RESUMEN
Up until now, differences in HbA1c levels by socio-economic status (SES) have been identified, but not yet quantified in people with type 2 diabetes. The aim of this study was therefore to assess the difference in HbA1c levels between people with type 2 diabetes of different SES in a systematic review and meta-analysis. A systematic literature search was conducted in MEDLINE, Embase, Ebsco, and the Cochrane Library until January 14, 2018. Included studies described adults with type 2 diabetes in whom the association between SES and HbA1c levels was studied. Studies were rated for methodological quality and data were synthesized quantitatively (meta-analysis) and qualitatively (levels of evidence), stratified for type of SES variable, i.e., education, income, deprivation, and employment. Fifty-one studies were included: 15 high, 27 moderate, and 9 of low methodological quality. Strong evidence was provided that people of low SES have higher HbA1c levels than people of high SES, for deprivation, education, and employment status. The pooled mean difference in HbA1c levels between people of low and high SES was 0.26% (95% CI, 0.09-0.43) or 3.12 mmol/mol (95% CI, 1.21-5.04) for education and 0.20% (95% CI, -0.05 to 0.46) or 2.36 mmol/mol (95%CI, -0.61 to 5.33) for income. In conclusion, our systematic review and meta-analysis showed that there was an inverse association between SES and HbA1c levels in people with type 2 diabetes. Future research should focus on finding SES-sensitive strategies to reduce HbA1c levels in people with type 2 diabetes.
Asunto(s)
Glucemia/metabolismo , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/epidemiología , Adulto , Glucemia/análisis , Diabetes Mellitus Tipo 2/economía , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Humanos , Clase Social , Factores SocioeconómicosRESUMEN
OBJECTIVES: In this exploratory study we examined the associations between several social network characteristics and lifestyle behaviours in adults at increased risk of diabetes and cardiovascular diseases. In addition, we explored whether similarities in lifestyle between individuals and their network members, or the level of social support perceived by these individuals, could explain these associations. METHODS: From the control group of the Hoorn Prevention Study, participants with high and low educational attainment were approached for a structured interview between April and August 2010. Inclusion was stopped when fifty adults agreed to participate. Participants and a selection of their network members (e.g. spouses, best friends, neighbours, colleagues) completed a questionnaire on healthy lifestyle that included questions on fruit and vegetable intake, daily physical activity and leisure-time sedentary behaviour. We first examined associations between network characteristics and lifestyle using regression analyses. Second, we assessed associations between network characteristics and social support, social support and lifestyle, and compared the participants' lifestyles to those of their network members using concordance correlation coefficients. RESULTS: Fifty adults (50/83 x 100 = 62% response) and 170 of their network members (170/192 x 100 = 89% response) participated in the study. Individuals with more close-knit relationships, more friends who live nearby, and a larger and denser network showed higher levels of vegetable consumption and physical activity, and lower levels of sedentary behaviour. Perceived social norms or perceived support for behavioural change were not related to healthy lifestyle. Except for spousal concordance for vegetable intake, the lifestyle of individuals and their network members were not alike. CONCLUSIONS: Study results suggest that adults with a larger and denser social network have a healthier lifestyle. Underlying mechanisms for these associations should be further explored, as the current results suggest a minimal role for social support and modelling by network members.
Asunto(s)
Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Diabetes Mellitus/epidemiología , Diabetes Mellitus/etiología , Estilo de Vida , Red Social , Adulto , Ejercicio Físico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Riesgo , Factores de Riesgo , Apoyo Social , Factores Socioeconómicos , Encuestas y CuestionariosRESUMEN
BACKGROUND: In 2010, a national integrated health care standard for (childhood) obesity was published and disseminated in the Netherlands. The aim of this study is to gain insight into the needs of health care providers and the barriers they face in terms of implementing this integrated health care standard. METHODS: A mixed-methods approach was applied using focus groups, semi-structured, face-to-face interviews and an e-mail-based internet survey. The study's participants included: general practitioners (GPs) (focus groups); health care providers in different professions (face-to-face interviews) and health care providers, including GPs; youth health care workers; pediatricians; dieticians; psychologists and physiotherapists (survey). First, the transcripts from the focus groups were analyzed thematically. The themes identified in this process were then used to analyze the interviews. The results of the analysis of the qualitative data were used to construct the statements used in the e-mail-based internet survey. Responses to items were measured on a 5-point Likert scale and were categorized into three outcomes: 'agree' or 'important' (response categories 1 and 2), 'disagree' or 'not important'. RESULTS: Twenty-seven of the GPs that were invited (51 %) participated in four focus groups. Seven of the nine health care professionals that were invited (78 %) participated in the interviews and 222 questionnaires (17 %) were returned and included in the analysis. The following key barriers were identified with regard to the implementation of the integrated health care standard: reluctance to raise the subject; perceived lack of motivation and knowledge on the part of the parents; previous negative experiences with lifestyle programs; financial constraints and the lack of a structured multidisciplinary approach. The main needs identified were: increased knowledge and awareness on the part of both health care providers and parents/children; a social map of effective intervention; structural funding; task rearrangements; a central care coordinator and structural information feedback from the health care providers involved. CONCLUSIONS: The integrated health care standard stipulate that the care of overweight or obese children be provided using an integrated approach. The barriers and needs identified in this study can be used to define strategies to improve the implementation of the integrated health care standard pertaining to overweight and obese children in the Netherlands.
Asunto(s)
Servicios de Salud del Niño/organización & administración , Grupos Focales , Padres , Obesidad Infantil/prevención & control , Derivación y Consulta/estadística & datos numéricos , Nivel de Atención , Adolescente , Adulto , Actitud del Personal de Salud , Niño , Servicios de Salud del Niño/normas , Correo Electrónico , Femenino , Médicos Generales , Humanos , Masculino , Países Bajos/epidemiología , Obesidad Infantil/epidemiología , Relaciones Profesional-Familia , Investigación CualitativaRESUMEN
OBJECTIVE: To use contingent valuation (CV) to derive individual consumer values for both health and broader benefits of a public-health intervention directed at lifestyle behaviour change (LBC) and to examine the feasibility and validity of the method. METHOD: Participants of a lifestyle intervention trial (n = 515) were invited to complete an online CV survey. Respondents (n = 312) expressed willingness to invest money and time for changes in life expectancy, health-related quality of life (HRQOL) and broader quality of life aspects. Internal validity was tested for by exploring associations between explanatory variables (i.e. income, paid work, experience and risk factors for cardiovascular diseases) and willingness to invest, and by examining ordering effects and respondents' sensitivity to the scope of the benefits. RESULTS: The majority of respondents (94.3%) attached value to benefits of LBC, and 87.4% were willing to invest both money and time. Respondents were willing to invest more for improvements in HRQOL (42/month; 3 h/week) and broader quality of life aspects (40/month; 2.6 h/week) than for improvements in life expectancy (24/month; 2 h/week). Protest answers were limited (3%) and findings regarding internal validity were mixed. CONCLUSION: The importance of broader quality of life outcomes to consumers suggests that these outcomes are relevant to be considered in the decision making. Our research showed that CV is a feasible method to value both health and broader outcomes of LBC, but generalizability to other areas of public health still needs to be examined. Mixed evidence regarding internal validity pleads for caution to use CV as only the base for decision making.
Asunto(s)
Comportamiento del Consumidor/economía , Análisis Costo-Beneficio/métodos , Conductas Relacionadas con la Salud , Estilo de Vida , Adulto , Toma de Decisiones , Femenino , Humanos , Internet , Esperanza de Vida , Masculino , Persona de Mediana Edad , Calidad de Vida , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
BACKGROUND: Sedentary time has been identified as an important and independent risk factor for the development of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) in adults. However, to date most studies have focused on TV time, few also included other sedentary behaviours such as computer use and reading, and most studies had a cross-sectional design. We aimed to examine the prospective relationship between time spent on sedentary behaviours in different domains with individual and clustered cardiometabolic risk in adults. METHODS: Longitudinal data of 622 adults aged 30-50 years (42% males) at increased cardiometabolic risk were used. Leisure time TV viewing, computer use, reading and other sedentary activities (e.g. passive transport) were assessed using a subscale of the Activity Questionnaire for Adolescents and Adults (AQuAA), and summed into overall sedentary behaviour (min/day). Weight and blood pressure were measured, waist-to-hip ratio and BMI calculated, and fasting plasma levels of glucose, HbA1c, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides determined. T2DM risk score was estimated according to the ARIC formula and CVD mortality risk according to the SCORE formula. RESULTS: Generalized Estimating Equation analysis demonstrated that over a two-year period higher levels of overall sedentary time and TV time were weakly but negatively associated with one out of 13 studied cardiometabolic risk factors (i.e. HDL cholesterol). CONCLUSION: Overall sedentary time, as well as sedentary time in different domains, was virtually not related with cardiometabolic risk factors.
Asunto(s)
Enfermedades Cardiovasculares/prevención & control , Conducta Sedentaria , Adulto , Biomarcadores/sangre , Glucemia/metabolismo , Presión Sanguínea , Índice de Masa Corporal , Peso Corporal , HDL-Colesterol/sangre , LDL-Colesterol/sangre , Computadores , Estudios Transversales , Diabetes Mellitus Tipo 2/prevención & control , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Actividades Recreativas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Lectura , Factores de Riesgo , Encuestas y Cuestionarios , Televisión , Triglicéridos/sangre , Circunferencia de la Cintura , Relación Cintura-CaderaRESUMEN
BACKGROUND: The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. METHODS: In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. RESULTS: Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher ( 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). CONCLUSIONS: Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. TRIAL REGISTRATION: Current Controlled trials: ISRCTN66124817.
Asunto(s)
Protocolos Clínicos , Diabetes Mellitus Tipo 2/terapia , Costos de la Atención en Salud/estadística & datos numéricos , Recursos en Salud/estadística & datos numéricos , Programas Controlados de Atención en Salud/organización & administración , Atención Primaria de Salud/organización & administración , Anciano , Femenino , Humanos , Masculino , Programas Controlados de Atención en Salud/economía , Programas Controlados de Atención en Salud/estadística & datos numéricos , Países Bajos , Selección de Paciente , Atención Primaria de Salud/economía , Atención Primaria de Salud/estadística & datos numéricos , Calidad de la Atención de SaludRESUMEN
BACKGROUND: Social and physical environments are important drivers of socioeconomic inequalities in health behaviour. Although many interventions aiming to improve such environments are being implemented in underprivileged neighbourhoods, implementation processes are rarely studied. Acquiring insight into successful implementation may improve future interventions. The present study aimed to investigate factors influencing the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of social and physical environmental interventions aimed at promoting healthy behaviour in underprivileged neighbourhoods in The Netherlands. METHODS: A large set of theory-based factors of successful implementation was assessed for 18 implemented interventions in three underprivileged neighbourhoods. Expert and target group panels scored the RE-AIM dimensions for each intervention. We analyzed the statistical significance of associations between theory-based factors and the actual RE-AIM in a statistical model, to identify factors associated with increased RE-AIM. RESULTS: Six factors were identified: effectiveness and implementation success were higher when the target group was involved in the planning process, whereas maintenance increased in the absence of competition with other projects. If the current situation was inventoried during intervention development, the effectiveness, adoption and implementation were higher. These dimensions were also higher when the target group was informed before implementation. Involvement of the target group during implementation resulted in higher reach, effectiveness and adoption. Finally, lack of intervention staff worsened the reach. DISCUSSION: This study contributes to the evidence base for effective implementation of environmental measures aimed at promoting healthy behaviours. In particular, interventions in which the target group was involved in the implementation process were associated with higher RE-AIM outcomes.
Asunto(s)
Planificación Ambiental , Conductas Relacionadas con la Salud , Promoción de la Salud , Clase Social , Femenino , Humanos , Masculino , Pobreza , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To investigate risk of a recurrent cardiovascular event and its predictors in a population-based cohort. RESEARCH DESIGN AND METHODS: Participants of the Hoorn Study who had experienced a first cardiovascular event after baseline (n = 336) were followed with respect to a recurrent event. Absolute risk of a recurrent event was calculated for individuals with normal glucose metabolism, intermediate hyperglycemia, and type 2 diabetes. Cox regression models were used to investigate which variables, measured before the first vascular event, predicted a recurrent event using the stepwise backward procedure. RESULTS: During a median follow-up of 4.1 years, 44% (n = 148) of the population developed a recurrent vascular event. The rate of recurrent events per 100 person-years was 7.2 (95% CI 5.8-8.7) in individuals with normal glucose metabolism, compared with 9.8 (6.6-14.0) in individuals with intermediate hyperglycemia and 12.5 (8.5-17.6) in individuals with type 2 diabetes. Higher age (hazard ratio 1.02 [95% CI 1.00-1.04]), male sex (1.56 [1.08-2.25]), waist circumference (1.02 [1.02-1.03]), higher systolic blood pressure (1.01 [1.01-1.02]), higher HbA1c (%, 1.13 [0.97-1.31]/ mmol/mol, 1.01 [1.00-1.03]), and family history of myocardial infarction (1.38 [0.96-2.00]) predicted a recurrent cardiovascular event. CONCLUSIONS: Individuals with type 2 diabetes, but not individuals with intermediate hyperglycemia, are at increased risk for a recurrent vascular event compared with individuals with normal glucose metabolism. In people with a history of cardiovascular disease, people at increased risk of a recurrent event can be identified based on the patient's risk profile before the first event.
Asunto(s)
Enfermedades Cardiovasculares/epidemiología , Diabetes Mellitus Tipo 2/epidemiología , Hiperglucemia/epidemiología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Modelos de Riesgos Proporcionales , Recurrencia , RiesgoRESUMEN
OBJECTIVE: This study set out to assess the short- and long-term effects of a primary care-based lifestyle intervention on different domains of leisure-time sedentary behaviors in Dutch adults at risk of type 2 diabetes and cardiovascular diseases. METHODS: Between 2007 and 2009, adults (n=622) at risk were randomly assigned to a counseling intervention aimed at adopting healthy lifestyle behaviors, or a control group that only received health brochures. Follow-up measures were done after 6, 12 and 24months. Linear regression analysis was used to examine between-group differences in self-report minutes per day sedentary behaviors, adjusted for baseline values. Stratified analyses were performed for sex and educational attainment. RESULTS: Seventy-nine percent (n=490) of participants completed the last follow-up. Mean baseline sedentary behaviors were 254.6min per day (SD=136.2). Intention-to-treat analyses showed no significant differences in overall or domain-specific sedentary behaviors between the two groups at follow-up. Stratified analyses for educational attainment revealed a small and temporary between-group difference in favor of the intervention group, in those who finished secondary school. CONCLUSIONS: A primary care-based general lifestyle intervention was not more effective in reducing leisure-time sedentary behaviors than providing brochures in adults at risk for chronic diseases.
Asunto(s)
Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/prevención & control , Actividades Recreativas , Conducta de Reducción del Riesgo , Conducta Sedentaria , Adulto , Consejo/métodos , Femenino , Humanos , Actividades Recreativas/psicología , Masculino , Persona de Mediana Edad , Atención Primaria de Salud/métodos , Factores de RiesgoRESUMEN
BACKGROUND: Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases, addressing 'real-world' implementation, are needed. This study examines the cost-effectiveness of a primary care intervention from a societal perspective, compared with provision of health brochures, alongside a randomized controlled trial. METHODS: Adults aged 30-50 years, at risk of type 2 diabetes (T2DM) and/or cardiovascular disease (CVD), were recruited from twelve general practices in The Netherlands. They were randomized to the intervention (n = 314) or control group (n = 308). The intervention consisted of up to six face-to-face counseling sessions with a trained practice nurse, followed by three-monthly sessions by phone. Costs were collected using three-monthly retrospective questionnaires. Quality of life was measured with the EuroQol-5D-3L, at baseline, 6, 12 and 24 months. Nine-year risk of developing T2DM and ten-year risk of CVD mortality were estimated using the ARIC and SCORE formulae, respectively, based on measurements at baseline and 24 months while applying a fixed age of 60 years at both time points. RESULTS: Small, statistically non-significant differences in effects were found between the intervention and control group with regard to risk scores and Quality Adjusted Life Years (QALYs) gained. The mean difference in costs between the intervention and control group was -866 (95% confidence interval -2372; 370). The probability that the intervention was cost-effective varied from 93% at 8000/QALY to 88% at 80,000/QALY. CONCLUSION: A primary care lifestyle intervention aimed at adults at increased risk of T2DM and/or CVD could result in cost savings over a two-year period. However, due to methodological uncertainty no advice can be given regarding the implementation of the intervention in Dutch general practices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59358434.
Asunto(s)
Enfermedades Cardiovasculares/prevención & control , Costo de Enfermedad , Diabetes Mellitus Tipo 2/prevención & control , Promoción de la Salud/economía , Atención Primaria de Salud , Adulto , Enfermedades Cardiovasculares/economía , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/economía , Consejo Dirigido , Costos de los Medicamentos , Femenino , Conductas Relacionadas con la Salud , Servicios de Salud/economía , Servicios de Salud/estadística & datos numéricos , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Países Bajos , Folletos , Educación del Paciente como Asunto/economía , Atención Primaria de Salud/economía , Calidad de Vida , Años de Vida Ajustados por Calidad de VidaRESUMEN
BACKGROUND: Intensive lifestyle interventions in well-controlled settings are effective in lowering the risk of chronic diseases such as type 2 diabetes (T2DM) and cardiovascular diseases (CVD), but there are still no effective lifestyle interventions for everyday practice. In the Hoorn Prevention Study we aimed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality, and to motivate changes in lifestyle behaviors. METHODS: The Hoorn Prevention Study is a parallel group randomized controlled trial, implemented in the region of West-Friesland, the Netherlands. 622 adults with ≥10% estimated risk of T2DM and/or CVD mortality were randomly assigned and monitored over a period of 12 months. The intervention group (n=314) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment, provided by trained practice nurses in 12 general practices. The control group (n=308) received existing health brochures. Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities (ARIC) Study, and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation (SCORE) formula. Secondary outcomes included lifestyle behavior (diet, physical activity and smoking). The research assistants, the principal investigator and the general practitioners were blinded to group assignment. Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure, adjusted for baseline values. RESULTS: 536 (86.2%) of the 622 participants (age 43.5 years) completed the 6-month follow-up, and 502 (81.2%) completed the 12-month follow-up. The mean baseline T2DM risk was 18.9% (SD 8.2) and the mean CVD mortality risk was 3.8% (SD 3.0). The intervention group participated in a median of 2 sessions. Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up. CONCLUSIONS: The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN59358434.
Asunto(s)
Enfermedades Cardiovasculares/terapia , Diabetes Mellitus Tipo 2/terapia , Conductas Relacionadas con la Salud , Promoción de la Salud/métodos , Estilo de Vida , Entrevista Motivacional/métodos , Solución de Problemas , Adulto , Enfermedades Cardiovasculares/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Análisis de Intención de Tratar , Modelos Lineales , Modelos Logísticos , Masculino , Persona de Mediana Edad , Motivación , Países Bajos , Atención Primaria de Salud , Riesgo , Factores de Riesgo , Método Simple CiegoRESUMEN
OBJECTIVE: Health promotion (HP) interventions have outcomes that go beyond health. Such broader nonhealth outcomes are usually neglected in economic evaluation studies. To allow for their consideration, insights are needed into the types of nonhealth outcomes that HP interventions produce and their relative importance compared with health outcomes. This study explored consumer preferences for health and nonhealth outcomes of HP in the context of lifestyle behavior change. METHODS: A discrete choice experiment was conducted among participants in a lifestyle intervention (n = 132) and controls (n = 141). Respondents made 16 binary choices between situations that can be experienced after lifestyle behavior change. The situations were described by 10 attributes: future health state value, start point of future health state, life expectancy, clothing size above ideal, days with sufficient relaxation, endurance, experienced control over lifestyle choices, lifestyle improvement of partner and/or children, monetary cost per month, and time cost per week. RESULTS: With the exception of "time cost per week" and "start point of future health state," all attributes significantly determined consumer choices. Thus, both health and nonhealth outcomes affected consumer choice. Marginal rates of substitution between the price attribute and the other attributes revealed that the attributes "endurance," "days with sufficient relaxation," and "future health state value" had the greatest impact on consumer choices. The "life expectancy" attribute had a relatively low impact and for increases of less than 3 years, respondents were not willing to trade. CONCLUSIONS: Health outcomes and nonhealth outcomes of lifestyle behavior change were both important to consumers in this study. Decision makers should respond to consumer preferences and consider nonhealth outcomes when deciding about HP interventions.
Asunto(s)
Conducta de Elección , Conductas Relacionadas con la Salud , Promoción de la Salud/métodos , Evaluación de Resultado en la Atención de Salud/métodos , Prioridad del Paciente , Adulto , Toma de Decisiones , Femenino , Estado de Salud , Humanos , Esperanza de Vida , Estilo de Vida , Masculino , Persona de Mediana EdadRESUMEN
Effects of a cognitive behavioural treatment (CBT) in type 2 diabetes patients were studied in a randomised controlled trial. Patients were recruited from a diabetes care system (DCS). The intervention group (n = 76) received managed care from the DCS and CBT. The control group (n = 78) received managed care only. Effects on risk of developing coronary heart disease (CHD), clinical characteristics, lifestyle, determinants of behaviour change, quality of life, and depression were assessed after 6 and 12 months. The intervention did not result in a significant reduction of CHD risk (difference between intervention and control group was -0.32 % (95 % CI: -2.27; 1.63). The amount of heavy physical activity increased significantly in the intervention group at 6 months [intervention versus control group was 20.14 min/day (95 % CI: 4.6; 35.70)]. Quality of life and level of depression improved as well. All effects disappeared after 6 months. No effects were found on clinical characteristics.
Asunto(s)
Terapia Cognitivo-Conductual , Enfermedad Coronaria/etiología , Diabetes Mellitus Tipo 2/terapia , Programas Controlados de Atención en Salud , Calidad de Vida/psicología , Adulto , Anciano , Depresión , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/psicología , Femenino , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Riesgo , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
Given the importance of glycemic control in the development of diabetes complications, the plethora of tools now available to monitor the day-to-day trends in glycemia is remarkable. In this regard, self-monitoring of blood glucose (SMBG) has been considered a key component of patient management. Arguably, there remains almost universal agreement that SMBG should be available to all diabetic patients regardless of current treatment strategy. However, recently there have been reports that have challenged the current paradigm that all patients should use SMBG and concluded that SMBG for type 2 diabetic patients not on insulin may not be beneficial on glycemic control and must be weighed against the expense and inconvenience. In this two-part point-counterpoint narrative, Malanda et al. and Polonsky and Fisher take opposing views on the utility of SMBG to be valuable for individuals with type 2 diabetes not using insulin. In the narrative below, Malanda et al. suggest that the evidence for potentially beneficial SMBG-induced effects on glycemic control, hypoglycemic periods, and potential harms in type 2 diabetic patients who are not treated with insulin does not justify the use of SMBG. Moreover, the use of SMBG is associated with huge costs, which should be better redirected to effective strategies to improve health for this category of patients. -William T. Cefalu, MD Editor in Chief, Diabetes Care.
Asunto(s)
Automonitorización de la Glucosa Sanguínea , Glucemia/análisis , Diabetes Mellitus Tipo 2/sangre , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , HumanosRESUMEN
OBJECTIVE: Patients with type 2 diabetes mellitus (T2DM) underestimate their risk of developing severe complications, and they do not always understand the risk communication by their caregivers. The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease (CVD) in patients with T2DM. RESEARCH DESIGN AND METHODS: A randomized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System (DCS) West-Friesland, a managed-care system in the Netherlands. The intervention group (n = 131) received a six-step CVD risk communication. Control subjects (n = 130) received standard managed care. The primary outcome measure was appropriateness of risk perception (difference between actual CVD risk calculated by the UK Prospective Diabetes Study risk engine and risk perception). Secondary outcome measures were illness perceptions, attitude and intention to change behavior, satisfaction with the communication, and anxiety and worry about CVD risk. Patients completed questionnaires at baseline, at 2 weeks (immediately after the intervention), and at 12 weeks. RESULTS: Appropriateness of risk perception improved between the intervention and control groups at 2 weeks. This effect disappeared at 12 weeks. No effects were found on illness perceptions, attitude and intention to change behavior, or anxiety and worry about CVD risk. Patients in the intervention group were significantly more satisfied with the communication. CONCLUSIONS: This risk communication method improved patients' risk perception at 2 weeks but not at 12 weeks. Negative effects were not found, as patients did not become anxious or worried after the CVD risk communication.
Asunto(s)
Enfermedades Cardiovasculares/etiología , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/psicología , Enfermedades Cardiovasculares/epidemiología , Comunicación , Diabetes Mellitus Tipo 2/epidemiología , Humanos , Países Bajos , Percepción/fisiologíaRESUMEN
OBJECTIVE: To provide insights into health promotion outcomes that are not captured by conventional measures of health outcome used in economic evaluation studies, such as EQ5D based QALYs. METHODS: Twelve semi-structured interviews and five focus group discussions were conducted with participants of a randomized controlled trial (n=52) evaluating the effectiveness of a theory-based lifestyle intervention in Dutch adults at risk for diabetes mellitus and/or cardiovascular disease. Transcripts were analysed by two independent researchers using a thematic analysis approach. RESULTS: In total we identified twelve non-health outcome themes that were important from the participant perspective. Four of these were reported as direct outcomes of the lifestyle intervention and eight were reported as consequences of lifestyle behaviour change. Our findings also suggest that lifestyle behaviour change may have spillover effects to other people in the participants' direct environment. CONCLUSION: This study provides evidence that in the context of lifestyle behaviour change EQ5D based QALYs capture health promotion outcomes only partially. More insights are needed into non-health outcomes and spillover effects produced by health promotion in other contexts and how participants and society value these. Methods to account for these outcomes within an economic evaluation framework need to be developed and tested.
Asunto(s)
Promoción de la Salud , Conducta de Reducción del Riesgo , Adulto , Imagen Corporal , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus/prevención & control , Femenino , Grupos Focales , Conductas Relacionadas con la Salud , Conocimientos, Actitudes y Práctica en Salud , Promoción de la Salud/estadística & datos numéricos , Humanos , Relaciones Interpersonales , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Motivación , Evaluación de Resultado en la Atención de Salud , Satisfacción PersonalRESUMEN
BACKGROUND: Self-monitoring of blood glucose (SMBG) has been found to be effective for patients with type 1 diabetes and for patients with type 2 diabetes using insulin. There is much debate on the effectiveness of SMBG as a tool in the self-management for patients with type 2 diabetes who are not using insulin. OBJECTIVES: To assess the effects of SMBG in patients with type 2 diabetes mellitus who are not using insulin. SEARCH METHODS: Multiple electronic bibliographic and ongoing trial databases were searched supplemented with handsearches of references of retrieved articles (date of last search: 07 July 2011). SELECTION CRITERIA: Randomised controlled trials investigating the effects of SMBG compared with usual care, self-monitoring of urine glucose (SMUG) or both in patients with type 2 diabetes who where not using insulin. Studies that used glycosylated haemoglobin A(1c) (HbA(1c)) as primary outcome were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from included studies and evaluated the studies' risk of bias. Data from the studies were compared to decide whether they were sufficiently homogeneous to pool in a meta-analysis. Primary outcomes were HbA(1c), health-related quality of life, well-being and patient satisfaction. Secondary outcomes were fasting plasma glucose level, hypoglycaemic episodes, morbidity, adverse effects and costs. MAIN RESULTS: Twelve randomised controlled trials were included and evaluated outcomes in 3259 randomised patients. Intervention duration ranged from 6 months (26 weeks) to 12 months (52 weeks). Nine trials compared SMBG with usual care without monitoring, one study compared SMBG with SMUG, one study was a three-armed trial comparing SMBG and SMUG with usual care and one study was a three-armed trial comparing less intensive SMBG and more intensive SMBG with a control group. Seven out of 11 studies had a low risk of bias for most indicators. Meta-analysis of studies including patients with a diabetes duration of one year or more showed a statistically significant SMBG induced decrease in HbA(1c) at up to six months follow-up (-0.3; 95% confidence interval (CI) -0.4 to -0.1; 2324 participants, nine trials), yet an overall statistically non-significant SMBG induced decrease was seen at 12 month follow-up (-0.1; 95% CI -0.3 to 0.04; 493 participants, two trials). Qualitative analysis of the effect of SMBG on well-being and quality of life showed no effect on patient satisfaction, general well-being or general health-related quality of life. Two trials reported costs of self-monitoring: One trial compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. Authors concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another trial reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. Higher losses to follow-up in the more intensive self-monitoring group were responsible for the difference in costs, compared to the less intensive self-monitoring group.There were few data on the effects on other outcomes and these effects were not statistically significant. None of the studies reported data on morbidity. AUTHORS' CONCLUSIONS: From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications.
Asunto(s)
Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 2/sangre , Automonitorización de la Glucosa Sanguínea/métodos , Diabetes Mellitus Tipo 2/orina , Humanos , Hiperglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: We developed the Determinants of Lifestyle Behavior Questionnaire (DLBQ) to measure determinants of lifestyle behavioral change according to the Theory of Planned Behavior (TPB) in adults at high risk of diabetes type 2 (T2DM) and cardiovascular diseases (CVD). The aim of the current study was to test the validity of the DLBQ. METHODS: From February to September 2008, a cross-sectional survey was conducted in the region West-Friesland (The Netherlands) among 622 adults, aged 30-50 years at high risk of T2DM or CVD participating in a lifestyle intervention trial. Structural equation modeling techniques were used for confirmatory factor analysis and to test correlations between the TPB constructs. RESULTS: The results demonstrate the factorial validity of the DLBQ in this population. The theoretical factor structure of the DLBQ is supported, and 41-56% of the variance in intentions to improve lifestyle behaviors is explained. CONCLUSIONS: The DLBQ proves to be a valid instrument for measuring important determinants of the intention to change three lifestyle behaviors in adults at high risk of T2DM and CVD. PRACTICE IMPLICATIONS: The identified 'key-determinants' of the TPB that seem to contribute to an increased intention to change behavior could be of value in designing future lifestyle interventions.
Asunto(s)
Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/prevención & control , Conductas Relacionadas con la Salud , Estilo de Vida , Prevención Primaria , Encuestas y Cuestionarios , Adulto , Estudios Transversales , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países BajosRESUMEN
BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe diabetes related complications, especially cardiovascular disease (CVD). The risk to develop CVD can be estimated by means of risk formulas. However, patients have difficulties to understand the outcomes of these formulas. As a result, they may not recognize the importance of changing lifestyle and taking medication in time. Therefore, it is important to develop risk communication methods, that will improve the patients' understanding of risks associated with having diabetes, which enables them to make informed choices about their diabetes care.The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory. METHODS: A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group. DISCUSSION: This innovative risk communication method based on two behavioural theories might improve patient's appropriateness of risk perception and attitude concerning lifestyle change. With a better understanding of their CVD risk, patients will be able to make informed choices concerning diabetes care. TRIAL REGISTRATION: The trial is registered as NTR1556 in the Dutch Trial Register.
Asunto(s)
Comunicación , Diabetes Mellitus Tipo 2/complicaciones , Proyectos de Investigación , Medición de Riesgo , Enfermedades Cardiovasculares/etiología , Femenino , Humanos , Masculino , Países Bajos , Conducta de Reducción del Riesgo , Encuestas y CuestionariosRESUMEN
BACKGROUND: Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM). Possibly, offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients' belief they are able to manage their illness. It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy. METHODS AND DESIGN: Six hundred patients with T2DM (45 < or = 75 years) who receive care in a structured diabetes care system, HbA1c > or = 7.0%, and not using insulin will be recruited and randomized into 3 groups; Self-monitoring of Blood Glucose (SMBG), Self-monitoring of Urine Glucose (SMUG) and usual care (n = 200 per group). Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year. All 3 groups will receive standardized diabetes care. The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results. Main outcome measures are changes in diabetes specific emotional distress and self-efficacy. Secondary outcome measures include difference in HbA1c, patient satisfaction, occurrence of hypoglycaemia, physical activity, costs of direct and indirect healthcare and changes in illness beliefs. DISCUSSION: The IN CONTROL-trial is designed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy. Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions, guiding the patient to reduce emotional responses to experienced threats, and influences the patients ability to perform and maintain self-management skills.