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.

Effectiveness of a decision aid for patients with depression: A randomized controlled trial.

BACKGROUND: Shared decision making is an important component of patient-centred care and decision aids are tools designed to support patients' decision making and help patients with depression to make informed choices. OBJECTIVE: The study aim was to assess the effectiveness of a web-based decision aid for patients with unipolar depression. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: Adults diagnosed with a major depressive disorder and recruited in primary care centres were included and randomized to the decision aid (n=68) or usual care (n=79). INTERVENTION: Patients in the decision aid group reviewed the decision aid accompanied by a researcher. OUTCOME MEASURES: Knowledge about treatment options, decisional conflict, treatment intention and preference for participation in decision making. We also developed a pilot measure of concordance between patients' goals and concerns about treatment options and their treatment intention. RESULTS: Intervention significantly improved knowledge (P<.001) and decisional conflict (P<.001), and no differences were observed in treatment intention, preferences for participation, or concordance. One of the scales developed to measure goals and concerns showed validity issues. CONCLUSION: The decision aid "Decision making in depression" is effective improving knowledge of treatment options and reducing decisional conflict of patients with unipolar depression. More research is needed to establish a valid and reliable measure of concordance between patients' goals and concerns regarding pharmacological and psychological treatment, and the choice made.

Mental health professionals' attitudes to partnership in medicine taking: a validation study of the Leeds Attitude to Concordance Scale II.

PURPOSE: To explore psychiatrists' attitudes toward concordance by validating the Leeds Attitude to Concordance Scale II (LATCon II) in a Spanish sample. METHODS: This was a cross-sectional survey. An opportunistic sample of 125 psychiatrist and 100 psychiatry registrars attending a national conference completed the LATCon II questionnaire and sociodemographic and professional data. The principal component analysis of the LATCon II items was performed. Associations with sociodemographic and mental health professional variables were calculated. RESULTS: Principal component analysis yielded three components labeled "communication/empathy," "shared control," and "eventual paternalistic style." Women obtained significantly lower scores than men on the second component. Mental health professional variables were not related to attitude to concordance. CONCLUSIONS: Psychiatrists show a favorable attitude to involve patients in a process of reciprocal communication, where patients' preferences, values, and expectations are considered, but they are more cautious in their attitude to sharing decisions with patients. There is scope for the different kinds of research in this area: studying sex-based differences in psychiatrists' attitudes to concordance and also exploring the gap in mental health care between patients' and professionals' views of shared decision making. Only in this way can the real partnership for shared decision making be fully understood.

Attitudes toward concordance in psychiatry: a comparative, cross-sectional study of psychiatric patients and mental health professionals.

BACKGROUND: Concordance and Shared Decision-Making (SDM) are considered measures of the quality of care that improves communication, promotes patient participation, creates a positive relationship with the healthcare professional, and results in greater adherence with the treatment plan. METHODS: This study compares the attitudes of 225 mental health professionals (125 psychiatrists and 100 psychiatry registrars) and 449 psychiatric outpatients towards SDM and concordance in medicine taking by using the "Leeds Attitude toward Concordance Scale" (LATCon). RESULTS: The internal consistency of the scale was good in all three samples (Cronbach's α: patients = 0.82, psychiatrists = 0.76, and registrars = 0.82). Patients scored significantly lower (1.96 ± 0.48) than professionals (P < .001 in both cases), while no statistically significant differences between psychiatrists (2.32 ± 0.32) and registrars (2.23 ± 0.35) were registered; the three groups showed a positive attitude towards concordance in most indicators. Patients are clearly in favor of being informed and that their views and preferences be taken into account during the decision-making process, although they widely consider that the final decision must be the doctor's responsibility. Among mental health professionals, the broader experience provides a greater conviction of the importance of the patient's decision about treatment. CONCLUSIONS: We observed a positive attitude towards concordance in the field of psychotropic drugs prescription both in professionals and among patients, but further studies are needed to address the extent to which this apparently accepted model is reflected in the daily practice of mental health professionals.

Adaptation and validation study of the Beliefs about Medicines Questionnaire in psychiatric outpatients in a community mental health setting.

PURPOSE: The present study aims to establish the factor structure and reliability of the Spanish version of the Beliefs about Medicines Questionnaire (BMQ), adapted to psychiatric medication, and to analyze the potential differences between psychiatric outpatients, medical students, and psychology students. METHOD: The BMQ was tested on a sample of 405 psychiatric outpatients, 216 medical students, and 222 psychology students. Students completed only the BMQ-General scale, adapted for psychiatric medication, and patients completed also the BMQ-Specific scale. RESULTS: For the BMQ-General scale adapted items, the analysis shows a two-factor structure similar to that described for the Spanish validation of the original instrument, but when samples are analyzed separately, relevant differences are observed in the composition of the factor structures. Furthermore, the resulting scales show a medium-low internal consistency. For BMQ-Specific scale items, the results replicate previous data. Medical students tend to consider psychiatric medication as less harmful and less likely to be overprescribed than psychology students, with patients' scores in the middle of both groups. CONCLUSION: The BMQ-Specific scale has satisfactory psychometric properties for use in psychiatric outpatients in a community mental health setting. The adapted Spanish BMQ-General scale for psychotropics identified three different structures of the factors for each of the three samples studied.

Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: A randomized trial.

OBJECTIVE: Statin choice, an encounter decision aid (DA), was developed in the USA to facilitate shared decision making between patients and clinicians about the use of statins to reduce cardiovascular risk. We aimed to assess the efficacy of this DA, compared to usual primary care, in Spanish patients with type 2 diabetes. METHODS: Cluster randomized trial with 29 clinicians and 168 patients. Knowledge of statins, cardiovascular risk perception, decisional conflict, anxiety and satisfaction with the decision making process were assessed immediately after intervention, and self-reported adherence at three months. RESULTS: Intervention significantly improved knowledge (p=0.01), perception of the 10-year risk of myocardial infarction without (p=0.01) and with statins (p=0.08), and satisfaction (p=0.01). There were no significant differences in decisional conflict, anxiety, consultation time or adherence, although more intervention patients reported taking all pills during the last week (92.7% vs. 81%; p=0.19). CONCLUSION: The statin choice DA improved the quality of decision making about statins. PRACTICE IMPLICATIONS: This trial contributes to the body of evidence substantiating the efficacy of statin choice and extending it to Spanish clinicians and their patients with type 2 diabetes. TRIAL REGISTRATION: This trial is registered with the European Union Clinical Trials Register (EudraCT: 2010-023912-14).

Patient participation in a Clinical Guideline Development for Systemic Lupus Erythematosus.

OBJECTIVE: To incorporate patients' perspective in the design of a clinical practice guideline (CPG) for Systemic Lupus Erythematosus in Spain. METHODS: A systematic review (SR) of literature and a Delphi-based consultation to patients were carried out. RESULTS: From the SR, most relevant health problems are classified as physical, psychological, familial, and socio-economic. Dissatisfaction is mainly due to unmet information needs and limited access to care. In the consultation (n=102), most frequently reported health problems were pain, fatigue, photosensitivity, mood disorders, renal damage, poor concentration, and memory loss. Dissatisfaction with poor coordination between primary and specialized care was reported. Information to improve self-management and on alternative therapies was requested. Relevant topics from both sources were merged and discussed by the guideline development group (including a patient representative) to set the key questions underpinning the CPG. CONCLUSION: Patient involvement in CPG development by a combination of methods can enhance patient-centered care by achieving clinical practice responsive to their needs. PRACTICE IMPLICATIONS: Involving patients in CPG development is feasible and useful to improve the advance of Health Services toward patient-centered care. A multicomponent strategy for involvement is suggested to address the gap between the available evidence and contextual current patient needs and preferences.

[Promoting citizen participation in healthcare through PyDEsalud.com]. / Promoción de la participación ciudadana en cuidados de salud a través de PyDEsalud.com.

This project supports the initiative promoted by the Spanish National Health System to provide informational materials, in printed or interactive format, to encourage public participation in decision making and healthcare. We present the newly created PyDEsalud.com, a web platform aimed at people with chronic diseases with a high socioeconomic impact, such as breast cancer, depression, and diabetes. This platform uses scientific methodology and contains three information service modules (Patients' experiences, Shared decision making, and Research needs), aimed at promoting health education for patients and families.

[Looking for a more participative healthcare: sharing medical decision making]. / En busca de una salud más participativa: compartiendo decisiones de salud.

The healthcare model is shifting from a paternalistic towards a more inclusive and participative approach, such as shared decision making (SDM). SDM considers patients as autonomous and responsible agents. SDM is a therapeutic approach where healthcare providers and patients share the best evidence available to make a decision according to the values and preferences of the patient. Decision aids are tools that can facilitate this information exchange. These tools help patients to increase knowledge about options, reduce decisional conflict and improve satisfaction. Additionally, communication skills play a key role within the professional-patient relationship, as they facilitate sharing information and preferences in an effective and respectful manner. This therapeutic approach could support the reduction of health inequalities that affect Latin America, as it promotes an active and informed participation of patients in their healthcare process.

Sociodemographic and clinical predictors of compliance with antidepressants for depressive disorders: systematic review of observational studies.

BACKGROUND: The literature shows that compliance with antidepressant treatment is unsatisfactory. Several personal and disease-related variables have been shown to be related to compliance behavior. The objective of this study was to review the literature about sociodemographic and clinical predictors of compliance in patients with depressive disorders. METHODS: The Medline, Embase, Cochrane Central, PsycInfo, and Cinahl databases were searched until May 2012. Studies that analyzed sociodemographic and clinical predictors or correlates of compliance in patients with depressive disorder were included. A quantitative synthesis was not performed because of the heterogeneity and availability of the data reported. For similar reasons, the results were not classified according to the different phases of treatment. The search was limited to studies published in English and Spanish. RESULTS: Thirty-two studies fulfilled the inclusion criteria. The most consistent associations with compliance were found for age (older patients showed more compliance) and race (white patients were more likely to adhere to treatment than minority ethnic groups). Few studies assessed clinical factors, and the most plausible predictors of compliance were certain comorbidities and substance abuse. Severity of depression did not play an important role in predicting compliance. CONCLUSION: The impact of the variables studied on compliance behavior appeared to be inconsistent. Identifying potential predictors of compliance with antidepressant treatment is important, both for the routine practice of the mental health professional and for refining interventions to enhance adherence and target them to specific populations at risk of noncompliance.

Shared decision making in Spain: current state and future perspectives.

In the last two decades there has been a growing recognition in the Spanish National Health System (NHS) of the importance of considering patients' values and preferences in clinical decisions. Patient participation in shared decision making (SDM) is gaining importance as a suitable approach to patient-health professional communication and decision making in Spain. In addition, the NHS is funding the development of patients' decision aids (PtDAs) for shared decision making (SDM) by Health Technology Assessment Agencies. However, the NHS has still not incorporated reforms in law that includes SDM and PtDAs as a key component of health care services and professional curricula, nor is there a standardised implementation of interventions to support decisions in routine care. Most patients are not very familiar with their rights to be kept informed and participate in their own health care decisions. Most professionals are not familiar with or educated about patients' rights to be kept informed and participate in health care decisions either. The future of SDM in Spain is promising. The next course of action should be to maintain the production and adaptation of high-quality PtDAs while at the same time reinforcing effective dissemination strategies among patients and training programmes for professionals focused on SDM.

Patient involvement and shared decision-making in mental health care.

There is growing interest in shared decision-making (SDM) in which the provider and patient go through each phase of the decision-making process together, share treatment preferences, and reach an agreement on treatment choice. Although a majority of the research evaluating SDM has been conducted under "physical" health conditions, patients' participation and SDM for mental health conditions has received increasing interest since the mid 1990s. SDM in mental health care can be more complex than in general health care because that several patient characteristics, health care provider, and system level factors may hinder normalization and implementation of this model into clinical practice. To date, in comparison with other health problems, there are few studies which have assessed SDM in this context. In spite of that, evidence points favorably towards the inclusion of SDM in mental health treatment decisions, given that the majority of patients with mental illness prefer to be involved in the process and wish to have information. However, more studies are needed to provide evidence about the impact of SDM on treatment compliance and health care outcomes. In this overview, the authors present the current state and the future perspectives of SDM in mental health.

Decision aids for patients facing health treatment decisions in Spain: preliminary results.

OBJECTIVE: This study presents ongoing research aimed at understanding the suitability and impact of various decision aids (DAs) on patients with different chronic conditions in the Spanish National Health System. METHODS: A three-phase process was employed to develop and evaluate DAs for patients with hip or knee osteoarthritis (OA), benign prostatic hyperplasia (BPH), and depression, including: (1) systematic reviews on the effectiveness of shared decision making (SDM) interventions (including DAs); (2) the development of DAs; (3) a pilot study assessing the DAs. RESULTS: Systematic reviews carried out highlight that there are few studies assessing the effectiveness of DAs for OA, BPH, and depression. The development of DAs and their assessment currently differs for each medical condition. The DAs assessed for OA and BHP are well accepted. In a pilot study with OA patients, the DA produced a significant improvement in the decisional conflict "informed" subscale. CONCLUSION: Research on SDM and DAs for different chronic conditions is at a very early stage in Spain. It is not possible to draw any definite conclusions about the effectiveness of DAs for clinical practice. PRACTICE IMPLICATIONS: It is necessary to conduct more high quality studies to evaluate the effects of DAs in the Spanish context.

En busca de una salud más participativa: compartiendo decisiones de salud / Looking for a more participative healthcare: sharing medical decision making

El modelo de atención en salud paternalista está derivando hacia modelos más participativos, como lo es la toma de decisiones compartidas (TDC), en el que se considera al paciente como agente responsable y autónomo. La TDC representa un enfoque terapéutico en el que profesionales y pacientes comparten la mejor evidencia científica disponible para tomar una decisión, incorporando los valores y preferencias del paciente. Este intercambio de información puede facilitarse mediante el uso de herramientas de ayuda para la TDC, que han demostrado ser efectivas para mejorar el conocimiento, la satisfacción del paciente, y reducir el conflicto decisional. En este sentido, las habilidades comunicacionales ejercen un rol fundamental en el establecimiento de la relación profesional - paciente, facilitando el intercambio de información y preferencias de manera efectiva y respetuosa. Esta aproximación terapéutica podría apoyar la reducción de las disparidades en salud que prevalecen en Latinoamérica, al facilitar que las personas puedan participar informada y activamente en el cuidado de su salud.

The healthcare model is shifting from a paternalistic towards a more inclusive and participative approach, such as shared decision making (SDM). SDM considers patients as autonomous and responsible agents. SDM is a therapeutic approach where healthcare providers and patients share the best evidence available to make a decision according to the values and preferences of the patient. Decision aids are tools that can facilitate this information exchange. These tools help patients to increase knowledge about options, reduce decisional conflict and improve satisfaction. Additionally, communication skills play a key role within the professional-patient relationship, as they facilitate sharing information and preferences in an effective and respectful manner. This therapeutic approach could support the reduction of health inequalities that affect Latin America, as it promotes an active and informed participation of patients in their healthcare process.

Promoción de la participación ciudadana en cuidados de salud a través de PyDEsalud. com / Promoting citizen participation in healthcare through PyDEsalud. com

Este proyecto apoya la iniciativa, promovida por el Sistema Nacional de Salud en España, de facilitar materiales informativos, en formato impreso o interactivo, que impulsen la participación ciudadana en las decisiones y los cuidados de salud. Se presenta la recientemente creada Plataforma Web PyDEsalud.com, dirigida a personas afectadas por enfermedades crónicas de gran impacto socioeconómico, como son el cáncer de mama, la depresión o la diabetes. Siguiendo una metodología científica de trabajo, esta Plataforma incluye tres módulos de servicios informativos (Experiencias de pacientes, Toma de decisiones compartida y Necesidades de investigación), dirigidos a promocionar la educación sanitaria de pacientes y familiares (AU)

This project supports the initiative promoted by the Spanish National Health System to provide informational materials, in printed or interactive format, to encourage public participation in decision making and healthcare. We present the newly created PyDEsalud.com, a web platform aimed at people with chronic diseases with a high socioeconomic impact, such as breast cancer, depression, and diabetes. This platform uses scientific methodology and contains three information service modules (Patients' experiences, Shared decision making, and Research needs), aimed at promoting health education for patients and families (AU)

Toma de decisiones compartidas en Oncología / Shared decision making in oncology

El concepto de “toma de decisiones compartidas” (TDC) surge en contextos donde pacientes y profesionales sanitarios han de tomar decisiones sobre pruebas diagnósticas o tratamientos en los que no se dispone de una única o “mejor” opción. Para facilitar la TDC se han diseñado las Herramientas de Ayuda para la Toma de Decisiones (HATD), definidas como intervenciones que permiten apoyar a las personas para tomar decisiones entre varias opciones diagnósticas o terapéuticas, proporcionando información acerca de las opciones y resultados esperados sobre el estado de salud de una persona. El uso de las HATD produce un aumento del conocimiento de los pacientes en relación con su condición de salud, disminuye el conflicto decisional, reduce la proporción de personas pasivas en el proceso de toma de decisiones y disminuye el número de personas que permanecen indecisas. No obstante, a pesar de los aparentes efectos positivos de las HATD en muchas áreas de atención sanitaria, incluyendo oncología, aún no se ha alcanzado la normalización de su uso en la asistencia sanitaria. Por tanto, resulta esencial explorar el nivel deseado de implicación de los pacientes y profesionales sanitarios en el proceso de TDC, así como identificar las posibles barreras y facilitadores que influyen en la implementación de estas HATD en nuestro contexto (AU)

Shared decision-making (SDM) arises in contexts where patients and health professionals must make decisions about screening tests or treatments without a single or “best” option. Decision Aids (DAs) are created to facilitate the SDM process. They are interventions designed to help people participate in decision making between various screening tests and therapeutic options, providing information about options and patient’s health outcome status. Using DAs increases patients’ knowledge regarding their health status, decreases decisional conflict, reduces the proportion of people who were passive in decision-making and reduces the proportion of people who remained undecided post-intervention. Nevertheless, despite the apparent positive effects of DAs in many health care specialties, including oncology, a standard use has not been yet reached. Therefore, it is essential to explore desired level involvement of patients and health professionals in SDM process, and identify potential barriers and facilitators influencing implementation of DAs in our context (AU)