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Type I Error Rates For A One Factor Within-Subjects Design With Missing Values.

Missing data are a common problem in educational research. A promising technique, that can be implemented in SAS PROC MIXED and is therefore widely available, is to use maximum likelihood to estimate model parameters and base hypothesis tests on these estimates. However, it is not clear which test statistic in PROC MIXED performs better with missing data. The performance of the Hotelling-Lawley-McKeon and Kenward-Roger omnibus test statistics on the means for a single factor within-subject ANOVA are compared. The results indicate that the Kenward-Roger statistic performed better in terms of keeping the Type I error close to the nominal alpha level.

Journal Article↗

Bayesian analysis of prevalence with covariates using simulation-based techniques: applications to HIV screening.

Ignoring the limited precision of medical diagnostic tests can incur serious bias in prevalence estimation. Conversely, treating the values of sensitivity and specificity as constants, as in most studies, inevitably underestimates the variability of prevalence estimates. Bayesian inference provides a natural framework with which to integrate the variability in the estimates of sensitivity and specificity with estimation of prevalence. However, the resulting model becomes quite complicated and presents a computational challenge. Recently, Mendoza-Blanco et al. proposed a missing-data approach with simulation-based techniques to deal with the computational difficulties. Although their approach is quite effective in reducing the computational complexity into manageable tasks, their developed methodology is not general enough for modelling the effects of covariates in prevalence estimation. In this paper, we extend their work in this direction by combining their missing-data approach with a latent variable technique for modelling discrete data. The present work also generalizes the methods of Albert and Chib for Bayesian analysis of binary response data with errors in the response. We illustrate the methodology with several real data examples extracted from the literature.

AIDS Serodiagnosis↗

Patient-assessed measures of health outcome in asthma: a comparison of four approaches.

The study compares the psychometric properties of four different approaches to patient-assessed health outcomes in asthma, including the Asthma Quality of Life Questionnaire (AQLQ), Newcastle Asthma Symptoms Questionnaire (NASQ), SF-12 and EuroQol. The instruments were administered by means of a self-completed postal questionnaire to 394 patients recruited from general practices in the North East of England. Patients completed a follow-up questionnaire at 6 months. The levels of missing data were assessed and instrument scores compared using correlational analysis. Scores were related to self-reports of smoking behaviour, socioeconomic status and health transition. Responsiveness was assessed using standardized response means. Two hundred and thirty-five patients took part in the study giving a response rate of 59.6%. There was a relatively large amount of missing data for the individualized section of the AQLQ. Correlational analysis provided evidence of convergent validity between the specific instruments; the largest correlation was found between NASQ scores and the asthma symptoms scale of the AQLQ (r = 0.84). The NASQ was found to be the most powerful at discriminating between smokers and non-smokers. All four instruments were linearly related to self-reported asthma transition (P<0.05); the specific instruments having the strongest association. The specific instruments showed good levels of responsiveness with the NASQ producing a large SRM of 0.82. SRMs for the AQLQ were of a moderate to large size (0.32-0.77) and the SRMs for the SF-12 and EuroQol were of a small size. The two specific instruments are capable of greater levels of discrimination between groups of patients and are more responsive to changes in health than the generic SF-12 and EuroQol. The greater responsiveness of the NASQ is probably due to its focus being restricted to symptoms of asthma compared to the broader focus of the AQLQ domains. The NASQ has a strong relationship with the AQLQ and is a more practical instrument that is more acceptable to patients. However, the AQLQ does measure broader patient concerns. The SF-12 and EuroQol have greater potential to capture side-effects and have wider scope for application in economic evaluation.

Asthma↗

Omnibus permutation tests of the association of an ensemble of genetic markers with disease in case-control studies.

An omnibus permutation test of the overall null hypothesis can be used to assess the association of an entire ensemble of genetic markers with disease in case-control studies. In this approach, p-values for univariate marker-specific Armitage trend tests are combined to form a scalar statistic, which is then used in a permutation test to determine an overall p-value. Two previously described competing methods utilize either a standard two-sample Hotelling's T2 statistic or a global U statistic that is a weighted sum of univariate U statistics. In contrast to Hotelling's test, omnibus tests are much less sensitive to missing data, and utilize all available data. In contrast to the global U test, omnibus tests do not require that the direction of the effects of the individual markers on the risk of disease be correctly specified in advance; in fact, any combination of one- and two-sided univariate tests can be used. Simulations show that, even under circumstances favoring the competing tests (no missing data; direction of effects known), omnibus permutation tests based on Fisher's combining function or the Anderson-Darling statistic typically have power comparable to or greater than Hotelling's and the global U tests.

Case-Control Studies↗

[Hospital mortality at a cardiosurgical unit in Torino: international comparisons and time trend].

OBJECTIVE: To compare hospital mortality in a cardiac surgery unit with external data and to assess changes in time (patients undergoing surgery in two different periods). MATERIALS AND METHODS: Data on risk factors for hospital mortality were collected from clinical records (retrospectively for the first period and prospectively for the second) for all patients undergoing open heart surgery at the Heart Surgery Unit of the University of Turin (Italy) during 1991 and 1995 (n = 1794) and 1999 (n = 892). Comparisons of in-hospital mortality, expressed as Standardized Mortality Ratios (SMR), were adjusted for risk factors defined according to EuroSCORE (European System for Cardiac Operative Risk Evaluation). RESULTS: In the first and second period, complete information on all the 17 EuroSCORE items was available for 58.3% and 89.6% patients respectively. After exclusion of patients with one or more missing data, observed and expected numbers of death were found to be very similar, with SMRs ranging between 0.82 (isolated bypass in the second period) and 1.06 ("other" surgery in the first period). Mortality was higher among patients with missing data, but at least in 1999 the latter had a limited impact on the overall estimates. Compared to the first period, mortality was reduced during 1999 (from 5.9% to 5.4%), in particular for isolated bypass (from 4.4% to 3.4%). CONCLUSIONS: In the unit under investigation, hospital mortality following heart surgery was similar to that predicted from EuroSCORE and seemed to be lower in 1999 than in 1991-95, particularly for isolated bypass. Incompleteness of data on individual risk factors may have been a source of bias, especially when data were collected retrospectively.

Adolescent↗

A new approach to outcome prediction in trauma: A comparison with the TRISS model.

BACKGROUND: The Trauma Audit & Research Network (TARN) has been using the TRISS methodology since 1989. Its database contains 200,000 hospital admissions from 110 hospitals over the country. To improve outcome prediction, a revision of the current model became necessary. Our model tried to overcome some of the concerns of the trauma community, namely missing data, functional form of the predictors, inclusion criteria and patient's death within 30 days. METHODS: The data for modeling consisted of 100,399 anonymized hospital trauma admissions during the period 1996 to 2001. Cross validation was performed on this data set, and a multiple logistic regression model was derived using the prediction set and then its prediction ability was tested on the validation set. Fractional polynomials modeling showed that the linear functional form of the Injury Severity Score (ISS) in the model was not satisfactory. Using the Glasgow Coma Score (GCS) instead of the revised trauma score (RTS) has dramatically reduced the number of missing cases. Sex and its interaction with age have also been included in the model. The model was tested on different subsets of cases, traditionally excluded, such as children, those with penetrating injuries, and ventilated and transferred patients. The new model included all those subsets using age, a transformation of ISS, GCS, sex, and sex by age interaction as predictors. RESULTS: The model has shown a good discriminant ability tested by the Area under the Receiver Operating Characteristic (AROC) curve. The values of the AROC for the new model were 0.947 (95% confidence interval [CI]: 0.943-0.951) on the prediction set and 0.952 (95% CI: 0.946-0.957) on the validation set compared, respectively, with 0.937 (95% CI: 0.932-0.943) and 0.941 (95% CI: 0.936-0.952) for TRISS. CONCLUSION: The new model has enabled us to include most of the cases that were excluded under the TRISSs inclusion criteria, less missing data are incurred and the predictive performance was significantly better than that of the TRISS model as shown by the AROC curves.

Adolescent↗

Modelling of chronic wound healing dynamics.

Following chronic wound area over time can give a general overview of wound healing dynamics. Decrease or increase in wound area over time has been modelled using either exponential or linear models, which are two-parameter mathematical models. In many cases of chronic wound healing, a delay of healing process was noticed. Such dynamics cannot be described solely with two parameters. The reported study deals with two-, three-, and four-parameter models. Assessment of the models was based on weekly measurements of 226 chronic wounds of various aetiologies. Several quantitative fitting criteria, i.e. goodness of fit, handling missing data and prediction capability, and qualitative criteria, i.e. number of parameters and their biophysical meaning were considered. The median of goodness of fit of three- and four-parameter models was between 0.937 and 0.958, and the median of two-parameter models was 0.821 to 0.883. Two-parameter models fitted wound area over time significantly (p = 0.01) worse than three- and four-parameter models. The criterion handling missing data provided similar results, with no significant difference between three- and four-parameter models. Median prediction error of two-parameter models was between 111 and 746; three-parameter models resulted in an error of 64 to 128, and finally four-parameter models resulted in the highest prediction error of 407 and 238. Based on the values of quantitative fitting criteria obtained, three parameters were chosen as the most appropriate. Based on qualitative criteria, the delayed exponential model was selected as the most general three-parameter model. It was found to have good prediction capability and in this capacity it could be used to help physicians choose the most appropriate treatment for patients with chronic wounds after an initial three-week observation period, when the median error increase of fitting is 74%.

Chronic Disease↗

Applications of multiple imputation in medical studies: from AIDS to NHANES.

Rubin's multiple imputation is a three-step method for handling complex missing data, or more generally, incomplete-data problems, which arise frequently in medical studies. At the first step, m (> 1) completed-data sets are created by imputing the unobserved data m times using m independent draws from an imputation model, which is constructed to reasonably approximate the true distributional relationship between the unobserved data and the available information, and thus reduce potentially very serious nonresponse bias due to systematic difference between the observed data and the unobserved ones. At the second step, m complete-data analyses are performed by treating each completed-data set as a real complete-data set, and thus standard complete-data procedures and software can be utilized directly. At the third step, the results from the m complete-data analyses are combined in a simple, appropriate way to obtain the so-called repeated-imputation inference, which properly takes into account the uncertainty in the imputed values. This paper reviews three applications of Rubin's method that are directly relevant for medical studies. The first is about estimating the reporting delay in acquired immune deficiency syndrome (AIDS) surveillance systems for the purpose of estimating survival time after AIDS diagnosis. The second focuses on the issue of missing data and noncompliance in randomized experiments, where a school choice experiment is used as an illustration. The third looks at handling nonresponse in United States National Health and Nutrition Examination Surveys (NHANES). The emphasis of our review is on the building of imputation models (i.e. the first step), which is the most fundamental aspect of the method.

Acquired Immunodeficiency Syndrome↗

Predicting attrition in a pediatric asthma intervention study.

OBJECTIVES: To operationalize a comprehensive description of attrition, including pre-inclusion, dropout, and attrition due to intermittent missing data, and to test a predictive model of attrition using a data set from a randomized controlled intervention in pediatric asthma. METHODS: Participants included children, ages 4-12, diagnosed with asthma and their caregivers. Demographic variables and outcome measures of asthma morbidity were examined in 327 families to determine their association with attrition. RESULTS: Families who did not complete randomization and the intervention tended to have younger caregivers than did completers. Caregiver age emerged as the most consistent predictor of pre-inclusion and dropout attrition. There were no significant predictors of attrition due to intermittent missing data. CONCLUSION: Younger caregivers may be at particular risk for attrition in pediatric asthma intervention studies and warrant special attention by investigators.

Asthma↗

Likelihood methods for treatment noncompliance and subsequent nonresponse in randomized trials.

While several new methods that account for noncompliance or missing data in randomized trials have been proposed, the dual effects of noncompliance and nonresponse are rarely dealt with simultaneously. We construct a maximum likelihood estimator (MLE) of the causal effect of treatment assignment for a two-armed randomized trial assuming all-or-none treatment noncompliance and allowing for subsequent nonresponse. The EM algorithm is used for parameter estimation. Our likelihood procedure relies on a latent compliance state covariate that describes the behavior of a subject under all possible treatment assignments and characterizes the missing data mechanism as in Frangakis and Rubin (1999, Biometrika 86, 365-379). Using simulated data, we show that the MLE for normal outcomes compares favorably to the method-of-moments (MOM) and the standard intention-to-treat (ITT) estimators under (1) both normal and non-normal data, and (2) departures from the latent ignorability and compound exclusion restriction assumptions. We illustrate methods using data from a trial to compare the efficacy of two antipsychotics for adults with refractory schizophrenia.

Algorithms↗

The effect of psychological interventions on anxiety and depression in cancer patients: results of two meta-analyses.

The findings of two meta-analyses of trials of psychological interventions in patients with cancer are presented: the first using anxiety and the second depression, as a main outcome measure. The majority of the trials were preventative, selecting subjects on the basis of a cancer diagnosis rather than on psychological criteria. For anxiety, 25 trials were identified and six were excluded because of missing data. The remaining 19 trials (including five unpublished) had a combined effect size of 0.42 standard deviations in favour of treatment against no-treatment controls (95% confidence interval (CI) 0.08-0.74, total sample size 1023). A most robust estimate is 0.36 which is based on a subset of trials which were randomized, scored well on a rating of study quality, had a sample size > 40 and in which the effect of trials with very large effects were cancelled out. For depression, 30 trials were identified, but ten were excluded because of missing data. The remaining 20 trials (including six unpublished) had a combined effect size of 0.36 standard deviations in favour of treatment against no-treatment controls (95% CI 0.06-0.66, sample size 1101). This estimate was robust for publication bias, but not study quality, and was inflated by three trials with very large effects. A more robust estimate of mean effect is the clinically weak to negligible value of 0.19. Group therapy is at least as effective as individual. Only four trials targeted interventions at those identified as at risk of, or suffering significant psychological distress, these were associated with clinically powerful effects (trend) relative to unscreened subjects. The findings suggest that preventative psychological interventions in cancer patients may have a moderate clinical effect upon anxiety but not depression. There are indications that interventions targeted at those at risk of or suffering significant psychological distress have strong clinical effects. Evidence on the effectiveness of such targeted interventions and of the feasibility and effects of group therapy in a European context is required.

Anxiety↗

A randomised controlled trial of postal versus interviewer administration of a questionnaire measuring satisfaction with, and use of, services received in the year before death.

STUDY OBJECTIVES: To develop a short form of an interview schedule used successfully in previous national surveys of care for the dying, and to investigate the effect of administering it by post on response rate, response bias and on the nature of responses to questions. DESIGN: Randomised controlled trial. SETTING: An inner London health authority. PARTICIPANTS: Informants (person registering death) of random sample of cancer deaths between June 1995 and July 1996. MAIN RESULTS: The shortened questionnaire (VOICES) has 158 questions. Response rate did not differ significantly between postal and interview groups (interview; 56% (69 of 123), postal: 52% (161 of 308). Responders in the two groups did not differ in terms of their sociodemographic characteristics. Postal questionnaires had significantly more missing data, particularly on questions about service provision and satisfaction with services. Responses to questions differed between the groups on 11 of 158 questions. Interview group respondents were more likely to give top ranking responses to questions on service satisfaction and symptom control. CONCLUSIONS: Postal questionnaires are an acceptable alternative to interviews in retrospective post-bereavement surveys of care for the dying, at least in terms of response rate and response bias. However, the increased costs of interview surveys need to be balanced against the fact that postal questionnaires result in more missing data, and possibly less reliable answers to some questions. Caution is needed in combining results from the two data collection methods as interview respondents gave more positive answers to some questions.

Adult↗

Assessing inner-city patients' hospital experiences. A controlled trial of telephone interviews versus mailed surveys.

OBJECTIVES: Obtaining accurate and representative patient-centered data may be difficult among poor, inner-city patients because of changing addresses, variable access to telephones, and a higher prevalence of illiteracy than in the populations in which many survey instruments were developed and tested. Assumptions about the usefulness of mailed surveys versus telephone interviews may not hold for the urban poor. Therefore, identifying the most efficient mode of survey administration in this population becomes an important methodological question. METHODS: We conducted a randomized trial of patients discharged from the inpatient medicine service of an urban teaching hospital to compare telephone interview with mailed self-administration of a detailed instrument for measuring patients' experiences with hospital care. Our primary outcomes were response rate, missing data, and data collection costs. Patients were excluded if they were not discharged to home or were mentally or physically unable to complete mailed or telephone interviews. The research assistant contacted eligible patients while hospitalized, informed them of the postdischarge survey, and obtained current phone numbers and addresses. Patients then were randomized to receive a 116-item satisfaction survey via one of two survey methods: mail-first (mailed surveys with follow-up on nonrespondents by telephone) or telephone-first (telephone interviews with follow-up of nonrespondents by mail). RESULTS: Of the 252 patients enrolled, 130 were randomized to the mail-first and 122 to the telephone-first method. Response rates were higher with the telephone-first (73%) compared with the mail-first method (50%; P < 0.0001). Surveys obtained by the telephone-first method had fewer missing data (0.7 +/- 2.39) for those items not involved in skip patterns compared with the mail-first method (7.1 +/- 12.3; P < 0.001) and were 42% less expensive per completed survey ($26.32 versus $37.35; P < 0.0001). CONCLUSIONS: In this survey of patients served by an urban teaching hospital, a strategy of telephone interviews with mail follow-up proved less expensive and yielded a higher response rate with more complete data than using a method where mailed surveys were followed by back-up telephone interviews. In addition, we believe that the improved response rate for telephone interviews compared with those reported in the literature for similar populations is the result of informing inpatients of the survey and obtaining telephone numbers and addresses in the hospital.

Female↗

Digital Mindfulness Intervention for Pregnant Women With Affective Disorders and Acute Stress Reactions: Prespecified Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Pregnant women with ICD-10 (International Statistical Classification of Diseases, Tenth Revision) affective or stress-related disorders face an elevated risk of perinatal depression and anxiety, yet evidence on digital nonpharmacologic interventions for this population remains limited. OBJECTIVE: This study evaluated the effectiveness of an 8-week digital mindfulness-based intervention (eMBI) compared with treatment as usual (TAU) among pregnant women with ICD-10 affective or stress-related disorders participating in a randomized controlled trial (RCT). METHODS: This prespecified secondary analysis was conducted within a multicenter RCT in Baden-W&#xfc;rttemberg, Germany. Pregnant women aged 18 years and older with elevated depressive symptoms (Edinburgh Postnatal Depression Scale [EPDS]>9) and ICD-10-diagnosed affective or stress-related disorders were randomized 1:1 to eMBI or TAU. The intervention consisted of 8 weekly app-based mindfulness sessions (45 min each) delivered during gestational weeks 29-36, with no direct therapist contact. The primary outcome was continuous depressive symptom severity measured with the EPDS at 4-6 weeks post partum. Secondary outcomes included the EPDS at 6 months post partum, generalized anxiety (State-Trait Anxiety Inventory-State [STAI-S], State-Trait Anxiety Inventory-Trait [STAI-T]), and Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R). Analyses followed the intention-to-treat (ITT) principle, using mixed models for repeated measures and multiple imputation. RESULTS: Of the 5299 screened women, 147 met the inclusion criteria for this subgroup analysis (intervention group [IG] had n=73 women and control group had n=74 women). Groups were comparable at baseline. The IG showed significantly greater reductions in EPDS scores at gestational week 34 (&#x394;=-2.21, P=.01), week 36 (&#x394;=-3.25, P=.01), and 4-6 weeks post partum (&#x394;=-4.81, P=.007). Treatment effects remained robust under conservative missing-data assumptions. At 4-6 weeks post partum, a higher proportion of participants in the IG achieved clinically meaningful improvement (31/73, 42.5% vs 21/74, 28.4%; adjusted odds ratio 1.56, 95% CI 1.19-2.05; P=.001). Anxiety outcomes followed a similar pattern, whereas pregnancy-related anxiety did not differ between groups. CONCLUSIONS: In this prespecified subgroup of pregnant women with ICD-10 affective or stress-related disorders, the eMBI was associated with clinically meaningful reductions in depressive symptoms from late pregnancy to 4-6 weeks post partum. Effects at 6 months post partum were attenuated and less stable across missing-data assumptions. These findings support eMBIs as a scalable, nonpharmacological adjunct to perinatal mental health care for women with affective or stress-related disorders, while confirmation in adequately powered trials with strategies to reduce postpartum attrition is warranted.

Humans↗

Bayesian and maximum likelihood estimation of genetic maps.

There has recently been increased interest in the use of Markov Chain Monte Carlo (MCMC)-based Bayesian methods for estimating genetic maps. The advantage of these methods is that they can deal accurately with missing data and genotyping errors. Here we present an extension of the previous methods that makes the Bayesian method applicable to large data sets. We present an extensive simulation study examining the statistical properties of the method and comparing it with the likelihood method implemented in Mapmaker. We show that the Maximum A Posteriori (MAP) estimator of the genetic distances, corresponding to the maximum likelihood estimator, performs better than estimators based on the posterior expectation. We also show that while the performance is similar between Mapmaker and the MCMC-based method in the absence of genotyping errors, the MCMC-based method has a distinct advantage in the presence of genotyping errors. A similar advantage of the Bayesian method was not observed for missing data. We also re-analyse a recently published set of data from the eggplant and show that the use of the MCMC-based method leads to smaller estimates of genetic distances.

Algorithms↗

Performance characteristics of a composite multivariate quality control system.

We present the results of an evaluation of the performance characteristics of a composite multivariate quality control (CMQC) system that incorporates quality control rules for univariate, multivariate, and correlation conditions. The CMQC system evaluated is designed to help analysts detect unacceptable trends and systematic error in one or more variables, unacceptable random error in one or more variables, and unacceptable changes in the correlation structure of any pair of variables. It is also designed to be tolerant of missing data, to allow analysts to reject as few as one or as many as all variables in a run, and to provide analysts with control statistics and graphics that logically relate to sources of analytical error. We show that the various components of the CMQC system have adequate statistical power to detect systematic errors, random errors, and correlation changes under the conditions likely to be encountered with multivariate analytical measurement systems: (1) a single variable with increased systematic or random error; (2) all variables or a subgroup of variables affected by a common problem that increases systematic or random error; and (3) missing data for one or more variables in a run. We also show that the power of the multivariate component of the CMQC system to detect systematic and random errors is higher than the power of an alternative multivariate test criterion.

Chemistry Techniques, Analytical↗

Comparing Rasch analyses probability estimates to sensitivity, specificity and likelihood ratios when examining the utility of medical diagnostic tests.

INTRODUCTION: Medical diagnostic tests are evaluated based on measures of sensitivity (Sn), specificity (Sp), and likelihood ratios (LR). These procedures are limited in the event of a biased gold standard or missing data. Interpretations of these measures are frequently inappropriate. PURPOSE: The Rasch measurement model (RMM) was examined as a method to provide evidence of diagnostic test utility in order to overcome the limitations of Sn, Sp, and LR. METHODS: Patients suspected of a knee ligament tear (n = 825) were studied, by evaluating four diagnostic tests. The RMM probability estimates for each test were compared to estimates of Sn, Sp, and LR. RESULTS: The RMM provided probability estimates for the diagnosis that were comparable to likelihood ratios. These probability estimates correlated with the estimates of Sn, Sp, and LR. The RMM estimates were not affected by missing data. DISCUSSION: The RMM may provide an alternative means to study the utility of medical diagnostic tests to estimate the probability of disease presence/absence.

Anterior Cruciate Ligament Injuries↗

Evaluation of the quality of life in dementia with a generic quality of life questionnaire: the Duke Health Profile.

OBJECTIVE: The study was designed to determine the acceptability, feasibility and validity of measuring quality of life in a representative sample of dementia patients with a generic instrument, the Duke Health Profile. METHOD: The French version of the Duke Health Profile was administered to 148 subjects with a mental disorder according to the DSM-III-R diagnostic criteria. The feasibility and acceptability of employing the instrument were determined by the refusal rate, the type of administration, and the percentage and distribution of missing data. Reliability was determined with Cronbach's alpha coefficient. Instrument reproducibility was assessed with the intraclass correlation coefficient for test-retest values. Internal construct validity was determined by factor analysis. Discriminant capacity was determined by comparing the average scores on each measure among patients with and without an additional chronic pathology. The measurements obtained were compared by source of information (patient, family proxy and care provider proxy). RESULTS: The feasibility and acceptability of the instrument was good. Only 2% of the patients refused to complete the questionnaire. Help from the interviewer was necessary in 79% of the cases. The average completion time was 10.6 min. Missing data exist in only 3.5% of the cases on average, except among patients with severe dementia (Mini Mental State Examination <10). For reliability, internal consistency was acceptable (Cronbach's coefficient alpha = 0.5--0.7) when the self-esteem (0.23) and social health (0.26) concepts were eliminated. Reproducibility as measured by test-retest scores was moderate to good (intraclass correlation coefficient r = 0.53--0.80), except for anxiety (0.48) and perceived health (0.45). Severity of dementia mainly affected the feasibility, acceptability and reproducibility of the instrument. The family proxy seemed to agree more with the patient than did the care provider proxy. CONCLUSION: Quality of life can be measured in patients with dementia, but special tools need to be developed for severe dementia.

Aged↗