Perception of pregnant individuals, health providers and decision makers on interventions to cease substance consumption during pregnancy: a qualitative study.

BACKGROUND: Despite multiple recommendations and strategies implemented at a national and international level, cigarette smoking, alcohol consumption, and cannabis use during pregnancy remains high in most countries. The objective of this study was to examine key stakeholders' perception of the treatment interventions adopted in Spain, to identify political, organizational and personal factors associated with successful implementation, and to propose strategies for improvement. METHODS: A qualitative study with a phenomenological approach was conducted in 2022. The target groups were: (1) clinical decision makers in the field of addiction science, (2) health professionals who carry out treatment interventions, and (3) pregnant individuals who use tobacco, alcohol or cannabis. Two focus groups and eight in-depth interviews were conducted, recorded, and transcribed. Exploratory analysis and inductive open coding was performed, codes were merged into categories, and subcategories were identified. RESULTS: The analysis resulted in 10 subcategories which were further merged into three main categories: (1) Degree of adoption and utility of treatment interventions implemented; (2) Needs and demands with respect to the organization of treatment interventions; and, (3) Personal barriers to and facilitators for treatment. Respondents reported that despite multiple national and regional cessation initiatives, treatment interventions were rarely adopted in clinical practice. Health care administrators demanded reliable records to quantify substance use for better planning of activities. Health care professionals advocated for additional time and training and both echoed the importance of integrating cessation interventions into routine prenatal care and creating in-house specialized units. The difficulty in quitting, lack of awareness of risk for foetus and child and the controversial advice were identified as barriers by pregnant individuals. CONCLUSIONS: Consistent with previous work, this study found that cessation strategies implemented by the health authorities are not effective if they are not accompanied by organizational and behavioral changes. The current study identifies a set of factors that could be pivotal in ensuring the success of treatment interventions targeting tobacco, alcohol and cannabis use among pregnant individuals.

Recommendations by the Spanish Society of Rheumatology on risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis.

OBJECTIVE: To present recommendations based on the available evidence and the consensus of experts, for risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis. METHODS: Clinical research questions relevant to the purpose of the document were identified. These questions were reformulated in PICO format (patient, intervention, comparison, outcome or outcome) by a panel of experts, selected based on their experience in the area. A systematic review of the evidence was carried out, grading according to the GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation). Specific recommendations were then formulated. RESULTS: 6 PICO questions were proposed by the panel of experts based on their clinical relevance and the existence of recent information regarding the risk of occurrence of serious infections, the risk of reactivation of the hepatitis B virus, the risk of reactivation of the virus varicella-zoster, the risk of appearance of skin (melanoma and non-melanoma) or haematological cancer, the risk of appearance of thromboembolic disease and the risk of progression of the human papilloma virus. A total of 28 recommendations were formulated, structured by question, based on the evidence found and the consensus of the experts. CONCLUSIONS: The SER recommendations on risk management of treatment with biologic therapies and JAK inhibitors in rheumatoid arthritis are presented.

Consideraciones para el diseño e implementación de las intervenciones para la cesación de consumo de tabaco, alcohol y cannabis en el embarazo. Un estudio cualitativo / Considerations for the design and implementation of interventions for the cessation of tobacco, alcohol and cannabis use in pregnancy: A qualitative study

Objetivo: Explorar la opinión de distintos actores clave, en relación con los requisitos que deberían cumplir las intervenciones de cesación de consumo de tabaco, alcohol y/o cannabis durante el embarazo para que puedan ser implementadas y resulten aceptables y útiles. Diseño: Estudio cualitativo con aproximación fenomenológica. Sitio: Se realizó en España en 2022. Participantes: Gestores, profesionales sanitarios, embarazadas consumidoras de tabaco, alcohol y/o cannabis y sus parejas también consumidoras. Métodos: Los datos se recogieron mediante grupos focales y entrevistas en profundidad, hasta alcanzar la saturación del discurso y se transcribieron de manera exacta. Se realizó un análisis exploratorio y codificación abierta inductiva, se fusionaron los códigos en categorías y se identificaron subcategorías. Resultados: Se identificaron cuatro categorías y 18 subcategorías. Los resultados apuntan a que las intervenciones deberían de ser multicomponente. Entre las intervenciones más aceptadas por parte de las mujeres embarazadas y sus parejas, las consultas específicas de cesación, la información, el apoyo de un igual (aunque no precisan de qué manera) y los incentivos económicos. Entre otras opciones a considerar, la cooximetría, propuesta por gestores para obtener un registro objetivo. Conclusiones: Se extrae que esta intervención debe realizarse a nivel de la atención prenatal realizada en atención primaria. Existen dudas respecto de la frecuencia, fin y seguimiento de esta intervención multicomponente, así como a la posibilidad de incorporar a las parejas.(AU)

Objective: To explore the opinion of different key stakeholders regarding the requirements that tobacco, alcohol and/or cannabis cessation interventions should meet to be implemented and to be acceptable and useful during pregnancy. Design: A qualitative study with phenomenological approach. Site: The study was conducted in Spain in 2022. Participants: Decision makers, health professionals, pregnant women using tobacco, alcohol and/or cannabis and their partners who are also users. Methods: Data were collected through focus groups and in-depth interviews, until discourse saturation was reached and accurately transcribed. Exploratory analysis and inductive open coding were conducted, codes were merged into categories and subcategories were identified. Results: Four categories and 18 subcategories were identified. The results suggest that interventions should be multicomponent. Among the interventions most accepted by pregnant women and their partners were specific cessation consultations, information, peer support (although they did not specify how) and financial incentives. Among other options to consider, co-oximetry, proposed by managers to obtain an objective register. Conclusions: The conclusion is that this intervention should be carried out at the level of prenatal care in primary care. There are doubts regarding the frequency, purpose, and follow-up of this multicomponent intervention, as well as the possibility of incorporating couples.(AU)

[Considerations for the design and implementation of interventions for the cessation of tobacco, alcohol and cannabis use in pregnancy: A qualitative study]. / Consideraciones para el diseño e implementación de las intervenciones para la cesación de consumo de tabaco, alcohol y cannabis en el embarazo. Un estudio cualitativo.

OBJECTIVE: To explore the opinion of different key stakeholders regarding the requirements that tobacco, alcohol and/or cannabis cessation interventions should meet to be implemented and to be acceptable and useful during pregnancy. DESIGN: A qualitative study with phenomenological approach. SITE: The study was conducted in Spain in 2022. PARTICIPANTS: Decision makers, health professionals, pregnant women using tobacco, alcohol and/or cannabis and their partners who are also users. METHODS: Data were collected through focus groups and in-depth interviews, until discourse saturation was reached and accurately transcribed. Exploratory analysis and inductive open coding were conducted, codes were merged into categories and subcategories were identified. RESULTS: Four categories and 18 subcategories were identified. The results suggest that interventions should be multicomponent. Among the interventions most accepted by pregnant women and their partners were specific cessation consultations, information, peer support (although they did not specify how) and financial incentives. Among other options to consider, co-oximetry, proposed by managers to obtain an objective register. CONCLUSIONS: The conclusion is that this intervention should be carried out at the level of prenatal care in primary care. There are doubts regarding the frequency, purpose, and follow-up of this multicomponent intervention, as well as the possibility of incorporating couples.

Development of a decisional flowchart for meaningful patient involvement in Health Technology Assessment.

INTRODUCTION: This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence. METHODS: A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study. RESULTS: The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients' experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study. CONCLUSIONS: The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

Evaluation of patient involvement strategies in health technology assessment in Spain: the viewpoint of HTA researchers.

OBJECTIVE: The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework. METHODS: A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors. RESULTS: Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future. CONCLUSIONS: PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.

Defective Endogenous Pain Modulation in Fibromyalgia: A Meta-Analysis of Temporal Summation and Conditioned Pain Modulation Paradigms.

To study the characteristics of temporal summation (TS) and conditioned pain modulation (CPM) in fibromyalgia (FM) patients, we systematically searched Pubmed and EMBASE for studies using TS or CPM comparing FM patients with healthy controls. We computed Hedges' g, risk of bias, sensitivity analysis, and meta-regression tests with 10,000 Monte-Carlo permutations. Twenty-three studies (625 female and 23 male FM patients and 591 female and 81 male healthy controls) were included. The meta-analyses showed an effect size of .53 for TS (P < .001; 95% confidence interval = .23-.83), which is a 68% relative difference between patients and controls, and of .57 for CPM (P < .001; 95% confidence interval = -.88 to -.26), representing a 65% relative difference between the groups. The qualitative analyses revealed large heterogeneity between study protocols. Although studies were of low risk of bias, lack of blinding was substantial. Sensitivity analysis and meta-regression identified type and site of stimulation, age, lab, sample size, and medication control as important sources of between-study variability. We showed a significant alteration of pain modulation mechanisms in FM patients. PERSPECTIVE: This novel meta-analysis provides evidence for defective endogenous pain modulation in FM patients. We explored the effect of covariates on between-study variability in these paradigms. These biomarkers may aid in diagnosis, and treatment of patients. However, validation requires further investigation under strict methodological settings, and into individual patient covariates.

Guía de práctica clínica sobre la depresión mayor en la infancia y adolescencia: actualización / Clinical practice guide on major depression in childhood and adolescence: update

Objetivos: Mejorar la atención sanitaria prestada a los niños y adolescentes con depresión en el ámbito de la atención primaria y especializada. Ofrecer recomendaciones al profesional sanitario para la atención de estos pacientes. Desarrollar indicadores de evaluación de la calidad asistencial. Ayudar a los pacientes y a sus familiares a la toma de decisiones informada y a la mejora de la comunicación entre los pacientes y los profesionales. No se abordan otros servicios, como los sociales, educacionales o de tiempo libre. Aspectos contemplados Las áreas clínicas que contempla la guía son: - Criterios diagnósticos y caracterización de la depresión infanto-juvenil. - Factores de riesgo y de protección. - Evaluación. - Perspectivas de pacientes y familiares. - Cribado en atención primaria. - Opciones de tratamiento de la depresión: - Tratamiento psicológico (modalidades, numero de sesiones, duración). - Manejo farmacológico (indicación, dosis, duración, cese, efectos secundarios, toxicidad y ausencia de respuesta a la medicación). - Tratamiento combinado. - Prevención de recaídas/recurrencia. - Estrategias para la depresión que no responde al tratamiento. - Tratamiento de la depresión mayor con síntomas psicóticos. - Otras alternativas terapéuticas: ejercicio físico, intervenciones online y terapias alternativas. - El consentimiento informado desde el punto de vista legal en España. - Algoritmo terapéutico: criterios de derivación y manejo según gravedad. Aspectos no abordados en la GPC 1) Los trastornos distímico, bipolar, ni el adaptativo. 2) La prevención primaria de la depresión en la infancia y adolescencia. 3) La prevención de la conducta suicida, debido a que este aspecto se recoge en la GPC de Prevención y Tratamiento de la Conducta Suicida del Programa de GPC en el SNS, en su apartado especifico sobre infancia y adolescencia.

Guía de práctica clínica para el tratamiento de depresión en adultos / Clinical practice guideline for the treatment of depression in adults

La guía trata de temas relacionados al tratamiento de la depresión, tocando temas como: las perspectivas y experiencias de los pacientes con depresión y sus familiares; evaluación y cribado de la depresión; los modelos de atención; tratamiento psicoterapéutico, tratamiento farmacológico; estrategias psicoterapéuticas y farmacológicas en la depresión resistente.

Effects of stimuli intensity and frequency on auditory p50 and n100 sensory gating.

Sensory gating is the brain's ability to adjust its sensitivity to incoming stimuli, i.e., to diminish its response to irrelevant or repetitive stimuli (gating out) and to increase it when a novel stimulus is presented (gating in). Most of the existing studies have investigated the gating out mechanism, giving little attention to the gating in function. Although both the P50 and N100 components of the auditory ERPs (event related potentials) show amplitude reductions to stimuli repetition, it is not clear if both components are part of a common gating system or if their sensory modulation is uncorrelated. In order to respond to these questions and to further characterize the sensory gating functions, we examined to what extent P50 and N100 are influenced by changes in the stimuli parameters and whether the sensory modulation of both components are interrelated. To this end, we obtained ERPs from 23 healthy volunteers using pairs of auditory stimuli which could be identical (S1 = S2), different in frequency (S1 = 1000 Hz; S2 = 2000 Hz) or different in intensity (S1 = 80 dB SPL; S2 = 100 dB SPL). As expected, the amplitudes of P50 and N100 decreased in response to the second stimuli of the identical pairs. With non-identical pairs, amplitude increases of P50 and N100 were observed only in pairs with different intensity, but not frequency. Thus, the results showed that both P50 and N100 are sensory modulated, showing that amplitude decreased to stimuli repetition (gating out) and increased when the two stimuli of a pair differed in intensity (gating in). A correlational analysis of the sensory gating indices (S2/S1 ratio and S1-S2 difference) obtained for P50 and N100 suggested that the sensory gating function of both components may be of a different nature. The reliability of the ratio and the difference indices of sensory gating is also discussed.