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PubMed2001

The power of outcomes: FOTO Industrial Outcomes Tool -- Initial assessment.

OBJECTIVE: To demonstrate how outcomes assessment can assist in describing clients receiving rehabilitation in occupational health rehabilitation clinics and to describe the preliminary assessment of internal consistency reliability and construct validity of the FOTO Industrial Outcomes Tool. METHODS: 266 adults referred for acute work rehabilitation (AWR), work conditioning/hardening (WC/WH) or a Functional Capacity Evaluation (FCE) comprised the data set. Clients were treated between July 1998 and January 1999 in 15 clinics from 6 states by 46 clinicians participating in the Focus on Therapeutic Outcomes (FOTO) national rehabilitation database beta test. For AWR and WC/WH, clients completed a health status questionnaire on intake and discharge, and health status was assessed prior to the FCE. Comprehensive demographic data were collected describing the clinics, clinicians, clients and work status collected 2 weeks following discharge. RESULTS: Internal consistency reliability coefficients for the health status scores ranged from 0.57 to 0.89. Construct validity was supported. CONCLUSION: Results demonstrate the power of collecting outcomes from a variety of constructs for clients receiving industrial rehabilitation services. Initial reliability and construct validity findings were adequate and support continuing data analyses.

Journal Article↗

PubMed1990

Outcome and predictors of outcome in pediatric submersion victims receiving prehospital care in King County, Washington.

Predictors of outcome in pediatric submersion victims treated by Seattle and King County's prehospital emergency services were studied. Victims less than 20 years old were identified from hospital admissions and paramedic and medical examiners' reports. The proportion of fatal or severe outcomes in patients were compared with various risk factors. Of 135 patients, 45 died and 5 had severe neurologic impairment. A subset of 38 victims found in cardiopulmonary arrest had a 32% survival rate, with 67% of survivors unimpaired or only mildly impaired. The two risk factors that occurred most commonly in victims who died or were severely impaired were submersion duration greater than 9 minutes (28 patients) and cardiopulmonary resuscitation duration longer than 25 minutes (20 patients). Both factors were ascertained in the prehospital phase of care. Submersion duration was associated with a steadily increasing risk of severe or fatal outcomes: 10% risk (7/67) for 0 to 5 minutes, 56% risk (5/9) for 6 to 9 minutes, 88% risk (21/25) for 10 to 25 minutes, 100% risk (4/4) for greater than 25 minutes. None of 20 children receiving greater than 25 minutes of cardiopulmonary resuscitation escaped death or severe neurologic impairment. Our rates for saving all victims, particularly victims in cardiopulmonary arrest, are considerably higher than has been reported before the children. Prompt prehospital advanced cardiac life support is the most effective means of medical intervention for the pediatric submersion victim. Prehospital information provided the most valuable predictors of outcome.

Adolescent↗

PubMed2000

Nursing record systems: effects on nursing practice and health care outcomes.

BACKGROUND: A nursing record system is the record of care planned and/or given to individual patients/clients by qualified nurses or other caregivers under the direction of a qualified nurse. Nursing record systems may be an effective way of influencing nurse practice. OBJECTIVES: To assess the effects of nursing record systems on nursing practice and patient outcomes. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, Cinahl, Sigle, and databases of the Royal College of Nursing, King's Fund, the NHS Centre for Reviews and Dissemination, and the Institute of Electrical Engineers up to August 1999; and OCLC First Search, Department of Health database, NHS Register of Computer Applications and the Health Visitors' Association database up to the end of 1995. We hand searched the Journal of Nursing Administration (1971-1999), Computers in Nursing (1984-1999), Information Technology in Nursing (1989-1999) and reference lists of articles. We also hand searched the major health informatics conference proceedings. We contacted experts in the field of nursing informatics, suppliers of nursing computer systems, and relevant Internet groups. SELECTION CRITERIA: Randomised trials, controlled before and after studies and interrupted time series comparing one kind of nursing record system with another, in hospital, community or primary care settings. The participants were qualified nurses, students or health care assistants working under the direction of a qualified nurse and patients receiving care recorded and/or planned using nursing record systems. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Six trials involving 1407 people were included. In three studies of client held records, there were no overall positive or negative effects, although some administrative benefits through fewer missing notes were suggested. A paediatric pain management sheet study showed a positive effect on the children's pain intensity. A computerised nursing care planning study showed a negative effect on documented nursing care planning. A controlled before-and-after study of two paper nursing record systems showed improvement in meeting documentation standards. REVIEWER'S CONCLUSIONS: No evidence was found of effects on practice attributable to changes in record systems. Although there is a paucity of studies of sufficient methodological rigour to yield reliable results in this area, it is clear from the literature that it is possible to set up randomised trials or other quasi-experimental designs needed to produce evidence for practice. The research undertaken so far may have suffered both from methodological problems and faulty hypotheses.

Humans↗

PubMed2006

The Italian CABG Outcome Study: short-term outcomes in patients with coronary artery bypass graft surgery.

OBJECTIVE: During the last decade, a worldwide growing interest in evaluating performance of health services through 'outcome studies' took place. This study started in early 2002 and represents the first National Health System (NHS) experience to evaluate adjusted performance indicators at national level. The aim of this study was to compare 30 days mortality after coronary artery bypass graft (CABG) between cardiac surgery centres, adjusting by confounding risk factors. METHODS: All patients, aged 15-99 years, undergoing a CABG intervention after 1st January 2002 in 82 participating centres were eligible for this observational longitudinal study. For each patient, data on severity and risk factors were collected (type of procedure, haemodynamic condition, co-morbidities, recent myocardial infarction and unstable angina, ventricular function, emergency condition, vital status at 30 days). Using a multiple logistic regression analysis the best predictive model was developed for risk-adjustment; a cross-validation procedure was applied; specific risk adjusted mortality rates (RAMR) were estimated. The overall study population was used as reference standard. RESULTS: 34,310 isolated CABG were performed in 64 of the 82 participating centres. Thirty days mortality resulted 2.61%, ranging from 0.33 to 7.63%; eight centres presented a RAMR significantly lower and seven significantly higher than the reference. CONCLUSIONS: The study provides valid measures of the heterogeneity between outcomes of the Italian cardiac surgery centres, to support decision-making by NHS management and individual patients. Although not statistically significant, RAMR dropped from year 2002 to 2004 (2.8-2.4%) suggesting that this comparative outcome assessment can contribute to the improvement of performances in cardiac surgery.

Adolescent↗

PubMed2003

Health-related quality of life and associated outcomes among hemodialysis patients of different ethnicities in the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

BACKGROUND: In the United States, an association between mortality risk and ethnicity has been observed among hemodialysis patients. This study was developed to assess whether health-related quality of life (HRQOL) scores also vary among patients of different ethnic backgrounds. Associations between HRQOL and adverse dialysis outcomes (ie, death and hospitalization) also were assessed for all patients and by ethnicity. METHODS: Data are from the Dialysis Outcomes and Practice Patterns Study for 6,151 hemodialysis patients treated in 148 US dialysis facilities who filled out the Kidney Disease Quality of Life Short Form. We determined scores for three components of HRQOL: Physical Component Summary (PCS), Mental Component Summary (MCS), and Kidney Disease Component Summary (KDCS). Patients were classified by ethnicity as Hispanic and five non-Hispanic categories: white, African American, Asian, Native American, and other. Multiple linear regression models were used to estimate differences in HRQOL scores among ethnic groups, using whites as the referent category. Cox regression models were used for associations between HRQOL and outcomes. Regression models were adjusted for sociodemographic variables, delivered dialysis dose (equilibrated Kt/V), body mass index, years on dialysis therapy, and several laboratory/comorbidity variables. RESULTS: Compared with whites, African Americans showed higher HRQOL scores for all three components (MCS, PCS, and KDCS). Asians had higher adjusted PCS scores than whites, but did not differ for MCS or KDCS scores. Compared with whites, Hispanic patients had significantly higher PCS scores and lower MCS and KDCS scores. Native Americans showed significantly lower adjusted MCS scores than whites. The three major components of HRQOL were significantly associated with death and hospitalization for the entire pooled population, independent of ethnicity. CONCLUSION: The data indicate important differences in HRQOL among patients of different ethnic groups in the United States. Furthermore, HRQOL scores predict death and hospitalization among these patients.

Comorbidity↗

PubMed1997

Outcomes and cost-effectiveness of initiating dialysis and continuing aggressive care in seriously ill hospitalized adults. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Renal failure requiring dialysis in the setting of hospitalization for serious illness is a poor prognostic sign, and dialysis and aggressive care are sometimes withheld. OBJECTIVE: To evaluate the clinical outcomes and cost-effectiveness of initiating dialysis and continuing aggressive care for seriously ill hospitalized patients. DESIGN: Prospective cohort study and cost-effectiveness analysis. SETTING: Five geographically diverse teaching hospitals. PATIENTS: 490 patients (median age, 61 years; 58% women) enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) in whom dialysis was initiated. MEASUREMENTS: Survival, functional status, quality of life, and health care costs. Life expectancy was estimated by extrapolating survival data (up to 4.4 years of follow-up) using a declining exponential function. Utilities (quality-of-life weights) were estimated by using time-tradeoff questions. Costs were based on data from SUPPORT and published Medicare data. RESULTS: Median duration of survival was 32 days, and only 27% of patients were alive after 5 months. Survivors reported a median of one dependency in activities of daily living, and 62% rated their quality of life as "good" or better. Overall, the estimated cost per quality-adjusted life-year saved by initiating dialysis and continuing aggressive care rather than withholding dialysis and allowing death to occur was $128,200. For the 103 patients in the worst prognostic category, the estimated cost per quality-adjusted life-year was $274,100; for the 94 patients in the best prognostic category, the cost per quality-adjusted life-year was $61,900. CONCLUSIONS: For the few patients who survived, clinical outcomes were fairly good. With the exception of patients with the best prognoses, however, the cost-effectiveness of initiating dialysis and continuing aggressive care far exceeded $50,000 per quality-adjusted life-year, a commonly cited threshold for cost-effective care.

Aged↗

PubMed1994

Second renal transplantations. Ethical issues clarified by outcome; outcome enhanced by a reliable crossmatch.

OBJECTIVE: To determine whether the appropriate use of scarce donor resources has been accomplished by renal retransplantation by reviewing the initial and long-term outcomes of second-renal transplant recipients at the Massachusetts General Hospital, Boston. PATIENTS AND RESULTS: With a mean follow-up of nearly 5 years following transplantation, 54 (68%) of 80 second-transplant recipients had functioning allografts (allograft failure was defined by patient death or a return to dialysis). Rejection was the most common cause of failure (14 [54%] of 26 patients). The 1-, 3-, and 5-year actuarial allograft survival rates were 86%, 78%, and 69%, respectively, which were not significantly different from the survival rates of primary allografts at this center. These results support the continued approach of providing both cadaver-donor and living-donor renal allografts for recipients whose primary renal allograft has failed. The antiglobulin crossmatch may have contributed to the successful outcome by accurately determining compatibility and by averting early rejection failures. CONCLUSIONS: Health care policy reviewers should clearly distinguish the prospects for successful second renal transplants from the outcomes of extrarenal retransplantation. Moreover, because excellent second-renal allograft survival is attainable and comparable to primary-renal allograft survival and because the costs are comparable, restricting suitable patients to subsequent lifelong dialysis becomes unethical.

Adult↗

PubMed1992

Acceptance, attrition, and outcome in an outpatient treatment programme for alcoholics. A comparison between a randomized and a non-randomized process-outcome study.

Acceptance, attrition and outcome of the same outpatient treatment programme for alcoholics was studied first in a non-randomized and later in a randomized study. There was a lower (15%) rate of acceptance and a higher (19%) rate of attrition in the randomized study. Among treatment completers drinking outcome during the third year after commencement of treatment did not differ between the non-randomized and the randomized study. It is concluded that the characteristics of subjects accepting a randomly assigned study should always be clearly presented. The absence of a patient-therapist matching in a randomized design could negatively effect attrition and probably also acceptance of treatment, while it seems to be less influential on outcome in those completing therapy.

Adult↗

PubMed2006

Understanding cancer patients' experience and outcomes: development and pilot study of the Cancer Care Outcomes Research and Surveillance patient survey.

GOALS OF WORK: The National Cancer Institute's Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium is conducting a population-based study of newly diagnosed patients with lung and colorectal cancer to describe the experience of persons living with cancer and to understand which barriers present the most significant obstacles to their receipt of appropriate care. The keystone to this effort is the baseline patient survey administered approximately 4 months after diagnosis. PATIENTS AND METHODS: We developed a survey to obtain information from patients newly diagnosed with lung and colorectal cancer about their personal characteristics, decision making, experience of care, and outcomes. We conducted a pilot study to evaluate the feasibility of a lengthy and clinically detailed interview in a convenience sample of patients within 8 months of diagnosis (n=71). MAIN RESULTS: The median length of the interviews was 75 min for patients with lung cancer (range 43-130) and 82 min for patients with colorectal cancer (range 46-119). Most patients had received some form of treatment for their cancer: 66.1% had undergone surgery, 28.2% had received radiation therapy, and 54.9% were treated with chemotherapy. In addition, 26.7% reported their overall health was less than 70 on a 0-100 scale, demonstrating that patients with substantial health impairment were able to complete the survey. CONCLUSIONS: A clinically detailed survey of newly diagnosed lung and colorectal cancer patients is feasible. A modified version of this survey is being fielded by the CanCORS Consortium and should provide much needed population-based data regarding patients' experiences across the continuum of cancer care and their outcomes.

Aged↗

PubMed2006

Cancer outcomes measurement: Through the lens of the Medical Outcomes Trust framework.

BACKGROUND: In 2001, the U.S. National Cancer Institute established the Cancer Outcomes Measurement Working Group (COMWG) to evaluate and advance the state of the science in patient-reported outcome (PRO) measurement, with a focus on health-related quality of life (HRQOL). To guide its work, the COMWG adopted the revised Medical Outcomes Trust (MOT) attributes and review criteria for evaluating health status and quality-of-life instruments. OBJECTIVE: With the MOT attributes providing the organizing principle, this paper summarizes and draws inferences from key COMWG findings about the methodological soundness of HRQOL assessment in cancer and steps required to move the field forward. RESULTS AND CONCLUSIONS: Across a range of cancer research applications, especially clinical trials, a variety of generic, general cancer, and cancer site-specific measures of HRQOL have demonstrated adequate reliability, validity, responsiveness, feasibility, and cultural and language adaptation. Methodological challenges remain in the interpretability of HRQOL measures, though substantial progress has been made in defining a "minimum important difference" in scale scores. Much work remains in forging a stronger link between the conceptual model and measurement model in HRQOL instrumentation. Progress along all MOT attributes will likely accelerate with the growing application of modern psychometrics, particularly item response theory modeling, which provides the underpinnings for item banking and computer-adaptive assessment of HRQOL. Future research should emphasize prospectively designed studies to evaluate PRO measures within the MOT framework and in-depth investigations of the role of PRO measures in cancer decision making at all levels.

Endpoint Determination↗

PubMed2005

The relation of renal function to ischemic and bleeding outcomes with 2 different glycoprotein IIb/IIIa inhibitors: the do Tirofiban and ReoPro Give Similar Efficacy Outcome (TARGET) trial.

BACKGROUND: Renal function significantly impacts morbidity and mortality after a percutaneous coronary intervention. Platelet glycoprotein (GP) IIb/IIIa inhibitors reduce ischemic complications during percutaneous coronary intervention; little is known of whether their safety and efficacy are influenced by renal function. In particular, whether outcome differences exist between agents that are renally excreted (tirofiban) or not (abciximab) in patients with mild renal impairment is not known. METHODS: The TARGET trial randomized 4623 patients to tirofiban or abciximab. In this analysis, patients were grouped in creatinine clearance quartiles (<70, 70-90, 90-114, >114 mL/min) and analyzed for efficacy and bleeding risk. Univariate and multivariate analyses were performed to identify interactions between GP IIb/IIIa inhibitor used and creatinine clearance with respect to ischemic outcomes and bleeding. RESULTS: Using unadjusted logistic regression tests for trend, 30-day death/myocardial infarction/urgent target vessel revascularization was greater in patients with lower creatinine clearances (7.3%, 8.5%, 5.1%, and 5.8%, P = .005), as were both major and minor bleeding. There was no interaction between assigned GP IIb/IIIa inhibitor, creatinine clearance and ischemic outcome, major bleeding or minor bleeding. CONCLUSIONS: Both ischemic and bleeding complications are highest in the lowest creatinine clearance quartile of patients treated with GP IIb/IIIa inhibitors. Although tirofiban is renally cleared and abciximab is not, there was no interaction between these GP IIb/IIIa inhibitors and creatinine clearance regarding ischemic or bleeding events.

Abciximab↗

PubMed2006

Health outcomes in older men with localized prostate cancer: results from the Prostate Cancer Outcomes Study.

PURPOSE: We compared health-related quality-of-life (HRQOL) outcomes and survival of men with localized prostate cancer who received aggressive treatment with those receiving conservative management. METHODS: We conducted a population-based cohort study of men aged 75 to 84 years when diagnosed with a clinically localized cancer in 1994 or 1995. We used medical record abstractions and patient surveys to obtain clinical and HRQOL data at diagnosis and 24-month follow-up. We used a propensity score method to adjust for baseline differences between men treated with radical prostatectomy or radiation therapy (n = 175) and men who received hormone therapy or no treatment (n = 290). Propensity scores were used in regression analyses comparing HRQOL outcomes between treatment groups. Overall and disease-specific survivals were estimated with multivariate proportional hazards models. RESULTS: At 24 months following diagnosis, aggressively treated men were more likely to report daily urinary leakage (odds ratio [OR] = 2.9, 95% confidence interval [CI] 1.2-7.0) and to be bothered by urinary problems (OR = 5.1, 95% CI, 1.3-9.1) and sexual problems (OR = 2.8, 95% CI, 1.2-6.3). The adjusted disease-specific mortality hazard ratio was 0.43 (95% CI, 0.15, 1.28), favoring aggressive treatment. However, the absolute 5-year disease-specific survival difference was only 6% (98% vs 92%). Over 80% of all deaths were from other causes. CONCLUSIONS: Aggressive treatment was associated with significant decreases in disease-specific HRQOL. However, men who were aggressively treated for localized cancer had a minimally reduced absolute risk of dying from prostate cancer. Physicians and older patients should consider these outcomes in making decisions about screening and treatment.

Age Factors↗

PubMed2005

Outcome following TVT sling procedure: a comparison of outcome recorded by surgeons to that reported by their patients at a London district general hospital.

OBJECTIVE: Retrospective study to assess patient satisfaction rates after TVT sling procedure for stress urinary incontinence (SUI), and comparison of these results to the post-operative progress documented by the surgeons in the clinical notes. METHODS: All TVT sling cases at our institution during February 1999 to December 2002 were included. Data was collected from clinical notes on post-operative outcome as recorded by the surgeons, and a patient satisfaction questionnaire was used to assess patients' perception of their progress. RESULTS: The response rate to the patient satisfaction questionnaire was 72%. Overall 94% of the patients were satisfied with the procedure. However, they reported cure rates of only 44%. This is comparable to the 46% cure rates documented by the surgeons. CONCLUSION: The surgeons' and the patients' perceptions regarding outcome and change in symptoms after TVT sling for SUI at our hospital, correlate well. Hence, the documentation in the clinical notes by the surgeons can be relied upon as an accurate representation of post-operative patient progress. Despite the relatively low cure rates (44-46%) for SUI with TVT sling procedure, the patient satisfaction rates with the outcome are high (94%), reiterating that there is a poor correlation between quality of life impairment and the concept of cure.

Adult↗

PubMed2006

Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome.

OBJECTIVES: The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting. BACKGROUND: The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes. METHODS: We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001). CONCLUSIONS: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.

Angina Pectoris↗

PubMed2004

The Patient Outcomes of Surgery-Hand/Arm (POS-Hand/Arm): a new patient-based outcome measure.

The purpose of this study was to develop and validate a new patient-based outcome measure for hand/arm disorders for use in audit, clinical trials and effectiveness studies. There were three stages. First, we carried out interviews with 40 patients with hand/arm disorders to develop and pilot questionnaire content. Second, in a postal survey with 165 pre- and 181 post-surgery patients, we reduced the number of items and identified scales. Third, in a postal survey with 132 pre- and 204 post-surgery patients we evaluated the psychometric properties of the measure. Findings confirmed the acceptability, reliability, validity and responsiveness to clinical change of the questionnaire. The Patient Outcomes of Surgery-Hand/Arm (POS-Hand/Arm) is a new surgical outcome measure that can be used before and after surgery (29 and 33 items, respectively) to evaluate and compare new techniques, surgical teams and units.

Activities of Daily Living↗

PubMed2003

Subjective and Objective Numerical Outcome Measure Assessment (SONOMA). A combined outcome measure tool: findings on a study of reliability.

OBJECTIVE: To determine the reliability of a combined tool, namely that of Subjective and Objective Numerical Outcome Measure Assessment (SONOMA). METHODS: Testing was conducted, limited to patients with neck, midback, or lower back pain, with or without radiculopathy, in an outpatient chiropractic office setting. Test-retest reliability of the objective analysis of SONOMA was carried out on the same day (n = 50) with an interval time period of less than 60 minutes. Between-day reliability of the subjective analysis of SONOMA was carried out with an interval time period of 24 hours (n = 50). Individual and combined parameter reliability was established for the tool. RESULTS: Short-term objective and between-day subjective reliability coefficients were high. The Pearson correlation coefficient for the combined tool was .96, and the coefficient for the individual parameters ranged from .55 through .93. All these correlations were statistically significant, with a P value not more than .0001. CONCLUSIONS: The SONOMA combined numerical outcome measure tool demonstrated a high degree of reliability. This outcome tool measures directly and therefore reflects patient pain perception, functional status, and provider-driven objective assessment. We believe this tool provides the unique combination of both subjective and objective functional capacity assessment. It should be valuable for day-to-day practical application, as well as considered for future clinical trials and quality-of-care studies. This combined tool shows promise as having a high degree of reliability and, hence, may demonstrate a comprehensive representation of the patient-clinical picture, particularly in regard to functional capacity assessment.

Activities of Daily Living↗

PubMed2005

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media.

OBJECTIVE: Outcomes for patients with otitis media were assessed in this prospective, multicenter study. STUDY DESIGN AND SETTING: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure. RESULTS: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month follow-up. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling. CONCLUSIONS: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered. SIGNIFICANCE: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis media into surgical versus medical interventions. EBM RATING: C.

Child↗

PubMed1998

Outcome of pregnancies after intracytoplasmic sperm injection and the effect of sperm origin and quality on this outcome.

OBJECTIVE: To describe the outcome of pregnancies obtained after intracytoplasmic sperm injection (ICSI) and the impact of the origin and quality of sperm used on this outcome. DESIGN: Retrospective analysis. SETTING: A tertiary referral center for assisted reproduction. PATIENT(S): Pregnant patients conceived after microinjection of ejaculated sperm (n=1,427), epididymal sperm (n=79), and testicular sperm (n=93). INTERVENTION(S): ICSI, epididymal sperm aspiration, and testicular biopsy. MAIN OUTCOME MEASURE(S): Stillbirth, prematurity, and early perinatal mortality. RESULT(S): The delivery rate of multiple births was 31.4%, and the preterm delivery rate was 25.6%. The prematurity rates in singletons, twins, and triplets were 9.9%, 56.7%, and 96.6%, respectively. The early perinatal mortality rate of the entire population was 26.1 per thousand. In the ejaculated-sperm group, when the sperm was severely defective (group 1), 14 intrauterine deaths occurred (3.1%). In the second and third groups, in which sperm was moderately defective, there were 2 deaths and 1 death (0.6% and 0.4%), respectively. The difference between the number of deaths in group 1 vs. groups 2/3 was statistically significant. CONCLUSION(S): The rates of multiple pregnancies, preterm deliveries, low birth weight, and early perinatal mortality were higher after ICSI than after natural conception. In the ejaculated-sperm group, the rate of intrauterine death was higher in the severely defective sperm group than in the better-quality sperm groups.

Adult↗