Quality indicators in pediatric orthopaedic surgery: a systematic review.

BACKGROUND: The ability to measure health system quality has become a priority for governments, the private sector, and the public. Quality indicators (QIs) refer to clear, measurable items related to outcomes. The use of QIs can initiate local quality improvement and track changes in quality over time as interventions are implemented. QUESTIONS/PURPOSES: We identified existing evidence-based indicators of quality pediatric orthopaedic care and evaluated published QIs that may be applicable to pediatric orthopaedic care. SEARCH STRATEGY: Using five standard search engines we searched the literature using terms such as "quality indicators," "orthopaedic surgery," and "pediatric." Study selection was performed in a stepwise manner, first by title, then abstract, and then full-text review. Of the 604 citations identified, 13 articles were selected for inclusion. Eight papers included only pediatric patients. RESULTS: The most commonly reported indicator was mortality followed by postoperative complications. Reoperation and readmission rates were also reported along with patient-centered QIs, although with less frequency. CONCLUSION: Although mortality and postoperative complications were the most frequently reported QIs, concern for their applicability was raised because of their relative infrequency in pediatrics. Patient-centered QIs appear to be the most useful tools reported, although their use is somewhat limited in the published literature. Although there are benefits and drawbacks to all reported QIs, patient-centered and surgeon-defined outcomes along with cost-effectiveness have important roles in evaluating the quality of pediatric orthopaedic care.

Single-dose versus multiple-dose antibiotic prophylaxis for the surgical treatment of closed fractures.

BACKGROUND AND PURPOSE: Recent meta-analyses have suggested similar wound infection rates when using single- or multiple-dose antibiotic prophylaxis in the operative management of closed long bone fractures. In order to assist clinicians in choosing the optimal prophylaxis strategy, we performed a cost-effectiveness analysis comparing single- and multiple-dose prophylaxis. METHODS: A cost-effectiveness analysis comparing the two prophylactic strategies was performed using time horizons of 60 days and 1 year. Infection probabilities, costs, and quality-adjusted life days (QALD) for each strategy were estimated from the literature. All costs were reported in 2007 US dollars. A base case analysis was performed for the surgical treatment of a closed ankle fracture. Sensitivity analysis was performed for all variables, including probabilistic sensitivity analysis using Monte Carlo simulation. RESULTS: Single-dose prophylaxis results in lower cost and a similar amount of quality-adjusted life days gained. The single-dose strategy had an average cost of $2,576 for an average gain of 272 QALD. Multiple doses had an average cost of $2,596 for 272 QALD gained. These results are sensitive to the incidence of surgical site infection and deep wound infection for the single-dose treatment arm. Probabilistic sensitivity analysis using all model variables also demonstrated preference for the single-dose strategy. INTERPRETATION: Assuming similar infection rates between the prophylactic groups, our results suggest that single-dose prophylaxis is slightly more cost-effective than multiple-dose regimens for the treatment of closed fractures. Extensive sensitivity analysis demonstrates these results to be stable using published meta-analysis infection rates.

Incidence and mortality of hip fractures in the United States.

CONTEXT: Understanding the incidence and subsequent mortality following hip fracture is essential to measuring population health and the value of improvements in health care. OBJECTIVE: To examine trends in hip fracture incidence and resulting mortality over 20 years in the US Medicare population. DESIGN, SETTING, AND PATIENTS: Observational study using data from a 20% sample of Medicare claims from 1985-2005. In patients 65 years or older, we identified 786,717 hip fractures for analysis. Medication data were obtained from 109,805 respondents to the Medicare Current Beneficiary Survey between 1992 and 2005. MAIN OUTCOME MEASURES: Age- and sex-specific incidence of hip fracture and age- and risk-adjusted mortality rates. RESULTS: Between 1986 and 2005, the annual mean number of hip fractures was 957.3 per 100,000 (95% confidence interval [CI], 921.7-992.9) for women and 414.4 per 100,000 (95% CI, 401.6-427.3) for men. The age-adjusted incidence of hip fracture increased from 1986 to 1995 and then steadily declined from 1995 to 2005. In women, incidence increased 9.0%, from 964.2 per 100,000 (95% CI, 958.3-970.1) in 1986 to 1050.9 (95% CI, 1045.2-1056.7) in 1995, with a subsequent decline of 24.5% to 793.5 (95% CI, 788.7-798.3) in 2005. In men, the increase in incidence from 1986 to 1995 was 16.4%, from 392.4 (95% CI, 387.8-397.0) to 456.6 (95% CI, 452.0-461.3), and the subsequent decrease to 2005 was 19.2%, to 369.0 (95% CI, 365.1-372.8). Age- and risk-adjusted mortality in women declined by 11.9%, 14.9%, and 8.8% for 30-, 180-, and 360-day mortality, respectively. For men, age- and risk-adjusted mortality decreased by 21.8%, 25.4%, and 20.0% for 30-, 180-, and 360-day mortality, respectively. Over time, patients with hip fracture have had an increase in all comorbidities recorded except paralysis. The incidence decrease is coincident with increased use of bisphosphonates. CONCLUSION: In the United States, hip fracture rates and subsequent mortality among persons 65 years and older are declining, and comorbidities among patients with hip fractures have increased.

An economic analysis of the timing of microsurgical reconstruction in brachial plexus birth palsy.

BACKGROUND: The role and timing of microsurgical reconstruction of the brachial plexus in infants who have no signs of biceps recovery within the first six months of life is controversial. The purpose of the present study was to create an economic model to compare microsurgical treatment at three as opposed to six months in patients with brachial plexus birth palsy who had no return of biceps function at three months. METHODS: A cost-minimization study was performed with use of a decision-analysis model. Natural history, success, and tendon transfer and osteotomy rates were estimated from the literature. Costs were estimated from a single center. RESULTS: The literature on patients without nerve root avulsion supports an 80% rate of biceps recovery between three and six months of age. On the basis of this value, microsurgical intervention at three months was more expensive than microsurgical intervention at six months. Microsurgical intervention at three months cost more than twice as much as intervention at six months. Sensitivity analysis revealed that when the rate of biceps recovery was 40% and surgery at three months was three times more successful than surgery at six months, then both treatments had equal costs. CONCLUSIONS: It is unlikely that microsurgical intervention at three months for the treatment of rupture injuries of the brachial plexus will be successful enough to produce overall cost savings. While our results should not be used to dictate policy decisions as they are not definitive and remain contingent on future studies, it is still reasonable to consider economic factors and quality-of-life outcomes in brachial plexus birth palsy treatment strategies and future research.

Quality-adjusted life years: how useful in medico economic studies.

Cost-effectiveness analysis has evolved as a practical response to the need to allocate limited resources for health care. It can be used to compare interventions whose effects on health are different if the measure of effectiveness captures all the important health dimensions of the effects of the interventions. Using the quality-adjusted life year (QALY) as the unit of effectiveness attempts to approach this ideal and is currently the approach recommended by many consensus groups. Conventional QALYs represent time spend in a series of "quality-weighted" health states, where the quality weights reflect the desirability of living in the state. Many challenges arise when preferences are incorporated into an economic analysis. The purpose of this paper is to highlight some of the issues surrounding the use of QALYs and to encourage researchers to present their methodology in a clear and transparent way.

An economic evaluation of operative compared with nonoperative management of displaced intra-articular calcaneal fractures.

BACKGROUND: The choice of therapy for a displaced intra-articular calcaneal fracture has long been a source of uncertainty in orthopaedic surgery, both in terms of the impact of the therapy on clinical outcomes and on health-care and non-health-care costs. We performed an economic evaluation, based on the results of a randomized clinical trial, to evaluate the economic implications of operative compared with nonoperative management of this fracture. METHODS: An economic evaluation was performed, with use of a four-year time horizon, to determine the effect on costs and health benefits of operative compared with nonoperative management for a group of patients with displaced intra-articular fractures of the calcaneus. The complication rate, arthrodesis rate, survival data, and health-outcome data were estimated prospectively from a recent randomized clinical trial. Direct health-care costs and indirect costs (the cost of time lost from work) were estimated retrospectively from the center treating the majority of the patients. RESULTS: Operative management resulted in a lower rate of subtalar arthrodesis and a shorter time off from work compared with nonoperative treatment. When indirect costs, such as the time lost from work, were included in the analysis, operative management was less costly (an average savings of Can$19,000 per patient) and more effective, thus making it the preferred strategy. The result was most sensitive to the estimates of the costs of time lost from work. When these costs were excluded, operative treatment remained more effective, but with an increased average cost of Can$2800 per patient. CONCLUSIONS: Calcaneal fractures have been recognized as having relatively poor clinical outcomes and a major socioeconomic impact with regard to time lost from work and recreation. Our analysis suggests that operative management of displaced intra-articular fractures is economically attractive. However, further exploration of the impact and valuation of time lost from work and patient outcomes is required.

Cost-utility analyses in orthopaedic surgery.

BACKGROUND: The rising cost of health care has increased the need for the orthopaedic community to understand and apply economic evaluations. We critically reviewed the literature on orthopaedic cost-utility analysis to determine which subspecialty areas are represented, the cost-utility ratios that have been utilized, and the quality of the present literature. METHODS: We searched the English-language medical literature published between 1976 and 2001 for orthopaedic-related cost-utility analyses in which outcomes were reported as cost per quality-adjusted life year. Two trained reviewers independently audited each article to abstract data on the methods and reporting practices used in the study as well as the cost-utility ratios derived by the analysis. RESULTS: Our search yielded thirty-seven studies, in which 116 cost-utility ratios were presented. Eleven of the studies were investigations of treatment strategies in total joint arthroplasty. Study methods varied substantially, with only five studies (14%) including four key criteria recommended by the United States Panel on Cost-Effectiveness in Health and Medicine. According to a reader-assigned measure of study quality, cost-utility analyses in orthopaedics were of lower quality than those in other areas of medicine (p = 0.04). While the number of orthopaedic studies has increased in the last decade, the quality did not improve over time and did not differ according to subspecialty area or journal type. For the majority of the interventions that were studied, the cost-utility ratio was below the commonly used threshold of $50,000 per quality-adjusted life year for acceptable cost-effectiveness. CONCLUSIONS: Because of limitations in methodology, the current body of literature on orthopaedic cost-utility analyses has a limited ability to guide policy, but it can be useful for setting priorities and guiding research. Future research with clear and transparent reporting is needed in all subspecialty areas of orthopaedic practice.

Using observational data for decision analysis and economic analysis.

In orthopaedic surgery, clinical decisions must often be made with imperfect information from observational studies and limited resources. Decision analysis and cost-effectiveness analysis have emerged as evidence-based tools to assist in making choices in situations in which uncertainty exists. This review demonstrates how decision-analysis and cost-effectiveness-analysis tools can be used to expand on published observational studies within the context of a specific clinical scenario. Critical evaluation of clinical and economic data is of increasing importance in today's health-care delivery climate. The use of decision analysis and cost-effectiveness analysis as tools to augment observational studies can assist clinicians, patients, and policy makers in choosing techniques that will optimize benefits. A clear understanding of and the ability to use and apply these tools will allow surgeons to participate effectively in health-policy decisions to enhance the overall quality and efficiency of care that is delivered.

Trends in cost effectiveness analyses in orthopaedic surgery.

Worldwide, programs dealing with musculoskeletal health are required to set priorities and allocate resources within the constraint of limited funding. There is increasing pressure for medical technology assessment, which traditionally has involved evaluating safety and effectiveness, to also include consideration of cost effectiveness. We updated our database of orthopaedic cost-effectiveness studies, critically reviewed their methods, and examined trends over time. Current analyses have numerous shortcomings, such as the inclusion of relatively few studies, inconsistent methodologic approaches, and lack of transparency. The wide variation in cost-effectiveness ratios observed among current interventions suggests efficiency can be improved. Despite reimbursement authorities in many other countries formally considering cost-effectiveness when determining coverage of new technologies, Medicare has been resistant to considering costs of treatments. Regardless of this policy deficiency, conducting cost-effectiveness analyses represents a prudent step forward in illuminating the tradeoffs involved in difficult resource allocation decisions, and there is an urgent need to consider economic impact in future studies using standardized and transparent methods.

Quality of clinical and economic evidence in dossier formulary submissions.

OBJECTIVE: To investigate the quality and completeness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions. STUDY DESIGN: We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington; enrollment 1.6 million) between January 2002 and September 2005. For dossiers submitted in 2003, we examined the clinical studies included. METHODS: Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs. RESULTS: Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. Of 115 dossiers submitted between 2002 and 2005, 53 (46%) included economic analyses. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis; 38% stated the study perspective; 37% discussed relevant treatment alternatives; 20% stated assumptions clearly; and 18% mentioned caveats to conclusions. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices. CONCLUSIONS: Drug companies are submitting dossiers of evidence to formulary committees. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.

Trends in the measurement of health utilities in published cost-utility analyses.

OBJECTIVE: The Panel on Cost-Effectiveness in Health and Medicine recommended the compilation of a catalog of health state utility weights for use in cost-utility analyses (CUAs), and has given methodological recommendations. This study presents an update, through 2001, to our current registry of utility weights (available at http://www.tufts-nemc.org/cearegistry; previously at http://www.hsph.harvard.edu/cearegistry), and documents recent changes in methods used for utility weight elicitation. METHODS: We searched the English-language medical literature for original CUAs reporting outcomes as cost per quality-adjusted life-year (QALY). Two trained readers independently audited each article, abstracting data on the health state descriptions, corresponding utility weights, methods of elicitation, and sources of the estimates. The utility elicitation methods from 1998 to 2001 were compared with the methods used to obtain utilities before 1998. RESULTS: We identified 306 CUAs published after 1998, reporting 1210 separate health-related utility estimates, bringing the total in our catalog to 2159 weights. Most frequently, health states pertained to the circulatory system and oncology. Methods varied substantially: 36% of authors used direct elicitation (standard gamble, time trade-off or rating scale), 23% used generic health status instruments (EQ-5D, Health Utilities Index, etc.), and 25% estimated weights based on clinical judgment. Community preferences were used in 27% of the values. Compared with pre-1998, utilities published from 1998 to 2001 were more likely to be elicited using a generic instrument, more likely elicited from community samples, and less likely derived from expert opinion, with no formally employed methodology. CONCLUSIONS: Increasingly, analysts conducting CUAs are using generic, preference-weighted instruments, and relying on community-based preferences. Our catalog of utility weights provides a useful reference tool for producers and consumers of CUAs, but also highlights the continued need for improvement in methods and transparency.