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1.
F1000Res ; 8: 1041, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31656589

RESUMEN

Background: The development of clinical practice guidelines (CPGs) has increasing global growth; however, the certainty of impact on patients and health systems, as well as the magnitude of the impact, is not apparent. The objective of this systematic review was to assess the effectiveness of the application of CPGs for the improvement of the quality of health care in three domains: structure, process and results in the patient for the management of cardiovascular disease. Methods: We followed the methods described by the Cochrane Handbook and present a descriptive analysis because of the high heterogeneity found across the included studies. We searched the Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE databases, as well as the grey literature, between 1990 and June 2016. No language restrictions were applied. Only randomised clinical trials (RCTs) were selected. Three authors independently carried out the data extraction, using a modified version of the Cochrane Effective Practice and Organization of Care form. Results: Of the total of 84 interventions included in the nine RCTs evaluated, three (4%) were related to health care structure, 54 (64%) to the health care delivery process and 27 (32%) to patient outcomes. Regarding the impact of using the CPGs, in 55 interventions (65%), there were no significant differences between control and experimental groups. In four interventions (5%), the result favoured the control group, and the result favoured the intervention group on 25 of the interventions (30%). Conclusions: This systematic review showed that CPGs could be useful to improve the process and structure of health care and, to a lesser extent, to improve the results in patients. However, evidence was weak. There are probably still undiscovered variables that interfere with the use of the CPGs and, therefore, with their impact. Therefore, more studies of good quality are needed. Registration: PROSPERO CRD42013003589.

2.
Global Health ; 13(1): 74, 2017 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-28923096

RESUMEN

As part of the MASCOT/WOTRO multinational team conducting the maternal health literature mapping, four Latin American researchers were particularly interested in analysing information specific to their region. The mapping started with 45,959 papers uploaded from MEDLINE, CINAHL, Embase, LILACAS, PopLINE, PsycINFO and Web of Knowledge. From these, 4175 full texts were reviewed and 2295 papers were subsequently included. Latin America experienced an average maternal mortality decline of 40% between 1990 and 2013. Nevertheless, the region's performance was below the global average and short of the 75% reduction set in Millennium Development Goal 5 for 2015. The main outcomes show that research on maternal health in the countries where the most impoverished populations of the world are living is not always aligned with their compelling needs. From another perspective, the review made it possible to recognize that research funding as well as the amount of scientific literature produced concentrate on issues that are not necessarily among the main causes of maternal deaths. Even though research on maternal health in Latin America has grown from an average of 92.5 publications per year in 2000-2003 to 236.7 between 2008 and 2012, it's not satisfactorily keeping pace with other regions. In conclusion, it is critical to effectively orient research funding and production to respond to the health needs of the population. At the same time, there is a need for innovative mechanisms to strengthen the production and uptake of scientific evidence that can properly inform public health decision making.


Asunto(s)
Países en Desarrollo , Salud Materna , Investigación/tendencias , Femenino , Humanos , América Latina , Mortalidad Materna/tendencias , Salud Pública
3.
J Clin Epidemiol ; 90: 76-83, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28389397

RESUMEN

OBJECTIVES: The aim of this paper is to describe a conceptual framework for how to consider health equity in the Grading Recommendations Assessment and Development Evidence (GRADE) guideline development process. STUDY DESIGN AND SETTING: Consensus-based guidance developed by the GRADE working group members and other methodologists. RESULTS: We developed consensus-based guidance to help address health equity when rating the certainty of synthesized evidence (i.e., quality of evidence). When health inequity is determined to be a concern by stakeholders, we propose five methods for explicitly assessing health equity: (1) include health equity as an outcome; (2) consider patient-important outcomes relevant to health equity; (3) assess differences in the relative effect size of the treatment; (4) assess differences in baseline risk and the differing impacts on absolute effects; and (5) assess indirectness of evidence to disadvantaged populations and/or settings. CONCLUSION: The most important priority for research on health inequity and guidelines is to identify and document examples where health equity has been considered explicitly in guidelines. Although there is a weak scientific evidence base for assessing health equity, this should not discourage the explicit consideration of how guidelines and recommendations affect the most vulnerable members of society.


Asunto(s)
Equidad en Salud , Guías de Práctica Clínica como Asunto/normas , Literatura de Revisión como Asunto , Poblaciones Vulnerables , Práctica Clínica Basada en la Evidencia , Humanos , Metaanálisis como Asunto , Proyectos de Investigación
4.
J Clin Epidemiol ; 90: 59-67, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28412464

RESUMEN

OBJECTIVES: This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines. STUDY DESIGN AND SETTING: We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. RESULTS: We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. CONCLUSION: Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development.


Asunto(s)
Equidad en Salud , Guías de Práctica Clínica como Asunto/normas , Poblaciones Vulnerables , Práctica Clínica Basada en la Evidencia , Humanos , Proyectos de Investigación
5.
Global Health ; 12(1): 51, 2016 08 25.
Artículo en Inglés | MEDLINE | ID: mdl-27562360

RESUMEN

BACKGROUND: Mapping studies describe a broad body of literature, and differ from classical systematic reviews, which assess more narrowly-defined questions and evaluate the quality of the studies included in the review. While the steps involved in mapping studies have been described previously, a detailed qualitative account of the methodology could inform the design of future mapping studies. OBJECTIVES: Describe the perspectives of a large research team on the methods used and collaborative experiences in a study that mapped the literature published on maternal health interventions in low- and middle-income countries (2292 full text articles included, after screening 35,048 titles and abstracts in duplicate). METHODS: Fifteen members of the mapping team, drawn from eight countries, provided their experiences and perspectives of the study in response to a list of questions and probes. The responses were collated and analysed thematically following a grounded theory approach. RESULTS: The objectives of the mapping evolved over time, posing difficulties in ensuring a uniform understanding of the purpose of the mapping among the team members. Ambiguity of some study variables and modifications in data extraction codes were the main threats to the quality of data extraction. The desire for obtaining detailed information on a few topics needed to be weighed against the benefits of collecting more superficial data on a wider range of topics. Team members acquired skills in systematic review methodology and software, and a broad knowledge of maternal health literature. Participation in analysis and dissemination was lower than during the screening of articles for eligibility and data coding. Though all respondents believed the workload involved was high, study outputs were viewed as novel and important contributions to evidence. Overall, most believed there was a favourable balance between the amount of work done and the project's outputs. CONCLUSIONS: A large mapping of literature is feasible with a committed team aiming to build their research capacity, and with a limited, simplified set of data extraction codes. In the team's view, the balance between the time spent on the review, and the outputs and skills acquired was favourable. Assessments of the value of a mapping need, however, to take into account the limitations inherent in such exercises, especially the exclusion of grey literature and of assessments of the quality of the studies identified.


Asunto(s)
Países en Desarrollo , Cooperación Internacional , Servicios de Salud Materna/normas , Investigación/normas , Humanos
6.
Int J Qual Health Care ; 28(3): 268-74, 2016 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27097885

RESUMEN

Guideline development is challenging, expensive and labor-intensive. A high-quality guideline with 90 recommendations for breast cancer treatment was developed within 6 months with limited resources in Costa Rica. We describe the experience and propose a process others can use and adapt.The ADAPTE method (using existing guidelines to minimize repeating work that has been done) was used but existing guidelines were not current. The method was extended to use databases that systematically identify, appraise and synthesize evidence for clinical application (DynaMed, EBM Guidelines) to provide current evidence searches and critical appraisal of evidence. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. Draft recommendations with supporting evidence were provided to panel members for facilitated voting to target panel discussion to areas necessary for reaching consensus.Training panelists in guideline development methodology facilitated rapid consensus development. Extending 'guideline adaptation' to 'evidence database adaptation' was highly effective and efficient. Methods were created to simplify mapping DynaMed evidence ratings to GRADE ratings. Twelve steps are presented to facilitate rapid guideline development and enable further adaptation by others.This is a case report and the RAPADAPTE method was retrospectively derived. Prospective replication and validation will support advances for the guideline development community. If guideline development can be accelerated without compromising validity and relevance of the resulting recommendations this would greatly improve our ability to impact clinical care.


Asunto(s)
Medicina Basada en la Evidencia/organización & administración , Guías de Práctica Clínica como Asunto , Calidad de la Atención de Salud/organización & administración , Neoplasias de la Mama/terapia , Consenso , Bases de Datos Factuales , Humanos , Relaciones Interprofesionales , Estudios de Casos Organizacionales , Calidad de la Atención de Salud/normas
7.
Cochrane Database Syst Rev ; (8): CD008736, 2015 Aug 05.
Artículo en Inglés | MEDLINE | ID: mdl-26246011

RESUMEN

BACKGROUND: Leishmaniasis is caused by the Leishmania parasite, and transmitted by infected phlebotomine sandflies. Of the two distinct clinical syndromes, cutaneous leishmaniasis (CL) affects the skin and mucous membranes, and visceral leishmaniasis (VL) affects internal organs. Approaches to prevent transmission include vector control by reducing human contact with infected sandflies, and reservoir control, by reducing the number of infected animals. OBJECTIVES: To assess the effects of vector and reservoir control interventions for cutaneous and for visceral leishmaniasis. SEARCH METHODS: We searched the following databases to 13 January 2015: Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, EMBASE, LILACS and WHOLIS, Web of Science, and RePORTER. We also searched trials registers for ongoing trials. SELECTION CRITERIA: Randomized controlled trials (RCTs) evaluating the effects of vector and reservoir control interventions in leishmaniasis-endemic regions. DATA COLLECTION AND ANALYSIS: Two review authors independently searched for trials and extracted data from included RCTs. We resolved any disagreements by discussion with a third review author. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included 14 RCTs that evaluated a range of interventions across different settings. The study methods were generally poorly described, and consequently all included trials were judged to be at high or unclear risk of selection and reporting bias. Only seven trials reported clinical outcome data which limits our ability to make broad generalizations to different epidemiological settings and cultures. Cutaneous leishmaniasisOne four-arm RCT from Afghanistan compared indoor residual spraying (IRS), insecticide-treated bednets (ITNs), and insecticide-treated bedsheets, with no intervention. Over 15 months follow-up, all three insecticide-based interventions had a lower incidence of CL than the control area (IRS: risk ratio (RR) 0.61, 95% confidence interval (CI) 0.38 to 0.97, 2892 participants, moderate quality evidence; ITNs: RR 0.32, 95% CI 0.18 to 0.56, 2954 participants, low quality evidence; ITS: RR 0.34, 95% CI 0.20 to 0.57, 2784 participants, low quality evidence). No difference was detected between the three interventions (low quality evidence). One additional trial of ITNs from Iran was underpowered to show a difference.Insecticide treated curtains were compared with no intervention in one RCT from Venezuela, where there were no CL episodes in the intervention areas over 12 months follow-up compared to 142 in control areas (RR 0.00, 95% CI 0.00 to 0.49, one trial, 2938 participants, low quality evidence).Personal protection using insecticide treated clothing was evaluated by two RCTs in soldiers, but the trials were underpowered to reliably detect effects on the incidence of CL (RR 0.40, 95% CI 0.13 to 1.20, two trials, 558 participants, low quality evidence). Visceral leishmaniasisIn a single RCT of ITNs versus no intervention from India and Nepal, the incidence of VL was low in both groups and no difference was detected (RR 0.99, 95% CI 0.46 to 2.15, one trial, 19,810 participants, moderate quality evidence).Two trials from Brazil evaluated the effects of culling infected dogs compared to no intervention or IRS. Although they report a reduction in seroconversion over 18 months follow-up, they did not measure or report effects on clinical disease. AUTHORS' CONCLUSIONS: Using insecticides to reduce phlebotomine sandfly numbers may be effective at reducing the incidence of CL, but there is insufficient evidence from trials to know whether it is better to spray the internal walls of houses or to treat bednets, curtains, bedsheets or clothing.


Asunto(s)
Reservorios de Enfermedades/parasitología , Vectores de Enfermedades , Insecticidas , Leishmaniasis Cutánea/prevención & control , Leishmaniasis Visceral/prevención & control , Sacrificio de Animales , Animales , Vestuario , Enfermedades de los Perros/prevención & control , Perros , Artículos Domésticos , Humanos , Mosquiteros Tratados con Insecticida , Leishmaniasis Cutánea/veterinaria , Leishmaniasis Visceral/veterinaria , Densidad de Población , Ensayos Clínicos Controlados Aleatorios como Asunto
8.
Health Info Libr J ; 32(4): 276-86, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26192997

RESUMEN

OBJECTIVES: Journals in languages other than English that publish original clinical research are often not well covered in the main biomedical databases and therefore often not included in systematic reviews. This study aimed to identify Spanish language biomedical journals from Spain and Latin America and to describe their main features. METHODS: Journals were identified in electronic databases, publishers' catalogues and local registries. Eligibility was determined by assessing data from these sources or the journals' websites, when available. FINDINGS: A total of 2457 journals were initially identified; 1498 met inclusion criteria. Spain (27.3%), Mexico (16.0%), Argentina (15.1%) and Chile (11.9%) had the highest number of journals. Most (85.8%) are currently active; 87.8% have an ISSN. The median and mean length of publication were 22 and 29 years, respectively. A total of 66.0% were indexed in at least one database; 3.0% had an impact factor in 2012. A total of 845 journals had websites (56.4%), of which 700 (82.8%) were searchable and 681 (80.6%) free of charge. CONCLUSIONS: Most of the identified journals have no impact factor or are not indexed in any of the major databases. The list of identified biomedical journals can be a useful resource when conducting hand searching activities and identifying clinical trials that otherwise would not be retrieved.


Asunto(s)
Bases de Datos Bibliográficas/provisión & distribución , Lenguaje , Edición/tendencias , Humanos , Factor de Impacto de la Revista , América Latina , Edición/provisión & distribución , Investigación/estadística & datos numéricos , España
9.
Cochrane Database Syst Rev ; (7): CD005638, 2014 Jul 28.
Artículo en Inglés | MEDLINE | ID: mdl-25101365

RESUMEN

Background Prophylactic oophorectomy alongside hysterectomy in premenopausal women is a common procedure. The decision to remove or conserve the ovaries is often based on the perceived risk for ovarian cancer and the need for additional gynaecological surgical interventions,and is weighed against the perceived risk of negative health effects caused by surgically induced menopause. The evidence needed to recommend either prophylactic bilateral oophorectomy or conservation of ovaries at the time of hysterectomy in premenopausal women is limited. This is an update of the original version of this systematic review published in 2008.Objectives To compare hysterectomy alone versus hysterectomy plus bilateral oophorectomy in women with benign gynaecological conditions,with respect to rates of mortality or subsequent gynaecological surgical interventions.Search methods We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (December 2005 to January 2014) and the following electronic databases: CENTRAL (The Cochrane Library 2013, Issue 12), MEDLINE (January 1966 to January 2014),EMBASE (January 1985 to January 2014), and PsycINFO (1806 to January 2014).Selection criteria Randomised controlled trials (RCTs) of hysterectomy alone versus hysterectomy with bilateral oophorectomy in premenopausal women with benign gynaecological conditions were eligible. Any surgical approach could be used.Data collection and analysis Three review authors independently assessed trials for inclusion. Study authors were contacted if information was unclear.Main results Only one RCT comparing the benefits and risks of hysterectomy with or without oophorectomy was identified. The results of this pilot RCT have not been published and we have not been able to obtain the results. Therefore, no data could be included in this review. Authors' conclusions The conclusions of this review are limited by a lack of RCTs. Although no evidence is available from RCTs, there is growing evidence from observational studies that surgical menopause may impact negatively on cardiovascular health and all cause mortality.


Asunto(s)
Enfermedades de los Genitales Femeninos/cirugía , Histerectomía/métodos , Ovariectomía/métodos , Premenopausia , Terapia Combinada/métodos , Femenino , Humanos
10.
Cochrane Database Syst Rev ; (8): CD007687, 2012 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-22895965

RESUMEN

BACKGROUND: Uterine fibroids are the most common benign uterine tumours present in women of reproductive age. Mifepristone (RU-486) competitively binds and inhibits progesterone receptors. Studies have suggested that fibroid growth depends on the sexual steroids. Mifepristone has been shown to decrease fibroid size. This review summarises the effects of mifepristone treatment on fibroids and the associated adverse effects as described in randomised controlled trials. OBJECTIVES: To determine the efficacy and safety of mifepristone for the management of uterine fibroids in pre-menopausal women. SEARCH METHODS: We searched the specialised register of the Cochrane Menstrual Disorders and Subfertility (Cochrane Menstrual Disorders and subfertility Review Group), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), MEDLINE, EMBASE, PsycINFO, and CINAHL (to November 2011). We handsearched a number of journals, and searched reference lists, databases of ongoing trials and the Internet. There were no language restrictions. SELECTION CRITERIA: Only truly randomised controlled trials of mifepristone versus other forms of medical therapy or placebo in pre-menopausal women with confirmed uterine fibroids were included. DATA COLLECTION AND ANALYSIS: Four authors independently extracted data and assessed trial quality. Data were analysed using the Peto odds ratios (OR) for dichotomous data and the weighted mean differences for continuous data, with 95% confidence intervals (CI). Meta-analyses were performed using the fixed-effect model. MAIN RESULTS: Three studies involving 112 participants were included. Comparison interventions included different dosages of mifepristone, placebo and vitamin B tablets. There is evidence that treatment with mifepristone relieves heavy menstrual bleeding compared with placebo (Peto OR 17.84; 95% CI 6.72 to 47.38; 2 RCTs, 77 women, I(2) = 0%). Three studies (Bagaria 2009; Engman 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on the fibroid volume (standardised mean difference (SMD) -0.02; 95% CI -0.38 to 0.41; 99 women). Two studies (Bagaria 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on uterine volume (mean difference (MD) -77.24; 95% CI -240.62 to 86.14; 72 women). The pooled data suggest an increased adverse event (abnormal endometrial histology) in the mifepristone group compared to placebo (OR 31.65; 95% CI 4.83 to 207.35; 2 RCTs; 54 women; I(2) = 0%). Only one study (Bagaria 2009) reported endometrial hyperplasia at the end of the therapy (12/19 women in the mifepristone group versus 0/16 in the placebo group; OR 55.0; 95% CI 2.86 to 105.67). Engman 2009 found a significantly higher rate of cystic glandular dilatation in women in the mifepristone group (5/8 women biopsied) compared with the placebo group (1/11 women biopsied) (OR 16.67; 95% CI 1.36 to 204.03). One study (Fiscella 2006) suggested significant improvements (P < 0.001) for specific quality of life outcomes. AUTHORS' CONCLUSIONS: Mifepristone reduced heavy menstrual bleeding and improved fibroid-specific quality of life. However, it was not found to reduce fibroid volume. Further well-designed, adequately powered RCTs are needed before a recommendation can be made on the use of mifepristone for the treatment of uterine fibroids.


Asunto(s)
Leiomioma/tratamiento farmacológico , Mifepristona/uso terapéutico , Receptores de Progesterona/antagonistas & inhibidores , Femenino , Humanos , Leiomioma/patología , Menorragia/tratamiento farmacológico , Mifepristona/efectos adversos , Premenopausia , Ensayos Clínicos Controlados Aleatorios como Asunto , Carga Tumoral/efectos de los fármacos , Neoplasias Uterinas/tratamiento farmacológico , Neoplasias Uterinas/patología
11.
Cochrane Database Syst Rev ; (3): CD005638, 2008 Jul 16.
Artículo en Inglés | MEDLINE | ID: mdl-18646133

RESUMEN

BACKGROUND: Prophylactic oophorectomy alongside hysterectomy in premenopausal women is common. The decision to remove or conserve the ovaries is often based on the perceived risk for ovarian cancer and the need for other additional gynaecological surgical interventions. The benefits or harms of prophylactic bilateral oophorectomy at the time of hysterectomy in premenopausal women are unknown. OBJECTIVES: To determine whether premenopausal women with hysterectomy without oophorectomy for benign gynaecological conditions versus hysterectomy plus bilateral oophorectomy would have a higher mortality rate and future gynaecological surgical interventions. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (December 2005 to October 2007) and the following electronic databases: CENTRAL (The Cochrane Library 2007, Issue 4), MEDLINE (January 1966 to October 2007), EMBASE (January 1985 to October 2007), LILACS (January 1982 to October 2007), Biological Abstracts (January 1968 to October 2007), NHS Economic Evaluation Database (inception to October 2007), Health Technology Assessment Database (inception to October 2007), and the Meta RCTs (inception to October 2007). Reference lists of relevant articles were also searched. SELECTION CRITERIA: Randomised controlled and controlled trials of hysterectomy (using any surgical approach) without oophorectomy versus hysterectomy (using any surgical approach) with bilateral oophorectomy in premenopausal women with benign gynaecological conditions. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion, determined study quality and extracted data. Study authors were contacted where information was unclear. MAIN RESULTS: Of the 119 studies identified, only one controlled trial was included. Therefore, a quantitative meta-analysis was not feasible. The results of this study (with two publications) including 362 women were summarised in a narrative format. No randomised controlled trials were found. Neither publication reported on the primary outcomes stated in this review. The trial showed evidence of very low quality of a positive effect on psychological well-being for both groups at one year follow up. No significant differences were found between the groups of women studied regarding any aspect of their sexuality. AUTHORS' CONCLUSIONS: The conclusions of this review are limited by the lack of data. More research of higher methodological quality is needed.


Asunto(s)
Enfermedades de los Genitales Femeninos/cirugía , Histerectomía/métodos , Ovariectomía/métodos , Premenopausia , Femenino , Humanos
15.
Rev. panam. salud pública ; 19(6): 417-422, jun. 2006. tab
Artículo en Inglés | LILACS | ID: lil-433462

RESUMEN

Debido a los sesgos que afectan a la publicación de ensayos clínicos y sus resultados, los estudios cuyos resultados son positivos son más fáciles de encontrar que los que tienen resultados sin significación estadística y a ello se debe que los primeros estén sobrerrepresentados. Para contrarrestar este tipo de sesgo se ha propuesto ingresar en un registro toda investigación, desde sus comienzos. No obstante, estos registros se encuentran en distintas fases de evolución, especialmente en países en desarrollo, de tal manera que la Red Cochrane Iberoamericana, parte de la Colaboración Cochrane, ha establecido el Registro Latinoamericano de Ensayos Clínicos en Curso (LATINREC, por Latin American Clinical Trial Registry) con la idea de facilitar el registro de los datos contenidos en el protocolo de todo ensayo clínico que se esté llevando a cabo en un momento dado y poner esa información a la disposición del público. El LATINREC, que viene a respaldar los objetivos de la Organización Mundial de la Salud (OMS), representa un intento por reducir la duplicación de trabajo y el financiamiento poco equitativo de la investigación sobre enfermedades rezagadas al olvido; por evitar que se efectúen investigaciones sobre asuntos de poca cuantía o que se midan resultados poco útiles; y por fomentar las prácticas éticas y la transparencia. Se han detectado algunos obstáculos mayores que hasta ahora han impedido crear un registro único y común de ensayos clínicos. Con el fin de franquearlos, LATINREC será un registro gratuito que permitirá hacer búsquedas y que se ceñirá a la Plataforma Internacional de Registro de Ensayos Clínicos (ICTRP) de la OMS. Además, LATINREC permitirá que los investigadores ingresen en el registro cualquier modificación del protocolo, así como los resultados preliminares. LATINREC ofrecerá grandes ventajas para los consumidores, el gobierno, los profesionales de la salud pública y la industria farmacéutica al incrementar la accesibilidad de la información y la participación en los ensayos clínicos. La disponibilidad de información objetiva acerca de todo ensayo clínico que se inicie ayudará a garantizar que todos tengan libre acceso a los conocimientos generados.


Asunto(s)
Ensayos Clínicos como Asunto , Sistema de Registros , América Latina , Sesgo de Publicación , Edición
17.
Diabetes Care ; 26(1): 24-9, 2003 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-12502654

RESUMEN

OBJECTIVE: The prevalence of type 2 diabetes, especially in developing countries, has grown over the past decades. We performed a controlled clinical study to determine whether a community-based, group-centered public health intervention addressing nutrition and exercise can ameliorate glycemic control and associated cardiovascular risk factors in type 2 diabetic patients in rural Costa Rica. RESEARCH DESIGN AND METHODS: A total of 75 adults with type 2 diabetes, mean age 59 years, were randomly assigned to the intervention group or the control group. All participants received basic diabetes education. The subjects in the intervention group participated in 11 weekly nutrition classes (90 min each session). Subjects for whom exercise was deemed safe also participated in triweekly walking groups (60 min each session). Glycosylated hemoglobin, fasting plasma glucose, total cholesterol, triglycerides, HDL and LDL cholesterol, height, weight, BMI, and blood pressure were measured at baseline and the end of the study (after 12 weeks). RESULTS: The intervention group lost 1.0 +/- 2.2 kg compared with a weight gain in the control group of 0.4 +/- 2.3 kg (P = 0.028). Fasting plasma glucose decreased 19 +/- 55 mg/dl in the intervention group and increased 16 +/- 78 mg/dl in the control group (P = 0.048). Glycosylated hemoglobin decreased 1.8 +/- 2.3% in the intervention group and 0.4 +/- 2.3% in the control group (P = 0.028). CONCLUSIONS: Glycemic control of type 2 diabetic patients can be improved through community-based, group-centered public health interventions addressing nutrition and exercise. This pilot study provides an economically feasible model for programs that aim to improve the health status of people with type 2 diabetes.


Asunto(s)
Enfermedades Cardiovasculares/epidemiología , Diabetes Mellitus Tipo 2/dietoterapia , Diabetes Mellitus Tipo 2/epidemiología , Ejercicio Físico , Hiperglucemia/prevención & control , Anciano , Glucemia , Costa Rica/epidemiología , Femenino , Humanos , Hiperglucemia/dietoterapia , Hiperglucemia/epidemiología , Masculino , Persona de Mediana Edad , Evaluación Nutricional , Educación del Paciente como Asunto , Proyectos Piloto , Prevalencia , Atención Primaria de Salud , Factores de Riesgo , Población Rural
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