded. All participants had BMD testing conducted through the Ontario OP Strategy Fracture Screening and Prevention program, thus providing us with fracture risk assessment data. Our primary study outcome was treatment initiation at follow-up within 6 months of screening. Gender differences were compared using Fisher's exact test, at p < 0.05. RESULTS: After adjusting for subsequent fracture risk, study participants did not show a statistically significant gender difference in pharmacotherapy initiation at follow-up (p > 0.05). 68.4% of women and 66.2% of men at high risk were treated within 6 months of screening. CONCLUSION: Needs-based analyses show no difference by gender in treatment of high-risk fragility fracture patients. An intensive coordinator-based fracture prevention model adopted in Ontario, Canada was not associated with gender inequity in OP treatment of fragility fracture patients after fracture risk adjustment.

Factors influencing the pharmacological management of osteoporosis after fragility fracture: results from the Ontario Osteoporosis Strategy's fracture clinic screening program.

UNLABELLED: Potential mediating factors in the pathway to initiation of osteoporosis treatment following a fragility fracture were evaluated. Patients' perceived need for treatment, mediated by their perception of bone density test results, was central to treatment initiation. Interventions focusing on patients' perceptions of need and test results may improve treatment rates. INTRODUCTION: We tested a hypothesized pathway to osteoporosis (OP) pharmacotherapy initiation in fragility fracture patients. We hypothesized that bone mineral density (BMD) testing is strongly associated with treatment initiation and perception of BMD test results would inform patients' perceived need for treatment, which would mediate the effect between BMD testing and treatment initiation. METHODS: A longitudinal cohort study followed patients, ≥50 years of age, screened for fragility fracture in 31 fracture clinics in Ontario, Canada who had no prior diagnosis of or treatment for OP. At screening, OP risk factors, baseline-patient perception of OP risk, OP knowledge, and perceived benefits of medication were reported by patients. Patients were followed up within 6 months of fracture to determine BMD testing and prescription of and adherence to first-line OP pharmacotherapy. Structural equation modeling tested the hypothesized pathway. Significance and magnitude of the coefficients and indicators of overall model fit were used to test our model. RESULTS: The direct path from BMD testing to OP treatment initiation was non-significant. The pathway to treatment initiation was mediated by patients' perception of their need, which was influenced by their self-reported BMD results. Baseline fracture risk factors, knowledge of OP, and perceived benefits of treatment-predicted patient-perceived need for treatment at follow-up and initiation of OP treatment. CONCLUSIONS: Patient perceptions were central factors in the path to initiation of OP pharmacotherapy. Interventions to facilitate accurate patient perceptions of BMD test results and OP risk status could prove helpful in improving OP treatment initiation.

Assessing domain match and feasibility of candidate instruments matching with OMERACT endorsed domains to measure flare in knee and hip osteoarthritis.

PURPOSE: To evaluate the domain match (truth) and feasibility of candidate instruments assessing flare in knee and hip osteoarthritis (OA) according to the identified domains. MATERIAL AND METHODS: From a literature review (575 papers), instruments were selected and evaluated using the truth and feasibility elements of the OMERACT Filter 2.2. These were evaluated by 26 experts, including patients, in two Delphi survey rounds. The final selection was obtained by a vote. RESULTS: 44 instruments were identified. In Delphi Round 1, five instruments were selected. In Round 2, all instruments obtained at least 75 % in terms of content match with the endorsed domains and feasibility. In the final selection, the Flare-OA questionnaire obtained 100 % favorable votes. CONCLUSION: Through consensus of the working group, the Flare-OA questionnaire was selected as the best candidate instrument to move into a full assessment of its measurement properties using the OMERACT Filter 2.2.

Return to work and workplace activity limitations following total hip or knee replacement.

OBJECTIVE: Total hip (THR) and knee (TKR) replacements increasingly are performed on younger people making return to work a salient outcome. This research evaluates characteristics of individuals with early and later return to work following THR and TKR. Additionally, at work limitations pre-surgery and upon returning to work, and factors associated with work limitations were evaluated. METHODS: 190 THR and 170 TKR of a total 931 cohort participants were eligible (i.e., working or on short-term disability pre-surgery). They completed questionnaires pre-surgery and 1, 3, 6 and 12 months post-surgery that included demographics, type of occupation, and the Workplace Activity Limitations Scale (WALS). RESULTS: 166 (87%) and 144 (85%) returned to work by 12 months following THR and TKR, respectively. Early (1 month) return to work was associated with, male gender, university education, working in business, finance or administration, and low physical demand work. People with THR returned to work earlier than those with TKR. For both groups, less pain and every day functional limitations were associated with less workplace activity limitations at the time return to work. CONCLUSIONS: The majority of individuals working prior to surgery return to work following hip or knee replacement for osteoarthritis (OA) and experience fewer limitations at work than pre-surgery. The changing workforce dynamics and trends toward surgery at younger ages mean that these are important outcomes for clinicians to assess. Additionally, this is important information for employers in understanding continued participation in employment for people with OA.

The trajectory of recovery and the inter-relationships of symptoms, activity and participation in the first year following total hip and knee replacement.

OBJECTIVE: Primary total hip (THR) and knee (TKR) replacement outcomes typically include pain and function with a single time of follow-up post-surgery. This research evaluated the trajectory of recovery and inter-relationships within and across time of physical impairments (PI) (e.g., symptoms), activity limitations (AL), and social participation restrictions (PR) in the year following THR and TKR for osteoarthritis. DESIGN: Participants (hip: n=437; knee: 494) completed measures pre-surgery and at 2 weeks, 1, 3, 6 and 12 months post-surgery. These included PI (Hip Disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms and Chronic Pain Grade); AL (HOOS/KOOS activities of daily living and sports/leisure activities); and, PR (Late Life Disability and the Calderdale community mobility). Repeated measures analysis of variance (RANOVA) was used to evaluate the trajectory of recovery of outcomes and the inter-relationships of PI, AL and PR were evaluated using path analysis. All analyses were adjusted for age, sex, obesity, THR/TKR, low back pain and mood. RESULTS: THR: age 31-86 years with 55% female; TKR: age 35-88 years with 65% female. Significant improvements in outcomes were observed over time. However, improvements were lagged over time with earlier improvements in PI and AL and later improvements in PR. Within and across time, PI was associated with AL and AL was associated with PR. The magnitude of these inter-relationships varied over time. CONCLUSION: Given the lagged inter-relationship of PI, AL and PR, the provision and timing of interventions targeting all constructs are critical to maximizing outcome. Current care pathways focusing on short-term follow-up with limited attention to social and community participation should be re-evaluated.

A review of patient-centred post-fracture interventions in the context of theories of health behaviour change.

The purpose of this literature review is to determine whether and to what extent current post-fracture osteoporosis interventions utilize theories of health behaviour change and whether those that are theory-based are more successful in producing desired behaviour changes. Studies were identified by applying additional criteria to the final selection stage of a systematic review of non-surgical osteoporosis interventions in the orthopaedic environment. We identified 42 primary studies targeted at patients and improving post-fracture osteoporosis care. As well as describing the studies (in terms of design, population, interventions, outcomes), we focused on theoretical framework and elements of behaviour change models. The 42 studies included in this review utilized a variety of post-fracture interventions; however, none of them reported using an underlying theoretical base. Only three studies drew on what we felt to be elements of a theoretical framework. The lack of theoretically based studies points to a currently under-utilized area of behaviour change research that could be applied to post-fracture interventions in order to make them more effective. Despite an abundance of literature supporting theories of behaviour change, post-fracture osteoporosis interventions do not report utilizing these theories. Theories of behaviour change could be applied to post-fracture osteoporosis interventions to explain why patients initiate osteoporosis management. Future research should explore the application of theories of health behaviour change to post-fracture interventions.

Osteoporosis quality indicators using healthcare utilization data.

SUMMARY: Healthcare utilization data may be used to examine the quality of osteoporosis management by identifying dual-energy X-ray absorptiometry (DXA) testing (sensitivity = 98%, specificity = 93%) and osteoporosis pharmacotherapy (κ = 0.81) with minimal measurement error. INTRODUCTION: In osteoporosis, key quality indicators among older women include risk assessment by DXA and/or pharmacotherapy within 6 months following fracture. METHODS: The purpose of this study was to examine healthcare utilization data for use as quality indicators of osteoporosis management. We linked data from 858 community-dwelling women aged over 65 years who completed a standardized telephone interview about osteoporosis management to their healthcare utilization (medical and pharmacy claims) data. Agreement between self-report of osteoporosis pharmacotherapy and pharmacy claims was examined using kappa statistics. We examined the sensitivity and specificity of medical claims to identify DXA testing as well as the sensitivity and specificity of medical and pharmacy claims to identify those with DXA-documented osteoporosis (T-score ≤ -2.5). RESULTS: Participants were aged 75 (SD = 6) years on average; 96% were Caucasian. Agreement between self-report and claims-based osteoporosis pharmacotherapy was very good (κ = 0.81; 95% CI = 0.76, 0.86). The sensitivity of medical claims to identify DXA testing was 98% (95% CI = 95.9, 99.1), with estimated specificity of 93% (95% CI = 89.8, 95.4). We abstracted DXA results from test reports of 359 women, of whom 114 (32%) were identified with osteoporosis. Medical (osteoporosis diagnosis) and pharmacy (osteoporosis pharmacotherapy) claims within a year after DXA testing had a sensitivity of 80% (95% CI = 71.3, 86.8) and specificity of 72% (95% CI = 66.2, 77.8) to identify DXA-documented osteoporosis. CONCLUSION: Healthcare utilization data may be used to examine the quality of osteoporosis management by identifying DXA testing and osteoporosis pharmacotherapy (care processes) with minimal measurement error. However, medical and pharmacy claims alone do not provide a good means for identifying women with underlying osteoporosis.

Coordinator-based systems for secondary prevention in fragility fracture patients.

The underlying causes of incident fractures--bone fragility and the tendency to fall--remain under-diagnosed and under-treated. This care gap in secondary prevention must be addressed to minimise both the debilitating consequences of subsequent fractures for patients and the associated economic burden to healthcare systems. Clinical systems aimed at ensuring appropriate management of patients following fracture have been developed around the world. A systematic review of the literature showed that 65% of systems reported include a dedicated coordinator who acts as the link between the orthopaedic team, the osteoporosis and falls services, the patient and the primary care physician. Coordinator-based systems facilitate bone mineral density testing, osteoporosis education and care in patients following a fragility fracture and have been shown to be cost-saving. Other success factors included a fracture registry and a database to monitor the care provided to the fracture patient. Implementation of such a system requires an audit of existing arrangements, creation of a network of healthcare professionals with clearly defined roles and the identification of a 'medical champion' to lead the project. A business case is needed to acquire the necessary funding. Incremental, achievable targets should be identified. Clinical pathways should be supported by evidence-based recommendations from national or regional guidelines. Endorsement of the proposed model within national healthcare policies and advocacy programmes can achieve alignment of the objectives of policy makers, professionals and patients. Successful transformation of care relies upon consensus amongst all participants in the multi-disciplinary team that cares for fragility fracture patients.

Patient acceptance of osteoporosis treatment: Application of the stages of change model.

OBJECTIVES: To examine whether a commonly used model of behaviour change, stages of change, is helpful in understanding osteoporosis treatment initiation in a cohort of fragility fracture patients. STUDY DESIGN: This longitudinal cohort study used data from a provincial osteoporosis screening program targeting fragility fracture patients age 50 and over. Logistic regression was used to identify baseline factors associated with patients moving from the first, pre-contemplation stage at baseline to the more advanced stages of action/maintenance at follow-up, when treatment is initiated and maintained. MAIN OUTCOME MEASURE: Patient's stage-of-change readiness to accept osteoporosis treatment. RESULTS: At baseline, 91% of patients were in the pre-contemplation stage. Of these, 74.1% remained at the same stage at follow-up, 2.7% moved to contemplation and preparation while 23.2% moved to action/maintenance. The adjusted analysis showed that those who moved from pre-contemplation to action/maintenance were more likely to have a previous fracture OR 1.5 (1.1-2.0), history of oral steroid use OR 2.1 (1.3-3.5), higher perceived benefits to osteoporosis drug treatment OR 1.2 (1.0-1.3), perception of bones as "thin" OR 2.8 (2.0-4.0) and were less likely to perceive that they were taking too many medications OR 0.6 (0.5-0.9). CONCLUSIONS: With the majority of patients in the pre-contemplation and the action/maintenance stages, our results suggest an existence of a two-stage model. The baseline factors that we identified can be used to predict which patients are less likely to initiate treatment, which in turn, can be used to inform post-fracture interventions and facilitate behaviour change.

Evaluating changes in health status: reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders.

OBJECTIVES: To compare the measurement properties over time of five generic health status assessment techniques. METHODS: Five health status measures were completed on two occasions by a sample of workers with musculoskeletal disorders. They included the SF-36, Nottingham Health Profile, Health Status Section of the Ontario Health Survey (OHS), Duke Health Profile, the Sickness Impact Profile and a self-report of change in health between tests. SETTING: Subjects were accrued from a work site (within one week of injury) (n = 53), physiotherapy clinics (four weeks after injury), (n = 34), and a tertiary level rehabilitation center (more than four weeks after injury) (n = 40). ANALYSIS: Intraclass correlation coefficients (ICC) derived from nonparametric one-way analysis of variance were used for test-retest reliability in those who had not changed (n = 49). Various responsiveness statistics were used to evaluate responsiveness in those who claimed they had a positive change in health (n = 45) and in those who would have been expected to have a positive change (n = 79). RESULTS: Of the 127 subjects recruited, 114 completed both questionnaires (89.8%). In the subjects who reported no change in health, analysis of targeted dimensions (overall scores, physical function, and pain) demonstrated acceptable to excellent test-retest reliability in all but the Duke Health Profile. In subjects with change in health, the SF-36 was the most responsive measure (moderate to large effect sizes [0.55-0.97] and standardized response means ranging between 0.81 and 1.13). CONCLUSIONS: The results suggest that the SF-36 was the most appropriate questionnaire to measure health changes in the population studied. The selection of a health status measure must be context-specific, taking into account the purpose and population of the planned research.

A taxonomy for responsiveness.

Responsiveness is quickly becoming a critical criterion for the selection of outcomes measures in studies of treatment effectiveness, economic appraisals, and other program evaluations. Statistical characteristics, specifically "large effect sizes," are often felt to indicate the relative worth of one instrument over another. However, debates about their meaning led the present authors to propose a taxonomy for responsiveness based on the context of the study concerned. The three axes underlying the classification system relate to: who is this being analyzed for (individuals or groups); which scores are being contrasted (over time/at one point in time); and the type of change being quantified (for example, observed change or important change). It is concluded that responsiveness should be considered a highly contextualized attribute of an instrument, rather than a static property and should be described only in that way. A questionnaire could thus be described as being "responsive to" a given category in the new taxonomy.

Rasch analysis of the Western Ontario McMaster (WOMAC) Osteoarthritis Index: results from community and arthroplasty samples.

BACKGROUND AND OBJECTIVE: This study is based on secondary analysis of Western Ontario McMaster Osteoarthritis Index (WOMAC) data from a community sample over 55 years and total hip or knee arthroplasty samples presurgery and 1-year postoperative. METHODS: The WOMAC data were evaluated by Rasch analysis. Data were considered to fit the Rasch mathematical model for the pain and physical dimensions of the WOMAC if unidimensionality was confirmed by principle component analysis of the subscale and the residuals from the Rasch analysis, infit and outfit statistics were in the range of 0.80 to 1.20; if there was no differential item functioning based on gender or hip vs. knee subjects; and, if there was stability of the item logits across the three data samples. RESULTS: A three-item pain dimension (excluding night pain and pain on standing) and a 14-item physical dimension (excluding heavy domestic duties, getting in and out of the bath and getting on and off the toilet) fit the Rasch model based on these criteria. CONCLUSION: In evaluating existing health status questionnaires using Rasch methodology, it is important to evaluate relevant patient samples and longitudinal data when the measure is intended to evaluate change in status. By these criteria, a modified WOMAC questionnaire fits the Rasch model and has interval-level scaling properties.

Method for automated cartilage histomorphometry.

We have developed and tested a color-based method for automated computerized histomorphometric analysis of cartilage. Histological sections stained with safranin O from 29 rabbit periosteal agarose-cultured explants were selected with various amounts of cartilage (0-100%). Color photomicrographs of these sections were visually assessed by five expert observers who estimated the percent area occupied by cartilage and outlined (in pen) the areas they considered to be cartilage. Manual histomorphometry was performed by cutting out and weighing the outlined areas. The average area for each of the five observers ranged from 31% to 43% (intraclass correlation coefficient = 0.70). The average of these values was used as a "gold standard" against which to compare the computer measurements. When point counting histomorphometry was performed on the 29 sections, the data agreed with the measurements made by the other five cartilage experts (r2 = 0.96; p < 0.0001). The analysis of cartilage is based on safranin O stain, using a custom-designed Vidas 2.1 Image Analysis Program (Zeiss). The computer-based results correlated very closely with those obtained by manual (p = 0.0001; r2 = 0.92) and point counting (r2 = 0.92; p < 0.0001) histomorphometry. The mean percentage of the sections occupied by cartilage measured in the automated mode was only 6% higher than that using the gold standard. Histological complexity had only a minor effect on the computerized values. The automated computerized image analysis system has the advantages of objectivity, accuracy, repeatability, and ease of use.

Validation of a simple histological-histochemical cartilage scoring system.

In this study, we assessed the validity of a subjective histological-histochemical scoring system as compared to an automated histomorphometry program for analyzing cartilage repair tissue. In the first part of the study, we assessed the ability of the human eye to estimate the percent cartilage in a histological section. Twenty-nine rabbit periosteal explants that had been cultured in agarose transforming growth factor-beta (TGF-beta) were selected so that the percentage of cartilage in the specimens was distributed equally from 0% to 100%. Color photomicrographs were evaluated by 5 expert observers who gave a visual estimate of the percent cartilage. There was a strong correlation between the estimated and actual percent cartilage (R(2) = 0.92, p < 0.0001) and among the observers (I.C.C. = 0.89). On average, the estimated percent cartilage was within ten percent of the actual percent measured. In the second part, we compared the data derived using a simple cartilage score with those obtained by automated image analysis. The histological slides from 159 explants cultured under various experimental conditions (14 treatment groups) in two different experiments were analyzed. The cartilage content was estimated visually and a score from 0 to 3 was assigned. A previously validated, computerized image analysis system was used to measure the actual percent cartilage. Statistical analyses revealed a good linear regression (R(2) = 0.84, p = 0.0001), and even better polynomial correlation between the actual measurement and the score (R(2) = 0.88, p = 0.0001). These data demonstrate the validity of a simple histological-histochemical subjective scoring system. A computerized automated program such as the one employed in this study is preferable due to its many advantages. However, a subjective scoring system may be appropriate to use when the funding and expertise required for a computerized image analysis program are not available.

Measuring function of the shoulder. A cross-sectional comparison of five questionnaires.

Measures of both generic and disease-specific health status are being developed and used with increasing frequency for the appraisal of musculoskeletal conditions. The purpose of this study was to compare prospectively the validity of five questionnaires in the assessment of function of the shoulder. Ninety subjects who had various problems related to the shoulder agreed to enter the study. All of the subjects completed a questionnaire package that included the Shoulder Pain and Disability Index, the Simple Shoulder Test, the Subjective Shoulder Rating Scale, the Modified American Shoulder and Elbow Surgeons Shoulder Patient Self-Evaluation Form, and the Shoulder Severity Index as well as a measure of generic health status (the acute version of the Short Form 36 [SF-36]) and two questions that asked the patient to rate the severity of the problem and his or her over-all health. Frequency distributions were created and compared among questionnaires. Spearman rank correlations were calculated to compare the questionnaires with each other and with other assessments. One-way analysis of variance was used to determine the ability of the questionnaires to discriminate between self-rated severity of the problem and over-all health. The frequency distributions were similar among the five shoulder questionnaires, but those of the five shoulder questionnaires differed from that of the SF-36. The correlations were good (0.73 < or = r < or = 0.80) among all of the five shoulder questionnaires except the Subjective Shoulder Rating Scale; they were lower with the Subjective Shoulder Rating Scale and the physical function dimension of the SF-36 (0.12 < or = r < or = 0.60). The shoulder questionnaires discriminated between levels of severity (p < 0.0001) but not between levels of over-all health (0.10 < or = p < or = 0.86). In this concurrent comparison of measures of shoulder-specific outcome in the same subjects, the shoulder questionnaires performed similarly, both in describing function of the shoulder and in discriminating between levels of severity. The shoulder questionnaires performed differently than the SF-36, which confirms the need to use both disease-specific and generic health-status measures to evaluate patients who have a problem related to the shoulder.