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PubMed2004

Formularies, therapeutics, and outcomes: new opportunities.

The increasing prominence of drug therapies in health care and their rapidly rising costs have led to a dramatic escalation of interest in the use of outcomes data for therapeutics and formulary decisions. The expanded use of formulary submission dossiers, effectiveness data, health outcomes analysis, and pharmacoeconomic modeling has created an urgent need for outcomes research to investigate topics especially relevant for health plan drug therapy coverage decisions. This article examines the evolving use of outcomes data on drug formulary and other therapeutic decisions, and outlines several priority areas for outcomes research. These include research into surrogate measures of long-term health and economic outcomes, evaluations of new formulary submission programs, and research on the impact of pharmaceutical cost-sharing arrangements on health outcomes. The article also discusses the importance of evaluating patient compliance and health outcomes after implementation of a Medicare prescription drug benefit, and the need for new types of clinical trials that can respond to changing demands of pharmacy and therapeutics committees and providers

Adolescent↗

PubMed2004

Glasgow Coma Scale score, mortality, and functional outcome in head-injured patients.

BACKGROUND: Preresuscitation Glasgow Coma Scale (P-GCS) score is frequently obtained in injured patients and incorporated into mortality prediction. Data on functional outcome in head injury is sparse. A large group of patients with head injuries was analyzed to assess relationships between P-GCS score, mortality, and functional outcome as measured by the Functional Independence Measure (FIM). METHODS: Records for patients with International Classification of Diseases, Ninth Revision diagnosis codes indicating head injury in a statewide trauma registry between 1994 and 2002 were selected. P-GCS score, mortality, and FIM score at hospital discharge were integrated and analyzed. RESULTS: Of 138,750 patients, 22,924 patients were used for the mortality study and 7,150 patients for the FIM study. A good correlation exists between P-GCS score and FIM, as determined by rank correlation coefficients, whereas mortality falls steeply between a P-GCS score of 3 and a P-GCS score of 7 followed by a shallow fall. Although P-GCS score is related to mortality in head-injured patients, its relationship is nonlinear, which casts doubt on its use as a continuous measure or an equivalent set of categorical measures incorporated into outcome prediction models. The average FIM scores indicate substantial likelihood of good outcomes in survivors with low P-GCS scores, further complicating the use of the P-GCS score in the prediction of poor outcome at the time of initial patient evaluation. CONCLUSION: Although the P-GCS score is related to functional outcome as measured by the FIM score and mortality in head injury, current mortality prediction models may need to be modified to account for the nonlinear relationship between P-GCS score and mortality. The P-GCS score is not a good clinical tool for outcome prediction in individual head-injured patients, given the variability in mortality rates and functional outcomes at all scores.

Activities of Daily Living↗

PubMed2026

Effects of single-injection vs. continuous brachial plexus blocks for shoulder surgeries on patient-reported outcomes: a systematic review and meta-analysis with trial sequential analysis of randomised controlled trials.

INTRODUCTION: Single-injection and continuous brachial plexus block techniques are used widely for postoperative analgesia in patients undergoing shoulder surgery. Although patient-reported outcomes are described in individual studies, their effects have not been synthesised comprehensively using a patient-centred framework. We sought to compare the effects of single-injection vs. continuous brachial plexus block techniques on patient-reported outcomes in adult patients following elective shoulder surgery. METHODS: Databases were searched from inception to October 2025 and randomised controlled trials reporting patient-reported outcomes were included. Co-primary outcomes were postoperative patient-reported pain intensity at rest and during movement at 12 h, 24 h and 48 h post-surgery. Secondary outcomes included nausea and vomiting; sleep quality; patient satisfaction; opioid requests; and functional scores. Random-effects meta-analysis and trial sequential analysis were performed, with risk of bias and quality of patient-reported outcome reporting assessed. RESULTS: Twenty randomised controlled trials that included 1198 patients were analysed. Continuous brachial plexus blocks were associated with lower pain at rest at 12 h, 24 h and 48 h, with mean differences (MD) of -1.96 (95%CI -2.81 to -1.11, p < 0.001), -1.66 (95%CI -2.27 to -1.05, p < 0.001) and - 1.18 (95%CI -1.84 to -0.53, p < 0.001), respectively. Pain on movement could only be pooled at 24 h and 48 h and showed MD -2.04 (95%CI -4.26-0.19, p = 0.07) and - 1.30 (95%CI -3.67-1.07, p = 0.28) respectively. The co-primary outcomes approached or exceeded the predefined minimal clinically important difference for pain scores after shoulder surgery, in favour of continuous techniques. DISCUSSION: Continuous brachial plexus blocks are associated with better pain at rest and other patient-centred outcomes following shoulder surgery, while effects on dynamic pain and long-term functional recovery remain uncertain.

Humans↗

PubMed2004

Adult outcome for children with autism.

BACKGROUND: Information on long-term prognosis in autism is limited. Outcome is known to be poor for those with an IQ below 50, but there have been few systematic studies of individuals with an IQ above this. METHOD: Sixty-eight individuals meeting criteria for autism and with a performance IQ of 50 or above in childhood were followed up as adults. Their mean age when first seen was 7 years (range 3-15 years); at follow-up the average age was 29 years (range 21-48 years). Outcome measures included standardised cognitive, language and attainment tests. Information on social, communication and behavioural problems was obtained from the Autism Diagnostic Interview (ADI). RESULTS: Although a minority of adults had achieved relatively high levels of independence, most remained very dependent on their families or other support services. Few lived alone, had close friends, or permanent employment. Communication generally was impaired, and reading and spelling abilities were poor. Stereotyped behaviours or interests frequently persisted into adulthood. Ten individuals had developed epilepsy. Overall, only 12% were rated as having a 'Very Good' outcome; 10% were rated as 'Good' and 19% as 'Fair'. The majority was rated as having a 'Poor' (46%) or 'Very Poor' (12%) outcome. Individuals with a childhood performance IQ of at least 70 had a significantly better outcome than those with an IQ below this. However, within the normal IQ range outcome was very variable and, on an individual level, neither verbal nor performance IQ proved to be consistent prognostic indicators. CONCLUSIONS: Although outcome for adults with autism has improved over recent years, many remain highly dependent on others for support. This study provides some information on prognostic indicators, but more fine-grained research is needed into the childhood variables that are associated with good or poor outcome.

Activities of Daily Living↗

PubMed1991

The effect of induced abortion on subsequent pregnancy outcome.

OBJECTIVE: To investigate the effect of induced abortion on the outcome of the next pregnancy. DESIGN: Long-term prospective controlled cohort study. SETTING: Joint Royal College of General Practitioners/Royal College of Obstetricians and Gynaecologists study based in general practice in England, Scotland and Wales. SUBJECTS: 1311 women whose recruitment pregnancy had ended in induced abortion (the abortion group) and 2131 women whose recruitment pregnancy had a natural conclusion (the non-abortion group). MAIN OUTCOME MEASURES: Non-viable outcome (spontaneous or missed miscarriage, ectopic pregnancy or stillbirth), birthweight, length of gestation. RESULTS: Induced abortion was not materially associated with any of the three measures of adverse outcome. Compared with the non-abortion group the relative risk of a non-viable outcome in the abortion group was 1.01 (95% CI 0.81 to 1.27). In the abortion group birthweight was an average 23 g lighter (95% CI -76 g to + 30 g) and length of gestation an average 0.9 days shorter (95% CI -2.2 days to + 0.4 days) than in the non-abortion group. Women who had their abortions in NHS premises had an increased risk of a non-viable outcome (RR 2.55, 95% CI 1.31 to 4.94) and had babies with significantly lower mean birthweight (-119 g, 95% CI -233 g to +5 g) compared with those who obtained their operations in the private sector. Women whose abortion had been carried out by a consultant had the lowest risk of non-viable outcome. Although these differences remained after adjustment for a number of important variables, it is possible that factors not measured in the present study, such as economic status and occupation, played a contributory role. CONCLUSION: Overall, induced abortion was not associated with any important effect on the three measures of adverse outcome in the subsequent pregnancy.

Abortion, Induced↗

PubMed2001

Entry criteria and baseline characteristics predict outcome in acute stroke trials.

UNLABELLED: Background and Purpose-We sought to study the range of entry criteria and baseline characteristics in acute stroke trials and to understand their effects on patient outcomes. METHODS: -Randomized, placebo-controlled therapeutic trials in patients with acute ischemic stroke were identified. Entry criteria, baseline clinical characteristics, and outcome were extracted for the placebo group of each trial. The relationship between key variables was then determined. RESULTS: -Across 90 placebo groups identified, there was great variation in entry criteria and outcome measures. This was associated with divergent outcomes; for example, in some studies most placebo group patients died, while in other studies nearly all had no disability. Entry criteria were significantly correlated with outcome; for example, higher age cutoff for study entry correlated with 3-month mortality. Entry criteria also predicted baseline clinical characteristics; for example, wider time window for study entry correlated directly with time to treatment and inversely with stroke severity (initial National Institutes of Health Stroke Scale score). Baseline characteristics predicted outcome. Greater stroke severity predicted higher 3-month mortality rate; despite this, successful thrombolytic trials have enrolled more severe strokes than most trials. The mean age of enrollees also predicted 3-month mortality and was inversely related to percentage of patients with 3-month Barthel Index score >/=95. The strongest predictors of 3-month mortality were obtained with multivariate models. CONCLUSIONS: -Acute stroke studies vary widely in entry criteria and outcome measures. Across multiple studies, differences in entry criteria, and the baseline clinical characteristics they predict, influence patient outcomes along a continuum. In some studies, enrolling a specific subset of patients may have improved the chances of identifying a treatment-related effect, while in others, such chances may have been reduced. These findings may be useful in the design of future stroke therapeutic trials.

Acute Disease↗

PubMed1997

Psychiatric status, quality of life, and level of care as predictors of outcomes of acute inpatient treatment.

OBJECTIVE: The study examined the role of five types of variables--demographic characteristics, psychiatric status, functional quality of life, satisfaction with quality of life, and level of care--in predicting key outcomes of inpatient treatment. METHODS: Multivariate canonical regression and univariate multiple regression models were constructed using data from 1,053 inpatients at a public hospital in Washington State. The models were used to predict length of stay, change in symptom severity during hospitalization, psychiatrists' ratings of patients' insight into their illness at discharge, patients' global satisfaction with life, and rehospitalization within 18 months. Hierarchical stepwise procedures were used to select variables that were significant predictors of outcomes. RESULTS: All five classes of predictors were related to the outcomes. The roles of demographic characteristics and diagnoses were minimal. Previous hospitalization and severity of symptoms at admission were strong predictors of psychiatric status. Indicators of functional quality of life and satisfaction with quality of life explained significant variance in all models after accounting for the other classes of predictors. Frequency of family visits was the strongest functional quality-of-life predictor, relating to positive outcomes. Pretreatment satisfaction with life was a significant predictor of most outcomes, and increased satisfaction was associated with positive outcomes. CONCLUSIONS: Patients' quality of life before psychiatric inpatient treatment predicted treatment outcomes independently of psychiatric status, demographic characteristics, and level-of-care variables. Prospective studies are needed to predict outcomes using multidimensional constructs.

Adolescent↗

PubMed2000

Needs assessment for mentally disordered offenders: measurement of 'ability to benefit' and outcome.

BACKGROUND: The Department of Health defines needs as "the ability to benefit from healthcare interventions". Outcome measurement is an integral component of needs assessment because it underpins 'ability to benefit'. AIMS: To propose a framework for addressing the measurement of outcome in relation to mentally disordered offenders (MDOs). METHOD: Based on a literature search, the paper reviews the definition and measurement of outcome in general mental health care and specifically in relation to MDOs. It analyses the problems of conducting outcome research in relation to MDOs. RESULTS: A framework for outcome measurement in relation to MDOs is presented. Outcome is placed within a broader framework that relates to service evaluation. CONCLUSIONS: Current measurement of outcome in relation to MDOs is inadequate. A comprehensive framework that acknowledges the multi-dimensional nature of outcome is essential. Researchers must be able to justify the dimensions they prioritise.

Humans↗

PubMed2000

Do women fare worse: a metaanalysis of gender differences in traumatic brain injury outcome.

OBJECT: The purpose of this metaanalysis was to investigate possible gender differences in traumatic brain injury (TBI) sequelae. The case fatality rates in patients after TBI have previously been shown to be significantly higher in women as compared with men. METHODS: A quantitative review of published studies of TBI outcome revealed eight studies (20 outcome variables) of TBI, in which outcome was reported separately for men and women. CONCLUSIONS: Outcome was worse in women than in men for 85% of the measured variables, with an average effect size of -0.15. Although clinical opinion is often that women tend to experience better outcomes than men after TBI, the opposite pattern was suggested in the results of this metaanalysis. However, this conclusion is limited by the fact that, in only a small percentage of the total published reports on TBI outcome, was outcome described separately for each sex. A careful, prospective study of sex differences in TBI outcome is clearly needed.

Adult↗

PubMed2005

Potentially useful outcome measures for clinical research in pediatric neurosurgery.

The choice of outcome (or outcomes) and their measurement are critical for a sound clinical trial. Surgeons have traditionally measured simple outcomes such as death, duration of survival, or tumor recurrence but have recently developed more sophisticated measures of the effect of an intervention. Many outcome measures require a lengthy maturation process, which includes a determination of the instrument's validity, reliability, and sensitivity; thus, using established instruments rather than creating new ones is recommended. The authors illustrate several guidelines for the determination of appropriate outcome measures by using examples from their experience and describe several outcome measures that can be used in pediatric neurosurgery. These include general outcome measures such as the Pediatric Evaluation of Disability Inventory and the Functional Independence Measure for Children, which measure physical function and independence in chronically ill and disabled children as well as disease-specific measures for hydrocephalus (Hydrocephalus Outcome Questionnaire), cerebral palsy (gross motor function and performance measures), head injury (Pediatric Cerebral Performance Category and Children's Coma Scale), and oncology (Pediatric Cancer Quality-of-Life Inventory).

Activities of Daily Living↗

PubMed1999

Does what nurses do affect clinical outcomes for hospitalized patients? A review of the literature.

OBJECTIVE: Through a review of the literature, to identify and describe (1) empirical studies of inpatient nursing care quality that evaluate links between nursing care processes and health-related patient outcomes, (2) nursing care processes for which process-outcome links have been established, and (3) important nursing care processes that have not yet been evaluated. DATA SOURCES/STUDY SETTING: Published empirical studies of inpatient nursing care quality that evaluated links between processes of nursing care and health-related patient outcomes. STUDY DESIGN/DATA COLLECTION/EXTRACTION METHODS: This literature review used a five-step article search and review method. PRINCIPAL FINDINGS: Of 257 data-based studies of nursing care quality identified, 135 investigated a process-outcome link but only 17 met study inclusion criteria. The literature provides evidence that the quality of nursing care processes affects health-related patient outcomes during and after hospitalization. Gaps in the literature that evaluates nursing quality are identified. CONCLUSIONS: Although some nursing care processes affect health-related patient outcomes, the full extent of nursing process-outcome links is relatively understudied. Further evaluation of the interrelationships between nursing care processes and outcomes is critical.

Humans↗

PubMedDate not supplied

Birth center outcomes reported through automated technology.

UNLABELLED: BirthCare HealthCare is a multidisciplinary health care clinic and freestanding birth center in Salt Lake City, Utah. Highlights of a woman's labor assessment and birth outcomes are summarized in a paper birth log. The authors developed a relational database that facilitates efficient outcomes reporting. Examples of outcomes from this database are reported. OBJECTIVES: This study describes clinical outcomes from a freestanding birth center and the automated birth log database used to manage outcomes reporting. DESIGN: Retrospective data obtained primarily from a paper birth log and secondarily from the paper chart were entered into and extracted from an electronic database. PARTICIPANTS: 231 women who were evaluated in 269 encounters for delivery at the birth center between July 1, 1997, and June 30, 1999. MAIN CLINICAL OUTCOME MEASURES: The number of deliveries at the birth center; the percentage of intrapartum, postpartum, and newborn transfers to the inpatient hospital setting; cause-specific transfer rates; method of transfer; medication in labor; low and high birth weights; percentage of low Apgar scores; and average times from admission to birth and birth to discharge. CONCLUSION: Birth center clinical outcomes can be efficiently reported using an automated birth log. Clinical outcomes reported in this study are consistent with finding of previous research that demonstrates that birth centers are a safe alternative site for delivery.

Birth Weight↗

PubMed2004

Outcome of moderate and severe traumatic brain injury amongst the elderly in Singapore.

INTRODUCTION: In line with other established protocols, our unit has instituted a standardised protocol for the management of moderate and severe traumatic brain injury since 1996 in our neurointensive care unit. MATERIALS AND METHODS: We reviewed the outcomes, at 6 months' post-injury, in an elderly group aged > or = 64 years (73.86 +/- 8.0 years) and compared them to a younger group aged 20 to 40 years (29.2 +/- 5.7 years) in a cohort of 324 patients. Outcome was dichotomised as favourable (mild and moderate disability but independent; Glasgow Outcome Score [GOS] 4 and 5), unfavourable (severe disability and persistent vegetative state; GOS 2 and 3) and death (GOS 1). RESULTS: In the elderly group, the mortality (55.4%) was slightly more than double that of the younger group (20.9%); 21.5% had an unfavourable outcome (14.2% in the younger group) and only 23% had a favourable outcome (compared to 64.9% in the younger group). The final outcomes were significantly worse in all levels in the elderly group. This was in spite of data showing that the mechanism of injury was of a higher impact in the younger group, with a higher incidence of polytrauma and cervical spine injury. On admission, the mean Glasgow Coma Score (GCS) was 8.3 +/- 3.91 for the elderly group and 8.59 +/- 4.05 for the younger group (P = 0.763). Computed tomography scan showed that the elderly had a higher incidence of mass lesions (extradural haematoma and subdural haematoma) and traumatic subarachnoid haemorrhage. A subgroup (29.2%) of elderly patients had no surgical intervention based on poor clinical/neurological status, premorbid functional status and pre-existing medical conditions, with their family's consent. The GCS of < or = 8, on admission, was significant (P <0.001) in predicting mortality in the elderly. In the elderly group, the female gender had a higher mortality rate (70.4%) than the males (44.7%) (P = 0.19). CONCLUSION: Age must be considered an independent factor in outcome prediction in the elderly with moderate and severe traumatic brain injury. A more conservative approach in the management of an elderly patient with severe head injury may be reasonable given its dismal outcomes after careful dialogue with the relatives.

Adult↗

PubMed2005

Outcomes research in total joint replacement: a critical review and commentary.

The ostensible goal of outcomes research is to demonstrate the effectiveness of total joint replacement as it relates to appropriate use of health care resources and quality of care. Modern outcomes assessment focuses on identifying reproducible and valid instruments that can be used to collect and analyze patient outcomes. Validation of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) has had a major impact on obtaining meaningful outcomes data. Its use, as well as use of other outcomes instruments, is addressed in this article. The final frontier in outcomes research is the large-scale database. Early data from the Swedish National Total Hip Arthroplasty Registry is encouraging, but its ultimate usefulness is unknown. There are significant obstacles to development of such a system in the United States. At this time, the direction of outcomes research needs to be reassessed.

Age Factors↗

PubMed2006

[Deteriorating factors on the outcome in patients with fair grade of subarachnoid hemorrhage (WFNS grade I and II)].

BACKGROUND AND PURPOSE: Although, the overall treatment results in aneurysmal subarachnoid hemorrhage (SAH) has been improving in recent years, more than 10% of the patients with WFNS grade I and II we have sought to determine the clinical variables for predicting poor functional outcome and symptomatic vasospasm (VS) in patients with individual WFNS grades. MEASUREMENTS: The eligible patient fulfilled the following conditions; (1) ruptured aneurysm located in the anterior part of the circle of Willis, (2) surgically clipped followed by craniotomy under microscope, (3) early surgery within 72 hours, (4) classified to WFNS grade I or II. The medical records were retrospectively reviewed in 119 patients (63 of grade I and 56 of grade II). Sex, age, Fisher's CT group, intraventricular hemorrhage (IVH), site of aneurysm, VS, hydrocephalus, premature bleeding and complications of various kinds were selected as the dependent variables. The contributions of these factors to outcome (Glasgow Outcome Scale, GOS) as well as VS were analyzed using the logistic regression method. MAIN RESULTS: Outcome was better in WFNS grade I (p=0.039), and VS occurred less often and responded well to various interventional techniques and drug delivery. No significant variables contributed to the poor outcome or VS in WFNS grade I. In WFNS grade II, logistic regression analysis showed that VS (OR 34.6, 95% CI, 30.8-38.9, p =0.012) and the complications (OR 52.4, 95% CI, 46.5-59.1, p=0.004) were significant predictors for a poor outcome. Fisher's group 3 was also the only significant factors in VS (OR 3.78, 95% CI, 3.35-4.28, p =0.039). The cause for the difference in outcome and VS were discussed in detail. CONCLUSION: The vasospasm and various kinds of complications were the predictive factors of poor clinical outcome, in patient of WFNS garde II. Therefore, careful management and meticulous/pertinent surgical maneuvers are mandatory to obtain better results in aneurysmal SAH, even in better WFNS grades.

Aged↗

PubMed1993

A method for achieving consensus on rheumatoid arthritis outcome measures: the OMERACT conference process.

We describe the process used during the international Conference on Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). The objectives of the conference were (1) to broaden consensus on the minimum number of outcome measures to be included in all RA clinical trials in rheumatoid arthritis (RA); (2) to achieve consensus on criteria for (a) minimum clinically important improvement in patients with RA and (b) minimum important differences between treatment groups in RA clinical trials; and (3) to decide whether aggregate outcome measures (indices) are useful in the assessment of patients and trials. A combination of plenary sessions and structured nominal groups were employed during the conference. Simulated patient profiles and clinical trial profiles were used to generate discussion. The objective of the nominal group exercises was to capture each participant's judgments of the relative importance of each outcome measure and the degree of change required to indicate clinical improvement. Considerable discussion ensued on the content of the core set of outcome measures. An electronic interactive voting machine was used to obtain participants' views on a core set of outcome measures and methodological issues. To permit further discussion of outcome measures, the group explored the use of aggregate outcome measures (indices) in patient care and trials only in a preliminary way. A final plenary session dealt with patient perceptions of minimum important differences, a new classification of antirheumatic drugs, and a repeat of part of the preconference questionnaire. Concluding statements and future plans were developed at the conclusion of the meeting.

Arthritis, Rheumatoid↗

PubMed1998

Outcome of stroke in patients undergoing hemodialysis.

BACKGROUND: While elevated levels of serum creatinine have been shown to be a risk factor for diminished survival after stroke, it is unknown how renal replacement therapy may affect the outcome. METHODS: Strokes occurring in 26 consecutive patients undergoing hemodialysis at our institution were reviewed and clinical and laboratory variables and outcome were compared with those of patients who had a stroke but had normal renal function. RESULTS: Twenty-four strokes in the patients undergoing hemodialysis were ischemic while only 2 were hemorrhagic. Virtually all the patients had hypertension, half had diabetes mellitus, and most had some prior evidence of cardiovascular disease at the time of their stroke. Fifty percent of the patients undergoing hemodialysis had a good outcome (defined as being discharged home) while the remainder had a poor outcome (defined as dying or being discharged to a nursing facility). The combined presence of hypertension and coronary artery disease had a sensitivity of 91.2% for identifying patients with a poor outcome, while male sex, the presence of coronary artery disease, and the combined presence of hypertension, coronary artery disease, and/or congestive heart failure had sensitivities greater than 80% but low specificity. The outcome of patients undergoing hemodialysis was comparable with that of a control group of patients who had a stroke but had normal renal function, although the length of hospital stay was greater (mean [+/-SEM] 29.8+/-6.4 days vs 12.7+/-1.1 days, respectively; P<.01). CONCLUSIONS: Hospitalized patients undergoing hemodialysis in whom stroke occurs appear to have as good an outcome as that of patients with normal renal function, although they are hospitalized longer. In addition, certain clinical variables seem to be associated with a worse outcome. Aggressive measures to prevent and treat stroke seem as warranted for patients undergoing hemodialysis as for patients with normal renal function, although interventions to reduce the length of hospital stay are needed.

Adult↗

PubMed2002

Short-duration prophylaxis against venous thromboembolism after total hip or knee replacement: a meta-analysis of prospective studies investigating symptomatic outcomes.

BACKGROUND: The prevalence of asymptomatic deep vein thrombosis diagnosed by venography after hip or knee replacement remains high despite 7 to 10 days of anticoagulant prophylaxis. However, the risk of symptomatic events in such patients is unclear. We performed a meta-analysis to provide reliable estimates of the risk of symptomatic venous thromboembolism occurring within 3 months of hip or knee replacement in patients who received short-duration (7-10 days) anticoagulant prophylaxis. METHODS: The MEDLINE, EMBASE, and Cochrane databases were searched from January 1993 to March 2001, supplemented by a manual search of bibliographies and conference abstracts, to identify prospective studies of patients undergoing hip or knee replacement who received short-duration prophylaxis (ie, 7-10 days of fixed-dose low-molecular-weight heparin or adjusted-dose warfarin, with a target international normalized ratio of 2.0-3.0). Studies were classified as clinical outcome studies if the outcome was symptomatic venous thromboembolism or as venographic outcome studies if the outcome was asymptomatic deep vein thrombosis diagnosed after bilateral venography. RESULTS: There were 4 clinical outcome studies with 6089 patients who had 3 months of follow-up, and 13 venographic outcome studies with 7080 patients who had venography 7 to 10 days after surgery. In clinical outcome studies, the 3-month incidence of nonfatal venous thromboembolism was 3.2% (95% confidence interval [CI], 2.0%-4.4%), and the 3-month incidence of fatal pulmonary embolism was 0.10% (95% CI, 0.02%-0.20%). The postprophylaxis incidence of nonfatal venous thromboembolism was 2.2% (95% CI, 1.4%-3.0%), and the incidence of fatal pulmonary embolism was 0.05% (95% CI, 0%-0.12%). The postprophylaxis incidence of symptomatic venous thromboembolism was higher after hip than after knee replacement (2.5% vs 1.4%; P=.02). In venographic outcome studies, the prevalence of deep vein thrombosis (total and proximal) was higher after knee than after hip replacement (total: 38.8% vs 16.4%; P<.001; proximal: 7.6% vs 3.8%; P<.001). CONCLUSIONS: In patients who undergo hip or knee replacement and receive short-duration anticoagulant prophylaxis, symptomatic nonfatal venous thromboembolism will occur in about 1 of 32 patients and fatal pulmonary embolism will occur in about 1 of 1000 patients within 3 months of the surgery. Although the prevalence of asymptomatic deep vein thrombosis is more than 2-fold higher after knee replacement than after hip replacement 7 to 10 days after surgery, in the subsequent 3 months, symptomatic venous thromboembolism is more likely to occur after hip replacement.

Anticoagulants↗