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Outcomes of surgery for posterior segment intraocular foreign bodies--a retrospective review of 17 years of clinical experience.

BACKGROUND: To determine the outcome of surgery in patients who presented with posterior segment intraocular foreign bodies (IOFBs) and to identify factors associated with poor visual outcome. To assess whether improvement in vitreo-retinal surgical techniques over the past 17 years has resulted in an improvement in the outcome of these patients. METHODS: A retrospective cohort study carried out at Moorfields Eye Hospital, London. Patients who underwent a primary surgical repair and removal of a posterior segment IOFB were identified using a hospital database. Of the 140 patients identified, 114 (81%) were included in the study. Data on age, activity at time of injury, presenting clinical features, surgical techniques, complications and final visual outcome were recorded and analyzed. RESULTS: The mean age at time of injury was 34.6+/-12.4 years. All patients were male. The majority of IOFBs were metal (83%). Hammering and chiselling were the most common activities at the time of injury (66%). Fifty-three percent of patients presented with a visual acuity of 6/ 36 or better. Primary closure was achieved in a median of 1 day (interquartile range 1-3 days) following injury. A final visual outcome of 6/60 or worse was documented in 31%. Presentation with a relative afferent pupillary defect (P<0.001), hyphaema (P=0.024), vitreous haemorrhage (P=0.003), uveal prolapse (P=0.038) or retinal detachment (P=0.031) was associated with a poor visual outcome (6/60 or worse). Postoperative complications of retinal detachment (P<0.001) and proliferative vitreoretinopathy (P<0.001) were prognostic of poor final visual acuity. Improvements in surgical techniques, e.g. panoramic viewing systems has resulted in a significant improvement in the final visual outcome of these patients (P=0.043). CONCLUSION: This large series of posterior segment IOFBs shows that recent advances in surgical techniques are associated with a significant improvement in prognosis.

Adult↗

The SAGES Bariatric Surgery Outcome Initiative.

BACKGROUND: The recent initiative for identifying centers of excellence in bariatric surgery calls for documentation of surgical outcomes. The SAGES Outcomes Initiative is a national database introduced in 1999 as a method for surgeons to accumulate and compare their data with summary national data. A bariatric-specific dataset was established later in 2001. The aim of this study was to compare the outcomes of bariatric surgery from the Society of American Gastrointestinal Endoscopic Surgeons' (SAGES) bariatric database with data derived from a national administrative database of academic centers. METHODS: Between 2001 and 2004, 24 surgeons with 1,954 patients participated in the SAGES Bariatric Outcome Initiative, and 97 institutions with 42,847 patients participated in the University HealthSystem Consortium (UHC) database. Only 7 of the 24 surgeons participating in the SAGES Bariatric Outcome Initiative submitted more than 50 cases. The main outcome measures included demographics, comorbidities, type of bariatric procedure, operative time, length of hospital stay, short- and long-term complications, mortality, and weight loss. RESULTS: Both datasets were comparable for gender. Roux-en-Y gastric bypass had been performed for 88% of the patients in the SAGES database and 96% of the patients in the UHC database. Associated comorbidities were similar between the two groups except for a higher rate of hyperlipidemia for the patients in the SAGES database. The SAGES database contains more bariatric-specific information such as body mass index, operative time, blood loss, bariatric-specific complications, long-term complications, and weight loss data than the UHC database. According to the available data, no statistically significant differences exist between the two datasets in terms of perioperative complications and mortality. CONCLUSIONS: The SAGES Bariatric Outcome Initiative provides valuable bariatric-specific data not currently available in an administrative database that may be useful for benchmarking purposes. However, this database is currently underutilized.

Adult↗

Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study.

CONTEXT: Acute respiratory and ear symptoms are frequently treated with antibiotics. Anthroposophic treatment of these symptoms relies primarily on anthroposophic medications. OBJECTIVE: To compare anthroposophic treatment to conventional treatment of acute respiratory and ear symptoms regarding clinical outcome, medication use and safety, and patient satisfaction. DESIGN: Prospective, non-randomised comparison of outcomes in patients self-selected to anthroposophic or conventional therapy under real-world conditions. SETTING: 29 primary care practices in Austria, Germany, Netherlands, UK, and USA. PARTICIPANTS AND THERAPY: 1016 consecutive outpatients aged > or = 1 month, consulting an anthroposophic (n = 715 A-patients) or conventional physician (n = 301 C-patients) with a chief complaint of acute (< or = 7 days) sore throat, ear pain, sinus pain, runny nose or cough. Patients were treated according to the physician's discretion. PRIMARY OUTCOME: Patients' self-report of treatment outcome (complete recovery/major improvement/slight to moderate improvement/no change/deterioration) at Day 14. RESULTS: Most common chief complaints were cough (39.9% of A-patients vs. 33.9% of C-patients, p = 0.0772), sore throat (26.3% vs. 23.3%, p=0.3436), and ear pain (20.0% vs. 18.9%, p=0.7302). Baseline chief complaint severity was severe or very severe in 60.5% of A-patients and 53.3% of C-patients (p=0.0444), mean severity (0-4) of complaint-related symptoms was 1.3 +/- 0.7 vs. 1.2 +/- 0.6 (p=0.5197). During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 33.6% of C-patients (p<0.0001), anthroposophic medicines were prescribed to all A-patients and no C-patient. OUTCOMES: Improvement within 24 hours occurred in 30.9% (221/715) of A-patients and 16.6% (50/301) of C-patients (p<0.0001), improvement within 3 days in 73.1% and 57.1% (p<0.0001). At Day 7 complete recovery or major improvement was reported by 77.1% of A-patients and 66.1% of C-patients (p=0.0004), at Day 14 by 89.7% and 84.4% (p=0.0198). Complete recovery rates at Day 7 were 30.5% and 23.3% (p<0.0001); at Day 14 they were 64.2% and 49.5% (p<0.0001). 69.9% of A-patients and 60.5% of C-patients were very satisfied with their physician (p=0.0043); 95.7% and 83.4% would choose the same therapy again for their chief complaint (p<0.0001). After adjustment for country, gender, age, chief complaint, duration of complaint, previous episode of complaint within last year, and baseline symptom severity, odds ratios favoured the A-group for all these outcomes. Adverse drug reactions were reported in 2.7% of A-patients and 6.0% of C-patients (p=0.0157). CONCLUSION: Compared to conventional treatment, anthroposophic treatment of primary care patients with acute respiratory and ear symptoms had more favourable outcomes, lower antibiotic prescription rates, less adverse drug reactions, and higher patient satisfaction.

Acute Disease↗

A predictive model for outcome after conservative decompression surgery for lumbar spinal stenosis.

This study was designed to develop predictive models for surgical outcome based on information available prior to lumbar stenosis surgery. Forty patients underwent decompressive laminarthrectomy. Preop and 1-year postop evaluation included Waddell's nonorganic signs, CT scan, Waddell disability index, Oswestry low back pain disability questionnaire, low back outcome score (LBOS), visual analog scale (VAS) for pain intensity, and trunk strength testing. Statistical comparisons of data used adjusted error rates within families of predictors. Mathematical models were developed to predict outcome success using stepwise logistic regression and decision-tree methodologies (chi-squared automatic interaction detection, or CHAID). Successful outcome was defined as improvement in at least three of four criteria: VAS, LBOS, and reductions in claudication and leg pain. Exact logistic regression analysis resulted in a three-predictor model. This model was more accurate in predicting unsuccessful outcome (negative predictive value 75.0%) than in successful outcome (positive predictive value 69.6%). A CHAID model correctly classified 90.1% of successful outcomes (positive predictive value 85.7%, negative predictive value 100%). The use of conservative surgical decompression for lumbar stenosis can be recommended, as it demonstrated a success rate similar to that of more invasive techniques. Given its physiologic and biomechanical advantages, it can be recommended as the surgical method of choice in this indication. Underlying subclinical vascular factors may be involved in the complaints of spinal stenosis patients. Those factors should be investigated more thoroughly, as they may account for some of the failures of surgical relief. The CHAID decision tree appears to be a novel and useful tool for predicting the results of spinal stenosis surgery

Adolescent↗

Functional outcome after posterolateral spinal fusion using pedicle screws: comparison between primary and salvage procedure.

Lumbar spinal fusion is a commonly performed surgical procedure, yet both the indications for its performance and its results remain controversial. It is generally believed that apart from situations where obvious measurable instability exists, a repeat surgical procedure such as spinal fusion does not improve the functional outcome in more than an average of 50% of cases. The aim of this study was to analyse functional outcome after posterolateral lumbar or lumbosacral spinal fusion, comparing primary and salvage procedures. It was designed as a prospective case/referent study with a 2-year follow-up. A total of 39 patients underwent a short posterior fusion with Cotrel-Dubousset (CD) pedicle screw fixation after earlier surgery of the lumbar spine. Two patients were erroneously omitted from the study at the index, so 37 patients were included in the salvage group. In the same period, 69 patients underwent lumbar fusion with pedicle screw fixation (CD) as primary surgery (referent group). Functional outcome was assessed by means of the Dallas Pain Questionnaire preoperatively and 1 and 2 years postoperatively. Fusion rates were determined by ordinary X-ray evaluation by two independent observers. Patients who had undergone previous spinal surgery had a significant improvement in functional outcome in terms of daily activity, work and leisure-time activities and anxiety/depression. With regard to social functioning, a significantly inferior outcome was found after the salvage procedure. The return-to-work rates at 2 years after surgery were 50% in the salvage group and 53% in the referent group. There was a significant correlation between radiological evaluation of the fusion mass and the functional outcome. The fusion rate was 76% in the salvage group and 72% in the referent group. This study demonstrates that a posterolateral spinal fusion can be effectively used as a salvage procedure. The functional and radiological outcome of the patients with revision surgery did not differ from those of the group of patients who underwent primary surgery. There was, however a clear indication of inferior social functioning after revision surgery.

Adult↗

Analysis of outcome of pregnancy in type 1 diabetics treated with insulin pump or conventional insulin therapy.

We evaluated the outcome of pregnancies followed between 1990 and 2000 in 93 women with type 1 diabetes, treated with conventional intensive insulin therapy (n=68) or continuous subcutaneous insulin infusion (n=25). We evaluated metabolic control (fasting and 1-hour post-prandial plasma glucose and HbA1c levels), spontaneous or induced abortions, time and mode of delivery, maternal outcome (pregnancy-induced hypertension, preeclampsia, placental insufficiency, hydramnios, hypoglycemic coma, ketoacidosis) and fetal outcome (weight, hypoglycemia, hypocalcemia, hyperbilirubinemia, fetal distress, asphyxia, hyaline membrane disease, polycythemia, shoulder dystocia, malformations). Patients treated with insulin pump more frequently had background retinopathy and clinical neuropathy. No significant differences were observed between the two groups in metabolic control and maternal outcome. Glycemic control, non-optimal in the prepregnancy state, improved significantly during pregnancy, as shown by the progressive reduction in HbA1c levels. As regards fetal outcome, no differences were observed between the two groups in morbidity and especially in malformation rate. Patients with malformed babies did not have optimal metabolic control at conception. Thus, maternal and perinatal outcomes were comparable in patients treated with insulin pump and continuous subcutaneous insulin therapy, and depended on metabolic control. In patients in higher White's class and with more unstable glycemia, we achieved metabolic control and outcomes comparable with those of women of lower White's class and more stable glycemic values using the insulin pump. Our data suggest that insulin pump therapy is useful in problematic, complicated cases of women who want a baby.

Adult↗

Current treatment strategies and factors influencing outcome in patients with bacterial brain abscess.

We clearly determined the key to managing patients with brain abscess by retrospectively evaluating the factors affecting poor outcome in these patients. This study included 113 patients with brain abscess diagnosed in the CT era. Basic characteristics and therapeutic parameters were estimated as independent predictors of poor outcome by using univariate and multivariate logistic regression analysis. Patients with poor outcomes more frequently had deeply-located abscesses (p < 0.02), IVROBA (intraventricular rupture of brain abscess (p < 0.001) and were in a severely deteriorated neurological state (p < 0.001) than those with good outcomes. Multiple logistic regression analysis predicted that IVROBA (ORs, 24.5; 95% CI, 3.04 to 197.9) and severely deteriorated cases (ORs, 13.7; 95% CI, 2.34 to 80.8) resulting from IVROBA increased the relative risk of poor outcome. Patients with IVROBA more frequently had also deeply-located abscesses (p < 0.005), positively immunocompromised states (p < 0.05) and were in a severely deteriorated condition (p < 0.003) than those without IVROBA. Patients with metastatic abscess had also IVROBA (p < 0.006). Multiple logistic regression analysis anticipated that deeply-located abscess (ORs, 3.90; 95% CI, 1.38 to 11.04), and metastatic abscess (ORs, 12.26; 95% CI, 1.35 to 111.2) increased the relative risk of IVROBA. Patients in an obtunded state and with marked neurological deficit had IVROBA more often than patients in an alert state and/or mild neurological deficit (ORs, 3.23; 95% CI, 1.17 to 8.86, p < 0.03) before treatment. Our findings suggest that IVROBA strongly influences poor outcome in patients with brain abscess. The key to decreasing poor outcomes may be the prevention and management of IVROBA, by evaluating intracranial pressure pathophysiology. IVROBA should be aggressively treated by aspiration methods for the abscess coupled with appropriate intravenous and intrathecial administration of antibiotics.

Adolescent↗

Factors of surgical outcome in tumoural epilepsy.

OBJECTIVES: The purposes of the study were the assessment of the role of surgery in the suppression of epilepsy due to low-grade primitive cerebral tumours and the search for factors relevant to the surgical outcome. PATIENTS AND METHODS: Forty-eight patients with epilepsy due to low-grade supratentorial cerebral tumours were considered. They presented drug-resistant daily to monthly seizures since for least one year (mean 7 yrs). Twenty-four patients underwent a combined tumour and epileptogenic zone resection ("epilepsy surgery") and 24 tumour resection alone ("lesionectomy"). The surgical outcome was evaluated two years after surgery. Several variables related to the characteristics of the epilepsy, the tumour and surgery, were considered for a possible association with the outcome. Statistical analyses were performed. RESULTS: Seizure freedom, including aura, was obtained in 35 patients (72.9%). Mild permanent complications occurred in 6 cases. Seizure suppression was significantly associated with complete tumour resection (post-surgical CT or MRI) and relatively low presurgical seizure frequency; it was also related, though not significantly, to small tumour size and histological grade I. The surgical outcome was only slightly better following "epilepsy surgery" than "lesionectomy". However: i) the extent of tumour resection was not relevant regarding the "epilepsy surgery" outcome, while significantly influencing the outcome after "lesionectomy"; ii) the presurgical frequency of seizures and, to a less extent, the tumour size, had a higher influence on the outcome after "lesionectomy". CONCLUSION: Long-lasting and drug-resistant epilepsy due to cerebral tumours can be suppressed surgically in the majority of cases. The extent of tumour resection and the frequency of the seizures are the most relevant prognostic factors. Both "epilepsy surgery" and "lesionectomy" can provide good results. However, the two approaches should not be regarded as interchangeable: a choice of the approach based on the characteristics of seizures and of the tumour appears relevant to improve the surgical prognosis.

Adolescent↗

Effect of self-activating phthalocyanine gel on palatal donor site healing, inflammatory biomarkers, somatosensory and patient-centered outcomes: a randomized split-mouth clinical trial.

OBJECTIVES: To evaluate effects of self-activating phthalocyanine (PHY) gel on palatal donor site after subepithelial connective tissue graft (SCTG) harvesting, considering clinical outcomes, inflammatory biomarkers, patient-centered outcomes, and quantitative somatosensory changes. MATERIALS AND METHODS: Twenty participants were included in this randomized, crossover, split-mouth clinical trial. Donor sites received topical PHY gel (PHY group-PHYG) and placebo gel (control group-CG). Clinical parameters (residual wound area-RWA, wound epithelialization-WE, residual remodeling area-RRA and tissue thickness-TM) were assessed at baseline, 7, 14, 30, and 60 days. Patient-centered outcomes were recorded during 14 postoperative days and inflammatory biomarkers at 3 and 7 days postoperatively. Mechanical detection threshold (MDT) and mechanical pain threshold (MPT) were evaluated at baseline, 2 months, and 6 months. RESULTS: PHYG and CG exhibited similar clinical outcomes, but PHYG demonstrated superior performance in reducing RRA. Both groups presented positive postoperative progression of patient-centered outcomes. IL-10 levels showed a significant increase in PHYG, suggesting a more favorable anti-inflammatory response. MDT remained stable but, donor sites exhibited transient hypersensitivity (MPT) at 2 months. CONCLUSIONS: PHYG and CG protocols promoted satisfactory healing of palatal donor sites. Most clinical parameters and patient-centered outcomes were similar between groups. The PHYG presented reduced RRA and increased IL-10 levels. Donor sites exhibited transient hypersensitivity, which tended to resolve over time. CLINICAL RELEVANCE: Both postoperative protocols resulted in favorable healing of palatal donor sites following SCTG harvesting, with comparable clinical and patient-centered outcomes. Quantitative sensory testing indicates that hypersensitivity may occur during healing, but sensory function tends to recover progressively.

Humans↗

Impact of drug-resistant Mycobacterium tuberculosis on treatment outcome of culture-positive cases of tuberculosis in the Archangel oblast, Russia, in 1999.

The objective of this study was to evaluate the outcome of treatment of culture-positive cases of tuberculosis registered in Archangel, Russia, in 1999, and to analyse the influence of Mycobacterium tuberculosis drug resistance on treatment outcome. The outcome of tuberculosis treatment was evaluated for 235 new and 61 previously treated culture-positive cases diagnosed in 1999. Of the 235 new cases, there were 150 (63.8%) cases of treatment completion, 20 (8.5%) cases of treatment failure, 29 (12.3%) cases of death during treatment, and 29 (12.3%) cases in which the patient failed to pick up medications for at least 2 consecutive months. The outcome in 7 (3%) cases was unknown, as the patients were transferred outside the oblast region. Among the 61 previously treated cases, the rate of treatment completion was low (26.2%), and rates of treatment failure (23%) and failure to pick up medications for at least 2 consecutive months (29.5%) were high. The relation between the susceptibility pattern of the infecting strain as determined by the Bactec method and tuberculosis treatment outcome was analysed for 76 patients. The majority (69%) of patients infected with drug-susceptible strains was cured. A large proportion (58.8%) of patients infected with Mycobacterium tuberculosis resistant to more than two drugs did not respond to treatment, i.e. the treatment failed or the patients died. The high rates of death (16.7%) and failure (66.7%) among patients infected with multidrug-resistant strains illustrate the negative impact of multidrug resistance on the outcome of tuberculosis treatment. Pan-resistance was significantly associated with treatment failure (P<0.001). The spread of resistant Mycobacterium tuberculosis has a serious negative impact on the outcome of tuberculosis treatment in Archangel, Russia.

Antitubercular Agents↗

Can community change be measured for an outcomes-based initiative? A comparative case study of the success by 6 initiative.

One of the challenges facing nonprofit organizations today is the demand for measurable results. Increasingly, these organizations are focusing less on program outputs and program outcomes in favor of community outcomes or changes demonstrated in the larger community. Success by 6(R) is a popular United Way initiative that emphasizes defining and measuring community outcomes. In this paper, we describe our work with 24 Success by 6(R) initiatives around the country. It is clear that not all of these initiatives are measuring community outcomes. Of those initiatives that are experiencing some success measuring community outcomes, similar measurement strategies are reported. Additionally, our experience suggests several United Way employees express dissatisfaction with the logic model as a framework for defining and measuring community outcomes although no preferred alternative model is identified. Evaluators working with community-wide initiatives must find ways to communicate the differences between program and community outcomes to key stakeholders and funders.

Community Mental Health Services↗

Cosmetic outcome of breast conserving therapy after sentinel node biopsy versus axillary lymph node dissection.

INTRODUCTION: Next to locoregional control, good cosmetic outcome is one of the main goals of breast conserving treatment (BCT) for breast cancer surgery. Factors affecting cosmetic outcome are well known. The sentinel node (SN) procedure avoids lymphedema in the breast, which might influence cosmetic outcome. The aim of this study was to evaluate the cosmetic outcome of BCT after the SN procedure compared to that after axillary lymph node dissection (ALND). METHODS: The subjects were 20 patients who underwent ALND and 20 patients who underwent the SN procedure. After a minimum follow-up period of 43 months, we photographed each patient. Fifteen healthy women served as control subjects. We used the percentage breast retraction assessment index (pBRA=BRA/reference length x 100) to compare cosmetic outcome. RESULTS: The median pBRAs of the ALND group and SN group (14.3 and 6.71, respectively) significantly differed ( p=0.001). The pBRA of the SN group was comparable to the pBRA (6.1) of the control group ( p=0.317). CONCLUSION: Cosmetic outcome of BCT after the SN procedure was superior compared to the cosmetic outcome after ALND. This is an important additional reason to implement the SN procedure in routine daily practice.

Axilla↗

Usefulness of clinical scores to predict outcome in bacterial meningitis.

The predictive usefulness of clinical scores in patients with acute bacterial meningitis was investigated. Fifty-one consecutive patients with acute bacterial meningitis were scored on days 1, 3, 5, 8, and 14 after admission according to the Sandinavian Stroke Scale (SSS), Glasgow Coma-Scale (GCS) and Hunt & Hess Scale (HH). As an index of their usefulness to predict the outcome, the scales were correlated with short-term outcome on day 21 assessed by the Glasgow Outcome Scale (GOS). The scores of all three scales correlated highly significantly with short-term outcome. Depending on the day of assessment, Spearman correlation coefficients ranged between 0.52 and 0.88 for SSS, between 0.50 and 0.84 for GCS, and between -0.47 and -0.82 for HH. The scales differed in their ability to predict outcome on and after day 1: mortality was best predicted by GCS, and complete recovery was best predicted by SSS. The use of scales in bacterial meningitis provides a rational quantitative basis to predict outcome more graduated than in dead or alive. Because the scales accentuate different aspects of outcome (e.g. mortality, restitution), the selection of a scale to be used in clinical trials should take into consideration the main focus of the study.

Acute Disease↗

The importance of data in improving practice: effective clinical use of outcomes data.

We are in a transition stage from the widespread use of clinical judgment to the use of risk-adjusted outcomes data for clinical decision-making and quality assessment and improvement. The ultimate long-term goal for the use of predicted outcomes is to be able to inform patients at the earliest state of their symptoms as to the anticipated course of their disease and the results of alternative therapies. For outcomes analyses to be routinely used in clinical practice, they must be formulated succinctly. Because a small number of adverse outcomes may make a big difference in outcome statistics over a short period such as a year, it is important that purchasers of health services take a longer-term view. The demand for public disclosure of every aspect of medical therapy is on the increase, and it is likely that each physician, hospital, specialty group, and so on, is likely to receive some type of report card in the near future. However, I believe it will be very difficult to educate the public, given the enthusiasm we currently see in the press for producing headlines that are not always supported by the facts in the article. Although the importance of outcomes data is unquestioned, it is important to remember that our methods for utilizing the data are still somewhat infantile. Therefore, it is important for us as a profession to question the accuracy and the interpretations of outcomes data.

Cardiac Surgical Procedures↗

The relationship of hospital process variables to patient outcome post-myocardial infarction.

This study examined the hospital process variables of nursing care, medical care, information, and hospital environment, as evaluated by patients, in relation to their outcome post-myocardial infarction (MI). The sample included 68 hospitalized men and women, aged 29-92, who were diagnosed with an MI. At the time of discharge, they responded to four subscales of the Patient Judgment of Hospital Quality Questionnaire, which measured the hospital process variables, and the Revised Haussman and Hegyvary Outcome Criteria Instrument for Acute Myocardial Infarction, which measured patient outcome post-MI. Data also were collected from patient charts and nurses. Correlational analyses revealed statistically significant relationships between nursing care and patient outcome, and between hospital environment and patient outcome; neither medical care nor information correlated appreciably with patient outcome post-MI. Regression analysis indicated that nursing care was the only significant predictor of patient outcome post-MI.

Adult↗

Adverse pregnancy outcome after a false-positive screen for Down syndrome using multiple markers.

OBJECTIVE: To assess the relative risk of an adverse pregnancy outcome in women whose multiple-marker screening (maternal serum alpha-fetoprotein [MSAFP], unconjugated estriol [E3], and hCG levels, and age) indicating an increased risk for Down syndrome (more than 1:250) was not confirmed by amniocentesis. METHODS: Fifty-eight women with false-positive screens for Down syndrome were matched with a control group of 116 women whose screens indicated a risk for Down syndrome of less than 1:250. The risk for adverse pregnancy outcome was compared for the two groups, and the roles of MSAFP, unconjugated E3, and hCG as predictors of adverse pregnancy outcome were determined. RESULTS: Women with false-positive screens for Down syndrome were significantly different from their matched controls in the incidence of preterm delivery (20.6 versus 8.6%, respectively), preeclampsia (6.9 versus 0%), small for gestational age newborns (5.2 versus 0%), and fetal demise after 20 weeks' gestation (5.2 versus 0%). An adverse outcome occurred in 19 of 58 pregnancies (32.8%) in the study group and in 14 of 116 matched control pregnancies (12%) (odds ratio [OR] 3.5, 95% confidence interval [CI] 1.6-7.8; P < .01). Unconjugated E3 of 0.75 multiples of the mean (MoM) or less was significantly associated with adverse pregnancy outcome after controlling for the effects of MSAFP and hCG (OR 2.5, 95% CI 1.13-5.55; P < .02). CONCLUSION: One in three women with a false-positive screen for Down syndrome may experience an adverse pregnancy outcome. In this study, unconjugated E3 of 0.75 MoM or less appeared to be a better predictor of adverse pregnancy outcome than were MSAFP and hCG levels.

Adult↗

Assessing patient outcomes with higher hematocrit levels.

Quality improvement theory teaches that, as providers of health care, physicians must determine and then meet the needs of their primary customers, the patients and payers. The needs of patients and payers are met and measured by the outcome of services and treatments delivered by providers to patients. In general, outcomes fall into three main categories: clinical, financial, and patient based. All parties within the end-stage renal disease (ESRD) community seek the best value (quality/cost) when receiving, delivering, or paying for ESRD services. Because there is not yet a consensus on the definition(s) of quality in the care of ESRD patients, a determination of value remains largely cost dependent. Thus payers, who have no easy or reliable way to compare the quality of providers, based many of their decisions on the best available price. Patient-based outcomes include the assessment of patient satisfaction and health status (health-related quality of life). These outcomes broaden the perspective on quality of care beyond the clinical and laboratory measures traditionally used in the ESRD Program. The assessment of these outcomes can give providers additional insights into the burdens of renal failure and its treatment on the lives of their patients. This information then can be used to design or modify the services provided. Physicians are required to provide high-quality, effective, appropriate, and cost-efficient services. How to meet the often conflicting outcome needs of payers and patients remains a significant challenge. It is essential that all within the ESRD community reach some agreement on the operational definition(s) of quality process and outcome indicators.(ABSTRACT TRUNCATED AT 250 WORDS)

Hematocrit↗

Sarcoma therapy: functional outcome and relationship to treatment parameters.

PURPOSE: To systematically assess the functional outcome of patients treated with surgery and irradiation for extremity or truncal sarcomas, and to correlate this outcome with a detailed analysis of the radiation dose distribution and surgical technique. Conservative surgery and radiation therapy (RT) are known to provide excellent local control, but the relationship of technique to functional outcome requires further study. METHODS AND MATERIALS: Forty-one patients were treated for lower extremity (25 patients, 61%), upper extremity (8 patients, 19.5%), and truncal (8, 19.5%) sarcomas from 1983 to 1990. Most patients had malignant fibrous histiocytoma (15), liposarcoma (8), or aggressive fibromatosis (6). Age ranged from 13 to 85 years (median 54). All patients received RT and 39 (95%) had surgery. The mean total RT dose was 59 Gy (range 55.8-64.8 Gy). A protocol for functional assessment was devised and included a 4 point scale (0-3) for each of seven functional parameters (range of motion, fibrosis, edema, pain, skin changes, muscle strength, gait, or upper extremity performance). An aggregate score was obtained by adding the seven parameter scores and compared with both a patient and physician overall functional rating score (excellent, good, fair, poor). Based on this analysis, aggregate scores were defined as < or = 3 = excellent, < or = 8 = good, < or = 13 = fair, and > 13 = poor, with 21 as the worst possible score. The same orthopaedic surgeon and radiation oncologist independently examined and rated 22 patients. An additional 17 patients were evaluated by record review. The median time from completion of radiation therapy was 30.5 months (range 7-95 months). A computerized radiation therapy dosimetric analysis was performed on 34 patients. RESULTS: Local control was achieved in 39 patients (95%), including 6 with aggressive fibromatosis. The mean functional outcome score was 5.1 with a range of 0-16. 34 patients (83%) had good or excellent functional outcomes. The rating system demonstrated minimal interobserver variability. There was a positive relationship between volume irradiated to > or = 55 Gy and functional score, strength, fibrosis, and skin changes. Total dose independent of volume was significantly associated with skin changes. Increasing peak dose (hot spot dose) was associated with fibrosis and skin changes. More fibrosis developed as the volume of the peak dose increased. A portion of the joint was treated in 5/33 extremity patients and the entire joint in 24/33 (mean dose 55.8 Gy, range 45-65 Gy). Neither range of motion nor total functional score was correlated with joint dose. Edema and functional score were not related to either the volume or percent of limb spared (receiving < or = 40 Gy). The physician functional status ratings generally concurred with patient self-assessments. CONCLUSIONS: A system for functional assessment has been developed which is easily performed and provides detailed information about patient functional outcome. This system can be used to evaluate the morbidity of combined modality sarcoma therapy. Doses up to 65 Gy, even over joint spaces, are not associated with significant morbidity. Only a small volume treated to < or = 40 Gy is required to maintain good outcome. The most important parameter appears to be the volume treated to > or = 55 Gy.

Adolescent↗