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1.  Variability in Recommendations for Total Knee Arthroplasty among Rheumatologists and Orthopedic Surgeons 
The Journal of rheumatology  2013;41(1):10.3899/jrheum.130762.
The most rapidly growing population of patients undergoing total knee arthroplasty (TKA) is under the age of 65. The objective of this study was to gain insight into the factors influencing physicians’ recommendations for persons in this age group with moderate osteoarthritis (OA).
Rheumatologists and orthopedic surgeons attending national meetings were asked to complete a survey including a standardized scenario of a 62 year old person with knee OA who has moderate knee pain limiting strenuous activity despite medical management. We used an experimental 2×2×2 design to examine the effects of gender, employment status and severity of radiographic OA on physicians’ recommendations. Each physician was asked to rate a single scenario.
The percent of physicians recommending TKA varied from 30% to 55% for scenarios describing a patient with mild radiographic OA, and from 39% to 71% for scenarios describing a patient with moderate radiographic OA. Surgeons were less likely to recommend TKA for women compared to men of the same age, employment status, symptom severity and functional status, and x-rays. Rheumatologists practicing in academic settings were more likely to recommend TKA compared to those practicing in non-academic settings, and American surgeons were more likely to recommend TKA compared to their European counterparts.
Orthopedic surgeons and rheumatologists vary significantly in their recommendations for patients with moderate knee pain and functional limitations. Both patient and physician characteristics influence physicians’ recommendations and rheumatologists and orthopedic surgeons display different patterns of decision-making.
PMCID: PMC3880398  PMID: 24293580
Total Joint Arthroplasty; Practice Patterns; Physician Bias; Unwarranted Variability
2.  Expanding Paramedicine in the Community (EPIC): study protocol for a randomized controlled trial 
Trials  2014;15(1):473.
The incidence of chronic diseases, including diabetes mellitus (DM), heart failure (HF) and chronic obstructive pulmonary disease (COPD) is on the rise. The existing health care system must evolve to meet the growing needs of patients with these chronic diseases and reduce the strain on both acute care and hospital-based health care resources. Paramedics are an allied health care resource consisting of highly-trained practitioners who are comfortable working independently and in collaboration with other resources in the out-of-hospital setting. Expanding the paramedic’s scope of practice to include community-based care may decrease the utilization of acute care and hospital-based health care resources by patients with chronic disease.
This will be a pragmatic, randomized controlled trial comparing a community paramedic intervention to standard of care for patients with one of three chronic diseases. The objective of the trial is to determine whether community paramedics conducting regular home visits, including health assessments and evidence-based treatments, in partnership with primary care physicians and other community based resources, will decrease the rate of hospitalization and emergency department use for patients with DM, HF and COPD. The primary outcome measure will be the rate of hospitalization at one year. Secondary outcomes will include measures of health system utilization, overall health status, and cost-effectiveness of the intervention over the same time period. Outcome measures will be assessed using both Poisson regression and negative binomial regression analyses to assess the primary outcome.
The results of this study will be used to inform decisions around the implementation of community paramedic programs. If successful in preventing hospitalizations, it has the ability to be scaled up to other regions, both nationally and internationally. The methods described in this paper will serve as a basis for future work related to this study.
Trial registration NCT02034045. Date: 9 January 2014.
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-473) contains supplementary material, which is available to authorized users.
PMCID: PMC4289358  PMID: 25467772
Randomized controlled trial; Community health services; Primary health care; Allied health personnel
3.  You’ll know when you’re ready: a qualitative study exploring how patients decide when the time is right for joint replacement surgery 
While some studies have identified patient readiness as a key component in their decision whether to have total joint replacement surgery (TJR), none have examined how patients determine their readiness for surgery. The study purpose was to explore the concept of patient readiness and describe the factors patients consider when assessing their readiness for TJR.
Nine focus groups (4 pre-surgery, 5 post-surgery) were held in four Canadian cities. Participants had been either referred to or seen by an orthopaedic surgeon for TJR or had undergone TJR. The method of analysis was qualitative thematic analysis.
There were 65 participants, 66% female and 34% male, 80% urban, with an average age of 65 years (SD 10). Readiness reflected both the surgeon’s advice that the patient was clinically ready for surgery and the patient’s feeling that they were both mentally and physically ready for surgery. Mental readiness was described as an internal state or feeling of being ready or prepared while physical readiness was described as being physically fit and in good shape for surgery. Factors associated with readiness included: 1) pain: its severity, the ability to cope with it, and how it affected their quality of life; 2) mental preparation; 3) physical preparation; 4) the optimal timing of surgery, including age, anticipated rate of deterioration, prosthesis lifespan and the length of the waiting list.
Patient readiness should be assessed prior to TJR. By assessing patient readiness, health professionals can elucidate and deal with concerns and fears, understand and calibrate expectations, assess coping strategies, and use this information to help determine optimal timing, both before and after the surgical consultation.
PMCID: PMC4283088  PMID: 25278186
Decision making; Readiness; Total joint replacement; Qualitative research; Osteoarthritis
4.  Obstructive sleep apnea and the prevalence and incidence of cancer 
A link between obstructive sleep apnea and cancer development or progression has been suggested, possibly through chronic hypoxemia, but supporting evidence is limited. We examined the association between the severity of obstructive sleep apnea and prevalent and incident cancer, controlling for known risk factors for cancer development.
We included all adults referred with possible obstructive sleep apnea who underwent a first diagnostic sleep study at a single large academic hospital between 1994 and 2010. We linked patient data with data from Ontario health administrative databases from 1991 to 2013. Cancer diagnosis was derived from the Ontario Cancer Registry. We assessed the cross-sectional association between obstructive sleep apnea and prevalent cancer at the time of the sleep study (baseline) using logistic regression analysis. Cox regression models were used to investigate the association between obstructive sleep apnea and incident cancer among patients free of cancer at baseline.
Of 10 149 patients who underwent a sleep study, 520 (5.1%) had a cancer diagnosis at baseline. Over a median follow-up of 7.8 years, 627 (6.5%) of the 9629 patients who were free of cancer at baseline had incident cancer. In multivariable regression models, the severity of sleep apnea was not significantly associated with either prevalent or incident cancer after adjustment for age, sex, body mass index and smoking status at baseline (apnea–hypopnea index > 30 v. < 5: adjusted odds ratio [OR] 0.96, 95% confidence interval [CI] 0.71–1.30, for prevalent cancer, and adjusted hazard ratio [HR] 1.02, 95% CI 0.80–1.31, for incident cancer; sleep time spent with oxygen saturation < 90%, per 10-minute increase: adjusted OR 1.01, 95% CI 1.00–1.03, for prevalent cancer, and adjusted HR 1.00, 95% CI 0.99–1.02, for incident cancer).
In a large cohort, the severity of obstructive sleep apnea was not independently associated with either prevalent or incident cancer. Additional studies are needed to elucidate whether there is an independent association with specific types of cancer.
PMCID: PMC4162778  PMID: 25096668
5.  The role of pain and functional impairment in the decision to recommend total joint replacement in hip and knee osteoarthritis: an international cross-sectional study of 1909 patients. Report of the OARSI-OMERACT Task Force on total joint replacement 
To assess the pain and functional disability levels corresponding to an indication for total joint replacement (TJR) in hip and knee osteoarthritis (OA).
Design: international cross-sectional study in 10 countries. Patients: consecutive outpatients with definite hip or knee OA attending an orthopaedic outpatient clinic. Gold standard measure for recommendation for TJR: surgeon's decision that TJR is justified. Outcome measures: pain (ICOAP: intermittent and constant osteoarthritis pain, 0-100) and functional impairment (HOOS-PS/KOOS-PS: Hip/Knee injury and Osteoarthritis Outcome Score Physical function Short-form, 0-100). Analyses: Comparison of patients with versus without surgeons' indication for TJR. ROC curve analyses and logistic regression were applied to determine cut-points of pain and disability defining recommendation for TJR.
In all, 1909 patients were included (1130 knee/779 hip OA). Mean age was 66.4 (SD 10.9) years, 58.1% were women; 628/1130 (55.6%) knee OA and 574/779 (73.7%) hip OA patients were recommended for TJR. Although patients recommended for TJR (yes versus no) had worse symptom levels (pain, 55.5 [95% confidence interval 54.2, 56.8] vs. 44.9 [43.2, 46.6], and functional impairment, 59.8 [58.7, 60.9] vs. 50.9 [49.3, 52.4], respectively, both p<0.0001), there was substantial overlap in symptom levels between groups, even when adjusting for radiographic joint status. Thus, it was not possible to determine cut points for pain and function defining ‘requirement for TJR’.
Although symptom levels were higher in patients recommended for TJR, pain and functional disability alone did not discriminate between those who were and were not considered to need TJR by the orthopaedic surgeon.
PMCID: PMC4151518  PMID: 21044689
Knee; hip; osteoarthritis; joint replacement; surgery; symptom
6.  Impact of a chronic disease self-management program on health care utilization in rural communities: a retrospective cohort study using linked administrative data 
Internationally, chronic disease self-management programs (CDSMPs) have been widely promoted with the assumption that confident, knowledgeable patients practicing self-management behavior will experience improved health and utilize fewer healthcare resources. However, there is a paucity of published data supporting this claim and the majority of the evidence is based on self-report.
We used a retrospective cohort study using linked administrative health data. Data from 104 tele-CDSMP participants from 13 rural and remote communities in the province of Ontario, Canada were linked to administrative databases containing emergency department (ED) and physician visits and hospitalizations. Patterns of health care utilization prior to and after participation in the tele-CDSMP were compared. Poisson Generalized Estimating Equations regression was used to examine the impact of the tele-CDSMP on health care utilization after adjusting for covariates.
There were no differences in patterns of health care utilization before and after participating in the tele-CDSMP. Among participants ≤ 66 years, however, there was a 34% increase in physician visits in the 12 months following the program (OR = 1.34, 95% CI 1.11-1.61) and a trend for decreased ED visits in those >66 years (OR = 0.59, 95% CI 0.33-1.06).
This is the first study to examine health care use following participation in the CDSMP in a Canadian population and to use administrative data to measure health care utilization. Similar to other studies that used self-report measures to evaluate health care use we found no differences in health care utilization before and after participation in the CDSMP. Future research needs to confirm our findings and examine the impact of the CDSMP on health care utilization in different age groups to help to determine whether these interventions are more effective with select population groups.
PMCID: PMC4036726  PMID: 24885135
7.  Impact of a change in physician reimbursement on bone mineral density testing in Ontario, Canada: a population-based study 
CMAJ Open  2014;2(2):E45-E50.
On Apr. 1, 2008, a revision was made to the fee schedule for bone mineral density testing with dual-energy x-ray absorptiometry (DXA) in the province of Ontario, Canada, reducing the frequency of repeat screening in individuals at low risk of osteoporosis. We evaluated whether the change in physician reimbursement successfully promoted appropriate bone mineral density testing, with reduced use among women at low risk and increased use among women and men at higher risk of osteoporosis-related fracture.
We analyzed data from administrative databases on physician billings, hospital discharges and emergency department visits. We included all physician claims for DXA in the province to assess patterns in bone mineral density testing from Apr. 1, 2002, to Mar. 31, 2011. People at risk of an osteoporosis-related fracture were defined as women and men aged 65 years or more and those who had a recent (< 6 mo) fracture after age 40 years. Joinpoint regression analysis was used to examine trends in DXA testing.
Before the policy change, the overall number of DXA tests increased from 433 419 in 2002/03 to 507 658 in 2007/08; after revision of the fee schedule, the number decreased to 422 915 by 2010/11. Most of this reduction was due to a decrease in the age-standardized rate of DXA testing among women deemed to be at low risk, from 5.7 per 100 population in 2008/09 to 1.8 per 100 in 2010/11. In the high-risk group of people aged 65 or more, the age-standardized rate of testing increased after the policy change among men but decreased among women. Among those at high risk because of a recent clinical fracture, the age-standardized rate of DXA testing increased for both sexes and then decreased after the policy change.
A change in reimbursement designed to restrict access to bone mineral density testing among low-risk women was associated with an overall reduction in testing. Efforts to communicate guidelines for bone mineral density testing with greater clarity, particularly as they relate to high-risk individuals, need to be explored.
PMCID: PMC4084743  PMID: 25077129
8.  All-Cause Mortality and Serious Cardiovascular Events in People with Hip and Knee Osteoarthritis: A Population Based Cohort Study 
PLoS ONE  2014;9(3):e91286.
Because individuals with osteoarthritis (OA) avoid physical activities that exacerbate symptoms, potentially increasing risk for cardiovascular disease (CVD) and death, we assessed the relationship between OA disability and these outcomes.
In a population cohort aged 55+ years with at least moderately severe symptomatic hip and/or knee OA, OA disability (Western Ontario McMaster Universities (WOMAC) OA scores; Health Assessment Questionnaire (HAQ) walking score; use of walking aids) and other covariates were assessed by questionnaire. Survey data were linked to health administrative data to determine the relationship between baseline OA symptom severity to all-cause mortality and occurrence of a composite CVD outcome (acute myocardial infarction, coronary revascularization, heart failure, stroke or transient ischemic attack) over a median follow-up of 13.2 and 9.2 years, respectively.
Of 2156 participants, 1,236 (57.3%) died and 822 (38.1%) experienced a CVD outcome during follow-up. Higher (worse) baseline WOMAC function scores and walking disability were independently associated with a higher all-cause mortality (adjusted hazard ratio, aHR, per 10-point increase in WOMAC function score 1.04, 95% confidence interval, CI 1.01–1.07, p = 0.004; aHR per unit increase in HAQ walking score 1.30, 95% CI 1.22–1.39, p<0.001; and aHR for those using versus not using a walking aid 1.51, 95% CI 1.34–1.70, p<0.001). In survival analysis, censoring on death, risk of our composite CVD outcome was also significantly and independently associated with greater baseline walking disability ((aHR for use of a walking aid  = 1.27, 95% CI 1.10–1.47, p = 0.001; aHR per unit increase in HAQ walking score  = 1.17, 95% CI 1.08–1.27, p<0.001).
Among individuals with hip and/or knee OA, severity of OA disability was associated with a significant increase in all-cause mortality and serious CVD events after controlling for multiple confounders. Research is needed to elucidate modifiable mechanisms.
PMCID: PMC3946823  PMID: 24608134
9.  Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial 
To evaluate feasibility and potential effectiveness of a patient decision aid (PtDA) for patients and a preference report for surgeons to reduce wait times and improve decision quality in patients with osteoarthritis considering total knee replacement.
A prospective two-arm pilot randomized controlled trial. Patients with osteoarthritis were eligible if they understood English and were referred for surgical consultation about an initial total knee arthroplasty at a Canadian orthopaedic joint assessment clinic. Patients were randomized to the PtDA intervention or usual education. The intervention was an osteoarthritis PtDA for patients and a one-page preference report summarizing patients’ clinical and decisional data for their surgeon. The main feasibility outcomes were rates of recruitment and questionnaire completion; the preliminary effectiveness outcomes were wait times and decision quality.
Of 180 patients eligible for surgical consultation, 142 (79%) were recruited and randomized to the PtDA intervention (n = 71) or usual education (n = 71). Data collection yielded a 93% questionnaire completion rate with less than 1% missing items. After one year, 13% of patients remained on the surgical wait list. The median time from referral to being off the wait list (censored using survival analysis techniques) was 33.4 weeks for the PtDA group (n = 69, 95% CI: 26.0, 41.4) and 33.0 weeks for usual education (n = 71, 95% CI: 26.1, 39.9). Patients exposed to the PtDA had higher decision quality based on knowledge (71% versus 47%; p < 0.0001) and quality decision being an informed choice that is consistent with their values for option outcomes (56.4% versus 25.0%; p < 0.001).
Recruitment of patients with osteoarthritis considering surgery and data collection were feasible. As some patients remained on the surgical waiting list after one year, follow-up should be extended to two years. Patients exposed to the PtDA achieved higher decision quality compared to those receiving usual education but there was no difference in wait for surgery.
Trials registration
ClinicalTrials.Gov NCT00743951
PMCID: PMC3937455  PMID: 24564877
Patient decision aids; Patient preferences; Osteoarthritis; Joint arthroplasty; Wait times; Decision quality
10.  Obstructive Sleep Apnea and Risk of Cardiovascular Events and All-Cause Mortality: A Decade-Long Historical Cohort Study 
PLoS Medicine  2014;11(2):e1001599.
Tetyana Kendzerska and colleagues explore the association between physiological measures of obstructive sleep apnea other than the apnea-hypopnea index and the risk of cardiovascular events.
Please see later in the article for the Editors' Summary
Obstructive sleep apnea (OSA) has been reported to be a risk factor for cardiovascular (CV) disease. Although the apnea-hypopnea index (AHI) is the most commonly used measure of OSA, other less well studied OSA-related variables may be more pathophysiologically relevant and offer better prediction. The objective of this study was to evaluate the relationship between OSA-related variables and risk of CV events.
Methods and Findings
A historical cohort study was conducted using clinical database and health administrative data. Adults referred for suspected OSA who underwent diagnostic polysomnography at the sleep laboratory at St Michael's Hospital (Toronto, Canada) between 1994 and 2010 were followed through provincial health administrative data (Ontario, Canada) until May 2011 to examine the occurrence of a composite outcome (myocardial infarction, stroke, congestive heart failure, revascularization procedures, or death from any cause). Cox regression models were used to investigate the association between baseline OSA-related variables and composite outcome controlling for traditional risk factors. The results were expressed as hazard ratios (HRs) and 95% CIs; for continuous variables, HRs compare the 75th and 25th percentiles. Over a median follow-up of 68 months, 1,172 (11.5%) of 10,149 participants experienced our composite outcome. In a fully adjusted model, other than AHI OSA-related variables were significant independent predictors: time spent with oxygen saturation <90% (9 minutes versus 0; HR = 1.50, 95% CI 1.25–1.79), sleep time (4.9 versus 6.4 hours; HR = 1.20, 95% CI 1.12–1.27), awakenings (35 versus 18; HR = 1.06, 95% CI 1.02–1.10), periodic leg movements (13 versus 0/hour; HR = 1.05, 95% CI 1.03–1.07), heart rate (70 versus 56 beats per minute [bpm]; HR = 1.28, 95% CI 1.19–1.37), and daytime sleepiness (HR = 1.13, 95% CI 1.01–1.28).The main study limitation was lack of information about continuous positive airway pressure (CPAP) adherence.
OSA-related factors other than AHI were shown as important predictors of composite CV outcome and should be considered in future studies and clinical practice.
Please see later in the article for the Editors' Summary
Editors' Summary
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder, particularly among middle-aged and elderly people. It is characterized by apnea—a brief interruption in breathing that lasts at least 10 seconds—and hypopnea—a decrease of more than 50% in the amplitude of breathing that lasts at least 10 seconds or clear but smaller decrease in amplitude associated with either oxygen desaturation or an arousal. Patients with OSA experience numerous episodes of apnea and hypopnea during the night; severe OSA is defined as having 30 or more episodes per hour (an apnea-hypopnea index [AHI] of >30). These breathing interruptions occur when relaxation of the upper airway muscles decreases the airflow, which lowers the amount of oxygen in the blood. As a result, affected individuals frequently wake from deep sleep as they struggle to breathe. Symptoms of OSA include loud snoring and daytime sleepiness. Treatments include lifestyle changes such as losing weight (excess fat around the neck increases airway collapse) and smoking cessation. For severe OSA, doctors recommend continuous positive airway pressure (CPAP), in which a machine blows pressurized air through a face mask into the airway to keep it open.
Why Was This Study Done?
OSA can be life-threatening. Most directly, daytime sleepiness can cause accidents, but OSA is also associated with an increased risk of developing cardiovascular disease (CVD, disease that affects the heart and the circulation). To date, studies that have investigated the association between OSA and the risk of myocardial infarction (heart attack), congestive heart failure, stroke, and other CVDs have used the AHI to diagnose and categorize the severity of OSA. However, by focussing on AHI, clinicians and researchers may be missing opportunities to improve their ability to predict which patients are at the highest risk of CVD. In this historical cohort study, the researchers investigate the association between other OSA-related variables (for example, blood oxygen saturation and sleep fragmentation) and the risk of cardiovascular events and all-cause mortality (death). A historical cohort study examines the medical records of groups of individuals who have different characteristics at baseline for the subsequent occurrence of specific outcomes.
What Did the Researchers Do and Find?
The researchers used administrative data (including hospitalization records and physicians' claims for services supplied to patients) to follow up adults referred for suspected OSA who underwent diagnostic polysomnography (a sleep study) at a single Canadian hospital between 1994 and 2010. A database of the polysomnography results provided information on OSA-related variables for all the study participants. Over an average follow-up of about 6 years, 11.5% of the 10,149 participants were hospitalized for a myocardial infarction, stroke, or congestive heart failure, underwent a revascularization procedure (an intervention that restores the blood supply to an organ or tissue after CVD has blocked a blood vessel), or had died from any cause. After adjusting for multiple established risk factors for CVD such as smoking and age in Cox regression models (a statistical approach that examines associations between patient variables and outcomes), several OSA-related variables (but not AHI) were significant predictors of CVD. The strongest OSA-related predictor of cardiovascular events or all-cause mortality was total sleep time spent with oxygen saturation below 90%, which increased the risk of a cardiovascular event or death by 50%. Other statistically significant OSA-related predictors (predictors that were unlikely to be associated with the outcome through chance) of cardiovascular events or death included total sleep time, number of awakenings, frequency of periodic leg movements, heart rate, and daytime sleepiness.
What Do These Findings Mean?
These findings indicate that OSA-related factors other than AHI are important predictors of the composite outcome of a cardiovascular event or all-cause mortality. Indeed, although AHI was significantly associated with the researchers' composite outcome in an analysis that did not consider other established risk factors for CVD (“confounders”), the association became non-significant after controlling for potential confounders. The accuracy of these findings, which need to be confirmed in other settings, is likely to be limited by the lack of information available about the use of CPAP by study participants and by the lack of adjustment for some important confounders. Importantly, however, these findings suggest that OSA-related factors other than AHI should be considered as predictors of CVD in future studies and in clinical practice.
Additional Information
Please access these websites via the online version of this summary at
The US National Heart Lung and Blood Institute has information (including several videos) about obstructive sleep apnea (in English and Spanish), sleep studies, heart disease, and other cardiovascular diseases (some information in English and Spanish)
The UK National Health Service Choices website provides information (including personal stories) about sleep apnea and about cardiovascular disease
The not-for-profit American Sleep Apnea Association provides detailed information about sleep apnea for patients and health-care professionals, including personal stories about the condition
The MedlinePlus encyclopedia has pages on obstructive sleep apnea and on polysomnography; MedlinePlus provides links to further information and advice about obstructive sleep apnea, heart diseases, and vascular diseases (in English and Spanish)
PMCID: PMC3913558  PMID: 24503600
11.  Comparison of orally administered bisphosphonate drugs in reducing the risk of hip fracture in older adults: a population-based cohort study 
CMAJ Open  2013;1(3):E97-E105.
Orally administered bisphosphonate drugs (i.e., alendronate, etidronate, risedronate) can reduce the risk of vertebral fracture. However, only alendronate and risedronate have proven efficacy in reducing the risk of hip fracture. We sought to examine the comparative effectiveness of orally administered bisphosphonate drugs in reducing hip fractures among older adults.
We identified new users of orally administered bisphosphonate drugs in British Columbia and Ontario between 2001 and 2008. We used province- and sex-specific propensity score–matching strategies to maximize comparability between exposure groups. We used Cox proportional hazards models to compare time-to-hip fracture within 1 year of treatment between exposures by sex in each province. Our secondary analyses considered hip fracture rates within 2 and 3 years’ follow-up. We used alendronate as the reference for all comparisons and pooled provincial estimates using random effects variance-weighted meta-analysis.
We identified 321 755 patients who were eligible for inclusion in the study. We found little difference in fracture rates between men (pooled hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.74–1.14) or women (pooled HR 1.15, 95% CI 0.73–1.56) taking risedronate and those taking alendronate. We similarly identified little difference in fracture rates between women taking etidronate and those taking alendronate (pooled HR 1.00, 95% CI 0.82–1.18). However, we identified lower rates of hip fracture among men taking etidronate relative to alendronate (pooled HR 0.77, 95% CI 0.60–0.94). Results extended to 2 and 3 years’ follow-up were similar. However, with 3 years’ follow-up, rates of hip fracture were lower among women in British Columbia who had taken alendronate.
We identified little overall difference between alendronate and risedronate in reducing the risk of hip fracture in men or women. Our finding that etidronate is associated with lower fracture risk among men is likely due to selection bias. The long-term comparative effects of orally administered bisphosphonate drugs warrant further study.
PMCID: PMC3986012  PMID: 25077113
12.  Increasing Access to Chronic Disease Self-Management Programs in Rural and Remote Communities Using Telehealth 
Telemedicine Journal and e-Health  2013;19(6):467-473.
Objective: This study examined whether a telehealth chronic disease self-management program (CDSMP) would lead to improvements in self-efficacy, health behaviors, and health status for chronically ill adults living in Northern Ontario, Canada. Two telehealth models were used: (1) single site, groups formed by participants at one telehealth site; and (2) multi-site, participants linked from multiple sites to form one telehealth group, as a strategy to increase access to the intervention for individuals living in rural and remote communities. Subjects and Methods: Two hundred thirteen participants diagnosed with heart disease, stroke, lung disease, or arthritis attended the CDSMP at a preexisting Ontario Telemedicine Network studio from September 2007 to June 2008. The program includes six weekly, peer-facilitated sessions designed to help participants develop important self-management skills to improve their health and quality of life. Baseline and 4-month follow-up surveys were administered to assess self-efficacy beliefs, health behaviors, and health status information. Results were compared between single- and multi-site delivery models. Results: Statistically significant improvements from baseline to 4-month follow-up were found for self-efficacy (6.6±1.8 to 7.0±1.8; p<0.001), exercise behavior, cognitive symptom management, communication with physicians, role function, psychological well-being, energy, health distress, and self-rated health. There were no statistically significant differences in outcomes between single- and multi-site groups. Conclusions: Improvements in self-efficacy, health status, and health behaviors were equally effective in single- and multi-site groups. Access to self-management programs could be greatly increased with telehealth using single- and multi-site groups in rural and remote communities.
PMCID: PMC3696947  PMID: 23570277
telehealth; policy; cardiology/cardiovascular disease; self-care
13.  The Challenge of Pain for Patients with OA 
HSS Journal  2012;8(1):42-44.
PMCID: PMC3295951  PMID: 23372528
symptoms; pain; quality of life; fatigue; osteoarthritis outcomes; Medicine & Public Health; Rheumatology; Imaging / Radiology; Anesthesiology; Orthopedics; Surgical Orthopedics; Sports Medicine
14.  OARSI/OMERACT Initiative to Define States of Severity and Indication for Joint Replacement in Hip and Knee Osteoarthritis. An OMERACT 10 Special Interest Group 
The Journal of Rheumatology  2011;38(8):1765-1769.
To define pain and physical function cutpoints that would, coupled with structural severity, define a surrogate measure of “need for joint replacement surgery,” for use as an outcome measure for potential structure-modifying interventions for osteoarthritis (OA).
New scores were developed for pain and physical function in knee and hip OA. A cross-sectional international study in 1909 patients was conducted to define data-driven cutpoints corresponding to the orthopedic surgeons’ indication for joint replacement. A post hoc analysis of 8 randomized clinical trials (1379 patients) evaluated the prevalence and validity of cutpoints, among patients with symptomatic hip/knee OA.
In the international cross-sectional study, there was substantial overlap in symptom levels between patients with and patients without indication for joint replacement; indeed, it was not possible to determine cutpoints for pain and function defining this indication. The post hoc analysis of trial data showed that the prevalence of cases that combined radiological progression, high level of pain, and high degree of function impairment was low (2%–12%). The most discriminatory cutpoint to define an indication for joint replacement was found to be [pain (0–100) + physical function (0–100) > 80].
These results do not support a specific level of pain or function that defines an indication for joint replacement. However, a tentative cutpoint for pain and physical function levels is proposed for further evaluation. Potentially, this symptom level, coupled with radiographic progression, could be used to define “nonresponders” to disease-modifying drugs in OA clinical trials.
PMCID: PMC3260473  PMID: 21807799
15.  Patient Gender Affects the Referral and Recommendation for Total Joint Arthroplasty 
Rates of use of total joint arthroplasty among appropriate and willing candidates are lower in women than in men. A number of factors may explain this gender disparity, including patients’ preferences for surgery, gender bias influencing physicians’ clinical decision-making, and the patient-physician interaction.
We propose a framework of how patient gender affects the patient and physician decision-making process of referral and recommendation for total joint arthroplasty and consider potential interventions to close the gender gap in total joint arthroplasty utilization.
The process involved in the referral and recommendation for total joint arthroplasty involves eight discrete steps. A systematic review is used to describe the influence of patient gender and related clinical and nonclinical factors at each step.
Where are we now?
Patient gender plays an important role in the process of referral and recommendation for total joint arthroplasty. Female gender primarily affects Steps 3 through 8, suggesting barriers unique to women exist in the patient-physician interaction.
Where do we need to go?
Developing and evaluating interventions that improve the quality of the patient-physician interaction should be the focus of future research.
How do we get there?
Potential interventions include using decision support tools that facilitate shared decision-making between patients and their physicians and promoting cultural competency and shared decision-making skills programs as a core component of medical education. Increasing physicians’ acceptance and awareness of the unconscious biases that may be influencing their clinical decision-making may require additional skills programs.
PMCID: PMC3111793  PMID: 21448775
16.  American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials 
Arthritis and rheumatism  2011;63(3):573-586.
With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials.
A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes.
Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all <1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI is < 3.3.
We propose two new definitions of remission both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected in each trial as an outcome and that the results on both be reported in each trial.
PMCID: PMC3115717  PMID: 21294106
17.  A prospective study of mental health care for comorbid depressed mood in older adults with painful osteoarthritis 
BMC Psychiatry  2011;11:147.
Comorbid depression is common among adults with painful osteoarthritis (OA). We evaluated the relationship between depressed mood and receipt of mental health (MH) care services.
In a cohort with OA, annual interviews assessed comorbidity, arthritis severity, and MH (SF-36 mental health score). Surveys were linked to administrative health databases to identify mental health-related visits to physicians in the two years following the baseline interview (1996-98). Prescriptions for anti-depressants were ascertained for participants aged 65+ years (eligible for drug benefits). The relationship between MH scores and MH-related physician visits was assessed using zero-inflated negative binomial regression, adjusting for confounders. For those aged 65+ years, logistic regression examined the probability of receiving any MH-related care (physician visit or anti-depressant prescription).
Analyses were based on 2,005 (90.1%) individuals (mean age 70.8 years). Of 576 (28.7%) with probable depression (MH score < 60/100), 42.5% experienced one or more MH-related physician visits during follow-up. The likelihood of a physician visit was associated with sex (adjusted OR women vs. men = 5.87, p = 0.005) and MH score (adjusted OR per 10-point decrease in MH score = 1.63, p = 0.003). Among those aged 65+, 56.7% with probable depression received any MH care. The likelihood of receiving any MH care exhibited a significant interaction between MH score and self-reported health status (p = 0.0009); with good general health, worsening MH was associated with increased likelihood of MH care; as general health declined, this effect was attenuated.
Among older adults with painful OA, more than one-quarter had depressed mood, but almost half received no mental health care, suggesting a care gap.
PMCID: PMC3184052  PMID: 21910895
18.  The 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis 
Arthritis and rheumatism  2010;62(9):2582-2591.
The American College of Rheumatology and the European League Against Rheumatism have developed new classification criteria for rheumatoid arthritis (RA). The aim of Phase 2 of the development process was to achieve expert consensus on the clinical and laboratory variables that should contribute to the final criteria set.
Twenty-four expert RA clinicians (12 from Europe and 12 from North America) participated in Phase 2. A consensus-based decision analysis approach was used to identify factors (and their relative weights) that influence the probability of “developing RA,” complemented by data from the Phase 1 study. Patient case scenarios were used to identify and reach consensus on factors important in determining the probability of RA development. Decision analytic software was used to derive the relative weights for each of the factors and their categories, using choice-based conjoint analysis.
The expert panel agreed that the new classification criteria should be applied to individuals with undifferentiated inflammatory arthritis in whom at least 1 joint is deemed by an expert assessor to be swollen, indicating definite synovitis. In this clinical setting, they identified 4 additional criteria as being important: number of joints involved and site of involvement, serologic abnormality, acute-phase response, and duration of symptoms in the involved joints. These criteria were consistent with those identified in the Phase 1 data-driven approach.
The consensus-based, decision analysis approach used in Phase 2 complemented the Phase 1 efforts. The 4 criteria and their relative weights form the basis of the final criteria set.
PMCID: PMC3077961  PMID: 20872596
19.  Decision to take osteoporosis medication in patients who have had a fracture and are 'high' risk for future fracture: A qualitative study 
Patients' values and preferences are fundamental tenets of evidence-based practice, yet current osteoporosis (OP) clinical guidelines pay little attention to these issues in therapeutic decision making. This may be in part due to the fact that few studies have examined the factors that influence the initial decision to take OP medication. The purpose of our study was to examine patients' experiences with the decision to take OP medication after they sustained a fracture.
A phenomenological qualitative study was conducted with outpatients identified in a university teaching hospital fracture clinic OP program. Individuals aged 65+ who had sustained a fragility fracture within 5 years, were 'high risk' for future fracture, and were prescribed OP medication were eligible. Analysis of interview data was guided by Giorgi's methodology.
21 patients (6 males, 15 females) aged 65-88 years participated. All participants had low bone mass; 9 had OP. Fourteen patients were taking a bisphosphonate while 7 patients were taking no OP medications. For 12 participants, the decision to take OP medication occurred at the time of prescription and involved minimal contemplation (10/12 were on medication). These patients made their decision because they liked/trusted their health care provider. However, 4/10 participants in this group indicated their OP medication-taking status might change. For the remaining 9 patients, the decision was more difficult (4/9 were on medication). These patients were unconvinced by their health care provider, engaged in risk-benefit analyses using other information sources, and were concerned about side effects; 7/9 patients indicated that their OP medication-taking status might change at a later date.
Almost half of our older patients who had sustained a fracture found the decision to take OP medication a difficult one. In general, the decision was not considered permanent. Health care providers should be aware of their potential role in patients' decisions and monitor patients' decisions over time.
PMCID: PMC3103493  PMID: 21554729
20.  Improving shared decision making in osteoarthritis 
BMJ : British Medical Journal  2008;336(7650):954-955.
The burden of chronic pain for those who have it and their families is substantial, says Henry McQuay (doi: 10.1136/bmj.39520.699190.94), and these patients deserve better. Dawn Stacey and colleagues describe an example of quality improvement in practice for one group of people with chronic pain, those with osteoarthritis
PMCID: PMC2335259  PMID: 18397937
21.  Measuring patient perceptions about osteoporosis pharmacotherapy 
BMC Research Notes  2009;2:133.
Adherence to osteoporosis pharmacotherapy is poor, and linked with patient perceptions of the benefits of, and barriers to taking these treatments. To better understand the association between patient perceptions and osteoporosis pharmacotherapy, we generated thirteen items that may tap into patient perceptions about the benefits of, and barriers to osteoporosis treatment; and included these items as part of a standardized telephone interview of women aged 65–90 years (n = 871). The purpose of this paper is to report the psychometric evaluation of our scale.
Upon detailed analysis, six of the thirteen items were omitted: four redundant, one did not correlate well with any other item and one factorial complex. From the remaining seven items, two distinct unidimensional domains emerged (variance explained = 78%). Internal consistency of the 5-item osteoporosis drug treatment benefits domain was good (Cronbach's alpha = 0.88), and was supported by construct validity; women reporting a physician-diagnosis or taking osteoporosis pharmacotherapy had higher osteoporosis treatment benefit scores compared to those reporting no osteoporosis diagnosis or treatment respectively. Because only two items were identified as tapping into treatment barriers, we recommend they each be used as a separate item assessing potential barriers to adherence to osteoporosis pharmacotherapy, rather than combined into a single scale.
The 5-item osteoporosis drug treatment benefits scale may be useful to examine perceptions about the benefits of osteoporosis pharmacotherapy. Further research is needed to develop scales that adequately measure perceived barriers to osteoporosis pharmacotherapy.
PMCID: PMC2714860  PMID: 19602268
23.  Patient characteristics affecting the prognosis of total hip and knee joint arthroplasty: a systematic review 
Canadian Journal of Surgery  2008;51(6):428-436.
Total joint arthroplasty is a highly efficacious and cost-effective procedure for moderate to severe arthritis in the hip and knee. Although patient characteristics are considered to be important determinants of who receives total joint arthroplasty, no systematic review has addressed how they affect the outcomes of total joint arthroplasty. This study addresses how patient characteristics influence the outcomes of hip and knee arthroplasty in patients with osteoarthritis.
We searched 4 bibliographic databases (MEDLINE 1980–2001, CINAHL 1982–2001, EMBASE 1980–2001, HealthStar 1998–1999) for studies involving more than 500 patients with osteoarthritis and 1 or more of the following outcomes after total joint arthroplasty: pain, physical function, postoperative complications (short-and long-term) and time to revision. Prognostic patient characteristics of interest included age, sex, race, body weight, socioeconomic status and work status.
Sixty-four of 14 276 studies were eligible for inclusion and had extractable data. Younger age (variably defined) and male sex increased the risk of revision 3-fold to 5-fold for hip and knee arthroplasty. The influence of weight on the risk of revision was contradictory. Mortality was greatest in the oldest age group and among men. Function for older patients was worse after hip arthroplasty (particularly in women). Function after knee arthroplasty was worse for obese patients.
Although further research is required, our findings suggest that, after total joint arthroplasty, younger age and male sex are associated with increased risk of revision, older age and male sex are associated with increased risk of mortality, older age is related to worse function (particularly among women), and age and sex do not influence the outcome of pain. Despite these findings, all subgroups derived benefit from total joint arthroplasty, suggesting that surgeons should not restrict access to these procedures based on patient characteristics. In addition, future research needs to provide standardized measures of outcomes.
PMCID: PMC2592576  PMID: 19057730
24.  Vitamin K Supplementation in Postmenopausal Women with Osteopenia (ECKO Trial): A Randomized Controlled Trial 
PLoS Medicine  2008;5(10):1-12.
Vitamin K has been widely promoted as a supplement for decreasing bone loss in postmenopausal women, but the long-term benefits and potential harms are unknown. This study was conducted to determine whether daily high-dose vitamin K1 supplementation safely reduces bone loss, bone turnover, and fractures.
Methods and Findings
This single-center study was designed as a 2-y randomized, placebo-controlled, double-blind trial, extended for earlier participants for up to an additional 2 y because of interest in long-term safety and fractures. A total of 440 postmenopausal women with osteopenia were randomized to either 5 mg of vitamin K1 or placebo daily. Primary outcomes were changes in BMD at the lumbar spine and total hip at 2 y. Secondary outcomes included changes in BMD at other sites and other time points, bone turnover markers, height, fractures, adverse effects, and health-related quality of life. This study has a power of 90% to detect 3% differences in BMD between the two groups. The women in this study were vitamin D replete, with a mean serum 25-hydroxyvitamin D level of 77 nmol/l at baseline. Over 2 y, BMD decreased by −1.28% and −1.22% (p = 0.84) (difference of −0.06%; 95% confidence interval [CI] −0.67% to 0.54%) at the lumbar spine and −0.69% and −0.88% (p = 0.51) (difference of 0.19%; 95% CI −0.37% to 0.75%) at the total hip in the vitamin K and placebo groups, respectively. There were no significant differences in changes in BMD at any site between the two groups over the 2- to 4-y period. Daily vitamin K1 supplementation increased serum vitamin K1 levels by 10-fold, and decreased the percentage of undercarboxylated osteocalcin and total osteocalcin levels (bone formation marker). However, C-telopeptide levels (bone resorption marker) were not significantly different between the two groups. Fewer women in the vitamin K group had clinical fractures (nine versus 20, p = 0.04) and fewer had cancers (three versus 12, p = 0.02). Vitamin K supplements were well-tolerated over the 4-y period. There were no significant differences in adverse effects or health-related quality of life between the two groups. The study was not powered to examine fractures or cancers, and their numbers were small.
Daily 5 mg of vitamin K1 supplementation for 2 to 4 y does not protect against age-related decline in BMD, but may protect against fractures and cancers in postmenopausal women with osteopenia. More studies are needed to further examine the effect of vitamin K on fractures and cancers.
Trial registration: (#NCT00150969) and Current Controlled Trials (#ISRCTN61708241)
Angela Cheung and colleagues investigate whether vitamin K1 can prevent bone loss among postmenopausal women with osteopenia.
Editors' Summary
Osteoporosis is a bone disease in which the bones gradually become less dense and more likely to break. In the US, 10 million people have osteoporosis and 18 million have osteopenia, a milder condition that precedes osteoporosis. In both conditions, insufficient new bone is made and/or too much old bone is absorbed. Although bone appears solid and unchanging, very little bone in the human body is more than 10 y old. Old bone is continually absorbed and new bone built using calcium, phosphorous, and proteins. Because the sex hormones control calcium and phosphorous deposition in the bones and thus bone strength, the leading cause of osteoporosis in women is reduced estrogen levels after menopause. In men, an age-related decline in testosterone levels can cause osteoporosis. Most people discover they have osteoporosis only when they break a bone, but the condition can be diagnosed and monitored using bone mineral density (BMD) scans. Treatments can slow down or reverse bone loss (antiresorptive therapies) and some (bone formation therapies) can even make bone and build bone tissue.
Why Was This Study Done?
Although regular exercise and a healthy diet can help to keep bones strong, other ways of preventing osteoporosis are badly needed. Recently, the lay media has promoted vitamin K supplements as a way to reduce bone loss in postmenopausal women. Vitamin K (which is found mainly in leafy green vegetables) is required for a chemical modification of proteins called carboxylation. This modification is essential for the activity of three bone-building proteins. In addition, there is some evidence that low bone density and fractures are associated with a low vitamin K intake. However, little is known about the long-term benefits or harms of vitamin K supplements. In this study, the researchers investigate whether a high-dose daily vitamin K supplement can safely reduce bone loss, bone turnover, and fractures in postmenopausal women with osteopenia in a randomized controlled trial called the “Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia” (ECKO) trial.
What Did the Researchers Do and Find?
In the study, 440 postmenopausal women with osteopenia were randomized to receive 5mg of vitamin K1 (the type of vitamin K in North American food; the recommended daily adult intake of vitamin K1 is about 0.1 mg) or an inactive tablet (placebo) daily for 2 y; 261 of the women continued their treatment for 2 y to gather information about the long-term effects of vitamin K1 supplementation. All the women had regular bone density scans of their lower back and hips and were examined for fractures and for changes in bone turnover. After 2 y and after 4 y, lower back and hip bone density measurements had decreased by similar amounts in both treatment groups. The women who took vitamin K1 had 10-fold higher amounts of vitamin K1 in their blood than the women who took placebo and lower amounts of a bone formation marker; the levels of a bone resorption marker were similar in both groups. Over the 4-y period, fewer women in the vitamin K group had fractures (nine versus 20 women in the placebo group), and fewer had cancer (three versus 12). Finally, vitamin K supplementation was well tolerated over the 4-y period and adverse health effects were similar in the two treatment groups.
What Do These Findings Mean?
These findings indicate that a high daily dose of vitamin K1 provides no protection against the age-related decline in bone density in postmenopausal women with osteopenia, but that vitamin K1 supplementation may protect against fractures and cancers in these women. The apparent contradiction between the effects of vitamin K1 on bone density and on fractures could mean that vitamin K1 supplements strengthen bone by changing factors other than bone density, e.g., by changing its fine structure rather than making it denser. However, because so few study participants had fractures, the difference in the fracture rate between the two treatment groups might have occurred by chance. Larger studies are therefore needed to examine the effect of vitamin K1 on fractures (and on cancer) and, until these are done, high-dose vitamin K1 supplementation should not be recommended for the prevention of osteoporosis.
Additional Information.
Please access these Web sites via the online version of this summary at
The US National Institute of Arthritis and Musculoskeletal and Skin Diseases provides detailed information about osteoporosis (in English and Spanish) and links to other resources, including an interactive web tool called Check Up On Your Bones
MedlinePlus provides links to additional information about osteoporosis (in English and Spanish)
The MedlinePlus Encyclopedia has a page about vitamin K
The UK Food Standards Agency provides information about vitamin K
Full details about the ECKO trial are available on the Web site
The Canadian Task Force for Preventive Health Care provides recommendations on the prevention of osteoporosis and osteoporotic fractures in postmenopausal women
Osteoporosis Canada provides information on current topics related to osteoporosis
PMCID: PMC2566998  PMID: 18922041
25.  Fatigue in osteoarthritis: a qualitative study 
Fatigue is recognized as a disabling symptom in many chronic conditions including rheumatic disorders such as rheumatoid arthritis (RA) and lupus. Fatigue in osteoarthritis (OA) is not routinely evaluated and has only been considered in a very limited number of studies. To date, these studies have focused primarily on patients with OA under rheumatological care, which represent the minority of people living with OA. The purpose of this study was to increase our understanding of the fatigue experience in community dwelling people with OA.
In 2004, 8 focus groups were conducted with 28 men and 18 women (mean age 72.3) with symptomatic hip or knee OA recruited from a population-based cohort. Participants completed a self-administered questionnaire, which included demographics, measures of OA severity (WOMAC), depression (CES-D) and fatigue (FACIT). Sessions were audio taped and transcribed verbatim. Two researchers independently reviewed the transcripts to identify themes. Findings were compared and consensus reached.
Mean pain, disability, depression and fatigue scores were 8.7/20, 27.8/68, 15.4/60, and 30.9/52, respectively. Participants described their fatigue as exhaustion, being tired and "coming up against a brick wall". Participants generally perceived fatigue as different from sleepiness and distinguished physical from mental fatigue. Factors believed to increase fatigue included OA pain and pain medications, aging, various types of weather and poor sleep. Mental health was identified as both affecting fatigue and being affected by fatigue. Participants described fatigue as impacting physical function, and their ability to participate in social activities and to do household chores. Rest, exercise, and avoiding or getting assistance with activities were cited as ways of coping. Participants generally did not discuss their fatigue with anyone except their spouses.
Participants with OA described experiencing notable amounts of fatigue and indicated that it had a substantial impact on their lives. Further research is required to better understand the role of fatigue in OA in order to identify strategies to reduce its impact.
PMCID: PMC2386135  PMID: 18452607

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