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PubMed2006

Accurate prediction of need for invasive treatment in alpha1-blocker treated patients with benign prostatic hyperplasia not possible: bootstrap validation analysis.

OBJECTIVES: Frequently, statistically significant prognostic factors are reported in published studies with suggestions that disease management should be modified. However, the clinical relevance of such factors is rarely quantified. We evaluated the accuracy of predicting the need for invasive treatment among patients with benign prostatic hyperplasia treated conservatively with alpha1-blockers. METHODS: Information on eight prognostic factors was collected from 280 patients treated with alpha1-blockers. Using the proportional hazards regression coefficients, a risk score for retreatment was calculated for each patient. The analyses were repeated on 1000 groups of 280 patients sampled from the original case series. The results from these "bootstrap analyses" were compared with the original results. RESULTS: Three statistically significant predictors of retreatment were identified. The 20% of patients with the greatest risk score had an 18-month risk of retreatment of only 20% (this should ideally approach 100%). Analyses of less than one half of all the bootstrap samples resulted in the same three significant prognostic factors. The 20% of patients with the greatest risk score in each of the 1000 samples experienced a highly variable risk of retreatment of 0% to 42%. CONCLUSIONS: Strongly significant predictors for retreatment suggest the need for a change in disease management, but 4 of the 5 high-risk patients would be overtreated with a modified policy. The subclassification of patients with a relatively low risk and high risk of retreatment appeared far from accurate. Internal validation procedures may warn against the invalid translation of statistical significance into clinical relevance.

Adrenergic alpha-Antagonists↗

PubMed2004

International comparison of performance measures for screening mammography: can it be done?

OBJECTIVE: Published screening mammography performance measures vary across countries. An inter-national study was undertaken to assess the comparability of two performance measures: the recall rate and positive predictive value (PPV). These measures were selected because they do not require identification of all cancers in the screening population, which is not always possible. SETTING: The screening mammography programs or data registries in 25 member countries of the International Breast Cancer Screening Network (IBSN). METHODS: In 1999 an assessment form was distributed to IBSN country representatives in order to obtain information on how screening mammography was performed and what specific data related to recall rates and PPV were collected. Participating countries were then asked to provide data to allow calculation of recall rates, PPV and cancer detection rates for screening mammography by age group for women screened in the period 1997-1999. RESULTS: Twenty-two countries completed the assessment form and 14 countries provided performance data. Differences in screening mammography delivery and data collection were evident. For most countries, recall rates were higher for initial than for subsequent mammograms. There was no consistent relationship of initial to subsequent PPV, although PPV generally decreased as the recall rate increased. Recall rates decreased with increasing age, while PPV increased as age increased. CONCLUSION: Similar patterns for mammography performance measures were evident across countries.However, the development of a more standardized approach to defining and collecting data would allow more valid international comparisons, with the potential to optimize mammography performance. At present, international comparisons of performance should be made with caution due to differences in defining and collecting mammography data.

Breast Neoplasms↗

PubMed2006

Validation of a formula that calculates the estimated risk of respiratory distress syndrome.

OBJECTIVE: Several groups, including ours, have developed probabilistic models that incorporate both the surfactant-to-albumin ratio (TDx-FLM II) and gestational age to more accurately predict the risk of neonatal respiratory distress syndrome (RDS) and eliminate the current categorical "immature"/"indeterminate"/"mature" interpretation. We validate our model using a separate data set, with the goal of providing the clinician with a risk score. METHODS: The medical records of all women who had TDx-FLM II testing performed at Brigham and Women's Hospital between January 1, 2003, and December 31, 2005, were reviewed to gather a population upon which to validate our previous logistic regression model. Receiver operating characteristic curve and Hosmer-Lemeshow analysis was conducted to determine the performance of our model and another model in this new population. RESULTS: A total of 233 mother-neonate pairs (21 RDS, 212 non-RDS) met criteria for analysis. The receiver operating characteristic analysis illustrated that our previous formula was a strong predictor of the risk of RDS with an area under the curve of 0.902 (95% confidence interval 0.849-0.955). In addition, using the Hosmer-Lemeshow analysis, our formula produced an excellent overall fit (P=.95), whereas another published model was a poor fit to our data (P=.002). CONCLUSION: Our previously derived logistic regression model formula incorporating TDx-FLM II results and gestational age to predict risk of neonatal respiratory distress syndrome was robust and stable over time in an independent data set. The results suggest that the equation can be implemented clinically to assist physicians and patients and used by other institutions after their own internal validation. LEVEL OF EVIDENCE: III.

Humans↗

PubMed2005

Asthma, atopic eczema and allergic rhino-conjunctivitis in school children.

International Study of Asthma and Allergies of Childhood (ISAAC) phase one study had already been completed in two age groups in 156 collaborating centers of 56 countries involving a total of 721601 children. Bangladesh did not participate earlier in this worldwide study. To determine the prevalence of asthma, allergic rhinitis and eczema in school children of Dhaka district using ISAAC protocol. A school based cross sectional study done in 2000 by using both written questionnaires (WQ) and video questionnaires (VQ). Students of class-VIII (13-14 years) filled up both the WQ and VQ and the parents of class I (6-7 years) filled up only the WQ on behalf of the students. Sixty five (6)5 primary schools and 39 high schools were randomly selected from all 19 thanas to cover equally both the urban and rural schools of the entire area of Dhaka district. A total of 6260 written questionnaires were eligible for the analysis (3029 form 6-7 years of class I and 3231 from 13-14 years of class VIII). In addition, the validated international video questionnaires were used for the older age group (3231). The symptoms of atopic diseases in the previous 12 months or ever in all children, both age groups, both sexes and in both urban and rural areas. The life time (ever) and 12-month period (recent) prevalence of three allergic conditions with 95% CI were as follows : wheezing 13.8% (12.9-14.6), 7.6% (6.9-8.2); allergic rhinitis 25.0% (23.9-26.1), 20.0% (19.1-21.1) and eczema 8.7% (CI 8.0-9.4), 6.5% (5.9-7.2). respectively. The prevalence of wheezing and other atopic features in both age groups of 6-7 years and 13-14 years showed higher features of recent wheeze in the younger children than in the older children, recent wheeze 9.1% Vs 6.1%; but the other atopic features were found lower in younger age group, recent rhinitis 16.3% Vs 23.5%, 0.001; conjunctivitis 6.4% Vs 8.3%, 0.001; recent eczema 6.0% Vs 7.1% 0.001. Male children were found to be more suffering from all types allergic conditions than their female peers: recent wheeze 9.0% Vs 5.9%, recent rhinitis 21.9% Vs 17.9%, recent allergic conjunctivitis 8.7% Vs 6.7% and recent eczema 6.8% Vs 6.2%). Though the prevalence of asthma and atopic eczema was lower than those of developed countries but still appeared to be a major health problem for our children. Allergic rhinitis was the commonest of all atopic problems in children. The younger children (6-7 years) were more likely to suffer from wheeze (asthma) but other allergic problems were more in older group of children (13-14 years). Male children were more prone to all types of allergic problems, whether wheeze or other atopic conditions, than the female peers.

Adolescent↗

PubMed2003

[Cross-cultural adaptation of the Portuguese version of the Conflict Tactics Scales Form R (CTS-1) used to assess marital violence: semantic and measurement equivalence].

This paper focuses on the cross-cultural adaptation of the Portuguese version of the Conflict Tactics Scales (CTS-1). Semantic equivalence was evaluated with regard to the referential meaning of words and the general connotative meaning of each item. Measurement equivalence between the Portuguese version and the original instrument was assessed by means of the version's psychometric properties, namely, intra-observer reliability, construct validity, internal consistency, and factor structure. For the different relationships, measurement agreement for physical aggression was moderate to substantial. Cronbach's a's were high for the physical and verbal aggression scales and low for the negotiation scale. As in the original instrument, factor analysis identified three dimensions, representing the negotiation, verbal aggression, and physical aggression scales, plus a severe physical aggression sub-scale. Although some problems still remain, the overall results suggest an adequate process of cross-cultural adaptation of the CTS-1, thus endorsing its use in the Brazilian setting.

Brazil↗

PubMed2001

Collaborative study for the establishment of erysipelas ELISA coating antigen. European Biological Reference Preparation batch no. 1.

The development and validation of suitable alternatives for the replacement of in vivo challenge testing in the evaluation of vaccines is an important goal for national authorities and manufacturers involved in the assessment of quality, safety and efficacy of such products. To that end, 13 laboratories from 9 European countries, including 5 manufacturers, 7 authorities and EDQM, have taken part in a collaborative study to evaluate the suitability of a candidate reference preparation of erysipelas coating antigen for ELISA as a European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP No. 1). The new Ph. Eur. BRP is intended for use in a serological assay, which would significantly reduce the suffering of animals in the potency assays of inactivated erysipelas vaccines. Participants were provided with sufficient study material, including the candidate coating antigen, and a panel of test sera from mice which had been immunised with vaccines representative of products on the European market, in order to evaluate the performance of the coating antigen in an enzyme-linked immunosorbent assay (ELISA) which had previously performed successfully in a prevalidation study [1] and in an international validation study [2]. Results of the collaborative study indicate that the candidate batch of erysipelas ELISA coating antigen is suitable to act as a Ph. Eur. biological reference preparation. The final study report was presented at the 110th session of the Ph. Eur. Commission (June 19-21, 2001) and the material was duly adopted as Erysipelas ELISA Coating Antigen Ph. Eur. BRP No. 1 for use in the enzyme-linked immunosorbent assay in the context of the serological potency assay for inactivated erysipelas vaccines.

Animals↗

PubMed2002

Project IMPACT: results from a pilot validity study of a new observational database.

OBJECTIVE: The objective of this study was to evaluate the accuracy of the information contained in the Project IMPACT database. Project IMPACT is a comprehensive database system developed to measure and describe the care of intensive care patients. This database is being used by a large group of hospitals to help clinicians improve the care of these patients. Data on patient demographics, diagnoses, treatment, and outcomes are entered into the Project IMPACT database by staff at participating hospitals. This pilot study was a first step in assessing the accuracy of these data to determine the usefulness of the Project IMPACT database for measuring intensive care unit (ICU) performance and patient outcomes. DESIGN: The design of the pilot study was the independent abstraction of selected data items from a random sample of ICU patient records from two hospitals participating in Project IMPACT. The abstracted data were compared with the data existing in the Project IMPACT database for agreement. SETTING: Abstraction was performed onsite at the two pilot hospitals by a trained abstractor who was not affiliated with either hospital. PATIENTS: Patients whose records were abstracted included 45 randomly selected ICU patients at each of the two pilot hospitals. MEASUREMENTS AND MAIN RESULTS: Comparison of the Project IMPACT data with the independently abstracted data indicated good agreement (80% or above) on discrete items, such as type of ICU patient. Poorer agreement (under 80%) was seen for continuous items (e.g., 24-hr urine output) and coded items requiring judgment (e.g., reason for ICU admission). CONCLUSIONS: The pilot study showed good internal validity for most of the abstracted variables. High agreement rates were observed, regardless of method of original data capture (electronic download or manual entry), although agreement was higher for some data items that had been electronically downloaded into the Project IMPACT database. The results suggest that Project IMPACT is a valuable resource for ICUs to collect and evaluate information about treatment and patient outcomes.

Database Management Systems↗

PubMed2003

Validation of the Parents' Postoperative Pain Measure in Finnish children aged 1-6 years.

The Canadian Parents' Postoperative Pain Measure (PPPM) is a behavioural pain measure for children. The purpose of this study was to test validity and reliability of this measure in 1-6-year-old Finnish children at home after minor day surgery. Children (n = 85) and their parents from four hospitals were included in the sample. The parents, mostly mothers (93%), filled in at home a questionnaire including PPPM during the day of operation, and the first and second postoperative days. Parents (n = 85) rated the presence or absence of behavioural changes from a checklist and also the child's worst pain during each day (using a Visual Analogue Scale, VAS). The response rate was 58. Principal component factor analysis, testing of correlation coefficient, cross-tabulations and Cronbach's alpha were used to test the instrument. The findings showed that construct validity of the measure was satisfactory. The PPPM was successful in discriminating between children who had no/low pain and children who had a clinically significant pain measured by VAS (convergence validity). Scores on the PPPM decreased from days 0 to 1 and from days 1 to 2 (predictive validity). Internal consistency of the measure and correlations with the pain scores on VAS were high on all days following surgery (equivalence). Sensitivity was satisfactory only when specificity was weaker. The findings of this study can be utilized in the development of children's postoperative pain assessment at home. However, further studies are needed to test the instrument in larger samples.

Adult↗

PubMed2004

Growth patterns reflect response to antiretroviral therapy in HIV-positive infants: potential utility in resource-poor settings.

Laboratory monitoring of HIV-infected children is the current standard of care in the United States to guide the appropriate use of antiretroviral therapy (ART). Although ART is becoming a reality in some developing countries, laboratory monitoring of ART is costly, necessitating creative approaches to monitoring. As an initial step to guide monitoring of HIV progression in low resource settings, we assessed the utility of the physical examination to predict clinical progression of HIV. We conducted a retrospective cohort study of HIV-infected children using data from Pediatric AIDS Clinical Trials Group Protocol 300. We developed a clinical predictive model, and compared the utility of the clinical model to the change in HIV RNA viral load as diagnostic tests of ART failure. The clinical model incorporated treatment regimen, age, and height velocity: a three-level clinical predictive model provided likelihood ratios of 0.3, 3.9, and 14. For decline in RNA the likelihood ratios were 0.2 (> 1 log decline), 1.4, and 3.5 (> log increase). We developed a simple clinical predictive model that was able to predict clinical progression of HIV after initiation of new ART. The clinical model performed similarly to using changes in HIV RNA viral load. These data should be validated internationally and prospectively, because the test subjects were from a resource rich environment and growth patterns in undernourished children may be impacted differently by HIV and its treatment. The model was most pertinent to children 36 months of age or younger, and was conducted in children receiving monotherapy and dual therapy.

Anti-HIV Agents↗

PubMed2006

Issues in the planning and conduct of non-randomised studies.

This paper discusses topics related to the planning and implementation of non-randomised clinical studies in orthopaedics. A well-conducted case-series is appropriate to demonstrate the safety of a surgical intervention. The case-series design involves the provision of a defined intervention to a group of patients with the ultimate objective of describing the final outcome, including such occurrences as complications. There is no alternative procedure serving as a control. The key aspects are to ensure enrolment of all eligible patients and to obtain a sufficiently large sample size to allow precise and valid estimation of complication risks. Targeted complications should be clearly defined and fully documented during a pre-defined follow-up period. Loss to follow-up should be minimised. Comparative studies are required to demonstrate treatment effectiveness. If a randomised controlled trial (RCT) is not feasible, an observational design such as a cohort or a case-control study should be considered. In observational designs, the treatment decision is made by the surgeons. In a case-control study, patients are selected based on their outcomes and their treatment or exposure status is recorded retrospectively. In a cohort study, groups of patients are selected based on their treatment and are followed for outcomes. There are numerous variations. Data can be collected prospectively or retrospectively; comparison groups may be concurrent or non-concurrent, or studied at different locations. The optimal design is tailored to clinical questions and research settings, while keeping in mind the respective methodological strengths and weaknesses of available options. The strength of the observational study is its proximity to daily clinical practice. The limitations are the possibility of numerous biases and confounding factors. Despite many challenges to the internal validity of non-randomised studies in orthopaedics surgery, it is possible to use such designs in order to provide reasonably valid answers to clinically important questions.

Algorithms↗

PubMed2004

Validity of the Boston qualitative scoring system for the Rey-Osterrieth complex figure among depressed elderly patients.

A recent qualitative scoring method for the Rey-Osterrieth Complex Figure (ROCF), the Boston Qualitative Scoring System (BQSS), purports to assess visuospatial organization, visual memory and executive function by using multiple series of scores with well-defined criteria. The first objective of this study was to determine whether the BQSS cores correlated with scores derived from the tradition Osterrieth scoring method and which method was more efficient at separating the diagnostics groups. The second objective was to correlate the BQSS executive scores to other nonverbal and verbal tests of executive function, working memory, processing speed, and episodic memory to determine what cognitive abilities the BQSS scores were measuring. The subjects, older depressed patients and healthy controls, were free of any clinical sign of incipient dementia or comorbid neurological disease. Their ROCF drawings were scored using both the Osterrieth and BQSS methods. The BQSS summary drawing scores correlated well with the Osterrieth summary scores for the copy and short-delay recall phases, the percent retained over the delay period and recognition. The BQSS executive scores for Planning, which included both copy and recall phases, correlated with Matrix Reasoning indicating that they assessed nonverbal reasoning but they did not correlate with other traditional executive tests. Planning also contributed to the separation of diagnostics groups and was the most effective score for predicting the percent of the ROCF retained over a short delay. The remaining executive scores did not show a pattern of correlations with other nonverbal executive or working memory scores that would satisfy concerns regarding their interpretation or internal validity when used in an older and/or depressed population. No differences emerged between the two scoring methods in their efficiency for predicting depression.

Aged↗

PubMed2003

External validation is necessary in prediction research: a clinical example.

BACKGROUND AND OBJECTIVES: Prediction models tend to perform better on data on which the model was constructed than on new data. This difference in performance is an indication of the optimism in the apparent performance in the derivation set. For internal model validation, bootstrapping methods are recommended to provide bias-corrected estimates of model performance. Results are often accepted without sufficient regard to the importance of external validation. This report illustrates the limitations of internal validation to determine generalizability of a diagnostic prediction model to future settings. METHODS: A prediction model for the presence of serious bacterial infections in children with fever without source was derived and validated internally using bootstrap resampling techniques. Subsequently, the model was validated externally. RESULTS: In the derivation set (n=376), nine predictors were identified. The apparent area under the receiver operating characteristic curve (95% confidence interval) of the model was 0.83 (0.78-0.87) and 0.76 (0.67-0.85) after bootstrap correction. In the validation set (n=179) the performance was 0.57 (0.47-0.67). CONCLUSION: For relatively small data sets, internal validation of prediction models by bootstrap techniques may not be sufficient and indicative for the model's performance in future patients. External validation is essential before implementing prediction models in clinical practice.

Bacterial Infections↗

PubMed2005

Comparisons of survival predictions using survival risk ratios based on International Classification of Diseases, Ninth Revision and Abbreviated Injury Scale trauma diagnosis codes.

BACKGROUND: We conducted a comparison of methods for predicting survival using survival risk ratios (SRRs), including new comparisons based on International Classification of Diseases, Ninth Revision (ICD-9) versus Abbreviated Injury Scale (AIS) six-digit codes. METHODS: From the Pennsylvania trauma center's registry, all direct trauma admissions were collected through June 22, 1999. Patients with no comorbid medical diagnoses and both ICD-9 and AIS injury codes were used for comparisons based on a single set of data. SRRs for ICD-9 and then for AIS diagnostic codes were each calculated two ways: from the survival rate of patients with each diagnosis and when each diagnosis was an isolated diagnosis. Probabilities of survival for the cohort were calculated using each set of SRRs by the multiplicative ICISS method and, where appropriate, the minimum SRR method. These prediction sets were then internally validated against actual survival by the Hosmer-Lemeshow goodness-of-fit statistic. RESULTS: The 41,364 patients had 1,224 different ICD-9 injury diagnoses in 32,261 combinations and 1,263 corresponding AIS injury diagnoses in 31,755 combinations, ranging from 1 to 27 injuries per patient. All conventional ICD-9-based combinations of SRRs and methods had better Hosmer-Lemeshow goodness-of-fit statistic fits than their AIS-based counterparts. The minimum SRR method produced better calibration than the multiplicative methods, presumably because it did not magnify inaccuracies in the SRRs that might occur with multiplication. CONCLUSION: Predictions of survival based on anatomic injury alone can be performed using ICD-9 codes, with no advantage from extra coding of AIS diagnoses. Predictions based on the single worst SRR were closer to actual outcomes than those based on multiplying SRRs.

Abbreviated Injury Scale↗

PubMed1999

Alternatives to placebo-controlled trials in psychiatry. ECNP Consensus Meeting, September 26, 1996, Amsterdam. European College of Neuropsychopharmacology.

Patients receiving placebo do not merely receive an inert substance but also receive support, concern, and reassurance that assists the therapeutic alliance and encourages the positive attitude that forms the basis of cognitive treatment. Response to non-specific factors is seen in all fields of medicine but is particularly potent in psychiatry. The placebo response is variable across settings and across time and is unpredictable. Historical data cannot therefore provide an adequate control for treatment effects in studies of new drugs. The scientific position is clear that a comparison against placebo is required for the unequivocal demonstration of the efficacy of a treatment. Evidence from at least two positive well designed and conducted placebo-controlled studies is generally accepted as appropriate to establish the efficacy of a drug. Attention to diagnosis, severity of illness, and to possible comorbid conditions is needed in the design and conduct of placebo-controlled studies in order to optimise the chance of obtaining valid data. The use of all data obtained, including dropouts due to lack of efficacy, should be maximised. The use of placebo may not be possible in some conditions that represent medical emergencies or may be difficult to justify in serious disorders where an effective treatment has already been established. Alternative designs to placebo-controlled studies can be considered. Consistent superior efficacy compared with a well accepted, effective treatment, given in an easily defended dose, is considered to be good evidence of efficacy provided that the studies are well designed and well conducted. Evidence of superior efficacy to an established effective comparator treatment may be regarded as evidence of efficacy. The demonstration of a dose-response relationship where one dose is found to be significantly better than another, can be taken as evidence for efficacy, particularly where there is already placebo-controlled evidence of the efficacy of the identified dose. Where a new treatment is found, under controlled conditions, to be equivalent to an existing well accepted comparator treatment, given at a clearly effective dose, this may be taken as evidence of efficacy, but only if the comparator is consistently superior to placebo and if equivalence has been defined beforehand. The claims for efficacy based on results from equivalence studies are less easily sustained than the evidence from placebo-controlled studies or studies demonstrating superior efficacy, due to the fact that those studies have no internal validation.

Controlled Clinical Trials as Topic↗

PubMed2005

[The clinical effect of anti-rotation reduction internal fixator on the treatment of fresh thoracolumbar spine fracture].

OBJECTIVE: To evaluate the effect of self-designed anti-rotation reduction internal fixator (ARRIF) on treating different spine segment fracture. METHODS: From August 1999 to March 2003, 76 patients(48 males and 28 females, aged from 22 to 59 with an average of 34.1) with thoracolumbar fracture were operatively treated by ARRIF. The follow-up period ranged from 6 to 21 months (15 months in average). Classification according to injury segment: flexion compression fracture 27 cases, burst fracture 42 cases, flexion distraction injury 3 cases, flexion revolving type fracture dislocation 2 cases, shear force type dislocation 2 cases. Classification according Frankel's grade: A grade 16 cases, B grade 15 cases, C grade 27 cases, D grade 10 cases, E grade 8 cases. Operation duration, volume of bleeding, incidence post-operation complication and effect of reduction-fixation were observed. RESULTS: The operation duration of ARRIF was 1.2 h in average, and there was about 200 ml volume of bleeding during operation. The nerve function showed one Frankel's grade improvement after operation were as follows: A grade 8 cases (50%), B grade 11 cases (73.3%), C grade 20 cases (74.1%), D grade 3 cases (30%); 2 Frankel's E cases have no nerve function changes. The nerve function damage have no aggravation in all the patients, the postoperation Cobb's angle was averagely corrected 22 degrees. The horizontal displacement of dislocation vertebrae was averagely corrected 28% in sagittal plane, the statistical analysis had significant variance (P < 0.01). ARRIF had no complications of the breakage of screws and rods. CONCLUSION: ARRIF proves to be a valid internal fixator in reducing and fixing different thoracic lumbar segment spine fracture.

Adult↗

PubMed2004

The assessment of patients' health-related quality of life during tuberculosis treatment in Wuhan, China.

OBJECTIVES: To validate the SF-36 questionnaire in a Chinese population and to assess the patients' health-related quality of life (HQoL) during tuberculosis (TB) treatment. DESIGN: The SF-36 (Chinese version) scores of 102 TB cases before treatment, after the initial phase and at the end of treatment were compared with those of 103 control subjects. RESULTS: The SF-36 scores were valid (internal consistency > 0.4) and reliable (Cronchbach's micro > 0.7). Before treatment, all except the role-emotional, social function and mental health scales of the TB patients were lower than those of the controls (P < 0.01); the patients' scores increased significantly during treatment (P < 0.01). In a stepwise regression model, age (P < 0.01, OR 0.95), white blood cell count (P < 0.01, OR 0.92) and number of symptoms (P < 0.05, OR 0.99) were associated with the total SF-36 score. At completion of treatment, sex (P < 0.01, OR 0.25) and haemoglobin (P < 0.05, OR 0.88) remained at the end of the model. CONCLUSION: The SF-36 scores of TB patients are low before treatment, indicating a decline in HQoL, with physical scales most affected. However, scores increase over the course of treatment. The Chinese version of SF-36 is a reliable tool for monitoring HQoL throughout TB treatment.

Adult↗

PubMed2003

Quality of life in women with fibromyalgia syndrome: validation of the QIF, the French version of the fibromyalgia impact questionnaire.

OBJECTIVE: To validate a translated and adapted version of the Fibromyalgia Impact Questionnaire (FIQ) for use in French-speaking populations. METHODS: The FIQ was translated into French by 2 independent translators and then back-translated into English to assess the conceptual equivalence. The translated version was tested and adapted by an expert committee to obtain the Questionnaire de mesure d'Impact de la Fibromyalgie (QIF), the French version of the FIQ. We administered the QIF to 102 women with fibromyalgia (FM): 71 women who consulted once, and 31 women who were follow for 3 visits (D0, M1, and M3). The patients were also asked to answer 4 other questionnaires: the McGill Pain Questionnaire, the Medical Outcome Study Short Form-36 (SF-36), the short form of the Arthritis Impact Measurement Scale 2 (AIMS2), and the General Health Questionnaire (GHQ) (for psychiatric assessment). To ensure test-retest reliability, the patients were asked to complete the QIF 7 days after the first visit and to send it back to the investigators by mail. During each visit, all patients were asked about pain intensity. A tender point count was obtained by thumb palpation and the tenderness threshold of each specific point was assessed by a 4-point scale score to determine the global tender point index. RESULTS: No major cultural adaptation was needed to obtain the French version of the FIQ. Test-retest reliability coefficients (intraclass correlation coefficient) for each question ranged from 0.04 to 0.84. Two items from the QIF (number of days when the patient felt good and visual analog scale stiffness) did not reach significant levels of test-retest reliability. Internal validity was good. The QIF score correlated well with the SF-36 and AIMS2 scores. The psychological aspects of the QIF were well correlated with those of GHQ-28. None of the items from the McGill Pain Questionnaire was correlated with QIF items. Similarly the clinical data concerning pain assessment were not correlated with QIF items. CONCLUSIONS: QIF is a valid instrument for measuring functional disability and health status in French women with FM. Some of the items were of a limited reliability, perhaps due to the variability of the multiple aspects of this syndrome.

Adult↗

PubMed2001

Management of acute exacerbations of chronic obstructive pulmonary disease: a summary and appraisal of published evidence.

PURPOSE: To review critically the available data on diagnostic evaluation, risk stratification, and therapeutic management of patients with acute exacerbations of chronic obstructive pulmonary disease (COPD). DATA SOURCES: English-language articles were identified by searching MEDLINE (1966 to 2000, week 5), EMBASE (1974 to 2000, week 18), HealthStar (1975 to June 2000), and the Cochrane Controlled Trials Register (2000, Issue 1). STUDY SELECTION: The best available evidence on each subtopic was selected for analysis. Randomized trials, sometimes buttressed by cohort studies, were used to evaluate therapeutic interventions. Cohort studies were used to evaluate diagnostic tests and risk stratification. DATA EXTRACTION: Study design and results were summarized in evidence tables. Individual studies were rated by internal validity, external validity, and quality of design. Statistical analyses of combined data were not performed. DATA SYNTHESIS: Data on the utility of most diagnostic tests are limited. However, chest radiography and arterial blood gas sampling seem useful while acute spirometry does not. Identifiable clinical variables are associated with risk for relapse and risk for death after hospitalization for an acute exacerbation. Evidence of efficacy was found for bronchodilators, corticosteroids, and noninvasive positive-pressure ventilation. There is also support for the use of antibiotics in patients with more severe exacerbations. On the basis of limited data, mucolytics and chest physiotherapy do not seem to be of benefit, and oxygen supplementation seems to increase the risk for respiratory failure only in an identifiable subgroup of patients. CONCLUSIONS: Although suggestions for appropriate management can be made on the basis of available evidence, the supporting literature is scarce and further high-quality research is necessary. Such research will require an improved, generally acceptable, and transportable definition of acute exacerbation of COPD, as well as improved methods for observing and measuring outcomes.

Acute Disease↗