Spanish validation of the International Spinal Cord Injury Pulmonary Function Basic Data Set questionnaire for the study of the repercussion of spinal cord injury in the respiratory system

Spanish validation of the International Spinal Cord Injury Pulmonary Function Basic Data Set questionnaire for the study of the repercussion of spinal cord injury in the respiratory system

Med Clin (Barc). 2015;145(11):477–481 www.elsevier.es/medicinaclinica Brief report Spanish validation of the International Spinal Cord Injury Pulmo...

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Med Clin (Barc). 2015;145(11):477–481

www.elsevier.es/medicinaclinica

Brief report

Spanish validation of the International Spinal Cord Injury Pulmonary Function Basic Data Set questionnaire for the study of the repercussion of spinal cord injury in the respiratory system夽 Alba Gómez Garrido a,∗ , Ana María León Espitia a , Lluïsa Montesinos Magraner b , Lucrecia Ramirez Galceran b , Emilia Soler Canudes a , Miguel Angel González Viejo b a Unidad de Rehabilitación Cardiorrespiratoria, Servicio de Rehabilitación, Hospital Universitario Vall d’Hebron, Instituto de Recerca Vall d’Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain b Unidad de Lesionados Medulares, Servicio de Rehabilitación, Hospital Universitario Vall d’Hebron, Instituto de Recerca Vall d’Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain

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Article history: Received 22 August 2014 Accepted 9 April 2015 Available online 20 April 2016 Keywords: Spinal cord injury International Spinal Cord Injury Pulmonary Function Basic Data Set Pulmonary function Respiratory complications

a b s t r a c t Introduction and objective: The dysfunction of the respiratory system and the breathing complications in persons with injured spinal cord has an effect on the morbidity and the mortality of the disease. The objectives were: (1) to translate to Spanish and validate the questionnaire of international consensus: International Spinal Cord Injury Pulmonary Function Basic Data Set, and (2) to determine the influence of chronic spinal cord injury in the respiratory system in terms of respiratory functionalism. Materials and method: Translation to Spanish and validation of the questionnaire of international consensus intended for the study of the pulmonary function in spinal cord injury disease. We tested the reliability of that questionnaire. We conducted a descriptive transversal study to determine the degree of involvement of the respiratory system in spinal cord injury. Results: A percentage of 91.9 did not have any respiratory pathology before spinal cord injury and 54.8% of patients smoked. A percentage of 27.4 of patients presented breathing complications one year after the injury. Results of the respiratory function tests were: FVC 67%, FEV1 72% and PEF 70%. Concordance and reliability were 98%. Conclusion: The Spanish version of the questionnaire of international consensus about the pulmonary function is a useful tool for the study of the respiratory involvement in spinal cord injury. ˜ S.L.U. All rights reserved. © 2015 Elsevier Espana,

˜ Validación espanola del cuestionario International Spinal Cord Injury Pulmonary Function Basic Data Set para valorar la repercusión de la lesión medular en el sistema respiratorio r e s u m e n Palabras clave: Lesión medular International Spinal Cord Injury Pulmonary Function Basic Data Set Función pulmonar Complicaciones respiratorias

Introducción y objetivo: La disfunción del sistema respiratorio y las complicaciones respiratorias en la lesión medular repercuten en la morbimortalidad. El objetivo de este trabajo fue: 1) traducir y validar ˜ el cuestionario de consenso internacional: International Spinal Cord Injury Pulmonary Function al espanol Basic Data Set, y 2) determinar la influencia de la lesión medular crónica en el sistema respiratorio, en términos de funcionalismo respiratorio. ˜ del cuestionario de consenso internacional de la Material y método: Traducción y validación al espanol función pulmonar para la lesión medular. Se realizó un estudio de fiabilidad del cuestionario y un estudio descriptivo transversal para determinar el estado del sistema respiratorio en los lesionados medulares.

夽 Please cite this article as: Gómez Garrido A, León Espitia AM, Montesinos Magraner L, Ramirez Galceran L, Soler Canudes E, González Viejo MA. Validación espanola ˜ del cuestionario International Spinal Cord Injury Pulmonary Function Basic Data Set para valorar la repercusión de la lesión medular en el sistema respiratorio. Med Clin (Barc). 2015;145:477–481. ∗ Corresponding author. E-mail address: [email protected] (A. Gómez Garrido). ˜ S.L.U. All rights reserved. 2387-0206/© 2015 Elsevier Espana,

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Resultados: El 91,9% no presentaban ninguna enfermedad respiratoria antes de la lesión medular. El 54,8% tenían historia tabáquica. El 27,4% presentaron complicaciones respiratorias. Los resultados de pruebas de función respiratoria fueron FVC 67%, FEV1 72% y PEF 70%. En cuanto a la fiabilidad y concordancia, fue del 98%. ˜ Conclusión: El cuestionario de consenso internacional sobre la función pulmonar en su versión espanola es una herramienta útil para el estudio de la afectación respiratoria en la lesión medular. ˜ S.L.U. Todos los derechos reservados. © 2015 Elsevier Espana,

Introduction

Study protocol

Spinal cord injury (SCI) is a devastating event for both the individual and for society, for the severe disability and significant loss of functionality and quality of life associated with it. Respiratory system (RS) dysfunction and respiratory complications (RC) have a huge impact in the lives of SCI patients, as they are one of the most important causes of premature mortality and increased disability.1 The consequences of SCI in the respiratory system are related to the degree and location of the neurological injury. That is, the higher and more severe SCI is, greater respiratory muscle involvement and RS impact. RS dysfunction produces poor ventilation, causing RC, it relates to impaired ventilatory capacity, retention of secretions and autonomic system dysfunction. But there are other variables that can increase the involvement of the RS, such as: age, smoking history and associated respiratory diseases.2 In recent years, the publications in this field of the SCI have increased; although the number of studies that explain how the SCI impacts on RS is still low. Recently an international consensus document on minimum variables to be analyzed in order to study lung function in spinal cord injury (International Spinal Cord Injury Pulmonary Function Basic Data Set)3 was published, backed by two of the most important scientific societies in SCI, the American Spinal Injury Association (ASIA) and the International Spinal Cord Society. Standardization of data allows to evaluate and compare the results with greater ease and rigor between different study groups and initiate research projects in this field on a large scale. The aim of this study is to validate the international consensus document for lung function in the SCI in Spanish.

The fieldwork was conducted between December 2013 and March 2014, including the following steps:

Patients and method A cross-sectional prospective descriptive study of reliability and validity of the Spanish version of the assessment of pulmonary function in patients with chronic SCI questionnaire was designed.

Study scope and sample The study sample is made up of 62 patients suffering from chronic SCI (more than a year of lesion progression) of traumatic origin controlled by the Spinal Cord Injury Unit of the Hospital Universitari Vall d’Hebron.

Instruments International Spinal Cord Injury Pulmonary Function Basic Data Set Questionnaire in its Spanish version (Annex).

- The patients were informed in general terms about the ongoing study and the need to validate the questionnaire in Spanish during their annual medical visit to the Spinal Cord Injury Unit. - Patients who were interested in joining the study were informed of the characteristics, and the benefits and possible damages that could be derived from their participation as per the patient information leaflet. - The inclusion and exclusion criteria for each of the participants were reviewed. - They were asked to participate voluntarily by signing an informed consent. Personal data protection This project complies with ethical requirements imposed in the Declaration of Helsinki of 1975, with the subsequent revision in 2000. A computerized encrypted and protected record of data has taken place, so as to preserve the privacy of the study group. The research project has been approved by the Clinical Research Ethics Committee of the Hospital Vall d’Hebron PR (ATR) 310/2013, dated 01/12/2013. This work has not been supported by any public or private entity or pharmaceutical industry. Statistic analysis We performed a multivariate statistical analysis with SPSS® , version 16. The description of the data is done by the mean and standard deviation for quantitative variables and frequencies and percentages for categorical variables. The comparison of means was performed using the Student t test for independent data and by ANOVA. The comparison between qualitative variables was performed using the Chi square test. Correlations were performed using Pearson’s correlation. Statistical significance was determined taking as a point of significance a p value <0.05. To determine the reliability of the questionnaire in Spanish between the 2 times it was used with the patients, a kappa symmetry test for qualitative variables and the interclass coefficient for quantitative variables were performed. In our case, the internal coherence is not evaluated, as it is a data collection questionnaire, not a measurement instrument. Items cannot be correlated with the final result since there is no final result in this study.

Results Translation procedure The standard translation and back-translation procedure was followed, including the original author’s recommendations (Dr. Biering).4

62 patients were assessed with a mean age of 47.31 years (13.50), 52 being males. The average number of years with SCI was 14.23 (SD 11.51). The level of distribution and involvement of the SCI is shown in Fig. 1.

A. Gómez Garrido et al. / Med Clin (Barc). 2015;145(11):477–481

ASIA

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Injury level 5% 16%

15% 18% 6% 8%

30% 71% 31%

A

B

C

D

C4-C5

C6-C8

T1-T6

T7-T10

T11-T12

Fig. 1. Distribution of the sample of spinal cord involvement according to the ASIA and injury level.

The reliability and consistency of the questionnaire in Spanish between the 2 times that it was applied (in person and by telephone, 15 days later) was 98%.

usually occurs at early ages of life (the average published age is 40.2 years), with the highest prevalence between 15 and 29 years.5 In contrast, the prevalence of smoking history in the study population is high, which is consistent with what has been published in medical literature, where a higher prevalence of smoking is observed in the population with disabilities.6 The RC, such as respiratory infections and atelectasis, represent a major medical problem in patients with chronic SCI, being more important in complete quadriplegic cases, with more years of SCI7,8 and worse spirometric values, this is consistent with data published in the medical literature.9 3 spirometric variables that should be studied are FVC, FEV1 and PEF, as they relate directly to the level of injury, the years of progression, the strength of the respiratory muscles and RC. Previous studies have shown that low values of FVC, such as FEV1 are good mortality predictors in patients with SCI, increasing it to 3%.10

Discussion

Conclusions

The results of this study support the validity of this adaptation to Spanish of the international consensus document in the assessment of pulmonary function for spinal cord injuries International Spinal Cord Injury Pulmonary Function Basic Data Set. The data obtained by us shows that the prevalence of respiratory diseases shown by patients before suffering SCI is very low, only 8.9%. This is explained by the very epidemiology of SCI, since it

The international consensus document on pulmonary function in the Spanish version is a useful and reliable tool to assess periodically the RS in patients with spinal cord injury.

Description of results and Spanish version of the questionnaire 91.9% of patients analyzed showed no respiratory disease before the SCI. 54.8% had a history of smoking (cigarettes), being 30.6% former smokers and 24.2% current smokers. 27.4% had showed RC in the last year; these were: 21% pneumonias, 1.6% SAHS and 4.8% showed another type of RC, not specified in the consensus questionnaire. Only 11.3% of patients needed ventilatory support. Respiratory function tests are as follows: FVC 3.15 l (67%), FEV1 2.68 l (72%) and PEF 6.3 l (70%). Reliability study

Conflict of interest The authors declare no conflict of interest.

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Annex. International consensus document on pulmonary pathology in spinal cord injury, Spanish version

Fecha: Enfermedades respiratorias ANTES de la lesión medular (recogida única): o Ninguna o Asma o EPOC (enfermedad pulmonar obstructiva crónica, incluye bronquitis y enfisema) o Apnea del sueño o Otra, especifique____________________________________________________ o Desconocido Historia tabáquica (consumo de tabaco): o Nunca ha fumado o Exfumador o Fumador actualmente o Desconocido Si es exfumador, ¿en qué año dejó de fumar? _______ Si es exfumador o fumador actualmente, ¿por cuántos años ha fumado? _____años Si es exfumador o fumador actualmente, en promedio cuántos cigarrillos fuma (fumaba) diariamente (señale todas las que apliquen): _____ Cigarrillos _____ Puros _____ Pipas _____ Desconocido Para exfumadores o fumadores de cigarrillos únicamente, número de paquetes por año: ([promedio de cigarrillos fumados diariamente]/20)×(número de años en los que ha fumado): _____ paquetes-año Complicaciones respiratorias o enfermedades respiratorias TRAS la lesión medular en el último año: o Ninguna o Neumonía: Número de episodios de neumonías tratadas con antibióticos: ______ Número de episodios de neumonías que han requerido ingreso hospitalario: _____ o Asma o Enfermedad pulmonar obstructiva crónica (EPOC incluyendo bronquitis y enfisema) o Apnea del sueño o Otras condiciones respiratorias, especifique: ______________________________ o Desconocida Uso de asistencia ventilatoria actualmente: o Ninguna o Ventilación mecánica: o Sí, menos de 24 horas al día o Sí, 24 horas al día o Sí, cantidad de horas desconocida al día o Marcapaso diafragmático: fecha de la intervención: ______________________ o Estimulador del nervio frénico: fecha de intervención:_______________________ o BI-PAP: fecha en la que inició su uso:__________________________ o Otra, especifique:____________________________________________________ o Desconocida Pruebas de función pulmonar: Fecha de realización: __________________________________________________________ Capacidad Vital Forzada (FVC): _____ litros Volumen Espiratorio Forzado en el primer segundo (FEV1): _____ litros Pico de Flujo Espiratorio (PEF): _____ litros/minuto

References 1. Jackson AB, Groomes TE. Incidence of respiratory complications following spinal cord injury. Arch Phys Med Rehabil. 1994;75:270–5. 2. Garshick E. Respiratory physiologic changes following spinal cord injury. UpToDate. 2013.

3. Biering-Sørensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, et al. International spinal cord injury pulmonary function basic data set. Spinal Cord. 2012;50:418–21. 4. Biering-Sørensen F, Alexander MS, Burns S, Charlifue S, DeVivo M, Dietz V, et al. Recommendations for translation and reliability testing of International Spinal Cord Injury Data Sets. Spinal Cord. 2011;49:357–60. 5. Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine (Phila Pa 1976). 2006;31: 799–805.

A. Gómez Garrido et al. / Med Clin (Barc). 2015;145(11):477–481 6. Weaver FM, Smith B, LaVela SL, Evans CT, Ullrich P, Miskevics S, et al. Smoking behavior and delivery of evidence-based care for veterans with spinal cord injuries and disorders. J Spinal Cord Med. 2011;34:35–45. 7. Brown R, DiMarco AF, Hoit JD, Garshick E. Respiratory dysfunction and management in spinal cord injury. Respir Care. 2006;51:853–70. 8. Postma K, Bussmann JB, Haisma JA, van der Woude LH, Bergen MP, Stam HJ. Predicting respiratory infection one year after inpatient rehabilitation with pulmonary function measured at discharge in persons with spinal cord injury. J Rehabil Med. 2009;41:729–33.

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