First-line combination therapy versus first-line monotherapy for primary hypertension.

BACKGROUND: This is the first update of a review originally published in 2017. Starting with one drug and starting with a combination of two drugs are strategies suggested in clinical guidelines as initial treatment of hypertension. The recommendations are not based on evidence about clinically relevant outcomes. Some antihypertensive combinations have been shown to be harmful. The actual harm-to-benefit balance of each strategy is unknown. OBJECTIVES: To determine if there are differences in clinical outcomes between monotherapy and combination therapy as initial treatment for primary hypertension. SEARCH METHODS: The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to April 2019: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 2005), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We used no language restrictions. We also searched clinical studies repositories of pharmaceutical companies, reviews of combination drugs on the US Food and Drug Administration and European Medicines Agency websites, and lists of references in reviews and clinical practice guidelines. SELECTION CRITERIA: We included randomised, double-blind trials with at least 12 months' follow-up in adults with primary hypertension (systolic blood pressure/diastolic blood pressure 140/90 mmHg or higher, or 130/80 mmHg or higher if participants had diabetes), which compared combination of two first-line antihypertensive drugs with monotherapy as initial treatment. Trials had to include at least 50 participants per group and report mortality, cardiovascular mortality, cardiovascular events, or serious adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, evaluated the risk of bias, and performed data entry. The primary outcomes were mortality, serious adverse events, cardiovascular events, and cardiovascular mortality. Secondary outcomes were withdrawals due to drug-related adverse effects, reaching blood pressure control (as defined in each trial), and blood pressure change from baseline. Analyses were based on the intention-to-treat principle. We summarised data on dichotomous outcomes as risk ratios (RR) with 95% confidence intervals (CI). MAIN RESULTS: This update included one new study in which a subgroup of participants met our inclusion criteria. As none of the four included studies focused solely on people initiating antihypertensive treatment, we asked investigators for data for this subgroup. One study (PREVER-treatment 2016) used a combination of thiazide-type diuretic/potassium-sparing diuretic; as the former is not indicated in monotherapy, we analysed this study separately. The three original trials in the main comparison (monotherapy: 335 participants; combination therapy: 233 participants) included outpatients, mostly European and white people. Two trials only included people with type 2 diabetes; the remaining trial excluded people treated with diabetes, hypocholesterolaemia, or cardiovascular drugs. The follow-up was 12 months in two trials and 36 months in one trial. It is very uncertain whether combination therapy versus monotherapy reduces total mortality (RR 1.35, 95% CI 0.08 to 21.72), cardiovascular mortality (zero events reported), cardiovascular events (RR 0.98, 95% CI 0.22 to 4.41), serious adverse events (RR 0.77, 95% CI 0.31 to 1.92), or withdrawals due to adverse effects (RR 0.85, 95% CI 0.53 to 1.35); all outcomes had 568 participants, and the evidence was rated as of very low certainty due to serious imprecision and for using a subgroup that was not defined in advance. The confidence intervals were extremely wide for all important outcomes and included both appreciable harm and benefit. The PREVER-treatment 2016 trial, which used a combination therapy with potassium-sparing diuretic (monotherapy: 84 participants; combination therapy: 116 participants), included outpatients. This trial was conducted in Brazil and had a follow-up of 18 months. The number of events was very low and confidence intervals very wide, with zero events reported for cardiovascular mortality and withdrawals due to adverse events. It is very uncertain if there are differences in clinical outcomes between monotherapy and combination therapy in this trial. AUTHORS' CONCLUSIONS: The numbers of included participants, and hence the number of events, were too small to draw any conclusion about the relative efficacy of monotherapy versus combination therapy as initial treatment for primary hypertension. There is a need for large clinical trials that address the review question and report clinically relevant endpoints.

First-line combination therapy versus first-line monotherapy for primary hypertension.

BACKGROUND: Starting with one drug and starting with a combination of two drugs are strategies suggested in clinical guidelines as initial treatment of hypertension. The recommendations are not based on evidence about clinically relevant outcomes. Some antihypertensive combinations have been shown to be harmful. The actual harm-to-benefit balance of each strategy is unknown. OBJECTIVES: To determine if there are differences in clinical outcomes between monotherapy and combination therapy as initial treatment for primary hypertension. SEARCH METHODS: We searched the Hypertension Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 2), Ovid MEDLINE, Ovid Embase, LILACS, ClinicalTrials.gov, Current Controlled Trials, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) up to February 2016. We searched in clinical studies repositories of pharmaceutical companies, reviews of combination drugs in Food and Drug Administration and European Medicines Agency, and lists of references in reviews and clinical practice guidelines. SELECTION CRITERIA: Randomized, double-blind trials with at least 12 months' follow-up in adults with primary hypertension (systolic blood pressure/diastolic blood pressure 140/90 mmHg or higher, or 130/80 mmHg or higher if participants had diabetes), which compared combination of two first-line antihypertensive drug with monotherapy as initial treatment. Trials had to include at least 50 participants per group and report mortality, cardiovascular mortality, cardiovascular events or serious adverse events. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials for inclusion, evaluated the risk of bias and entered the data. Primary outcomes were mortality, serious adverse events, cardiovascular events and cardiovascular mortality. Secondary outcomes were withdrawals due to drug-related adverse effects, reaching blood pressure control (as defined in each trial) and blood pressure change from baseline. Analyses were based on the intention-to-treat principle. We summarized data on dichotomous outcomes as risk ratios with 95% confidence intervals. MAIN RESULTS: We found three studies in which a subgroup of participants met our inclusion criteria. None of the studies focused solely on people initiating antihypertensive treatment so we asked investigators for data for this subgroup (monotherapy: 335 participants; combination therapy: 233 participants). They included outpatients, and mostly European and white people. Two trials included only people with type 2 diabetes, whereas the other trial excluded people treated with diabetes, hypocholesterolaemia or cardiovascular drugs. The follow-up was 12 months in two trials and 36 months in one trial. Certainty of evidence was very low due to the serious imprecision, and for using a subgroup not defined in advance. Confidence intervals were extremely wide for all important outcomes and included both appreciable harm and benefit. AUTHORS' CONCLUSIONS: The numbers of included participants and, hence the number of events, were too small to draw any conclusion about the relative efficacy of monotherapy versus combination therapy as initial treatment for primary hypertension. There is a need for large clinical trials that address the question and report clinically relevant endpoints.

Qualitative Evaluation of the Implementation of an Integrated Care Delivery Model for Chronic Patients with Multi-Morbidity in the Basque Country.

INTRODUCTION: The objective of this study was to assess a model for improving healthcare integration for patients with multiple chronic diseases in an integrated healthcare organisation in the Basque Country and to propose areas for improvement. METHODS: We organised four nominal groups composed of representatives from different categories of clinicians involved in the development of an integrated healthcare organisation and in the integrated care of patients with multiple diseases, namely, internists, general practitioners, and primary care and hospital nurses. RESULTS: The aspect rated most positively was the concept itself of an integrated care model, which is able to improve communication between levels of care, increase the quality of the care provided and enhance patient safety. Additionally, it was agreed that the role of assigned clinicians is a key element. The problems identified mostly concern its implementation in daily practice. CONCLUSIONS: The results of this study made it possible to suggest at least 8 areas of improvement to be implemented. These are related to: nurses' roles; care and monitoring of stable patients; team work; communication with patients; coordination with social workers and between internists and family doctors; as well as the development of an office of medical services to lead the integration process.

Use of clinical practice guidelines and factors related to their uptake: a survey of health professionals in Spain.

RATIONALE, AIMS AND OBJECTIVE: This study aims to assess the use of clinical practice guidelines (CPGs) among health professionals and factors related to their uptake in clinical practice. METHODS: Cross-sectional study based on an online survey conducted among primary care (PC) and hospital-based care (HC) doctors in Spain in 2011. Questionnaire development included adaptation of similar surveys and contextualization through a qualitative study. After a pilot study and review, the final survey contained five domains: demographics, involvement in CPGs, consultation of CPGs, perceptions and attitudes regarding CPGs and Spanish NHS CPGs Programme. Professionals from selected health care centres in seven regions were contacted by email with an invitation and link to the Web-based questionnaire. We analysed between-group differences and explored potential predictors of CPGs use by means of a logistic regression. RESULTS: Six hundred seventy-six doctors responded to the survey (27.7% response rate). 47.1% were PC and 49.5% were HC doctors. 32.5% stated previous involvement in CPGs and 56.5% stated training in research methodology. 67.5% of the surveyed professionals reported using CPGs more than one time per week. The use of a system for classifying the quality of evidence (62.3%) and for grading the strength of the recommendations (58.6%), as well as the use of a rigorous methodology (49.6%), were the most frequently reported aspects related to CPG credibility. The lack of time (56.4%), especially in PC (65.3% versus 49.5% in HC; P < 0.001), and the absence of brief and easily accessible format (42.2%) were the main reported barriers to using CPGs. None of the studied factors showed statistically significant association in the logistic regression model. CONCLUSIONS: Study results suggest that, in general, Spanish doctors trust and use CPGs frequently. To improve uptake by health professionals and to overcome existing barriers, CPGs should be rigorously developed and made accessible at the point-of-care in user-friendly electronic formats. Due to the low response rate, findings should be extrapolated with caution.

Attitudes and perceptions about clinical guidelines: a qualitative study with Spanish physicians.

BACKGROUND: Clinical guidelines (CGs) are popular for healthcare decision making but their acceptability and use by healthcare providers is influenced by numerous factors. Some of these factors are professional-related, such as knowledge and perceptions of and attitudes toward CGs in general. The aim of our study was to evaluate attitudes and perceptions of Spanish physicians towards CGs. METHODS: We coordinated six discussion groups with a total of 46 physicians. The participants were drawn from 12 medical specialties from both specialized and primary care. We recorded the sessions and transcribed the content verbatim. We analyzed the data using an approach based on the grounded theory. RESULTS: We identified two main constructs that defined the physicians' perceptions towards guidelines: knowledge and usefulness. "Knowledge" defined the theoretical meanings of guidelines, while "Usefulness" referred to the pragmatic approach to guidelines. These constructs were interrelated through a series of categories such as confidence, usability, accessibility, dissemination and formats. CONCLUSIONS: In our study, the constructs that impacted most on physician's attitudes to clinical guidelines were knowledge and usefulness. The tension between the theoretical and the pragmatic constructs determined the attitudes and how physicians use guidelines. Groups developing guidelines should ask relevant clinical questions and develop implementable and context specific recommendations. Developers should be explicit and consistent in the development and presentation of recommendations.

Explaining medically unexplained symptoms: somatizing patients' responses in primary care.

OBJECTIVE: To examine (1) how physicians present an explanation of symptoms in terms of a hormonal imbalance as a means to initiate a psychosocial discussion with somatizing patients; and (2) how they respond to this explanation of symptoms. METHODS: Qualitative study of 11 sequences in which physicians explain patients' symptoms in terms of a hormonal imbalance are micro-analyzed using Conversation Analysis. RESULTS: Symptom explanations (SEs) were vague, tentative, and uncertain. Two patterns of SEs (general vs. specific) and five different patterns of patient response were found. Patient responses are classified according to whether they occur during or after the SE, and according to the degree of work patients carry out to verbalize a response. CONCLUSION: Symptom explanations elicited varying degrees of patient agreement, and allowed physicians to obtain patients' permission to conduct a psychosocial exploration. PRACTICE IMPLICATIONS: Physicians may start SEs by associating symptoms to a hormonal imbalance, and by relating them to universally recognizable emotions and familiar situations. Excessive emphasis on long and complex SEs and on seeking extended verbalizations of patient agreement may be counterproductive and antagonize the patient.

Cultura de la confidencialidad en los hospitales del norte de España / The culture of confidentiality in Northern Spain hospitals

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Extinción diferencial de los acontecimientos vitales en pacientes depresivos / Differential extinction of life events in depressed patients

Introducción: La pérdida constituye un aspecto central de la mayoría de los acontecimientos vitales (AV) que llevan a la depresión. En este trabajo investigamos si aquellos AV que suponen una pérdida importante generan un mayor impacto en la génesis de la enfermedad y si tienen un mayor tiempo de extinción que el resto de los sucesos. Método: Utilizamos una muestra de casos y controles de 50 pacientes deprimidos que habían sido diagnosticados con un episodio depresivo en los 6 meses previos a la entrevista, 50 controles sanos y una muestra comunitaria de 609 mujeres. La Life Events and Difficulties Schedule (LEDS) se aplicó a todos los sujetos. Se utilizó un método estadístico de extinción diferencial que segrega los AV según la existencia de acontecimientos importantes de pérdida. Resultados: En ambas muestras, los pacientes depresivos presentaban un incremento significativo de AV graves en las 52 semanas previas al desencadenamiento del trastorno. La mejor diferenciación entre grupos se correspondió con los tiempos de extinción más elevados. La diferencia de medias de la amenaza residual en la muestra comunitaria entre AV con pérdida y sin ella en sujetos depresivos y controles fue significativamente más alta en los AV con pérdida. Conclusiones: El método de extinción diferencial que segrega los AV en función de la existencia de pérdida o no permite una mejor diferenciación entre pacientes depresivos y controles. Aquellos AV que suponen una pérdida importante generan un mayor impacto en la génesis de la enfermedad y tienen un mayor tiempo de extinción que el resto de los sucesos

Extinción diferencial de los acontecimientos vitales en pacientes depresivos / Differential extinction of life events in depressed patients

Introducción: La pérdida constituye un aspecto central de la mayoría de los acontecimientos vitales (AV) que llevan a la depresión. En este trabajo investigamos si aquellos AV que suponen una pérdida importante generan un mayor impacto en la génesis de la enfermedad y si tienen un mayor tiempo de extinción que el resto de los sucesos. Método: Utilizamos una muestra de casos y controles de 50 pacientes deprimidos que habían sido diagnosticados con un episodio depresivo en los 6 meses previos a la entrevista, 50 controles sanos y una muestra comunitaria de 609 mujeres. La Life Events and Difficulties Schedule (LEDS) se aplicó a todos los sujetos. Se utilizó un método estadístico de extinción diferencial que segrega los AV según la existencia de acontecimientos importantes de pérdida. Resultados: En ambas muestras, los pacientes depresivos presentaban un incremento significativo de AV graves en las 52 semanas previas al desencadenamiento del trastorno. La mejor diferenciación entre grupos se correspondió con los tiempos de extinción más elevados. La diferencia de medias de la amenaza residual en la muestra comunitaria entre AV con pérdida y sin ella en sujetos depresivos y controles fue significativamente más alta en los AV con pérdida. Conclusiones: El método de extinción diferencial que segrega los AV en función de la existencia de pérdida o no permite una mejor diferenciación entre pacientes depresivos y controles. Aquellos AV que suponen una pérdida importante generan un mayor impacto en la génesis de la enfermedad y tienen un mayor tiempo de extinción que el resto de los sucesos (AU)

Diabetic retinopathy screening with non-mydriatic retinography by general practitioners: 2-year results.

AIMS: To ascertain in real practice the diagnosis rate of diabetic retinopathy (DR) in patients considered to have positive screening test by general practitioners (GPs) and what are the reasons for the false positive diagnosis. METHODS: Four GPs previously instructed in the interpretation of retinal photographs evaluated the digital retinography images of patients with diabetes obtained during a 2-year period. When the images were considered normal, a new appointment was scheduled for 1 year later and a report was emailed to the referring physician. Patients with any sign of DR or other suspicious retinal alterations and those whose images were considered difficult or impossible to assess were referred to an ophthalmologist. RESULTS: A total of 2750 patients were referred for screening. The images of 2036 (74%) patients were considered normal, and the images of 714 (26%) patients were sent to ophthalmologists. Among the referred patients, 392 (55%) did not have DR, 244 (34%) had DR, and 78 (11%) had unreadable images. The retinal images of 240 patients whose fundi were considered normal were read again by ophthalmologists to evaluate false negatives. Of them, 16 patients (7%) had DR but only two patients (1%) had treatable DR. CONCLUSIONS: After adequate training, GPs can screen for DR with a high level of accuracy using non-mydriatic retinography. There is a need to strengthen the training of GPs in order to recognize non-visual threatening abnormalities.

Perceptions and attitudes of clinicians in Spain toward clinical practice guidelines and grading systems: a protocol for a qualitative study and a national survey.

BACKGROUND: Clinical practice guidelines (CPGs) have become a very popular tool for decision making in healthcare. While there is some evidence that CPGs improve outcomes, there are numerous factors that influence their acceptability and use by healthcare providers. While evidence of clinicians' knowledge, perceptions and attitudes toward CPGs is extensive, results are still disperse and not conclusive. Our study will evaluate these issues in a large and representative sample of clinicians in Spain. METHODS/DESIGN: A mixed-method design combining qualitative and quantitative research techniques will evaluate general practitioners (GPs) and hospital-based specialists in Spain with the objective of exploring attitudes and perceptions about CPGs and evidence grading systems. The project will consist of two phases: during the first phase, group discussions will be carried out to gain insight into perceptions and attitudes of the participants, and during the second phase, this information will be completed by means of a survey, reaching a greater number of clinicians. We will explore these issues in GPs and hospital-based practitioners, with or without previous experience in guideline development. DISCUSSION: Our study will identify and gain insight into the perceived problems and barriers of Spanish practitioners in relation to guideline knowledge and use. The study will also explore beliefs and attitudes of clinicians towards CPGs and evidence grading systems used to rate the quality of the evidence and the strength of recommendations. Our results will provide guidance to healthcare researchers and healthcare decision makers to improve the use of guidelines in Spain and elsewhere.

Diabetic retinopathy screening using tele-ophthalmology in a primary care setting.

We evaluated tele-ophthalmology for diabetic retinopathy screening in a primary care setting. Four general practitioners (GPs) were taught to assess non-mydriatic retinography images of patients with diabetes. After training, a total of 1223 patients were screened using this method: 926 (76%) did not have diabetic retinopathy and 297 (24%) were referred for an ophthalmologic assessment. Of the 297 patients, 186 (15%) did not have diabetic retinopathy and were considered to be false positives, 85 (7%) had diabetic retinopathy and in 26 cases (2%) the retinography images were unreadable. The specificity of GPs for detecting diabetic retinopathy by non-mydriatic retinography was 83%. Ophthalmologists also assessed 120 patients who had been diagnosed as normal to detect false negatives. Ten patients (8.3%) had mild non-proliferative diabetic retinopathy with small isolated retinal hemorrhages. Only one patient (0.8%) had treatable diabetic retinopathy with hard exudates and microaneurysms. The sensitivity of GPs for detecting diabetic retinopathy was 90.9%; the sensitivity for detecting treatable lesions was 99.2%. We concluded that adequately trained GPs can screen for treatable lesions of diabetic retinopathy with a very high level of reliability using non-mydriatic retinography.

Somatisation in primary care: experiences of primary care physicians involved in a training program and in a randomised controlled trial.

BACKGROUND: A new intervention aimed at managing patients with medically unexplained symptoms (MUS) based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT) for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. METHODS: A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. RESULTS: Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. CONCLUSION: GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. TRIAL REGISTRATION: US ClinicalTrials.gov NCT00130988.

The diagnostic challenges presented by patients with medically unexplained symptoms in general practice.

OBJECTIVE: To describe the complexity of somatizing patients' symptomatology and the difficulties involved in the diagnostic process. DESIGN. Cross-sectional study of patients with medically unexplained symptoms. SETTING: Basque Health Service primary care centres in Bizkaia, Spain. SUBJECTS: The study comprised 156 patients selected at random from a list of 468 patients who had presented, over the course of their lives, six or more medically unexplained somatic symptoms for females and four or more for males, identified retrospectively by their practitioners. MAIN OUTCOME MEASURES: Physicians interviewed these patients using the somatoform symptoms section of the Composite International Diagnostic Interview (CIDI), and the Primary Care Evaluation of Mental Disorders (PRIME-MD). The Medical Outcomes Survey Short Form 36 (SF-36) was filled in at home. Organic diseases whose diagnosis was established during the previous year were included in the study by consulting patients' medical records. RESULTS: Patients were found to have a median of three medically explained and 12 medically unexplained symptoms. Mental disorders were found in 83% of cases, associated with other morbidity categories in 78%. The predictive value of symptoms was lower than 26% for diagnosing broad disease categories. CONCLUSIONS: These results depict an extremely difficult scenario for dichotomous diagnostic strategies aimed at classifying patients' symptoms as either organic or functional. Rather than struggling to choose one of these hypotheses, it is suggested that both of them should always be addressed concurrently.

A randomized controlled clinical trial of a psychosocial and communication intervention carried out by GPs for patients with medically unexplained symptoms.

BACKGROUND: Somatizing patients are a challenge to general practitioners (GPs). A cluster randomized controlled trial was conducted to asses the effect of specific communication techniques delivered by GPs on somatizing patients' self-perceived health. METHOD: Thirty-nine GPs were assigned randomly to two parallel groups. GPs in the intervention group treated somatic patients according to specific communication techniques focused on offering a physical explanation - release of hormones - and approaching sensitive topics in the patient's experience indirectly. Control GPs used the standard Goldberg reattribution technique. A total of 156 patients, aged 18-65 years, were selected randomly from a list of 468 patients with six or more active symptoms for women and four or more for men. All patients had six programmed 30-min consultations. Health-related quality of life (assessed with the 36-item Short-Form Health Survey, SF-36) and a summary utility index were used as outcome measures. Patients were interviewed at home at baseline and at 3, 8 and 12 months after the beginning of the intervention. RESULTS: Patients in both groups improved in all dimensions of the SF-36. The time course of the quality of life was significantly better for the intervention group in five of the eight scales of the SF-36 (bodily pain, mental health, physical functioning, vitality, and social functioning) and in the utility index (p<0.039). CONCLUSIONS: Communication techniques were found to have a clinically relevant impact on body pain. This finding, together with a trend towards better scores in the remaining scales, justifies the use of these techniques in psychosocial interventions delivered to patients with medically unexplained symptoms.

[Effect on quality of life of nCPAP treatment in patients with obstructive sleep apnea]. / Efecto del tratamiento con presión positiva continua en la vía respiratoria durante la noche en la calidad de vida de los pacientes con apnea del sueño.

BACKGROUND AND OBJECTIVE: The standard treatment of the obstructive sleep apnea syndrome (OSAS) is the nCPAP. There is evidence that its use improves the quality of life of patients. The objective of the study is to measure the effect of nCPAP on the quality of life of patients in a Spanish cohort. PATIENTS AND METHOD: We have used 3 quality of life questionnaires: SF-36, EuroQol 5D and FOSQ. OSAS patients were interviewed at baseline prior to the start of the treatment and at 3 months follow-up. Two measures were employed to analyze the data: distribution based measures such as the effect size and instruments that evaluate the sensitivity to change of the questionnaires such as the ROC curves. RESULTS: We interviewed 124 patients. The benefit in terms of utility of the nCPAP was 0.03 with SF-36 and 0.04 with EuroQol 5D. Effect size varies from small (0.21) with EuroQol 5D to moderate (0.51) with FOSQ. SF-36 obtained intermediate scores (0.35). EuroQol 5D was the questionnaire that obtained the biggest area under the ROC curve. Nevertheless, the area size was small in all cases. CONCLUSIONS: nCPAP improves significantly the quality of life of OSAS patients. The assessment of the quality of life of OSAS patients with the available instruments is only partially satisfactory.

Efecto del tratamiento con presión positiva continua en la vía respiratoria durante la noche en la calidad de vida de los pacientes con apnea del sueño / Effect on quality of life of nCPAP treatment in patients with obstructive sleep apnea

Fundamento y objetivo: La utilización de la presión positiva continua en la vía respiratoria durante la noche (nCPAP) en el tratamiento del síndrome de apneas-hipopneas durante el sueño (SAHS) es una opción terapéutica consolidada. Su uso mejora la calidad de vida de los pacientes. El objetivo de este estudio es medir su efecto sobre la calidad de vida tanto en términos de significación clínica como de utilidades. Pacientes y método: Se han utilizado 3 cuestionarios de calidad de vida: SF-36, EuroQol-5D y FOSQ. Se estudió a los pacientes con SAHS antes del comienzo del tratamiento y 3 meses después. Los resultados se interpretaron mediante medidas basadas en la distribución como el tamaño de efecto y medidas que permiten identificar la sensibilidad de los instrumentos como las curvas de eficacia diagnóstica (curvas ROC). Resultados: El número de pacientes fue de 124. El beneficio del tratamiento en términos de utilidades fue 0,03 medido con el SF-36 y 0,04 con el EuroQol-5D. El tamaño de efecto variaba desde pequeño con EuroQol-5D (0,21) hasta moderado con FOSQ (0,51) y SF-36 (0,35). EuroQol-5D es el cuestionario que produce mayor área bajo la curva ROC. Sin embargo, el tamaño del área es pequeño en todos los casos. Conclusiones: El tratamiento mejora de forma significativa la calidad de vida de los pacientes con SAHS. La medida del impacto del SAHS en las diferentes dimensiones psicosociales y funcionales de la calidad de vida permitiría una mejora del manejo clínico de los pacientes. Sin embargo, es un reto pendiente al que los cuestionarios utilizados en este estudio dan una respuesta limitada

Background and objective: The standard treatment of the obstructive sleep apnea syndrome (OSAS) is the nCPAP. There is evidence that its use improves the quality of life of patients. The objective of the study is to measure the effect of nCPAP on the quality of life of patients in a Spanish cohort. Patients and method: We have used 3 quality of life questionnaires: SF-36, EuroQol 5D and FOSQ. OSAS patients were interviewed at baseline prior to the start of the treatment and at 3 months follow-up. Two measures were employed to analyze the data: distribution based measures such as the effect size and instruments that evaluate the sensitivity to change of the questionnaires such as the ROC curves. Results: We interviewed 124 patients. The benefit in terms of utility of the nCPAP was 0.03 with SF-36 and 0.04 with EuroQol 5D. Effect size varies from small (0.21) with EuroQol 5D to moderate (0.51) with FOSQ. SF-36 obtained intermediate scores (0.35). EuroQol 5D was the questionnaire that obtained the biggest area under the ROC curve. Nevertheless, the area size was small in all cases. Conclusions: nCPAP improves significantly the quality of life of OSAS patients. The assessment of the quality of life of OSAS patients with the available instruments is only partially satisfactory