Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

[Evidence based comparative analysis for managing osteoporosis in a primary health care setting]. / Análisis comparativo frente a la evidencia del manejo de la osteoporosis en una comarca de atención primaria.

OBJECTIVE: To find out how physicians are managing osteoporosis in a primary care setting. DESIGN: Cross-sectional study. CONTEXT: Primary care setting with a target population of 276,000 inhabitants, grouped into 9 basic health areas, Spain. PARTICIPANTS: Women older than 45 years old on treatments for osteoporosis. INTERVENTIONS: Standardised questionnaire self-filled in by women and compared with clinical records. MAIN MEASUREMENTS: Suitability of the indication of diagnostic tests, proportion of treatments supported by diagnostic tests and according to evidence. RESULTS: The mean age of the sample was 65.3 (9.6) years. Of the women included, 73.2% (n=243) had an indication for densitometry and only 60.2% (n=200) of them had this performed. The results of the densitometries were: 14% (n=28) normal, 31% (n=62) osteopenia and 55% (n=110) osteoporosis. Based on risk factors, in those women with densitometry indication, 39.5% (n=96) did not have it performed. In those women with no risk factors to justify the indication of densitometry (n=89), 59.6% (n=53) did have it performed. The two-year follow densitometry was not carried out on 78.7% (n=261) of women. Statistically significant differences were observed in the percentages of adequacy of the indications of densitometry and in the percentages of adequacy of the treatments in the different medical specialities analyzed (P < .05). Of the women who had densitometry, 42.4% (n=81) were inadequately treated. CONCLUSIONS: The indication of densitometry is clearly improvable and there is a high variability in its adequacy in all the medical specialities studied. To a great extent, the indication of treatments for osteoporosis is not based on densitometry and is against the recommendations of the evidence based studies recently published.

Análisis comparativo frente a la evidencia del manejo de la osteoporosis en una comarca de atención primaria / Evidence based comparative analysis for managing osteoporosis in a primary health care setting

Objetivo. Conocer la adecuación a las guías de práctica clínica del proceso diagnóstico y terapéutico de la osteoporosis en una comarca. Diseño. Estudio transversal. Emplazamiento. Comarca de 276.000 habitantes, agrupada en 9 centros de salud. Participantes. Mujeres mayores de 45 años con prescripción de fármacos para la osteoporosis. Intervenciones. Cuestionario estandarizado rellenado por las pacientes y contrastadocon las historias clínicas. Mediciones principales. Adecuación de la indicación de pruebas diagnósticas, proporción de tratamientos soportados en criterios diagnósticos y ajuste de dichos tratamientos a la evidencia. Resultados. Analizamos a 332 mujeres cuya media de edad fue 65,3 ± 9,6 años. De las mujeres analizadas, el 73,2% (n = 243) tenía indicación de densitometría y sólo el 60,2% (n = 200) la había realizado. El resultado de las densitometrías fue: el 14% (n = 28),normal; el 31% (n = 62), osteopenia, y el 55% (n = 110), osteoporosis. Entre las mujeres con indicación de densitometría, el 39,5% (n = 96) no la había realizado. Entre las mujeres sin factores de riesgo y sin indicación de densitometría (n = 89), el 59,6% (n = 53)la había realizado. Por otro lado, el 78,7% (n = 261) de las mujeres no tenía una densitometría de control. Hubo diferencias estadísticamente significativas (p < 0,05) en la adecuación de las indicaciones de densitometría y de los tratamientos entre las diferentes especialidades. Finalmente,el 42,4% (n = 81) de las mujeres con prueba densitométrica realizada estaban inadecuadamente tratadas. Conclusiones. La indicación de densitometría es claramente mejorable y hay una altavariabilidad en su adecuación en todas las especialidades. La prescripción para la osteoporosis en gran medida no está sustentada en pruebas diagnósticas y se contrapone a los estudios de calidad publicados recientemente (AU)

Objective. To find out how physicians are managing osteoporosis in a primary care setting. Design. Cross-sectional study. Context. Primary care setting with a target population of 276 000 inhabitants, grouped into 9 basic health areas, Spain. Participants. Women older than 45 years old on treatments for osteoporosis. Interventions. Standardised questionnaire self-filled in by women and compared with clinical records. Main measurements. Suitability of the indication of diagnostic tests, proportion of treatments supported by diagnostic tests and according to evidence. Results. The mean age of the sample was 65.3 (9.6) years. Of the women included, 73.2% (n=243) had an indication for densitometry and only 60.2% (n=200) of them had this performed. The results of the densitometries were: 14% (n=28) normal, 31% (n=62) osteopenia and 55% (n=110) osteoporosis. Based on risk factors, in those women with densitometry indication, 39.5% (n=96) did not have it performed. In those women with no risk factors to justify the indication of densitometry (n=89), 59.6% (n=53) did have it performed. The two-year follow densitometry was not carried out on 78.7% (n=261) of women. Statistically significant differences were observed in the percentages of adequacy of the indications of densitometry and in the percentages of adequacy of the treatments in the different medical specialities analyzed (P<.05). Of the women who had densitometry, 42.4% (n=81) were inadequately treated. Conclusions. The indication of densitometryis clearly improvable and there is a high variability in its adequacy in all the medical specialities studied. To a great extent, the indication of treatments for osteoporosisis not based on densitometry and is against the recommendations of the evidence based studies recently published (AU)

[Predictive value of ultra-sound densitometry as a method of selective screening for osteoporosis in primary care]. / Valor predictivo de la densitometría por ultrasonidos como método de cribado selectivo de la osteoporosis en atención primaria.

OBJECTIVE: To determine the cut-off point of calcaneous quantitative ultrasound densitometry (QUS) as a selection method in primary care for referral of postmenopausal women for dual energy x-ray absorptiometry (DXA). DESIGN: Diagnostic techniques trial. SETTING: Four general practices in the Basque Country Autonomous Region, Spain. PARTICIPANTS: Randomly selected Caucasian women older than 45, chosen at random. A sample size of 146 women was used. INTERVENTIONS: Calcaneous ultrasound bone mineral density (BMD) measurement, using Achilles Express(R) and DXA. PRINCIPAL MEASUREMENTS: T-score BMD measurement on both devices. The sensitivity, specificity and positive predictive values of QUS and finally the ideal cut-off value were calculated. RESULTS: The mean age of the sample was 58.2 (17.7) (range, 48-83 years old). The prevalence of women with osteoporosis, osteopaenia and normal DXA was 14.1%, 50.4% and 35.5%, respectively. The estimated sensitivity of QUS was 78.9% (56.7-91.5) and the specificity was 64.7% (55.6-72.8). The negative predictive value (NPV) was 94.9% (87.7-98.0) and the positive predictive value (PPV) was 26.8% (17.0-39.6). After the COR curve analysis, the ideal cut-off for QUS was determined as a T-score

Prevalencia de cierto hábitos determinantes de osteoporosis en mujeres postmenopausicas del País Vasco en 2003 / Prevalence of certain osteoporosis-determining habits among post menopausal women in the Basque Country, Spain, in 2003

Fundamento: Al planificar estrategias de promoción de lasalud sobre una patología o condición es necesario conocer elestado de situación de los factores que influyen sobre lamisma. El objetivo de este trabajo es analizar en el País Vasco(PV) los hábitos de vida que interactúan para regular el picomáximo de densidad ósea en mujeres postmenopáusicas.Métodos: El estudio se realizó entre febrero y mayo de 2003en una muestra de 555 mujeres mayores de 45 años escogidas demanera aleatoria en el País Vasco. El 82,8% de ellas respondieronuna encuesta de hábitos de vida y una encuesta dietética derecuerdo de tres días. Se realizó un estudio descriptivo de tendenciacentral para variables cuantitativas y de frecuencias para variablescualitativas. Se comparó la prevalencia entre grupos seleccionadosmediante test de chi-cuadrado y test de la "t" de Student.Resultados: el 27,4% de las mujeres estudiadas eranmayores de 65 años (edad media 58,51). El 40% de las mujeresrealizaban ejercicio físico de forma activa. El 4,1% de lasmujeres tenían una exposición solar ocasional o excepcional.La ingestión media de calcio fue de 788,17 mg/día(DEM=218,35). El 0,3% tenían consumo de alcohol de riesgoy 14,7% consumo moderado. En cuanto al consumo de tabacoel 12,6% de las mujeres de la muestra fumaban menos de unpaquete al día y 3,5% más de un paquete al día.Conclusiones: Las mujeres estudiadas presentaban comofactores de riesgo para padecer osteoporosis un bajo nivel deejercicio activo, baja ingestión de calcio y en las menores de65 años un mayor consumo de tabaco(AU)

Backgound: On planning health promotion strategies fora disease or condition, one must know the current situation ofthe factors which have a bearing thereon. This study is aimedat analyzing, in the Basque Country, those living habits whichinteract to control the maximum bone density peak inpostmenopausal women.Methods: This study was conducted in February-May 2003on a sample of 555 women over 45 years of age selected atrandom in the Basque Country. A total of 82.8% thereofanswered a living habit survey and a three-day recall diet survey.A descriptive core trend study was made for quantitativevariable and frequencies for qualitative variables. A comparisonwas drawn between the prevalence among groups selected byway of the chi-square test and Student's t-test.Results: A total of 27.4% of the women studied were over65 years of age (average age 58.51). Forty percent (40%) ofthe women were actively involved in physical exercise. A totalof 4.1% of the women had sun exposure occasionally orexceptionally. The average calcium intake was 788.17 mg/day(SD=218.35). A total 0.3% had risk-level alcohol consumptionand 14.7% moderate consumption. In relation to smoking,12.6% of the women in the sample smoked less than a pack aday, and 3.5% more than one pack a day.Conclusions: The women studied showed as risk factorsfor having osteoporosis: a low level of active exercise, lowcalcium intake and in those women younger that 65 years ofage and high degree of smoking(AU)

[Prevalence of certain osteoporosis-determining habits among post menopausal women in the Basque Country, Spain, in 2003]. / Prevalencia de ciertos hábitos determinantes de osteoporosis en mujeres postmenopáusicas del País Vasco en 2003.

BACKGROUND: [corrected] On planning health promotion strategies for a disease or condition, one must know the current situation of the factors which have a bearing thereon. This study is aimed at analyzing, in the Basque Country, those living habits which interact to control the maximum bone density peak in postmenopausal women. METHODS: This study was conducted in February-May 2003 on a sample of 555 women over 45 years of age selected at random in the Basque Country. A total of 82.8% thereof answered a living habit survey and a three-day recall diet survey. A descriptive core trend study was made for quantitative variable and frequencies for qualitative variables. A comparison was drawn between the prevalence among groups selected by way of the chi-square test and Student's t-test. RESULTS: A total of 27.4% of the women studied were over 65 years of age (average age 58.51). Forty percent (40%) of the women were actively involved in physical exercise. A total of 4.1% of the women had sun exposure occasionally or exceptionally. The average calcium intake was 788.17 mg/day (SD=218.35). A total 0.3% had risk-level alcohol consumption and 14.7% moderate consumption. In relation to smoking, 12.6% of the women in the sample smoked less than a pack a day, and 3.5% more than one pack a day. CONCLUSIONS: The women studied showed as risk factors for having osteoporosis: a low level of active exercise, low calcium intake and in those women younger that 65 years of age and high degree of smoking.

Entre el consenso y la evidencia científica / Between consensus and scientific evidence

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[Assessment of clinical practice guidelines evaluation. Scales and criteria]. / Valoración de escalas y criterios para la evaluación de Guías de Práctica Clínica.

Not only are there large number of guides, protocols and other support tools available for the clinical decision-making process in the Spanish National Health System, but there is also a major degree of variability among them, reflecting inconsistencies and low quality of those documents. This study is aimed at conducting all inventory of the Clinical Practice Guideline assessment scales and clinical analysis tools and to propose a scale or set of criteria for assessing the quality of the Clinical Practice Guidelines put out in Spain. A systematic search of critical evaluation scales was conducted. The inclusion criteria and the concordance analysis of the items by three evaluators were independently applied. The discordances were resolved by explicit consensus. Ten suggested critical assessment scales and sets of criteria from eleven institutions were identified, eight of which consist of scales and tools proposed for assessing the quality of the Clinical Practice Guidelines, the other two being proposals for assessing the implementation and inclusion of the Clinical Practice Guidelines in a register. In the comparative analysis, the criteria most often repeated on the scales analysed were related to the areas included in the AGREE Instrument. The areas considered in most of the critical assessment scales were the same as those of the AGREE Instrument. Although this tool does not take in criteria for guide implementation assessment purposes, it is considered suitable for use in the assessment prior to inclusion to the national CPG register.