Traducción validada al español de cuestionarios de evaluación de pacientes con síndrome de piernas inquietas / Validated translation to Spanish of the evaluation questionnaire of patients with restless legs syndrome

Introducción. El síndrome de piernas inquietas (SPI) es un trastorno sensitivo y motor frecuente, caracterizado por una necesidad imperiosa de mover las piernas cuando el sujeto se encuentra sentado o tumbado, generalmente al final de la tarde o por la noche. Objetivo. Describir el proceso de adaptación al español de tres herramientas diferentes de estudio del SPI: los criterios para el diagnóstico, un cuestionario de detección de SPI por el clínico en atención primaria (Practitioner Screening Questionnaire, PSQ) y un conjunto básico de preguntas para estudios epidemiológicos (Basic Set of Questions for Epidemiological Studies, CBPEP). Se propone un procedimiento que puede ser adoptado para generar las herramientas en otros idiomas. Métodos. Se utilizó el método de traducción-retrotraducción. Participaron cinco traductores: dos para traducciones directas y dos para las inversas, y un quinto cuando se introdujeron cambios, trabajando de forma independiente en su lengua materna. Dos evaluadores expertos determinaron la equivalencia entre el instrumento original y la versión traducida. La comprensión de los cuestionarios adaptados fue evaluada mediante administración autoaplicada a una muestra de estudiantes y a otra administración heteroaplicada a pacientes con SPI. Resultados. El procedimiento seguido varió ligeramente según el uso previsto de cada instrumento: por profesionales de la salud (criterios de diagnóstico de una enfermedad) o para administración a pacientes (cuestionarios heteroaplicados o autoaplicados). El PSQ y CBPEP no presentaron importantes diferencias, tras su adaptación, con la versión original. Se ha buscado mantener la equivalencia conceptual para garantizar que el instrumento adaptado conservara la función y validez originales. Se utilizó una misma terminología en los diferentes instrumentos para proporcionarles coherencia si se usan conjuntamente. La versión española del PSQ ha ampliado el primer ítem con ejemplos de sensaciones para facilitar su comprensión por pacientes de diferentes partes de España. Conclusiones. Se han obtenido versiones españolas de tres cuestionarios como base para futuras validaciones psicométricas que permitan su uso en España. El instrumento adaptado en último lugar es el que mostró el mejor resultado, en cuanto a equivalencia, obtenido durante el proceso (AU)

Introduction. Restless legs syndrome (RLS) is a common sensory- motor condition, characterised by the irresistible need to move the legs while sitting or lying down, usually presenting late in the day, from the end of the afternoon into the night. Objective. To describe the translation process to Spanish of three different research RLS tools: the diagnosis criteria, the Practitioner Screening Questionnaire and the Basic Set of Questions for Epidemiological Studies. A procedure is proposed for the translation of these tools into other languages. Methods. The back translation method was employed. Five translators took part: two translated into their mother tongue and two into their foreign tongue, and once the translations were completed, a fifth independent translator introduced the changes using his mother tongue. Two expert analysts determined the equivalence between the original questionnaire and the translation. The clarity of the translated questionnaires was evaluated in a sample of students, who completed these themselves, and in RLS patients, for whom the doctor(s) or another authorised person filled them out. Results. The procedure undertaken varied according as to how each instrument were to be used either by health care professionals (diagnosis criteria) or to obtain information from patients (the questionnaire being directly completed by the patient directly or indirectly by a health care professional). No significant differences between the original and the translation of the practitioner screening questionnaire and the basic set of questions for epidemiological studies were found. The translators aimed to maintain concept equivalence function and validity of the original instrument were preserved in the trans lation. The same terminology was employed in the di fferent translations to make sure they were all consistent should they be used together. The Spanish version of the practitioner screening questionnaire has added terms to the first item by providing examples of sensations to ensure its understanding by patients from different parts of Spain. Conclusions. Spanish translated versions of three different questionnaires have been obtained to be used for RLS assessment in Spain, following appropriate psychometric validation. The instrument translated in the third place showed the closest equivalence with original (AU)

[Restless legs syndrome: detection, diagnosis, impact on health and utilization of health care resources]. / El síndrome de piernas inquietas: detección, diagnóstico, consecuencias sobre la salud y utilización de recursos sanitarios.

INTRODUCTION: Despite the high prevalence of Restless Legs Syndrome (RLS) reported, little information is available about this disorder in Spain. The present study was conducted to obtain information on this condition from patients identified by a simple screening questionnaire and subsequent diagnostic confirmation by the Primary Care Practitioner (PCP). MATERIALS AND METHODS: Three-stage, cross-sectional and retrospective (resource utilization), observational study in a sample of adult patients (2,047 subject) attending 10 outpatient Primary Care centers in Madrid, Barcelona and Valencia. A screening questionnaire containing the 4 RLS diagnostic criteria was used. Clinical assessment and RLS diagnosis confirmation was performed using a structured questionnaire. Other variables assessed were quality of life by SF-36 questionnaire scoring; sleep by the MOS sleep scale; symptom severity of RLS symptoms by the IRLS scales; health care resource utilization in the previous 12 months by completion of questionnaire following patient chart review. The diagnosis made by the PCP was confirmed in a small sample of patients by a neurologist expert in Movement Disorders. RESULTS: A total of 19.7% (404 out of 2,047) subjects positively answered the 4 diagnostic questions of the RLS screening questionnaire. Of these, 185 (9.0%) reported moderate to severe symptoms at least twice weekly. The PCP made a diagnosis of RLS in 79 of 154 patients completing the diagnostic interview. Thus, prevalence of RLS estimated in this adult population was 4.6%. The predictive value of the screening RLS questionnaire was 51.3%. Average age of symptom onset was 42 years (range: 20 - over 80 years). RLS symptoms were moderately (50.6%) or extremely (38%) distressing and 73.4% of RLS patients slept poorly at least two nights a week. This diagnosis represents 9.4% of all patients presenting to PCP and experiencing poor sleep. Mean score in the IRLS scale (0 - 40) was 19.4. Average score of SF-36 questionnaire (0-100) was 54.6, lower than the Spanish general reference population (61.4). About one third of the RLS patients had seen a physician because of RLS symptoms. However, a diagnosis was made in only 48% of these and only 5% the diagnosis was RLS. CONCLUSIONS: The DECODE RLS - Spain study shows that many patients with classical RLS symptoms frequently see their PCP without being adequately diagnosed and treated. Screening tools such as that used in this study may contribute to the detection of these patients.

El síndrome de piernas inquietas: detección, diagnóstico, consecuencias sobre la salud y utilización de recursos sanitarios / Restless legs syndrome: detection, diagnosis, impact on health and utilization of health care resources

Introducción: Pese a la elevada prevalencia del síndrome de piernas inquietas (SPI), se cuenta con escasa información sobre este trastorno en nuestro país. El objetivo de este estudio fue obtener información sobre este problema de salud a partir de pacientes identificados mediante un cuestionario de cribado y posterior confirmación diagnóstica por médicos de Atención Primaria (AP). Material y métodos: Estudio en tres etapas, transversal y retrospectivo (utilización de recursos), en una muestra de pacientes adultos (2.047 sujetos) que acudió a consultas ambulatorias de 10 centros de Atención Primaria (Madrid, Barcelona y Valencia). Se utilizó un cuestionario de detección con los 4 criterios diagnósticos de SPI. Se realizó la evaluación clínica y confirmación diagnóstica mediante un cuestionario estandarizado. Otras variables evaluadas fueron: calidad de vida, mediante la puntuación del Cuestionario SF-36 de salud; sueño, mediante la puntuación de la escala de sueño MOS; intensidad de los síntomas de SPI, mediante la puntuación de la escala IRLS; utilización de recursos sanitarios en los 12 meses previos. Confirmación del diagnóstico del médico de AP, por un neurólogo especialista en trastornos del movimiento en una muestra reducida aleatoria de pacientes. Resultados: Un 19,7% (404 de 2.047) de los sujetos respondió positivamente a las 4 preguntas diagnósticas del cuestionario de detección del SPI. De ellos, 185 sujetos (9,0%) presentaban síntomas por lo menos dos veces a la semana, de intensidad moderada a grave. El médico de AP confirmó el diagnóstico de SPI en 79 de los 154 pacientes que completaron la entrevista diagnóstica. La prevalencia en esta población adulta fue del 4,6%. El valor predictivo del cuestionario de detección del SPI fue de un 51,3%. La edad media de inicio de síntomas fue de 42 años (rango: 20-más de 80 años). Los síntomas de SPI fueron moderados en el 50,6% y graves en el 38%. El 73,4% de los pacientes con SPI dormía mal, al menos dos noches por semana. La puntuación media de la escala IRLS (0-40) fue de 19,4. La puntuación media del cuestionario SF-36 (0-100) fue de 54,6, más baja que la de la población española de referencia (61,4). Aproximadamente un tercio de los pacientes había consultado antes con un médico por los síntomas de SPI. No obstante, sólo un 48% contaba con un diagnóstico y sólo en un 5% éste era de SPI. Conclusiones: El estudio DECODE RSL indica que muchos pacientes con síntomas clásicos de SPI visitan frecuentemente a su médico de AP sin ser diagnosticados ni, por lo tanto, recibir un tratamiento adecuado. Herramientas como la utilizada en este estudio pueden ayudar a la detección de estos pacientes (AU)

Introduction: Despite the high prevalence of Restless Legs Syndrome (RLS) reported, little information is available about this disorder in Spain. The present study was conducted to obtain information on this condition from patients identified by a simple screening questionnaire and subsequent diagnostic confirmation by the Primary Care Practitioner (PCP). Materials and methods: Three-stage, cross-sectional and retrospective (resource utilization), observational study in a sample of adult patients (2,047 subject) attending 10 outpatient Primary Care centers in Madrid, Barcelona and Valencia. A screening questionnaire containing the 4 RLS diagnostic criteria was used. Clinical assessment and RLS diagnosis confirmation was performed using a structured questionnaire. Other variables assessed were quality of life by SF-36 questionnaire scoring; sleep by the MOS sleep scale; symptom severity of RLS symptoms by the IRLS scales; health care resource utilization in the previous 12 months by completion of questionnaire following patient chart review. The diagnosis made by the PCP was confirmed in a small sample of patients by a neurologist expert in Movement Disorders. Results: A total of 19.7% (404 out of 2,047) subjects positively answered the 4 diagnostic questions of the RLS screening questionnaire. Of these, 185 (9.0%) reported moderate to severe symptoms at least twice weekly. The PCP made a diagnosis of RLS in 79 of 154 patients completing the diagnostic interview. Thus, prevalence of RLS estimated in this adult population was 4.6%. The predictive value of the screening RLS questionnaire was 51.3%. Average age of symptom onset was 42 years (range: 20 - over 80 years). RLS symptoms were moderately (50.6%) or extremely (38%) distressing and 73.4% of RLS patients slept poorly at least two nights a week. This diagnosis represents 9.4% of all patients presenting to PCP and experiencing poor sleep. Mean score in the IRLS scale (0 - 40) was 19.4. Average score of SF-36 questionnaire (0-100) was 54.6, lower than the Spanish general reference population (61.4). About one third of the RLS patients had seen a physician because of RLS symptoms. However, a diagnosis was made in only 48% of these and only 5% the diagnosis was RLS. Conclusions: The DECODE RLS - Spain study shows that many patients with classical RLS symptoms frequently see their PCP without being adequately diagnosed and treated. Screening tools such as that used in this study may contribute to the detection of these patients (AU)

[The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry]. / Normas de buena práctica clínica en los ensayos con medicamentos realizados en España. Encuesta a la industria farmacéutica.

BACKGROUND: The objective of this survey was to assess the state of the art of the implementation of Good Clinical Practice in the Spanish Pharmaceutical Industry. METHODS: A questionnaire was sent to the sixty first laboratories according to their sales of ethical products. In the questionnaire there were questions concerning nationality of the company, personnel in clinical research, use and characteristics of standard operating procedures (SOPs), auditing and quality assurance as well as questions in connection with the future implications of SOPs implementation. RESULTS: The level of answer was 42%. Twenty one out of the 24 companies that answered the questionnaire had SOPs implemented. In total 150 clinical research projects were carried out in 1990. One hundred one out of this 150 were performed under GCP. Fourteen companies agreed that with their current structure were able to accomplish 100% of the projects with GCP. The most frequent estimation of cost increase due to GCP was 30% (min. 10%; max. 70%). In overall 26 external audits were performed in 1990. Twenty one laboratories stated that they had not acceptance problems of GCP among the investigators. CONCLUSIONS: The sample seems to be representative of the Spanish pharmaceutical industry attitude with respect to GCP implementation. Although the exigency level was not detailed, around 42% of the clinical trials sponsored by the pharmaceutical industry are performed according to GCP. There is a positive impression as to the possibility to implement GCP as well as to the attitude of the investigators to this respect.

[Ischemic muscular pain. II. Its evaluation by the McGill Pain Questionnaire in the repeated performance of an experimental test]. / Dolor isquémico muscular. II. Su evaluación mediante el cuestionario McGill del dolor en la realización repetida de un test experimental.

Muscular ischaemic pain experienced by 11 healthy subjects during the performance of an experimental test repeated on three succesive occasions was evaluated by the scoring and analysis of the McGill Pain Questionnaire, completed by the individual after each test. A statistically significant reduction in three scores: Number of Words Chosen, Pain Rating Index Total and Pain Rating Index Sensory was observed between the first and third tests. Indices related to the Affective and Evaluative aspects of pain did not exhibit significant variations. Possible interpretations for these findings, especially those related to the nature of the experimental test and the previously reported increase in Pain Tolerance from the first to the third test in this group are discussed. These results stress the need of using adequate control groups when analgesic measures are evaluated by experimental methods.

[Muscular ischemic pain. Effect of "training" after repeated performance of an experimental test]. / Dolor isquémico muscular. Efecto de "entrenamiento" tras la realización repetida de un test experimental.

Ischaemic muscle pain is a commonly used experimental stimulus in the evaluation of therapeutic analgesic measures. However, some doubts have recently been cast on the reliability of the results obtained with these methods. In this study, the reproducibility of Pain Threshold and Pain Tolerance time was investigated in 11 subjects who performed a tourniquet test on three occasions. Pain experienced between these two parameters was estimated using a Visual Analogue Scale. A statistically significant increase (p = 0.007) in Pain Tolerance was observed between the first and third tests. A non-linear relationship between perceived intensity of pain and time of painful muscular activity was similarly verified. These results were interpreted as a training effect. Caution on the experimental design of studies sequentially using ischaemic muscle pain methods is therefore recommended.