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Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION : How to present economic evaluations to non-technical audiences? Randomized trials with professionals and the general population

Renata Linertová, Aránzazu Hernández-Yumar, Carmen Guirado-Fuentes, Benjamín Rodríguez-Díaz, Cristina Valcárcel-Nazco, Iñaki Imaz-Iglesia, Montserrat Carmona-Rodríguez, Lidia García-Pérez

ABSTRACT

Background

Cost-effectiveness analyses of health technologies have become a part of the decision-making process in healthcare policies. Nevertheless, economic results are not always presented in comprehensible formats for non-technical audiences, such as the general population, healthcare professionals or decision-makers. The purpose of this study was to observe which formats best convey the key message of an economic evaluation, and which are best received by two different audiences.

Methods

The summary of a hypothetical cost-effectiveness analysis was edited in different formats: infographic, plain language text and video-abstract for the general population; executive summary and policy brief for a specialized population, i.e. clinicians, clinical and non-clinical managers, or methodologists in health-technology assessment. Participants were randomly shown one of the formats, and data on objective and subjective comprehension, and perceived usefulness/acceptability were gathered by means of online questionnaires. Statistical differences between formats within each audience were analysed.

Results

In the general population (N = 324), objective comprehension was statistically significantly better for infographic than for video-abstract (p = 0.005), and for plain text than for video-abstract (p = 0.024). There were no differences in subjective comprehension, but video-abstract was considered statistically significantly more useful to understand the information than plain text (p = 0.011). In the specialized population (N = 100), no statistically significant differences were observed for objective and subjective comprehension, although policy brief was perceived as statistically significantly more useful than executive summary (p = 0.005).

Conclusions

A balance between effectivity of conveying the message and attractivity of the format needs to be sought, to facilitate non-technical audiences’ understanding of economic data and, consequently, perceive decision-making processes as more transparent and legitimate. The infographic and policy brief could be robust ways to present economic data to the general public and specialized audience, respectively.

You can read the full article here.

 

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: The three-domain impact framework for characterizing impact of patient involvement in health technology assessment

Verónica López Gousset, Aline Silveira Silva, Anke-Peggy Holtorf, Ana Toledo-Chávarri, Ann Single.

ABSTRACT

Objectives

Evaluating the impact of patient involvement in health technology assessments (HTA) may help improve practices and avoid ineffective activities. Evaluation, however, continues to be infrequent, inconsistent, and often only relates to process quantity or quality. The Patient and Citizen Involvement in HTA Interest Group (PCIG) within Health Technology Assessment International set out to contextualize this impact to support evaluation.

Methods

Given the lack of established methodology to measure impact, the team performed a qualitative analysis of first-hand accounts about perceived changes in HTA due to involvement of patient stakeholders. A questionnaire was developed, piloted, and rolled out to collect personal perspectives from stakeholders with relevant experience. The stories were analyzed in the aggregate to identify themes in the data.

Results

From January 2019 to September 2021, twenty-four responses were collected through PCIG’s network. Responses (including one joint industry-HTA body submission) came from patient representatives (12), HTA bodies (11), and industry representatives (2) from North America (5), South America (3), Europe (13), and Asia Pacific (3). Based on themes commonly reported, a three-domain framework for evaluating impact is proposed: impact on basis of HTA result or recommendation, impact on HTA body, and impact on patient participants. The framework includes components under each domain to support reporting.

Conclusions

Using the Three-Domain Impact Framework may be useful in identifying, evaluating, and communicating the value of patient involvement in HTA. Enhancing and increasing reporting practices may improve transparency and facilitate process improvements for meaningful integration of patient stakeholders into HTA appraisals across jurisdictions.

Keywords

patient involvement; health technology assessment; impact; qualitative evaluation

You can read the full article here.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: A qualitative evidence synthesis of continuous subcutaneous insulin infusion: acceptability, implementation, equity

Ana Toledo-Chávarri, Janet Delgado, María Padilla, Beatriz Rodríguez-Martín

ABSTRACT

This work provides a synthesis of the perceptions of people with type 1 diabetes mellitus (T1DM) and healthcare professionals regarding the acceptability, implementation, and equity of continuous subcutaneous insulin infusion (CSII). A qualitative evidence synthesis was carried out. Three online databases (Medline, Embase, and Web of Science) were searched. Qualitative articles available in Spanish or English were included. A descriptive thematic synthesis was conducted according to PRISMA and ENTREQ guidelines.

Thirty-two references met the inclusion criteria of the study and were included from an initial 345 identified references. Seven main themes were identified:
(a) acceptability,
(b) adaptation to the insulin pump,
(c) facilitators for the adequate use of the insulin pump,
(d) variability of acceptability,
(e) barriers to the use of the insulin pump,
(f) feasibility and implementation considerations, and
(g) equity.

CSII is well accepted by most people with T1DM, with some exceptions. It can relieve the burden of disease management, increase autonomy and flexibility, and improve family relationships. There were multiple perceived barriers to its continued use. Future studies should continue to analyze inequalities in access to and use of CSII.

You can read the full article here.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: The Importance of Early Detection and Treatment in NKX2-1-Related Disorders

1) Systematic review of thyroid function in NKX2-1-related disorders: Screening and diagnosis

Beatriz Carmona Hidalgo, Carmen Martín-Gómez, Estefanía Herrera-Ramos, Rocío Rodríguez-López, Laia-Nou Fontanet, José C Moreno, Juan Antonio Blasco-Amaro, Juliane Léger, Juan Darío Ortigoza Escobar, Grupo de trabajo de directrices sobre trastornos relacionados con NKX2-1

ABSTRACT

Background: NKX2-1-related disorders (NKX2-1-RD) are rare conditions affecting lung, thyroid, and brain development, primarily caused by pathogenic variants or deletions in the NKX2-1 gene. Congenital hypothyroidism (CH) is a common endocrine manifestation, leading to irreversible intellectual disability if left untreated.

Objectives: The aim was to evaluate the current evidence for the use of screening and diagnostic techniques for endocrine alterations in patients with NKX2-1-RD.

Methods: This systematic review was reported following the PRISMA guidelines. Two separate research questions in PICO format were addressed to cover initial screening and diagnosis procedures for endocrine diseases in patients with NKX2-1-RD. Eligibility criteria focused on patients with genetic confirmation of the disease and hypothyroidism. Various databases were searched, and data were extracted and assessed independently by two reviewers.

Results: Out of 1012 potentially relevant studies, 46 were included, for a total of 113 patients. CH was the most frequent endocrine alteration (45% of patients). Neonatal screening was reported in only 21% of patients based on blood TSH measurements. TSH thresholds varied widely across studies, making hypothyroidism detection ranges difficult to establish. Diagnostic tests using serum TSH were used to diagnose hypothyroidism or confirm its presence. 35% of patients were diagnosed at neonatal age, and 42% at adult age. Other hormonal dysfunctions identified due to clinical signs, such as anterior pituitary deficiencies, were detected later in life. Thyroid scintigraphy and ultrasonography allowed for the description of the thyroid gland in 30% of cases of hypothyroidism. Phenotypic variability was observed in individuals with the same variants, making genotype-phenotype correlations challenging.

Conclusion: This review highlights the need for standardized protocols in endocrine screening for NKX2-1-RD, emphasizing the importance of consistent methodology and hormone threshold levels. Variability in NKX2-1 gene variants further complicates diagnostic efforts. Future research should concentrate on optimizing early screening protocols and diagnostic strategies.

You can read the full article here.

 

2) Systematic review of thyroid function in NKX2-1-related disorders: Treatment and follow-up

Beatriz Carmona Hidalgo, Estefanía Herrera-Ramos, Rocío Rodríguez-López, Laia Nou-Fontanet, José C Moreno, Juan Antonio Blasco-Amaro, Juliane Léger, Juan Darío Ortigoza Escobar, Grupo de trabajo de directrices sobre trastornos relacionados con NKX2-1

ABSTRACT

Background: NKX2-1, a crucial transcription factor in thyroid, lung, and brain development, is associated with rare disorders featuring thyroid dysfunction, neurological abnormalities, and respiratory symptoms. The primary challenge in managing NKX2-1-related disorders (NKX2-1-RD) is early diagnosis of the genetic defect and treating specific endocrine disorders. Levothyroxine (LT4) serves as the standard hypothyroidism treatment, with required dosages influenced by the severity of the individual’s disorder, which varies widely among affected individuals.

Objectives: This systematic review aims to assess the effectiveness of LT4 treatment in NKX2-1-RD and explore optimal dosing strategies. The primary focus is on the challenges associated with the prompt diagnosis of genetic defects, rather than the established treatment protocols for individual endocrine failures.

Methods: Adhering to PRISMA guidelines, the review includes 42 studies involving 110 genetically confirmed NKX2-1-RD patients with hypothyroidism. The study investigates congenital hypothyroidism as the most prevalent endocrine alteration, along with gestational and overt hypothyroidism. The administration of LT4 treatment, dosages, and patient responses are analyzed.

Results: Among the findings, congenital hypothyroidism emerges as the predominant endocrine alteration in 41% of patients. Notably, LT4 treatment is administered in only 10% of cases, with a mean dose of 52 μg/day. The variability in initiation and dosage is likely influenced by the age at diagnosis. Positive responses, characterized by TSH adjustments within normal ranges, are observed in 11 monitored patients.

Conclusions: Early detection of congenital hypothyroidism is emphasized for timely LT4 initiation. Challenges in standardization are highlighted due to the variability in clinical manifestations and diagnostic procedures across NKX2-1-RD cases. While this review provides valuable insights into thyroid and pituitary disease treatment, limited details on LT4 treatment represent a significant study limitation. Key reporting points for future case studies are proposed to enhance the understanding and management of NKX2-1-RD hypothyroidism.

You can read the full article here.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS publication: Genicular artery embolization for knee osteoarthritis: a systematic review with meta-analysis and cost-analysis

Aránzazu Hernández-Yumar, Yadira González-Hernández, Tasmania del Pino-Sedeño, Cristina Valcárcel-Nazco, Aythami de Armas-Castellano, Estefanía Herrera-Ramos, Julián Portero Navarro, Montserrat Carmona-Rodríguez, María Ximena Rojas-Reyes, María M. Trujillo-Martín

ABSTRACT

Objetive

To assess the effectiveness, safety, and cost-effectiveness of genicular artery embolization (GAE) for the treatment of mild or moderate knee osteoarthritis (KO) refractory to standard treatment, and/or severe KO in individuals not eligible for surgery.

Method

We conducted a systematic review with meta-analysis, supplemented by a cost-analysis, comparing GAE and standard treatment, from the perspective of the Spanish National Health System (NHS) over a one-year time horizon. The health improvement required for GAE to be deemed cost-effective was quantified, considering a willingness-to-pay threshold of 25 000 €/quality-adjusted life year (QALY).

Results

We included two randomized controlled trials in our analysis. Pain estimates showed inconsistent results, and no significant effects were observed for overall function, health-related quality of life, or changes in the need for pain management medication. No serious complications or major adverse events were observed. GRADE quality of evidence ranged from moderate to low. No economic evaluations were identified. Our cost-analysis revealed that GAE would result in an incremental cost of € 3432.37 per patient, requiring a health improvement of 0.137 QALY per patient to be deemed a cost-effective technology.

Conclusions

In summary, based on moderate to low-certainty evidence, it remains inconclusive whether there is any difference between GAE and standard treatment for KO. However, the use of GAE would increase the costs. Larger randomized controlled trials are needed to determine the effects of using GAE for chronic pain secondary to KO and, consequently, to ascertain whether this technology could potentially become cost-effective from the NHS perspective.

Keywords

Genicular artery; Embolization; Knee osteoarthritis; Pain; Systematic review; Economic evaluation.

You can read the full article here.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: Correlates of Control Preferences, Participation in Decision-making and Activation in Patients with Substance Use Disorder

Pedro Serrano-Pérez, Amado Rivero-Santana, Constanza Daigre-Blanco, Raúl Felipe Palma-Álvarez, Icía Nistal-Franco, Josep Antoni Ramos-Quiroga, Lara Grau-López

Background: Treatment of Substance Use Disorder (SUD) is complex and therefore including patients in the therapeutic process is needed. Patient-Centered Care (PCC) and Shared Decision-Making (SDM) have been associated with greater satisfaction, self-control, and less substance use. However, correlates of SDM have not been investigated in this population.

Method: A cross-sectional analysis was carried out in 214 SUD patients to identify sociodemographic, clinical and psychological correlates of preferences and perceptions about participation in SDM and degree of activation. The Control Preference Scale (CPS), the Shared Decision-Making Questionnaire (SDM-9-Q) and the Patient Activation Measure (PAM) were used to assess the PCC elements. Multinomial logistic regression was used to analyze the correlates of the CPS variables (preferred role, perceived role, and role matching). For SDM-9-Q and PAM, multilevel linear regression was used.

Results: Preferring an active role, compared to a shared one, was significantly associated with higher educational level, lower neuroticism, absence of affective and alcohol use disorders, and higher quality of life. Perceiving greater participation was significantly associated with not being a new patient, having fewer legal problems, higher severity of alcohol consumption, not presenting polydrug use and main substance use different than opioids or sedatives. Activation was associated with higher scores in the personality trait activity, a preference for an active role and greater perception of being involved in the decision process.

Conclusions: Patients with milder clinical profiles prefer an active role compared to a shared one. Patients who prefer or perceive a shared or passive role did not show relevant differences. Greater activation was related to preference for an active role and the perception of having been involved in decisions.

Keywords
shared decision-making; patient preference; substance use disorder; patient autonomy

You can read the full article here.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: Fostering Shared Decision-Making Between Patients and Health Care Professionals in Clinical Practice Guidelines: Protocol for a Project to Develop and Test a Tool for Guideline Developers

Lena Fischer, Fülöp Scheibler, Corinna Schaefer, Torsten Karge, Thomas Langer, Leon Vincent Schewe, Ivan D Florez, Andrew Hutchinson, Sheyu Li, Marta Maes-Carballo, Zachary Munn, Lilisbeth Perestelo-Perez, Livia Puljak, Anne Stiggelbout, Dawid Pieper

ABSTRACT

Background: Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking.

Objective: The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation.

Methods: The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs.

Results: The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026.

Conclusions: The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs will create a systematic link between CPGs, SDM, and PDAs, which may facilitate SDM in clinical practice.

KEYWORDS

shared decision-making; practice guidelines as topic; decision support techniques; support; decision-making; decisions; tool;
testing tool; protocol; medical decision-making; patient decision aid; decision aid; tool development

You can read the full article here.

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SESCS PUBLICATION: Effectiveness of Psychological Interventions in Endometriosis: A Systematic Review with Meta-Analysis

del Pino-Sedeño T, Cabrera-Maroto M, Abrante-Luis A, González-Hernández Y, Ortíz Herrera M C.

ABSTRACT

Introduction: Endometriosis is a chronic gynecological disease associated with chronic debilitating pain, poor mental health and quality of life. The objective of this paper is to evaluate the effectiveness of psychological interventions aimed at improving the pain, quality of life and mental health of women with endometriosis.

Methods: A systematic review (SR) of the literature with meta-analysis (MA) was carried out. MEDLINE, Embase, PsycINFO and CENTRAL were searched to locate Randomized Controlled Trials (RCTs). The risk of bias assessment of each study was conducted using the Cochrane Collaboration’s RoB 2.0 tool.

Results: Seven RCTs were included (N = 757). The data obtained suggest that psychological interventions reduce dyspareunia [standardized mean difference (SMD): -0.54, 95% CI: −0.86, −0.22] and dyschezia [mean difference (MD): -2.90, 95% CI: −4.55, −1.26] and increase mental health levels (SMD: 0.70, 95% CI: 0. 42, 0.99); they also point to a large reduction in levels of trait anxiety (MD: -6.63, 95% CI: −8.27, −4.99) and depression (MD: -2.49, 95% CI: −3.20, −1.79), and a likely reduction in state anxiety (MD: -9.72, 95% CI: −13.11, −6.33) experienced by women with endometriosis. It was also identified that psychological interventions probably slightly reduce pelvic pain and may increase physical health. However, most of the included studies have a high overall risk of bias or have certain concerns, which limit conclusions about the certainty of the evidence.

Discussion: The available evidence indicates that psychological interventions are effective in improving the pain, quality of life and mental health variables of women with endometriosis.

You can read the full article (in English) here.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: Recommendations on self-management interventions for adults living with obesity: COMPAR-EU project

Melixa Medina Aedo, Jessica Beltrán, Claudia Valli, Carlos Canelo Aybar, Canción Yang, Marta Ballester, Jacqueline Bowman-Busato, Cristo Cristogiannis, María G. Grammatikopoulou, Oliver Groene, Monique Heijmans, Martine Hoogendorn, Sarah Louise Killeen, Katerina-Maria Kontouli, Dimitris Mavridis, Miñambres Inka, Beate Sigrid Mueller, Ena Niño de Guzmán, Janneke Noordman, Carola Orrego, Lilisbeth Perestelo-Pérez, Zuleika Saz-Parkinson, Georgios Seitidis, Rosa Suñol, Sofía Tsokani, Pablo Alonso Coello

ABSTRACT

Self-management interventions (SMIs) may improve disease management in adults living with obesity. We formulated evidence-based recommendations for SMIs within the context of the COMPAR-EU project. The multidisciplinary panel selected critical outcomes based on the COMPAR-EU core outcome set and established decision thresholds for each outcome. Recommendations were informed by systematic reviews of effects, cost-effectiveness, and a contextual assessment. To assess the certainty of the evidence and formulate the recommendations, we used the GRADE approach guidance. Overall, SMIs were deemed to have a small impact, but the absence of harmful effects and potential cumulative benefits indicated a favourable balance of effects, despite low certainty. SMIs showed variations in structure, intensity, and resource utilisation, but overall are likely to be cost-effective. Adapting SMIs to local contexts would enhance equity, acceptability, and feasibility, considering patients’ values, and availability of resources and teamwork. Consequently, the panel made conditional recommendations favouring SMIs over usual care. The rigorous and explicit recommendations demonstrated the effectiveness of SMIs for adults living with obesity. However, the gaps in the literature influenced the panel to make only conditional recommendations in favour of SMIs. Further research is needed to strengthen the evidence base and improve recommendations’ certainty and applicability.

Keywords: guideline; obesity; recommendations; self‐management interventions.

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Or, if you prefer, you can access it via PUBMED.

Predictores sociodemográficos y clínicos de la adherencia a los antidepresivos en los trastornos depresivos: una revisión sistemática con un metanálisis
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SESCS PUBLICATION: Effectiveness of interventions to improve adherence to antidepressant medication in patients with depressive disorders: a cluster-randomized controlled trial

Tasmania del Pino-Sedeño, Himar González-Pacheco, Beatriz González de León, Pedro Serrano Pérez, Francisco Javier Acosta Artiles, Cristina Valcárcel-Nazco, Isabel Hurtado Navarro, Cristobalina Rodríguez Álvarez, María M. Trujillo-Martín.

ABSTRACT

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.

You can read the full text here.