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PubMed2001

Effect of continuous versus dichotomous outcome variables on study power when sample sizes of orthopaedic randomized trials are small.

It is often not feasible to conduct large trials in orthopaedic surgery. Therefore, surgeons must identify strategies to optimize the statistical power of their smaller studies. The aim of this study was to compare study power in randomized trials with continuous versus dichotomous outcome variables. We performed a systematic review of the literature to identify randomized trials in orthopaedic trauma. Of these, we examined only those trials with small sample sizes (50 patients or less). The outcomes in each eligible study were categorized as continuous or dichotomous. Standard power calculations were performed for each study, and comparisons were made between continuous and dichotomous outcome variables. We identified 196 randomized trials in orthopaedic trauma. Of these, 76 trials had a sample size of 50 patients or fewer (29 trials with continuous outcomes, 47 trials with dichotomous outcomes). Studies that reported continuous outcomes had a significantly higher mean power than those that reported dichotomous variables (power 49% vs 38%, p=0.042). Twice as many trials with continuous outcome variables reached acceptable levels of study power (i.e. >80% power) when compared with trials with dichotomous variables (37% vs 18.6%, p=0.04). When orthopaedic surgeons anticipate small sample sizes for their study, they can optimize their study's statistical power by choosing a continuous outcome variable.

Cluster Analysis↗
PubMed2005

Association between interleukin-1 beta (IL-1beta) gene polymorphism and outcome after head injury: an early report.

BACKGROUND: Recent studies focusing on the genetic influences on outcome after head injury (HI) have suggested that different alleles of certain genes are associated with different outcomes. Interleukin-1 beta (IL-1beta) gene, especially beta2 polymorphism, is frequently observed in Alzheimer's disease, a remarkable degenerative state in which HI is among the known risk factors. Therefore, the aim of this paper was to search for the possible association between the outcome and IL-1beta gene polymorphism in human HI. METHODS: The study group was composed of the 69 patients admitted to the neurosurgery department after HI. The severity of the initial injury was evaluated by means of the Glasgow Coma Scale and outcome six months later was assessed by means of the Glasgow Outcome Scale. IL-1beta genotypes were determined from blood samples by standard methods. FINDINGS: Fourteen of 25 (56%) patients with IL-1beta +3953 allele 2 had an unfavourable outcome (dead, vegetative state or severe disability) compared with eight of 44 (18.1%) patients without IL-1beta +3953 (p = 0.0004). Similarly, 20 of 28 (71.4%) patients with IL-1beta -511 allele 2 had an unfavourable outcome compared with two of 41 (4.8%) patients without IL-1beta -511 (p = 0.005). Patients who had a composite of IL-1beta 2/2 or 1/2 genotype from both -511 and +3953 region of the chromosome 2 were more prone to have bad prognosis. CONCLUSION: Results of our study demonstrated that there might be a significant association between IL-1beta gene polymorphism and outcome after HI, supporting the hypothesis of a genetically determined influence.

Adult↗
PubMed1992

Unexplained elevated maternal serum alpha-fetoprotein is not predictive of adverse perinatal outcome in an indigent urban population.

OBJECTIVE: The null hypothesis of this study is that in an urban, indigent obstetric population at high risk for adverse perinatal outcome, unexplained elevations of maternal serum alpha-fetoprotein are not an additional predictor of adverse perinatal outcome. STUDY DESIGN: Perinatal outcomes of 72 patients from a clinic for indigent patients with unexplained elevated maternal serum alpha-fetoprotein levels were compared with those of matched controls from the same population with normal maternal serum alpha-fetoprotein levels. Subjects and controls were matched for age, race, parity, and presence or absence of Hollister risk factors. The frequency of adverse perinatal outcome in the two groups was subjected to matched-pair chi 2 analysis. RESULTS: Adverse perinatal outcome occurred in 38.9% (28 of 72) of subjects with unexplained elevated maternal serum alpha-fetoprotein levels greater than or equal to 2.5 multiples of the median, compared with 31.9% (23 of 72) of controls with normal maternal serum alpha-fetoprotein levels (p = 0.5). No statistically significant difference in adverse perinatal outcomes was found. CONCLUSIONS: Elevated maternal serum alpha-fetoprotein levels offer little if any additional predictive value for adverse perinatal outcome in populations already at high risk for such outcomes on the basis of obstetric or socioeconomic criteria.

Adolescent↗
PubMed1993

An association between elevated levels of human chorionic gonadotropin in the midtrimester and adverse pregnancy outcome.

OBJECTIVE: Unexplained elevations in maternal serum alpha-fetoprotein in the midtrimester are associated with adverse pregnancy outcome. Recently it has also been suggested that elevations of maternal serum human chorionic gonadotropin in the second trimester may be associated with adverse pregnancy outcome. STUDY DESIGN: We conducted a cohort study of 460 women at Swedish Medical Center, Seattle, Washington, between Jan. 1, 1990, and Aug. 15, 1991, inclusive. Entry criteria for the cohort included (1) triple screen analysis (maternal serum alpha-fetoprotein, human chorionic gonadotropin, unconjugated estriol) between 15 and 18 weeks' gestation, (2) a risk for Down syndrome of more than one in 195 on the basis of triple screen analysis, (3) study group human chorionic gonadotropin > or = 2 multiples of the median and referent group < or = 2 multiples of the median, alpha-fetoprotein < or = 2 multiples of the median, unconjugated estriol > or = 0.5 multiples of the median, and (4) chromosomally normal single gestation without anomalies. Cumulative incidence risk ratios were estimated for each pregnancy outcome as a measure of the relative association with elevated human chorionic gonadotropin (> or = 2.0 multiples of the median) and adverse pregnancy outcome: low birth weight, < or = 2500 gm; preterm delivery, < 37 weeks' gestation; and small for gestational age, < or = 10th percentile. The Mantel extension test was used to evaluate any apparent linear trend in risk between level of human chorionic gonadotropin and adverse pregnancy outcome. RESULTS: Elevated human chorionic gonadotropin levels were associated with an increased risk for low birth weight (relative risk = 4.0), preterm delivery (relative risk = 2.8), and small for gestational age (relative risk = 1.8). The risk for each adverse outcome increased with increasing levels of human chorionic gonadotropin. CONCLUSIONS: Elevations of human chorionic gonadotropin in the midtrimester appear to be associated with adverse pregnancy outcome. The magnitude of the risk correlates with the level of human chorionic gonadotropin. This risk appears to be independent of the risk for adverse pregnancy outcome associated with unexplained elevations of maternal serum alpha-fetoprotein.

Chorionic Gonadotropin↗
PubMedDate not supplied

Severe head injury: should expected outcome influence resuscitation and first-day decisions?

An early 'prognosis' based on initial findings can influence clinical decisions. To evaluate the quality of first-day outcome prediction based on either clinical or neuroradiological information, we prospectively examined 100 consecutive severely head-injured patients from the surgical intensive care unit. The prognoses were always made by the same experienced neurosurgeon and neuroradiologist according to a contracted Glasgow Outcome Scale (GOS). Every patient's outcome was predicted according to a three-class GOS within 24 h after injury. Correct 'first-day' prognoses were made in 59 and 56% of the cases by the neuroradiologist and neurosurgeon, respectively. In those instances where the prognoses made by the clinician and the radiologist coincided, the prognoses were correct for 73% of the patients. Based on accepted criteria, the neuroradiologist tended to overpredict favorable outcomes and missed many of the unfavorable outcomes (dead or vegetative) whereas the clinician overestimated unfavorable outcomes. Our study showed that outcome prognosis of patients with severe head injury has limited accuracy when made within 24 h after the injury, although an improvement in accuracy occurred when there was agreement between clinical and radiological predictions. Even with sophisticated clinical and radiological technologies, it is not possible to predict outcome on the first day after the accident with sufficient accuracy to guide early management.

Adult↗
PubMed1993

An empirical evaluation of multidimensional clinical outcome in chronic low back pain patients.

Individuals with persisting pain often present a constellation of symptoms that includes pain, health-related impairment and dysphoric mood. It is now widely accepted that comprehensive assessment must address each of these dimensions. Despite recognition of the value of multidimensional assessment, no empirical efforts have validated the construct of a multidimensional clinical outcome presentation based on the dimensions of pain, impairment and dysphoric mood. We employed cluster analytic procedures on standard measures of pain, impairment and depression in chronic low back pain (CLBP) patients (n = 96) attending a general orthopedic clinic in order to empirically characterize multidimensional clinical outcomes. Results indicated that 3 groups could be identified reliably: (1) 'Chronic Pain Syndrome' (n = 25; high levels of pain, impairment and depression), (2) 'Positive Adaptation to Pain' (n = 24; high levels of pain with low levels of impairment and depression) and (3) 'Good Pain Control' (n = 47; low levels of pain, impairment and depression). The reliability of this cluster solution was supported by several tests of internal consistency. Discriminability of the clusters was examined across both the outcome measures themselves and several additional independent variables. The cluster solution was then cross-validated in an independent sample of pain clinic CLBP patients (n = 180) to test its generalizability. Finally the stability of the cluster dimensions over time was tested by re-assessing 36 CLBP patients 6 months after they initially were characterized into 1 of the 3 outcome groups on the same measures. MANOVA results indicated that the outcome groups were differentiated statistically across assessments. The multiple outcome measures did not change significantly across time, nor did the outcome groups change differentially across time on these measures. We conclude that the outcome dimensions of pain, impairment and depression are relatively stable phenomena that differentially describe CLBP patients.

Adult↗
PubMedDate not supplied

The Medical Outcomes Study: a nursing perspective.

The authors analyze the Medical Outcomes Study framework as a means of measuring the effectiveness of a multidimensional, interdisciplinary health care delivery system. The potential for this model to measure outcomes resulting from the interventions of nurses is demonstrated. The similarities between variables in the Medical Outcomes Study (MOS) framework and in research in nursing are presented. Modifications in the framework are suggested that would represent the collaboration among physicians, nurses, and allied health practitioners and the influence of their interaction on patient outcomes. The authors also suggest adding the domain of societal outcomes to include such outcome variables as cost. These modifications will enhance future health outcomes research based on the MOS conceptual framework and will encourage investigations of the interactive effects of health care providers on patient outcomes.

Cross-Sectional Studies↗
PubMed2006

The use of patient-centered outcome measures in radiology: a systematic review.

RATIONALE AND OBJECTIVES: To undertake a systematic review of literature on patient centred outcomes and explore the use of patient defined outcomes in radiology research. MATERIALS AND METHODS: i) DATA SOURCES: Published empirical studies in peer reviewed journals. ii) STUDY SELECTION: Systematic search of English language radiology literature between 1990-2003, using four electronic databases, and reference lists of papers. Work relating to diagnostic or interventional imaging was included. Screening was excluded, together with articles based solely on the audit of patients' medical records. Patients needed to have inputted directly into the study, for example responding to questionnaires or participating in interviews. iii) DATA EXTRACTION: Abstracts were retrieved and relevant full text articles obtained. Each paper was reviewed independently by two reviewers (research team members) using a data extraction form, developed by the authors. Categorisation of papers was undertaken at team meetings. RESULTS: A total of 26 publications met the inclusion criteria for the review. Papers were placed within three categories: i) the primary aim of the study was investigate patient centred outcomes (n = 10); ii) the primary aim of the study was to describe the radiological procedure itself but patient contact was made post-procedure (n = 5) and iii) the primary aim of the study was to investigate patients' experiences during procedures (n = 11). Validated outcome measures were used in 10 studies. None of the outcome measures used were developed specifically for radiology. No papers were found where researchers had used patient defined outcomes. CONCLUSION: The research highlighted difficulties relating to the review and reporting of outcomes research. The results indicated little patient engagement in outcome research in radiology.

Databases, Factual↗
PubMed2005

Association of chronic kidney disease with clinical outcomes after coronary revascularization: the Arterial Revascularization Therapies Study (ARTS).

BACKGROUND: Chronic kidney disease (CKD) is associated with adverse outcomes after coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCI), but it is unclear which of these revascularization strategies is associated with lower risk for morbidity and mortality in this population. In the Arterial Revascularization Therapies Study (ARTS), we compared long-term clinical outcomes after CABG or PCI with multivessel stenting in patients with CKD. METHODS: The ARTS randomly assigned 1205 participants with and without CKD to CABG or PCI with multivessel stenting. We defined CKD as creatinine clearance < or =60 mL/min, estimated by the Cockroft-Gault equation. The primary outcome was the composite of death, myocardial infarction (MI), or stroke; and, a secondary outcome was repeat revascularization. Participants were followed for a mean of 3 years after their intervention. We evaluated whether randomization to CABG or PCI was associated with different outcomes among participants with CKD. RESULTS: Two hundred ninety participants (25%) had CKD at entry into ARTS. One hundred fifty-one received PCI, and 139 received CABG. No difference was observed in the primary endpoint with CABG or PCI among CKD participants (adjusted Hazard Ratio [HR] CABG vs PCI = 0.93; 95% CI 0.54-1.60; P = .97). However, CABG was associated with a reduced risk for repeat revascularization (HR = 0.28; 95% CI 0.14-0.54; P < .01). Compared with participants with normal renal function, CKD was associated with a nearly 2-fold risk for the primary outcome (unadjusted HR = 1.9; 95% CI 1.4-2.7; P < .01). After multivariate adjustment, this association remained significant (HR 1.6; 95% CI 1.1-2.4). CONCLUSIONS: In patients with multivessel CAD and CKD, treatment with CABG or PCI with multivessel stenting led to similar outcomes of death, MI, or stroke, but CABG was associated with decreased repeat revascularizations. When compared with ARTS participants with normal renal function, those with CKD had substantially elevated risk of adverse clinical outcomes after coronary revascularization.

Aged↗
PubMed2004

Useful benchmarks to evaluate outcomes after esophagectomy and pancreaticoduodenectomy.

BACKGROUND: Multiple publications have suggested that outcomes after complex operations are better at high-volume centers. However, of all the potential "outcomes" to measure, only mortality has been studied extensively. The broadest difference in mortality between low- and high-volume centers has been measured after esophagectomy (EG) and pancreaticoduodenectomy (PD). If a low-volume center recorded high mortality, then a broader set of outcomes beyond mortality would be useful for self-assessment. METHODS: Two single-surgeon prospective databases for outcomes of EG and PD were reviewed in a multispecialty clinic within a tertiary-referral, resident-training hospital. Between January 1996 and December 2002, 174 consecutive patients underwent EG performed by 1 surgeon (25 cases/y), and 232 consecutive patients underwent PD performed by another surgeon (34 cases/y). We measured hospital and 30-day mortality rate, mean operation time (OR time), mean estimated intraoperative blood loss (EBL), mean length of stay (LOS), and the anastomotic leak rate. These outcomes were compared with those of recently published cases for EG and PD. RESULTS: Mortality for both operations was zero. After EG, OR time was 394 minutes (literature = 336), EBL was 204 mL (literature = 964), transfusion rate was 3.5% (literature = 34%), LOS was 11.1 days (literature = 16.6), leak was 2.9% (literature = 9.1%), and reoperation was 1.7% (literature = not stated). After PD, OR time was 450 minutes (literature = 431), EBL was 382 mL (literature = 1,183), transfusion rate was 7.3% (literature = not stated), LOS was 11.2 days (literature = 17.8), leak was 6.5% (literature = 9.9%), and reoperation was 0.4% (literature = 3.8%). CONCLUSIONS: These 2 single-surgeon series provide benchmarks to help better define acceptable outcomes after EG and PD. This assessment demonstrated lower mortality and LOS in a high-volume surgical practice. These outcomes are not associated with OR time but with lower EBL, less need for transfusion, and lower need for reoperation. Anastomotic leaks occurred in both series; however, this was not associated with mortality because of early recognition and the use of nonsurgical minimally invasive techniques. If mortality is high at a low-volume center, then the additional benchmarks of this study, in addition to mortality and LOS, could be used to lower mortality through self-assessment by identifying specific outcomes that need improvement.

Adolescent↗
PubMed2005

Clinical characteristics and rehabilitation outcomes of patients with posterior cerebral artery stroke.

OBJECTIVES: To describe the demographics, clinical profile, and functional outcomes in posterior cerebral artery (PCA) stroke and to identify factors associated with functional change during rehabilitation and discharge disposition. DESIGN: Retrospective study of patients with PCA stroke admitted to a rehabilitation hospital over an 8-year period. SETTING: Free-standing urban rehabilitation hospital in the United States. PARTICIPANTS: Eighty-nine consecutive patients with PCA stroke (48 men, 41 women; mean age, 71.5y) met inclusion criteria. INTERVENTION: Inpatient multidisciplinary comprehensive rehabilitation program. MAIN OUTCOME MEASURES: Demographic, clinical, and discharge disposition information were collected. Functional status was measured using the FIM instrument, recorded at admission and discharge. The main outcome measures were the discharge total FIM score, the change in total FIM score (DeltaFIM), and the discharge disposition. Multiple and logistic regression analyses were performed to identify factors associated with the main outcome measures. RESULTS: The most common impairments were motor paresis (65%), followed by visual field defects (54%) and confusion or agitation (43%). The mean discharge total FIM score +/- standard deviation was 88.3+/-28.2. The mean DeltaFIM was 23.3+/-16.4. Fifty-five (62%) patients were discharged home. On multiple regression analysis, higher admission total FIM score, longer length of stay (LOS), and a rehabilitation stay free of interruptions were associated with higher discharge total FIM score and greater DeltaFIM. Absence of diabetes mellitus and younger age were also associated with higher discharge total FIM scores, and male sex had greater DeltaFIM. On logistic regression analysis, younger patients, higher discharge FIM scores, presence of a caregiver, and the nonnecessity for 24-hour support were associated with a discharge to home. CONCLUSIONS: Motor, visual, and cognitive impairments are common in PCA stroke, and good functional gains are achievable after comprehensive rehabilitation. Higher admission FIM scores, longer LOS, and younger and male patients were associated with better functional outcomes. Most patients were discharged home, particularly those with caregivers and those for whom 24-hour support was not required. Further research should aim at the development of functional outcome measures of greater breadth and sensitivity to visual and cognitive deficits and should compare PCA stroke outcomes with outcomes of strokes in other vascular territories.

Aged↗
PubMed2005

Stroke rehabilitation patients, practice, and outcomes: is earlier and more aggressive therapy better?

UNLABELLED: Horn SD, DeJong G, Smout RJ, Gassaway J, James R, Conroy B. Stroke rehabilitation patients, practice, and outcomes: is earlier and more aggressive therapy better? OBJECTIVE: To examine associations of patient characteristics, rehabilitation therapies, neurotropic medications, nutritional support, and timing of initiation of rehabilitation with functional outcomes and discharge destination for inpatient stroke rehabilitation patients. DESIGN: Prospective observational cohort study. SETTING: Five U.S. inpatient rehabilitation facilities. PARTICIPANTS: Post-stroke rehabilitation patients (N=830; age, >18 y) with moderate or severe strokes, from the Post-Stroke Rehabilitation Outcomes Project database. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Discharge total, motor, and cognitive FIM scores and discharge destination. RESULTS: Controlling for patient differences, various activities and interventions were associated with better outcomes including earlier initiation of rehabilitation, more time spent per day in higher-level rehabilitation activities such as gait, upper-extremity control, and problem solving, use of newer psychiatric medications, and enteral feeding. Several findings part with conventional practice, such as starting gait training in the first 3 hours of physical therapy, even for low-level patients, was associated with better outcomes. CONCLUSIONS: Specific therapy activities and interventions are associated with better outcomes. Earlier rehabilitation admission, higher-level activities early in the rehabilitation process, tube feeding, and newer medications are associated with better stroke rehabilitation outcomes.

Activities of Daily Living↗
PubMed2004

State of the science: outcomes of acute inpatient psychiatric care.

Identifying client outcomes related to nursing care is critical to establish empirical evidence that supports the effectiveness of psychiatric nursing. The purpose of this article is to conduct a methodological review of the literature that examines client outcomes after treatment in acute care inpatient psychiatric hospitals and psychiatric units of general hospitals. The databases Medline, CINAHL, HealthSTAR/Ovid HealthSTAR and psycINFO were searched for articles published between 1991and 2004. A review of literature was conducted of studies related to client outcomes after inpatient psychiatric treatment. Forty-seven studies were reviewed. There is a dearth of literature related to client outcomes after inpatient psychiatric treatment. The existing literature has conceptual and methodological limitations. The organization of psychiatric nursing care, in relation to outcomes is nonexistent in the literature. Outcomes that are sensitive to nursing care must be conceptualized theoretically and then examined empirically. The Quality Health Outcomes model is proposed to conceptualize outcomes of acute inpatient psychiatric treatment that are sensitive to nursing interventions and the organization of nursing care.

Acute Disease↗
PubMed2004

Clinical predictors of surgical outcome in patients with thoracic outlet syndrome operated on via transaxillary approach.

OBJECTIVES: Although the transaxillary route appears to be the optimal approach in patients with thoracic outlet syndrome (TOS), the effect of clinical features on surgical outcome remains unclear. We conducted a study to determine the clinical predictors of surgical outcome in patients with TOS. METHODS: We examined the data charts of patients with TOS who underwent operation via transaxillary approach. We investigated the possible correlations between the clinical features and surgical outcomes, and analyzed the data with logistic regression model to clarify the effect of clinical features on surgical outcome. RESULTS: A total of 127 patients with a mean age of 32.1+/-10.0 years (range 14-62 years) were analyzed. The rates of favorable and poor surgical outcomes were 82.7 and 17.3%, respectively. The subgroups of symptom duration (P=0.023), the subgroups of ulnar nerve conduction velocity (P=0.033) and the presence of cervical rib (P=0.003) showed a significant correlation with surgical outcome. Multivariate analysis revealed that the shorter duration of symptoms (P=0.017) and the presence of a cervical rib (P=0.026) had a significantly unfavorable effect on surgical outcome. CONCLUSIONS: The shorter duration of symptoms and the presence of a cervical rib may imply an unfavorable surgical outcome in patients with TOS.

Adolescent↗
PubMed2004

Relationship of shuttle walk test and lung cancer surgical outcome.

OBJECTIVE: Surgery remains the treatment of choice in patients with potentially resectable lung carcinoma. Both the British Thoracic Society and American Chest Physician guidelines for the selection of patients with lung cancer surgery suggest the use of a shuttle walk test to predict outcome in patients with borderline lung function. The guidelines suggest that if the patient is unable to walk 250 m during a shuttle walk test, they are high risk for surgery. However, there is no published evidence to support this recommendation. Therefore, we undertook a prospective study to examine the relationship between shuttle walk test and surgical outcome in 139 patients undergoing assessment for possible lung cancer surgery. METHODS: The shuttle walk test was performed in 139 potentially resectable patients, recruited over a 2 year period, prior to surgery. One hundred and eleven patients underwent surgery. Outcome of surgery, including duration of hospital stay, complication and mortality rates was recorded. Student's t-test was used to compare the shuttle walk distance in patients with good and poor outcome from surgery. RESULTS: Mean age of patients undergoing surgery was 69 years (42-85). Mean shuttle walk distance was 395 m (145-780), with a mean oxygen desaturation of 4% (0-14) during the test. Sixty nine patients had a good surgical outcome and 34 had a poor outcome. The shuttle walk distance was not statistically different in the two outcome groups. CONCLUSION: Shuttle walk distance should not be used to predict poor surgical outcome in lung cancer patients, contrary to current recommendations. It is therefore advisable to perform a formal cardiopulmonary exercise test if at all possible. The usefulness of a shuttle walk test might be improved. It could be compared to a predicted value, as for a formal cardiopulmonary exercise test.

Adult↗
PubMed2006

Predictors of outcome in patients with papillary thyroid carcinoma.

AIM OF THE STUDY: To evaluate prognostic factors with respect to the outcome in a consecutive series of patients with papillary thyroid carcinoma (PTC) treated at the same institution during a 20-year-period, and to evaluate further the predictive ability of outcome of the pTNM, AMES and MACIS prognostic systems in these patients. MATERIALS AND METHODS: Two hundred and twenty consecutive patients operated on for primary PTC at the Karolinska Hospital between 1980 and 1999 were examined retrospectively. Patient and tumour characteristics at the time of surgery were compared to the patients' outcomes. Univariate and multiple logistic regression analyses were used to identify independently significant prognostic factors with respect to the outcome. In addition, the classification of the patients according to the pTNM, AMES and MACIS prognostic systems were compared to the outcomes. RESULTS: At the end of the follow-up period 201 patients were still alive without disease, 6.5% had died from PTC and 2.5% were alive with persisting disease. In 16 patients, radical surgery could not be performed due to extensive tumour growth and/or distant metastases. Recurrences were detected in 14% of the patients considered as radically operated. The strongest independent predictors for local or distant recurrences and poor clinical outcome were the lack of radical surgery and increasing tumour size. In this investigation MACIS appeared to be the better system, regarding efficacy in predicting the outcome of PTC. CONCLUSION: Removal of all tumour tissue appears most important to a favorable outcome and in our patients MACIS appears the most useful prognostic system taking completeness of resection into account.

Adolescent↗
PubMed2005

Quality management systems and clinical outcomes in Dutch nursing homes.

The objective of the article is to explore the impact quality management systems and quality assurance activities in nursing homes have on clinical outcomes. The results are based on a cross-sectional study in 65 Dutch nursing homes. The management of the nursing homes as well as the residents (N = 12,377) participated in the study. Primary survey-data about the implementation of quality management systems and quality assurance activities were collected in 1994/1995 and in 1998, and were combined with information on resident characteristics and the prevalence of undesirable clinical outcomes. The results demonstrate that there are differences between nursing homes in the prevalence of undesirable clinical outcomes. In the nursing homes with the lowest scores, undesirable outcomes occur approximately 10 times less often than in nursing homes with the highest scores. The multi-level analysis has demonstrated that the differences in outcomes are mainly caused by differences between residents and, to some extent, also by differences between nursing homes. Resident characteristics explain 48% of the differences between residents and 72% of the differences between nursing homes. The size of the nursing home, the involvement of a client council and the implementation of a quality management system could explain a small part of the remaining variation in the number of undesirable outcomes. It seems that the implementation of a quality management system and the involvement of a client council had significant influence on the number of undesirable outcomes. Approximately 50% of the undesirable outcomes cannot be explained by the selected resident characteristics, the size of the nursing home and the implementation of quality management systems or quality assurance activities.

Aged↗
PubMed2006

Using the outcome for imputation of missing predictor values was preferred.

BACKGROUND AND OBJECTIVE: Epidemiologic studies commonly estimate associations between predictors (risk factors) and outcome. Most software automatically exclude subjects with missing values. This commonly causes bias because missing values seldom occur completely at random (MCAR) but rather selectively based on other (observed) variables, missing at random (MAR). Multiple imputation (MI) of missing predictor values using all observed information including outcome is advocated to deal with selective missing values. This seems a self-fulfilling prophecy. METHODS: We tested this hypothesis using data from a study on diagnosis of pulmonary embolism. We selected five predictors of pulmonary embolism without missing values. Their regression coefficients and standard errors (SEs) estimated from the original sample were considered as "true" values. We assigned missing values to these predictors--both MCAR and MAR--and repeated this 1,000 times using simulations. Per simulation we multiple imputed the missing values without and with the outcome, and compared the regression coefficients and SEs to the truth. RESULTS: Regression coefficients based on MI including outcome were close to the truth. MI without outcome yielded very biased--underestimated--coefficients. SEs and coverage of the 90% confidence intervals were not different between MI with and without outcome. Results were the same for MCAR and MAR. CONCLUSION: For all types of missing values, imputation of missing predictor values using the outcome is preferred over imputation without outcome and is no self-fulfilling prophecy.

Adult↗