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PubMed1996

Impact of traumatic subarachnoid hemorrhage on outcome in nonpenetrating head injury. Part II: Relationship to clinical course and outcome variables during acute hospitalization.

Patients with a nonpenetrating head injury and traumatic subarachnoid hemorrhage (tSAH) on admission head computed tomography scan (n = 240) were compared with patients without tSAH matched in terms of admission postresuscitation Glasgow Coma Scale (GCS) values, age, sex, and the presence of one or more types of intracranial mass lesions. Admission Injury Severity Score was higher only in tSAH patients with admission GCS scores between 13 and 15; GCS values at 6, 24, and 48 hours were lower for tSAH patients. Patients with tSAH underwent fewer craniotomies, but more than twice as many tSAH patients had high intracranial pressure at the time of ventriculostomy placement and 6 hours after admission. tSAH patients underwent more chest procedures and their incidence of hypoxia and hypotension was greater. tSAH patients spent more days in intensive care unit, more total days hospitalized, and had worse Glasgow Outcome Scale scores at acute hospital discharge. Fewer tSAH patients were discharged home, and almost 1.5 times as many tSAH patients died during hospitalization. Given a similar overall degree of injury at admission, patients with tSAH associated with a nonpenetrating head injury had a worse outcome than similar patients without tSAH.

Accidents, Traffic↗

PubMedDate not supplied

Mucopurulent cervicitis as a predictor of chlamydial infection and adverse pregnancy outcome. The Investigators of the Johns Hopkins Study of Cervicitis and Adverse Pregnancy Outcome.

The role of mucopurulent cervicitis in identifying pregnant women with Chlamydia trachomatis infection and poor pregnancy outcome was examined at the Johns Hopkins Hospital Obstetric Clinic in Baltimore, Maryland. The women studied were at high risk for chlamydial infection (14%), low birthweight (12%), and preterm delivery (13%). Yellow endocervical discharge on a cotton swab had a sensitivity of 23.9%, specificity of 89.4%, and positive predictive value of 28.6% for predicting chlamydial infection. The presence of greater than or equal to 30 polymorphonuclear cells per 1000 x field had a sensitivity of 25.0%, specificity of 87.6% and positive predictive value of 24.3%. Women with cervicitis defined by greater than or equal to 30 polymorphonuclear cells per 1000 x field were twice as likely to deliver a low-birthweight infant. Adjustment for potential confounding variables did not explain this association. The poor sensitivity, specificity, and positive predictive value of mucopurulent cervicitis suggests that this parameter is not a useful screening tool for chlamydial infection in pregnant women. However, mucopurulent cervicitis may be an indicator of increased risk for poor pregnancy outcome.

Adolescent↗

PubMed2005

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.

OBJECTIVE: To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. METHODS: Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. RESULTS: Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. CONCLUSION: Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. LEVEL OF EVIDENCE: II-3.

Adult↗

PubMedDate not supplied

Responsiveness and uniqueness of the pediatric outcomes data collection instrument compared to the gross motor function measure for measuring orthopaedic and neurosurgical outcomes in cerebral palsy.

The Pediatrics Outcomes Data Collection Instrument (PODCI) is a valid and reliable measure of functional health status in children with acute and chronic musculoskeletal disorders, including cerebral palsy (CP), but its responsiveness has not been documented specifically for this population. The Gross Motor Function Measure (GMFM) and the Pediatric Evaluation of Disability Inventory (PEDI) are the only two instruments validated specifically as evaluative measures for CP, and while widely used, they are limited by a ceiling effect when assessing higher-functioning children. The PEDI is further restricted to children who are 7 years old or less. The goal of this study was to evaluate the responsiveness, and secondarily the uniqueness, of the PODCI compared with the GMFM for evaluating surgical outcomes in CP. Changes in the GMFM and PODCI Parent forms were assessed at two time points in 64 children with spastic CP who underwent muscle-tendon lengthenings (MT; n = 22) or neurosurgical spasticity reduction consisting of either selective dorsal rhizotomy (SDR; n = 18) or intrathecal baclofen pump implantation (ITB; n = 11) or who had no surgery between assessments (n = 13). The GMFM Total score was responsive to change after both MT surgery and SDR, with a nearly equivalent magnitude of change in both groups. However, the PODCI Global Function Scale was responsive to changes only after MT surgery, with improvement in the Sports and Physical Function subscale particularly prominent. No significant changes were noted in the ITB group for either measure.

Adolescent↗

PubMedDate not supplied

Towards a National Pediatric Musculoskeletal Trauma Outcomes Registry: the Pediatric Orthopaedic Trauma Outcomes Research Group (POTORG) experience.

This study is a pilot effort towards the broader implementation of a national pediatric musculoskeletal trauma outcomes registry. The primary goal of this project is to explore the feasibility of a web-based data acquisition and management platform and to identify catalysts and obstacles to multi-center collaboration. A prospective cohort of children presenting to the Pediatric Emergency Departments with ankle, femur, supracondylar humerus, tibial spine, or open fractures at five clinical centers between October 2001 and March 2003 comprised the study population. Patients were enrolled via the treating orthopaedic resident, using a web-based data acquisition and management system. Orthopaedic attendees were sent an automated reminder to complete a follow-up form one week after treatment, and parents of enrolled children were sent child and parent health questionnaires by e-mail and mail in order to capture health-related quality of life and post-traumatic stress symptoms. A total of 299 patients were enrolled in the study with an average age of 7.3 years. Post-treatment follow-up questionnaires were completed by 39% of the attending orthopaedic surgeons, and by 43% of the enrolled patients or patient's parents. Children old enough to complete health questionnaires scored lower in 5 of 12 functional domains including Physical Function, Role/Social Emotional/Behavioral, Parental Impact-Emotional, Family Activities, and Family Cohesion. Within the subset of patients sustaining femur fractures whose parents completed health questionnaires, 9.5% reported significant post-traumatic stress symptoms. This study demonstrates the potential of a multi-center web-based registry to facilitate the collection of a rich array of pediatric trauma, treatment and patient-based outcomes data, although new regulatory issues regarding patient privacy pose challenges to such an approach.

Child↗

PubMed2004

The core outcomes for neck pain: validation of a new outcome measure.

STUDY DESIGN: Patients enrolled in a randomized controlled trial were asked to complete various questionnaires, which were then compared to establish validity for a new neck pain questionnaire. OBJECTIVES: To validate a new and brief outcome measure for use with patients with mechanical neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is a very common problem and one that clinicians will be required to treat with some regularity. In today's climate of evidence-based practice and the need to quantify and justify clinical intervention, a quick and easy method to evaluate progress is required. Such a measure has already been produced for those experiencing back pain, but as yet, there is no such measure for neck pain and this needs to be addressed. METHODS: The back pain measure was adapted to enable its use with patients with neck pain. Repeatability was assessed by using a 1-week test/retest on 104 patients who were enrolled in a neck pain trial. Validity was assessed by comparing the new questionnaire against other already well validated measures (i.e., the Neck Disability Index and a Visual Analogue Scale for pain) with 133 patients. RESULTS: The test/retest showed excellent repeatability with high intraclass correlations and P < 0.001 for each question tested. The Core Neck Pain Questionnaire also showed good validity, giving close agreement to the other comparison measures. CONCLUSION: The short Core Neck Pain Questionnaire has been demonstrated to be repeatable and valid as a brief outcome measure for use with patients with mechanical neck pain.

Adult↗

PubMed2006

Outcome-based assessment of endolymphatic sac decompression for Ménière's disease using the Ménière's disease outcome questionnaire: a review of 90 patients.

OBJECTIVE: To evaluate the quality of life (QOL) of patients treated by endolymphatic sac decompression (ELSD) for Ménière's disease (MD) with a dedicated questionnaire, while recording the results of this surgery on vertigo attacks using the American Academy of Otolaryngology-Head and Neck Surgery criteria. STUDY DESIGN: Retrospective case review in a tertiary referral care center. MATERIAL AND METHODS: Ninety patients who have MD were treated by ELSD at our institution between 1986 and 2004. They were sent a 40-question Ménière's Disease QOL dedicated questionnaire (Ménière's Disease Outcome Questionnaire) concerning physical, mental, and social well-being. Five scores out of 100 were calculated (S1-S5): S3 for preoperative QOL score, S4 for postoperative QOL score, S5 for change in QOL score (S5 = S4 - S3), and S1 and S2 representing the answers to two other paired questions about the "overall" feeling of the patients. In parallel, results of ELSD on vertigo attacks and hearing were evaluated using the Academy of Otolaryngology-Head and Neck Surgery criteria. RESULTS: Fifty-nine interpretable answers (65.6%) to the Ménière's Disease Outcome Questionnaire were obtained from 28 men and 31 women (mean age, 56 yr and 9 mo), all suffering from "definite" MD. The mean S3 was 32.5 (range, 9.7-84.7), and the mean S4 was 60.8 (range, 0-98.6). Consecutively, S5 score was 28.3 (range, -34.7 to 77.4). QOL improved in 81.4% of cases with an average duration of follow-up of 57.5 months (range, 4-156 mo) (p < 0.001), worsened in 11.9% and was stable in 6.8%. There was no statistically significant difference as a function of sex (p = 0.7) or length of follow-up (p = 0.6). There was a significant correlation between S1 and S3 (p < 0.0001), and S2 and S4 (p < 0.0001), validating the whole questionnaire. In addition, 71% of satisfactory control of vertigo at 2 years postoperatively was noted. Hearing was improved or unchanged in 79% of cases at 3 months postoperatively. CONCLUSION: These results show that ELSD significantly improves the health of patients. It represents a first-line procedure that preserves the vestibular and afferent structures, unlike vestibular neurotomy and chemical labyrinthectomy, which may be indicated as a second line.

Adult↗

PubMed2007

Influence of caseload and surgical speciality on outcome following surgery for colorectal cancer: a review of evidence. Part 2: long-term outcome.

OBJECTIVE: We reviewed recent literature to assess the impact of hospital caseload, surgeon's caseload and education on long-term outcome following colorectal cancer surgery. METHOD: We searched the MEDLINE and Cochrane Library databases for relevant literature starting from 1992. We selected hospital caseload, surgeon's caseload and surgeon's education, type of hospital, and surgeon's experience as variables of interest. Measures of outcome were recurrence-free survival and overall survival, and for rectal cancer frequency of permanent stoma. We reviewed the 34 studies according to tumour location: colonic cancer, rectal cancer, or colorectal cancer. We described the studies individually and performed a meta-analysis whenever it was considered appropriate. RESULTS: For colonic cancer, overall survival improved with increasing hospital caseload, odds ratio (OR) 1.22 [95% confidence interval (CI) 1.16-1.28], and surgeon's education. For rectal cancer, overall survival improved with increasing hospital caseload, OR 1.38 (95% CI 1.19-1.60), and, possibly by surgeon' education and experience. Cancer-free survival was strongly influenced by surgeon's education. The colostomy rate was less in high caseload hospitals, OR 0.76 (95% CI 0.68-0.85). For colorectal cancer, overall survival improved with surgeon's education. CONCLUSION: The data have provided evidence that long-term survival following colorectal cancer surgery in general improved significantly with increasing hospital caseload and surgeon's education.

Colonic Neoplasms↗

PubMed2004

Ethnicity and birth outcome: New Zealand trends 1980-2001: Part 4. Pregnancy outcomes for European/other women.

BACKGROUND: In the early 1980s European/other women made up 80% of New Zealand's population and experienced rates of preterm birth that were lower than for other ethnic groups. Rates of small for gestational age (SGA) and late fetal death were intermediate between those of Maori and Pacific women. AIMS: To examine trends in preterm birth, SGA and late fetal death for European/other women during 1980-2001 and to explore risk factors which make this group vulnerable to adverse birth outcome. METHODS: De-identified birth registration data from 1 189 120 singleton live births and 5775 stillbirths were analysed for 1980-2001. Outcomes of interest included preterm birth, SGA and late fetal death while explanatory variables included maternal ethnicity, age and NZ Deprivation Index decile. Trend analysis was undertaken for 1980-1994 and multivariate logistic regression was used to explore risk factors for 1996-2001. RESULTS: During 1980-1994, rates of preterm birth rose by 30% for European/other women, in contrast to a non-significant decline of 7% for Maori women and 4% for Pacific women. Rates of SGA declined 19% for European/other women, compared to 25% for Maori and 30% for Pacific women. Preterm birth and SGA were positively associated with teenage pregnancy and increasing NZDep deprivation. During 1980-1994, rates of late fetal death declined by 49%, with declines being similar for all ethnic groups. CONCLUSIONS: The progressive rise in preterm birth during the past two decades is a cause of concern for European/other women, particularly as it appears confined to this ethnic group. While rates of SGA have declined, albeit at a slower rate than for other ethnic groups, the elevated risk amongst teenagers and those living in the more deprived NZDep areas suggests that greater gains are achievable if interventions are targeted towards these particular groups.

Adolescent↗

PubMedDate not supplied

The routine collation of health outcomes data from hospital treated subjects in the Health Outcomes Data Repository (HODaR): descriptive analysis from the first 20,000 subjects.

OBJECTIVES: Health technology assessment requires data covering many different facets of treatment. A new resource, the Health Outcomes Data Repository (HODaR), is described and evaluated for its use in the pharmaceutical research and development process. METHODS: Data were collated for subjects treated at Cardiff and Vale National Health Service (NHS) Hospitals Trust, United Kingdom. Inpatients are surveyed 6 weeks postdischarge by postal survey, whilst outpatients are handed a survey pack when they attend. Survey data cover sociodemographics, resource use, production losses, and quality of life. Electronic hospital data are available for all responders, and linked with survey returns. Sample characteristics, coverage of disease areas, and a more detailed description of data values for diabetes are described. RESULTS: Survey responses relating to 16,188 admissions and 4476 outpatient attendances were available relating to around 2000 different diagnoses. Over 5000 pharmacy items and 400,000 biochemistry test results were available. Analysis of utility data showed a broad coverage of diseases. For patients with diabetes the pattern of EQ-5D scores across subgroups is not clear. Health service resource use showed a linear relationship with respect to number of comorbidities. CONCLUSIONS: HODaR represents a new approach to accessing patient data, and gathers both routine and survey-based data. Although linking survey data to routine hospital systems is a complex task, which produces some limitations, it can produce health outcomes data at relatively low cost. Its performance within the pharmaceutical research and development process needs to be further evaluated in order to assess its most appropriate role.

Adult↗

PubMed2002

Cornea procurement from very old donors: post organ culture cornea outcome and recipient graft outcome.

AIM: To study the suitability of corneas from very old donors for graft after banking and their clinical and endothelial outcomes in recipients. METHODS: 419 corneas stored in organ culture were divided into group 1, donors under 85 years (330 corneas) and group 2, "very old" donors aged 85 years and over (89 corneas). Endothelial cell density (ECD) before and after organ culture, discard rate before and after storage, and clinical and endothelial outcomes of the 196 penetrating keratoplasties (PKP) (158 in group 1 and 38 in group 2) were compared in a prospective longitudinal study. RESULTS: Initial ECD was lower in group 2 than in group 1 and elimination for low ECD was more frequent in group 2 (respectively 38% v 20.2%, p=0.001). At the end of storage, because very old corneas lost fewer ECs than younger ones (respectively 4.2% v 9.5%, p=0.022), ECD was comparable between the two groups. The corneas of very old donors had a poorer macroscopic appearance at procurement and during surgery. Despite this, in grafted patients, overall graft survival in groups 1 and 2 (respectively 87.4% v 80.6%, p=0.197), visual acuity, and ECD did not differ at completion of the study (mean follow up 25 months). CONCLUSION: This study suggests that endothelial cell count during banking ensures that functional and cellular results of PKPs are not dramatically influenced by very old donor age. Considering Europe's ageing population, the very elderly should not be deemed off limits for corneal procurement.

Adolescent↗

PubMed1999

Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab: one-year outcome in the EPILOG trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade.

BACKGROUND: Blockade of the platelet glycoprotein IIb/IIIa receptor with the monoclonal antibody fragment abciximab was shown in a placebo-controlled randomized trial to reduce the incidence of acute ischemic complications within 30 days among a broad spectrum of patients undergoing percutaneous coronary revascularization. The durability of clinical benefit in this setting has not been established. METHODS AND RESULTS: A total of 2792 patients enrolled in the Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade (EPILOG) trial were followed with maintenance of double-blinding for 1 year. Patients had been assigned at the time of their index coronary interventional procedure to receive placebo with standard-dose, weight-adjusted heparin (100 U/kg initial bolus), abciximab with standard-dose, weight-adjusted heparin, or abciximab with low-dose, weight-adjusted heparin (70 U/kg initial bolus). The primary outcome was the composite of death, myocardial infarction, or urgent repeat revascularization by 30 days; this composite end point and its individual components were also assessed at 6 months and 1 year. Rates of any repeat revascularization (urgent or elective), target vessel revascularization, and a composite of death, myocardial infarction, or any repeat revascularization were also reported. Follow-up at 1 year was 99% complete for survival status and 97% complete for other end points. By 1 year, the incidence of the primary composite end point was 16.1% in the placebo group, 9.6% in the abciximab with low-dose heparin group (P<0.001), and 9.5% in the abciximab with standard-dose heparin group (P<0.001). Each of the components of this composite end point was reduced to a similar extent. Nonurgent or target vessel repeat revascularization rates were not significantly decreased by abciximab therapy. Mortality rates over 1 year increased with increasing levels of periprocedural creatine kinase MB fraction elevation. CONCLUSIONS: Acute reductions in ischemic events after percutaneous coronary intervention by abciximab are sustained over follow-up to at least 1 year. Early periprocedural myocardial infarctions suppressed by this therapy are associated with long-term mortality rates.

Abciximab↗

PubMed2026

Bempedoic Acid and First and Recurrent Limb Outcomes in Statin-Intolerant Patients With Peripheral Artery Disease: Insights From the CLEAR Outcomes Trial.

BACKGROUND: Patients with peripheral artery disease (PAD) are at high risk of major adverse limb events (MALE) and major adverse cardiovascular events (MACE). Recently, bempedoic acid was shown to reduce MACE in primary and secondary prevention patients. Whether bempedoic acid reduces the risk of MALE in patients with PAD is unknown. METHODS: CLEAR Outcomes (Cholesterol Lowering via Bempedoic Acid [ETC1002], an ACL-Inhibiting Regimen) randomized 13 970 patients to bempedoic acid 180 mg or placebo from December 22, 2016, to August 14, 2019. The trial primary end point was MACE-4, defined as death resulting from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. A clinical history of PAD was reported by investigators at baseline. Two blinded vascular medicine specialists independently adjudicated MALE, including adverse events indicating worsening PAD symptoms leading to revascularization, chronic limb-threatening ischemia, and acute limb ischemia. Outcomes were assessed as time to first event and total (including recurrent) events with a negative binomial approach. RESULTS: A total of 1624 of the enrolled patients (mean±SD age, 63.9±9.9 years; 915 [56.3%] female) had PAD at baseline. In patients with PAD in the placebo group, 69 (8.3%) had MALE over a median of 40.6 months, with rate of recurrent events of 4.0%/y. Bempedoic acid reduced the risk of MALE by 36% (hazard ratio, 0.64 [95% CI, 0.44-0.93]; P=0.018). Bempedoic acid reduced total MALE by 45% (relative risk, 0.55 [95% CI, 0.35-0.85]; P=0.007). First MACE-4 or MALE was reduced overall by 13% (hazard ratio, 0.87 [95% CI, 0.80-0.95]) with consistent effects with PAD (hazard ratio, 0.82 [95% CI, 0.64-1.04]) and without PAD (hazard ratio, 0.87 [95% CI, 0.79-0.86]; Pinteraction=NS) but not statistically significant within the PAD subgroup alone. Total MACE-4 or MALE was reduced (relative risk, 0.81 [95% CI, 0.73-0.90]) overall with consistent effects in PAD (relative risk, 0.71 [95% CI, 0.54-0.95]) and without PAD (relative risk, 0.82 [95% CI, 0.73-0.92]; Pinteraction=NS). CONCLUSIONS: Patients with PAD are at high risk of MALE and MACE. Bempedoic acid reduces both MACE and MALE in patients with atherosclerotic vascular disease, with notable absolute benefits in patients with PAD. These findings support (1) the importance of lowering low-density lipoprotein cholesterol in patients with PAD to reduce overall vascular risk and (2) the benefits of bempedoic acid in this population.

Humans↗

PubMed2000

Aims, outcome measures, study sites and patient sample. EPSILON Study 1. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs.

BACKGROUND: Cross-national research into the care of people with severe mental illnesses is hampered by a lack of standardised measures. The European Psychiatric Services: Inputs Linked to Outcome Domains and Needs (EPSILON) Study is a European Union funded project within the BIOMED-2 programme. The project aims to develop standardised instruments to facilitate future cross-national research. AIMS: To describe the aims, outcome measures, study sites and patient samples of the EPSILON Study. METHOD, RESULTS, CONCLUSIONS: See companion papers in this supplement.

Adolescent↗

PubMed2000

Translation and cross-cultural adaptation of outcome measurements for schizophrenia. EPSILON Study 2. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs.

BACKGROUND: Research on the comparison of mental health services has identified the need for internationally standardised and reliable measurements. AIMS: To describe the strategies adopted in the European Psychiatric Services: Inputs Linked to Outcome Domains and Needs (EPSILON) Study for the translation and cross-cultural adaptation of five European versions of the instruments. METHOD: A protocol was developed for translation of the outcome scales, describing each step in the translation procedure. Disputed items were discussed in focus groups, which faced seven tasks: a list of topics to be discussed; choosing where the group should meet; composition of participants; conducting the group; data collection; data completion afterwards; reporting results. RESULTS: Modifications made to instruments were: changes in the instrument structure, contents and concepts; adjustments to the instrument structure; and modifications to the instrument manual. CONCLUSION: Use of focus groups is an adequate method to apply if concepts, constructs and translation issues are to be addressed; otherwise, less time-consuming methods should be considered.

Cross-Cultural Comparison↗

PubMed1995

Influence of molecular characteristics on clinical outcome in human immunodeficiency virus-associated non-Hodgkin's lymphoma: identification of a subgroup with favorable clinical outcome.

The relationship between clinical and molecular characteristics of 45 treated individuals with histologically-documented human immunodeficiency virus (HIV)-associated B-cell non-Hodgkin's lymphoma was examined to determine whether differences in molecular features of lymphoma were associated with differences in clinical outcome. Tissue specimens from these tumors were evaluated for evidence of Ig heavy-chain gene rearrangements using both Southern blot analysis and reverse transcriptase polymerase chain reaction (RT-PCR). Lymphomas were also evaluated for the presence of Epstein-Barr virus (EBV) DNA sequences and c-myc gene rearrangements. Twenty-five lymphomas were characterized as polyclonal and 20 as monoclonal. PCR amplification of expressed Ig variable (V)-region genes confirmed polyclonality in three extensively studied polyclonal lymphomas. The median CD4 count was significantly higher in the group with polyclonal disease (277/microL) than in the group with monoclonal disease (123/microL), P = .04. The complete response rate to therapy was significantly higher in patients with polyclonal disease (78%) and CD4 greater than 200/microL (81%) than in those with monoclonal disease (31%) and CD4 less than 200/microL (33%). CD4 count, clonality, and presence of EBV DNA sequences were the most important predictors of survival. Both Kaplan-Meier and Cox proportional hazards analyses showed a markedly prolonged survival in those patients with both CD4 > or = 200/microL and polyclonal disease. Histologically the polyclonal lymphomas were high grade in appearance and contained prominent macrophages. All seven surviving patients were in this group. Median survival for those individuals whose tumors contained EBV sequences was only 3.2 months (range, 0.4 to 19.5), whereas those with EBV- tumors survived for a median of 9.0 months (range, 0.7 to 65.2), P = .0007. These data indicate that molecular features of HIV-associated lymphomas may be important predictors of clinical outcome. These characteristics define a distinct subset of patients with polyclonal EBV- tumors and CD4 counts greater than 200/microL that appear to have a less aggressive clinical course.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1994

Client outcomes II: Longitudinal client data from the Colorado treatment outcome study.

The outcomes of a reform of the Denver mental health system, cosponsored by the state and the RWJF, are contrasted with changes in a comparison area of the state. The study examines the structural characteristics of the mental health system, staff attitudes and satisfaction, and client-reported services and outcome. Results indicate that, in Denver, structural changes, the introduction of new services, and an intervening financial crisis increased worker dissatisfaction. Client reports documented parallel changes in the following variables: continuity of care, unmet need for case management services, frequency of symptoms, and satisfaction with services. The reform had no impact, however, on most quality-of-life indicators. The possibly adverse consequences of centralizing the system and the indirect influences of system integration on quality of life are discussed.

Adult↗

PubMed1997

Competing outcomes after heart transplantation: a comparison of eras and outcomes.

To understand the time relatedness of the various causes of death after heart transplantation, a study was undertaken to examine the relative importance of each of these causes of death across time, as well as between eras. The analysis, which was in the competing outcomes domain, involved 326 patients undergoing primary heart transplantation between November 1981 and June 1994, of which 122 patients died. Two eras were considered--an earlier era (1981 to 1986) and a later era (1987 to 1994). During the later era, the estimated survival rate at 1 year and 5 years was 85% and 69%, respectively. During the first posttransplantation year, patients in the earlier era were three times more likely to die of early graft failure than in the later era, but the difference may have been due to chance (p > 0.2). During the first posttransplantation year, patients were three times as likely to die of acute rejection in the earlier era (p = 0.02). Patients surviving 3 or more years in both eras had a similar (approximately 3%) likelihood of death from coronary artery disease over the ensuing 4 years. In the later era, the risk of dying of malignancy (2.5%), infection (3.2%), or miscellaneous other causes (4.1%) was as likely after 3 years as dying of coronary artery disease (3.2%). Competing outcomes analysis is a useful means of portraying the distribution of multiple time-related causes of death. In the current era, the deleterious long-term effects of immunosuppression (malignancy and infection), as well as coronary artery disease, threaten long-term survival.

Adolescent↗