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Research shows the important role of parents' mental health literacy in detecting depressive symptoms and supporting their children to seek professional help. Improving mental health literacy in parents has recently gained even greater importance due to the negative impact of the COVID-19 pandemic on children and adolescents' mental health. The aim of the present experimental pre-post-follow-up study was to examine knowledge change after the reception of contents from an innovative web-based platform (www.ich-bin-alles.de/eltern) containing evidence-based information on youth depression and mental health in parents of adolescents with a history of depression. A second aim was to assess evaluation of the layout and the acceptance of the platform. N = 33 parents of adolescents with a history of depression (either current or remitted depression) were presented different content domains of the website. Participants' knowledge about depression was assessed at pre- and post-intervention, and at a four week follow-up. Moreover, parents evaluated the acceptance and the layout of the website. The trial was preregistered at clinicaltrials.gov (NCT05335564). The results showed a significant increase in total knowledge from pre to post, which remained stable over the course of four weeks. Explorative analyses showed that sociodemographic variables did not influence the extent of knowledge gain. Acceptance rates were high and evaluations of the website's layout were positive. The findings show that the web-based information portal is a promising and appealing means to increase parental knowledge on youth depression. Low-threshold psychoeducational approaches like websites are particularly relevant in times of crisis and increased prevalence rates of depressive symptoms and disorders (ehealth). These results are an important basis for future studies as well as approaches that aim to impart knowledge about mental disorders like youth depression via web-based means. Furthermore, they bear implications for policy decisions concerning mental health education and campaigns. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic led to psychological distress among children and adolescents. Due to multiple psychosocial burdens, the youth in residential care were especially exposed to an increased risk of mental health problems during the pandemic. In a multi-center, single-arm feasibility trial, N = 45 children and adolescents aged 7–14 years were allocated to a 6-week blended care intervention, conducted in six outpatient residential child welfare facilities. The intervention covered a once weekly face-to-face group session for guided creative (art therapy, drama therapy) and movement-oriented (children's yoga, nature therapy) activities. This was accompanied by a resilience-oriented mental-health app. Feasibility and acceptance analyses covered app usage data and qualitative data. Effectiveness was determined by pre-post comparisons in quantitative data on psychological symptoms and resources. Further, subgroups for poorer treatment outcome were explored. The intervention and app were considered to be feasible and were accepted by residential staff and the children. No significant pre-post changes were found across quantitative outcomes. However, being female, being in current psychosocial crisis, a migration background, or a mentally ill parent were correlated with change in score of outcomes from baseline. These preliminary findings pave the way for future research on blended care interventions among at-risk children and adolescents. [ABSTRACT FROM AUTHOR]

Background: Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The lack of consensus on answers to these questions highlights the need for ethical guidance.Main Body: Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of healthcare research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views.Conclusion: While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research. [ABSTRACT FROM AUTHOR]

This article provides an educational review covering the consideration of conducting 'value for money' analyses as part of non-randomised study designs including service evaluations. These evaluations represent a vehicle for producing evidence such as value for money of a care intervention or service delivery model. Decision makers including charities and local and national governing bodies often rely on evidence from non-randomised data and service evaluations to inform their resource allocation decision-making. However, as randomised data obtained from randomised controlled trials are considered the 'gold standard' for assessing causation, the use of this alternative vehicle for producing an evidence base requires careful consideration. We refer to value for money analyses, but reflect on methods associated with economic evaluations as a form of analysis used to inform resource allocation decision-making alongside a finite budget. Not all forms of value for money analysis are considered a full economic evaluation with implications for the information provided to decision makers. The type of value for money analysis to be conducted requires considerations such as the outcome(s) of interest, study design, statistical methods to control for confounding and bias, and how to quantify and describe uncertainty and opportunity costs to decision makers in any resulting value for money estimates. Service evaluations as vehicles for producing evidence present different challenges to analysts than what is commonly associated with research, randomised controlled trials and health technology appraisals, requiring specific study design and analytic considerations. This educational review describes and discusses these considerations, as overlooking them could affect the information provided to decision makers who may make an 'ill-informed' decision based on 'poor' or 'inaccurate' information with long-term implications. We make direct comparisons between randomised controlled trials relative to non-randomised data as vehicles for assessing causation; given 'gold standard' randomised controlled trials have limitations. Although we use UK-based decision makers as examples, we reflect on the needs of decision makers internationally for evidence-based decision-making specific to resource allocation. We make recommendations based on the experiences of the authors in the UK, reflecting on the wide variety of methods available, used as documented in the empirical literature. These methods may not have been fully considered relevant to non-randomised study designs and/or service evaluations, but could improve and aid the analysis conducted to inform the relevant value for money decision problem. [ABSTRACT FROM AUTHOR]

Rare cancers are a growing group as a result of reclassification of common cancers by molecular markers. There is therefore an increasing need to identify methods to assess interventions that are sufficiently robust to potentially affect clinical practice in this setting. Methods advocated for clinical trials in rare diseases are not necessarily applicable in rare cancers. This Series paper describes research methods that are relevant for rare cancers in relation to the range of incidence levels. Strategies that maximise recruitment, minimise sample size, or maximise the usefulness of the evidence could enable the application of conventional clinical trial design to rare cancer populations. Alternative designs that address specific challenges for rare cancers with the aim of potentially changing clinical practice include Bayesian designs, uncontrolled n-of-1 trials, and umbrella and basket trials. Pragmatic solutions must be sought to enable some level of evidence-based health care for patients with rare cancers. [ABSTRACT FROM AUTHOR]

Objective: To design a methodology for rigorously eliciting narratives about patients' experiences with clinical care that is potentially useful for public reporting and quality improvement.Data Sources/study Setting: Two rounds of experimental data (N = 48 each) collected in 2013-2014, using a nationally representative Internet panel.Study Design: Our study (1) articulates and operationalizes criteria for assessing narrative elicitation protocols; (2) establishes a "gold standard" for assessment of such protocols; and (3) creates and tests a protocol for narratives about outpatient treatment experiences.Data Collection/extraction Methods: We randomized participants between telephone and web-based modalities and between protocols placed before and after a closed-ended survey.Principal Findings: Elicited narratives can be assessed relative to a gold standard using four criteria: (1) meaningfulness, (2) completeness, (3) whether the narrative accurately reflects the balance of positive and negative events, and (4) representativeness, which reflects the protocol's performance across respondent subgroups. We demonstrate that a five-question protocol that has been tested and refined yields three- to sixfold increases in completeness and four- to tenfold increases in meaningfulness, compared to a single open-ended question. It performs equally well for healthy and sick patients.Conclusions: Narrative elicitation protocols suitable for inclusion in extant patient experience surveys can be designed and tested against objective performance criteria, thus advancing the science of public reporting. [ABSTRACT FROM AUTHOR]

Background: The National Institutes of Health (NIH) Health Care Systems Research Collaboratory (NIH Collaboratory) seeks to produce generalizable knowledge about the conduct of pragmatic research in health systems. This analysis applied the PRECIS-2 pragmatic trial criteria to five NIH Collaboratory pragmatic trials to better understand 1) the pragmatic aspects of the design and implementation of treatments delivered in real world settings and 2) the usability of the PRECIS-2 criteria for assessing pragmatic features across studies and across time.Methods/design: Using the PRECIS-2 criteria, five pragmatic trials were each rated by eight raters. For each trial, we reviewed the original grant application and a required progress report written at the end of a 1-year planning period that included changes to the protocol or implementation approach. We calculated median scores and interrater reliability for each PRECIS domain and for the overall trial at both time points, as well as the differences in scores between the two time points. We also reviewed the rater comments associated with the scores.Results: All five trials were rated to be more pragmatic than explanatory, with comments indicating that raters generally perceived them to closely mirror routine clinical care across multiple domains. The PRECIS-2 domains for which the trials were, on average, rated as most pragmatic on the 1 to 5 scale at the conclusion of the planning period included primary analysis (mean = 4.7 (range = 4.5 to 4.9)), recruitment (4.3 (3.6 to 4.8)), eligibility (4.1 (3.4 to 4.8)), setting (4.1 (4.0 to 4.4)), follow-up (4.1 (3.4 to 4.9)), and primary outcome (4.1 (3.5 to 4.9)). On average, the less pragmatic domains were organization (3.3 (2.6 to 4.4)), flexibility of intervention delivery (3.5 (2.1-4.5)), and flexibility of intervention adherence (3.8 (2.8-4.5)). Interrater agreement was modest but statistically significant for four trials (Gwet's AC1 statistic range 0.23 to 0.40) and the intraclass correlation coefficient ranged from 0.05 to 0.31. Rating challenges included assigning a single score for domains that may relate to both patients and care settings (that is, eligibility or recruitment) and determining to what extent aspects of complex research interventions differ from usual care.Conclusions: These five trials in diverse healthcare settings were rated as highly pragmatic using the PRECIS-2 criteria. Applying the tool generated insightful discussion about real-world design decisions but also highlighted challenges using the tool. PRECIS-2 raters would benefit from additional guidance about how to rate the interwoven patient and practice-level considerations that arise in pragmatic trials.Trial Registrations: Clinicaltrials.gov trial registrations: NCT02019225 , NCT01742065 , NCT02015455 , NCT02113592 , NCT02063867 . [ABSTRACT FROM AUTHOR]

Background: This study aimed to develop and provide a psychometric and feasibility pilot evaluation of the Heart Failure (HF) Symptom Tracker (HFaST), a new patient-reported tool designed to facilitate communication between patients and health care providers (HCPs) in routine clinical care. The HFaST enables patients to identify worsening HF symptoms, with a long-term goal of preventing hospitalizations or emergency room visits. Methods: The HFaST was developed drawing on evidence from the literature, qualitatively with cognitive interviews (12 patient/caregiver and 8 HCPs), and evaluated quantitatively (psychometric, feasibility assessment). The HFaST was administered for 7 consecutive days to 100 individuals diagnosed with HF during a multisite, non-interventional US pilot study. Health care providers then completed a survey assessing the feasibility and importance of the HFaST in clinical practice. Qualitative development included a literature review and cognitive interviews with patients, caregivers, and HCPs. The psychometric properties of the HFaST were evaluated using classical test theory methods. Descriptive statistics provided insight into HCPs' perceptions of the feasibility of using the HFaST in clinical practice. Results: A preliminary set of 40 items was developed for the symptom tracker and iteratively reduced to 10 items based on the qualitative phase. Test-retest reliability (weighted kappa 0.71–0.97), discriminating validity, and construct validity of the HFaST were acceptable. HCPs rated the HFaST as a good (70%) or excellent (30%) means of tracking HF symptoms. Six HFaST items were ultimately retained, covering concepts of fatigue, shortness of breath (3 items), swelling, and rapid weight gain. Conclusions: The 6-item HFaST is an easy-to-use tool designed to raise patients' awareness of HF symptoms and facilitate communication with HCPs. Future research should evaluate HFaST implementation in clinical practice and effectiveness as an intervention to potentially prevent hospitalizations and emergency room visits. [ABSTRACT FROM AUTHOR]