Assessing the methodological strengths and limitations of the Spanish Society of Medical Oncology (SEOM) guidelines : a critical appraisal using AGREE II and AGREE-REX tool

Altres ajuts: acords transformatius de la UABThe Spanish Society of Medical Oncology (SEOM) has provided open-access guidelines for cancer since 2014. However, no independent assessment of their quality has been conducted to date. This study aimed to critically evaluate the quality of SEOM guidelines on cancer treatment. Appraisal of Guidelines for Research and Evaluation II (AGREE II) and AGREE-REX tool was used to evaluate the qualities of the guidelines. We assessed 33 guidelines, with 84.8% rated as "high quality". The highest median standardized scores (96.3) were observed in the domain "clarity of presentation", whereas "applicability" was distinctively low (31.4), with only one guideline scoring above 60%. SEOM guidelines did not include the views and preferences of the target population, nor did specify updating methods. Although developed with acceptable methodological rigor, SEOM guidelines could be improved in the future, particularly in terms of clinical applicability and patient perspectives

Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999-2003)

To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at (7%) was lower. RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research

Risk-of-bias assessment of the randomized clinical trials and systematic reviews on surgical treatments for breast cancer-related lymphedema : A mapping review

Altres ajuts: acords transformatius de la UABBreast cancer treatment is the principal cause of lymphedema in the upper extremities. Breast cancer-related lymphedema (BCRL) treatments were previously based on conservative therapy; surgical treatments are alternative options that could be highly beneficial, especially for patients who are not responsive to conservative therapy. The main aim of this study was to describe and critically assess the risk of bias of randomized clinical trials (RCTs) and systematic reviews (SRs) on surgical treatment for BCRL. We conducted an evidence mapping review according to the methodology proposed by Global Evidence Mapping (GEM). An update was done for our previous systematic search in MEDLINE, EMBASE, CENTRAL (Cochrane), and Epistemonikos from the year 2000 onward. We assessed the risk of bias for the RCTs and SRs using the RoB-2 and ROBIS tools, respectively. Two surgical RCTs and eight SRs were found among the 47 surgical studies that met the eligibility criteria. The overall risk-of-bias assessments of these studies were rated as some concerns (six outcomes) and high risk (three outcomes) for the measured outcomes among the RCTs and as a high risk of bias (five studies) and low risk (three studies) for the included SRs. The overall evidence in the literature on surgical treatment for BCRL is low, as there are few published RCTs and SRs, and the risk-of-bias assessment for the majority was rated as high risk of bias or with some concerns. High-quality studies are needed to improve evidence-based decision-making by surgeons and patients

Evidence mapping based on systematic reviews of therapeutic interventions for soft tissue sarcomas

Soft tissue sarcomas are a heterogeneous group of rare tumours of mesenchymal origin. Evidence mapping is one of the most didactic and friendly approaches to organise and summarise the range of research activity in broad topic fields. The objective of this evidence mapping is to identify, describe and organise the current available evidence about therapeutic interventions on soft tissues sarcomas. We followed the methodology of global evidence mapping. We performed a search of the PubMed, EMBASE, The Cochrane Library and Epistemonikos to identify systematic reviews (SRs) with or without meta-analyses published between 1990 and March 2016. Two independent literature reviewers assessed eligibility and extracted data. Methodological quality of the included systematic reviews was assessed using AMSTAR. We organised the results according to identified PICO questions and used tables and a bubble plot to display the results. The map is based on 24 SRs that met eligibility criteria and included 66 individual studies. Three-quarters were either observational or uncontrolled clinical trials. The quality of the included SRs was in general moderate or high. We identified 64 PICO questions from them. The corresponding results mostly favoured the intervention arm. This evidence mapping was built on the basis of SRs, which mostly included non-experimental studies and were qualified by the AMSTAR tool as of moderate quality. The evidence mapping created from PICO questions is a useful approach to describe complex and huge clinical topics through graphical media and orientate further research to fulfil the existing gaps. However, it is important to delimitate the steps of the evidence mapping in a pre-established protocol

Prevalence study of intermittent hormonal therapy of Prostate Cancer patients in Spain

Background: Although intermittent androgen deprivation therapy was introduced many years ago to improve patients' quality of life with the same carcinologic efficiency as continuous hormonal therapy, recent data suggest that intermittency could be underutilised. This study aims to estimate the prevalence of prostate cancer patients receiving intermittent androgen deprivation therapy in Spain. Methods: A retrospective, longitudinal study was conducted using electronic drug dispensation data from four Spanish autonomous communities, which encompass 17.23 million inhabitants (36.22% of the total population in Spain). We estimated intermittent androgen therapy use (%IAD) and the prevalence of patients under intermittent androgen therapy in reference to the total number of PC patients using hormonal therapy (P IAD) and stratified by region. Other outcome variables included the pharmaceutical forms dispensed and the total direct annual expenditure on androgen deprivation therapy-associated medications. Results: A total of 863,005 dispensations corresponding to a total of 65,752 men were identified, treated with either luteinizing hormone-releasing hormone (LHRH) analogues (353,162) administered alone or in combination with anti-androgens (509,843). Overall, the mean (±SD) age of the patients was 76.9 (±10.4) years. Results revealed that the mean annual P IAD along the study was 6.6% in the total population studied, and the overall %IAD during the five-year study period was 5.6%. The mean cost of hormonal therapy per year was 25 million euros for LHRH analogues and 6.3 million euros for anti-androgens. Conclusions: Few prostate cancer patients in Spain use the intermittent androgen deprivation therapy suggesting underutilization of a perfectly valid option for a significant proportion of patients, missing the opportunity to improve their quality of life and to reduce costs for the National Health Service with comparable overall survival rates than continuous therapy.</p

Comparative analysis of systemic oncological treatments and best supportive care for advanced gastresophageal cancer : A comprehensive scoping review and evidence map

Altres ajuts: acords transformatius de la UABTo identify, describe, and organize the available evidence regarding systemic oncological treatments compared to best supportive care (BSC) for advanced gastresophageal cancer. We conducted a thorough search across MEDLINE (PubMed), EMbase (Ovid), The Cochrane Library, Epistemonikos, PROSPERO, and Clinicaltrials.gov. Our inclusion criteria encompassed systematic reviews, randomized controlled trials, quasi-experimental and observational studies involving patients with advanced esophageal or gastric cancer receiving chemotherapy, immunotherapy or biological/targeted therapy compared to BSC. The outcomes included survival, quality of life, functional status, toxicity, and quality of end-of-life care. We included and mapped 72 studies, comprising SRs, experimental and observational designs, 12 on esophageal cancer, 51 on gastric cancer, and 10 both locations. Most compared schemes including chemotherapy (47 studies), but did not report therapeutic lines. Moreover, BSC as a control arm was poorly defined, including integral support and placebo. Data favor the use of systemic oncological treatments in survival outcomes and BSC in toxicity. Data for outcomes including quality of life, functional status, and quality of end-of-life care were limited. We found sundry evidence gaps specifically in assessing new treatments such as immunotherapy and important outcomes such as functional status, symptoms control, hospital admissions, and the quality of end-life care for all the treatments. There are important evidence gaps regarding new for patients with advanced gastresophageal cancer and the effect of systemic oncological treatments on important patient-centered outcomes beyond survival. Future research should clearly describe the population included, specifying previous treatments and considering therapeutic, and consider all patient-centered outcomes. Otherwise, it will be complex to apply research results into practice

Systemic Oncological Treatments versus Supportive Care for Patients with Advanced Hepatobiliary Cancers : An Overview of Systematic Reviews

Altres ajuts: This study is funded through a grant from Instituto de Salud Carlos III (PI18/00034), co-financed by funds from the European Regional Development Fund.Hepatobiliary cancers (that include hepatocellular carcinoma, intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) are usually treated with systemic oncological treatments (i.e., chemotherapy, immunotherapy and biological or targeted therapies) mainly due to their improvement in survival. However, the trade-off between these therapies and usual practice supportive care is not clear, and other outcomes beyond survival should be considered in advanced stages, such as quality of life or symptom control. The present study is part of a wider project aiming to conduct broad evidence syntheses assessing the effects of systemic oncological treatments versus usual practice supportive care for patients with advanced non-intestinal digestive cancers. We performed an overview of systematic reviews assessing the effects of systemic oncological treatments versus usual practice supportive care for patients with primary advanced hepatobiliary cancer. We found evidence that for these patients (specifically for advanced hepatocellular carcinoma), systemic oncological treatments tend to improve survival at the expense of greater toxicity. Much of systematic reviews included was of low quality and highly overlapped. Nevertheless, the evidence we found failed to report other important outcomes that could be critical for decision making, including quality of life or symptom control. Future research assessing these patient-important outcomes is needed. Background: The trade-off between systemic oncological treatments (SOTs) and UPSC in patients with primary advanced hepatobiliary cancers (HBCs) is not clear in terms of patient-centred outcomes beyond survival. This overview aims to assess the effectiveness of SOTs (chemotherapy, immunotherapy and targeted/biological therapies) versus UPSC in advanced HBCs. Methods: We searched for systematic reviews (SRs) in PubMed, EMBASE, the Cochrane Library, Epistemonikos and PROSPERO. Two authors assessed eligibility independently and performed data extraction. We estimated the quality of SRs and the overlap of primary studies, performed de novo meta-analyses and assessed the certainty of evidence for each outcome. Results: We included 18 SRs, most of which were of low quality and highly overlapped. For advanced hepatocellular carcinoma, SOTs showed better overall survival (HR = 0.62, 95% CI 0.55-0.77, high certainty for first-line therapy; HR = 0.85, 95% CI 0.79-0.92, moderate certainty for second-line therapy) with higher toxicity (RR = 1.18, 95% CI 0.87-1.60, very low certainty for first-line therapy; RR = 1.58, 95% CI 1.28-1.96, low certainty for second-line therapy). Survival was also better for SOTs in advanced gallbladder cancer. No outcomes beyond survival and toxicity could be meta-analysed. Conclusion: SOTs in advanced HBCs tend to improve survival at the expense of greater toxicity. Future research should inform other patient-important outcomes to guide clinical decision making

Bladder cancer index: cross-cultural adaptation into Spanish and psychometric evaluation

BACKGROUND: The Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties. METHODS: For the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach's alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness. RESULTS: Reliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53. CONCLUSIONS: The Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients

Detection of errors in health care and evaluation of preventive measures for patient safety

Introducció Els errors en la pràctica clínica són un greu problema que pot amenaçar la qualitat de l'atenció i la seguretat del pacient, provocant esdeveniments adversos amb resultats nocius. L'error humà és sovint un símptoma de falles subjacents del sistema i no és el principal culpable quan els sistemes socio-técniques complexos funcionen malament. A pesar que s'han publicat molts estudis d'intervencions per a prevenir esdeveniments adversos, es necessita evidència sintetitzada per a guiar la presa de decisions basada en l'evidència. Objectius Analitzar els errors durant el procés d'atenció i avaluar les intervencions per prevenir esdeveniments adversos a l'àmbit hospitalari. Mètodes Es van realitzar tres estudis amb diferents dissenys metodològics. En primer lloc, es va realitzar un estudi qualitatiu per a explorar els factors del sistema que contribueixen als errors d'identificació dels pacients durant els trasllats intrahospitalaris. En segon lloc, es va realitzar un estudi transversal per a determinar la prevalença i magnitud dels errors de medicació i la seva associació amb les característiques sociodemogràfiques i clíniques dels pacients i les condicions de treball de les infermeres. En tercer lloc, es va realitzar una revisió de revisions sistemàtiques per a brindar una visió general de l'efectivitat de les intervencions no farmacològiques dirigides a la prevenció d'esdeveniments adversos a les unitats de cures intensives (UCI). Resultats A l'estudi qualitatiu, els processos d'identificació de pacients no tenien una pràctica uniforme i eren diferents a les polítiques institucionals, particularment pel que fa a la comunicació de transferència efectiva i activa. El procés d'identificació positiva de pacients (PPID, per les seves sigles en anglès) no va ser dissenyat per a detectar falles, i no tot el personal estava capacitat en aquest procés o tenia coneixement d'ell. També notem que la forma actual de PPID és un delicat equilibri de tots els components del sistema que interactuen. A l'estudi transversal, més de la meitat dels casos observats presentaven errors de medicació en la prescripció i administració de medicaments, amb una magnitud de l'error rellevant, i la percepció de la càrrega de treball de l'infermer es va associar a una interrupció durant l'administració de medicaments. A la revisió de la revisió sistemàtica, algunes intervencions no farmacològiques van reduir els esdeveniments adversos a l'UCI; no obstant això, la qualitat metodològica de les revisions en general va ser críticament baixa. Malgrat una lleugera superposició general en aquest revisió, la nostra avaluació a nivell de desenllaç va mostrar una alta superposició per a algunes intervencions efectives. Conclusions Les persones/equips, les eines/tecnologies i l'organització són els principals factors humans involucrats en la identificació errònia del pacient; per tant, es necessita un disseny adaptat a la pràctica actual que integri els factors humans i l'avaluació crítica contínua. Els errors de medicació en la prescripció i administració continuen tenint una alta prevalença, i la majoria d'ells podrien ser previsibles. És important que el personal de salut estigui capacitat per a fer front a les interrupcions i factors tecnològics. Existeixen intervencions no farmacològiques que redueixen els esdeveniments adversos a l'entorn de les unitats de cures intensives. No obstant això, és necessari millorar la recerca per donar una atenció més segura, de manera que la millor evidència pugui incorporar-se a la presa de decisions i transferir-se a la pràctica clínica.Introducción Los errores en la práctica clínica son un grave problema que puede amenazar la calidad de la atención y la seguridad del paciente, provocando eventos adversos con resultados nocivos. El error humano es a menudo un síntoma de fallas subyacentes del sistema y no es el principal culpable cuando los sistemas sociotécnicos complejos funcionan mal. A pesar de que se han publicado muchos estudios de intervenciones para prevenir eventos adversos, se necesita información sintetizada para guiar la toma de decisiones basada en evidencia. Objetivos Analizar los errores durante el proceso de atención y evaluar las intervenciones para prevenir los eventos adversos en el ámbito hospitalario. Métodos Se realizaron tres estudios con diferentes diseños metodológicos. En primer lugar, se realizó un estudio cualitativo para explorar los factores del sistema que contribuyen a los errores de identificación de los pacientes durante los traslados intrahospitalarios. En segundo lugar, se realizó un estudio transversal para determinar la prevalencia y magnitud de los errores de medicación y su asociación con las características sociodemográficas y clínicas de los pacientes y las condiciones de trabajo de las enfermeras. En tercer lugar, se realizó una revisión de revisiones sistemáticas para brindar una visión general de la efectividad de las intervenciones no farmacológicas dirigidas a la prevención de eventos adversos en la unidad de cuidados intensivos (UCI). Resultados En el estudio cualitativo, los procesos de identificación de pacientes no tenían una práctica uniforme y eran diferentes a las políticas institucionales, particularmente en lo que se refiere a la comunicación de transferencia efectiva y activa. El proceso de identificación positiva de pacientes (PPID, por sus siglas en inglés) no fue diseñado para detectar fallas, y no todo el personal estaba capacitado en este proceso o tenía conocimiento de él. También notamos que la forma actual de PPID es un delicado equilibrio de todos los componentes del sistema que interactúan. En el estudio transversal, más de la mitad de los casos observados presentaban errores de medicación en la prescripción y administración de medicamentos, con una magnitud del error relevante, y la percepción de la carga de trabajo del enfermero se asoció a una interrupción durante la administración de medicamentos. En la revisión de la revisión sistemática, algunas intervenciones no farmacológicas redujeron los eventos adversos en la UCI; sin embargo, la calidad metodológica general fue críticamente baja. A pesar de una ligera superposición general en esta revisión, nuestra evaluación a nivel de desenlace mostró una alta superposición para algunas intervenciones efectivas. Conclusiones Las personas/equipos, las herramientas/tecnologías y la organización son los principales factores humanos involucrados en la identificación errónea del paciente; por lo tanto, se necesita un diseño adaptado a la práctica actual que integre los factores humanos y la evaluación crítica continua. Los errores de medicación en la prescripción y administración siguen teniendo una alta prevalencia, y la mayoría de ellos podrían ser prevenibles. Es importante que el personal de salud esté capacitado para hacer frente a las interrupciones y factores tecnológicos. Existen intervenciones no farmacológicas que reducen los eventos adversos en el entorno de cuidados intensivos. Sin embargo, es necesario mejorar la investigación para brindar la atención más segura, de modo que la mejor evidencia pueda incorporarse en la toma de decisiones y transferirse a la práctica clínica.Introduction Errors in clinical practice are a serious problem that may threaten the quality of care and patient safety, causing adverse events with harmful results. Human error is often a symptom of underlying system failures and is not primarily at fault when complex sociotechnical systems malfunction. Although many studies of interventions to prevent adverse events have been published, integrative information is necessary to guide evidence-informed decision-making. Objectives To analyse errors during the care process and evaluate the interventions to prevent adverse events in the hospital setting. Methods Three studies with different methodological designs were performed. First, to explore systems factors contributing to patient identification errors during intra-hospital transfers, a qualitative study was conducted. Second, to determine the prevalence and magnitude of medication errors and their association with patients' sociodemographic and clinical characteristics and nurses' work conditions, a cross-sectional study was undertaken. Third, to provide an overview of the effectiveness of non-pharmacological interventions aimed at preventing adverse events in the intensive care unit (ICU), a review of systematic reviews was carried out. Results In the qualitative study, patient identification processes did not have a uniform practice and were different from the institutional policies, particularly regarding effective and active transfer communication. The positive patient identification (PPID) process was not designed to catch failures, and not all staff were trained in this process or had knowledge of it. We also noticed that the current way of PPID is a delicate balance of all interacting studied components. In the cross-sectional study, over half of the cases observed had medication errors in the prescription and administration of drugs, with a relevant magnitude of the error, and the nurse's workload perception was associated with an interruption during drug administration. In the review of systematic review, some non-pharmacological interventions reduced adverse events in ICU; however, the overall methodological quality was critically low. Despite a slight overall overlap in this overview, our assessment at the outcome level showed a high overlap for some effective interventions. Conclusions People/teams, tools/technologies, and organisation are the main human factors involved in patient misidentification; therefore, a design adapted to current practice that integrates human factors and ongoing critical assessment is needed. Medication errors in prescription and administration still have a high prevalence, and most of them could be preventable. It is important that healthcare staff be trained to deal with interruptions and technological factors. There are nonpharmacological interventions that reduce adverse events in the intensive care setting. However, it is necessary to improve the research to deliver the safest care, so the best evidence can be incorporated into decision-making and be transferred into clinical practice

How oral health care organizations formulate actionable statements to inform practice and policy : A protocol for a systematic survey

Background: Oral diseases are a major global public health problem that impacts the quality of life of those affected. While widespread consensus exists on the importance of high-quality, evidence-informed guidelines to inform practice and public health decisions in medicine, appropriate methodologies and standards are not commonly adhered to among producers of oral health guidelines. This systematic survey aims to identify organizations developing evidence-informed guidelines and policy documents in oral health globally, and describe the methods and processes used. Methods: We will conduct manual searches on the websites of guideline developers, Ministries of Health, and scientific societies. Additionally, we will systematically search electronic databases to identify published guidelines and collect the name of the responsible entity. We will include organizations that regularly develop guidelines on any oral health topic and that explicitly declare the inclusion of research evidence in its development process. Subsequently, we will use a standardized form to extract data about the characteristics of the organization, the characteristics of their guideline or policy documents, and their formal recommendation development processes. These data will be extracted from various sources, such as the organization's official website, the methods section of each guideline, or methodological handbooks. We will use descriptive statistics to analyze the extracted data. Discussion: This systematic survey will synthesize key characteristics and methodologies used by organizations developing evidence-informed guidelines. This study will provide the basis for future development of a sustainable and connected collaborative network for evidence-informed guidelines and policy documents in oral health globally. The results will be disseminated through peer-reviewed publications, conference presentations, and targeted dissemination of findings with the identified organizations. Our systematic survey represents a necessary first step toward improving the field of oral health policies and guidelines