Palliative chemotherapy for advanced gallbladder cancer. / Quimioterapia paliativa en cáncer de vesícula avanzado.

INTRODUCTION: Gallbladder cancer is the most common malignancy of the biliary tract. Given the lack of therapeutic alternatives for advanced stage patients studies have suggested that palliative chemotherapy could benefit these patients. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis, and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified two systematic reviews including two studies overall, of which one was a randomized trial. We concluded that palliative chemotherapy may increase survival in advanced gallbladder cancer patients. However, palliative chemotherapy probably increases adverse effects. In addition, it is essential to carry out a new systematic review, since methodological errors were identified in the analysis and there is new evidence that has not been included in the previous reviews.

INTRODUCCIÓN: El cáncer de vesícula es el cáncer más frecuente de la vía biliar. Debido a la escasez de alternativas terapéuticas para pacientes con etapas avanzadas de la enfermedad, se ha planteado que quimioterapia paliativa puede ser beneficiosa para estos pacientes. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos dos revisiones sistemáticas que en conjunto incluyeron dos estudios primarios, de los cuales, uno corresponde a un ensayo aleatorizado. Concluimos que la quimioterapia paliativa podría aumentar la sobrevida en cáncer de vesícula biliar avanzado. Sin embargo, probablemente aumenta los efectos adversos. Además, es imprescindible realizar una nueva revisión sistemática, ya que se identificaron errores metodológicos importantes en el análisis realizado y existe nueva evidencia que no ha sido incluida en revisiones previas.

Colonoscopy-guided therapy for the prevention of post-operative recurrence of Crohn's disease.

BACKGROUND: About half of patients with Crohn's disease (CD) require surgery within 10 years of diagnosis. Resection of the affected segment is highly effective, however the majority of patients experience clinical recurrence after surgery. Most of these patients have asymptomatic endoscopic recurrence weeks or months before starting with symptoms. This inflammation can be detected by colonoscopy and is a good predictor of poor prognosis.Therapy guided by colonoscopy could tailor the management and improve the prognosis of postoperative CD. OBJECTIVES: To assess the effects of prophylactic therapy guided by colonoscopy in reducing the postoperative recurrence of CD in adults. SEARCH METHODS: The following electronic databases were searched up to 17 December 2019: MEDLINE, Embase, CENTRAL, Clinical Trials.gov, WHO Trial Registry and Cochrane IBD specialized register. Reference lists of included articles, as well as conference proceedings were handsearched. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs and cohort studies comparing colonoscopy-guided management versus management non-guided by colonoscopy. DATA COLLECTION AND ANALYSIS: Two review authors independently considered studies for eligibility, extracted the data and assessed study quality. Methodological quality was assessed using both the Cochrane 'Risk of bias' tool for RCTs and Newcastle-Ottawa scale (NOS) for cohort studies. The primary outcome was clinical recurrence. Secondary outcomes included: endoscopic, surgical recurrence and adverse events. We calculated the risk ratio (RR) for each dichotomous outcome and extracted the hazard ratio (HR) for time-to-event outcomes. All estimates were reported with their corresponding 95% confidence interval (CI). Data were analysed on an intention-to-treat (ITT) basis. The overall quality of the evidence was evaluated using GRADE criteria. MAIN RESULTS: Two RCTs (237 participants) and five cohort studies (794 participants) met the inclusion criteria. Meta-analysis was not conducted as the studies were highly heterogeneous. We included two comparisons. Intensification of prophylactic-therapy guided by colonoscopy versus intensification guided by clinical recurrence One unblinded RCT and four retrospective cohort studies addressed this comparison. All participants received the same prophylactic therapy immediately after surgery. In the colonoscopy-based management group the therapy was intensified in case of endoscopic recurrence; in the control group the therapy was intensified only in case of symptoms. In the RCT, clinical recurrence (defined as Crohn's Disease Activity Index (CDAI) > 150 points) in the colonoscopy-based management group was 37.7% (46/122) compared to 46.1% (21/52) in the control group at 18 months' follow up (RR 0.82, 95% CI: 0.56 to 1.18, 174 participants, low-certainty evidence). There may be a reduction in endoscopic recurrence at 18 months with colonoscopy-based management (RR 0.73, 95% CI 0.56 to 0.95, 1 RCT, 174 participants, low-certainty evidence). The certainty of the evidence for surgical recurrence was very low, due to only four cohort studies with inconsistent results reporting this outcome. Adverse events at 18 months were similar in both groups, with 82% in the intervention group (100/122) and 86.5% in the control group (45/52) (RR 0.95, 95% CI:0.83 to 1.08, 1 RCT, 174 participants, low-certainty of evidence).The most common adverse events reported were alopecia, wound infection, sensory symptoms, systemic lupus, vasculitis and severe injection site reaction. Perforations or haemorrhages secondary to colonoscopy were not reported. Initiation of prophylactic-therapy guided by colonoscopy versus initiation immediately after surgery An unblinded RCT and two retrospective cohort studies addressed this comparison. The control group received prophylactic therapy immediately after surgery, and in the colonoscopy-based management group the therapy was delayed up to detection of endoscopic recurrence. The effects on clinical and endoscopic recurrence are uncertain (clinical recurrence until week 102: RR 1.16, 95% CI 0.73 to 1.84; endoscopic recurrence at week 102: RR 1.16, 95% CI 0.73 to 1.84; 1 RCT, 63 participants, very low-certainty evidence). Results from one cohort study were similarly uncertain (median follow-up 32 months, 199 participants). The effects on surgical recurrence at a median follow-up of 50 to 55 months were also uncertain in one cohort study (RR 0.79, 95% CI 0.38 to 1.62, 133 participants, very low-certainty evidence). There were fewer adverse events with colonoscopy-based management (54.8% (17/31)) compared with the control group (93.8% (30/32)) but the evidence is very uncertain (RR 0.58, 95% CI 0.42 to 0.82; 1 RCT, 63 participants). Common adverse events were infections, gastrointestinal intolerance, leukopenia, pancreatitis and skin lesions. Perforations or haemorrhages secondary to colonoscopy were not reported. AUTHORS' CONCLUSIONS: Intensification of prophylactic-therapy guided by colonoscopy may reduce clinical and endoscopic postoperative recurrence of CD compared to intensification guided by symptoms, and there may be little or no difference in adverse effects. We are uncertain whether initiation of therapy guided by colonoscopy impacts postoperative recurrence and adverse events when compared to initiation immediately after surgery, as the certainty of the evidence is very low. Further studies are necessary to improve the certainty of the evidence of this review.

Communication skills training for healthcare professionals working with people who have cancer.

BACKGROUND: This is the third update of a review that was originally published in the Cochrane Library in 2002, Issue 2. People with cancer, their families and carers have a high prevalence of psychological stress, which may be minimised by effective communication and support from their attending healthcare professionals (HCPs). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses that may improve communication skills for HCPs involved in cancer care. A variety of communication skills training (CST) courses are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective. OBJECTIVES: To assess whether communication skills training is effective in changing behaviour of HCPs working in cancer care and in improving HCP well-being, patient health status and satisfaction. SEARCH METHODS: For this update, we searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid, Embase via Ovid, PsycInfo and CINAHL up to May 2018. In addition, we searched the US National Library of Medicine Clinical Trial Registry and handsearched the reference lists of relevant articles and conference proceedings for additional studies. SELECTION CRITERIA: The original review was a narrative review that included randomised controlled trials (RCTs) and controlled before-and-after studies. In updated versions, we limited our criteria to RCTs evaluating CST compared with no CST or other CST in HCPs working in cancer care. Primary outcomes were changes in HCP communication skills measured in interactions with real or simulated people with cancer or both, using objective scales. We excluded studies whose focus was communication skills in encounters related to informed consent for research. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials and extracted data to a pre-designed data collection form. We pooled data using the random-effects method. For continuous data, we used standardised mean differences (SMDs). MAIN RESULTS: We included 17 RCTs conducted mainly in outpatient settings. Eleven trials compared CST with no CST intervention; three trials compared the effect of a follow-up CST intervention after initial CST training; two trials compared the effect of CST and patient coaching; and one trial compared two types of CST. The types of CST courses evaluated in these trials were diverse. Study participants included oncologists, residents, other doctors, nurses and a mixed team of HCPs. Overall, 1240 HCPs participated (612 doctors including 151 residents, 532 nurses, and 96 mixed HCPs).Ten trials contributed data to the meta-analyses. HCPs in the intervention groups were more likely to use open questions in the post-intervention interviews than the control group (SMD 0.25, 95% CI 0.02 to 0.48; P = 0.03, I² = 62%; 5 studies, 796 participant interviews; very low-certainty evidence); more likely to show empathy towards their patients (SMD 0.18, 95% CI 0.05 to 0.32; P = 0.008, I² = 0%; 6 studies, 844 participant interviews; moderate-certainty evidence), and less likely to give facts only (SMD -0.26, 95% CI -0.51 to -0.01; P = 0.05, I² = 68%; 5 studies, 780 participant interviews; low-certainty evidence). Evidence suggesting no difference between CST and no CST on eliciting patient concerns and providing appropriate information was of a moderate-certainty. There was no evidence of differences in the other HCP communication skills, including clarifying and/or summarising information, and negotiation. Doctors and nurses did not perform differently for any HCP outcomes.There were no differences between the groups with regard to HCP 'burnout' (low-certainty evidence) nor with regard to patient satisfaction or patient perception of the HCPs communication skills (very low-certainty evidence). Out of the 17 included RCTs 15 were considered to be at a low risk of overall bias. AUTHORS' CONCLUSIONS: Various CST courses appear to be effective in improving HCP communication skills related to supportive skills and to help HCPs to be less likely to give facts only without individualising their responses to the patient's emotions or offering support. We were unable to determine whether the effects of CST are sustained over time, whether consolidation sessions are necessary, and which types of CST programs are most likely to work. We found no evidence to support a beneficial effect of CST on HCP 'burnout', the mental or physical health and satisfaction of people with cancer.

Do cannabinoids constitute a therapeutic alternative for anorexia nervosa? / ¿Constituyen los cannabinoides una alternativa terapéutica en anorexia nerviosa?

INTRODUCTION: Cannabinoids have been postulated as an alternative for anorexia nervosa. However, their actual clinical efficacy and safety are still discussed. METHODS: To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified four systematic reviews including two primary studies, both corresponding to randomized trials. We concluded cannabinoids might not increase weight or improve symptoms in anorexia nervosa, and are probably associated to frequent adverse effects.

INTRODUCCIÓN: Se ha planteado que la estimulación del apetito con cannabinoides podría constituir una alternativa terapéutica en anorexia nerviosa. Sin embargo, su utilidad clínica y seguridad genera controversia. MÉTODOS: Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, preparamos tablas de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES:: Identificamos cuatro revisiones sistemáticas que en conjunto incluyen dos estudios primarios, ambos correspondientes a ensayos aleatorizados. Concluimos que los cannabinoides podrían no aumentar el peso ni mejorar la sintomatología en la anorexia nerviosa, y se asocian a efectos adversos frecuentes.

Are cannabinoids effective for Parkinson’s disease? / ¿Son efectivos los cannabinoides en la enfermedad de Parkinson?

It is postulated cannabinoids may have benefits in Parkinson's disease. However, its actual clinical effectiveness is still discussed. To answer this question, we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We identified six systematic reviews including eight studies overall, of which four were randomized trials relevant for the question of interest. We extracted data from the systematic reviews, reanalyzed data of primary studies included in these reviews, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. We concluded cannabinoids probably do not decrease symptoms in Parkinson’s disease or dyskinesia, and probably are associated to frequent adverse effects in patients with Parkinson’s disease.

Se postula que los cannabinoides pudieran tener beneficios en la enfermedad de Parkinson. No obstante, su real efectividad clínica aún es discutida. Para responder a esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Identificamos seis revisiones sistemáticas que en conjunto incluyen ocho estudios, de los cuales cuatro corresponden a ensayos aleatorizados. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios y preparamos tablas de resumen de los resultados utilizando el método GRADE. Concluimos que los cannabinoides probablemente no disminuyen los síntomas ni las discinesias, y se asocian a efectos adversos frecuentes en pacientes con enfermedad de Parkinson.

Sevelamer versus calcium-based phosphate binders for chronic kidney disease. / Sevelamer comparado con quelantes de fósforo en base a calcio para la insuficiencia renal crónica.

Chronic kidney disease-mineral and bone disorder is prevalent. There is controversy regarding whether calcium-based phosphate binders or sevelamer - a non-calcium phosphate binder – constitute a better therapeutic alternative. Searching in Epistemonikos database, which is maintained by screening multiple information sources, we identified 12 systematic reviews comprising 61 studies of which 41 correspond to randomized trials addressing the question of this article. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded sevelamer may decrease hypercalcemia, but with a higher incidence of gastrointestinal effects than calcium based phosphate binders. It is unclear if there are differences in mortality because the certainty of the evidence is very low.

Los trastornos minerales y óseos asociados a la enfermedad renal crónica son frecuentes. Para su tratamiento existen quelantes de fósforo en base a calcio y otros no cálcicos como el sevelamer, pero no está claro cuál constituye una mejor opción. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples fuentes de información, identificamos 12 revisiones sistemáticas que en conjunto incluyen 61 estudios primarios, de los cuales 41 corresponden a ensayos aleatorizados. Extrajimos los datos, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. Concluimos que el sevelamer, en comparación con los quelantes de fósforo en base a calcio, podría disminuir los eventos de hipercalcemia, pero con una mayor incidencia de efectos gastrointestinales. Por otra parte, no está claro si existen diferencias en cuanto a mortalidad porque la certeza de la evidencia es muy baja.

Is dexamethasone as effective as other corticosteroids for acute asthma exacerbation in children? / ¿Es la dexametasona tan efectiva como otros corticoides durante una exacerbación asmática en niños?

Dexamethasone has been proposed as an alternative in the treatment of acute asthma exacerbation in children. It allows shortening the duration of treatment, reducing costs and adverse effects. However, it is not clear whether its efficacy is similar to the traditional steroid regimen. To answer this question, we searched in Epistemonikos database, which is maintained by screening multiple information sources. We identified six systematic reviews including 10 randomized trials. We extracted data, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. We concluded dexamethasone has probably fewer adverse effects than others corticosteroids, and might be equally effective in reducing hospitalizations and revisits.

La dexametasona se ha planteado como una opción en el tratamiento de exacerbación asmática en niños, acortando el tratamiento, lo que además de ventajas prácticas, podría reducir costos y potenciales efectos adversos. No está claro, sin embargo, si su eficacia es similar al esquema esteroidal tradicional. Para responder esta interrogante utilizamos la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples fuentes de información. Identificamos seis revisiones sistemáticas que en conjunto incluyen diez ensayos controlados aleatorizados. Extrajimos los datos, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. Concluimos que la dexametasona, en comparación con otros corticoides, probablemente tiene menos efectos adversos, y podría ser igual de efectiva en reducir hospitalizaciones y reconsulta.

Are perioperative statins beneficial for cardiac surgery? / ¿Son beneficiosas las estatinas en el periodo perioperatorio de una cirugía cardiaca?

The use of perioperative statins has been proposed as a measure to reduce morbidity and mortality in cardiac surgery. However, their clinical role is controversial. Searching in Epistemonikos database, which is maintained by screening multiple databases, we identified 36 systematic reviews comprising 92 primary studies addressing the question of this article, including 22 randomized trials. We extracted data, combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded perioperative statins probably do not decrease mortality in cardiac surgery and it is unclear if they have any benefit because the certainty of the evidence is very low.

Se ha propuesto el uso de estatinas perioperatorias como una medida para disminuir la morbimortalidad en cirugía cardíaca. No obstante, su impacto clínico es controvertido. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples bases de datos, identificamos 36 revisiones sistemáticas que en conjunto incluyen 92 estudios primarios de los cuales 22 son estudios aleatorizados. Realizamos un metanálisis y tablas de resumen de los resultados utilizando el método GRADE. Concluimos que las estatinas perioperatorias probablemente no disminuyen la mortalidad en cirugía cardíaca y no está claro si tienen algún beneficio porque la certeza de la evidencia es muy baja.

Is folic acid supplementation useful for chronic kidney disease? / ¿Tiene algún rol la suplementación con ácido fólico en la insuficiencia renal crónica?

Patients with chronic kidney disease have higher cardiovascular risk than general population, a fact that has been linked to high homocysteine levels. Folic acid supplementation can reduce homocysteine levels, which would reduce cardiovascular events. However, there is controversy about the clinical effects of this measure. Searching in Epistemonikos database, which is maintained by screening 30 databases, we identified six systematic reviews comprising 13 trials addressing the question of this article. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded folic acid supplementation does not reduce the risk of myocardial infarction or stroke in patients with chronic kidney disease, and might have no effect on mortality.

At which stage of end-stage kidney disease should chronic dialysis be started? / ¿Cuándo debe iniciarse la diálisis crónica en pacientes con insuficiencia renal terminal?

The number of patients requiring renal replacement therapy has increased exponentially in recent years. However, there is still controversy regarding the best moment to initiate chronic dialysis. Searching in Epistemonikos database, which is maintained by screening 30 databases, we identified five systematic reviews comprising 21 trials addressing the question of this article. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded delaying the initiation of dialysis probably does not increase mortality risk in chronic kidney disease and makes little or no difference in the risk of requiring a temporary catheter or having to check the vascular access.