Recommendations on self-management interventions for adults living with obesity: COMPAR-EU project.

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.

COMPAR-EU Recommendations on Self-Management Interventions in Type 2 Diabetes Mellitus.

Self-management interventions (SMIs) offer a promising approach to actively engage patients in the management of their chronic diseases. Within the scope of the COMPAR-EU project, our goal is to provide evidence-based recommendations for the utilisation and implementation of SMIs in the care of adult individuals with type 2 diabetes mellitus (T2DM). A multidisciplinary panel of experts, utilising a core outcome set (COS), identified critical outcomes and established effect thresholds for each outcome. The panel formulated recommendations using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, a transparent and rigorous framework for developing and presenting the best available evidence for the formulation of recommendations. All recommendations are based on systematic reviews (SR) of the effects and of values and preferences, a contextual analysis, and a cost-effectiveness analysis. The COMPAR-EU panel is in favour of using SMIs rather than usual care (UC) alone (conditional, very low certainty of the evidence). Furthermore, the panel specifically is in favour of using ten selected SMIs, rather than UC alone (conditional, low certainty of the evidence), mostly encompassing education, self-monitoring, and behavioural techniques. The panel acknowledges that, for most SMIs, moderate resource requirements exist, and cost-effectiveness analyses do not distinctly favour either the SMI or UC. Additionally, it recognises that SMIs are likely to enhance equity, deeming them acceptable and feasible for implementation.

Effectiveness and Cost-Effectiveness of Self-Management Interventions for Adults Living with Heart Failure to Improve Patient-Important Outcomes: An Evidence Map of Randomized Controlled Trials.

Self-management interventions (SMIs) may enhance heart failure (HF) outcomes and address challenges associated with disease management. This study aims to review randomized evidence and identify knowledge gaps in SMIs for adult HF patients. Within the COMPAR-EU project, from 2010 to 2018, we conducted searches in the databases MEDLINE, CINAHL, Embase, Cochrane, and PsycINFO. We performed a descriptive analysis using predefined categories and developed an evidence map of randomized controlled trials (RCTs). We found 282 RCTs examining SMIs for HF patients, comparing two to four interventions, primarily targeting individual patients (97%) globally (34 countries, only 31% from an European country). These interventions involved support techniques such as information sharing (95%) and self-monitoring (62%), often through a mix of in-person and remote sessions (43%). Commonly assessed outcomes included quality of life, hospital admissions, mortality, exercise capacity, and self-efficacy. Few studies have focused on lower socio-economic or minority groups. Nurses (68%) and physicians (30%) were the primary providers, and most studies were at low risk of bias in generating a random sequence for participant allocation; however, the reporting was noticeably unclear of methods used to conceal the allocation process. Our analysis has revealed prevalent support techniques and delivery methods while highlighting methodological challenges. These findings provide valuable insights for researchers, clinicians, and policymakers striving to optimize SMIs for individuals living with HF.

Psychometric properties of the Greek versions of the Pandemic-Related Pregnancy Stress Scale and the Pandemic-Related Postpartum Stress Scale and associated risk factors during the second year of the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has affected perinatal mental health. Reliable tools are needed to assess perinatal stress during pandemic situations. AIMS: To assess the psychometric properties of the Greek versions of the Pandemic-Related Pregnancy Stress Scale (PREPS) and the Pandemic-Related Postpartum Stress Scale (PREPS-PP) and to explore the associations between women's characteristics and perinatal stress during the second pandemic wave. METHODS: The PREPS and PREPS-PP were completed by 264 pregnant and 188 postpartum women, respectively, who also completed the State-Trait Anxiety Inventory (STAI) and the Edinburgh Perinatal Depression Scale (EPDS). RESULTS: The internal consistency was similar for PREPS and PREPS-PP. It was good for preparedness stress (a = 0.77 and α = 0.71, respectively) and infection stress (α = 0.83 for both scales) but low for positive appraisal (α = 0.46 and α = 0.41, respectively). Of the pregnant women, 55.33% and 55.27%, respectively, reported scores of ≥40 on STAI-S and STAI-T, and the respective percentages for the postpartum women were 47.34% and 46.80%. In addition, 14.39% of the pregnant women and 20.74% of the postpartum women scored ≥13 on the EPDS. Higher preparedness stress on PREPS and PREPS-PP was associated with primiparity (P = 0.022 and P = 0.021, respectively) and disrupted perinatal care (P = 0.069 and P = 0.007, respectively). In postpartum women, higher infection stress was associated with chronic disease (P = 0.037), primiparity (P = 0.02) and perceived risk of infection (P = 0.065). Higher score on infection stress was associated with disrupted perinatal care in both groups (P = 0.107 and P = 0.010, respectively). CONCLUSIONS: The Greek versions of PREPS and PREPS-PP are valid tools for the assessment of women at risk of perinatal stress during a health crisis.

Graphical tools for visualizing the results of network meta-analysis of multicomponent interventions.

Network meta-analysis (NMA) is an established method for assessing the comparative efficacy and safety of competing interventions. It is often the case that we deal with interventions that consist of multiple, possibly interacting, components. Examples of interventions' components include characteristics of the intervention, mode (face-to-face, remotely etc.), location (hospital, home etc.), provider (physician, nurse etc.), time of communication (synchronous, asynchronous etc.) and other context related components. Networks of multicomponent interventions are typically sparse and classical NMA inference is not straightforward and prone to confounding. Ideally, we would like to disentangle the effect of each component to find out what works (or does not work). To this aim, we propose novel ways of visualizing the NMA results, describe their use, and illustrate their application in real-life examples. We developed an R package viscomp to produce all the suggested figures.

Exploring the Effectiveness of Self-Management Interventions in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Chronic diseases are a leading cause of global morbidity and mortality. In response to this challenge, self-management interventions (SMIs) have emerged as an essential tool in improving patient outcomes. However, the diverse and complex nature of SMIs pose significant challenges in measuring their effectiveness. This work aims to investigate the comparative effectiveness of SMIs on Type 2 diabetes mellitus (T2DM) outcomes. METHODS: A rigorous analytical framework was employed to assess the relative effectiveness of different SMIs, encompassing both pairwise and network meta-analysis (NMA), as well as component network meta-analysis (CNMA). Various outcomes were considered, including glycated hemoglobin (HbA1c) control, body mass index (BMI) reduction and low-density lipoprotein (LDL) cholesterol. Visualization tools were also utilized to enhance the interpretation of results. RESULTS: SMIs were found promising in improving clinical outcomes and patient-reported measures. However, considerable heterogeneity and inconsistency across studies challenged the validity of NMA results. CNMA along with various visualization tools offered insights into the contributions of individual SMI components, highlighting the complexity of these interventions. DISCUSSION/CONCLUSIONS: SMIs represent a valuable approach to managing chronic conditions, but their effectiveness is context-dependent. Further research is needed to elucidate the contextual factors influencing SMI outcomes. This work contributes to a comprehensive understanding of SMIs' role in T2DM management, aiming to aid decision-makers, clinicians, and patients in selecting tailored interventions.

EAES rapid guideline: systematic review, meta-analysis, GRADE assessment, and evidence-informed European recommendations on appendicitis in pregnancy.

BACKGROUND: Clinical practice recommendations for the management of acute appendicitis in pregnancy are lacking. OBJECTIVE: To develop an evidence-informed, trustworthy guideline on the management of appendicitis in pregnancy. We aimed to address the questions of conservative or surgical management, and laparoscopic or open surgery for acute appendicitis. METHODS: We performed a systematic review, meta-analysis, and evidence appraisal using the GRADE methodology. A European, multidisciplinary panel of surgeons, obstetricians/gynecologists, a midwife, and 3 patient representatives reached consensus through an evidence-to-decision framework and a Delphi process to formulate the recommendations. The project was developed in an online authoring and publication platform (MAGICapp). RESULTS: Research evidence was of very low certainty. We recommend operative treatment over conservative management in pregnant patients with complicated appendicitis or appendicolith on imaging studies (strong recommendation). We suggest operative treatment over conservative management in pregnant patients with uncomplicated appendicitis and no appendicolith on imaging studies (weak recommendation). We suggest laparoscopic appendectomy in patients with acute appendicitis until the 20th week of gestation, or when the fundus of the uterus is below the level of the umbilicus; and laparoscopic or open appendectomy in patients with acute appendicitis beyond the 20th week of gestation, or when the fundus of the uterus is above the level of the umbilicus, depending on the preference and expertise of the surgeon. CONCLUSION: Through a structured, evidence-informed approach, an interdisciplinary panel provides a strong recommendation to perform appendectomy for complicated appendicitis or appendicolith, and laparoscopic or open appendectomy beyond the 20th week, based on the surgeon's preference and expertise. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN210.

The WHOQOL-BREF instrument: Psychometric evaluation of the Greek version in patients with advanced cancer and pain and associations with psychological distress.

OBJECTIVES: Assessment of the psychometric characteristics of the Greek version of the brief World Health Organization Quality of Life Instrument (WHOQOL-BREF) in patients with advanced cancer and pain, and exploration of the association between psychological distress and quality of life (QoL). METHOD: The sample consisted of 145 patients with advanced cancer and pain who completed the WHOQOL-BREF, the Symptom Checklist-90 (SCL-90), and the Pain Visual Analogue Scale (VAS). In analysis, the following methods were used: Cronbach's alpha, Item Response Theory (IRT), polychoric, Pearson and polyserial correlation, t-test, and Linear regression. RESULTS: The internal consistency was high for all domains of the WHOQOL-BREF (Cronbach's α ≥ 0.731). Similarly, with the exception of three items, the WHOQOL-BREF items has large discrimination parameters suggesting that they have a high ability in differentiating subjects. On SCL-90, the three dimensions with the highest scores were Depression, Somatization, and Anxiety. The overall score for psychological distress, the Global Severity Index (GSI), showed significant negative association with all the WHOQOL-BREF factor scores (Physical Health: B = -1.488, p < 0.001, Psychological Health: B = -1.688, p < 0.001, Social Relationships: B = -0.910, p < 0.001, Environment: B = -1.064, p < 0.001). Male gender was associated with lower scores for Social Relationships (B = -0.358, p = 0.007) and Environment (B = -0.293, p = 0.026). SIGNIFICANCE OF RESULTS: The Greek version of the WHOQOL-BREF showed good psychometric properties in patients with advanced cancer and can be used as a reliable instrument in clinical practice. The level of psychological distress can be considered a determinant of QoL in patients with advanced cancer and pain, independently of pain intensity or other clinical characteristics. In cancer, the disease process can activate multiple physiological and psychological mechanisms that lead to a wide range of symptoms of psychological distress. To improve their QoL, psychological intervention focused on the identification and alleviation of psychological distress in patients with advanced cancer, and help in finding meaning in their experience, should be provided.

Intravenous Thrombolysis with Tenecteplase for the Treatment of Acute Ischemic Stroke.

OBJECTIVE: Intravenous thrombolysis (IVT) with tenecteplase has been associated with better clinical outcomes in acute ischemic stroke (AIS) patients with confirmed large vessel occlusions compared to IVT with alteplase. However, the utility of tenecteplase for the treatment of all AIS patients eligible for IVT has not been established. METHODS: We compared the safety and efficacy of tenecteplase versus alteplase in AIS patients by analyzing propensity score matched data from 20 centers participating in the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register. Patients receiving IVT with tenecteplase were matched with up to 3 patients receiving alteplase from the same center. The primary outcome of interest was the distribution of 3-month functional outcomes. Secondary outcomes included the rates of patients with symptomatic intracranial hemorrhage (SICH) in the first 24 hours, excellent (modified Rankin Scale [mRS] score = 0-1) or good (mRS score = 0-2) functional outcome, and all-cause mortality at 3 months. RESULTS: A total of 331 tenecteplase-treated AIS patients were matched to 797 patients treated with alteplase (median age = 70 years, 43.9% women, median National Institutes of Health Stroke Scale score = 11, interquartile range = 6-17). Patients treated with tenecteplase had better 3-month functional outcomes (common odds ratio [OR] = 1.54, 95% confidence interval [CI] = 1.18-2.00) with higher odds of good functional outcome (OR = 2.00, 95% CI = 1.45-2.77) and a lower likelihood of all-cause mortality (OR = 0.43, 95% CI = 0.27-0.67) at 3 months, compared to alteplase-treated patients. No difference was found in the likelihood of the 3-month excellent functional outcomes (OR = 1.31, 95% CI = 0.96-1.78) and 24-hour SICH (1.0% vs 1.3%, OR = 0.72, 95% CI = 0.20-2.64). INTERPRETATION: IVT with tenecteplase was associated with better 3-month clinical outcomes compared to IVT with alteplase in AIS patients, with no increased risk of symptomatic intracranial bleeding. ANN NEUROL 2022;92:349-357.