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PubMed2006

School-level intraclass correlation for physical activity in sixth grade girls.

PURPOSE: The Trial for Activity in Adolescent Girls (TAAG) is a group-randomized trial (GRT) to reduce the usual decline in moderate to vigorous physical activity (MVPA) among middle school girls. We report the school-level intraclass correlation (ICC) for MVPA from the TAAG baseline survey of sixth grade girls and describe the relationship between the schedule of data collection and the ICC. METHODS: Each of six sites recruited six schools and randomly selected 60 sixth grade girls from each school; 74.2% participated. Girls were grouped in waves defined by the date measurements began and asked to wear an Actigraph accelerometer for 6 d. Occasional missing data were replaced by imputation, and counts above 1500 per 30 s were treated as MVPA, converted into metabolic equivalents (METs), and summed over 6 a.m.-midnight to provide MET-minutes per 18-h day. Mixed-model regression was used to estimate ICC. RESULTS: The school-level ICC were higher when estimated from a single wave compared with three waves (e.g., 0.057 vs 0.022) and across weekdays compared with weekend days (e.g., 0.024 vs 0.012). Power in a new trial would be greater with some schedules (e.g., 88% given three waves and 6 d) than with others (e.g., 23% given one wave and Tuesday only). CONCLUSIONS: The schedule of data collection can have a dramatic effect on the ICC for MVPA. In turn, this can have a dramatic effect on the standard error for an intervention effect and on power. Investigators will need to consider the expected magnitude of the ICC and the validity of the MVPA estimates associated with their data collection schedule in planning a new study.

Child↗
PubMed2004

Multicomponent fortified human milk for promoting growth in preterm infants.

BACKGROUND: For term infants, human milk provides adequate nutrition to facilitate growth, as well as potential beneficial effects on immunity and the maternal-infant emotional state. However, the role of human milk in premature infants is less well defined as it contains insufficient quantities of some nutrients to meet the estimated needs of the infant. Observational studies have suggested that infants fed formula have a higher rate of growth than infants who are breast fed. However, there are potential short term and long term benefits from human milk. Commercially-produced multicomponent fortifiers provide additional nutrients to supplement human milk (in the form of protein, calcium, phosphate, and carbohydrate, as well as vitamins and trace minerals). OBJECTIVES: The main objective was to determine if addition of multicomponent nutritional supplements to human milk leads to improved growth, bone metabolism and neurodevelopmental outcomes without significant adverse effects in premature infants. SEARCH STRATEGY: Searches were made of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 3003), MEDLINE (searched August 29, 2003), previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal handsearching mainly in the English language. SELECTION CRITERIA: All trials utilising random or quasi-random allocation to supplementation of human milk with multiple nutrients or no supplementation in premature infants within a nursery setting were eligible. DATA COLLECTION AND ANALYSIS: Data were extracted using the standard methods of the Cochrane Collaboration and its Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author and synthesis of data using relative risk and weighted mean difference. MAIN RESULTS: Supplementation of human milk with multicomponent fortifiers is associated with short term increases in weight gain, linear and head growth. There is no effect on serum alkaline phosphatase levels; it is not clear if there is an effect on bone mineral content. Nitrogen retention and blood urea levels appear to be increased. There are insufficient data to evaluate long term neurodevelopmental and growth outcomes, although there appears to be no effect on growth beyond one year of life. Use of multicomponent fortifiers does not appear to be associated with adverse effects, although the total number of infants studied and the large amount of missing data reduces confidence in this conclusion. Blood urea levels are increased and blood pH levels minimally decreased, but the clinical significance of this is uncertain. REVIEWER'S CONCLUSIONS: Multicomponent fortification of human milk is associated with short-term improvements in weight gain, linear and head growth. Despite the absence of evidence of long-term benefit and insufficient evidence to be reassured that there are no deleterious effects, it is unlikely that further studies evaluating fortification of human milk versus no supplementation will be performed. Further research should be directed toward comparisons between different proprietary preparations and evaluating both short-term and long-term outcomes in search of the "optimal" composition of fortifiers.

Food, Fortified↗
PubMed2006

Recombinant factor VIIa in the management of postpartum bleeds: an audit of clinical use.

BACKGROUND: This paper presents an analysis of 25 patient cases in which recombinant factor VIIa was used in the management of postpartum hemorrhage, including severe and/or life-threatening bleeds. Anecdotal experiences in the empirical use of this agent are described and dosing regimens, effects on bleeding, and safety data are presented. METHODS: Data were extracted from the international, internet-based, voluntary registry, haemostasis.com. Search results were manually cross-checked against monthly summary reports and cases of confirmed postpartum hemorrhage were analyzed by the authors. Case providers were contacted individually to approve the use of their cases, supply any missing data, and validate the data already held. RESULTS: Of 43 reported gynecological admissions for hemorrhage, 13 were excluded as they did not relate to childbirth, and 5 due to insufficient data. The remaining 25 records, all associated with postpartum hemorrhage, were submitted by 14 doctors from 5 countries. Following administration of recombinant factor VIIa, bleeding stopped in 18 cases (72%), markedly decreased in 2 (8%), and decreased in 4 (16%). Bleeding increased following recombinant factor VIIa administration in only 1 patient (4%). Requirements for replacement blood products and crystalloids/colloids were also greatly curtailed. A full recovery was achieved by most patients (22/25, 88%) with few complications, even when recombinant factor VIIa was administered as salvage therapy. There were no thrombotic complications associated with recombinant factor VIIa administration. CONCLUSIONS: This review provides the largest aggregate of cases in which recombinant factor VIIa has been used to control obstetrical bleeding. A review of these cases suggests that this agent may be a useful and safe adjunctive therapy in the management of postpartum hemorrhage.

Adult↗
PubMed2005

Complexity of the relation between physical activity and stroke: a meta-analysis.

OBJECTIVE: To explore the associations of recreational and occupational physical activity with ischemic and hemorrhagic stroke by means of meta-analysis. DATA SOURCES: PUBMED was searched for studies published in English up to December 2001. Keywords used were physical activity, exercise, cerebrovascular disease, stroke, ischaemic stroke, and haemorrhagic stroke. Reference lists were reviewed for additional studies. STUDY SELECTION: Cohort and case-control studies investigating the relation between physical activity and stroke were identified (n = 36). The article reporting the longest follow-up time was included if there was > or =1 report of the same study (4 exclusions). Studies had to report a measure of physical activity. A study that measured physical fitness was excluded. DATA EXTRACTION: Details of study methods, samples, levels of physical activity, types of stroke, and estimates of risk (relative risk, RR) were extracted independently by 3 reviewers from the 24 cohort and 7 case-control studies that were included. Authors of relevant studies were contacted to obtain missing data. Risk estimates were standardized. Risks for subgroups within the samples (e.g., women and men) were treated as separate study units. Physical activity was separated into occupational and leisure activity. MAIN RESULTS: In studies of occupational activity, risk of hemorrhagic stroke (RR, 0.31; 95% CI, 0.13-0.76; 1 study) and risk of ischemic stroke (RR, 0.57; CI, 0.43-0.77; 5 studies) were lower for people most active versus inactive at work, risk of ischemic stroke was lower for people who were most active versus moderately active (RR, 0.77; CI, 0.60-0.98; 5 studies), and risk of total stroke was lower for people moderately active versus inactive (RR, 0.64; CI, 0.48-0.87; 4 studies), but none of the other 8 comparisons of level of occupational activity showed significant differences. In studies of leisure-time activity, risk of total stroke (RR, 0.78; CI, 0.71-0.85; 19 studies), risk of hemorrhagic stroke (RR, 0.74; CI, 0.57-0.96, 9 studies), and risk of ischemic stroke (RR, 0.79; CI, 0.69-0.91; 11 studies) were lower for people most active versus inactive. Risk of total stroke was lower for people moderately active versus inactive (RR, 0.85; CI, 0.78-0.93; 15 studies), but none of the other 7 comparisons showed significant differences. In regression analysis weighted by methodologic quality, RR of stroke for active persons was slightly lower, with narrower confidence intervals. Leisure-time activity compared with inactivity was associated with a greater reduction in risk of hemorrhagic stroke in men (RR, 0.54; CI, 0.36-0.81) than in women (RR, 0.76; CI, 0.67-0.86). Studies conducted in Europe found more effect of activity (RR, 0.47; CI, 0.33-0.66; 3 studies) than US studies (RR, 0.82; CI, 0.75-0.90). Study results did not differ by type of study or year of publication. CONCLUSIONS: Recreational and occupational physical activity were both associated with reductions in risk of stroke. Studies varied widely in their estimates of risk; lower risks were found for active versus inactive men than women and for European versus US studies.

Journal Article↗
PubMed2003

[Is it possible to rate digestive toxicities of NSAIDs?].

EPIDEMIOLOGICAL STUDIES: Most often case-control studies, based on serious GI complications reported in hospitalization statistics are available to compare the gastro-intestinal (GI) safety and tolerability of the various NSAIDs currently on the market. Based on pooled data regarding 5 medicinal products among the most widely used and best documented (ibuprofen, diclofenac, naproxen, indomethacin and piroxicam), the relative result consistency of these studies is striking, thus these 5 NSAIDs may be legitimately classified from the least gastro-toxic (ibuprofen) to the most gastrotoxic (piroxicam). MISSING DATA: But epidemiological survey results may be questioned. Indeed, the volume of prescriptions written, individual dosages and the route of administration are not well documented. Above all, the disease justifying the prescription of an NSAID is never specified. Yet, it is likely that some major anti-inflammatory agents are prescribed more often, at higher doses in patients more seriously and chronically affected, and thus more likely to develop serious gastro-intestinal adverse effects. Data for recently marketed NSAIDs are less comprehensive, with the number of subjects exposed to these new NSAIDs being low, and the validity of the results reported, limited. Regarding currently marketed specific cyclo-oxygenase 2 inhibitors, recent cohort studies demonstrating that the relative risk of ulcer is about half compared to subjects treated with traditional NSAIDs are available. IN SUMMARY: The epidemiological survey results can only be extrapolated to individual clinical practice with great caution.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2001

Measuring quality of life in women with vertebral fractures due to osteoporosis: a comparison of the OQLQ and QUALEFFO.

INTRODUCTION: Studies comparing the performance of health-related quality of life instruments in osteoporosis are lacking. We compared the feasibility, validity and reliability of the osteoporosis quality of life questionnaire (OQLQ) and the QUALEFFO (test version) in women with vertebral deformities due to osteoporosis. METHODS: Three hundred and thirty-eight patients diagnosed with primary osteoporosis and vertebral deformity and a random sample of 304 women from the general population (control group) were recruited. Patients and controls were randomly assigned to receive either the OQLQ or the QUALEFFO, and the SF-36 and EQ-5D. Test-retest reliability was assessed in the patient group. RESULTS: The QUALEFFO had more items with missing data and took slightly longer to administer (20.7 vs. 18.7 min). Cronbach's alpha and intraclass correlation coefficient (ICC) values for OQLQ domains (alpha: 0.75-0.91; ICC: 0.85-0.93) were slightly higher than for the QUALEFFO (alpha: 0.63-0.90; and ICC: 0.80-0.93). OQLQ and QUALEFFO domain scores correlated as expected with SF-36 and EQ-5D domains. Both questionnaires discriminated between patients and controls though the OQLQ showed slightly better discriminant power. DISCUSSION: The superior performance of the OQLQ in terms of administration time, missing responses, and discriminatory capacity needs to be weighed against the advantages of using a self-administered instrument such as the QUALEFFO. A full comparison also requires data on sensitivity to change.

Aged↗
PubMed2004

Analysis of longitudinal studies with death and drop-out: a case study.

The analysis of longitudinal data has recently been an active area of biostatistical research. Two main approaches to analysis have emerged, the first concentrating on modelling evolution of marginal distributions of the main response variable of interest and the other on subject-specific trajectories. In epidemiology the analysis is usually complicated by missing data and by death of study participants. Motivated by a study of cognitive decline in the elderly, this paper argues that these two types of incomplete follow-up may need to be treated differently in the analysis, and proposes an extension to the marginal modelling approach. The problem of informative drop-out is also discussed. The methods are implemented in the 'Stata' statistical package.

Age Factors↗
PubMedDate not supplied

[Treatment and temperature series study for use in public health. The case of Castilla-La Mancha, Spain].

BACKGROUND: Numerous articles relate atmospheric variables to health indicators. In large regions, such as Castilla-La Mancha, it may be necessary to divide the region into areas in terms of the atmospheric variables available by selecting a representative weather station for each zone. This article focuses on analyzing the daily temperature data from numerous Castilla La Mancha observatories and reducing the number thereof to a few representative stations for being used in studies relating atmospheric variables to health indicators in this region. METHODS: Castilla-La Mancha weather stations were selected in terms of the number of years available and missing data. After filling in the gaps in the selected series, to detect any possible discontinuities and to homogenize the series, the daily temperature data is used in hierarchical cluster and factorial analyses by principal components. RESULTS: Factorial analyses extract one single factor by using the maximum, mean or minimum temperature series. For the maximum temperatures, this factor explains 93.45% of the variance, with an eigenvalue of 39.249. The "Compuesta" station in Toledo shows correlation coefficients in the principal components matrix of 0.987, 0.991 and 0.981 respectively for the maximum, mean and minimum temperature series. CONCLUSIONS: Castilla-La Mancha is an isoclimatic region in terms of the temperature, the "Compuesta" station in Toledo being selected as the representative station for the region for public health studies. The results afford the possibility of conducting studies broken down into small units such as the provinces, with the stations in the government capitals as a reference.

Public Health↗
PubMedDate not supplied

[Health financing in Lebanon. I. Organization of health care services, coverage system and contribution of the Ministry of Public Health].

This paper intends to analyze the health care system in Lebanon from the organizational and financial points of view. It allows for an understanding of the health services' market by tackling it from different angles: supply versus demand, private versus public sectors, curative versus preventive services, hospital versus ambulatory care. This study necessitated a review of all previous surveys made in this field, during the after-war period. It also needed the daily collection and follow-up of pertinent data with all private and public agencies and concerned ministries, over a one-year period. In addition, a critical analysis has been made to the survey Conditions de vie des ménages, en 1997, that was carried out by the Central Administration of Statistics, that came to complete the missing data concerning household expenditures on insurance and health services. Especially that this survey covered the same period (1997), subject of this study. The paper reveals that, although the private sector is the main provider of both hospital and ambulatory care, private hospitals are flourishing on public money, whereas outpatients care is mainly financed by the households. Evidence shows that the Lebanese health care system succeeded in resolving the problem of accessibility to primary, secondary and tertiary health care, responding thus to the value of equity. But, at the price of an ever escalating cost, threatening the sustainability of the system. This is what is attained in this paper, as it shows clearly that expenditures on health have reached an alarming level of the GDP share. Our purpose being providing solid arguments in favor of reforming the health system.

Budgets↗
PubMed1989

A cautionary note on the use of autoregressive models in analysis of longitudinal data.

Rosner et al. presented a simple, easily implemented modelling method for retaining time order relationships in analyses of longitudinal data when successive measures are correlated. Evaluation of time order is particularly useful in epidemiologic studies concerned with exposure to potentially toxic substances and subsequent outcome, but may also have use in more traditional growth studies that relate intake to subsequent development. The analysis allows for unequally spaced measures and missing data. The estimation method permits varying numbers of observations per subject and, with measures equally spaced, one can fit the model with use of ordinary least squares regression software. We report on a potential false association that can result when both exposure and outcome are related to time. We illustrate this problem with a small scale simulation and example. We also note a more serious problem with Rosner's approach in interpreting parameters. Although the model may be useful for prediction, parameters depend on the autocorrelation and are not readily interpretable. We recommend alternative modelling strategies be used when autocorrelation of errors is suspected.

Age Factors↗
PubMed1997

[The classification of the severely and multiply injured--what has been established?].

Among the numerous scores available for the quantitative evaluation of injury severity, only few have proved themselves effective in clinical practice. The "Revised Trauma Score"--based on physiological variables--is the most widespread in preclinical use. The "Injury Severity Score"--based on anatomical data--is the most accepted for defined indices. However, a combination of the two, known as the "Trauma and Injury Severity Score (TRISS)", represents an international standard for quality control. Recent experience with TRISS in central Europe has shown that an increasing number of patients cannot be registered due to missing data. One reason for this is the intense preclinical treatment and its influence on physiological variables. The practicability of this method for quality control--combined with additional efforts--must be questioned in Germany. A score system based, for example, on the obligatory score of the "International Classification of Diseases", might be a good alternative with less effort required for each patient. Further investigations are necessary, however, before any final decisions are made.

Acute Disease↗
PubMed2006

Talking the talk on walking the walk: a 12-item generic walking scale suitable for neurological conditions?

BACKGROUND: The Multiple Sclerosis Walking Scale (MSWS-12) was developed to measure the impact of multiple sclerosis on walking. Many other disabling neurological conditions affect patients' ability to walk, and a generic measure of walking could provide valuable insights into patients' perceptions in clinical trials and epidemiological studies as well as routine clinical practice. OBJECTIVE: To evaluate the clinical usefulness and psychometric properties of the Walking Impact Scale (Walk-12), a modified version of the MSWS-12, in patients with neurological conditions. DESIGN: A prospective, observational study of 120 consecutive patients admitted for rehabilitation. The Walk-12 was used to measure the impact of neurological disability on walking. Traditional psychometric methods (data quality, scaling assumptions, targeting, reliability, validity and responsiveness) were used to assess the Walk-12. Transition questions were used on discharge to measure perception of change. Outcome was also measured using the timed walk test (TWT), Barthel Index (BI) and Functional Independence Measure (FIM). RESULTS: For the total group, missing data were few, scaling assumptions were satisfied, and internal consistency was 0.94. Correlations between the Walk-12 and TWT, BI and FIM motor score were moderate (r=-0.58, -0.26, -0.31). Responsiveness of the Walk-12 was high (effect size=1.12). Relationships between effect size and patients' and physiotherapists' opinion of change in walking demonstrated good concordance. Preliminary subgroup analyses indicate satisfactory psychometric properties across different neurological conditions; however, sample numbers in these analyses are small. CONCLUSIONS: In this sample of neurologically disabled patients the Walk-12 was clinically useful and satisfied standard psychometric criteria. This provides preliminary evidence that it may be suitable as a generic measure of walking ability.

Adolescent↗
PubMed1999

Comparison of genetic algorithms and other classification methods in the diagnosis of female urinary incontinence.

Galactica, a newly developed machine-learning system that utilizes a genetic algorithm for learning, was compared with discriminant analysis, logistic regression, k-means cluster analysis, a C4.5 decision-tree generator and a random bit climber hill-climbing algorithm. The methods were evaluated in the diagnosis of female urinary incontinence in terms of prediction accuracy of classifiers, on the basis of patient data. The best methods were discriminant analysis, logistic regression, C4.5 and Galactica. Practically no statistically significant differences existed between the prediction accuracy of these classification methods. We consider that machine-learning systems C4.5 and Galactica are preferable for automatic construction of medical decision aids, because they can cope with missing data values directly and can present a classifier in a comprehensible form. Galactica performed nearly as well as C4.5. The results are in agreement with the results of earlier research, indicating that genetic algorithms are a competitive method for constructing classifiers from medical data.

Algorithms↗
PubMed2006

Estimation of the Bath Ankylosing Spondylitis Disease Activity Index cutoff for perceived symptom relief in patients with spondyloarthropathies.

OBJECTIVE: To estimate the best Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) cutoff based on patients' perceptions of symptom relief collected in a large population of patients with spondyloarthropathies (SpA), in comparison to the BASDAI cutoff determined by experts. METHODS: A survey of patient perceptions about current disease control was conducted among the members of Spondylis, one of the main not-for-profit SpA patient organizations in France. BASDAI was among data collected by the questionnaire. To estimate the best BASDAI cutoff for discriminating between poor and well perceived controlled groups, we plotted the receiver operating characteristic (ROC) curve. We also determined the cutoff separately in male and female patients. RESULTS: Of the 1000 mailed questionnaires, 485 were returned without any missing data regarding perceived disease control and the BASDAI. Of these patients, 55.3% perceived inadequate control of their disease. The mean BASDAI in the overall population was 43.5 +/- 22.9, 30.4 +/- 19.9 in the well controlled group and 54 +/- 19.4 in the poorly controlled group (p < 0.001). The best BASDAI cutoff for discriminating between patients in the 2 groups was 39 (sensitivity 74.6% and specificity 72.4%). According to gender, the best cutoff was 44 for women and 36 for men. CONCLUSION: The best BASDAI cutoff of 39 based on patients' perceptions was very similar to that selected by international experts, i.e., 40. Gender affected the cutoff for perceived symptom relief in our study. These results need to be confirmed by further studies collecting the opinions of both patients and physicians.

Antirheumatic Agents↗
PubMed1991

Running average analysis of clinical trial ambulatory blood pressure data.

A method is presented for analyzing ambulatory blood pressure monitoring (ABPM) time series data obtained from well-controlled clinical trials. The method uses running averages based on fixed time-of-day intervals (rather than a fixed number of neighboring measurements). These "interval running averages" effectively estimate average blood pressure during the specified time intervals, adjusting for unequal spacing between measurements, embedded missing data, varying measurement times-of-day, and doses of study medication taken during ABP monitoring. Blood pressure changes from baseline may be computed using the interval running averages in order to separate treatment effects from patients' normal daily blood pressure cycles. To ensure valid estimation of treatment effects over time, study medication dosing times should be rigorously controlled in the trial design and conduct. Interval running average curves may be presented graphically, and from them summary statistics may be computed for purposes of statistical analysis. By allowing for the inherent complications of ABP data collection, the effect of antihypertensive treatment in well-controlled clinical trials can be discerned.

Ambulatory Care↗
PubMed2004

Lessons learned from the data analysis of the second harvest (1998-2001) of the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database.

OBJECTIVE: The analysis of the second harvest of the STS Congenital Heart Surgery Database produced meaningful outcome data and several critical lessons relevant to congenital heart surgery outcomes analysis worldwide. METHODS: This data harvest represents the first STS multi-institutional experience with software utilizing the nomenclature and database requirements adopted by the STS and EACTS (April 2000 Annals of Thoracic Surgery). Members of the STS Congenital Heart Committee analyzed the STS data. RESULTS: This STS harvest includes data from 16 centers (12787 cases, 2881 neonates, 4124 infants). In 2002, the EACTS reported similar outcome data utilizing the same database definitions (41 centers, 12736 cases, 2245 neonates, 4195 infants). Lessons from the analysis include: (1) Death must be clearly defined. (2) The Primary Procedure in a given operation must be documented. (3) Inclusionary and exclusionary criteria for all diagnoses and procedures must be agreed upon. (4) Missing data values remain an issue for the database. (5) Generic terms in the nomenclature lists, that is terms ending in Not Otherwise Specified (NOS), are redundant and decrease the clarity of data analysis. (6) Methodology needs to be developed and implemented to assure and verify data completeness and data accuracy. 'Operative Mortality' and 'Mortality Assigned to this Operation' were defined by the STS and EACTS; these definitions were not utilized uniformly. 'Thirty Day Mortality' was problematic because some centers did not track mortality after hospital discharge. Only 'Mortality Prior to Discharge' was consistently reported. Designation of Primary Procedure for a given operation determines its location for analysis. Until Complexity Scores lead to automated methodology for choosing the Primary Procedure, the surgeon must designate the Primary Procedure. Inclusionary and exclusionary criteria for all diagnoses and procedures have been developed in an effort to define acceptable concomitant diagnoses and procedures for each analysis. Improvements in data completeness can be achieved using a variety of techniques including developing more functional techniques of data entry at individual institutions and software improvements. Future versions of the STS Congenital Database will request that the coding of diagnoses and procedures avoid the terms ending in NOS. CONCLUSIONS: Lessons from this data harvest should improve congenital heart surgery outcome analysis.

Databases, Factual↗
PubMed1999

The consequences of treatment and disease in patients with primary CNS non-Hodgkin's lymphoma: cognitive function and performance status. North Central Cancer Treatment Group.

Per protocol, patients with primary CNS non-Hodgkin's lymphoma in an intergroup phase II trial conducted by the North Central Cancer Treatment Group and the Eastern Cooperative Oncology Group had their cognitive functions measured using the Folstein and Folstein Mini-Mental Status Examination (MMSE) and their physical functions measured using the Eastern Cooperative Oncology Group Performance Score (PS) at study entry, at each treatment evaluation, and at quarterly intervals thereafter until disease progression or death. Of the 53 eligible participants who began therapy, 46 (87%) had baseline MMSE scores recorded, 36 (68%) had at least one follow-up MMSE, and 32 (60%) had both, while 52 (98%) had baseline PS, 49 (92%) had at least one follow-up PS, and 48 (91%) had both. Patterns of MMSE and PS values over time were studied in each individual, in the group as a whole, in the 20 patients who completed the study regimen, in the 23 who survived more than a year, and in patients who were classified as nonprogressors at each key evaluation. For each patient, all recorded values were plotted versus time, with dates of disease progression and death included, to look for signs of decline in cognitive or physical function preceding adverse events. Long-term declines in scores of both cognitive and physical function were observed in many treated patients with primary CNS non-Hodgkin's lymphoma. Nearly all patients who were alive more than 52 weeks after study entry had a demonstrable decline in cognitive and physical functionality. Such declines may occur before disease progression is documented; they may also occur in some patients who have long-term follow-up without evidence of disease progression. Declining MMSE and PS was a poor predictor of disease progression. There was no association of PS and toxicity. The data from this study demonstrated the considerable difficulties we encountered conducting an ancillary study such as this within a multicenter clinical trial. Firstly, the test instruments written into the protocol were unable to tell if the declines seen were due to disease, treatment, co-morbidity, or other factors. Secondly, the missing data created difficulties in interpreting outcome.

Adult↗
PubMed2002

[Factors associated to hospitalization of children under five years of age, São Paulo, Brazil].

OBJECTIVE: In developing countries acute respiratory infection (ARI) is the leading cause of hospitalization among children under five years of age. Their underprivileged life conditions and restricted access to health care services are important determining factors. The objective of the study was to assess hospital morbidity and to identify factors associated to hospitalization of children under five years of age. METHODS: A data set derived from a cross-sectional study on health conditions of children under five years of age in the city of Embu, a county located in the metropolitan region of São Paulo, Brazil, was used. The inclusion criteria were one child per family (random selection). The exclusion criteria were missing data on any study variable. The sample size was 893 children. Data was collected using household interviews with mother or caretaker. Statistical analysis was performed using logistic regression models to identify factors associated with hospitalization. RESULTS/CONCLUSIONS: Sixty-five (7.7%) children were hospitalized. Of them, 41.5% were admitted with a respiratory tract disease, mainly due to an ARI (27.7 %). Factors associated to hospitalization included: low birth weight; perinatal problems; chronic illness; death of a sibling under the age of five; grandmother as day caretaker; living in overcrowded places, and mother's higher educational level.

Acute Disease↗