Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea.

BACKGROUND: Non-invasive ventilation (NIV) is an effective form of treatment in patients with obesity hypoventilation syndrome (OHS) who have concomitant severe obstructive sleep apnoea (OSA). However, there is a paucity of evidence on the efficacy of NIV in patients with OHS without severe OSA. We performed a multicentre randomised clinical trial to determine the comparative efficacy of NIV versus lifestyle modification (control group) using daytime arterial carbon dioxide tension (PaCO2) as the main outcome measure. METHODS: Between May 2009 and December 2014 we sequentially screened patients with OHS without severe OSA. Participants were randomised to NIV versus lifestyle modification and were followed for 2 months. Arterial blood gas parameters, clinical symptoms, health-related quality of life assessments, polysomnography, spirometry, 6-min walk distance test, blood pressure measurements and healthcare resource utilisation were evaluated. Statistical analysis was performed using intention-to-treat analysis. RESULTS: A total of 365 patients were screened of whom 58 were excluded. Severe OSA was present in 221 and the remaining 86 patients without severe OSA were randomised. NIV led to a significantly larger improvement in PaCO2 of -6 (95% CI -7.7 to -4.2) mm Hg versus -2.8 (95% CI -4.3 to -1.3) mm Hg, (p<0.001) and serum bicarbonate of -3.4 (95% CI -4.5 to -2.3) versus -1 (95% CI -1.7 to -0.2 95% CI)  mmol/L (p<0.001). PaCO2 change adjusted for NIV compliance did not further improve the inter-group statistical significance. Sleepiness, some health-related quality of life assessments and polysomnographic parameters improved significantly more with NIV than with lifestyle modification. Additionally, there was a tendency towards lower healthcare resource utilisation in the NIV group. CONCLUSIONS: NIV is more effective than lifestyle modification in improving daytime PaCO2, sleepiness and polysomnographic parameters. Long-term prospective studies are necessary to determine whether NIV reduces healthcare resource utilisation, cardiovascular events and mortality. TRIAL REGISTRATION NUMBER: NCT01405976; results.

Noninvasive ventilation for severely acidotic patients in respiratory intermediate care units : Precision medicine in intermediate care units.

BACKGROUND: Severe acidosis can cause noninvasive ventilation (NIV) failure in chronic obstructive pulmonary disease (COPD) patients with acute hypercapnic respiratory failure (AHRF). NIV is therefore contraindicated outside of intensive care units (ICUs) in these patients. Less is known about NIV failure in patients with acute cardiogenic pulmonary edema (ACPE) and obesity hypoventilation syndrome (OHS). Therefore, the objective of the present study was to compare NIV failure rates between patients with severe and non-severe acidosis admitted to a respiratory intermediate care unit (RICU) with AHRF resulting from ACPE, COPD or OHS. METHODS: We prospectively included acidotic patients admitted to seven RICUs, where they were provided NIV as an initial ventilatory support measure. The clinical characteristics, pH evolutions, hospitalization or RICU stay durations and NIV failure rates were compared between patients with a pH ≥ 7.25 and a pH < 7.25. Logistic regression analysis was performed to determine the independent risk factors contributing to NIV failure. RESULTS: We included 969 patients (240 with ACPE, 540 with COPD and 189 with OHS). The baseline rates of severe acidosis were similar among the groups (45 % in the ACPE group, 41 % in the COPD group, and 38 % in the OHS group). Most of the patients with severe acidosis had increased disease severity compared with those with non-severe acidosis: the APACHE II scores were 21 ± 7.2 and 19 ± 5.8 for the ACPE patients (p < 0.05), 20 ± 5.7 and 19 ± 5.1 for the COPD patients (p < 0.01) and 18 ± 5.9 and 17 ± 4.7 for the OHS patients, respectively (NS). The patients with severe acidosis also exhibited worse arterial blood gas parameters: the PaCO2 levels were 87 ± 22 and 70 ± 15 in the ACPE patients (p < 0.001), 87 ± 21 and 76 ± 14 in the COPD patients, and 83 ± 17 and 74 ± 14 in the OHS patients (NS)., respectively Further, the patients with severe acidosis required a longer duration to achieve pH normalization than those with non-severe acidosis (patients with a normalized pH after the first hour: ACPE, 8 % vs. 43 %, p < 0.001; COPD, 11 % vs. 43 %, p < 0.001; and OHS, 13 % vs. 51 %, p < 0.001), and they had longer RICU stays, particularly those in the COPD group (ACPE, 4 ± 3.1 vs. 3.6 ± 2.5, NS; COPD, 5.1 ± 3 vs. 3.6 ± 2.1, p < 0.001; and OHS, 4.3 ± 2.6 vs. 3.7 ± 3.2, NS). The NIV failure rates were similar between the patients with severe and non-severe acidosis in the three disease groups (ACPE, 16 % vs. 12 %; COPD, 7 % vs. 7 %; and OHS, 11 % vs. 4 %). No common predictive factor for NIV failure was identified among the groups. CONCLUSIONS: ACPE, COPD and OHS patients with AHRF and severe acidosis (pH ≤ 7.25) who are admitted to an RICU can be successfully treated with NIV in these units. These results may be used to determine precise RICU admission criteria.

Noninvasive ventilation during the weaning process in chronically critically ill patients.

Chronically critically ill patients often undergo prolonged mechanical ventilation. The role of noninvasive ventilation (NIV) during weaning of these patients remains unclear. The aim of this study was to determine the value of NIV and whether a parameter can predict the need for NIV in chronically critically ill patients during the weaning process. We conducted a prospective study that included chronically critically ill patients admitted to Spanish respiratory care units. The weaning method used consisted of progressive periods of spontaneous breathing trials. Patients were transferred to NIV when it proved impossible to increase the duration of spontaneous breathing trials beyond 18 h. 231 chronically critically ill patients were included in the study. 198 (85.71%) patients achieved weaning success (mean weaning time 25.45±16.71 days), of whom 40 (21.4%) needed NIV during the weaning process. The variable which predicted the need for NIV was arterial carbon dioxide tension at respiratory care unit admission (OR 1.08 (95% CI 1.01-1.15), p=0.013), with a cut-off point of 45.5 mmHg (sensitivity 0.76, specificity 0.67, positive predictive value 0.76, negative predictive value 0.97). NIV is a useful tool during weaning in chronically critically ill patients. Hypercapnia despite mechanical ventilation at respiratory care unit admission is the main predictor of the need for NIV during weaning.

Guía para el seguimiento de la enfermedad de Pompe de inicio tardío / Guidelines for monitoring late-onset Pompe disease

Aunque el tratamiento con alglucosidasa alfa ha contribuido a mejorar el pronóstico de los pacientes con enfermedad de Pompe de inicio tardío, es necesario hacer un seguimiento periódico de la evolución de la enfermedad y de la eficacia del tratamiento. Por este motivo, un comité de expertos españoles ha elaborado una guía para el seguimiento de estos pacientes. El comité propone un modelo de pruebas de seguimiento para la enfermedad de Pompe de inicio tardío. En primer lugar, ha de valorarse el estado nutricional y la función deglutoria. En segundo lugar, y debido a la variabilidad del cuadro clínico, el comité recomienda el uso simultáneo de varias escalas que midan distintas funciones y pará- metros. De este modo, la fuerza muscular se evalúa con la escala del Medical Research Council; la función motora, con la prueba de la marcha en seis minutos y pruebas cronometradas; la discapacidad, con la escala de actividad específica de la enfermedad de Pompe construida según el análisis de Rasch; la función respiratoria, con la medida de la capacidad vital forzada y la saturación de oxígeno; y la fatiga, con la escala de intensidad de la fatiga. Por último, la seguridad y la tolerabilidad del tratamiento enzimático sustitutivo se controlan con el registro y tratamiento de los potenciales efectos adversos y la medición de los anticuerpos antialglucosidasa alfa. Se incluyen también diversas recomendaciones generales (AU)

Although treatment with alglucosidase alfa has helped improve the prognosis of patients with late-onset Pompe disease, both the development of the disease and the effectiveness of the treatment need to be monitored on a regular basis. This is the reason that has led a committee of Spanish experts to draw up a series of guidelines on how to follow up these patients. The committee proposes a model of follow-up tests for late-onset Pompe disease. First of all, the nutritional status and swallowing function must be evaluated. Second, and due to the variability of the clinical features, the committee recommends the simultaneous use of several scales to measure different functions and parameters. Thus, muscular force is assessed with the Medical Research Council scale; motor functioning, with the six-minute walk test and timed tests; disability, with the Rasch-built Pompe-specific Activity scale; respiratory functioning, with measurement of the forced vital capacity and oxygen saturation; and fatigue, with the fatigue intensity scale. Lastly, the safety and tolerability of enzyme replacement therapy are controlled by registering and treating the potential side effects and measurement of the anti-alglucosidase alfa antibodies. A number of different general recommendations are also included (AU)

[Guidelines for monitoring late-onset Pompe disease.Sociedad Española de Medicina Interna (SEMI), Sociedad Española de Neurología (SEN) y Sociedad Española de Neumología y CirugíaTorácica (SEPAR)]. / Guía para el seguimiento de la enfermedad de Pompe de inicio tardío.

Although treatment with alglucosidase alfa has helped improve the prognosis of patients with late-onset Pompe disease, both the development of the disease and the effectiveness of the treatment need to be monitored on a regular basis. This is the reason that has led a committee of Spanish experts to draw up a series of guidelines on how to follow up these patients. The committee proposes a model of follow-up tests for late-onset Pompe disease. First of all, the nutritional status and swallowing function must be evaluated. Second, and due to the variability of the clinical features, the committee recommends the simultaneous use of several scales to measure different functions and parameters. Thus, muscular force is assessed with the Medical Research Council scale; motor functioning, with the six-minute walk test and timed tests; disability, with the Rasch-built Pompe-specific Activity scale; respiratory functioning, with measurement of the forced vital capacity and oxygen saturation; and fatigue, with the fatigue intensity scale. Lastly, the safety and tolerability of enzyme replacement therapy are controlled by registering and treating the potential side effects and measurement of the anti-alglucosidase alfa antibodies. A number of different general recommendations are also included.

TITLE: Guia para el seguimiento de la enfermedad de Pompe de inicio tardio.Aunque el tratamiento con alglucosidasa alfa ha contribuido a mejorar el pronostico de los pacientes con enfermedad de Pompe de inicio tardio, es necesario hacer un seguimiento periodico de la evolucion de la enfermedad y de la eficacia del tratamiento. Por este motivo, un comite de expertos españoles ha elaborado una guia para el seguimiento de estos pacientes. El comite propone un modelo de pruebas de seguimiento para la enfermedad de Pompe de inicio tardio. En primer lugar, ha de valorarse el estado nutricional y la funcion deglutoria. En segundo lugar, y debido a la variabilidad del cuadro clinico, el comite recomienda el uso simultaneo de varias escalas que midan distintas funciones y parametros. De este modo, la fuerza muscular se evalua con la escala del Medical Research Council; la funcion motora, con la prueba de la marcha en seis minutos y pruebas cronometradas; la discapacidad, con la escala de actividad especifica de la enfermedad de Pompe construida segun el analisis de Rasch; la funcion respiratoria, con la medida de la capacidad vital forzada y la saturacion de oxigeno; y la fatiga, con la escala de intensidad de la fatiga. Por ultimo, la seguridad y la tolerabilidad del tratamiento enzimatico sustitutivo se controlan con el registro y tratamiento de los potenciales efectos adversos y la medicion de los anticuerpos antialglucosidasa alfa. Se incluyen tambien diversas recomendaciones generales.

Cost-utility analysis of a telehealth programme for patients with severe chronic obstructive pulmonary disease treated with long-term oxygen therapy.

We conducted a cost-utility analysis of a telehealth programme for patients with severe chronic obstructive pulmonary disease (COPD) compared with usual care. A randomized controlled trial was carried out over four months with 45 patients treated with long-term oxygen therapy, 24 in the telehealth group (TG) and 21 in the control group (CG). The analysis took into account whether the severity of comorbidity (defined as the presence of additional chronic diseases co-occurring with COPD) was associated with differences in costs and/or quality-adjusted life years (QALYs). Results of cost-utility analysis were expressed in terms of the incremental cost-effectiveness ratio (ICER). The average total cost was €2300 for the TG and €1103 for the CG, and the average QALY gain was 0.0059 for the TG and 0.0006 for the CG (resulting an ICER of 223,726 €/QALY). For patients without comorbidity, the average total cost was €855 for the TG and €1354 for the CG, and the average QALY gain was 0.0288 for the TG and 0.0082 for the CG (resulting in the telehealth programme being the dominant strategy). For patients with comorbidity, the average total cost was €2782 for the TG and €949 for the CG, and the average QALY gain was -0.0017 for the TG and -0.0041 for the CG (resulting an ICER of 754,592 €/QALY). The telehealth programme may not have been cost-effective compared to usual care, although it could be considered cost-effective for patients without comorbidity.

Impact of bronchodilator responsiveness on quality of life and exercise capacity in patients with COPD.

BACKGROUND: Bronchial variability in COPD patients may be a phenotypic feature associated with clinical characteristics and differential treatment response. We analyzed whether symptoms, quality of life, and exercise capacity varied in COPD patients as a function of bronchodilator test results, and compared responses to an exercise program. METHODS: A positive bronchodilator test result was defined as FVC and/or FEV1 improvement of > 12% plus > 200 mL after 400 µg of salbutamol. We studied 198 COPD subjects: 94 with positive reversibility, and 104 with negative reversibility. Training sessions were carried out on 3 non-consecutive days each week, for 12 weeks, and consisted of a combination of resistance and strength training. Subjects were evaluated on 2 consecutive days at baseline, and at the end of the 12-week training program. RESULTS: Those with positive reversibility had shorter time to exhaustion in the endurance test (19.1 ± 12.6 min vs 24.5 ± 14.5 min, P = .03), shorter shuttle walk test distance (380.6 ± 158.2 m vs 438.5 ± 149.1 m, P = .02), and lower Chronic Respiratory Disease Questionnaire scores (18.7 ± 4.6 vs 19.8 ± 4.3, P = .01). There were no significant differences in peak exercise, peripheral muscle strength, dyspnea, or improvement after exercise training. CONCLUSIONS: Compared to COPD subjects with negative reversibility, those with positive reversibility walked for shorter distances, and had shorter endurance times and worse quality of life, but the improvements after exercise training were similar.

Exercise training in patients with chronic respiratory failure due to kyphoscoliosis: a randomized controlled trial.

BACKGROUND: Research has provided evidence for the safety, feasibility, and efficacy of exercise training in patients with COPD. However, little is known about the impact of exercise training in patients with chronic respiratory failure due to kyphoscoliosis. We evaluated the effect of an exercise training program on exercise capacity, muscle strength, dyspnea, and quality-of-life indices in subjects with chronic respiratory failure due to kyphoscoliosis. METHODS: The 34 subjects were clinically stable, had been receiving nighttime home mechanical ventilation for ≥ 6 months, and were randomly assigned to the exercise group (n = 17) or the control group (n = 17). The exercise group conducted cycle and strength training on 3 non-consecutive days per week for 12 weeks. We measured pulmonary function, exercise capacity, peripheral muscle strength, dyspnea scores, and quality of life. RESULTS: Statistical analysis was carried out on the data from 16 subjects in the exercise group and in 11 subjects in the control group. Three of the lung-function parameters in the exercise group significantly changed: PaCO2 (P = .04), inspiratory pressure (P = .03), and expiratory pressure (P = .04); and endurance time (P = .002) and shuttle walk distance (P = .001) increased significantly. The exercise group had significantly greater improvements in peripheral muscle strength, dyspnea, and quality of life. CONCLUSIONS: In patients with chronic respiratory failure due to kyphoscoliosis, exercise training improved exercise capacity, peripheral muscle strength, dyspnea, and quality of life. (Deutschen Register Klinischer Studien DRKS00000443).

Implementation of a telehealth programme for patients with severe chronic obstructive pulmonary disease treated with long-term oxygen therapy.

We conducted a pilot study of the effectiveness of home telehealth for patients with advanced chronic obstructive pulmonary disease treated with long-term oxygen therapy. Patients were randomized into a telehealth group (n = 24) and a control group (n = 21) who received usual care. Patients in the telehealth group measured their vital signs on weekdays and performed spirometry on two days per week. The data were transmitted automatically to a clinical call centre. After four months of monitoring the mean number of accident and emergency department visits in the telehealth group was slightly lower than in the control group (0.29 versus 0.43, P = 0.25). The mean number of hospital admissions was 0.38 in the telehealth group and 0.14 in the control group (P = 0.47). During the study a total of 40 alerts were detected. The clinical triage process detected eight clinical exacerbations which were escalated by the case manager for a specialist consultation. There were clinically important differences in health-related quality of life in both groups. The mean score on the SGRQ was 10.9 versus 4.5 in the control group (P = 0.53). The EuroQol-5D score improved by 0.036 in the telehealth group and by 0.003 in the control group (P = 0.68). Both patients and healthcare professionals showed a high level of satisfaction with the telehealth programme.

Guía clínica de la enfermedad de Pompe de inicio tardío / Clinical guidelines for late-onset Pompe disease

Resumen. Hasta 2006, la enfermedad de Pompe o glucogenosis tipo II era una enfermedad incurable y con tratamiento meramente paliativo. El desarrollo de la terapia de sustitución con la enzima α-glucosidasa recombinante humana ha constituido el primer tratamiento específico para esta enfermedad. El objetivo de esta guía es servir de referencia en el manejo de la variedad de inicio tardío de la enfermedad de Pompe, es decir, la que aparece después del primer año de vida. En la guía, un grupo de expertos españoles hace recomendaciones específicas en cuanto a diagnóstico, seguimiento y tratamiento de esta enfermedad. En cuanto al diagnóstico, el método de la muestra en sangre seca es imprescindible como primer paso para el diagnóstico de la enfermedad de Pompe, y el diagnóstico de confirmación de la enfermedad de Pompe debe realizarse mediante un estudio de la actividad enzimática en muestra líquida en linfocitos aislados o mediante el análisis mutacional del gen de la alfa-glucosidasa. En cuanto al tratamiento de la enfermedad con terapia de sustitución enzimática, los expertos afirman que es eficaz en la mejoría o estabilización de la función motora y pulmonar, y debe iniciarse cuando aparezcan los síntomas atribuibles a la enfermedad de Pompe (AU)

Summary. Before 2006, Pompe disease or glycogenosis storage disease type II was an incurable disease whose treatment was merely palliative. The development of a recombinant human alpha-glucosidase enzymatic replacement therapy has become the first specific treatment for this illness. The aim of this guide is to serve as reference for the management of the late-onset Pompe disease, the type of Pompe disease that develops after one year of age. In the guide a group of Spanish experts make specific recommendations about diagnosis, follow-up and treatment of this illness. With regard to diagnosis, the dried blood spots method is essential as the first step for the diagnosis of Pompe disease. The confirmation of the diagnosis of Pompe disease must be made by means of an study of enzymatic activity in isolated lymphocytes or a mutation analysis of the alpha-glucosidase gene. With regard to treatment with enzymatic replacement therapy, the experts say that is effective improving or stabilizating the motor function and the respiratory function and it must be introduced when the first symptoms attributable to Pompe disease appear (AU)

Factors predicting the initiation of a tobacco cessation program in Spain.

There have been limited studies regarding the characteristics of subjects who have decided to initiate a cessation program to quit tobacco smoking. Identifying such characteristics is important because it provides information regarding recruiting and tailoring strategies, as well as intervention methods. This observational trial with cross-sectional data analysis sought to identify the characteristics of subjects who have decided to initiate a smoking cessation program compared with those who did not. All subjects who asked for information about our cessation program between January 2000 and December 2005 were eligible for participation. All subjects were interviewed regarding their tobacco consumption practices. We also collected information on medical history and psychological conditions. Multivariate analysis was used to identify variables associated with the decision to initiate the cessation program. A total of 1,681 subjects asked for information about smoking cessation at our center, and 1,132 (67.3%) decided to enter our program. Independent factors associated with the decision to initiate the cessation program included female gender (OR: 1.54; 95% CI:1.23-1.93), having a university degree (OR: 1.46; 95% CI: 1.12-1.88), bronchial asthma (OR: 0.41; 95% CI: 0.24-0.71), nonpsychotic psychiatric disorders (OR: 0.52; 95% CI: 0.40-0.66), psychotic disorders (OR: 6.00; 95% CI: 2.74-13.14), and a history of insomnia (OR: 6.22; 95% CI: 1.85-20.87). Although all smokers should be counseled to quit smoking, our data may help to concentrate efforts on some subjects in order to increase the participation in smoking cessation programs.

Efectividad de un programa de orientación cognitiva con y sin tratamiento sustitutivo con nicotina en la cesación tabáquica en pacientes hospitalizados / Effectiveness of a Cognitive Orientation Program With and Without Nicotine Replacement Therapy in Stopping Smoking in Hospitalised Patients

IntroducciónAnalizamos la eficacia de una intervención conductual-cognitiva de alta intensidad frente a una intervención mínima iniciada durante un ingreso hospitalario, y si la combinación con tratamiento sustitutivo con nicotina (TSN) puede aumentar las tasas de abstinencia a los 12 meses de seguimiento.MétodoSe estudiaron 2.560 fumadores activos durante un ingreso hospitalario. De ellos, 717 fumadores rehusaron entrar en el estudio y tras una intervención mínima se les solicitaba poder telefonearlos al año para preguntar si continuaban fumando. El resto, 1.843 fumadores recibieron tratamiento cognitivo de alta intensidad y fueron aleatorizados para recibir o no TSN. El seguimiento tras el alta se realizaba en consultas externas o con sesiones telefónicas.ResultadosAl año de seguimiento, el 7% de los que rehusaron entrar en el estudio se mantenían sin fumar frente al 27% de los que entraron en el estudio (p<0,001). Existían diferencias significativas entre el grupo que realizó solo tratamiento conductual (21% de abstinencia) frente al grupo que además realizó TSN (33% de abstinencia; p=0,002). En este último grupo existían diferencias significativas (p=0,03) entre los que realizaron el seguimiento en consultas (39% de abstinencia) frente a los que hicieron el control telefónico (30%). En el análisis multivariante, los predictores de abstinencia a los 12 meses fueron: haber utilizado TSN (OR 12,2; 95% de CI, 5,2–32; p=0,002) y mayor puntuación en el test de Richmond (OR 10,1; 95% de CI, 3,9–24,2; p=0,01).ConclusionesUna intervención de orientación cognitiva iniciada en fumadores ingresados aumenta las tasas de abstinencia a los 12 meses frente a una intervención mínima, y aún aumenta de forma más significativa dichas tasas si se le añade TSN(AU)

IntroductionWe analysed the effectiveness of a high intensity behavioural-cognitive intervention compared to minimal intervention started during a hospital stay, to see if the combination of nicotine replacement therapy (NRT) can increase the quitting rate at 12 months of follow up.MethodA total of 2560 active smokers were studied during their hospital stay. Of these, 717 smokers refused to enter the study and after a minimal intervention they were asked if we could telephone them after one year to ask if they still smoked. The remaining 1843 smokers who received high intensity cognitive therapy were randomised to receive or not receive NRT. The follow up after discharge was carried out by outpatient visits or with telephone sessions.ResultsAt one year of follow up, 7% of those who declined to enter the study had stopped smoking compared to 27% of those who entered the study (p<0.001). There were significant differences between the group that only had behavioural therapy (21% stopped) compared to the group that also had NRT (33% stopped; p=0.002). In this latter group there were significant differences (p=0.03) between those who had follow up in clinics (39% stopped) compared to those who were followed up telephone sessions (30%). In the multivariate analysis, the predictors of quitting at 12 months were: to have used NRT (OR 12.2; 95% CI, 5.2–32; p=0.002) and a higher score in the Richmond Test (OR 10.1; 95% CI, 3.9–24.2; p=0.01).ConclusionsA cognitive type intervention started on smokers when admitted to hospital increases quitting rates at 12 months, compared to a minimal intervention, and these rates increase even more significantly if NRT is added(AU)

Effectiveness of a cognitive orientation program with and without nicotine replacement therapy in stopping smoking in hospitalised patients.

INTRODUCTION: We analysed the effectiveness of a high intensity behavioural-cognitive intervention compared to minimal intervention started during a hospital stay, to see if the combination of nicotine replacement therapy (NRT) can increase the quitting rate at 12 months of follow up. METHOD: A total of 2560 active smokers were studied during their hospital stay. Of these, 717 smokers refused to enter the study and after a minimal intervention they were asked if we could telephone them after one year to ask if they still smoked. The remaining 1843 smokers who received high intensity cognitive therapy were randomised to receive or not receive NRT. The follow up after discharge was carried out by outpatient visits or with telephone sessions. RESULTS: At one year of follow up, 7% of those who declined to enter the study had stopped smoking compared to 27% of those who entered the study (p<0.001). There were significant differences between the group that only had behavioural therapy (21% stopped) compared to the group that also had NRT (33% stopped; p=0.002). In this latter group there were significant differences (p=0.03) between those who had follow up in clinics (39% stopped) compared to those who were followed up telephone sessions (30%). In the multivariate analysis, the predictors of quitting at 12 months were: to have used NRT (OR 12.2; 95% CI, 5.2-32; p=0.002) and a higher score in the Richmond Test (OR 10.1; 95% CI, 3.9-24.2; p=0.01). CONCLUSIONS: A cognitive type intervention started on smokers when admitted to hospital increases quitting rates at 12 months, compared to a minimal intervention, and these rates increase even more significantly if NRT is added.

Modified BODE indexes: Agreement between multidimensional prognostic systems based on oxygen uptake.

AIM: It has been recently shown that the original BODE index has a high degree of correlation with two modified BODE indexes using maximal oxygen uptake expressed either as mL/min/kg (mBODE) or as the percentage predicted (mBODE%). In this study we investigated the agreement between the two modified BODE indexes (mBODE and mBODE%) in patients with stable chronic obstructive pulmonary disease (COPD). METHODS: A total of 169 patients with stable COPD were enrolled in this cross-sectional study. Differences between the two mBODE indexes were assessed using kappa coefficients and Bland-Altman plots. One out of every three patients underwent the six-minute walking test to investigate the agreement with the original BODE index. RESULTS: Correlations between the two mBODE indexes with each other (r = 0.96, P < 0.001) and with the original BODE index (mBODE r = 0.88, P < 0.001; mBODE% r = 0.93, P < 0.001) were excellent. However, the two mBODE indexes were significantly different from each other (mBODE 5.27 +/- 2.3 versus mBODE% 4.31 +/- 2.5; P < 0.001). The kappa coefficients were significantly lower (entire study group k = 0.5, P < 0.001) for every GOLD stage. The mean difference between the two mBODE indexes was 0.8 +/- 0.6 units. Differences with the original BODE were higher for the mBODE (1.8 +/- 0.9) than for the mBODE% (0.6 +/- 0.8). CONCLUSIONS: The new mBODE indexes are highly correlated but significantly different from each other. The differences between the novel indexes deserve further scrutiny.

Factors associated with quality of life in patients with chronic respiratory failure due to kyphoscoliosis.

OBJECTIVES: Patients with chronic respiratory failure due to kyphoscoliosis (CHRF-KS) constitute a specific population with impaired health-related quality of life (HRQL). Thus far, no studies have examined factors related to HRQL. The objective of the present study was to identify clinical, functional and exertion-related factors associated with HRQL. METHODS: We investigated 27 patients (12 males). Respiratory function tests, dyspnea ratings, peripheral and respiratory muscle function and exercise testing were performed. The Chronic Respiratory Disease Questionnaire (CRDQ) was used to assess HRQL. Bivariate correlations were used to investigate the relationships between CRDQ dimensions and the clinical, functional and exertion-related characteristics of the study participants. RESULTS: The general characteristics of the study sample were as follows: age: 61 (IQR: 12) years, FVC: 32.6% (IQR: 10.2) and pCO2: 48 mmHg (IQR: 8.7). Peripheral muscle strength, dyspnea and exercise capacity were identified as significant factors associated with poorer HRQL. The CRDQ dimensions of fatigue and emotional function showed greater correlations with the patients' general characteristics. Dyspnea CRDQ scores did not correlate with dyspnea in any of the scales used. CONCLUSION: Of the various factors examined, dyspnea, exercise capacity and peripheral muscle strength have been identified as significant factors associated with HRQL in CHRF-KS patients.

Transculturally adapted Spanish SRI questionnaire for home mechanically ventilated patients was viable, valid, and reliable.

OBJECTIVE: To validate the Spanish Severe Respiratory Insufficiency (SRI) questionnaire, the first health-related quality-of-life questionnaire specific for patients receiving home mechanical ventilation (HMV). STUDY DESIGN AND SETTING: This multicenter prospective study enrolled 115 patients (53 males, age 62+/-13 years) receiving HMV, recruited from five hospitals. Patients were scheduled for two visits during which sociodemographic and clinical data were recorded, and both the Spanish SRI and the SF-36 questionnaires were administered. Viability was assessed by recording timing and the response rate in the questionnaire. Reliability was assessed using intraclass correlation coefficient (ICC) and Cronbach alpha coefficient. Validity was studied by factor analysis, by a correlation test between the SRI and SF-36 questionnaires, and by establishing several simple, plausible, ad hoc hypotheses. RESULTS: The SRI was administered in 10+/-5 minutes with >or=96% responses for most items. Cronbach alpha coefficient was >0.7 for all scales except social relationships. ICCs were above 0.8 for all scales. Criterion validity obtained high correlations with SF-36, especially in psychosocial well-being and physical functioning scales. Factor analysis explained 60% of the variability. All ad hoc hypotheses were fulfilled. CONCLUSION: The Spanish version of the SRI questionnaire has good psychometric properties, similar to those of the original questionnaire.

Factors related to quality of life in patients receiving home mechanical ventilation.

OBJECTIVES: The objective of this study was to evaluate factors associated with health-related quality of life (HRQOL) among patients receiving home mechanical ventilation (HMV). METHODS: Observational, cross-sectional study. Patients receiving HMV were recruited from hospital outpatients facilities at five participating centers; a single follow-up visit was scheduled. The Spanish version of the Severe Respiratory Insufficiency (SRI) Questionnaire was used and the following variables were collected: socio-demographic status, previous medical history (Charlson-Age Comorbidity Index), current symptoms, administration of questionnaires, pulmonary function tests (PFT), current ventilatory support, and oxygen therapy. RESULTS: One hundred and fifteen patients (57 males and 58 females, mean age 62+/-13 years) were investigated. The reasons for HMV were as follows: thoracic cage abnormalities (33 patients), obesity hypoventilation syndrome (37 patients), neuromuscular disorders (18 patients), sequelae of tuberculosis (12 patients), and chronic obstructive pulmonary disease (15 patients). In a bivariate approach, dyspnea, the number of hospitalizations, and the number of emergency room admissions in last year were the main predictors of each HRQOL dimension. Multivariate analysis showed that dyspnea, FEV(1)/FVC, and the number of hospitalizations in the previous year were independently associated with HRQOL. CONCLUSIONS: HRQOL of patients receiving HMV is influenced by many factors, especially by dyspnea and the number of admissions. An obstructive pattern in the PFT also influences HRQOL. These findings may have therapeutic implications.

Shuttle walking versus maximal cycle testing: clinical correlates in patients with kyphoscoliosis.

A cross-sectional prospective design was used to compare the effectiveness of the shuttle walking test (SWT) and the maximal cycle ergometry test (CET) to assess the functional capacity of patients with chronic hypercapnic respiratory failure due to severe kyphoscoliosis. Twenty-four patients completed both the SWT and CET. Heart rate, blood pressure, leg fatigue, chest pain and dyspnea (Borg's scale) were measured immediately after each test. Correlation coefficients and Bland-Altman analysis were used to compare the two methods. Borg's dyspnea, leg and chest pain after exercise were not significantly different between tests. Only heart rate (SWT 130[20.7] versus CET 116[28.75]; p = 0.048) and diastolic blood pressure (SWT: 85.5[13.75] versus CET 95[17.5]; p = 0.021) were slightly but significantly different between the two protocols. There was a good positive correlation between the distance walked in SWT and maximal oxygen consumption (r = 0.675; p < 0.001). SWT and CET testing elicited similar clinical and hemodynamic responses. SWT is a feasible measure of functional capacity in this patient group.