An introduction to realist evaluation and synthesis for kidney research.

Realist research describes a methodological approach that aims to explore how and why interventions work, for whom, and under what circumstances. Rather than quantifying how well an intervention works under specific conditions, realist theory explores the function of interventions in detail and specifically considers how the contexts in which interventional components are delivered influence the mechanisms that lead to outcomes. Realist methods can be applied to primary data (realist evaluation) or secondary data (realist synthesis). Although realist techniques are increasingly being used in the evaluation of complex interventions, there are relatively few published studies in the field of kidney care. In this review, we outline the theory and principles behind realist methods through discussion of a published realist synthesis describing complex interventions promoting delivery of optimal chronic kidney disease care. We discuss other kidney studies that have used realist methodology and situations where realist techniques could be applied to advance our understanding of how to best deliver care to patients with kidney disease.

Treatment Effect Waning Assumptions: A Review of National Institute of Health and Care Excellence Technology Appraisals.

OBJECTIVES: This study aims to review the National Institute of Health and Care Excellence (NICE) technology assessments to gain insights into the implementation of treatment effect (TE) waning, whereby the hazard or survival in an assessed technology converges to that of the comparator. This analysis aims to contribute to inform future guidance in this area. METHODS: Technology appraisals published October 20, 2021 to September 20, 2023 were reviewed and data extracted on TE waning circumstances, methods, and rationale to compile a database based on 3 research questions: When are TE waning assumptions used? What methods are used? Why have the company/Evidence Assessment Group/committee preferred these methods? RESULTS: Both the evidence assessment group/company and the committee included TE waning assumptions in 28 appraisals. There was no pattern of waning assumptions between shorter (<20 years) and longer (>20 years) time horizons. The most prominent time point for applying waning assumptions was at 5 years, with 30 out of 59 (50.8%) of the methods applied used 5 years. Stopping rules were used in 21 out of 30 (70.1%) of the appraisals for which the committee included waning, and waning assumptions were used more in oncology. The most common reason given for including TE waning assumptions was precedent from prior appraisals. CONCLUSIONS: Considerable heterogeneity existed in both the methods used and justifications given for TE waning assumptions. This variability poses a risk of inconsistent decision making. Reliance on past appraisals emphasizes the necessity to advocate for evidence-driven approaches and underscores the demand for guidance on suitable methods for incorporating assumptions.

Hard to reach? Methodological challenges researching vulnerable, gang-involved, young people.

INTRODUCTION: Research with young people (YP) is ethically challenging and bound in a complex maze of issues relating to power, voice and representation. Such sensitivities mean that the challenges raised in researching marginalised YP are often hard to navigate. This paper reports on research carried out with YP to explore links between mental health, school exclusion and involvement in criminal gangs. It aims to provide a practical guide to negotiating some of the methodological and ethical challenges experienced. METHOD: In-depth interviews conducted with 28 YP (aged 14-24 years) who were gang involved or seen to be at risk of gang involvement. Research was conducted in youth clubs, alternative provision and youth justice settings. RESULTS: OBSERVATIONS/REFLECTIONS: We reflect on how navigating ethics can create barriers to involving YP as primary informants in research. We consider why it is important to overcome these hurdles and how public engagement work with recognised gatekeepers and the use of creative interview methods can facilitate meaningful encounters, where YP feel able to share valuable insights into their lives. CONCLUSION: Alongside a number of specific learning points, the paper reflects on theories behind research with YP, including the need for recognition of power imbalances and reflexivity. It concludes with thoughts on the practical realities of achieving meaningful participation or an 'authentic voice' with marginalised groups and the importance of this in informing policy and practice. PATIENT OR PUBLIC CONTRIBUTION: The focus of this work was to collect experiences of YP who are recognised as gang-involved or at risk of being so, with a view to informing health and education policies. The scoping study for the project involved extensive public engagement work with YP exploring and trialling suitable methods of accessing, recruiting and ultimately interviewing this target group. This is central to the discussion within the body of the paper.

Exercise treatments for lumbar spinal stenosis: A systematic review and intervention component analysis of randomised controlled trials.

OBJECTIVE: To analyse the components used in exercise interventions for people with symptoms of neurogenic claudication due to lumbar spinal stenosis and identify components associated with successful interventions. DATA SOURCES: Eligible papers published up to April 2023 from MEDLINE, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and trial registry websites. REVIEW METHODS: Literature searches were performed by an Information Specialist. We searched for randomised trials evaluating exercise interventions for people with neurogenic claudication symptoms (the primary symptom of lumbar spinal stenosis). Two authors independently performed study selection, data extraction, and quality assessments using the Cochrane Risk of Bias tool Version 2 and the TIDieR checklist for intervention reporting. Details of intervention components were extracted, tabulated, and synthesised using an intervention component analysis approach. RESULTS: We found thirteen trials reporting 23 exercise interventions delivered to 1440 participants. These featured 60 different components. Most exercise interventions included supervision and flexion-based exercises. Balance exercises were rarely included. Exercise components featured more frequently in successful interventions included stretches, strength or trunk muscle exercises, fitness exercises, especially cycling, and psychologically informed approaches. Interpretation is limited by low study numbers and heterogeneity. No conclusions could be drawn about exercise supervision or dose. DISCUSSION: Exercise interventions for people with neurogenic claudication typically feature multiple components. Common features such as supervision, lumbar flexion, and aerobic fitness exercises and also less common features such as stretches, strengthening exercises, and psychologically informed approaches warrant consideration for inclusion when designing and optimising exercise interventions for people with lumbar spinal stenosis.

Prep-Tok: a queer critical discourse analysis of TikToks regarding HIV-related pre-exposure prophylaxis.

Human immunodeficiency virus (HIV) continues to present a public health problem, and pre-exposure prophylaxis (PrEP) offers a promising preventative intervention; however, its uptake remains low, so investigating determinants of use is essential. This article applies queer critical discourse analysis to a corpus of 121 TikToks sampled via the TikTok algorithm, coded and refined into three overarching content categories: 'what makes a PrEP user?', 'what is PrEP as a drug?', and 'sexual health and HIV'. Examples from within these categories reveal four underlying discursive themes: (1) stigmatisation of HIV as a 'gay disease' with a poor prognosis; (2) stigmatisation of gay men as unsafe, high-risk and untrustworthy; (3) stigmatisation of PrEP as increasing 'unsafe' sexual practices; (4) poor healthcare and education gay men and other beneficiaries of PrEP. These themes are influenced by a broad spectrum of homophobic and heteronormative discourses available with specific examples reflecting parts of this spectrum from predominantly perpetuating to occasionally challenging. The findings report complementary evidence obtained from other media platforms yet offer a unique take while suggesting useful avenues for future public health messaging relating to PrEP which may be used to inform the next steps against HIV.

COVID-19, lockdowns, and the mental wellbeing of LGBTQ people in Australia.

LGBTQ communities around the world entered the COVID-19 pandemic with generally high rates of poor mental health and faced additional challenges including stigma, discrimination, and barriers to care. This study sample was drawn from a survey of 3135 LGBTQ adults residing in Australia during the pandemic. Regression analysis was used to explore individual differences in psychological distress and perceived change in mental wellbeing since the onset of the pandemic as well as the impact of lockdowns, by taking advantage of a natural experiment comparing the states that experienced more extensive lockdowns (Victoria and New South Wales) to the rest of Australia. The burden of mental health was found to vary across gender, sexual orientation, age, and area of residence. While no impact of lockdowns on psychological distress was observed, participants living in the states of Victoria (ß = -0.15; 95% CI = -0.23, -0.07) and New South Wales (ß = -0.13; 95% CI = -0.21, -0.05) self-reported a more negative impact of the pandemic on their mental wellbeing compared to the rest of the country. The findings suggest that the COVID-19 pandemic had a negative impact on the mental wellbeing of LGBTQ populations, particularly among those who experienced extensive lockdowns and highlight the need for increased efforts to enable access to mental health supports during times of crisis.

Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

Evaluation of an acute trust Domestic Abuse Coordinator role: Impact findings and a budget impact model.

Domestic Abuse Coordinators (DACs) work strategically across National Health Service (NHS) hospital and other off-site clinical settings to support clinical staff in domestic abuse enquiry and response, and to co-lead the development and implementation of effective clinical policies and procedures for the management of domestic abuse and the support of survivors. Drawing on data from a large NHS acute trust in central London, we analyse the impact of the DAC role in increasing the rate of referrals of high-risk domestic abuse cases, and generate plausible estimates of the budget impact of the DAC role in respect of costs accrued to NHS trusts. Using eight quarters of clinical data and an interrupted time series design, we find that evidence that implementation of a DAC role is linked with an increase in the rate of high-risk referrals of between 18% and 21% per quarter, indicating improved responses to victim-survivors at highest risk of imminent harm. Under a range of reasonable assumptions, initiation of the DAC role is shown to be cost-saving to an employing acute trust. Future work should seek to quantify the direct impacts to survivor health and wellbeing of the implementation of the DAC role.

Research review: Effects of parenting programs for children's conduct problems on children's emotional problems - a network meta-analysis.

BACKGROUND: Specific programs are often implemented for specific child mental health problems, while many children suffer from comorbid problems. Ideally, programs reduce a wider range of mental health problems. The present study tested whether parenting programs for children's conduct problems, and which individual and clusters of program elements, have additional effects on children's emotional problems. METHODS: We updated the search of a previous systematic review in 11 databases (e.g., PsycINFO and MEDLINE) and included studies published until July 2020 with keywords relating to 'parenting', 'program', and 'child behavioral problems'. Also, we searched for recent trials in four trial registries and contacted protocol authors. Studies were eligible for inclusion if they used a randomized controlled trial to evaluate the effects of a parenting program for children aged 2-10 years which was based on social learning theory and included a measure of children's emotional problems postintervention. RESULTS: We identified 69 eligible trials (159 effect sizes; 6,240 families). Robust variance estimation showed that parenting programs had small significant parent-reported additional effects on emotional problems immediately postintervention (Cohen's d = -0.14; 95% CI, -0.21, -0.07), but these effects faded over time. Teachers and children did not report significant effects. Additional effects on emotional problems were larger in samples with clinical baseline levels of such problems. No individual program elements predicted larger additional effects. Of the clusters of elements, combining behavior management and relationship enhancement elements was most likely to yield the strongest additional effects. CONCLUSIONS: The additional effects on emotional problems of parenting programs designed to reduce conduct problems are limited, but some clusters of elements predict larger effects. Our findings may contribute to realistic expectations of the benefits of parenting programs for children's conduct problems and inform the development of programs with wider benefits across mental health problems.

School-Based Interventions to Prevent Dating and Relationship Violence and Gender-Based Violence: Systematic Review and Network Meta-Analysis.

Background. Schools are sites of dating and relationship violence (DRV) and of gender-based violence (GBV) victimization and perpetration. School-based interventions can reach a broad range of students, targeting both individual and group processes that may underpin DRV and GBV. Considering DRV and GBV jointly is important because of their shared etiologies. Comparing the effectiveness of interventions using network meta-analysis (NMA) can support decision-making on optimal resource use. Objectives. To evaluate the comparative effectiveness of school-based interventions for children aged 5 to 18 years on DRV and GBV victimization, perpetration, and related mediators. Search Methods. We searched 21 databases in July 2020 and June 2021, alongside extensive supplementary search methods, including gray literature searches, forward and backward citation chasing, and searches on first and last author names. Selection Criteria. We included randomized-controlled trials of interventions for children of compulsory school age implemented within the school setting, and either partially or wholly aimed at changing DRV or GBV outcomes. Data Collection and Analysis. Pairwise meta-analyses using random-effects robust variance estimation considered intervention effectiveness on DRV and GBV victimization and perpetration using odds ratios, and on mediators (e.g., knowledge and attitudes) using standardized mean differences. Effects were divided into short-term (< 12 months postbaseline) and long-term (≥ 12 months postbaseline). NMAs on victimization and perpetration outcomes compared interventions categorized by breadth of mechanism and complexity of delivery and implementation. Meta-regression tested sensitivity to percentage of girls in the trial sample and country context. Main Results. Our analysis included 68 trials. Evidence was stronger overall for effects on DRV than for GBV, with significant long-term impacts on DRV victimization (odds ratio [OR] = 0.82; 95% confidence interval [CI] = 0.68, 0.99) and DRV perpetration (OR = 0.78; 95% CI = 0.64, 0.94). Knowledge and attitudinal effects were predominantly short-term (e.g., for DRV-related violence acceptance, d = 0.16; 95% CI = 0.08, 0.24). NMAs did not suggest the superiority of any intervention type; however, most analyses for GBV outcomes were inconsistent. A higher proportion of girls in the sample was associated with increased effectiveness on long-term victimization outcomes. Author's Conclusions. Evidence is stronger for DRV than for GBV, despite considerable heterogeneity. Certainty of findings was low or very low overall. Public Health Implications. Violence reductions may require more than 1 school year to become apparent. More extensive interventions may not be more effective. A possible reason for stronger effectiveness for DRV is that whereas GBV is ingrained in school cultures and practices, DRV is potentially more open to change via addressing individual knowledge and attitudes. (Am J Public Health. 2023;113(3):320-330. https://doi.org/10.2105/10.2105/AJPH.2022.307153).

Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

A survey and stakeholder consultation of Independent Domestic Violence Advisor (IDVA) programmes in English maternity services.

BACKGROUND: Healthcare-based Independent Domestic Violence Advisors (hIDVA) are evidence-based programmes that provide emotional and practical support to service users experiencing domestic abuse. hIDVA programmes are found to improve health outcomes for service users and are increasingly delivered across a range of healthcare settings. However, it is unclear how hIDVA programmes are implemented across maternity services and the key facilitators and barriers to their implementation. The aim of this study was to identify; how many English National Health Service (NHS) Trusts with maternity services have a hIDVA programme; which departments within the Trust they operate in; what format, content, and variation in hIDVA programmes exist; and key facilitators and barriers of implementation in maternity services. METHODS: A national survey of safeguarding midwives (Midwives whose role specifically tasks them to protect pregnant women from harm including physical, emotional, sexual and financial harm and neglect) within all maternity services across England; descriptive statistics were used to summarise responses. A World Café event (a participatory method, which aims to create a café atmosphere to facilitate informal conversation) with 38 national key stakeholders to examine barriers and facilitators to hIDVA programme implementation. RESULTS: 86/124 Trusts (69%) with a maternity service responded to the survey; 59(69%) of respondents reported that they had a hIDVA programme, and 47(55%) of the hIDVA programmes operated within maternity services. Key facilitators to implementation of hIDVA programmes included training of NHS staff about the hIDVA role and regular communication between Trust staff and hIDVA staff; hIDVA staff working directly from the Trust; co-creation of hIDVA programmes with experts by experience; governance and middle- and senior-management support. Key barriers included hIDVA staff having a lack of access to a private space for their work, insecure funding for hIDVA programmes and issues with recruitment and retention of hIDVA staff. CONCLUSIONS: Despite hIDVA programmes role in improving the health outcomes of service users experiencing domestic abuse, increased funding and staff training is needed to successfully implement hIDVA staff in maternity services. Integrated Care Board commissioning of acute and mental health trust services would benefit from ensuring hIDVA programmes and clinician DVA training are prioritised.

Patient, carer and family experiences of seeking redress and reconciliation following a life-changing event: Systematic review of qualitative evidence.

INTRODUCTION: We conducted a systematic review of qualitative evidence to improve understanding of the processes and outcomes of redress and reconciliation following a life-changing event from the perspectives of individuals experiencing the event and their families. METHODS: We searched six bibliographic databases for primary qualitative evidence exploring the views of individuals who have experienced a life-changing event, and/or their family or carers, of redress or reconciliation processes. This was supplemented with targeted database searches, forward and backward citation chasing and searches of Google Scholar and relevant websites. Title and abstract and full-text screening were undertaken independently by two reviewers. Data extraction and quality appraisal were conducted by one reviewer and checked by a second. We used a best-fit framework synthesis approach, drawing upon procedural and restorative justice concepts. FINDINGS: Fifty-three studies (61 papers) were eligible for inclusion. Forty-one studies (47 papers) were included in the synthesis, from which we identified four themes. Three themes 'Transparency', 'Person-centered' and 'Trustworthy' represent the procedural elements required to support a fair and objective process. The fourth, 'Restorative justice' encapsulates how a fair process feels to those who have experienced a life-changing event. This theme highlights the importance of an empathic relationship between the different parties involved in the redress-reconciliation process and the significance of being able to engage in meaningful action. CONCLUSION: Our findings highlight the procedural aspects and context of redress-reconciliation processes required to ensure that the process and outcomes are experienced as fair. These criteria may be applied to the processes used to investigate both recent and historical patient safety events. PUBLIC CONTRIBUTION: One member of the public affiliated with the Exeter Policy Research Programme Evidence Review Facility helped develop the review protocol. Two people with experience of medically life-changing events provided insight which corroborated our findings and identified important limitations of the evidence included in this review.

Affirming educational and workplace settings are associated with positive mental health and happiness outcomes for LGBTQA + youth in Australia.

BACKGROUND: Affirming socio-cultural settings are essential for protecting the mental health and wellbeing of lesbian, bisexual or pansexual, trans and gender diverse, asexual and queer (LGBTQA +) youth. However, limited research has explored the role of affirming educational and workplace settings, as reported by LGBTQA + youth themselves, with respect to their mental health and wellbeing. Moreover, existing research maintains a focus on mitigating poor mental health outcomes, with little attention to positive wellbeing outcomes among LGBTQA + youth. METHODS: Using data from the largest national survey of LGBTQA + youth aged 14-21 in Australia, multivariable regression analyses were conducted to explore associations between affirming educational and workplace settings and psychological distress and subjective wellbeing among 4,331 cisgender and 1,537 trans and gender diverse youth. Additionally, a series of multivariable regression analyses were conducted to explore individual sociodemographic traits that are associated with reporting affirming educational or workplace settings. RESULTS: Both cisgender and trans or gender diverse participants who reported that their education institution or workplace were affirming of their LGBTQA + identity reported lower levels of psychological distress as well as higher levels of subjective happiness. Additionally, affirming environments were not experienced equally across all subsections of LGBTQA + youth, with reporting of an affirming educational or workplace setting differing most noticeably across gender, type of educational institution and residential location. CONCLUSION: The findings demonstrate that affirming educational and workplace settings can result not only in better mental health, but also greater levels of subjective happiness among LGBTQA + youth. The outcomes illustrate the importance of ensuring all LGBTQA + youth are afforded the opportunity to thrive in environments where they feel validated and confident to express their identities. The findings further highlight a need to target education institutions and workplaces to ensure the implementation of policies and practices that promote not just inclusion of LGBTQA + youth but affirmation of their identities.

Perceptions of friendship, peers and influence on adolescent smoking according to tobacco control context: a systematic review and meta-ethnography of qualitative research.

BACKGROUND: A relationship between smoking and interpersonal influences has been well established within the literature. There have been cultural shifts in denormalisation and a reduction in tobacco smoking in many countries. Hence there is a need to understand social influences on adolescents' smoking across smoking normalisation contexts. METHODS: The search was conducted in July 2019 and updated in March 2022 within 11 databases and secondary sources. Search terms included schools, adolescents, smoking, peers, social norms and qualitative research. Screening was conducted by two researchers independently and in duplicate. Study quality was assessed using the eight-item Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-centre) tool for the appraisal of qualitative studies. Results were synthesised using a meta-narrative lens for meta-ethnography and compared across smoking normalisation contexts. RESULTS: Forty one studies were included and five themes were developed, mapping onto the socio ecological model. The social processes by which adolescents take up smoking differed according to a mixture of school type, peer group structure and the smoking culture within the school, as well as the wider cultural context. Data available from smoking denormalised contexts, described changes in social interactions around smoking to cope with its stigmatisation. This was manifested through i) direct peer influence, whereby subtle techniques were employed, ii) group belonging whereby smoking was less likely to be seen as a key determinant of group membership and smoking was less commonly reported to be used as a social tool, and iii) popularity and identity construction, whereby smoking was perceived more negatively in a denormalised context, compared with a normalised context. CONCLUSIONS: This meta-ethnography is the first study to demonstrate, drawing on international data, that peer processes in adolescent smoking may undergo changes as smoking norms within society change. Future research should focus on understanding differences across socioeconomic contexts, to inform the adaptation of interventions.

Optimising engagement in a digital parenting intervention to prevent violence against adolescents in Tanzania: protocol for a cluster randomised factorial trial.

BACKGROUND: Violence against adolescents is a universal reality, with severe individual and societal costs. There is a critical need for scalable and effective violence prevention strategies such as parenting programmes, particularly in low- and middle-income countries where rates of maltreatment are highest. Digital interventions may be a scalable and cost-effective alternative to in-person delivery, yet maximising caregiver engagement is a substantial challenge. This trial employs a cluster randomised factorial experiment and a novel mixed-methods analytic approach to assess the effectiveness, cost-effectiveness, and feasibility of intervention components designed to optimise engagement in an open-source parenting app, ParentApp for Teens. The app is based on the evidence-based Parenting for Lifelong Health for Teens programme, developed collaboratively by academic institutions in the Global South and North, the WHO, and UNICEF. METHODS/DESIGN: Sixteen neighbourhoods, i.e., clusters, will be randomised to one of eight experimental conditions which consist of any combination of three components (Support: self-guided/moderated WhatsApp groups; App Design: sequential workshops/non-sequential modules; Digital Literacy Training: on/off). The study will be conducted in low-income communities in Tanzania, targeting socioeconomically vulnerable caregivers of adolescents aged 10 to 17 years (16 clusters, 8 conditions, 640 caregivers, 80 per condition). The primary objective of this trial is to estimate the main effects of the three components on engagement. Secondary objectives are to explore the interactions between components, the effects of the components on caregiver behavioural outcomes, moderators and mediators of programme engagement and impact, and the cost-effectiveness of components. The study will also assess enablers and barriers to engagement qualitatively via interviews with a subset of low, medium, and high engaging participants. We will combine quantitative and qualitative data to develop an optimised ParentApp for Teens delivery package. DISCUSSION: This is the first known cluster randomised factorial trial for the optimisation of engagement in a digital parenting intervention in a low- and middle-income country. Findings will be used to inform the evaluation of the optimised app in a subsequent randomised controlled trial. TRIAL REGISTRATION: Pan African Clinical Trial Registry, PACTR202210657553944. Registered 11 October 2022, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24051 .

Estimated impact of the COVID-19 pandemic on the prevalence and treatment of depressive symptoms in Peru: an interrupted time series analysis in 2014-2021.

PURPOSE: The COVID-19 pandemic increased the burden of mental disorders worldwide. Peru has been one of the countries most affected by COVID-19, however, studies evaluating the medium and long-term consequences of the pandemic on Peruvians' mental health are recent and represent a new field of study in proliferation. We aimed to estimate the impact of the COVID-19 pandemic on the prevalence and treatment of depressive symptoms using nationally representative surveys in Peru. METHODS: Our study is an analysis of secondary data. We carried out a time series cross-sectional analysis based on the National Demographic and Health Survey of Peru, collected using a complex sampling design. The Patient Health Questionnaire-9 was used to measure mild (5-9 points), moderate (10-14 points), and severe (15 points or more) depressive symptoms. The participants were men and women aged 15 years and older, living in urban and rural areas of all regions of Peru. The main statistical analysis used segmented regression with Newey-West standard errors, taking into account that each year of the evaluation was divided into four measures (quarter measure). RESULTS: We included 259,516 participants. An average quarterly increase of 0.17% (95% CI 0.03-0.32%) in the prevalence of moderate depressive symptoms was identified after the onset of the COVID-19 pandemic (approximately an increase of 1583 new cases of moderate depressive symptoms by each quarter). The percentage of cases treated for mild depressive symptoms increased quarterly by an average of 0.46% (95% CI 0.20-0.71%) after the onset of the COVID-19 pandemic (approximately an increase of 1242 new cases treated for mild depressive symptoms by each quarter). CONCLUSION: In Peru, increases in the prevalence of moderate depressive symptoms and the proportion of cases treated with mild depressive symptoms were found after the COVID-19 pandemic. Therefore, this study is a precedent for future research assessing the prevalence of depressive symptoms and the proportion of cases receiving treatment during the pandemic and post-pandemic years.

Clinical effectiveness reporting of novel cancer drugs in the context of non-proportional hazards: a review of nice single technology appraisals.

OBJECTIVES: The hazard ratio (HR) is a commonly used summary statistic when comparing time to event (TTE) data between trial arms, but assumes the presence of proportional hazards (PH). Non-proportional hazards (NPH) are increasingly common in NICE technology appraisals (TAs) due to an abundance of novel cancer treatments, which have differing mechanisms of action compared with traditional chemotherapies. The goal of this study is to understand how pharmaceutical companies, evidence review groups (ERGs) and appraisal committees (ACs) test for PH and report clinical effectiveness in the context of NPH. METHODS: A thematic analysis of NICE TAs concerning novel cancer treatments published between 1 January 2020 and 31 December 2021 was undertaken. Data on PH testing and clinical effectiveness reporting for overall survival (OS) and progression-free survival (PFS) were obtained from company submissions, ERG reports, and final appraisal determinations (FADs). RESULTS: NPH were present for OS or PFS in 28/40 appraisals, with log-cumulative hazard plots the most common testing methodology (40/40), supplemented by Schoenfeld residuals (20/40) and/or other statistical methods (6/40). In the context of NPH, the HR was ubiquitously reported by companies, inconsistently critiqued by ERGs (10/28), and commonly reported in FADs (23/28). CONCLUSIONS: There is inconsistency in PH testing methodology used in TAs. ERGs are inconsistent in critiquing use of the HR in the context of NPH, and even when critiqued it remains a commonly reported outcome measure in FADs. Other measures of clinical effectiveness should be considered, along with guidance on clinical effectiveness reporting when NPH are present.

An evaluation of managed access agreements in England based on stakeholder experience.

OBJECTIVES: The objective of this research was to evaluate managed access policy in England, drawing upon the expertise of a range of stakeholders involved in its implementation. METHODS: Seven focus groups were conducted with payer and health technology assessment representatives, clinicians, and representatives from industry and patient/carer organizations within England. Transcripts were analyzed using framework analysis to identify stakeholders' views on the successes and challenges of managed access policy. RESULTS: Stakeholders discussed the many aims of managed access within the National Health Service in England, and how competing aims had affected decision making. While stakeholders highlighted a number of priorities within eligibility criteria for managed access agreements (MAAs), stakeholders agreed that strict eligibility criteria would be challenging to implement due to the highly variable nature of innovative technologies and their indications. Participants highlighted challenges faced with implementing MAAs, including evidence generation, supporting patients during and after the end of MAAs, and agreeing and reinforcing contractual agreements with industry. CONCLUSIONS: Managed access is one strategy that can be used by payers to resolve uncertainty for innovative technologies that present challenges for reimbursement and can also deliver earlier access to promising technologies for patients. However, participants cautioned that managed access is not a "silver bullet," and there is a need for greater clarity about the aims of managed access and how these should be prioritized in decision making. Discussions between key stakeholders involved in managed access identified challenges with implementing MAAs and these experiences should be used to inform future managed access policy.

Early access schemes for innovative health technologies: the views of international stakeholders.

OBJECTIVES: Early access schemes (EASs) are approaches used by payers to balance and facilitate earlier patient access to innovative health technologies while evidence generation is ongoing. Schemes require investment from payers and are associated with significant risk since not all technologies will be routinely reimbursed. The purpose of this study was to gain the perspectives of policy experts about the key challenges for EASs and potential solutions for their optimal design and implementation. METHODS: Two virtual workshops were convened including (i) UK-based policy experts (England, Wales, and Scotland) and (ii) representatives from multiple healthcare systems (England, France, Sweden, Canada, Poland, and Norway). Participants were encouraged to share their experiences with EASs in their healthcare system and highlight key challenges for policy makers. Discussions were transcribed and analyzed using framework analysis. RESULTS: Participants agreed that EASs have value when targeted toward innovative technologies with the potential for significant clinical benefit in an area of high unmet need. Participants discussed potential solutions to the challenges faced by payers implementing EASs, including defining eligibility criteria, supporting evidence generation, and approaches to reimbursement. CONCLUSIONS: Participants agreed that EASs are one possible solution for their healthcare systems and have the potential to deliver significant clinical value to patients. However, widespread adoption of EASs is limited due to concerns about the risks for patients and healthcare budgets, further solutions are needed to deliver EASs for targeted therapies.