Prevalence and dietetic management of mild gastrointestinal disorders in milk-fed infants.

AIM: To assess the prevalence of mild gastrointestinal disorders in milk-fed infants in paediatric practice, and to evaluate the effectiveness and satisfaction with dietetic treatment. METHODS: A cross-sectional epidemiological study was first carried out. A total of 285 paediatricians included 3487 children seen during a period of one week. In a second phase an observational, prospective and multicentre study was conducted and 2069 milk-fed infants with mild gastrointestinal disorders (colic, constipation, regurgitation and diarrhoea) were included. There was a baseline visit (start of treatment) and a final visit four weeks later. The effectiveness of the various Novalac formulas, as well as the satisfaction of the parents/tutors and paediatricians with the dietetic treatment were assessed at the final visit. RESULTS: The prevalence of mild gastrointestinal disorders was 27.8% of all paediatrician consultations (9.2%, 7.8%, 6.1% and 4.6% in relation to colic, constipation, regurgitation and diarrhoea, respectively). The several Novalac adapted milk formulas resolved 88.4% of the mild gastrointestinal disorders. Depending on the type of disorder, differences in response rate were observed. The highest effectiveness was recorded with respect to diarrhoea (92.6%), followed by constipation (91.6%), colic (87.6%) and regurgitation (81%). Overall, 91% of the paediatricians and 88.8% of the parents/tutors were satisfied or very satisfied with the Novalac adapted milk formulas. CONCLUSION: Mild gastrointestinal disorders show a high prevalence in paediatric practice. The Novalac adapted milk formulas have been shown to be effective in treating mild gastrointestinal disorders in milk-fed infants in the context of routine clinical practice.

[Validity of tests for initial diagnosis and its concordance with final diagnosis in patients with suspected benign prostatic hyperplasia]. / Validez de las pruebas utilizadas en el diagnóstico inicial y su concordancia con el diagnóstico final en pacientes con sospecha de hiperplasia benigna de próstata.

OBJECTIVE: To assess the validity of diagnostic tools available at the primary care setting [medical history (MH), I-PSS questionnaire, digital rectal examination (DRE) and prostate specific antigen (PSA) evaluation] for the diagnosis of benign prostatic hyperplasia (BPH). SUBJECTS AND METHODS: 363 patients with suspected prostatic disease referred to urology outpatient clinics were included. For every subject initial BPH diagnosis was collected at each of the following sequential procedures: 1) MH; 2) I-PSS; 3) DRE; and 4) PSA. Each of these diagnostic decisions were compared to a final diagnosis (gold standard) reached after the addition of urinary sediment analysis, ultrasonographic assessment of residual volume and prostatic volume, and peak urinary flow measurement. A descriptive analysis was undertaken: validity and concordance between each diagnostic step and the gold standard was calculated. RESULTS: Sensitivity, specificity, positive predictive value, and negative predictive value of diagnosis based on MH+I-PSS+DRE+PSA with respect to the gold standard were 91%, 65%, 95% and 50%, respectively. The percentage of agreement and kappa index between both diagnostic strategies were 87.9% and 0.5, respectively. CONCLUSIONS: Concordance between BPH initial diagnosis based on MH+I-PSS+DRE+PSA and diagnosis based on a full range of tests was high, thus allowing recommending the use of this group of initial diagnostic procedures, which are available to the primary care physician, not only as a first diagnostic step in patients with suspected BPH, but also as a valid strategy to prevent unnecessary delay in its initial management and to facilitate appropriate referral from primary to specialized care.

[Inspection validation of prescription: guaranteeing proper use of medicines or a cost-control measure?]. / Visados de inspección: garantía del uso adecuado de los medicamentos o medida de control del gasto?

OBJECTIVE: To assess the views of primary care physicians (PCPs) in Spain regarding the purpose of inspection validation of prescriptions (IVP) and its impact on prescription and patients, as well as doctors' acceptance of this measure. DESIGN: Cross-sectional study through a telephone survey. SETTING: Primary care centres. PARTICIPANTS: PCPs prescribing oral diabetes drugs requiring IVP, or who were familiar with IVP. METHODS: Telephone survey conducted in October-November, 2003, of 1471 PCPs. Sample size was calculated to ensure accuracy to 10% in each autonomous region. RESULTS: 91.9% of the 1600 PCPs contacted who agreed to participate in the study met the inclusion criteria. On average, they prescribed 30.6 drugs requiring IVP per month (95% CI, 28.0-33.2), requiring an additional 4.6 minutes per prescription (95% CI, 4.4-4.8). 64.7% of PCPs increased their clinical work-time for this reason. 71.3% of PCPs (95% CI, 69.0-73.6) considered IVP an obstacle when prescribing a drug that requires it and 44.5% (95% CI, 42.0-47.0) believed that the IVP puts patients' right to receive the appropriate treatment at risk. PCPs considered that inspectors refuse authorization of their prescriptions requiring IVP for administrative (43.3%), economic (36.5%), or clinical (13.2%) reasons. 87.1% of PCPs stated that medical prescription is a sufficient control system and that IVP is not necessary for medicines for diseases managed in primary care such as Type-2 DM. 76.2% believed that the health authorities imposed the IVP requirement for some oral diabetes drugs in order to control expenditure on drugs, and 75.4% supported its withdrawal. CONCLUSION: According to PCPs, the objective of the IVP is mainly economic and may affect negatively their clinical practice and patients. Therefore, in general, they do not support it, at least for drugs for diseases mainly managed in primary care.

Visados de inspección: ¿garantía del uso adecuado de los medicamentos o medida de control del gasto?

Objetivo. Conocer la opinión de los médicos de atención primariam (MAP) en España acerca de la finalidad del visado de inspección (visado) y su impacto en la prescripción y en los pacientes, así como la aceptación de esta medida. Diseño. Estudio transversal mediante encuesta telefónica. Emplazamiento. Centros de atención primaria. Participantes. Médicos de atención primaria que utilizaban antidiabéticos orales con visado o estaban familiarizados con ellos. Mediciones. Se realizó una encuesta telefónica en octubre-noviembre de 2003 a 1.471 MAP españoles. La muestra se calculó para asegurar una precisióndel 10 por ciento en cada comunidad autónoma. Resultados. Un 91,9 por ciento de los 1.600 MAP contactados que accedieron a participar en el estudio cumplió los criterios de inclusión. Los MAP realizan una media mensual de 30,6 (intervalo de confianza [IC] del 95 por ciento, 28,0-33,2) prescripciones de medicamentos con visado, requierendo un tempo adicional de 4,6 minutos por prescripción (IC del 95 por ciento, 4,4-4,8). El 64,7 por ciento de los MAP aumenta, por esa razón, el tiempo de trabajo clínico. Un 71,3 por ciento (IC del 95 por ciento, 69,0-73,6) de los MAP considera el visado un impedimiento para prescribir medicamentos que lo requieren y un 44,5 por ciento (IC del 95 por ciento, 42,0-47,0) de los MAP opina que el visado puede poner en riesgo el derecho del paciente a recibir el tratamiento más adecuado. Los MAP consideran que los inspectores rechazan sus prescripciones de medicamentos con visado por razones administrativas (43,3 por ciento), económicas (36,5 por ciento) o clínicas (13,2 por ciento). Un 87,1 por ciento de los MAP declara que para enfermedades tratadas en atención primaria, como la diabetes mellitus tipo 2, la prescripción médica es un sistema de control suficiente y no es necesario el visado. Un 76,2 por ciento opina que las autoridades sanitarias impusieron el visado a algunos antidiabéticos orales para controlar el gasto farmacéutico, y un 75,4 por ciento está a favor de su retirada. Conclusión. Según los MAP, el visado parece responder a una finalidad fundamentalmente económica y puede tener un impacto negativo en su práctica clínica y en los pacientes. Por tanto, en genral, no respaldan su aplicación, al menos en medicamentos para enfermedades mayoritariamente tratadas en atención primária.(AU)

[Prescription medicines information: Spanish general population survey]. / Información de medicamentos de prescripción: encuesta a la población general Española.

OBJECTIVE: To assess Spanish general population opinion on prescription medicine information which they currently access or would like to. Design. Cross-sectional descriptive study through telephone interviews. Setting. Spanish general population. February-March 2003. PARTICIPANTS: A total of 1069 subjects from 16 to 90 years old were interviewed. Main measures. Questionnaire developed after reviewing legislation and literature, and validated by an expert panel in medical information. RESULTS: A total of 87.7% of subjects usually obtain medicines upon medical prescription. The most important prescription medicine information sources are drug information leaflet (75.9%; 95% CI, 73.3-78.5), physicians (54.9%; 95% CI, 51.8-58.0), pharmacists (17.4%; 95% CI, 15.1-19.7 and nurses (6.7%; 95% CI, 5.2-8.2). Less than 3% of subjects obtain prescription medicine information through Internet. A total of 52.9% (95% CI, 49.9-55.8) of subjects feel they are inadequately informed about prescription medicine and would like to have more access to it through sources different than health care staff. A total of 45.6% (95% CI, 42.6-48.6) of subjects would find convenient to receive information from pharmaceutical companies. This information should be qualified and supervised by health authorities. Brief written materials provided by physicians or pharmacists, would be the most appropriate way for patients to obtain prescription medicine information from pharmaceutical companies. CONCLUSIONS: Spanish general population feel they have poor information on prescription medicine and would like to get access to qualified information from different sources, including the one provided by the pharmaceutical industry.

[Quality of life, time commitment and burden perceived by the principal informal caregiver of Alzheimer's patients]. / Calidad de vida, tiempo de dedicación y carga percibida por el cuidador principal informal del enfermo de Alzheimer.

OBJECTIVE: To evaluate the impact in Health Related Quality of Life (HRQoL), the time commitment and the burden perceived by the principal informal caregiver (PIC) of Alzheimer's patients (AP) in Spain, as well as the type and amount of external help received. DESIGN: Multicentric descriptive cross-sectional study. PATIENTS: A randomised sample of 268 PIC were included from 19 Alzheimer's Patient Family Associations (APFA) randomly selected from all Spanish regions. MEASURES: Data were collected using a structured telephone interview with the CATI system. HRQoL was measured using the questionnaire EuroQoL-5D. Information was also collected on the health problems of the PIC, the burden perceived (using the specific Zarit scale), the time commitment of PICs (hours per day), type of activity, as well as the amount and type of external help received. RESULTS: The HRQoL of the PIC showed to be worse than the general population in the EQ-5D, except in the self-care dimension. A total of 84% of PIC had physical problems related to the care given to the AP and 94.4% had psychological problems. The Zarit scale showed that 46.5% of caregivers had a level of burden between severe and moderated, while in 34.7% was severe. Time commitment was more than 8 hours per day in 72.1% of them and more than 20 hours per day in 39.6%. Only 26.9% of the PIC received some sort of socio-sanitary help and 76.5% received help from the APFA. CONCLUSIONS: Caregivers of AP suffer a negative impact on their health state and HRQoL; the time they dedicate to the patient is very high.

[Effect of type-2 diabetes mellitus on the quality of life of patients treated at primary care consultations in Spain]. / Impacto de la diabetes mellitus tipo 2 en la calidad de vida de los pacientes tratados en las consultas de atención primaria en España.

OBJECTIVES: To evaluate the impact of type-2 diabetes mellitus (DM2) on the health-related quality of life (HRQL) of patients and to analyse the impact of social-demographic and clinical variables and of resource use. DESIGN: Cross-sectional study with retrospective and prospective information gathering (HRQL questionnaire). Setting. 29 primary care centres from the whole of Spain. PARTICIPANTS: 1041 patients diagnosed with DM2 after the age of 30, chosen at random from patients' records at participating centres. Main measurements. HRQL evaluated through the general questionnaire EQ-5D, which enabled HRQL of patients to be compared with that of the general Spanish population, obtained from a sample of 8963 people. RESULTS: Patients with DM2 had worse HRQL (mean EVA index of 0.71) than people in the general population of the same age and gender (mean EVA index of 0.81). Women, older patients and obese patients had worse HRQL. In clinical terms, patients with some DM2-related complication, deficient glycaemic control and in receipt of insulin treatment had worse HRQL than patients without complications, acceptably controlled patients or those receiving non-pharmacological or oral anti-diabetes treatment. CONCLUSIONS: DM2 is associated with worse HRQL for patients, and more so for patients with complications, poor control of glucaemia or under insulin treatment.

[Instruments for measuring health-related quality of life in children and adolescents with asthma]. / Instrumentos de evaluación de la calidad de vida relacionada con la salud en niños y adolescentes con asma.

OBJECTIVES: Measures of health-related quality of life (HRQOL) are proving to be useful in providing a comprehensive evaluation of illness and its effects on patients' daily lives. The aim of this review is to describe HRQOL instruments that are currently available to measure the HRQOL in children and adolescents with asthma. METHODS: The MEDLINE database from 1980to 2000was reviewed, as well as the website of the American Thoracic Society and the Quality of Life Research journal. Studies that included instruments measuring HRQOL in children with asthma were included as long as the instruments included met the selection criteria of multidimensionality, scoring was through standardized ordinal scales and psychometric properties were evaluated. RESULTS: Of the 21instruments initially identified 7were excluded because they did not meet one or more of the selection criteria. Fourteen instruments were included in the final review, 6were generic instruments for children (CHQ, KINDL, PedsQL, FS-IIR, RAND and CHIP-AE) and eight were specific to children with asthma (SSES, ASDQ, AMA, CAQ, LAQCA, PACQLQ, PAQLQ and APBC). The generic instruments measured the four basic aspects of HRQOL (symptoms, physical, mental and social functioning), whilst the majority of the specific instruments focused more closely on symptom measurement and physical functioning. Reliability (Cronbach's alpha) and construct validity were the most widely tested psychometric properties. In general, sensitivity to change was the least widely tested property, and only three disease-specific instruments were sensitive to change (LAQCQ, PACQLQ and PAQLQ). All the instruments could be self-administered. Only two of the generic instruments (FS-IIR and RAND) had been validated for use in Spain. At present two more generic instruments (PedsQL and CHIP-AE) and two specific instruments (PACQLQ and PAQLQ) are currently being validated. CONCLUSION: The availability of instruments to measure the HRQOL of children with asthma in Spain is currently limited. Validated versions of the PedsQL (generic) and PAQLQ (specific) instruments, both of which have been demonstrated to be useful in other countries, should shortly be available to measure the HRQOL of children with asthma in Spain.

[Validation of the quality of life questionnaire in arterial hypertension (HQALY) for its use in Spain. Relationship between clinical variables and quality of life. Investigator Group of the HQALY study]. / Validación del cuestionario de calidad de vida en hipertensión arterial (CHAL) para su uso en España. Relación entre variables clínicas y calidad de vida. Grupo de Investigadores del Estudio CHAL.

OBJECTIVE: To evaluate the measurement properties of the Hypertension Quality of Life (HQALY) questionnaire, under normal clinical practice conditions, and the relationship between quality of life and clinical variables in patients with hypertension. DESIGN: Observational, prospective and multi-centred study. SETTING: 92 primary care centres in Spain. PARTICIPANTS: 269 patients, of both sexes and over 17, with hypertension, stratified by age (18-44, 45-64 and over 64), sex and organic complaint. 106 individuals over 17 with normal tension were chosen at random. INTERVENTIONS: Intensification of treatment in hypertense patients. MEASUREMENTS: Administration of the HQALY and the EuroQol-5D at every attendance (patients, basal and at a month; controls, basal). In addition, at the basal attendance social-demographic and clinical features were recorded, and at the attendance at a month the clinical features and changes in health status. MAIN RESULTS: Mean time of administration was 28 (23) minutes. VALIDITY: factor analysis showed two dimensions, state of mind and somatic manifestations, which correlated most closely with the dimensions of anxiety/depression (0.64) and pain/discomfort (0.55) on the EQ-5D, respectively. HQALY scores were higher (worse quality of life) in patients than in controls without hypertension (p < 0.01). Reliability: intraclass correlation coefficient was 0.88 in state of mind and 0.76 in somatic manifestations. Cronbach's alpha was 0.96 and 0.89, respectively. Sensitivity: the "size of the effect" at a month from starting treatment for hypertension was 0.40. Hypertension for over 10 years, more organs affected, gravity and morbid obesity were associated with worse quality of life, especially in the state-of-mind dimension. Cardiac frequency correlated closer with state of mind than somatic manifestations. CONCLUSIONS: The HQALY is the first specific hypertension questionnaire developed in Spain which has been shown valid, reliable and sensitive to changes. However, the number of items on it must be reduced for routine use in clinical practice.

[Validity of the King's Health questionnaire in the assessment of quality of life of patients with urinary incontinence. The King's Group]. / Validez del cuestionario King's Health para la evaluación de la calidad de vida en pacientes con incontinencia urinaria. Grupo King's.

BACKGROUND: To assess the validity of the Spanish version of the King's Health Questionnaire (KHQ) for measuring the quality of life of women with different types of urinary incontinence. PATIENTS AND METHODS: 77 women with urinary stress incontinence (USI), 51 with urge incontinence (UUI) and 34 with mixed urinary incontinence (MUI) were consecutively recruited. Subjects were diagnosed using urodynamic tests. Patients completed the KHQ and SF-36 questionnaires on inclusion in the study, after 15 days, and again after one month. RESULTS: There were no significant differences in socio-demographic and QOL characteristics between different UI groups. UUI and MUI patients had greater urinary frequency and urge than USI patients, and USI and MUI patients had a greater number of leakage episodes than UUI patients. Correlations between dimensions on the KHQ and the SF-36 were moderate to strong. Women with greater urinary frequency, greater urgency, more incontinence episodes during the week and who used pads and nappies perceived a worse quality of life. Changes in these variables correlated with changes in HRQOL. The internal consistency of dimensions was good (0.65-0.92) as was test-retest reliability (0.68-0.88). Dimensions most sensitive to change after one month of treatment were impact of UI, seriousness of UI, and the symptoms scale (effect size greater than 0.6). CONCLUSION: The KHQ is a valid instrument for measuring the quality of life of patients with different types of UI. Improvements in urinary frequency, urinary urgency, number of leakage episodes, and changes in the type of protective material produces an increase in HRQOL.

[The development and preliminary validation of the IU-4 questionnaire for the clinical classification of urinary incontinence]. / Elaboración y validación preliminar del cuestionario para la clasificación clínica de la incontinencia urinaria IU-4.

RATIONALE: To prepare and validate a simple and self-administered questionnaire for the clinical rating of patients with urinary incontinence (UI) for use in the clinical practice. METHODS: The questionnaire was prepared based on a review of the literature on urinary incontinence and the views of 7 urodynamic urologists. The initial questionnaire UI-5 included 5 items related to UI symptoms that divided patients into three categories: stress incontinence (UEI), urge incontinence (UUI) or mixed urinary incontinence (MUI). An additional question evaluates the impact of UI type on the quality of life. The of construct validity was analyzed correlating the responses to UI-5 items and the question on quality of life. The area under the ROC curve was calculated for each UI type correlating the UI-5 scores and the results of the urodynamic test. The cut-off values for each scale were determined based on sensitivity (SE) and specificity (SP). RESULTS: The study included 188 females with UI (73.4% with UEI, 13.3% with UUI and 13.3% with MUI; based on the urodynamics). Only 4.3% patients did not answer some UI-5 items. One item related to the protective material used was excluded as it was not related to UI types, and so the final questionnaire included only 4 items (UI-4). The results show that UI-4 discriminates the different types of incontinence: UEI (SE: 0.69/SP: 0.76; 1 item), UUI (SE: 0.83/SP: 0.65; 2 items), MUI (SE: 0.72/SP: 0.65; 1 item). 100% patients with MUI, 84% with UUI and 59.9% with UEI report some impact on their quality of life. CONCLUSIONS: UI-4 is simple, valid and easy to administer, and can be particularly valuable in the clinical rating of UI in settings where urodynamic testing is not easily available such is primary health care.

Determining correspondence between scores on the EQ-5D "thermometer" and a 5-point categorical rating scale.

BACKGROUND: "Feeling thermometers" and category rating scales (CRS) can be used to measure self-rated health, though the interpretation of scores on the feeling thermometer may be problematic. OBJECTIVES: To analyze correspondence between scores of self-rated health on the EuroQol-5D "feeling thermometer" and a five-Point CRS. To determine the influence of sociodemographic variables on correspondence. RESEARCH DESIGN: Correspondence between EQ-5D "thermometer" scores and CRS categories was determined in a within-subjects design using data from a large-scale health survey. SUBJECTS: Twelve thousand, two hundred and forty-five members of the Spanish general population interviewed in the Catalan Health Interview Survey. MEASURES: Instruments used were the EQ-5D "feeling thermometer" and a five-Point CRS with categories from "excellent" to "poor." RESULTS: Median scores on the thermometer corresponding to CRS categories were as follows: poor = 40; fair = 53; good = 76; and very good = 80; excellent = 90; differences were statistically significant (P < 0.05). Ranges in thermometer scores covered by CRS categories varied from 23.5 points for the category "poor" to 13 points for the category "very good" (range, 25-75 percentiles), with considerable overlap between categories at the upper end of the scale. Median thermometer scores corresponding to the categories "good,""fair," and "poor" were lower in older respondents and in those with a lower educational level. CONCLUSIONS: Determining correspondence between CRS and thermometer scores is useful in interpreting and categorizing thermometer scores. The age and level of education in particular affect the interpretation of CRS categories, and should be taken into account when analyzing results obtained with such instruments.