To extract and interpret quantitative data exploring the effectiveness of family health conversations (FHCs) on family functioning, perceived support, health-related quality of life, caregiver burden and family health in families living with critical or chronic health conditions.
Addressing the health of families affected by critical or chronic illnesses requires focused attention. The effective integration of FHCs is hampered by a scarcity of rigorous quantitative studies that provide solid evidence on best practices and outcomes.
A systematic review following the Joanna Briggs Institute guidelines.
The review is reported according to the PRISMA 2020 checklist. Appropriate studies were searched in PubMed, CINAHL, PsycINFO, Scopus and Cochrane Databases. Results of the search were imported into the Covidence web-based program. Included were studies with a quantitative research design, delivered to families with critical or chronic health conditions, describing FHCs based on the Calgary Family Assessment Model and/or the Calgary Family Intervention Model, and/or the Illness Beliefs Model, using reliable and validated instruments, published between 2008 and 2023, and written in English.
In total, 24 papers met the inclusion criteria. Sixteen papers used a quasi-experimental design, eight of which included a control group. Two papers used a mixed methods design, and six papers were randomised controlled trials (RCTs). A statistically significant effect of FHCs on family functioning was reported in two RCTs and three quasi-experimental papers. We also found that a statistically significant effect of FHCs was reported on perceived support in 9 of 15 papers, quality of life in 4 of 11 papers and caregiver burden in 1 of 3 papers.
The interventions reviewed revealed variability and partial results concerning the effectiveness of FHCs on family functioning. More rigorous research about short-term, intermediate- and long-term effectiveness is needed before conclusions can be drawn.
The study is reported according to the PRISMA 2020 (Preferred Reporting Items for Systematic reviews and Meta-Analyses) (File S1).
No patient or public contribution. Data were gathered from previously published studies.
Cardiovascular (CV) disease is the leading cause of morbidity and mortality globally. Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor of major adverse cardiovascular events. Patients without prior myocardial infarction (MI) or stroke but with established risk factors and elevated LDL-C may benefit from intensive lipid-lowering therapy (LLT); however, the size and potential healthcare burden of this population globally are not known. The benefits of evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in these patients, are currently being studied in the phase 3 Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) trial. To characterise the high-risk pre–CV-event (VESALIUS-CV–like) individuals in the real world, an observational study is being conducted across multiple countries.
This retrospective cohort study will use a common protocol and an analytical common data model approach to characterise VESALIUS-CV–like individuals in the real world across different geographical regions and healthcare settings. The study period will be from 2010 to 2022, subject to data availability in study sites. Patients aged 50 years and older at high risk of CV disease but without prior MI or stroke will be included in this study. VESALIUS-CV–like individuals are defined through a combination of the following: (1) one diagnosis of coronary artery disease, cerebrovascular disease, peripheral artery disease or diabetes with microvascular complications or chronic insulin use; (2) an elevated LDL-C measurement and (3) other high-risk factors. The objectives of this study are to estimate the prevalence of VESALIUS-CV–like individuals, describe their characteristics and care pathways and estimate their incidence rates of CV events and healthcare costs. The prevalence of VESALIUS-CV–like individuals will be expressed as annual prevalence; patient characteristics at index date will be presented using summary statistics; care pathways will be summarised as LLT prescription across time; and the incidence of defined CV events will be expressed as events per person-years as well as at certain time periods. Healthcare costs will be presented as CV-related costs in different time periods.
Approvals of the study protocol were obtained from relevant local ethics and regulatory frameworks for each participating database. The results of the study will be submitted to peer-reviewed scientific publications and presented at scientific conferences.
The primary objective of this trial is to evaluate the effect of replenishing coagulation factor XIII (FXIII) in women with postpartum haemorrhage (PPH) on measured blood loss (MBL). Based on earlier research, we hypothesise that the administration of FXIII leads to a significant reduction in postpartum blood loss.
This is a randomised, controlled trial that will allocate eligible patients in the event of a PPH and after receiving tranexamic acid either to the treatment group, receiving FXIII, or to the control group (standard of care). The primary endpoint is the MBL within 24 hours using a standardised method. For the primary analysis, estimation of the OR under a proportional odds assumption is conducted simultaneously for all possible cut-off points. A corresponding estimate, along with a two-sided 95% CI and two-sided p value against the null hypothesis OR=1, is obtained from the Continuous Outcome Logistic Regression model. More than 7000 patients will be screened in order to include a total of 988 eligible patients into the trial. Secondary outcomes include the rate of adverse maternal outcomes related to PPH, the rate of women breastfeeding after PPH and the safety of the administration of FXIII in women with PPH. Dynamics of blood coagulation factors in women with PPH and their association with MBL will be assessed in specific centres. A preliminary overview on costs and potential savings through early treatment of PPH with FXIII is included in the analysis as well as a patient and public involvement report, asking for patients’ personal experience during PPH in the main study centre.
Ethics approval was granted by the central ethics committee (Kantonale Ethikkommission Zürich/Switzerland) on 16 June 2024, reference number: BASEC 2024-00374. Results will be disseminated via open-access publication in a relevant medical journal.
ClinicalTrials.gov ID NCT06481995.