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Evaluating clinical trial data: outcome measures.

Schizophrenia is too often a severely disabling disease, and the discovery of interventions that can ease or eliminate symptoms without troubling side effects has long been the goal of schizophrenia research. In this endeavor, researchers, clinicians, and patients all desire an optimal outcome; outcome measures, which measure the relative success or failure of an intervention, are accordingly important. In addition, the costs of pharmacologic interventions-particularly of the atypical antipsychotics--in schizophrenia make the optimal measurement of treatment outcomes critical. Sometimes outcomes are focused on minimizing costly events, such as rehospitalization, rather than focusing on patient-oriented outcomes. This article discusses the outcome measures employed in 5 clinical trials comparing atypical antipsychotics, examining their usefulness and suggesting types of outcome measures that may be useful in the future.

Antipsychotic Agents↗

S-100B and neuron specific enolase in outcome prediction of severe head injury.

OBJECTIVE: To elucidate the role of S-100B and neuron specific enolase (NSE) in predicting the outcomes of patients with severe head injury. METHODS: Forty patients with severe head injury were included in this study. The serum concentrations of S-100B and NSE were measured within 12 hours after head injury to investigate the correlation between serum levels of S-100B and NSE and outcome. Validity of both S-100B and NSE in outcome prediction was assessed with Receiver Operator Characteristic (ROC) curve. RESULTS: The serum concentrations of S-100B and NSE of both groups, with favorable or unfavorable outcomes, were significantly higher than those of the normal group. The serum concentrations within 12 hours after head injury were closely correlated with the prognosis. Furthermore, according to the ROC curves of S-100B and NSE, S-100B was found better in predicting outcomes than NSE. CONCLUSIONS: S-100B and NSE may play important roles in outcome prediction after severe head injury. Moreover, S-100B is clearly superior to NSE in terms of predictive value and appears to be a more promising serum marker in outcome prediction after severe head injury.

Craniocerebral Trauma↗

Categorizing outcomes of health care delivery.

After a patient presents with symptoms of illness and undergoes treatment, there are three features of care that require assessment: the impact of delivering care on the patient, the benefits and harms of treatment, and the functioning of the health care system. This formulation leads to three types of outcomes of care delivery that require assessment: 1) patient outcomes, which reflect the impact on patients of undergoing care; 2) treatment outcomes, which reflect the intended and unintended medical consequences of undergoing therapy; and 3) system outcomes, which reflect the impact on the system of delivering health care to a group of patients. In this paper, examples of these three types of outcomes are presented, with particular reference to coronary artery bypass graft surgery. It is argued that the current focus of computer simulation models on system outcomes should be expanded to include patient and treatment outcomes.

Delivery of Health Care↗

Outcomes assessment in the NCCN.

Outcomes assessment has two primary goals: the evaluation of treatments and the evaluation of quality of care. Data on the outcomes associated with specific interventions may provide an empiric basis for guidelines in areas for which no randomized trial data are available. Also, monitoring of patterns of care and outcomes is an essential component of institutional efforts to implement guidelines and to benchmark themselves against regional and national norms. The National Comprehensive Cancer Network (NCCN) has adopted a three-phase approach to its outcomes assessment program. Phase 1, already completed, involved taking a systematic inventory of members' existing institutional data sources. Phase 2, which is currently in progress, entails pooling data from existing outcomes data bases. In particular, tumor registry data from the National Cancer Data Base are being used to examine patterns of care and outcomes in NCCN institutions and to benchmark them against national norms. Phase 3, begun within the past year, involves the creation of a uniform outcomes assessment system for the NCCN.

Breast Neoplasms↗

Patient characteristics that affect the outcome of total hip arthroplasty: a review.

OBJECTIVE: To review the literature regarding patient factors pertinent to the outcome of total hip arthroplasty (THA). DATA SOURCE: MEDLINE from 1966 onward (key words "hip prosthesis" and "treatment outcome") and literature previously known to the authors and cited in papers from all sources. STUDY SELECTION: All identified studies were included provided the methodology permitted assessment of the effect of patient factors and a clear outcome was defined (either prosthesis survival or specific functional outcomes). DATA EXTRACTION: The patient factors, methods and outcomes described in each paper were summarized on a data extraction form. DATA SYNTHESIS: All data were reviewed by one author. This process was repeated by a second author, and the findings were reviewed by the remaining 2 authors to verify the findings. The best functional outcomes and prosthesis survival rates were reported among patients who were between 45 and 75 years of age, weighed less than 70 kg, had strong social support, had a higher educational level, had better preoperative functional status and had no comorbid disease. CONCLUSION: Important research remains to be done to examine the magnitude and interaction of patient factors on the the outcome of THA.

Age Factors↗

Outcome of patients with traumatic brain injury managed on a standardised head injury protocol.

A standardised protocol in the management of severe head injury in our hospital enables pre-determined critical care-paths and consistent treatment regimes to be instituted. In Singapore there has been no previously reported data on the outcome of severely head injured patients. Over a 6-month period, 48 consecutive patients who were enrolled in our severe head injury protocol were prospectively studied. In addition to demographic and outcome data, physiologic measurements obtained from a computerised patient information system (Carevue Hewlett-Packard 9000) were analysed to determine the mean cerebral perfusion pressure (CPP) and intracranial pressure (ICP) achieved throughout the protocol period. Median Glasgow Coma Score for all patients on admission to the protocol was 6 (range 4 to 8). The mean age was 34.46 +/- 15.03 years with a male to female ratio of 43:5. The average duration of treatment on the protocol was 110.73 hours. Initial ICP measured was 25.5 +/- 19.68 mmHg. Outcome was measured at 6 months post-injury using the Glasgow Outcome Score. Favourable outcome (GOS 4-5) was seen in 29 of 48 patients (60.4%) while 12 out of 48 (25%) had an unfavourable outcome. There was a mortality of 14.6% (7 of 48 patients). Patients who survived had a higher mean CPP (P = 0.00005), a lower initial ICP and a mean ICP (P = 0.007 and 0.0009). The use of a protocol with standardised treatment goals in the management of traumatic brain injury allows for the optimal use of limited resources and provides consistency in treatment. Good outcome is related to early aggressive resuscitation to prevent hypotension and hypoxia, prompt evacuation of surgical mass lesions and the maintenance of an adequate cerebral perfusion pressure. Our results are comparable with that reported in other established neurotrauma systems.

Accidents↗

Processes of care, illness severity, and outcomes in the management of community-acquired pneumonia at academic hospitals.

BACKGROUND: Prompt antibiotic administration, oxygenation measurement, and blood cultures are generally considered markers of high-quality care in the inpatient management of community-acquired pneumonia (CAP). However, few studies have examined the relationship between prompt achievement of process-of-care markers and outcomes for patients with CAP. We examined whether antibiotic administration within 8 hours of hospital arrival, a blood culture within 24 hours, an oxygenation measurement within 24 hours, or performing blood cultures before giving antibiotics was associated with the following: (1) reaching clinical stability within 48 hours of hospital admission, (2) a decreased length of hospital stay, or (3) fewer inpatient deaths. METHODS: A retrospective medical record review identified 1062 eligible patients discharged from the hospital with a diagnosis of CAP between December 1, 1997, and February 28, 1998, among 38 US academic hospitals. We assessed the independent relationship between each process marker and the 3 clinical outcomes, controlling for the Pneumonia Severity Index on admission. We also examined the relationship of pneumonia severity on admission to process marker achievement and clinical outcomes. RESULTS: Overall, there was no consistent or statistically significant relationship between achieving process markers and better clinical outcomes (P>.40 for all). We did observe that performing blood cultures within 24 hours was related to not achieving clinical stability within 48 hours (odds ratio, 1.62; 95% confidence interval, 1.13-2.33). However, this finding likely reflects residual confounding by severity of illness, since increasing pneumonia severity on admission was associated with blood culture performance (P =.009) and with shorter times to antibiotic administration (P =.04). CONCLUSIONS: Achieving process-of-care markers was not associated with improved outcomes, but was related to the severity of pneumonia as assessed on admission. Our results highlight the difficulty in demonstrating a link between process-of-care markers and outcomes in observational studies of CAP. Randomized studies are needed to objectively evaluate the impact of process-of-care markers on CAP outcomes.

Aged↗

Nontraumatic coma. Glasgow coma score and coma etiology as predictors of 2-week outcome.

In 1987 and 1988, we carried out a prospective study of patients older than 10 years with nontraumatic coma in the intensive care units of Columbia-Presbyterian Medical Center, New York, NY. Of 188 patients with Glasgow Coma Scale (GCS) determinations within 72 hours, 61% were dead or in persistent coma by 2 weeks from onset. Age, sex, and ethnicity did not influence outcome. The 2-week outcome for patients with initial GCS of 3 to 5 was 14.8% awake; 85.2% were dead or in persistent coma. For the GCS 6 to 8 group, 53.1% were awake and 46.9% were dead or in persistent coma. Hypoxic or ischemic coma had the worst 2-week outcome (79% dead or comatose); coma caused by metabolic disease or sepsis (68%), focal cerebral lesions (66%), and general cerebral diseases (55%) were intermediate, while drug-induced coma had a favorable outcome (27% dead or comatose). The independent predictors of 2-week outcome were the first GCS and drug-induced coma. The predicted probability of waking at 2 weeks was eight times better for drug-induced coma than other causes when GCS was held constant. Patients with an initial GCS score of 6 to 8 were seven times more likely to waken than those with a score of 3 to 5. The motor subscore alone was a significant independent predictor of 2-week outcome. Modification of coma score to include etiology may give more accurate predictions of 2-week outcome after nontraumatic coma.

Adolescent↗

The natural ocular outcome of premature birth and retinopathy. Status at 1 year. Cryotherapy for Retinopathy of Prematurity Cooperative Group.

OBJECTIVE: To present the 1-year ocular outcome data from 2759 preterm infants. DESIGN: Data from all untreated eyes were tabulated. Retinopathy of prematurity (ROP) was listed by the lowest (most posterior) zone and highest (most severe) stage reached during the acute phase of ROP, based on examinations conducted at least biweekly. SETTING: Examinations were performed at 23 regional study centers. PATIENTS: The natural history cohort of the Multicenter Trial of Cryotherapy for ROP. MAIN OUTCOME MEASURES: Ocular structure and visual performance. RESULTS: The worst posterior fundus outcome rates were in eyes with zone I, stage 3 disease (59.3% unfavorable outcome) and zone II, stage 3+ ROP involving nine to 12 sectors of 30 degrees (43.9% unfavorable outcome). Eyes with zone II ROP without plus disease or with zone III ROP are at very low risk (< 1%) of unfavorable outcome. CONCLUSION: The more posterior the zone of ROP and the greater the extent of stage 3+ disease, the greater the unfavorable outcome rate.

Cohort Studies↗

Outcome of schizophrenic subtypes defined by four diagnostic systems.

This report examines the short- and long-term outcome of the subtypes of schizophrenia as defined by four diagnostic systems: DSM-III, Research Diagnostic Criteria, Ninth Revision of the International Classification of Diseases, and the Tsuang-Winokur (T-W) criteria. Patients were from the Iowa 500 study and met Washington University criteria for schizophrenia. Subtype diagnosis was based on extensive chart material reviewed by investigators blind to outcome. Short-term outcome, based on chart information, and long-term outcome, based on individual field follow-up, were both better for paranoid than for nonparanoid schizophrenia, the difference being greatest using the T-W criteria. The difference in outcome between paranoid and nonparanoid schizophrenia was greater at long-term than at short-term follow-up, and greater using residential and occupational than psychiatric outcome criteria. Outcome did not differ for the two common forms of nonparanoid schizophrenia: hebephrenic and undifferentiated. The subtyping of schizophrenia has important predictive validity, which was greatest using the T-W criteria.

Employment↗

Brief psychotherapy of bereavement reactions. The relationship of process to outcome.

We studied the relationship of dispositional and process variables with outcome in 52 bereaved patients given time-limited dynamic psychotherapy. Outcomes were generally favorable in symptom relief and improvement in relationship and occupational functioning. Patients' symptoms improved more than did their social and work functioning. Pretreatment levels of impairment or distress were significantly related to outcome, but most demographic and dispositional variables did not predict outcome. Process variables examined in relation to outcome--therapeutic alliance and actions by the therapist--were not significantly related to either type of outcome. When we considered the same process variables in interaction with two dispositional variables, motivation for dynamic therapy and developmental level of the self-concept, we found significant predictions of outcome. The major findings suggest that more exploratory actions were more suitable for highly motivated and/or better-organized patients and less suitable for patients with lower levels of motivation or organization of self-concept. More supportive actions were more suitable for patients at lower dispositional levels and less therapeutic for patients at higher levels.

Adjustment Disorders↗

Surgery for ulcerative colitis in elderly persons: changes in indications for surgery and outcome over time.

HYPOTHESIS: Medical therapy has changed the indications for surgery over the last 4 decades. Advances in perioperative care have significantly improved the outcome. DESIGN: The medical records of all patients 65 years and older who underwent surgery for ulcerative colitis during a 40-year period were analyzed retrospectively. SETTING: Tertiary referral center. PATIENTS: One hundred thirteen consecutive patients 65 years and older who underwent surgery for ulcerative colitis between January 1, 1960, and June 30, 1999. MAIN OUTCOME MEASURES: Changes in elective and urgent indications for surgery. Changes over time in outcome and the factors that brought about these changes. Predictors of poor outcome in an elderly population with ulcerative colitis. RESULTS: One hundred thirteen patients were divided into 3 cohorts of 38, 38, and 37 consecutive patients admitted to the hospital during the periods 1960 through 1984, 1985 through 1993, and 1994 through 1999, respectively. Indications for surgery and morbidity and mortality rates have changed with time. Dysplasia has replaced carcinoma as a major indication for elective surgery (P =.001). Toxic megacolon has become significantly less common as an indication for urgent surgery (P =.001). Surgery-associated adverse outcomes have decreased significantly from 50% (13% deaths, 37% major complications) to 27% (3% deaths, 24% major complications) (P =.04). Male sex, an albumin level of 2.8 g/dL or less, and urgent surgery were found to be independent predictors of poor outcome. CONCLUSIONS: In our referral center, the indications for urgent and elective surgery have changed during the past 4 decades from toxic megacolon and carcinoma, to disease refractory, to medical therapy and dysplasia, respectively. Morbidity and mortality have decreased dramatically over time. Urgent procedures, low levels of albumin, and male sex are all predictors of poor outcome.

Aged↗

Quality measurement of outcome in general surgery revisited: commentary and proposal.

Surgery has been trying to catch up to evidence-based medicine. Assessment of outcome in surgery is the child for quality assurance of patient care. We surgeons have our own set of mental variables that can predict good and poor outcomes. We value our experience and that of others, yet, are always inquisitive about which best predict morbidity and mortality. We all have our own functional equations for outcome that varies qualitatively and quantitatively. The main problem is lack of a uniform mathematical equation for individual patient risk factors that we refer to because of the limitations inherent in the equation or our understanding and awareness. Reviewing the literature in surgical outcome measurement, the impression is one of increasingly diverse messages with conclusions that are institution dependent. This can initiate confusion and controversy when comparing outcomes or extrapolating to one's own practice while hindering training surgeons to contribute to the evolving evidence of objective quality measurement early in a career. Overall, we are falling behind in recognizing this evolving problem. In this article, I address this controversy and attempt to offer new avenues in achieving a consensus among us in patient risk-adjusted outcomes by adopting and modifying well-recognized risk scoring systems from either side of the Atlantic Ocean. The millennium should see the birth of a new generation of surgeons charged with evidence-based ideas in quality outcome measurement and ready to improve current mathematical models.

Health Status Indicators↗

Patient outcomes in academic medical centers: influence of fellowship programs and in-house on-call attending surgeon.

BACKGROUND: There are very few data on characteristics or policies that improve patient outcomes in academic medical institutions. We were interested in 2 such policies or characteristics that are commonly implemented in academic centers: an in-house on-call attending physician policy and the existence of postgraduate medical education. HYPOTHESIS: An in-house attending surgeon on-call policy and the presence of trauma and critical care fellowship programs improve outcomes of critically injured patients. DESIGN: Multicenter cohort study. Two cohorts were analyzed: blunt trauma (n = 601; mortality, 16.0%) and penetrating abdominal trauma (n = 503; mortality, 7.5%). SETTING: Thirty-one academic level I trauma centers, 10 (32.3%) with in-house on-call policy and 11 (35.5%) with fellowship programs. MAIN OUTCOME MEASURES: Mortality, hospital length of stay, and intensive care unit length of stay. RESULTS: In-house on-call surgeon policy had no impact on mortality or length of hospital or intensive care unit stay for either the blunt or penetrating trauma cohort. However, the presence of fellowship programs was associated with a significant decrease in blunt trauma mortality (odds ratio, 0.4; 95% confidence interval [CI], 0.1-0.8) and a decrease in length of intensive care unit stay (mean difference, 4.7 days; 95% CI, 0.6-8.8 days) and hospital stay (mean difference, 3.2 days; 95% CI, 0.6-5.9 days). There were no significant effects of fellowship programs on penetrating trauma outcomes. CONCLUSIONS: An in-house on-call attending surgeon policy is not associated with improved outcomes. In contrast, presence of a trauma and surgical critical care fellowship program, a potential surrogate marker for an institution that is committed to this specialty interest, is associated with improved outcomes for critically injured patients. An investment in advanced postgraduate medical education has potential benefits in patient care and outcomes.

Academic Medical Centers↗

Potentially ineffective care. A new outcome to assess the limits of critical care.

OBJECTIVE: To examine the limits of the effectiveness of critical care through the study of patients for whom it was ineffective. DESIGN: We studied the relationship between resource use and long-term outcome (2-year follow-up) in 402 consecutively admitted critical care patients to develop a benchmark for ineffective applications of critical care. We defined an outcome called potentially ineffective care (PIC), developed and evaluated a model with an independent data set to predict PIC from a patient's response to treatment, and estimated the economic effects of limiting care after a prediction of PIC. SETTING: The combined medical and surgical intensive care unit at a 600-bed university teaching hospital. PATIENTS: Two groups of 402 consecutively admitted critical care patients, one from 1989, the other from 1991. MAIN OUTCOME MEASURES AND RESULTS: Based on observations from a two-dimensional plot of resource use vs benefit for 402 critical care patients, PIC was defined as resource use in the upper 25th percentile and survival for less than 100 days after discharge. Thirteen percent of the patients fell into the PIC category and used 32% of the resources. A product of the APACHE risk estimates on days 1 and 5 of at least 0.35 predicted 37% of PIC outcomes with a specificity of 98%. In a second data set, PIC outcome prediction had a sensitivity of 43% and a specificity of 94%, and a positive predictive value of 80%. For the hospital studied, reduction of intensity of treatment after a prediction of a PIC outcome would result in a reduction of hospital charges in the range of $1.8 million to $5 million per year. CONCLUSION: Patients in the PIC category consumed a large portion of the resources devoted to critical care at an academic teaching hospital. We suggest a change in focus from assessment of the quality of critical care and risk-adjusted mortality to an assessment of ineffective care based on outcome and resource use and a patient's response to treatment over time.

APACHE↗

An evaluation of poor pregnancy outcomes among Burundian refugees in Tanzania.

CONTEXT: Little is known about pregnancy outcomes among the approximately 11 million refugees worldwide, 25% of whom are women of reproductive age. OBJECTIVE: To estimate incidence of and determine risk factors for poor pregnancy outcomes and to calculate the contribution of mortality from neonatal and maternal deaths to overall mortality in a refugee camp. DESIGN: Cross-sectional review of records and survey, conducted in February and March 1998. SETTING: Mtendeli refugee camp, Tanzania. PARTICIPANTS: For the overall assessment, 664 Burundi women who had a pregnancy outcome during a recent 5-month period (September 1, 1997-January 31, 1998) and their 679 infants; 538 women (81%) completed the survey. MAIN OUTCOME MEASURES: Incidence of fetal death (fetus born > or =500 g or > or =22 weeks' gestation with no signs of life), low birth weight (<2500 g), neonatal death (death <28 days of life), and maternal death (deaths during or within 42 days of pregnancy from any cause related to or aggravated by the pregnancy or its management). RESULTS: The fetal death rate was 45.6 per 1000 births, the neonatal mortality rate was 29.3 per 1000 live births, and 22.4% of all live births were low birth weight. Compared with women without poor pregnancy outcome, those with poor pregnancy outcome were more likely to report prior high socioeconomic status (adjusted odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.4), having a first or second pregnancy (OR, 2.2; 95% CI, 1.4-3.4), and having 3 or more episodes of malaria during pregnancy (OR, 2.0; 95% CI, 1.4-3.1). Neonatal and maternal deaths accounted for 16% of all deaths during the period studied. CONCLUSIONS: Poor pregnancy outcomes were common in this refugee setting, and neonatal and maternal deaths, 2 important components of reproductive health-related deaths, contributed substantially to overall mortality.

Adult↗

Reproductive health indicators and outcomes among refugee and internally displaced persons in postemergency phase camps.

CONTEXT: Despite increasing awareness of the importance of reproductive health programs and services for refugee and internally displaced populations, there is a paucity of basic epidemiological data on reproductive health outcomes. OBJECTIVES: To collect data on reproductive health outcomes among refugees and internally displaced persons in postemergency phase camps and compare these outcomes with those of host country and country-of-origin populations. To determine programmatic factors that may affect reproductive health outcomes. DESIGN, SETTING, AND PARTICIPANTS: Retrospective study of data collected from August 1998 through March 2000 of 688,766 persons living in 52 postemergency phase camps in 7 countries. Reproductive health outcomes of refugee and internally displaced populations were compared with available data of reference populations within their respective host country and country of origin. MAIN OUTCOME MEASURES: Crude birth rate (CBR), neonatal mortality rate (NNMR), maternal mortality ratio (MMR), percentage of newborns with low birth weight (LBW), and incidence of complications of unsafe or spontaneous abortions. RESULTS: Six of 11 groups had lower CBRs than their country of origin and 5 of 9 groups had lower CBRs than their host country. Four of 5 had lower NNMRs than their country of origin and 6 of 9 had lower NNMRs than the host country. Four of 6 had lower MMRs than their country of origin, and 5 of 6 had lower MMRs than their host country. Seven of 9 had lower percentages of LBWs than in the country of origin and 5 of 9 had lower percentages of LBWs than the host country. Higher CBRs were associated with more recently established camps and higher numbers of local health staff per 1000 persons; and higher percentages of LBW newborns were associated with rainy season, more recently established camps, lower numbers of community health workers per 1000 persons, and camps without supplementary feeding programs. CONCLUSIONS: Refugees and internally displaced persons in most postemergency phase camps had better reproductive health outcomes than their respective host country and country-of-origin populations.

Abortion, Illegal↗

Clinical outcomes following institution of universal leukoreduction of blood transfusions for premature infants.

CONTEXT: Leukocytes present in stored blood products can have a variety of biological effects, including depression of immune function, thereby increasing nosocomial infections and possibly resulting in organ failure and death. Premature infants, given their immature immune state, may be uniquely predisposed to the effects of transfused leukocytes. OBJECTIVE: To evaluate the clinical outcomes following implementation of a universal prestorage red blood cell (RBC) leukoreduction program in premature infants admitted to neonatal intensive care units (NICUs). DESIGN AND SETTING: Retrospective before-and-after study conducted in 3 Canadian tertiary care NICUs from January 1998 to December 2000. PATIENTS: A total of 515 premature infants weighing less than 1250 g who were admitted to the NICU, received at least 1 RBC transfusion, and survived at least 48 hours were enrolled. The intervention group consisted of infants admitted in the 18-month period following the introduction of universal leukoreduction (n = 247) and the control group consisted of infants admitted during the 18 months prior to the introduction of universal leukoreduction (n = 268). MAIN OUTCOME MEASURES: Primary outcomes were nosocomial bacteremia and NICU mortality, compared before and after implementation of universal leukoreduction using multivariate regression. Secondary outcomes included bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage. RESULTS: The proportion of infants who acquired bacteremia after an RBC transfusion was 79/267 (29.6%) in the nonleukoreduction period and 63/246 (25.6%) in the leukoreduction period. For NICU mortality, there were 45 deaths (16.8%) in the nonleukoreduction period and 44 deaths (17.8%) in the leukoreduction period. The adjusted odds ratio (OR) for bacteremia was 0.59 (95% confidence interval [CI], 0.34-1.01) and for mortality was 1.22 (95% CI, 0.59-2.50). The adjusted ORs for bronchopulmonary dysplasia and retinopathy of prematurity were 0.42 (95% CI, 0.25-0.70) and 0.56 (95% CI, 0.33-0.93), respectively. The adjusted ORs for necrotizing enterocolitis and grade 3 or 4 intraventricular hemorrhage were 0.39 (95% CI, 0.17-0.90) and 0.65 (95% CI, 0.35-1.19), respectively. The adjusted OR for a composite measure of any major neonatal morbidity was 0.31 (95% CI, 0.17-0.56). Crude and adjusted rates for all secondary outcomes suggest that leukoreduction was associated with improved outcomes. CONCLUSION: Implementation of universal prestorage leukoreduction was not associated with significant reductions in NICU mortality or bacteremia but was associated with improvement in several clinical outcomes in premature infants requiring RBC transfusions.

Bacteremia↗