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J Sleep Res ; 29(1): e12889, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31257666


The high prevalence of obstructive sleep apnea has led to increasing interest in ambulatory diagnosis. The SleepMinder™ (SM) is a novel non-contact device that employs radiofrequency wave technology to assess the breathing pattern, and thereby estimate obstructive sleep apnea severity. We assessed the performance of SleepMinder™ in the home diagnosis of obstructive sleep apnea. One-hundred and twenty-two subjects were prospectively recruited in two protocols, one from an unselected sleep clinic cohort (n = 67, mean age 51 years) and a second from a hypertension clinic cohort (n = 55, mean age 58 years). All underwent 7 consecutive nights of home monitoring (SMHOME ) with the SleepMinder™ as well as inpatient-attended polysomnography in the sleep clinic cohort or cardiorespiratory polygraphy in the hypertension clinic cohort with simultaneous SleepMinder™ recordings (SMLAB ). In the sleep clinic cohort, median SMHOME apnea-hypopnea index correlated significantly with polysomnography apnea-hypopnea index (r = .68; p < .001), and in the hypertension clinic cohort with polygraphy apnea-hypopnea index (r = .7; p < .001). The median SMHOME performance against polysomnography in the sleep clinic cohort showed a sensitivity and specificity of 72% and 94% for apnea-hypopnea index ≥ 15. Device performance was inferior in females. In the hypertension clinic cohort, SMHOME showed a 50% sensitivity and 72% specificity for apnea-hypopnea index ≥ 15. SleepMinder™ classified 92% of cases correctly or within one severity class of the polygraphy classification. Night-to-night variability in home testing was relatively high, especially at lower apnea-hypopnea index levels. We conclude that the SleepMinder™ device provides a useful ambulatory screening tool, especially in a population suspected of obstructive sleep apnea, and is most accurate in moderate-severe obstructive sleep apnea.

N Engl J Med ; 376(26): 2534-2544, 2017 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-28402245


BACKGROUND: The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group trial involving 737 adults who were at least 65 years of age and who had persisting subclinical hypothyroidism (thyrotropin level, 4.60 to 19.99 mIU per liter; free thyroxine level within the reference range). A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 µg daily, or 25 µg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). RESULTS: The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. The mean (±SD) thyrotropin level was 6.40±2.01 mIU per liter at baseline; at 1 year, this level had decreased to 5.48 mIU per liter in the placebo group, as compared with 3.63 mIU per liter in the levothyroxine group (P<0.001), at a median dose of 50 µg. We found no differences in the mean change at 1 year in the Hypothyroid Symptoms score (0.2±15.3 in the placebo group and 0.2±14.4 in the levothyroxine group; between-group difference, 0.0; 95% confidence interval [CI], -2.0 to 2.1) or the Tiredness score (3.2±17.7 and 3.8±18.4, respectively; between-group difference, 0.4; 95% CI, -2.1 to 2.9). No beneficial effects of levothyroxine were seen on secondary-outcome measures. There was no significant excess of serious adverse events prespecified as being of special interest. CONCLUSIONS: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. (Funded by European Union FP7 and others; TRUST number, NCT01660126 .).

Hipotireoidismo/tratamento farmacológico , Tiroxina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Fadiga/etiologia , Feminino , Humanos , Hipotireoidismo/complicações , Análise de Intenção de Tratamento , Masculino , Qualidade de Vida , Tireotropina/sangue , Tiroxina/efeitos adversos , Tiroxina/sangue , Falha de Tratamento
Epidemiology ; 27(2): 276-83, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26605813


BACKGROUND: Physician's prescribing preference is increasingly used as an instrumental variable in studies of therapeutic effects. However, differences in prescribing patterns among physicians may reflect differences in preferences or in case-mix. Furthermore, there is debate regarding the possible assumptions for point estimation using physician's preference as an instrument. METHODS: A survey was sent to general practitioners (GPs) in The Netherlands, the United Kingdom, New Zealand, Ireland, Switzerland, and Germany, asking whether they would prescribe levothyroxine to eight fictitious patients with subclinical hypothyroidism. We investigated (1) whether variation in physician's preference was observable and to what extent it was explained by characteristics of GPs and their patient populations and (2) whether the data were compatible with deterministic and stochastic monotonicity assumptions. RESULTS: Levothyroxine prescriptions varied substantially among the 526 responding GPs. Between-GP variance in levothyroxine prescriptions (logit scale) was 9.9 (95% confidence interval: 8.0, 12) in the initial mixed effects logistic model, 8.3 (6.7, 10) after adding a fixed effect for country and 8.2 (6.6, 10) after adding GP characteristics. The occurring prescription patterns falsified the deterministic monotonicity assumption. All cases in all countries were more likely to receive levothyroxine if a different case of the same GP received levothyroxine, which is compatible with the stochastic monotonicity assumption. The data were incompatible with this assumption for a different definition of the instrument. CONCLUSIONS: Our study supports the existence of physician's preference as a determinant in treatment decisions. Deterministic monotonicity will generally not be plausible for physician's preference as an instrument. Depending on the definition of the instrument, stochastic monotonicity may be plausible.

Clínicos Gerais , Hipotireoidismo/tratamento farmacológico , Padrões de Prática Médica , Tiroxina/uso terapêutico , Feminino , Alemanha , Humanos , Irlanda , Modelos Logísticos , Masculino , Países Baixos , Nova Zelândia , Inquéritos e Questionários , Suíça , Reino Unido
Hypertens Res ; 38(8): 570-5, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25832917


Isolated nocturnal hypertension (INH) is associated with greater mortality and cardiovascular events. Subclinical target organ damage (TOD) is a prognostic marker for cardiovascular events. Our objective is to systematically summarize evidence on the association between INH and subclinical TOD. Observational population studies were considered. INH was defined as nighttime blood pressure (BP) ⩾120 and/or 70 mm Hg with daytime BP <135/85 mm Hg. We systematically searched Pubmed, EMBASE and the Cochrane Library. Abstracts were reviewed by two assessors. Potentially eligible articles were compared with inclusion criteria. The search yielded 954 titles, 13 abstracts were selected for review and four articles fulfilled inclusion criteria. INH was associated with higher ambulatory arterial stiffness index (0.4 unit vs. 0.35 unit, P<0.05), pulse wave velocity (16.2 m s(-1) vs. 14.7 m s(-1), P<0.05), central (140.4% vs. 134.0%, P<0.05) and peripheral (82.6% vs. 76.5%, P<0.01) augmentation index in a Chinese study. In the same population there was no association with left ventricular hypertrophy documented by electrocardiogram. INH was not associated with increased arterial stiffness or left venticular mass index in a Swedish study. An American study demonstrated higher left ventricular mass (152.46 g vs. 136.16 g, P=0.01) and greater odds of left ventricular hypertrophy (odds ratio 3.03, 95% confidence interval 1.02-9.05) in unadjusted analysis. There was no association with proteinuria. Evidence is inconclusive regarding the association between INH and subclinical TOD. Future research should focus on trying to elucidate the mechanisms that generate INH and contribute to the higher mortality associated with this BP pattern.

Pressão Sanguínea/fisiologia , Doenças Cardiovasculares/fisiopatologia , Ritmo Circadiano/fisiologia , Hipertensão/fisiopatologia , Monitorização Ambulatorial da Pressão Arterial , Humanos , Fatores de Risco
Br J Gen Pract ; 65(631): e121-32, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25624308


BACKGROUND: There is limited evidence about the impact of treatment for subclinical hypothyroidism, especially among older people. AIM: To investigate the variation in GP treatment strategies for older patients with subclinical hypothyroidism depending on country and patient characteristics. DESIGN AND SETTING: Case-based survey of GPs in the Netherlands, Germany, England, Ireland, Switzerland, and New Zealand. METHOD: The treatment strategy of GPs (treatment yes/no, starting-dose thyroxine) was assessed for eight cases presenting a woman with subclinical hypothyroidism. The cases differed in the patient characteristics of age (70 versus 85 years), vitality status (vital versus vulnerable), and thyroid-stimulating hormone (TSH) concentration (6 versus 15 mU/L). RESULTS: A total of 526 GPs participated (the Netherlands n = 129, Germany n = 61, England n = 22, Ireland n = 21, Switzerland n = 262, New Zealand n = 31; overall response 19%). Across countries, differences in treatment strategy were observed. GPs from the Netherlands (mean treatment percentage 34%), England (40%), and New Zealand (39%) were less inclined to start treatment than GPs in Germany (73%), Ireland (62%), and Switzerland (52%) (P = 0.05). Overall, GPs were less inclined to start treatment in 85-year-old than in 70-year-old females (pooled odds ratio [OR] 0.74 [95% confidence interval [CI] = 0.63 to 0.87]). Females with a TSH of 15 mU/L were more likely to get treated than those with a TSH of 6 mU/L (pooled OR 9.49 [95% CI = 5.81 to 15.5]). CONCLUSION: GP treatment strategies of older people with subclinical hypothyroidism vary largely by country and patient characteristics. This variation underlines the need for a new generation of international guidelines based on the outcomes of randomised clinical trials set within primary care.

Hipotireoidismo/tratamento farmacológico , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Inquéritos e Questionários , Tireotropina/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino
Qual Life Res ; 24(3): 769-80, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25194574


BACKGROUND AND PURPOSE: Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. METHODS: The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification. RESULTS: For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for. CONCLUSION: The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in international multicenter studies.

Comparação Transcultural , Avaliação de Resultados da Assistência ao Paciente , Qualidade de Vida/psicologia , Autorrelato , Doenças da Glândula Tireoide/terapia , Adulto , Cultura , Dinamarca , Feminino , Humanos , Índia , Itália , Linguagem , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Países Baixos , Satisfação Pessoal , Sérvia , Inquéritos e Questionários , Suécia , Doenças da Glândula Tireoide/diagnóstico , Traduções