Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): a randomised control trial

Objectives To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.
Design Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
Setting 20 orthopaedic surgery centres in Australia and New Zealand.
Participants 902 patients undergoing elective primary or revision total hip replacement surgery.
Intervention 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
Main outcome measures Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).
Results There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
Conclusions These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
Trial registration NCT00145730.

Variation in age and physical status prior to total knee and hip replacement surgery : a comparison of centers in Australia and Europe

Objective : To investigate whether variation exists in the preoperative age, pain, stiffness, and physical function of people undergoing total knee replacement (TKR) and total hip replacement (THR) at several centers in Australia and Europe.
Methods : Individual Western Ontario and McMaster Universities Osteoarthritis Index data (range 0-100, where 0 = best and 100 = worst) collected within 6 weeks prior to primary TKR and THR were extracted from 16 centers (n = 2,835) according to specified eligibility criteria. Analysis of covariance was used to evaluate differences in pain, stiffness, and physical function between centers, with adjustment for age and sex.
Results : There was marked variation in the age of people undergoing surgery between the centers (TKR mean age 67-73 years; F[6,1004] = 4.21, P < 0.01, and THR mean age 63-72 years; F[14,1807] = 7.27, P < 0.01). Large differences in preoperative status were observed between centers, most notably for pain (TKR adjusted mean pain 52.5-61.1; F[6,1002] = 4.26, P < 0.01, and THR adjusted mean pain 49.2-65.7; F[14,1802] = 8.44, P < 0.01) and physical function (TKR adjusted mean function 52.7-61.4; F[6,1002] = 5.27, P < 0.01, and THR adjusted mean function 53.3-71.0; F[14,1802] = 6.71, P < 0.01). Large effect sizes (up to 0.98) reflect the magnitude of variation between centers and highlight the clinical relevance of these findings.
Conclusion : The large variations in age and preoperative status indicate substantial differences in the timing of joint replacement across the centers studied, with potential for compromised surgical outcomes due to premature or delayed surgery. Possible contributing factors include patient preferences, the absence of concrete indications for surgery, and the capacity of the health care systems.

Development of a management algorithm for post-operative pain (MAPP) after total knee and total hip replacement: study rationale and design

Evidence from clinical practice and the extant literature suggests that post-operative pain assessment and treatment is often suboptimal. Poor pain management is likely to persist until pain management practices become consistent with guidelines developed from the best available scientific evidence. This work will address the priority in healthcare of improving the quality of pain management by standardising evidence-based care processes through the incorporation of an algorithm derived from best evidence into clinical practice. In this paper, the methodology for the creation and implementation of such an algorithm that will focus, in the first instance, on patients who have undergone total hip or knee replacement is described.

Cross-sectional analysis of association between socioeconomic status and utilization of primary total hip joint replacements 2006-7 : Australian orthopaedic association national joint replacement registry

Background The utilization of total hip replacement (THR) surgery is rapidly increasing, however few data examine whether these procedures are associated with socioeconomic status (SES) within Australia. This study examined primary THR across SES for both genders for the Barwon Statistical Division (BSD) of Victoria, Australia.

Methods Using the Australian Orthopaedic Association National Joint Replacement Registry data for 2006–7, primary THR with a diagnosis of osteoarthritis (OA) among residents of the BSD was ascertained. The Index of Relative Socioeconomic Disadvantage was used to measure SES; determined by matching residential addresses with Australian Bureau of Statistics census data. The data were categorised into quintiles; quintile 1 indicating the most disadvantaged. Age- and sex-specific rates of primary THR per 1,000 person years were reported for 10-year age bands using the total population at risk.

Results Females accounted for 46.9% of the 642 primary THR performed during 2006–7. THR utilization per 1,000 person years was 1.9 for males and 1.5 for females. The highest utilization of primary THR was observed in those aged 70–79 years (males 6.1, and females 5.4 per 1,000 person years). Overall, the U-shaped pattern of THR across SES gave the appearance of bimodality for both males and females, whereby rates were greater for both the most disadvantaged and least disadvantaged groups.

Conclusions Further work on a larger scale is required to determine whether relationships between SES and THR utilization for the diagnosis of OA is attributable to lifestyle factors related to SES, or alternatively reflects geographic and health system biases. Identifying contributing factors associated with SES may enhance resource planning and enable more effective and focussed preventive strategies for hip OA.

Severely compromised quality of life in women and those of lower socioeconomic status waiting for joint replacement surgery

Objective
To determine health-related quality of life (HRQOL), psychological distress, physical function, and self efficacy in persons waiting for lower-limb joint replacement surgery.

Methods
A total of 214 patients on a waiting list for unilateral primary total knee or hip replacement at a large Australian public teaching hospital completed questionnaires after entry to the list. HRQOL and psychological distress were compared with available population norms.

Results
Average HRQOL was extremely poor (mean ± SD 0.39 ± 0.24) and much lower (>2 SD) than the population norm. Near death-equivalent HRQOL or worse than death-equivalent HRQOL were reported by 15% of participants. High or very high psychological distress was up to 5 times more prevalent in the waiting list sample (relative risk 5.4 for participants ages 75 years and older; 95% confidence interval 3.3, 9.0). Women had significantly lower HRQOL, self efficacy, and physical function scores than men. After adjusting for age and sex, significant socioeconomic disparities were also found. Participants who received the lowest income had the poorest HRQOL; those with the least education or the lowest income had the highest psychological distress. Low self efficacy was moderately associated with poor HRQOL (r = 0.49, P < 0.001) and more strongly associated with high psychological distress (r = -0.55, P < 0.001).

Conclusion
Patients waiting for joint replacement have very poor HRQOL and high psychological distress, especially women and those from lower socioeconomic backgrounds. Lengthy waiting lists mean patients can experience extended and potentially avoidable morbidity. Interventions to address psychological distress and self efficacy could reduce this burden and should target women and lower socioeconomic groups.

Quality of life and depression among older patients waiting for joint replacement surgery

Purpose: Older patients waiting for joint replacement surgery in many western countries experience lengthy waits for their surgery. Although these patients suffer with mobility problems the nature of the disability associated with waiting for surgery is unclear. The purpose of this study was to determine health-related quality of life and symptoms of depression in persons waiting for their initial orthopaedic consultation following referral for total knee or total hip replacement surgery.

Methods: All patients who were waiting for an initial orthopaedic consultation for lower-limb joint replacement as at 25 August 2005 were surveyed. Participants were mailed questionnaires concerning demographic information, medical history, health-related quality of life (the Assessment of Quality of Life (AQoL) instrument), and symptoms of depression (Center for Epidemiologic Studies – Depression (CES-D) Scale).

Results: The 84 respondents (response rate 64%) had a mean age of 68.3 (SD 11.5 years), and 60% or respondents were women. Respondents reported an average of 1.6 (SD 0.9) medical conditions, and 85% reported osteoarthritis.} The average health-related quality of life was low (mean AQoL 0.38; SD 0.27), and near death-equivalent or worse than death-equivalent health-related quality of life (AQoL<0.1 of a maximum possible 1.0) was reported by 23% of the participants.The mean depression scale score was 16.5 (SD 11.1), and symptoms of depression (CES-D>16 of a maximum possible 60) were reported by 35% of the sample. There was a strong correlation between health-related quality of life and depression (r=–0.6).

Conclusions: Almost a third of patients waiting to see an orthopaedic surgeon about joint replacement surgery for their hip or knee had symptoms of depression. Geriatric rehabilitation services often provide interventions to these patients. The very poor quality of life reported suggests that more than exercise and strengthening will be needed to reduce disability.

Magnitude and meaningfulness of change in SF-36 scores in four types of orthopedic surgery

Background: The Medical Outcomes General Health Survey (SF-36) is a widely used health status measure; however, limited evidence is available for its performance in orthopedic settings. The aim of this study was to examine the magnitude and meaningfulness of change and sensitivity of SF-36 subscales following orthopedic surgery.

Methods: Longitudinal data on outcomes of total hip replacement (THR, n = 255), total knee replacement (TKR, n = 103), arthroscopic partial meniscectomy (APM, n = 74) and anterior cruciate ligament reconstruction (ACL, n = 62) were used to estimate the effect sizes (ES, magnitude of change) and minimal detectable change (sensitivity) at the group and individual level. To provide context for interpreting the magnitude of changes in SF-36 scores, we also compared patients' scores with age and sex-matched population norms. The studies were conducted in Sweden. Follow-up was five years in THR and TKR studies, two years in ACL, and three months in APM.

Results: On average, large effect sizes (ES≥0.80) were found after orthopedic surgery in SF-36 subscales measuring physical aspects (physical functioning, role physical, and bodily pain). Small (0.20–0.49) to moderate (0.50–0.79) effect sizes were found in subscales measuring mental and social aspects (role emotional, vitality, social functioning, and mental health). General health scores remained relatively unchanged during the follow-up. Despite improvements, post-surgery mean scores of patients were still below the age and sex matched population norms on physical subscales. Patients' scores on mental and social subscales approached population norms following the surgery. At the individual level, scores of a large proportion of patients were affected by floor or ceiling effects on several subscales and the sensitivity to individual change was very low.

Conclusion: Large to moderate meaningful changes in group scores were observed in all SF-36 subscales except General Health across the intervention groups. Therefore, in orthopedic settings, the SF-36 can be used to show changes for groups in physical, mental, and social dimensions and in comparison with population norms. However, SF-36 subscales have low sensitivity to individual change and so we caution against using SF-36 to monitor the health status of individual patients undergoing orthopedic surgery.

Can we reduce disease burden from osteoarthritis?

♦ The comparison of disparate interventions for the prevention and management of osteoarthritis (OA) is limited by the quality and quantity of published efficacy studies and the use of disparate measures for reporting clinical trial outcomes.

♦ The “transfer to utility” technique was used to translate published trial outcomes into a health-related quality-of-life (utility) scale, creating a common metric which supported comparisons between disparate interventions.

♦ Total hip replacement (THR) and total knee replacement (TKR) surgery were the most effective treatments and also highly cost-effective, at estimated cost per quality-adjusted life-year (QALY) of $7500 for THR and $10 000 for TKR (best estimate).

♦ Other apparently highly cost-effective interventions were exercise and strength training for knee OA (< $5000/QALY), knee bracing, and use of capsaicin or glucosamine sulfate (< $10 000/QALY).

♦ The cost per QALY estimates of non-specific and COX-2 inhibitor non-steroidal anti-inflammatory drugs were affected by treatment-related deaths and highly sensitive to the discounting of life-years lost.

♦ OA interventions that have been shown to be ineffective (eg, arthroscopy) are targets for redistribution of healthcare resources.

♦ OA interventions which lack efficacy studies (eg, prevention programs) require further research to assist priority setting.

♦ The application of the Health-sector Wide model to OA demonstrates its role as an evidence-based model that can be successfully applied to identify marginal interventions — those to be expanded and contracted to reduce the expected burden of disease, within current healthcare resources.

Unsupervised DRG upcoding detection in healthcare databases

Diagnosis Related Group (DRG) upcoding is an anomaly in healthcare data that costs hundreds of millions of dollars in many developed countries. DRG upcoding is typically detected through resource intensive auditing. As supervised modeling of DRG upcoding is severely constrained by scope and timeliness of past audit data, we propose in this paper an unsupervised algorithm to filter data for potential identification of DRG upcoding. The algorithm has been applied to a hip replacement/revision dataset and a heart-attack dataset. The results are consistent with the assumptions held by domain experts.

Evaluating quality of life in hip and knee replacement: psychometric properties of the World Health Organization Quality of Life short version instrument

Objective: To evaluate the psychometric properties of the World Health Organization Quality of Life short version instrument (WHOQOL-BREF), and to determine its responsiveness in assessing early outcome after total hip or knee replacement surgery.

Methods: At baseline (entry to an orthopedic waiting list), 279 participants completed the WHOQOL-BREF instrument, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Assessment of Quality of Life (AQOL) instrument, Kessler Psychological Distress (K10) scale, and the modified Health Assessment Questionnaire (MHAQ). A total of 74 patients completed reassessments 3 months after surgery.

Results: The WHOQOL-BREF demonstrated acceptable internal consistency for all domains (Cronbach's = 0.76-0.84) and moderate concurrent validity for the physical and psychological domains (r = 0.67 for physical versus AQOL; r = -0.71 for psychological versus K10). Minimal ceiling or floor effects were identified at baseline or 3 months, except for the social relationships domain. The disease-specific WOMAC subscales were most responsive to change (relative efficiency [RE] 0.66-1.00). Apart from social relationships, all WHOQOL-BREF scores improved significantly after surgery. The physical domain was more responsive than the AQOL (RE 0.50 versus 0.42) and was similar to the MHAQ (RE 0.55 for MHAQ). The responsiveness of the psychological domain was similar to that of the K10 scale (RE 0.11 versus 0.08).

Conclusion: The WHOQOL-BREF has good psychometric properties for use in persons with severe joint disease, and by providing complementary information, it offers clinicians and researchers an additional tool for comprehensively assessing quality of life in this patient group.