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PubMed2003

A randomized trial of four patient satisfaction questionnaires.

BACKGROUND: Patient satisfaction surveys are increasingly used by hospitals. Many questionnaires are available, but little evidence exists to guide the choice of the most suitable instrument. OBJECTIVE: To compare the acceptability and patient perceptions of 4 patient satisfaction questionnaires. RESEARCH DESIGN: Randomized trial of 4 satisfaction questionnaires: Picker, Patient Judgment System (PJS), Sequs, and a locally developed Lausanne questionnaire. SUBJECTS: Patients discharged from 2 Swiss teaching hospitals (n = 2850). MEASURES: Response rates, missing data, completion time, and patient ratings of the questionnaire (5-point agree-disagree scale). RESULTS: Response rates were similar across instruments (Picker: 70%, PJS: 71%, Sequs: 68%, Lausanne: 73%; P= 0.27). The Picker questionnaire had the most missing responses (mean per item: Picker: 3.1%, PJS: 1.9%, Sequs: 1.6%, Lausanne: 1.1%; P<0.001) and took the longest to complete (minutes: Picker: 19.3, PJS: 12.5, Sequs: 13.4, Lausanne: 13.1; P<0.001), but the fewest patients indicated that the questionnaire failed to address at least 1 important aspect of the hospital stay (Picker: 28.2%, PJS: 38.8%, Sequs: 39.1%, Lausanne: 28.9%; P<0.001). Patient evaluations of the questionnaires were generally similar; the most favorable assessment was chosen by approximately half of the respondents (average of 10 items: Picker: 46.5%, PJS: 46.2%, Sequs: 47.4%, Lausanne: 48.2%; P= 0.60). Key survey results differed considerably by questionnaire. CONCLUSIONS: No questionnaire emerged as uniformly better than the others in terms of acceptability and patient evaluations. All 4 could be used for patient satisfaction surveys.

Aged↗
PubMed2001

Methodologic lessons learned from hot flash studies.

PURPOSE: In the course of conducting a series of prospective clinical trials devoted to defining new treatment opportunities for hot flashes in cancer survivors, considerable experience has been acquired with related methodologic issues. This article has been written in response to many queries regarding this methodology. PATIENTS AND METHODS: A series of seven different clinical trials that involved 968 patients was used for this work. Reliable and valid definitions of hot flash intensity were developed from patient-reported descriptions. Concomitant validity and reliability assessment of patient-completed diaries was undertaken to compare hot flash data with toxicity and quality-of-life (QOL) end points and to examine consistency across patient groups using variability analysis and correlation procedures. Parametric data from this meta-analysis was used to examine relative power considerations for the design of phase II and phase III clinical trials. RESULTS: Daily diaries used in these studies exhibited consistency and reliability and had few missing data. Hot flash frequency and hot flash score (frequency multiplied by average severity) variables produced almost identical end point results. For phase III placebo-controlled studies, 50 patients per treatment arm seem appropriate to provide sufficient power specifications to detect a clinically meaningful change in hot flash activity. For phase II trials, 25 patients per trial seem to provide reasonable estimates of eventual hot flash efficacy to screen potential agents for more definitive testing. CONCLUSION: Given the data gained from these experiences, we can plan and carry out more efficient trials to identify efficacious agents for the reduction of hot flash activity.

Analysis of Variance↗
PubMed2001

Widespread pain and Sjögren's syndrome.

OBJECTIVE: Reports exist of an association between fibromyalgia (FM) and Sjogren's syndrome (SS). Widespread pain is a necessary component of FM. We explored the association of widespread pain and SS. METHODS: Data were abstracted from the records of the most recent 100 patients evaluated in the SS clinic. The subjects included individuals with or without SS who had screened for features of the disorder. Patients with confounding disorders or missing data were excluded. The presence of widespread pain was established by questionnaire in 92 subjects. Widespread pain followed the definition in the 1990 American College of Rheumatology classification criteria for FM. By objective criteria used in the clinic, patients were initially classified into SS (requiring keratoconjunctivitis sicca. positive labial salivary gland biopsy, and serological evidence of autoimmunity), incomplete SS (at least one of the latter objective findings), or non-SS (if all 3 objective findings were negative). For subsequent analyses, the study population was also classified into cases by applying the European criteria for SS, and the subjective or objective components of European criteria. Descriptive statistics and Cochran-Mantel chi-square tests were performed. RESULTS: Only 2/27 (7%) of those diagnosed with SS reported symptoms of widespread pain. The incomplete SS group consisted of 8/56 (14%), while the non-SS were 1/9 (11%). There was a trend toward greater widespread pain in those 9 of 52 (17%) subjects meeting the European criteria for SS who had widespread pain compared with 2 of 50 (5%) who did not. However, this was not significant (p = 0.0728). The greater the subjectivity of the criteria applied to classify cases of SS, the higher was the prevalence of widespread pain. No significant association was found between widespread pain and SS for any of the criteria applied. CONCLUSION: No significant association between widespread pain and SS was found in our study population. Further study is indicated to explore a possible lack of association between SS and FM.

Female↗
PubMedDate not supplied

Factors predicting survival for cancer of the ethmoid sinus.

OBJECTIVE: The aim of this study was to determine survival and prognostic factors for ethmoid sinus cancer. METHODS: From the Surveillance, Epidemiology, and End Results database for the time period 1988-1998, all cases of ethmoid sinus malignancy were extracted. Demographic, staging, treatment, and survival data were computed. Survival analysis was conducted with the Kaplan-Meier method. Clinical factors influencing survival were determined with the Cox proportional hazards model. RESULTS: After excluding patients with metastatic disease on presentation (8.9%) and patients with missing data for T stage, a total of 180 cases were identified. Average age was 60.2 years. Squamous cell carcinoma was the most common tumor (27.8%), followed by adenocarcinoma (12.8%). Overall mean survival was 57 months (median, 38 months) with a 5-year survival of 40.3%. The percentage of patients presenting with T4 lesions was 45.6%, which had a notably lower mean survival of 38 months (median, 18 months). Only 2.3% of patients had positive nodal disease. Increasing age, T stage, and absence of radiation therapy predicted poorer survival in the multivariate model Adenocarcinoma, adenoid cystic carcinoma, esthesioneuroblastoma, and melanoma showed more favorable survival than other tumor types. CONCLUSIONS: T stage and tumor histology are the most important prognostic factors in ethmoid sinus carcinoma. Survival for T4 lesions is markedly worse than survivalfor T1-T3 lesions. Radiation therapy offers a survival benefit in ethmoid sinus malignancy.

Adenocarcinoma↗
PubMed2006

Identifying genes associated with a quantitative trait or quantitative trait locus via selective transcriptional profiling.

Genetical genomics is an approach that blends the mapping of quantitative trait loci (QTL) with microarray analysis. The approach can be used to identify associations between the allelic state of a genomic region and a gene's transcript abundance. However, the large number of microarrays required for adequate power results in high material and labor costs that prevent wide adoption of the genetical genomics strategy outside of some well-funded laboratories. We present a method called selective transcriptional profiling that involves selecting an optimal subset of individuals to microarray from a larger set of individuals for which relatively inexpensive quantitative trait and molecular marker data are available. We show how to use microarray data from the selected individuals, along with the trait and marker data from all individuals, to identify genes whose transcript abundance is associated with a quantitative trait of interest through linkage to a trait QTL or correlation with the trait. Our methods for selection and analysis are derived within a missing data framework.

Alleles↗
PubMed1999

[Chronological trend of the incidence rate of Creutzfeldt-Jakob disease in Japan].

OBJECTIVE: The purpose of this study was to find whether the number of incidents of Creutzfeldt-Jakob disease has increased during the last decade in Japan. METHODS: The chronological trend was observed by examining the data from a nationwide epidemiologic survey conducted by a special committee sponsored by the Ministry of Health and Welfare of Japan in May 1996. The subjects of the survey were patients with Creutzfeldt-Jakob disease who had been diagnosed between January 1985 and May 1996. Although the number of patients reported each year increased continually during the 11-year 5-month period, there were two issues that remained to cast doubt on the accuracy of this apparently obvious chronological trend: (1) the existence of hospitals that did not respond to the survey, and (2) the existence of hospitals where no information was available before a specific time during the observation period. To make up for the incomplete data, the following two methods were proposed: (1) for those hospitals where the precise annual incidence was not known, the average annual incidence for those years when the information was available should be used to make up for the missing data and (2) when a hospital did not have the information for certain years, it would be considered to be a nonrespondent for those years; the response rate should be calculated year-by-year; then the total number of patients should be obtained by the reported number of patients divided by the response rate. The first method underestimates the annual trend if a trend does exist. To evaluate the trend mathematically, linear regression and quadratic regression models were used, in which the independent variable was the calendar year, the dependent variable, the number of patients. RESULTS: With either method, a trend for increases in incidence was noted. Statistical significance was obtained for the increasing trend in each model. It was found that the quadratic regression model was a better fit than the linear model. CONCLUSION: The incidence of Creutzfeldt-Jakob disease in Japan has increased during the last decade.

Creutzfeldt-Jakob Syndrome↗
PubMed2006

Pseudo-likelihood methods for longitudinal binary data with non-ignorable missing responses and covariates.

In this paper we consider longitudinal studies in which the outcome to be measured over time is binary, and the covariates of interest are categorical. In longitudinal studies it is common for the outcomes and any time-varying covariates to be missing due to missed study visits, resulting in non-monotone patterns of missingness. Moreover, the reasons for missed visits may be related to the specific values of the response and/or covariates that should have been obtained, i.e. missingness is non-ignorable. With non-monotone non-ignorable missing response and covariate data, a full likelihood approach is quite complicated, and maximum likelihood estimation can be computationally prohibitive when there are many occasions of follow-up. Furthermore, the full likelihood must be correctly specified to obtain consistent parameter estimates. We propose a pseudo-likelihood method for jointly estimating the covariate effects on the marginal probabilities of the outcomes and the parameters of the missing data mechanism. The pseudo-likelihood requires specification of the marginal distributions of the missingness indicator, outcome, and possibly missing covariates at each occasions, but avoids making assumptions about the joint distribution of the data at two or more occasions. Thus, the proposed method can be considered semi-parametric. The proposed method is an extension of the pseudo-likelihood approach in Troxel et al. to handle binary responses and possibly missing time-varying covariates. The method is illustrated using data from the Six Cities study, a longitudinal study of the health effects of air pollution.

Air Pollutants↗
PubMed2007

Analysis of antiretroviral immunotherapy trials with potentially non-normal and incomplete longitudinal data.

For many HIV-infected patients, use of antiretroviral therapy (ART) results in a sustained suppression of plasma viral load to undetectable levels. However, due to lack of antigenic stimulation, this may also result in a gradual loss of cell-mediated immune (CMI) responses that help control HIV infection. In concept, augmenting ART with periodic administrations of an HIV vaccine that boosts CMI responses could enhance control of viral replication. Researchers are designing 'antiretroviral immunotherapy' (ARI) trials to test this hypothesis. In a typical ARI trial, HIV-infected patients with sustained viral suppression will receive inoculations of an experimental HIV vaccine or a placebo, and subsequently stop taking their antiretroviral drugs. The goal is to assess whether plasma viral loads during the ART interruption phase are generally lower in the vaccine group. Assessment of a vaccine effect will be challenging if some subjects resume ART or drop out before the end of the treatment interruption phase. To tackle this 'missing' data problem and potential non-normality of the viral loads in ARI trials, we propose a two-step approach: multiple imputation of the missing values followed by use of the Wei-Lachin method with Wilcoxon scores. We use a numerical example and extensive simulations to illustrate the robustness and power advantages of our proposed method compared with other methods for incomplete longitudinal data, including REML, weighted GEE, last observation carried forward, and 'worst-rank' methods. Our proposed method is general enough for the robust analysis of longitudinal data in other therapeutic areas as well.

AIDS Vaccines↗
PubMed2002

MRSA bacteraemia: North/South Study of MRSA in Ireland 1999.

Retrospective aggregate data on all Staphylococcus aureus isolates recovered from blood cultures during 1998 were collected in both jurisdictions on the island of Ireland, Northern Ireland (North) and the Republic of Ireland (South), as part of the North/South Study of MRSA in Ireland 1999. A postal questionnaire was used to gather the data, and all diagnostic microbiology laboratories in the North and 98% of laboratories in the South participated. S. aureus bacteraemia occurred at rates of 20.4 per 100,000 population in the North and 24.5 per 100,000 in the South (missing data from one laboratory). In the North, 22% of patients who had blood cultures positive for S. aureus had methicillin-resistant S. aureus (MRSA) and 25% of S. aureus isolates were MRSA (some patients had more than one isolate). In the South, 31% of patients who had blood cultures positive for S. aureus had MRSA and 36% of S. aureus isolates were MRSA. There was a marked variation in rates between different regions. The percentage of patients with blood cultures positive for S. aureus that had MRSA was considerably lower in the North (22%) than in the South (31%), and in both jurisdictions was lower than that found in England and Wales in 1999 (37%). It is recommended that data on S. aureus bacteraemia and methicillin-resistance rates (already available in many laboratories) are gathered at regional and national level for the surveillance of antimicrobial resistance.

Bacteremia↗
PubMed2004

Haplotype reconstruction from genotype data using Imperfect Phylogeny.

UNLABELLED: Critical to the understanding of the genetic basis for complex diseases is the modeling of human variation. Most of this variation can be characterized by single nucleotide polymorphisms (SNPs) which are mutations at a single nucleotide position. To characterize the genetic variation between different people, we must determine an individual's haplotype or which nucleotide base occurs at each position of these common SNPs for each chromosome. In this paper, we present results for a highly accurate method for haplotype resolution from genotype data. Our method leverages a new insight into the underlying structure of haplotypes that shows that SNPs are organized in highly correlated 'blocks'. In a few recent studies, considerable parts of the human genome were partitioned into blocks, such that the majority of the sequenced genotypes have one of about four common haplotypes in each block. Our method partitions the SNPs into blocks, and for each block, we predict the common haplotypes and each individual's haplotype. We evaluate our method over biological data. Our method predicts the common haplotypes perfectly and has a very low error rate (<2% over the data) when taking into account the predictions for the uncommon haplotypes. Our method is extremely efficient compared with previous methods such as PHASE and HAPLOTYPER. Its efficiency allows us to find the block partition of the haplotypes, to cope with missing data and to work with large datasets. AVAILABILITY: The algorithm is available via a Web server at http://www.calit2.net/compbio/hap/

Algorithms↗
PubMed2002

Multiple Sclerosis Impact Scale (MSIS-29): reliability and validity in hospital based samples.

BACKGROUND AND AIM: The psychometric properties of rating scales are sample dependent and need evaluations in different samples. The Multiple Sclerosis Impact Scale (MSIS-29), a new patient based rating scale for multiple sclerosis (MS) was predominantly developed from a community based sample derived from the MS Society. A number of important patient characteristics of this sample remain unknown. The aim of the study was to evaluate five psychometric properties of the MSIS-29 in three hospital based samples: people admitted for rehabilitation, people admitted for intravenous corticosteroid treatment for MS relapses, and people with primary progressive MS. METHODS: People with MS were recruited from the three clinical settings. They completed several health measures. MSIS-29 data were evaluated for data quality, scaling assumptions, acceptability, reliability and validity, and compared with those from a previously reported community based study. RESULTS: A total of 233 people (rehabilitation p=53; corticosteroids p=76; primary progressive p=104) completed questionnaires. In all samples, missing data were low ( or=0.91). Correlations between the MSIS-29 and other scales were consistent with a priori hypotheses. Findings were consistent with those from the community samples. CONCLUSIONS: The psychometric properties of the MSIS-29 are consistent across three hospital based samples, and similar to those in the community samples. These findings further support its use as an outcome measure in different clinical settings.

Adolescent↗
PubMed1994

Difficulties in assessing drug/food interactions from chart audit in an elderly Barbadian sample group.

The aim of this study was to examine the prevalence of potential drug/food interactions among 290 elderly Barbadian outpatients. These findings indicate that chart audit is insensitive to definite interactions but was able to detect the prevalence of potential interactions (1.38 per outpatient). The risk of potential interactions was significantly higher among outpatients who were older, female, and those who used a larger number of prescribed medications. There were no significant differences in the prevalence of potential interactions among diabetics and nondiabetics. The findings indicate that the absence of relevant data on patients' symptoms, and anthropometric and laboratory measures in more than 80% of patients' charts makes it impossible to assess the prevalence of definite drug/food interactions from chart audit. Weight changes, nutrient levels, and symptoms were the most frequently missing data. Chart audit is therefore an invalid and unreliable approach to estimate definite drug/food medications.

Aged↗
PubMedDate not supplied

Factors underlying variation in receipt of physician advice on diet and exercise: applications of the behavioral model of health care utilization.

PURPOSE: To identify factors associated with receipt of physician advice on diet and exercise, including patient sociodemographic characteristics, health-related needs, and health care access, using Andersen's model of health care utilization. DESIGN: A cross-sectional analysis was performed using data from the 2000 National Health Interview Survey (NHIS). SETTING: NHIS data were collected through personal household interviews by Census interviewers. The overall response rate for the 2000 NHIS adult sample was 82.6%. SUBJECTS: Subjects were a representative sample of the American civilian, noninstitutionalized population aged 18 and older. After eliminating missing data and respondents who reported they did not see a doctor in the past 12 months, sample sizes for physician advice on diet and exercise were n = 26,255 and n = 26,158, respectively. MEASURES: Using the 2000 NHIS, the prevalence of receipt of physician advice on diet and exercise was assessed. Multiple logistic regression analyses were performed to examine the associations between receipt of physician advice on diet and exercise and potential predictors, adjusting for all covariates. RESULTS: By self-report, 21.3% and 24.5% of respondents received physician advice on diet and exercise, respectively. Being middle-aged (adjusted odds ratio [AOR] = 1.14, 95% confidence interval [CI], 1.0-1.29 for diet; AOR = 1.55, 95% CI = 1.33-1.79 for exercise) and having a baccalaureate degree or higher (AOR = 1.78, 95% CI = 1.52-2.08 for diet; AOR = 1.75, 95% CI = 1.47-2.07) were associated with a higher likelihood of receiving physician advice on diet and exercise. African-Americans (AOR = .78, 95% CI = .67-.92) and foreign-born immigrants (AOR = .57, 95% CI = .38-.86) were less likely to receive physician advice on exercise. The prevalence of physician advice was higher for persons who chose hospital outpatient departments as a usual source for care (AOR = 2.36, 95% CI = 1.66-3.36 for diet; AOR = 2.39, 95% CI = 1.68-3.4 for exercise) than for adults with other types of usual care sites. Poorer self-rated health status (AOR = 5.2, 95% CI = 4.12-6.57 for diet; AOR = 2.63, 95% CI = 2.04-3.38 for exercise) and obesity (AOR = 2.32, 95% CI = 2.02-2.66 for diet; AOR = 3.01, 95% CI = 2.46-3.69 for exercise) was positively associated with the likelihood of receiving physician advice on diet and exercise. CONCLUSIONS: Effective strategies to increase receipt of physician advice should include efforts to improve access to regular source of care and patient-physician communication. Sociodemographic factors remain independent and important predictors of who obtains such advice.

Adult↗
PubMed2005

Is malarial placental infection related to peripheral infection at any time of pregnancy?

Placental infection measured by placental smear at delivery is a standard indicator, widely used to characterize malaria infection in pregnant women. However, a single measure can hardly reflect the entire history of infection during pregnancy. To investigate the relation between this indicator and peripheral infection during pregnancy, we used data collected in a randomized trial of malaria prophylaxis in 928 pregnant women in Burkina Faso, 1987-1988, during which repeated measures of peripheral infection were taken. We analyzed placental infection using a logistic model, with two methods for handling missing data. Peripheral infection during two periods of pregnancy was significantly related to placental infection at delivery, before the fifth month: OR = 2.9 [1.3; 6.3]; after 7 months: OR = 4.9 [2.7; 8.8]). Therefore, an early peripheral infection may persist throughout gestation, and placental infection is a good indicator of the women's parasitological status during pregnancy.

Adult↗
PubMed2000

Sulpiride for schizophrenia.

BACKGROUND: The antipsychotic drug sulpiride was formulated over 20 years ago and was marked as having a low incidence of adverse effects and an effect on the negative symptoms of schizophrenia. This relatively inexpensive antipsychotic drug has a similar neuropharmacological profile to several novel atypical drugs. OBJECTIVES: To estimate the clinical efficacy and tolerability of sulpiride. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1982-1997), CINAHL (1982-1998), Cochrane Schizophrenia Group's Register (March 1998), Cochrane Library (Issue 1, 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1997), SIGLE (1994-1998), and Sociofile (1974-1997) were supplemented by reference searching, contacting authors and the manufacturers of sulpiride. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials focusing on the use of different doses of sulpiride or comparing sulpiride to (i) placebo; (ii) typical antipsychotic drugs; or (iii) atypical antipsychotic drugs, for those with schizophrenia or serious mental illness were selected. DATA COLLECTION AND ANALYSIS: Trials were reliably selected and quality rated. Data were independently extracted, by two reviewers (BGOS, MF), and analysed on an intention-to-treat basis. It was assumed that people who did not complete the follow up had no improvement. Authors of trials were contacted for additional and missing data. Relative risk (RR) and 95% confidence intervals (CI) of dichotomous data were calculated with the random effects model and weighted mean difference (WMD) was calculated for continuous data. MAIN RESULTS: The review currently includes 18 studies (30 citations). Studies are generally small and of poor quality. Limited evidence suggests that there is little difference between sulpiride and other drugs although the incidence of side effects may be less for sulpiride. There are no clear findings relating to negative symptoms. REVIEWER'S CONCLUSIONS: Sulpiride may be an effective antipsychotic drug but evidence is limited and data relating to claims for its value against negative symptoms is not trial-based.

Antipsychotic Agents↗
PubMed2001

Experience with St John's Wort (Hypericum perforatum) in children under 12 years with symptoms of depression and psychovegetative disturbances.

The value of an extract of Hypericum perforatum (St John's wort) for children with mild to moderate depressive symptoms was investigated for the first time in a multi-centre post-marketing surveillance study. One hundred and one children under 12 years were treated for a minimum of 4 weeks with an extension to 6 weeks with parental consent and medical practitioner recommendation. the dosage used ranged from 300 to 1800 mg per day. Compliance, tolerability and efficacy were assessed every 2 weeks by physicians and parents. Based on the data available for analysis, the number of physicians rating effectiveness as 'good' or 'excellent' was 72% after 2 weeks, 97% after 4 weeks and 100% after 6 weeks. The ratings by parents were very similar. There was, however, an increasing amount of missing data at each assessment point with the final evaluation including only 76% of the initial sample. Tolerability was good and no adverse events were reported. The results of this study suggest that Hypericum is a potentially safe and effective treatment for children with symptoms of depression.

Antidepressive Agents↗
PubMedDate not supplied

Composite linear models for incomplete multinomial data.

A composite linear model (CLM) is a matrix model for incomplete multinomial data. A CLM provides a unified approach for maximum likelihood inference which is applicable to a wide variety of problems involving incomplete multinomial data. By formulating a model as a CLM, one can simplify computation of maximum likelihood estimates and asymptotic standard errors. As an example, we use CLM to test marginal homogeneity for ordered categories, subject to both ignorable and non-ignorable missing-data mechanisms.

Algorithms↗
PubMed2003

Validation of an Italian version of the prolapse quality of life questionnaire.

OBJECTIVE: To validate the italian translated version of the prolapse quality of life questionnaire (P-QOL). STUDY DESIGN: The P-QOL questionnaire was translated into Italian and administered to women recruited from a gynaecology outpatient clinic. All women completed a P-QOL questionnaire at the time of the visit, and were examined in left lateral position using the ICS prolapse score. A second P-QOL questionnaire was posted and completed by women 1 week later. The validity was assessed by measuring levels of missing data, comparing symptom scores with objective prolapse stages and between affected and asymptomatic women. The reliability was assessed by testing internal consistency and stability using 1-week test retest analysis. RESULTS: 132 symptomatic and 61 asymptomatic women were studied. The number of missing items was 2%. P-QOL domain scores were significantly different between symptomatic and asymptomatic women (P<0.001). Severity according to P-QOL strongly correlated with the prolapse size (P<0.01, rho>0.5). All items achieved a Cronbach alpha greater than 0.8. The test retest reliability confirmed a highly significant correlation between the total scores for each domain. CONCLUSION: The Italian version of the P-QOL questionnaire has been validated, providing a reliable, easily comprehensible and valid instrument for the symptomatic assessment of Italian-speaking women with uterovaginal prolapse.

Adult↗