Effectiveness of interventions to improve adherence to antidepressant medication in patients with depressive disorders: a cluster randomized controlled trial.

Aim: To assess the effectiveness of two interventions of knowledge transfer and behavior modification to improve medication adherence in patients with depressive disorders. Methods: An open, multicenter, three-arm clinical trial with random allocation by cluster to usual care or to one of the two interventions. The intervention for psychiatrists (PsI) included an educational program based on a patient-centered care model. The intervention for patients and relatives (PtI) included a collaborative care program plus a reminder system that works using an already available medication reminder application. The primary outcome was patient adherence to antidepressant treatment assessed through the Sidorkiewicz Adherence Instrument. Secondary measures were depression severity, comorbid anxiety and health-related quality of life. Mixed regression models with repeated measures were used for data analysis. Results: Ten psychiatrists and 150 patients diagnosed with depressive disorder from eight Community Mental Health Units in the Canary Islands (Spain) were included. Compared with usual care, no differences in long-term adherence were observed in either group PsI or PtI. The PsI group had significantly improved depression symptoms (B = -0.39; 95%CI: -0.65, -0.12; p = 0.004) during the follow-up period. The PtI group presented improved depression symptoms (B = -0.63; 95%CI: -0.96, -0.30; p < 0.001) and mental quality of life (B = 0.08; 95%CI: 0.004, 0.15; p = 0.039) during the follow-up period. Conclusion: The assessed interventions to improve adherence in patients with depressive disorder were effective for depression symptoms and mental quality of life, even over the long term. However, no effect on antidepressant adherence was observed.

Sociodemographic and clinical predictors of adherence to antidepressants in depressive disorders: a systematic review with a meta-analysis.

Introduction: Current evidence reveals concerning rates of non-adherence to antidepressant treatment, possibly influenced by various relevant determinants such as sociodemographic factors or those related to the health system and their professionals. The aim of this paper is to review the scientific evidence on sociodemographic and clinical predictors of adherence to pharmacological treatment in patients diagnosed with a depressive disorder. Methods: a systematic review (SR) was conducted. The search for a previous SR was updated and de novo searches were performed in Medline, EMBASE, Web of Science (WoS) and PsycInfo (last 10 years). The risk of bias was assessed using the Cochrane tool for non-randomized studies-of Exposure (ROBINS-E). Meta-analyses were conducted. Results: Thirty-nine studies (n = 2,778,313) were included, 24 of them in the meta-analyses. In the initiation phase, no association of adherence was found with any of the predictors studied. In the implementation and discontinuation phases, middle-aged and older patients had better adherence rates and lower discontinuation rates than younger ones. White patients adhered to treatment better than African-American patients. Discussion: Age and ethnicity are presented as the predictive factors of pharmacological adherence. However, more research is needed in this field to obtain more conclusive results on other possible factors. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023414059], identifier [CRD42023414059].

[Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis.] / Enfriamiento del cuero cabelludo para la prevención de la alopecia secundaria a quimioterapia: revisión sistemática y metanálisis.

OBJECTIVE: Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the quality of life of patients who suffer from it. Among the interventions available for its prevention, scalp cooling (SC) is the most widely used. The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the prevention or the reduction of the extent of chemotherapy-induced alopecia. METHODS: A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected. The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesis of the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimated using a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically and through the test of heterogeneity χ2 and the Higgins I2 statistic. Sensitivity analyses and subgroup analyses were performed. RESULTS: 13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treatment applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC prevents alopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I2=63.8%). No statistically significant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious short- or medium-term adverse events related to SC were recorded. CONCLUSIONS: The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.

OBJETIVO: La alopecia es uno de los efectos adversos más comunes de la quimioterapia, con un impacto importante sobre la calidad de vida de los/las pacientes que la padecen. Entre las intervenciones disponibles para su prevención, el enfriamiento del cuero cabelludo (ECC) es la que cuenta con un uso más extendido. El objetivo de este estudio fue evaluar la eficacia y la seguridad del uso de sistemas de ECC durante las sesiones de quimioterapia para la prevención o reducción de la extensión de la alopecia secundaria a la quimioterapia. METODOS: Se llevó a cabo una revisión sistemática de la literatura publicada hasta noviembre de 2021. Se seleccionaron ensayos clínicos aleatorizados. La medida de resultado principal fue la alopecia (pérdida de cabello superior al 50%) durante y posteriormente al tratamiento de quimioterapia. Cuando fue posible, se realizó síntesis cuantitativa de los resultados mediante metanálisis con el programa Stata v.15.0. Se estimó el riesgo relativo (RR) de la variable alopecia, utilizando un modelo de efectos aleatorios siguiendo el método de Mantel-Haenszel. La heterogeneidad estadística de los resultados se evaluó gráficamente y mediante el test de la χ2 y el estadístico I2 de Higgins. Se realizaron análisis de sensibilidad y análisis de subgrupos. RESULTADOS: Se incluyeron 13 estudios con un total de 832 participantes (97,7% de mujeres). En la mayoría de los estudios, los agentes quimioterapéuticos principales aplicados fueron las antraciclinas o la combinación de antraciclinas y taxanos. Los resultados obtenidos indican que el ECC reduce la aparición de la alopecia un 43% frente al grupo control (RR=0,57; IC95%=0,46 a 0,69; k=9; n=494; I2=63,8%). No se encontró una diferencia estadísticamente significativa entre la eficacia de sistemas de enfriamiento automatizados y no automatizados (P=0,967). No se registraron eventos adversos graves a corto o medio plazo relacionados con el ECC. CONCLUSIONES: Los resultados sugieren que el ECC contribuye a prevenir la alopecia secundaria a la quimioterapia.

Barriers and Facilitating Factors of Adherence to Antidepressant Treatments: An Exploratory Qualitative Study with Patients and Psychiatrists.

This study examines the experiences and expectations of patients with depressive disorders regarding the disease and different antidepressants, as well as examining the barriers and facilitating factors that could affect their adherence to medications. An exploratory qualitative study was carried out. The study involved two focus groups made up of patients and caregivers and six semi-structured interviews with psychiatrists. In both cases, the participants were selected by intentional theoretical sampling, seeking maximum significance variation of social types. Prejudice about the side effects of medication was relevant. The importance of patients being well informed about the disease/treatments was noteworthy. The stigmatization of antidepressants by patients was identified as a barrier to medication adherence. The involvement of family members and the motivation of patients to be actively involved in the process to recover from the disease were identified as facilitating factors. The work carried out suggests the need for patients to have rigorous information about the disease/treatment to reduce the possible prejudices generated by beliefs. Maintaining greater contact and monitoring of patients/caregivers to help therapeutic adherence in patients with depressive disorders was also identified as being of great importance.

Molecular Biomarkers for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis.

Context: Prostate cancer (PCa) is the second most common type of cancer in men. Individualized risk stratification is crucial to adjust decision-making. A variety of molecular biomarkers have been developed in order to identify patients at risk of clinically significant PCa (csPCa) defined by the most common PCa risk stratification systems. Objective: The present study aims to examine the effectiveness (diagnostic accuracy) of blood or urine-based PCa biomarkers to identify patients at high risk of csPCa. Evidence acquisition: A systematic review of the literature was conducted. Medline and EMBASE were searched from inception to March 2021. Randomized or nonrandomized clinical trials, and cohort and case-control studies were eligible for inclusion. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Pooled estimates of sensitivity, specificity, and area under the curve were obtained. Evidence synthesis: Sixty-five studies (N = 34 287) were included. Not all studies included prostate-specific antigen-selected patients. The pooled data showed that the Prostate Health Index (PHI), with any cutoff point between 15 and 30, had sensitivity of 0.95-1.00 and specificity of 0.14-0.33 for csPCa detection. The pooled estimates for SelectMDx test sensitivity and specificity were 0.84 and 0.49, respectively. Conclusions: The PHI test has a high diagnostic accuracy rate for csPCa detection, and its incorporation in the diagnostic process could reduce unnecessary biopsies. However, there is a lack of evidence on patient-important outcomes and thus more research is needed. Patient summary: It has been possible to verify that the application of biomarkers could help detect prostate cancer (PCa) patients with a higher risk of poorer evolution. The Prostate Health Index shows an ability to identify 95-100 for every 100 patients suffering from clinically significant PCa who take the test, preventing unnecessary biopsies in 14-33% of men without PCa or insignificant PCa.

Effectiveness of interventions to improve medication adherence in adults with depressive disorders: a meta-analysis.

BACKGROUND: Non-adherence to medication is a major obstacle in the treatment of depressive disorders. We systematically reviewed the literature to evaluate the effectiveness of interventions aimed at improving adherence to medication among adults with depressive disorders with emphasis on initiation and implementation phase. METHODS: We searched Medline, EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, Social Science Citation Index and Science Citation Index for randomized or non-randomized controlled trials up to January 2022. Risk of bias was assessed using the criteria of the Cochrane Collaboration. Meta-analyses, cumulative and meta-regression analyses for adherence were conducted. RESULTS: Forty-six trials (n = 24,324) were included. Pooled estimate indicates an increase in the probability of adherence to antidepressants at 6 months with the different types of interventions (OR 1.33; 95% CI: 1.09 to 1.62). The improvement in adherence is obtained from 3 months (OR 1.62, 95% CI: 1.25 to 2.10) but it is attenuated at 12 months (OR 1.25, 95% CI: 1.02 to 1.53). Selected articles show methodological differences, mainly the diversity of both the severity of the depressive disorder and intervention procedures. In the samples of these studies, patients with depression and anxiety seem to benefit most from intervention (OR 2.77, 95% CI: 1.74 to 4.42) and collaborative care is the most effective intervention to improve adherence (OR 1.88, 95% CI: 1.40 to 2.54). CONCLUSIONS: Our findings indicate that interventions aimed at improving adherence to medication among adults with depressive disorders are effective up to six months. However, the evidence on the effectiveness of long-term adherence is insufficient and supports the need for further research efforts. TRIAL REGISTRATION: International Prospective Register for Systematic Reviews (PROSPERO) number: CRD42017065723 .

Prognostic Impact of Sarcopenia in Patients with Advanced Prostate Carcinoma: A Systematic Review.

Prostate cancer (PCa) is the second most common cancer in men and the fifth leading cause of death from cancer. The possibility of sarcopenia being a prognostic factor in advanced PCa patients has recently become a subject of interest. The aim of the present study was to evaluate the prognostic value of sarcopenia in advanced prostate carcinoma. A systematic review was conducted in Medline, EMBASE, and Web of Science (March, 2021). The quality of studies was assessed using the Quality in Prognosis Studies tool. Meta-analyses for overall, cancer-specific, and progression-free survival were performed. Nine studies (n = 1659) were included. Sarcopenia was borderline associated with a shorter overall survival (HR = 1.20, 95% CI: 1.01, 1.44, P = 0.04, I2 = 43%) but was significantly associated with progression-free survival (HR = 1.61, 95% CI: 1.26, 2.06, P < 0.01; k = 3; n = 588). Available evidence supports sarcopenia as an important prognostic factor of progression-free survival in patients with advanced PCa. However, sarcopenia has a weak association with a shorter overall survival. The evidence on the role of sarcopenia in prostate-cancer-specific survival is insufficient and supports the need for further research. Patient summary: The literature was reviewed to determine whether the loss of muscle mass (sarcopenia) affects the survival in patients with advanced PCa. Patients with advanced PCa and sarcopenia were found to have a shorter progression-free survival (the length of time during and after treatment of a cancer that the patient lives with the disease but it does not get worse), but sarcopenia did not have much influence on the overall survival and cancer-specific survival (the length of time from either the date of diagnosis or the start of treatment to the date of death due to the cancer).

[Mobile applications to improve drug adherence: Review and quality analysis]. / Aplicaciones móviles para mejorar la adherencia a la medicación: revisión y análisis de calidad.

OBJECTIVE: To review the mobile apps in the Spanish market to improve adherence to medications and evaluate their characteristics and quality to identify high-quality applications. METHOD: A review was carried out following a stepwise procedure similar to a systematic review of the scientific literature. Apple Apps Store and Google Play Store mobile application digital distribution platforms. Applications aimed at supporting self-management of treatment, which generate reminders, in Spanish, updated in the last 2 years and free. We evaluate the applications according to a set of characteristics considered desirable and the quality with the Mobile App Rating Scale tool. RESULTS: Out of 708 applications, 3 applications were selected. The Medisafe and Mytherapy applications had 89% and 78% of the desirable characteristics, respectively. Sergio Licea's application only had 56%. The highest global quality score was obtained by the MyTherapy application (3.79/5, IQR: 3-4), followed by Medisafe (3.72/5, (IQR: 3-4) and, finally, Sergio Licea (2.87/5, IQR: 2-4). The quality assessment coincides with the user assessment. There are many available applications, however, most did not meet the selection criteria. CONCLUSIONS: A systematic stepwise process was able to identify the quality application to be tested in a future study that will provide evidence on the use of a multicomponent intervention to improve medication adherence.

Cost-effectiveness of Platelet-Rich Plasma for Diabetic Foot Ulcer in Spain.

This study evaluated the cost-effectiveness of platelet-rich plasma (PRP) added to usual care versus usual care alone in elderly patients with chronic diabetic foot ulcer (DFU) from the Spanish health care system perpective. A 6-state Markov model with 3-month cycles was used to estimate costs and outcomes of wound healing and risk of recurrences, infections, and amputations over 5 years. Three treatment strategies were compared: (a) usual care plus PRP obtained with a commercial kit, (b) usual care plus PRP obtained manually, and (c) usual care. Data on effectiveness were taken from a recent meta-analysis. Outcomes and costs were discounted at 3% and resources were valued in 2018 euro. Compared with usual care, the PRP treatment with the manual method was more effective and less costly (dominant option), whereas the PRP treatment with the commercial kit was more effective but also more costly, with the incremental ratio being above the cost-effectiveness threshold (€57 916 per quality-adjusted life year). These results are sensitive to the price of PRP kits (a 20% discount would make the PRP treatment a cost-effective option) and effectiveness data, due to the heterogeneity of primary studies. In conclusion, PRP treatment for DFUs could be considered a cost-effective or even cost-saving alternative in Spain, depending on the method of obtaining the PRP. Despite the dominance of the manual method, its general use is limited to hospitals and specialized centers, whereas PRP kits could be used in primary care settings, but their prices should be negotiated by health authorities.

Effectiveness of a web-based decision aid for patients with generalised anxiety disorder: a protocol for a randomised controlled trial.

INTRODUCTION: Patients with generalised anxiety disorder (GAD) have concerns and needs about their health and the healthcare they receive. Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. PtDAs can improve shared decision-making and lead to better treatment outcomes. The aim of this study is to evaluate the effectiveness of a web-based PtDA for patients with GAD in primary care (PC). METHODS AND ANALYSIS: The general study design is comprised of two stages: (1) development of a web-based PtDA for patients with GAD, derived from an evidence-based Clinical Practice Guideline and (2) assessment of the effectiveness of the PtDA in a randomised controlled trial (RCT) design, in PC centres in Tenerife (Spain). This RCT will be carried out with 124 patients with GAD, comparing the PtDA to a fact sheet with general information on mental health. Patients will review the PtDA in one session accompanied by a researcher. Post-intervention measures will be administered immediately after the intervention and at 3-month follow-up. The primary outcome will be decisional conflict. Secondary outcomes will include knowledge about GAD and its treatment, treatment preference, concordance between treatment preference and choice, and decision quality (knowledge ≥60% and concordant decision). ETHICS AND DISSEMINATION: The project received ethics approval from the local committee at Nuestra Señora de la Candelaria (HUNSC) University Hospital in Santa Cruz de Tenerife (code: CHUNSC_2019_58). Informed consent will be obtained from each participant before randomisation. Results from the trial will be submitted for publication in international peer-reviewed scientific journals and will be disseminated through workshops and local and international conferences. TRIAL REGISTRATION NUMBER: NCT04364958.

Interventions to improve medication adherence in mental health: the update of a systematic review of cost-effectiveness.

OBJECTIVE: Medication non-adherence in mental health problems has social and economic costs. The objective of the study was to review the cost-effectiveness of interventions to enhance medication adherence in patients with mental health problems. METHODS: The update of a previous systematic review was performed. Databases were searched in June 2019: MEDLINE, PSYCINFO, EMBASE, CINAHL, CRD, WOS. Cost-effectiveness studies comparing an intervention to improve the medication adherence with other interventions/usual care in adults with mental health problems were included. Data were extracted, methodological quality of the studies was assessed and a narrative synthesis was performed. RESULTS: Nine studies were included in the review. The interventions that showed medication adherence increase were: a financial incentive when depot injection was taken by patients with psychotic disorders, a value-based benefit design policy including copayment and counselling in a company setting, and a medication treatment decision supported by a pharmacogenetic test. The other studies (coaching by pharmacists; a psychological and educational intervention at health care centres) did not find differences between groups. No study found cost differences between alternatives. CONCLUSIONS: Interventions to improve medication adherence in adults with mental health problems could be cost-effective, especially those based on financial incentives, although more research is needed. KEYPOINTS There are several types of interventions designed to enhance medication adherence in patients with mental health problems. Few of them have demonstrated cost-effectiveness. Two studies found that a financial incentive per depot injection in patients with psychotic disorders improved the medication adherence. Two other studies found improvement in adherence due to two specific interventions: a value-based benefit design policy in a company setting and a pharmacogenetic test supporting the medication treatment decision. No study found differences in costs between the intervention and the comparator. More research is needed to implement cost-effective interventions.

Relationship between glycemic control and chronic obstructive pulmonary disease in patients with type 2 diabetes: A nested case-control study.

AIMS: To evaluate the relationship between glycemic control and plasma glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus (T2D) and the risk of chronic obstructive pulmonary disease (COPD). METHODS: We conducted a population-based, retrospective, nested, case-control study involving 124,876 patients with DM2 from the Canary Islands, Spain. From the cohort, we selected all COPD cases and, for each case, five control subjects who were COPD free. We analyzed the association between glycemic control, HbA1c level and incident COPD. RESULTS: A total of 1320 incidence cases of COPD (1.06%) were identified and matched individually with 6600 controls according to age and sex. After multivariate adjustment, the COPD risk increased among patients with poor glycemic control compared to patients with good glycemic control [HbA1c levels <7% (53 mmol/mol)] (OR 1.18; 95% CI: 1.03-1.36). In comparison with patients exhibiting HbA1c levels <7% (53 mmol/mol), the risk of COPD was higher among people with HbA1c levels of 7-8% (53-64 mmol/mol) (OR 1.24; 95% CI: 1.05-1.47) and 8-9% (64-75 mmol/mol) (OR 1.31; 95% CI: 1.04-1.66). CONCLUSIONS: Poor glycemic control reveals a weak association with increased risk of COPD in T2D patients.

Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial.

BACKGROUND: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE). METHODS: The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned. DISCUSSION: Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting. TRIAL REGISTRATION: ClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Effectiveness and cost-effectiveness of a multicomponent intervention to improve medication adherence in people with depressive disorders - MAPDep: a study protocol for a cluster randomized controlled trial.

PURPOSE: Depression is a widespread mental disorder which can be treated effectively. However, low adherence to antidepressants is very common. The study of medication adherence in depression (MAPDep study) assesses the effectiveness and cost-effectiveness of a multicomponent strategy to enhance adherence toward medications in patients with depression. INTERVENTION: The intervention is a multicomponent one consisting of an educational program for psychiatrists and/or a collaborative care program for patients and relatives, plus a reminder system that works through the use of an already available high-quality medication reminder application. STUDY DESIGN: MAPDep study is an open, multicenter, four-arm cluster randomized controlled trial. The clusters are mental health units where psychiatrists are invited to participate. The clusters are randomly allocated to one of the three interventions or to usual care (control arm). Patients (18-65 years of age) diagnosed with depressive disorder, those taking antidepressant medication for an existing diagnosis of depression, and mobile phone users are selected. In group 1, only patients and relatives receive intervention; in group 2, only psychiatrists receive intervention; and in group 3, patients/relatives and psychiatrists receive intervention. The primary outcome is adherence to the antidepressant drug. The calculated sample size is 400 patients. To examine changes across time, generalized linear mixed model with repeated measures will be used. A cost-effectiveness analysis will be conducted. The effectiveness measure is quality-adjusted life years. Deterministic sensitivity analyses are planned. CONCLUSION: MAPDep study aims to assess a multicomponent strategy to improve adherence toward medications in patients with depression, based not only on clinical effectiveness but also on cost-effectiveness. This methodology will enhance the transferability of the expected results beyond mental health services (patients and psychiatrists) to health care policy decision making. CLINICAL TRIAL IDENTIFIER: NCT03668457.

Stereoelectroencephalography for Refractory Epileptic Patients Considered for Surgery: Systematic Review, Meta-Analysis, and Economic Evaluation.

BACKGROUND: Stereoelectroencephalography (SEEG) has been shown to be a valuable tool for the anatomoelectroclinical definition of the epileptogenic zone (EZ) in patients with medically refractory epilepsy considered for surgery (RES patients). In Spain, many of those patients are not offered this diagnostic procedure. OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of SEEG to define the EZ in RES patients compared to no SEEG intervention, ie, remaining with further antiepileptic drugs. METHODS: We undertook a systematic review with meta-analyses on the effectiveness and safety of SEEG. A cost-effectiveness analysis was conducted using a Markov model, which simulates the costs and health outcomes of individuals for a lifetime horizon from the perspective of the Spanish National Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. RESULTS: The EZ was found in 92% of patients who underwent SEEG (95% confidence interval [CI]: 0.87-0.96); 72% were eligible for epilepsy surgery (95% CI: 0.66-0.78) and 33% were free of seizures after surgery (95% CI: 0.27-0.42). Of the patients who underwent surgery, 47% were free of seizures after surgery (95% CI: 0.37-0.58). Complications related to implantation and monitoring of SEEG and the subsequent intervention occurred in 1.3% of patients (95% CI: 0.01-0.02). In the base case analysis, SEEG led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio of 10 368 EUR per QALY (95% CI: dominant-113 911), making the probability of cost-effectiveness between 75% and 88%. Further sensitivity analyses showed that the results of the study were robust. CONCLUSION: SEEG is a cost-effective technology in RES patients when compared to no SEEG intervention.

Platelet-rich plasma for the treatment of diabetic foot ulcers: A meta-analysis.

Foot ulcer is a major complication of diabetes mellitus and often precedes leg amputation. Among the different methods to achieve ulcer healing, the use of platelet-rich plasma, which is rich in multiple growth factors and cytokines and may have similarities to the natural wound healing process, is gaining in popularity. A systematic review with meta-analyses was performed to evaluate the safety and clinical effectiveness of platelet-rich plasma for the treatment of diabetic foot ulcers compared to standard treatment or any other alternative therapy. The electronic databases Medline, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials were consulted in March 2017 with no restrictions placed on the publication date. Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. Eight randomized clinical trials and two prospective longitudinal-observational studies with control group were included. Platelet-rich plasma treatment increased the likelihood of chronic wound healing (RR = 1.32; 95% CI: 1.11, 1.57, I2 = 15%) while the volume of the ulcer (MD = 0.12 cm2 ; 95% CI: 0.08, 0.16; p < 0.01; I2 = 0%) and time to complete wound healing (MD = -11.18 days; 95% CI: -20.69, -1.68; I2 = 53%) decreased. Regarding safety profile, platelet-rich plasma did not differ from standard treatment in terms of probability of occurrence of wound complications (RR = 0.57; 95% CI: 0.25, 1.28; I2 = 0%) or recurrences (RR = 2.76; 95% CI: 0.23, 33.36; p = 0.43; I2 = 82%) but it decreased the rate of adverse events (RR = 0.80; 95% CI: 0.66, 0.96; p = 0.02; I2 = 0%). Cumulative meta-analysis revealed that there is enough evidence to demonstrate a statistically significant benefit. However, studies included presented serious methodologic flaws. According to the results, platelet-rich plasma could be considered a candidate treatment for nonhealing of diabetic foot ulcers.

Efficacy, Effectiveness, Safety, and Cost-effectiveness of Epidural Adhesiolysis for Treating Failed Back Surgery Syndrome. A Systematic Review.

BACKGROUND: Failed back surgery syndrome (FBSS) has a profound impact on patients' quality of life and represents a major clinical challenge and a significant economic burden for society. Adhesiolysis is used as a treatment to eliminate perineural/epidural adhesions in patients with chronic pain attributed to FBSS. OBJECTIVE: To evaluate the efficacy, effectiveness, safety, and cost-effectiveness of epidural adhesiolysis compared with other procedures for treating FBSS. METHOD: A systematic review was conducted. The electronic databases Medline/PreMedline, EMBASE, Cochrane Library Plus, Centre for Reviews and Dissemination databases, SCOPUS, Science Citation Index, and PEDRO were consulted through April 2017. Predefined criteria were used to determine inclusion of the studies and to assess their methodological quality. RESULTS: Ten reports were included. No randomized controlled trials (RCTs) on efficacy or cost-effectiveness were found. Three reports (corresponding to two RCTs, N = 212) suggested that adhesiolysis was effective, especially for pain and disability. However, both studies presented serious methodological flaws. In addition to RCTs, seven observational studies with high risk of bias reported data on effectiveness and safety. Fifty-eight adverse events were reported among 130 patients undergoing endoscopic adhesiolysis, and 19 among the 110 undergoing percutaneous adhesiolysis. CONCLUSIONS: The evidence on the efficacy and cost-effectiveness of adhesiolysis for treating FBSS is nonexistent, whereas evidence on its effectiveness and safety is insufficient. Incorporating data from observational studies did not improve the quality of the evidence on effectiveness.

Cost-effectiveness of vaccines for the prevention of seasonal influenza in different age groups: a systematic review / Coste-efectividad de la vacunación contra la gripe estacional para diferentes grupos de edad: Una revisión sistemática

BACKGROUND: Given the economic burden of seasonal influenza for the healthcare system, we performed a systematic review aiming to update available evidence on the cost-effectiveness of vaccination of seasonal influenza in different age groups, including children. METHODS: A systematic review of the literature on economic evaluations of seasonal influenza vaccination programs in children and adults was carried out. The following databases were searched (January 2013 - April 2018): Medline and PREMEDLINE, EMBASE, EconLit and databases of the Centre for Reviews and Dissemination (DARE, HTA, NHS EED). RESULTS: A total of 11 economic evaluations were included. Methodological quality of included studies was acceptable. Scientific evidence shows that seasonal influenza vaccination programs in school-age children can be a cost-effective alternative from national health system perspective and can be cost-saving from societal perspective in European countries. However, available evidence does not allow us to conclude that influenza vaccination programs in healthy adults under 65 years of age were a cost-effective alternative in our context, due to the high uncertainty and the lack of studies carried out in Spanish context. CONCLUSIONS: Vaccination programs for the prevention of seasonal influenza in school-age children (3-16 years) can be a cost-effective strategy.

OBJETIVO: Dada la carga económica que supone para el sistema sanitario la gripe estacional, se plantea esta revisión sistemática cuyo objetivo fue actualizar la evidencia disponible sobre el coste-efectividad de vacunación contra la gripe estacional en diferentes grupos de edad, incluyendo población infantil. METODOS: Se llevó a cabo una revisión sistemática de la literatura de evaluaciones económicas de los programas de vacunación contra la gripe estacional en niños y adultos. Se realizaron búsquedas en las bases de datos (enero 2013 ­ abril 2018): Medline y PREMEDLINE, EMBASE, EconLit y en las bases de datos del Centre for Reviews and Dissemination (DARE, HTA, NHS EED). RESULTADOS: Se incluyeron 11 evaluaciones económicas. La calidad metodológica de los estudios incluidos fue buena. La evidencia científica muestra que los programas de vacunación contra la gripe estacional en niños en edad escolar pueden ser una estrategia coste-efectiva desde la perspectiva sanitaria en países europeos. La evidencia científica disponible hasta el momento no nos permite concluir que los programas de vacunación antigripal en adultos sanos de menos de 65 años de edad sean una alternativa costeefectiva en nuestro contexto, debido a la elevada incertidumbre existente y a la escasez de estudios realizados en el contexto español. CONCLUSIONES: Los programas de vacunación contra la gripe estacional en niños en edad escolar (3-16 años) pueden ser una estrategia coste-efectiva desde la perspectiva del SNS.

[Usefulness of scoring risk for adverse outcomes in older patients with the Identification of Seniors at Risk scale and the Triage Risk Screening Tool: a meta-analysis]. / Valor de los instrumentos ISAR y TRST para predecir resultados adversos en población general geriátrica asistida en los servicios de urgencias: metanálisis.

OBJECTIVES: A considerable proportion of the geriatric population experiences unfavorable outcomes of hospital emergency department care. An assessment of risk for adverse outcomes would facilitate making changes in clinical management by adjusting available resources to needs according to an individual patient's risk. Risk assessment tools are available, but their prognostic precision varies. This systematic review sought to quantify the prognostic precision of 2 geriatric screening and risk assessment tools commonly used in emergency settings for patients at high risk of adverse outcomes (revisits, functional deterioration, readmissions, or death): the Identification of Seniors at Risk (ISAR) scale and the Triage Risk Screening Tool (TRST). We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and SCOPUS, with no date limits, to find relevant studies. Quality was assessed with the QUADAS-2 checklist (for quality assessment of diagnostic accuracy studies). We pooled data for prognostic yield reported for the ISAR and TRST scores for each short- and medium-term outcome using bivariate random-effects modeling. The sensitivity of the ISAR scoring system as a whole ranged between 67% and 99%; specificity fell between 21% and 41%. TRST sensitivity ranged between 52% and 75% and specificity between 39% and 51%.We conclude that the tools currently used to assess risk of adverse outcomes in patients of advanced age attended in hospital emergency departments do not have adequate prognostic precision to be clinically useful.

OBJETIVO: Una importante proporción de la población geriátrica presenta resultados de salud desfavorables tras ser asistida en servicios de urgencia hospitalaria (SUH). La valoración del riesgo de resultados adversos permitiría modificar el manejo clí- nico, ajustando los recursos disponibles a las necesidades y riesgos de cada paciente. Existen instrumentos de valoración del riesgo, pero su precisión pronóstica varía. Esta revisión sistemática pretende cuantificar la precisión pronóstica de los dos instrumentos de cribado/estratificación de riesgo más empleados, el Identification of Seniors at Risk (ISAR) y Triage Risk Screening Tool (TRST), para identificar la población geriátrica, asistida en los SUH, con alto riesgo de resultados adversos (nuevas visitas a los SUH, deterioro funcional, reingresos hospitalarios y/o muerte). Para ello se realizaron búsquedas en PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) y SCOPUS, sin límite de fechas. La calidad de los estudios se evaluó mediante el instrumento QUADAS-2. Se llevaron a cabo metanálisis sobre el rendimiento pronóstico de los instumentos ISAR y TRST para cada variable de resultado a corto o medio plazo, siguiendo un modelo de efectos aleatorios bivariante. La sensibilidad y la especificidad globales del instrumento ISAR estuvieron comprendidas entre 67-99% y 21-41%, respectivamente; mientras que las estimaciones globales para la sensibilidad y especificidad del TSRT estuvieron comprendidas entre 52-75% y 39-51%, respectivamente. Se concluye que las herramientas evaluadas para determinar el riesgo de eventos adversos en adultos geriátricos atendidos en los SUH no cuentan en la actualidad con la suficiente precisión diagnóstica para ser de utilidad clínica.