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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 55 - 55
1 May 2016
Brown G
Full Access

Significance

In spite of evidence that total knee replacement (TKR) surgery is effective, numerous studies have demonstrated that approximately 20 percent of patients who have undergone TKR surgery are not satisfied. This relatively high rate of patients who are not satisfied is the result of unmet patient expectations. The strongest predictor of dissatisfaction after TKR is unmet expectations (RR = 10.7, Bourne, Chesworth, et al, 2010). This is confirmed by Dunbar, Richardson, and Robertsson (2013): “Unmet expectation seems to be a major cause of unsatisfactory outcomes and satisfaction is most strongly correlated with relief of pain, followed by improvement in physical function.” Objective: To develop patient reported outcome (PRO) recovery graphs for knee function, activity level, and pain relief to be used as a shared decision making tool for total knee replacement surgery.

Methods

A proprietary joint arthroplasty database of patient reported outcomes (PROs) was analyzed to determine the recovery curve means and standard deviations of four PROs at six time points: pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively for total knee replacement surgery. The recovery graphs are stratified by percentile (10%, 26%, 50%, 75%, and 90%) The PROs analyzed were: (1) European quality of life (EQ-5D); Oxford Knee Score (OKS); (3) Lower Extremity Activity Scale (LEAS); and (4) Likert Pain Scale (LPS). The minimum clinically important difference (MCID) was calculated using a distribution method where the MCID equals one half the standard deviation of the score change, MCID = σΔ/2. The LEAS and LPS are used to measure patients’ expectations for pain relief and activity improvement. Prior to discussing surgery, patients are asked to report their pre-operative pain and activity levels and to specify their expected pain relief and activity improvement one year after surgery.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 54 - 54
1 May 2016
Brown G
Full Access

Significance

Increasing health care costs are bankrupting the United States and other industrialized countries. To control and/or reduce costs in health care, hospitals, payers, and patients are turning to evidence-based meta-analyses and health economic analyses to identify medical treatments that provide value (value=outcome/cost). Objective: To determine if clinical outcome (patient reported outcomes) analyses or value/economic analyses are more likely to provide the evidence needed for adoption of new technologies in arthroplasty.

Methods

A proprietary joint arthroplasty database of patient reported outcomes (PROs) was analyzed to determine the minimum clinically important differences (MCIDs) for PROs used for total knee replacement surgery. The PROs analyzed were: (1) European quality of life (EQ-5D); Oxford Knee Score (OKS); (3) Lower Extremity Activity Scale (LEAS); and (4) Likert Pain Scale (LPS). The MCID was calculated using a distribution method where the MCID equals one half the standard deviation of the score change, MCID = σΔ/2. For clinical meta-analyses, new technologies must demonstrate statistically significant better PROs and the difference must be greater than the MCID. For economic analyses, quality adjusted life years (QALYs) are used. For example, if a total knee replacement (TKR) improved a patient's health-related quality of life by 10% (0.10) and the assumed implant life is 15 years, the patient received 1.5 QALYs (0.10 × 15 years). If the total cost of care for the knee replacement surgery is $30,000, the cost per QALY is $20,000 ($30,000/1.5 QALYs).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 52 - 52
1 Jan 2016
Brown G
Full Access

Significance

In spite of evidence that total knee replacement (TKR) surgery is effective, numerous studies have demonstrated that approximately 20 percent of patients who have undergone TKR surgery are not satisfied. This relatively high rate of patients who are not satisfied is the result of unmet patient expectations. The strongest predictor of dissatisfaction after TKR is unmet expectations (RR = 10.7, Bourne, Chesworth, et al, 2010). This is confirmed by Dunbar, Richardson, and Robertsson (2013): “Unmet expectation seems to be a major cause of unsatisfactory outcomes and satisfaction is most strongly correlated with relief of pain, followed by improvement in physical function.” Hypothesis: One year post-operative pain relief and activity level expectations can be measured pre-operatively and used for shared decision making.

Methods

A web–based system for prospectively collecting patient reported outcomes (PROs) has been developed. The data set for total hip/knee replacement surgery includes: (1) European quality of life, EQ-5D; Oxford Hip Score/Oxford Knee Score; (3) Lower Extremity Activity Scale (LEAS); and (4) Pain Likert Scale (PLS). The EQ-5D was selected as the health related quality of life (HRQL) general outcome measure because it has been adopted by multiple international joint replacement registries (Swedish Hip Arthroplasty Register, Norwegian Arthroplasty Register, United Kingdom National Joint Registry). The EQ-5D can be used to calculate quality adjusted life years (QALYs) for economic and/or comparative effectiveness analyses. The OHS/OKS questionnaires are used by the United Kingdom National Joint Registry and the New Zealand Joint Registry. The LEAS and PLS are used to measure patient's expectations for pain relief and functional improvement by asking patients to report their pre-operative pain and activity level before surgery and asking patients to report their pain and activity level expectations one year after surgery.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 53 - 53
1 Jan 2016
Brown G
Full Access

Significance

In ideal shared decision making (SDM), evidence-based treatment options, their likelihood of success, and the probability of adverse events is discussed with the patient. However, current SDM is fundamentally flawed because evidence for patient-specific treatment effectiveness and patient-specific adverse event risks is lacking. Observational outcome registries are better than randomized clinical trials for determining patient prognostic factors for outcomes and adverse events. No orthopaedic SDM clinical tools exist to predict patient-specific outcomes. Hypothesis: A patient-specific shared decision making tool can predict clinically significant outcomes and adverse events for total knee replacement (TKR) surgery.

Methods

A web–based prospective observational outcome registry collects patient reported outcomes (PROs) for TKR surgery. The data set for TKR surgery includes: (1) European quality of life (EQ-5D); (2) Oxford Knee Score (OKS); (3) Lower Extremity Activity Scale (LEAS); and (4) Pain Likert Scale (PLS). A TKR outcome calculator predicts patient-specific functional outcome with a regression model using patient-specific pre-operative Oxford Knee Scores, diagnosis, co-morbidities, and demographics. Patient-specific joint infection relative risk is calculated using diagnosis, co-morbidities, and demographics. Functional outcomes are presented as minimum clinically important differences (MCIDs). MCID=σΔ/2.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 60 - 60
1 Jul 2014
Brown G
Full Access

The selection of venous thromboembolism (VTE) prophylaxis after total joint arthroplasty (TJA) has been controversial. Although the aspirin controversy is presumably resolved, there is no medical evidence for the “optimal” VTE prophylaxis regime for individual patients.

A risk-stratified multi-modal VTE prophylaxis protocol was developed and adopted by consensus. VTE risk factors and bleeding risk factors were categorised into six VTE/bleeding risk levels: (1) pre-operative vitamin K antagonists (VKA) use, (2) bleeding risk factors, (3) hypercoagulable state, (4) pre-operative anti-platelet therapy [clopidogrel use], (5) VTE risk factors, (6) no VTE or bleeding risk factors. The pharmacologic agents used for each risk level were: (1) resume VKA with low molecular weight heparin (LMWH) bridge, (2) pharmacologic agents contra-indicated and mechanical prophylaxis only, (3) VKA for 90 days with LMWH bridge, (4) resume anti-platelet therapy, (5) LMWH in hospital and discharge on aspirin for 90 days, (6) aspirin for 90 days (starting in hospital). In addition to pharmacologic treatment, all patients received multi-modal prophylaxis including early mobilisation, mechanical foot pumps, and neuraxial anesthesia when not contra-indicated. Prior to surgery, a VTE/bleeding risk factor checklist was completed determining the risk level. The intervention cohort included all TJA patients from January 1, 2010 to December 31, 2012. The comparison cohort included all TJA patients from the year prior to implementation of the protocol at the same community hospital. Thirty day all-cause non-elective re-admissions, 30 day same-site re-operations, 90 day VTE events, and protocol compliance were abstracted from the electronic medical record.

The intervention group consisted of 2679 patients (1075 hip arthroplasty patients and 1604 knee arthroplasty patients). The comparison group consisted of 1118 patients (323 hip arthroplasty patients and 795 knee arthroplasty patients). The 30 day all cause non-elective re-admission rate was 2.72% (73/2679) in the intervention group and 4.29% (48/1118) in the comparison group (p=0.0148). The 30 day same-site re-operation rate was 1.38% (37/2679) in the intervention group and 1.25% (14/1118) in the comparison group (p=0.8773). The 90 day VTE event rate was 1.57% (42/2679) in the intervention group and 3.40% (38/1118) in the comparison group (p=0.0007). The VTE rate was higher for knee arthroplasty patients 2.00% (32/1604) than for hip arthroplasty patients 0.93% (10/1075) (p=0.0379). The rate of VTE events was higher for patients that deviated from the VTE protocol 5.03% (10/199) than for all risk groups treated per the protocol 1.29% (32/2481) (p=0.0007).

The risk-stratified multi-modal VTE prophylaxis protocol simultaneously reduced 30 day all-cause non-elective re-admissions and 90 day VTE events. The possible causes for reducing 30 day re-admissions and reducing 90 day VTE events are: (1) reducing bleeding events by using aspirin for VTE prophylaxis in more than 80% of patients, (2) extending VTE prophylaxis to 90 days, and (3) using multi-modal prophylaxis. The risk-stratified multi-modal VTE prophylaxis protocol for total joint arthroplasty is consistent with 9 of the 10 recommendations in the AAOS Clinical Practice Guideline. The risk-stratification checklist provides a standardised tool to assess risks, discuss risks, and make shared decision with patients. Patient treatment that deviated from the protocol had a significantly higher VTE rate (5.03%). Protocol compliance increased each year from 91.1% in 2010 to 94.2% in 2012.