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PubMed1997

Ability of Medicare claims data and cancer registries to identify cancer cases and treatment.

The objective of this study is to compare the ability of Medicare and cancer registry data to identify incident cancer cases and initial surgical therapy both singly and in combination. Data from the Virginia Cancer Registry (VCR) were linked to Medicare claims files (Medical Provider Analysis and Review File (MEDPAR)) for Virginia residents aged 65 years and over with breast, colorectal, lung, or prostate cancer diagnosed between 1986 and 1989. MEDPAR found 73-83% of cancer cases identified by VCR. Factors significantly associated with MEDPAR missing a case that was reported to VCR included younger age, male gender, living in an urban area, higher social class, in situ disease, and lack of cancer treatment. A total of 70-82% of cancer cases identified through Medicare claims were reported to the VCR. Older age, female gender, nonwhite race, comorbid conditions, no surgical procedures, multiple cancer admissions, and the position of the cancer diagnostic code on the MEDPAR record were factors significantly related to being missed by the VCR. The rate of capturing initial surgical therapies was similar to that of identifying cases. Combining information from VCR and MEDPAR resulted in increasing sensitivity for identifying incident cases to 92-97%. Using combined data from independent sources may improve reporting, increase the accuracy of cancer incidence estimates, and provide an opportunity to identify reasons for missing data.

Aged↗
PubMedDate not supplied

The quality of burns coding. Compliance with standards and the effects on clinical data.

Coded burns cases in two NSW public acute care facilities were reviewed to determine 1. the degree of compliance with Australian Coding Standards (ACS) relating to burns separations 2. the relationship between coding errors and poor quality documentation and 3. the impact of coding errors on ANDRG allocation. Despite high compliance with specific aspects of the ACS, coding errors occurred in 89% of cases. The ANDRG changed in 9% of total cases as a result of recoding. While some cases changed to a higher weighted ANDRG, overall the hospitals would have lost $98,445 after recoding. Significant associations were found between coding errors and poor quality documentation. The results indicate that while the ACS are adhered to, a high degree of coding variation still exists. This is largely due to inadequacies in medical record documentation. Clinicians and coders need to work together to ensure that coding variation is kept to a minimum.

Australia↗
PubMed2004

Validation of diagnostic codes within medical services claims.

OBJECTIVES: Few studies have attempted to validate the diagnostic information contained within medical service claims data, and only a small proportion of these have attempted to do so using the medical chart as a gold standard. The goal of this study is to determine the sensitivity and specificity of medical services claims diagnoses for surveillance of 14 drug disease contraindications used in drug utilization review, the Charlson comorbidity index and the Johns Hopkins Adjusted Care Group Case-Mix profile (ADGs). STUDY DESIGN AND SETTING: Diagnoses were abstracted from the medical charts of 14,980 patients, and were used as the "gold standard," against which diagnoses obtained from the administrative database for the same patients were compared. RESULTS: Conditions associated with drug disease contraindications with the exception of hypertension and chronic obstructive pulmonary disease (COPD) showed a specificity of 90% or higher. Sensitivity of claims data was substantially lower, with glaucoma, hypertension, and diabetes being the most sensitive conditions at 76, 69, and 64%, respectively. Each of the 18 disease conditions contained in the Charlson comorbidity index showed high specificity, but sensitivity was more variable among conditions as well as by coding definitions. Although ADG specificity was also high, the vast majority of ADGs had sensitivities of less than 60%. CONCLUSION: The administrative data was found to have diagnoses and conditions that were highly specific but that vary greatly by condition in terms of sensitivity. To appropriately obtain diagnostic profiles, it is recommended that data pertaining to all physician billings be used.

Aged↗
PubMed2002

Use of managed care claims data in the risk assessment of venous thromboembolism in outpatients.

BACKGROUND: Deep vein thrombosis (DVT) is a complication of immobilizing illness in both inpatient and outpatient settings and can lead to serious complications such as pulmonary embolism (PE). DVT and PE are collectively referred to as venous thromboembolism. OBJECTIVE: To develop DVT and PE risk assessment models that can be used in office-based practice and for population-based disease management efforts. METHODS: Data were culled from integrated medical and pharmacy claims paid by 37 health plans in the United States (the PharMetrics Integrated Outcomes Database, PharMetrics Inc., Watertown, MA), and included information on adult plan members enrolled during 1998 and 1999. Patients hospitalized for DVT or PE in 1999 were identified, and potential risk factors were assessed by reviewing claims for the entire study population in 1998 to document prior DVT or immobilizing illness. The contribution of each potential risk factor to the probability of the occurrence of DVT or PE was determined by means of multiple logistic regression analysis. A risk-scoring algorithm based on regression coefficients was then developed. RESULTS: Fifty-two percent of the study population of 2.8 million plan members were women. DVT or PE occurred in 1330 of those 2.8 million individuals (47 per 100,000). Logistic regression results confirmed the role of risk factors previously reported in the literature and revealed additional risk factors that have not been reported previously, including diabetes, renal failure, rheumatoid arthritis, cellulitis, use of warfarin, use of systemic corticosteroids, and use of potassium chloride. When risk scores were applied to the study population, the 1% identified as being at highest risk had a probability for the development of venous thromboembolism that was 10 times greater than that of the population average. CONCLUSIONS: This study confirms the feasibility of using managed care claims data to develop a risk assessment tool for venous thromboembolism that can be used in office-based practice and for population-based disease management.

Adult↗
PubMed2001

[Complaints in orthopedics reported to the Norwegian Patient Compensation System 1993-99].

BACKGROUND: The Norwegian Patient Compensation System (NPCS) was started up in January 1988. By the end of 1999, a total of 15,552 complaints had been received. This paper reviews the outcome of the complaint procedures in the field of orthopaedics. MATERIAL AND METHODS: From 1993 to 1999, the NPCS assessed a total of 8,520 complaints of which 4,041 (47%) were in orthopaedics. On the basis of abstracts of these cases, we retrieved more detailed information. RESULTS: Over the period, 39% of orthopaedic complaints resulted in compensation, with a decline from 45% in 1993 to 32% in 1999. 328 orthopaedic patients were awarded compensation on the basis of infection; they constituted 8% of all compensated claims and 21% of all compensated orthopaedic claims. These ratios remained fairly constant throughout the period. Compensation was given to 291 patients with loosening of prostheses following use of Boneloc cement; these cases represented 7% of all orthopaedics claims and 18% of all compensated claims. Complaints were most numerous in 1996 and 1997; this reflected the use of this cement in the early 1990s. Rejected complaints were appealed with increasing frequency; in 1999, 46% of all NPCS cases were appealed, 33% of all orthopaedic cases. Rejections overruled following appeal were within a range of 16% (1994) and 11% (1995). When initial rejections overruled on appeal are included, the total compensation-to-claims ratio increases from 39% to 41%. INTERPRETATION: The high number of complaints in orthopaedics probably reflects the high frequency of musculoskeletal disorders in the population. It is to be hoped that evaluation of treatment injuries will result in a higher quality of patient treatment.

Databases, Factual↗
PubMed2006

Injury and liability associated with monitored anesthesia care: a closed claims analysis.

BACKGROUND: To assess the patterns of injury and liability associated with monitored anesthesia care (MAC) compared with general and regional anesthesia, the authors reviewed closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1990. METHODS: All surgical anesthesia claims associated with MAC (n = 121) were compared with those associated with general (n = 1,519) and regional (n = 312) anesthesia. A detailed analysis of MAC claims was performed to identify causative mechanisms and liability patterns. RESULTS: MAC claims involved older and sicker patients compared with general anesthesia claims (P < 0.025), often undergoing elective eye surgery (21%) or facial plastic surgery (26%). More than 40% of claims associated with MAC involved death or permanent brain damage, similar to general anesthesia claims. In contrast, the proportion of regional anesthesia claims with death or permanent brain damage was less (P < 0.01). Respiratory depression, after absolute or relative overdose of sedative or opioid drugs, was the most common (21%, n = 25) specific damaging mechanism in MAC claims. Nearly half of these claims were judged as preventable by better monitoring, including capnography, improved vigilance, or audible alarms. On-the-patient operating room fires, from the use of electrocautery, in the presence of supplemental oxygen during facial surgery, resulted in burn injuries in 20 MAC claims (17%). CONCLUSION: Oversedation leading to respiratory depression was an important mechanism of patient injuries during MAC. Appropriate use of monitoring, vigilance, and early resuscitation could have prevented many of these injuries. Awareness and avoidance of the fire triad (oxidizer, fuel, and ignition source) is essential to prevent on-the-patient fires.

Adolescent↗
PubMed1994

Variation in approval by insurance companies of coverage for autologous bone marrow transplantation for breast cancer.

BACKGROUND: The proper evaluation of new forms of technology depends on the results of clinical trials. However, the treatment of patients in grant-sponsored clinical trials of cancer therapy usually requires that the proposed treatment be approved in advance by an insurance carrier in a process called predetermination. METHODS: We examined the consistency of predetermination decisions by insurance companies for 533 patients enrolled in grant-supported clinical trials of high-dose chemotherapy and autologous bone marrow transplantation (ABMT) for breast cancer from 1989 through 1992. These decisions about coverage were compared with peer-reviewed decision making according to the study protocol and with clinical outcomes. RESULTS: Requests for insurance coverage for ABMT were approved in 77 percent of the cases. Of these patients, 23 percent did not undergo bone marrow transplantation for protocol-based or medical reasons. Insurance coverage for ABMT was denied in response to the other requests, primarily because the therapy was considered experimental; of these patients, 51 percent eventually underwent bone marrow transplantation despite the denial of insurance. In some instances, the patient had to hire an attorney to gain coverage. The frequency of approval was not influenced by the pretreatment clinical characteristics of the patients, the design or phase of the study, the year in which the predetermination request was made, or the response to induction therapy. There was substantial inconsistency in the frequency of approval of coverage both among insurers and between decisions made by some individual insurers, even for patients in the same study protocol. CONCLUSIONS: The predetermination process as applied to patients receiving care in clinical research trials of cancer therapy was arbitrary and capricious. Although most of the patients eventually received financial coverage for entry into clinical trials, the process of predetermination by insurers did not correlate with protocol-based medical decision making, and it was a barrier to obtaining treatment.

Antineoplastic Agents↗
PubMed2002

Utility of the SEER-Medicare data to identify chemotherapy use.

BACKGROUND: Medicare claims include codes for chemotherapy administration and specific drugs given, and researchers are increasingly using these data to measure the use of chemotherapy. However, the validity and completeness of these data as a source of information has not been established. OBJECTIVES: This analysis is intended to assess the utility of the Medicare claims to capture chemotherapy use. METHODS: Persons with breast, colorectal, and ovarian cancer were identified from the linked SEER-Medicare data. Their Medicare claims were reviewed to determine if there were any bills for chemotherapy, and if so, if there were claims for specific agents. This information was compared with data on the first course of treatment obtained from hospitals and treating physicians by the SEER registries through an NCI-supported Patterns of Care Studies (POC). Agreement was measured using kappa statistics. The sensitivity of the Medicare claims to capture chemotherapy, as reported from the POC data, was also measured. An additional comparison assessed the agreement between the two data sources concerning which specific drugs had been given. RESULTS: For all of the cancers, there was a high level of agreement between the Medicare claims and the POC data regarding whether or not the patient had received chemotherapy (kappa >or=0.73). The sensitivity of the Medicare data to determine if a person had received chemotherapy was high (>or=88%). In cases where the Medicare claim included a code for a specific drug, there high agreement between Medicare and POC about the specific drug given in breast and colorectal cancers, although the agreement was lower for ovarian cancers. The sensitivity of the Medicare claims to identify specific agents varies by cancer type. CONCLUSIONS: The Medicare claims can be used to identify which persons are receiving chemotherapy. The utility of Medicare data to measure treatment with specific agents varies by cancer type and specific agent. For some cancers, it is possible to use these claims to assess use of specific drugs, while for other drugs the data are limited.

Aged↗
PubMed2004

Special report: reassessment of the ORL-HNS workforce: perceptions and realities.

OBJECTIVE: This Workforce Study re-examined the current scope and geographic distribution of Otolaryngology practice and assessed the otolaryngologists' role in relation to other specialists in the diagnosis and treatment of disorders of the ear, nose, throat, and related structures of the head and neck. Study design A national survey and review of federal, corporate and administrative databases, coupled wih a focus group of otolaryngologists, were analyzed to compile physician manpower figures, state and regional demographic data, and prediction modeling of Managed Care and FFS environments. RESULTS: The current and predicted workforce supply and demographic data support a geographic and proportionate increase in the number of otolaryngologists practicing and entering the workforce. Additional findings involving the role of the specialty specifically identified an increase in the treatment of allergic disease within the Managed Care sector and a diminution of the gatekeeper concept. Demographic findings represent a stable age distribution of 40 to 49 and 50 to 59 year old otolaryngologists, with a noted increase in the number of women entering the field. Empiric data reflects the continuous, diverse and dominant role otolaryngologists maintain in the treatment and care of patients with otolaryngologic and head and neck disease. CONCLUSIONS: This study continues the effort to identify otolaryngology workforce demographic profiles and make recommendations for a future national practice model. Continuous reassessment of the specialty is required.

Adult↗
PubMed2001

[Analysis of 700 orthopedic complaints reported to the Norwegian Patient Compensation System].

BACKGROUND: In the 1993-99 period, the NPCS reached decisions on 4,041 orthopaedic injury cases. This paper reviews the complaints lodged. MATERIAL AND METHODS: We have analysed data from 700 randomly selected cases in order to elucidate the reasons for complaint. RESULTS: Complaints were lodged against all types of hospitals and primary health care providers. The most frequent primary diagnosis were osteoarthritis of the hip, lumbar disc herniation, and various fractures. Complaints were most commonly related to faulty treatment, continued pain, nerve injuries, reduced function, mistaken diagnosis, malposition of bone or joint, and infection. 84% of complaints were related to treatment and to operative treatment in particular. In 209 cases (30%), the complaints were heard. Of these 209, 43% were heard because of the treatment given, 21% because of infection, 18% because of diagnostic fault, and 6% because of defective follow-up. 491 complaints were rejected; in 70% of them because the injury was acceptable according to general rules, in 19% because the basic disorder had caused the injury, and in 7% because there was in fact no injury. INTERPRETATION: In our opinion, better knowledge about treatment injury cases represents valuable information that contributes to a higher quality of care.

Adolescent↗
PubMed1994

Healthcare resource use and costs associated with migraine in a managed healthcare setting.

OBJECTIVE: To compare healthcare use and associated costs in patients with migraine and patients without migraine headache. DESIGN: Retrospective review of a managed care organization's medical and pharmacy claims databases for claims filed between January 1, 1989 and June 30, 1990. PATIENTS: Patients between 18 and 64 years old with a 12-month minimum enrollment in the health plan, including enrollment for the prescription drug benefit. Migraine group (n = 1336) inclusion required a medical claim with the diagnosis of migraine headache and a pharmacy claim for a medication potentially used for migraine treatment. Comparison group (n = 1336) inclusion required at least one medical claim with no diagnosis of migraine; a pharmacy claim was not required. Comparison group patients were matched to migraine group patients by age, gender, enrollment status, and subscriber or dependent enrollment status. OUTCOME MEASURES: Total health services use, diagnosis-specific use of services, diagnostic procedures performed, comorbid conditions, medication use, and associated costs were tallied. RESULTS: Migraineurs generated nearly twice as many medical claims as comparison group patients, and nearly 2.5 times as many pharmacy claims. Number of claims generated and numbers of patients who generated claims within each of 19 diagnostic categories indicated greater comorbidity in the migraine group. Migraineurs used emergency services more than did patients in the comparison group. Total medical and pharmacy claims costs were $3.4 million for the migraine group and $2.1 million for the comparison group. The average amount paid per member-month of enrollment was significantly greater in the migraine group than in the comparison group. Comorbid conditions were responsible for a significant portion of costs in the migraine group. The migraine group incurred $83,537 for diagnostic procedures compared with $13,140 incurred by the comparison group. CONCLUSIONS: Patients with migraine had greater morbidity in general and incurred 64 percent greater costs in healthcare resource use compared with patients without migraine.

Adolescent↗
PubMed2000

The economic burden of congestive heart failure in a managed care population.

OBJECTIVE: To examine the economic burden of and treatment patterns for congestive heart failure (CHF) in a managed care population. STUDY DESIGN: Retrospective review of medical and pharmacy claims. PATIENTS AND METHODS: We reviewed integrated medical and pharmacy claims data from 6 independent-practice-association model health maintenance organizations to identify patients diagnosed with CHF. Of the approximately 1.4 million people enrolled in these managed care plans during the study period (January through December 1994), a total of 2777 patients (mean age, 56.9 years) met the study criteria, which included diagnostic codes for CHF and claims eligibility of at least 1 year. We reviewed the charges incurred by patients diagnosed with CHF for the 6 months after the initial CHF medical claim. We also examined the treatment received by each of these patients. RESULTS: During the study period, 378 of the 2777 patients with CHF (14%) were admitted to the hospital at a cost of almost $3 million (an average of $7863 per hospitalized patient). Seventy-eight percent of the study population received prescription drugs, at an average per-patient cost of $942. The most commonly prescribed drug class was angiotensin-converting enzyme inhibitors, prescribed for 38% of patients. Calcium channel blockers were prescribed for 33% of patients, but beta-blockers were prescribed for only 18% of patients. Hospitalization accounted for 54% of the total cost for CHF treatment, with prescription drugs accounting for 38%. CONCLUSION: Congestive heart failure represents a significant financial burden within a non-elderly managed care population. Improved management of the condition is needed to reduce the morbidity and mortality, as well as the costs of treatment, associated with CHF. Considerable data indicate that drugs such as beta-blockers and angiotensin-converting enzyme inhibitors can significantly decrease the morbidity and mortality of CHF. Further investigation is needed into whether increased use of prescription pharmaceuticals may reduce hospitalization rates and overall costs for CHF in this setting.

Aged↗
PubMed1999

Administrative data for quality improvement.

This article discusses the use of administrative data for quality improvement in perinatal and neonatal medicine. We review the nature of administrative data and focus on hospital discharge abstract data as the primary source of hospital- and community-based assessments. Although discharge abstract data lack the richness of primary data, these data are the most accessible comparative data source for examining all patients admitted to a hospital. When aggregated to the state level as occurs in more than 30 states, hospital discharge data reflects hospital utilization and outcomes for an entire geographic population at the state and community level. This article reviews some of the weaknesses of administrative data and then focuses how these data can be used for hospital- and community-based assessment of perinatal care citing as examples the measures of perinatal process and outcome used by the National Perinatal Information Center in its Quality/Efficiency Reports for member hospitals and a study of perinatal high-risk care in the State of Florida. The use of discharge abstract data for performance measurement at either the hospital or the system level requires a thorough understanding of how to select a patient group, its characteristics, the intervention, and the outcomes relevant to that patient group. In the perinatal arena, the National Perinatal Information Center has selected and presents those measures that rely on data items shown to be the most reliable based on validity studies and clinician opinion, delineation of the intervention, and the measurement of what occurred. As hospitals respond to the recent pressures of the Joint Commission on Accreditation of Healthcare Organizations and other quality assurance entities, the accuracy of the discharge data will improve. With accepted caution, these data sets are invaluable to researchers studying comparative populations over time or across large geographic areas.

Birth Weight↗
PubMed1997

Adverse outcomes of managed care gatekeeping.

OBJECTIVES: To determine whether telephone preauthorization for reimbursement of ED care (medical "gate-keeping") by managed care organizations (MCOs) is associated with adverse outcomes. METHODS: A structured review was performed of case reports solicited during 1994 and 1995 with possible adverse outcomes related to managed care gatekeeping. Gatekeeping was defined as the requirement imposed by an MCO that ED staff contact on-call gatekeepers (i.e., clinical or nonclinical MCO personnel) to request preauthorization for ED treatment (a requirement that such MCOs enforce by refusing payment for the ED care unless preauthorization is obtained). Cases in which gatekeeper denial of preauthorization occurred were sought. Two physicians agreed on patient eligibility and classification criteria, then independently, retrospectively classified case reports identified as MCO ED payment denials into 1 of 4 categories: 1) adverse outcome; 2) patient placed at increased risk of death or disability; 3) "near miss" (emergency physicians prevented adverse outcome by caring for patient despite denial); and 4) none of the above. RESULTS: Of the 143 cases reviewed, 29 reports represented MCO ED payment denial. Of these 29 eligible cases, there were 4 (14%) patients with adverse outcomes, 4 (14%) patients placed at increased risk, and 21 (72%) near misses. All of the 29 cases came from different EDs, representing 9 different states, with the majority from California. Adverse outcomes included respiratory failure from fulminant meningococcemia, hypovolemic syncope from ruptured ectopic pregnancy, hypovolemic arrest from vascular fibroid hemorrhage necessitating emergency hysterectomy, and prolonged postoperative course following ruptured duodenal ulcer. Patients placed at increased risk were diagnosed as having epiglottitis, myocardial infarction, ruptured ectopic pregnancy, and delayed treatment of hip septic arthritis. Near misses included diagnoses of ectopic pregnancy (n = 2), pneumothorax (n = 2), alcohol withdrawal seizures and pancreatitis necessitating intensive care unit admission, appendicitis, bacterial meningitis, cerebrovascular accident, cryptococal meningitis in immuno comprised host, endocarditis, incarerated inguinal hernia, meningocococemia, meninoccocal meningitis, peritonsillar abscess, pneumococcal meningitis, ruptured abdominal aortic aneurysm, shock from gastrointestinal bleeding, small bowel obstruction, schizophrenic crisis resulting in psychiatric hospitalization, suicidal depression resulting in psychiatric hospitalization, and unstable angina. CONCLUSION: Adverse outcomes occur with MCO gatekeeping, Although the present study cannot ascertain whether this is a frequent event or a rare one, the safety of MCO gatekeeping deserves further study.

Adolescent↗
PubMed1994

Does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy?

Insurance carriers affected decisions regarding admissions and length of stay in our hospital in 1987. Charts were reviewed retrospectively to determine whether this affected morbidity and mortality rates following cleft lip and palate operations in infants. Two periods were studied: May of 1983 through April of 1987 (group I) and April of 1987 through May of 1991 (group II). A total of 248 infants with cleft lip and/or palate underwent 398 operations: lip adhesion (74), definitive lip repair (130), and palatoplasty (194). Half were performed in each period. Admission status, length of stay, length of operation, and short-term morbidity were documented. Morbidity included spontaneous and traumatic lip dehiscence, palatal dehiscence, and palatal fistula. Intergroup analysis was performed by the chi-squared method; p < or = 0.05 was statistically significant. In group I, 93 percent of patients were admitted before surgery. In group II, 5 percent were admitted before surgery and 79 percent the day of surgery. Hospital stay decreased nearly 2 days for each operation. There was no statistically significant difference between groups in distribution of operations, length of operations, or morbidity: lip surgery complications (p = 0.263), palatoplasty complications (p = 0.624). Reductions of hospital admissions and length of stay do not affect outcome of cleft lip and palate surgery in infants. The reduction in hospital days is equivalent to a savings of $138,000 (1991 dollars).

Ambulatory Surgical Procedures↗
PubMed1998

Medicare program; Medicare integrity program, intermediary and carrier functions, and conflict of interest requirements--HCFA. Proposed rule.

This proposed rule would implement section 1893 of the Social Security Act (the Act) by establishing the Medicare integrity program (MIP) to carry out Medicare program integrity activities that are funded from the Medicare Trust Funds. Section 1893 expands our contracting authority to allow us to contract with "eligible entities" to perform Medicare program integrity activities. These activities include review of provider and supplier activities, including medical, fraud, and utilization review: cost report audits; Medicare secondary payer determinations; education of providers, suppliers, beneficiaries, and other persons regarding payment integrity and benefit quality assurance issues; and developing and updating a list of durable medical equipment items that are subject to prior authorization. This proposed rule would set forth the definition of eligible entities, services to be procured, competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal), procedures for identification, evaluation, and resolution of conflicts of interest, and limitations on contractor liability. In addition, this proposed rule would bring certain sections of the Medicare regulations concerning fiscal intermediaries and carriers into conformity with the Act. The rule would distinguish between those functions that the statute requires be included in agreements with intermediaries and those that may be included in the agreements. It would also provide that some or all of the listed functions may be included in carrier contracts. Currently all these functions are mandatory for carrier contracts. These changes would give us the flexibility to transfer functions from one intermediary or carrier to another or to otherwise limit the functions an intermediary or carrier performs if we determine that to do so would result in more effective and efficient program administration.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2006

Gastrointestinal complications of over-the-counter nonsteroidal antiinflammatory drugs.

This study assessed the "real-world" risk of serious gastrointestinal (GI) toxicities, defined as perforations, ulcers and bleeds (PUBs) in a U.S. representative population that was using two commonly available over-the-counter (OTC) non-selective nonsteroidal antiinflammatory drugs (NSAIDs), naproxen or ibuprofen with or without concomitant aspirin usage. A retrospective review of a commercially available electronic medical record (EMR) database containing the ambulatory health record data for over 3.2 million individuals was conducted. Subjects were eligible for inclusion in the study if they received an OTC dosage of naproxen (220 mg) or ibuprofen (200 mg). An index date for each subject was defined as the first mention of an OTC NSAID in the medication list of the EMR dataset. Subjects were excluded from the analysis if they met any criteria, which can lead to GI bleeding complications. The dataset was analyzed for PUBs, as indicated by the ICD-9 diagnosis codes for gastric, duodenal, peptic, or gastrojejunal ulcers, or GI hemorrhage, as well as the concomitant use of aspirin. A pre/post-analysis was conducted using a case-crossover design with subjects as their own controls. The index date was the defining event, in order to determine the odds ratio associated with OTC NSAID usage. A pre-index time period of 365 days was used for prior PUBs. For the post-index time period, only PUBs that occurred within 90 days of the OTC NSAID index date were considered. The data set contained 11,957 subjects on naproxen and 38,507 subjects on ibuprofen. In both cases, OTC NSAID usage was associated with a statistically significant increase in the odds ratio for PUBs. Subjects on ibuprofen had an odds ratio of 1.38 (95% CI 1.07-1.78, P=0.01). Naproxen subjects exhibited an odds of 1.54 (95% CI 1.04-2.28, P=0.03). The concomitant aspirin population consisted of 2,328 naproxen subjects and 4,843 ibuprofen subjects. Concomitant aspirin usage was also associated with a significantly higher risk for PUBs than the corresponding monotherapy. Subjects taking both ibuprofen and aspirin had an odds ratio of 3.36 (2.36-4.80, P<.00001), while those on naproxen and aspirin had an odds ratio of 2.07 (1.23-3.49, P=.005) relative to those subjects on ibuprofen and naproxen monotherapy, respectively. Utilizing a national electronic medical record database representing patients seen predominantly in a primary care setting, this study has documented the "real-world" risk associated with the use of two common OTC NSAIDs, as well as the increased risk associated with concomitant aspirin use in this population.

Adolescent↗
PubMed2003

Risk factors of poor prognosis after whiplash injury.

Whiplash, a common injury following motor vehicle crashes, is associated with high costs and a prognosis that is variable and difficult to predict. In this paper, we review findings from the Quebec cohort epidemiological study on predictive factors of recovery from whiplash injury after a motor vehicle crash. We formed a population-based incident cohort of all 4,759 individuals who sustained a whiplash injury resulting from a motor vehicle crash in the province of Québec, Canada, in 1987, and followed these patients for up to seven years. The data were obtained from the universal automobile insurance plan (SAAQ) that covers all seven million residents of the Province for all vehicular-related injuries. From this cohort, we formed the cohort of 3,014 for whom a police report was completed. For this cohort, we obtained data on crash-related factors directly from the police report. We also formed the cohort of 2,627 subjects who had strictly a whiplash injury, without associated injuries. For this cohort, the data on signs and symptoms were obtained from the medical charts kept by the SAAQ. For both cohorts, data on the outcome, the recovery time from whiplash, was obtained from the SAAQ databases. The crash-related cohort study found that socio-demographic factors associated with a longer recovery from whiplash include older age, female sex, having dependents and not being employed full time and that each decreases the rate of recovery by 14 to 16 per cent. Factors related to the crash conditions indicate that being in a truck or bus, with a decrease of 52% in the rate of recovery, being a passenger in the vehicle (15%), colliding with a moving vehicle (16%), and a side or frontal collision (15%) all decrease the rate of recovery. We introduce a combined risk score that predicts longer recovery. In the cohort of subjects with signs and symptoms, the median recovery time was 32 days and 12% of subjects had still not recovered after 6 months. The signs and symptoms that were found to be independently associated with a slower recovery from whiplash, besides female gender and older age, were neck pain on palpation; muscle pain; pain or numbness radiating from neck to arms, hands or shoulders; and headache. Together, the presence of all these factors in females aged 60 predicted a median recovery time of 262 days, compared with 17 days for younger males aged 20 who do not have any of these factors. In contrast, using the Quebec classification of signs and symptoms, the median recovery time varied from 17 to 123 days. We conclude that several socio-demographic and crash-related factors, as well as several signs and symptoms, including a combination of specific musculoskeletal and neurological ones that whiplash patients present with, are predictive of a longer recovery period. These patients should be targeted for an early intervention programme aimed at managing whiplash patients with a poor prognosis.

Accidents, Traffic↗