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PubMed2006

Application and validation of chemometrics-assisted spectrophotometry and liquid chromatography for the simultaneous determination of six-component pharmaceuticals.

Three methods are developed for the simultaneous determination of theophylline anhydrous (TH), guaiphenesin (GP), diphenhydramine hydrochloride (DP), methylparaben (MP), propylparaben (PP) and sodium benzoate (BZ) in pharmaceutical syrup. The chromatographic method depends on a high performance liquid chromatographic separation on a reversed-phase C(18) column at ambient temperature with mobile phase consisting of 25 mM KH2PO4, pH 3.2-acetonitrile (60:40, v/v). Quantitation was achieved with UV detection at 222 nm based on peak area. The other two chemometric methods applied were partial least squares (PLS-1) and principal component regression (PCR). These approaches were successfully applied to quantify the six components in the studied mixture using information included in the UV absorption spectra of appropriate solutions in the wavelength range of 220-270 nm with Deltalambda=0.4 nm. The calibration PLS-1 and PCR models were evaluated by internal validation (prediction of compounds in its own designed training set of calibration), by cross-validation (obtaining statistical parameters that show the efficiency for a calibration fit model) and by external validation over synthetic and pharmaceutical preparation. The results of PLS-1 and PCR methods were compared with the HPLC method and a good agreement was found.

Antitussive Agents↗

PubMed2002

A multi-site study of alcohol subtypes: classification and overlap of unidimensional and multi-dimensional typologies.

AIMS: The current study examined the usefulness of four prevailing alcohol typologies, assessed in terms of replicability of the multi-dimensional schemas, percentage of the sample classified by each typology, distribution of subtypes by gender and treatment site and construct validity of Type 1/Type 2. In addition, overlap of classification systems was examined to determine whether the four typologies may be narrowed to a smaller set of meaningful, non-redundant subtype schemas. DESIGN: Baseline data from five treatment outcome studies were used to facilitate subtyping according to four alcohol typologies: antisocial (ASP) versus non-ASP, early versus late onset, Type 1/Type 2 and Type A/Type B. SETTING: The studies were conducted at several in-patient and out-patient treatment sites. PARTICIPANTS: The sample included 342 participants (23% female) who met DSM-III-R criteria for alcohol abuse or dependence. MEASUREMENTS: Subjects were assessed on substance use severity, family history, psychopathology, personality and psychosocial functioning. FINDINGS: Type 1/Type 2 and Type A/B typologies were replicated. Type 1/Type 2 had poor construct validity due to symptom cluster overlap between the two subgroups. Only 14% of the subjects met criteria for ASP. The two strongest associations including that between early versus late onset and Type 1/Type 2 and that between ASP versus non-ASP and Type A/Type B, were expected and reflect overlaps in conceptual definitions. In comparison, the relationship between early versus late onset and ASP versus non-ASP and Type A/B was weak. CONCLUSIONS: Clinical utility of the ASP/non-ASP typology is limited in non-Veterans Administration (VA) samples, due to low prevalence. The Type 1/Type 2 subtyping schema was redundant with the age of onset schema, and was the least internally valid of all four typologies. In general, the Type A/B schema was most promising of prevailing typologies studied. It was relatively inclusive, and the A, B groups were distinct from one another. However, dichotomous typologies may not be complex enough to be clinically useful descriptors of alcoholic samples. Aside from ASP and Type B, there appears to be heterogeneity within groups typically considered homogeneous, such as 'early versus late onset' alcoholics.

Adult↗

PubMed2005

Performance of a population-based cardiac risk stratification tool in Asian patients with chest pain.

OBJECTIVES: Most contemporary cardiac risk stratification tools have been derived and validated in mixed-race populations. Their validity in single-race populations has not been tested. The authors sought to compare the performance of a risk stratification tool between a mixed-race U.S. patient population and an Asian patient population. METHODS: This study is an analysis of data from the Internet Tracking Registry for Acute Coronary Syndromes (i(*)trACS) registry of patients with chest pain presenting to the emergency departments of eight U.S. centers and one site in Singapore. The Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) was computed for included patients, and its performance in predicting acute coronary syndrome (ACS) was compared between patients from the United States and Singapore. RESULTS: Of the 11,991 included patients, 1,120 experienced ACS. Although the ACI-TIPI demonstrated similar accuracy among groups (area under the curve, 0.729 [U.S.] vs. 0.719 [Singapore]; p = 0.5611), sensitivity and specificity were different when equal ACI-TIPI thresholds were considered. Recreating the logistic regression models used to create the ACI-TIPI showed similar results between the derived parameters and the parameters estimated for the U.S. group. In contrast, age older than 50 years (log-odds ratio [LOR], 0.107; 95% confidence interval [CI] = 0.518 to 0.713), male gender (LOR, 0.487; 95% CI = 0.149 to 1.122), and chest pain as a primary complaint (LOR, 0.237; 95% CI = 0.139 to 0.613) had little predictive power in patients from Singapore. CONCLUSIONS: Differences exist in presentation and factors associated with ACS among patients from the United States and Singapore that may affect the performance of risk stratification tools. These findings suggest that cardiac clinical decision rules need international validation.

Acute Disease↗

PubMedDate not supplied

Single laboratory validation of a method for the determination of hydroxymethylfurfural in honey by using solid-phase extraction cleanup and liquid chromatography.

A method is described for the determination of hydroxymethylfurfural (HMF) in honey. The method, which is based on solid-phase extraction cleanup followed by liquid chromatography (LC) with UV absorbance detection, was tested on a variety of different honey types: liquid, set, blended, filtered, crystalline, and comb honey. A sample of honey fortified with a known amount of HMF acted as an in-house reference material. LC with diode-array detection showed that the HMF peak did not contain any peaks of coeluting interfering species. Stability studies showed that honey samples should not be repeatedly frozen and thawed because the temperature changes caused a gradual increase in the HMF concentration. It was also shown that aqueous HMF standard solutions should be kept in the dark at 4 degrees C to avoid degradation of the HMF. The method was internally validated, and the measurement uncertainty was estimated to be +/-9.0 at 40 mg/kg, the legal limit. A comparison of the relative standard uncertainty with the Horwitz relative standard deviation showed that the method was suitable for its purpose and should be validated by a collaborative trial.

Chemistry Techniques, Analytical↗

PubMed2006

Derivation and validation of a new global method for assessing nutritional status in patients with cirrhosis.

Accurate assessments of nutritional status are difficult to obtain in patients with cirrhosis. The aim of this study was to devise and validate a global nutritional assessment scheme for use in this patient population. Measures of body mass index (BMI) and mid-arm muscle circumference (MAMC) were combined with details of dietary intake in a semistructured, algorithmic construct to provide a nutritional assessment scheme for use in patients with cirrhosis; evaluated individuals were classified as adequately nourished, moderately malnourished (or suspected to be), or severely malnourished. There was good interobserver agreement in the nutritional categorization of 50 patients with cirrhosis (34 men, 16 women) using this scheme (kappa = 0.79) and significant associations with the contributing objective variables--namely, BMI (Spearman's correlation r = -0.78; P < .001) and relative MAMC (r = -0.69; P < .001)--confirming its internal validity. There was a significant association between nutritional categorization in 20 patients with cirrhosis (10 men, 10 women) and estimates of total body protein obtained using a four-component model (r = -0.45; P = .046), confirming the external validity of the scheme. Finally, a significant association was found between poor nutritional status in 116 patients with cirrhosis (65 men, 51 women), followed for 14 to 52 months, and shorter subsequent survival (P = .0005), confirming the scheme's predictive validity. In conclusion, a global assessment scheme has been devised that provides a simple, reproducible, valid, and predictive method of assessing nutritional status in patients with cirrhosis.

Adult↗

PubMed2006

Febrile convulsions: development and validation of a questionnaire to measure parental knowledge, attitudes, concerns and practices.

BACKGROUND: The best medicine for febrile convulsions (FCs) is not prescription medications but effective communication of related information to parents. Therefore, a quick assessment tool for obtaining information about parental responses to FCs is essential for educating parents, clinical practice and research. This paper describes the development and psychometric testing of a questionnaire on parental knowledge, attitudes, concerns and practices (KACP) toward FC. METHODS: Questionnaire items were created via literature review, interview, and expert consultation. Ten parents were interviewed to develop the questionnaire contents. Nine experts and seven parents were consulted to review the content and face validity of the questionnaire. Of the 326 parents of children with FC visiting 11 emergency departments in southern Taiwan, 216 parents completed the questionnaire, and 64 completed the questionnaire again 2 weeks later. Content validity, internal consistency, test-retest reliability, and item analysis were evaluated. RESULTS: Cronbach's alpha exceeded 0.72 for the knowledge, attitudes and concerns domains. The item-total correlations in the knowledge and concerns domains ranged from 0.40 to 0.73, but were lower in the attitudes domain (only 4 in 10 items were within 0.40-0.70). The intraclass correlation coefficients (ICC) for the test-retest reliability of the knowledge, attitudes and concerns domains were 0.65, 0.68 and 0.58, respectively. The correlation coefficients between KACP domains were tested and significantly supported the theoretical basis of the questionnaire. CONCLUSION: For research purposes, the KACP questionnaire measures parental responses with a moderate level of reliability and validity. Cross-cultural investigation of the questionnaire is needed to facilitate its use in other countries.

Adult↗

PubMed2005

Screening test accuracy studies: how valid are our conclusions? Application to visual inspection methods for cervical screening.

While the basic concepts associated with screening are simple, studying the value of new tests requires a very strict methodology. This paper summarizes lessons learned regarding appropriate methodologies to assess the value of new screening approaches using visual inspection with acetic acid (VIA), a screening test for cervical pre-cancerous lesions, as an example. In addition to being convenient to, safe for and acceptable by target community members, a screening test should be reliable and have good test characteristics (i.e. be able to discriminate well between early disease and non disease). Test reliability assesses the degree to which repeated measurements of the test yields the same result. To ensure reproducibility of study findings, test reliability should be assessed before any evaluation of test accuracy. The accuracy of a test (specificity and sensitivity) is measured using cross-sectional studies with adequate sample size. Several basic features are necessary to ensure internal validity for such studies: (a) final disease status data should be obtained for all subjects, (b) all tests results must be determined independently of previous results, (c) the reference standard used to determine the disease status should be accurate, (d) the full "spectrum" of the disease should be included in the study. The study results should also have external validity to be applicable to other populations to which the test will be applied. All these consideration are exemplified by 17 very heterogeneous studies published to date assessing VIA test accuracy. The assessment of a new screening test is the first step in researching a new cancer prevention strategy. For this reason, this step should be carefully addressed through rigorous studies.

Acetic Acid↗

PubMed2006

Validation of a nomogram for prediction of side specific extracapsular extension at radical prostatectomy.

PURPOSE: We have previously have reported a tree structured regression model for predicting SS-ECE. Others recently reported a logistic regression based SS-ECE nomogram. We developed a nomogram and compared the performance and discriminant properties of the tree regression and the nomogram in a contemporary cohort of European patients treated with radical retropubic prostatectomy. MATERIALS AND METHODS: The cohort consisted of 1,118 patients with pretreatment prostate specific antigen 0.1 to 73.2 ng/ml (median 6.6). Each of the 2,236 prostate lobes was considered separately. Clinical stage, pretreatment PSA, biopsy Gleason sum, percent positive cores and percent cancer in the biopsy specimen were used as predictors in a logistic regression model predicting SS-ECE. Regression coefficients were then used to generate an SS-ECE nomogram. Performance characteristics and discriminant properties of the previously published tree regression were also tested in the same cohort. For internal validation and to decrease overfit bias 200 bootstrap re-samples were applied to accuracy estimates for each method. RESULTS: ECE was present in 303 of 1,118 radical retropubic prostatectomy specimens (27%) and in 385 lobes (17%). In logistic regression models all variables were statistically significant multivariate predictors of SS-ECE except the percent of positive biopsy cores (p = 0.7). Bootstrap corrected predictive accuracy of the SS-ECE nomogram was 0.840 vs 0.700 for the tree regression model. CONCLUSIONS: Logistic regression based nomogram predictions of SS-ECE are highly accurate and represent a valuable aid for assessing the risk of ECE prior to surgery.

Calibration↗

PubMed2001

Development of the Children's Eating Behaviour Questionnaire.

Individual differences in several aspects of eating style have been implicated in the development of weight problems in children and adults, but there are presently no reliable and valid scales that assess a range of dimensions of eating style. This paper describes the development and preliminary validation of a parent-rated instrument to assess eight dimensions of eating style in children; the Children's Eating Behaviour Questionnaire (CEBQ). Constructs for inclusion were derived both from the existing literature on eating behaviour in children and adults, and from interviews with parents. They included responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating. fussiness, emotional overeating, emotional undereating. and desire for drinks. A large pool of items covering each of these constructs was developed. The number of items was then successively culled through analysis of responses from three samples of families of young children (N = 131; N = 187; N = 218), to produce a 35-item instrument with eight scales which were internally valid and had good test-retest reliability. Investigation of variations by gender and age revealed only minimal gender differences in any aspect of eating style. Satiety responsiveness and slowness in eating diminished from age 3 to 8. Enjoyment of food and food responsiveness increased over this age range. The CEBQ should provide a useful measure of eating style for research into the early precursors of obesity or eating disorders. This is especially important in relation to the growing evidence for the heritability of obesity, where good measurement of the associated behavioural phenotype will be crucial in investigating the contribution of inherited variations in eating behaviour to the process of weight gain.

Body Constitution↗

PubMed1999

The emotional lability questionnaire: a new measure of emotional lability in amyotrophic lateral sclerosis.

In an ALS Clinic, use of the Pathological Laughter and Crying Scale of Robinson et al. [Robinson RG, Parikh RM, Lipsey JR, Starkstein SE, Price TR. Pathological laughter and crying following stroke: validation of a measurement scale and double-blind treatment study. American Journal of Psychiatry 1993;150(2):286-293] revealed several problems: reliance on self-rating, insufficient period of assessment, inadequate exploration of 'appropriateness of emotion', lack of an item for abnormal smiling, amusement rather than happiness being the cause of laughter in ALS, and a frequency-based rating system. The necessary modifications produced a new Emotional Lability Questionnaire (ELQ) that was tested in 43 ALS patients and 43 healthy controls. The self-rated version of the ELQ was administered as a structured interview to each participant, and the independent-relationship between subscales of the ELQ for both versions, thus confirming its internal validity. Greater emotional lability appeared associated with pseudobulbar symptoms. The question why 14 patients rated themselves as severely labile in the crying domain alone and four in the laughter domain alone, required further study.

Adult↗

PubMed2006

Subtypes of written expression in elementary school children: a linguistic-based model.

The purpose of this study was to provide a reliable and valid classification scheme for written expression that captured the linguistic variability present in a typical elementary school sample. This empirically derived classification model was based on the following linguistic-based writing skills: (a) understandability of discourse, (b) grammar, (c) semantics, (d) spelling, and (e) reading comprehension. The sample included 257 fourth-grade (n = 142) and fifth-grade (n = 115) students (46.3% boys, 79.4% White, age range = 8;3-11;7 years; M = 10.10). All of the students were receiving their writing instruction in the regular education setting, with approximately one third receiving some type of educational assistance. The sample fell in the middle socioeconomic stratum. Cluster analytic techniques derived different possible solutions. Results of a series of internal validity studies provided strong evidence that the six-cluster solution was both stable and interpretable, with subtypes reflecting normal as well as writing disability variants. Further, the writing disability subtypes ranged from global impairment to more specific linguistic impediments. Based on their characteristics, the clusters were named (a) Average Writers (n = 102), (b) Low Semantics (n = 31), (c) Low Grammar (n = 18), (d) Expert Writers (n = 33), (e) Low Spelling-Reading (n = 13), and (f) Poor Text Quality (n = 60). Subtypes differed on the percentages of children in selected subtypes manifesting specific writing deficits as well as on selected aspects of measures of metacognition, self-efficacy, and self-regulation of the writing process. Results provide researchers with a foundation to further investigate the underlying neurolinguistic and neurocognitive processes that may strengthen or undermine students' ability to produce a quality written product and to design and implement intervention techniques to address the various subtype patterns inherent in a regular elementary school classroom.

Analysis of Variance↗

PubMed2002

Predicting functional outcome and survival after acute ischemic stroke.

OBJECTIVE: Disability and mortality represent the most relevant clinical outcome after acute ischemic stroke. However, validated and comprehensive prognostic models for recovery have not been developed. An accurate model including all previously suggested independent outcome predictors could improve the design and analysis of clinical trials. We therefore developed prognostic models for functional dependence and death after 100 days in a large cohort of stroke patients. METHODS: From the German Stroke Database, 1754 prospectively collected records of patients with acute ischemic stroke were used for the development of prognostic models. Intubated patients and patients with low functional status before stroke were excluded. Functional independence was defined as a Barthel Index >/=95 after 100 days. Prognostic factors assessable within 72 hours after admission were identified by a systematic literature review. The final models of binary logistic regression analyses were internally validated and calibrated. RESULTS: The resulting cross-validated and calibrated models correctly classified more than 80 % of the patients and yielded the following prognostic factors for functional independence: Age, right and left arm paresis at admission, NIH-Stroke Scale at admission, Rankin Scale 48-72 hours later, gender, prior stroke, diabetes, fever, lenticulostriate infarction, neurological complications. The following variables were identified as prognostic factors for death: Age, NIH-Stroke Scale at admission, and fever. CONCLUSIONS: Our work gives an important insight into prognostic factors after acute ischemic stroke and presents predictive models with high prognostic accuracy. Together with a prospective validation study, currently underway, we hence hope to improve the prediction of functional outcome after ischemic stroke.

Activities of Daily Living↗

PubMed1999

Development of the physical therapy outpatient satisfaction survey (PTOPS).

BACKGROUND AND PURPOSE: The purposes of this 3-phase study were (1) to identify the underlying components of outpatient satisfaction in physical therapy and (2) to develop a test that would yield reliable and valid measurements of these components. SUBJECTS: Three samples, consisting of 177, 257, and 173 outpatients from 21 facilities, were used in phases 1, 2, and 3, respectively. METHODS AND RESULTS: In phase 1, principal component analyses (PCAs), reliability checks, and correlations with social desirability scales were used to reduce a pool of 98 items to 32 items. These analyses identified a 5-component model of outpatient satisfaction in physical therapy. The phase 2 PCA, with a revised pool of 48 items, indicated that 4 components rather than 5 components represented the best model and resulted in the 34-item Physical Therapy Outpatient Satisfaction Survey (PTOPS). Factor analyses conducted with phase 2 and phase 3 data supported this conclusion and provided evidence for the internal validity of the PTOPS scores. The 4-component scales were labeled "Enhancers," "Detractors," "Location," and "Cost." Responses from subsamples of phase 3 subjects provided evidence for validity of scores in that the PTOPS components of "Enhancers," "Detractors," and "Cost" appeared to differentiate overtly satisfied patients from overtly dissatisfied patients. "Location" and "Enhancer" scores discriminated subjects with excellent attendance at scheduled physical therapy sessions from those with poor attendance. CONCLUSION AND DISCUSSION: In this study, we identified components of outpatient satisfaction in physical therapy and used them to develop a test that would yield valid and reliable measurements of these components.

Adult↗

PubMed2005

Validation of an ELISA test kit for the detection of ochratoxin A in several food commodities by comparison with HPLC.

An ELISA Microtiter Plate, Ochratoxin Test called AgraQuant was validated to measure ochratoxin A in a range from 2 to 40 ppb in corn, milo, barley, wheat, soybeans and green coffee. The test is performed as a solid phase direct competitive ELISA using a horseradish peroxidase conjugate as the competing, measurable entity. For the test method, ochratoxin A is extracted from ground samples with 70% methanol and sample extracts plus conjugate are mixed and then added to the antibody-coated microwells. After 10 min incubation at room temperature, the plate is washed and enzyme substrate is added and allowed to incubate for an additional 5 min. Stop solution is then added and the intensity of the resulting yellow color is measured optically with a microplate reader at 450 nm. Results obtained from internal validation studies assessing accelerated stability indicate a 1 year shelf life; accuracy and precision are comparable to HPLC from 0 to 80 ppb and limit of detection in corn is 1.9 ppb and other food commodities is up to 3.8 ppb. Comparison of the method to HPLC, ability to detect individual ochratoxins, and ruggedness of the test kits determined this test to be rugged from 18 to 30 degrees C, sensitive, accurate, precise and effective comparable to HPLC for measuring ochratoxin A ranging from 2 to 40 ppb in several commodities.

Chromatography, High Pressure Liquid↗

PubMed1984

Measuring children's diets: evaluation of dietary assessment techniques in infancy and childhood.

Epidemiological studies of dietary habits in infancy and childhood face a number of difficulties, which are more or less specific for these ages. In connection with studies on dietary habits of Swedish infants and children an evaluation of different dietary assessment techniques was performed. Breastfeeding data obtained in retrospective interviews at six months had good validity. The reliability of breastfeeding and weaning data decreased over time. Short questions on food frequencies, often used in research and clinical practice, were shown to be a poor screening instrument and suffered from biases when used in groups of four- and eight-year-old children. Group mean estimations of dietary intake of four- and eight-year-old children obtained by 24-hour recalls were close to those of seven-day records from the same individuals. Dietary intake in a 13-year-old group according to 24-hour recall and dietary history differed significantly; the dietary history gave much higher estimations. The reliability of dietary history in a small group of 13-year-old boarding school children was fairly good. The internal validity of food recording was examined by use of chemical analysis of duplicate portions. Generally, there was good agreement between the records and the analysed duplicates. The intake of a number of nutrients varied during the week, often showing a maximum towards the weekend. The intake of vitamin C was higher in winter time, otherwise no seasonal variation was found. The intra-individual variation in dietary intake is illustrated and its consequences for dietary studies are discussed.

Adolescent↗

PubMed2006

The appraisal of social concerns scale: psychometric validation with a clinical sample of patients with social anxiety disorder.

The Appraisal of Social Concerns (ASC) Scale was created by Telch et al. (2004) to improve upon existing self-report measures of social anxiety-related cognition. In a largely nonclinical sample, the ASC was found to possess three factors and was psychometrically sound. In a smaller clinical sample, the ASC demonstrated sensitivity to the effects of cognitive behavioral therapy. In the present study, the psychometric properties of the ASC were examined in a larger sample of patients with social anxiety disorder. In this sample, the ASC exhibited a 2-factor structure; the nature of the factors was similar to the primary factors originally reported by Telch et al. The ASC also demonstrated strong validity, internal consistency, and sensitivity to treatment effects. It is concluded that the ASC may be useful in the assessment of cognition and cognitive change in patients with social anxiety disorder.

Adult↗

PubMed1995

A method for scoring the pain map of the McGill Pain Questionnaire for use in epidemiologic studies.

Identifying and quantifying the location of pain may be important for understanding specific functional impairments in elderly populations. The purpose of the present analysis was two-fold: first, to describe the reliability of a scoring method for the McGill Pain Map (MPM), and second, to validate the method of scoring the MPM as a tool for assessing areas of body pain in an epidemiologic study. In interviews performed at the subjects' homes, 411 community dwelling Mexican-American and non-Hispanic white subjects aged 65-74 from the San Antonio Longitudinal Study of Aging (SALSA) were asked to describe the location of their pain on the map of the human body included in the McGill Pain Questionnaire. The location of pain was scored by overlaying the survey figures with a MPM template divided into 36 anatomical areas. Inter- and intra-rater agreement among three raters was measured by calculating a kappa statistic for each of the body areas, and an intraclass correlation coefficient for the total number of painful areas (NPA). Internal validity was measured by Spearman's rho between the NPA and the Present Pain Index (PPI) and Pain Rating Index (PRI) of the McGill Pain Questionnaire, and external validity by correlation between NPA and the Perceived Health (PH), Amount of Bodily Pain (APB), and Pain Interference with Work (PIW) items of the Medical Outcomes Study, and the Perceived Physical Health (PPH) question of the San Antonio Heart Study. Average inter-rater agreement for individual MPM areas was 0.92 +/- 0.01, and average agreement for NPA was 0.96 +/- 0.01. Intra-rater agreement for individual areas averaged 0.94 +/- 0.01, and for NPA = 0.99 +/- 0.001. Pain in one or more areas was present in 47.7% of the subjects. For the whole sample, correlations between NPA and the validation indices were: PPI (0.91), PRI (0.89), PH (0.25), ABP (0.64), PIW (0.49), and PPH (0.20). Among the 196 subjects with pain, correlations were: PPI (0.34), PRI (0.34), PH (0.19), ABP (0.21), PIW (0.38), and PPH (0.19)-p < 0.01 for all correlations. In conclusion, we have developed a reliable method of scoring the MPM and have shown evidence of its validity in a community-based sample of elderly subjects. Patterns of painful body areas may be associated with specific diseases and functional impairments.

Aged↗

PubMed2006

Validation of a nomogram predicting the probability of lymph node invasion based on the extent of pelvic lymphadenectomy in patients with clinically localized prostate cancer.

OBJECTIVE: To develop a multivariate nomogram to predict the rate of lymph node invasion (LNI) in patients with clinically localized prostate cancer according to the extent of extended pelvic lymphadenectomy (PLND), which is associated with significantly higher rate of LNI. PATIENTS AND METHODS: The study comprised 781 consecutive patients (median age 66.6 years, range 45-85) treated with PLND and radical retropubic prostatectomy (RRP) for clinically localized prostate cancer. Their median (range) prostate-specific antigen (PSA) level was 7 (1.03-49.91) ng/mL, and their clinical stages were T1c in 433 (55.4%), T2 in 328 (42%) and T3 in 20 (2.6%). Biopsy Gleason sums were <or= 6 in 514 (65.8%), 7 in 204 (26.1%) and 8-10 in 63 (8.1%). Multivariate logistic regression models were used to test the association between predictors including PSA level, biopsy Gleason sum, clinical stage, number of nodes removed and the rate of LNI. Finally, regression coefficients were used to develop a nomogram, which was internally validated with 200 bootstrap re-samples. RESULTS: The median (range) number of lymph nodes removed was 14 (2-40); LNI was detected in 71 patients (9.1%). The univariate predictive accuracy for total PSA level, clinical stage, biopsy Gleason sum and number of total nodes removed and examined was 64.2%, 59.8%, 74% and 62.9%, respectively. Except for PSA (P = 0.2), all variables were statistically significant multivariate predictors of LNI at RRP (P <or= 0.001). A nomogram based on clinical stage, PSA level, biopsy Gleason sum and the number of total lymph nodes removed was 78.6% accurate, and 1.8% more accurate than a nomogram without the number of removed lymph nodes. CONCLUSIONS: The extent of PLND is directly related to the probability of LNI. The risk of LNI increases linearly, and is proportional to the number of nodes removed and examined. The effect of the increased probability of LNI is weighted more heavily in men with more advanced clinical stage and grade.

Aged↗