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Background: Traditionally, EB-CPGs have been believed to mainly improve the quality and consistency of health care, but this claim must be conclusively proven. We used the Donabedian three-dimensional model (structure, process, and patient outcomes) to assess improvements in the quality of medical care derived from implementing EB-CPGs. This study corresponds to the second systematic review carried out as a series of studies on different clinical issues that aim to evaluate the effectiveness of the application of the EB-CPG for improving the quality of care. Methods: We followed the methods described by the Cochrane Handbook and presented a descriptive analysis because of the high heterogeneity found across the included studies. We searched the Cochrane Central Register of Controlled Trials, PubMed, and EBSCO Host databases, as well as the grey literature, between 1990 and April 2021. No language restrictions were applied. Only randomised clinical trials (RCTs) were selected. Results: Of the total of 364 interventions included in the eleven RCTs evaluated, 11 (3%) were related to healthcare structure, 51 (14%) to the healthcare delivery process and 302 (83%) to patient outcomes. Regarding the impact of using the EB-CPGs, in 303 interventions (83%), there were no significant differences between the control and experimental groups. In 4 interventions (1%), the result favoured the control and intervention groups in 57 of the interventions (16%). Conclusions: Our study showed that EB-CPGs slightly enhanced the quality of health care in the three dimensions described by Donabedian. Future RCTs should improve their design and methodological rigour by considering the certainty of the evidence supporting the EB-CPGs recommendations. In that context, broader analyses could be performed, having more concise hypotheses for further research. Registration: PROSPERO CRD42020205594.
Assuntos
Neoplasias da Mama , Melhoria de Qualidade , Humanos , Feminino , Neoplasias da Mama/terapia , Atenção à SaúdeRESUMO
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.
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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.
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Países em Desenvolvimento , Saúde Materna , Pesquisa/tendências , Feminino , Humanos , América Latina , Mortalidade Materna/tendências , Saúde PúblicaRESUMO
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.
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Doenças dos Genitais Femininos/cirurgia , Histerectomia/métodos , Ovariectomia/métodos , Pré-Menopausa , Terapia Combinada/métodos , Feminino , HumanosRESUMO
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.
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Leiomioma/tratamento farmacológico , Mifepristona/uso terapêutico , Receptores de Progesterona/antagonistas & inibidores , Feminino , Humanos , Leiomioma/patologia , Menorragia/tratamento farmacológico , Mifepristona/efeitos adversos , Pré-Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto , Carga Tumoral/efeitos dos fármacos , Neoplasias Uterinas/tratamento farmacológico , Neoplasias Uterinas/patologiaRESUMO
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.