Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors.

INTRODUCTION: Children, adolescent, and young adult cancer survivors experience overall increased risks of infertility that are preventable through effective fertility preservation services prior to starting cancer treatment. Oncofertility care is the evidence-based practice of informing newly diagnosed cancer patients about their reproductive risks and supporting shared decision-making on fertility preservation services. Despite longstanding clinical guidelines, oncofertility care delivery continues to be limited and highly variable across adult and pediatric oncology settings. MATERIALS AND METHODS: We describe the design of a stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention conducted in 20 adult and pediatric oncology clinics across three health systems in Southern California. Intervention components are: 1) electronic health record-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. We hypothesize the intervention condition will be associated with increased proportions of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient's fertility goals) and improved patient-reported outcomes, compared to the usual care control condition. We will also evaluate intervention implementation in a mixed-methods study guided by implementation science frameworks. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention at cancer diagnosis for children, adolescent and young adult cancer patients to improve their future fertility and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05443737.

Implementation of state health insurance benefit mandates for cancer-related fertility preservation: following policy through a complex system.

BACKGROUND: A myriad of federal, state, and organizational policies are designed to improve access to evidence-based healthcare, but the impact of these policies likely varies due to contextual determinants of, reinterpretations of, and poor compliance with policy requirements throughout implementation. Strategies enhancing implementation and compliance with policy intent can improve population health. Critically assessing the multi-level environments where health policies and their related health services are implemented is essential to designing effective policy-level implementation strategies. California passed a 2019 health insurance benefit mandate requiring coverage of fertility preservation services for individuals at risk of infertility due to medical treatments, in order to improve access to services that are otherwise cost prohibitive. Our objective was to document and understand the multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to fertility preservation services. METHODS: We conducted a mixed-methods study and used the policy-optimized exploration, preparation, implementation, and sustainment (EPIS) framework to analyze the implementation of California's fertility preservation benefit mandate (SB 600) at and between the state insurance regulator, insurer, and clinic levels. RESULTS: Seventeen publicly available fertility preservation benefit mandate-relevant documents were reviewed. Interviews were conducted with four insurers; 25 financial, administrative, and provider participants from 16 oncology and fertility clinics; three fertility pharmaceutical representatives; and two patient advocates. The mandate and insurance regulator guidance represented two "Big P" (system level) policies that gave rise to a host of "little p" (organizational) policies by and between the regulator, insurers, clinics, and patients. Many little p policies were bridging factors to support implementation across levels and fertility preservation service access. Characterizing the mandate's functions (i.e., policy goals) and forms (i.e., ways that policies were enacted) led to identification of (1) intended and unintended implementation, service, and patient outcomes, (2) implementation processes by level and EPIS phase, (3) actor-delineated key processes and heterogeneity among them, and (4) inner and outer context determinants that drove adaptations. CONCLUSIONS: Following the midstream and downstream implementation of a state health insurance benefit mandate, data generated will enable development of policy-level implementation strategies, evaluation of determinants and important outcomes of effective implementation, and design of future mandates to improve fit and fidelity.

Assessing ad-hoc adaptations' alignment with therapeutic goals: a qualitative study of lay counselor-delivered family therapy in Eldoret, Kenya.

BACKGROUND: A key question in implementation science is how to balance adaptation and fidelity in translating interventions to new settings. There is growing consensus regarding the importance of planned adaptations to deliver interventions in contextually sensitive ways. However, less research has examined ad-hoc adaptations, or those that occur spontaneously in the course of intervention delivery. A key question is whether ad-hoc adaptations ultimately contribute to or detract from intervention goals. This study aimed to (a) identify ad-hoc adaptations made during delivery of a family therapy intervention and (b) assess whether they promoted or interrupted intervention goals. METHODS: Tuko Pamoja (Swahili: "We are Together") is an evidence-informed family therapy intervention aiming to improve family dynamics and mental health in Kenya. Tuko Pamoja employs a task-shifting model, delivered by lay counselors who are afforded a degree of flexibility in presenting content and in practices they use in sessions. We used transcripts of therapy sessions with 14 families to examine ad-hoc adaptations used by counselors. We first identified and characterized ad-hoc adaptations through a team-based code development, coding, and code description process. Then, we evaluated to what extent ad-hoc adaptations promoted the principles and strategies of the intervention ("TP-promoting"), disrupted them ("TP-interrupting"), or neither ("TP-neutral"). To do this, we first established inter-coder agreement on application of these categories with verification by the intervention developer. Then, coders categorized ad-hoc adaptation text segments as TP-promoting, TP-interrupting, or TP-neutral. RESULTS: Ad-hoc adaptations were frequent and included (in decreasing order): incorporation of religious content, exemplars/role models, community dynamics and resources, self-disclosure, and metaphors/proverbs. Ad-hoc adaptations were largely TP-promoting (49%) or neutral (39%), but practices were TP-interrupting 12% of the time. TP-interrupting practices most often occurred within religious content and exemplars/role models, which were also the most common practices overall. CONCLUSION: Extra attention is needed during planned adaptation, training, and supervision to promote intervention-aligned use of common ad-hoc adaptation practices. Discussing them in trainings can provide guidance for lay providers on how best to incorporate ad-hoc adaptations during delivery. Future research should evaluate whether well-aligned ad-hoc adaptations improve therapeutic outcomes. TRIAL REGISTRATION: Pilot trial registered at clinicaltrials.gov (C0058).

Intervening on women's health for rural young breast cancer survivors: A study protocol.

INTRODUCTION: From diagnosis to post-treatment, many young breast cancer survivors (YBCS) experience infertility, limited contraception choices, concern about pregnancy safety, and menopausal symptoms. Clinical guidelines recommend oncofertility care (counseling and/or clinical services that meet fertility, contraception, pregnancy health and/or menopausal symptom management needs) throughout the cancer care continuum. However, significant oncofertility care gaps exist in rural, community oncology settings. MATERIALS AND METHODS: We describe the design of an interrupted time series, effectiveness-implementation hybrid clinical trial that evaluates a multi-component intervention to improve YBCS engagement in oncofertility care. The intervention is comprised of 1) oncology clinic-based oncofertility needs screen; 2) a women's health survivorship care plan in Spanish and English; 3) remote patient navigation; and 4) telehealth oncofertility consultation. During the pre-intervention period (12 months), usual care will be delivered. During the intervention period (15 months), the multi-component intervention will be implemented at two rural oncology clinics with largely Latina, Spanish-speaking populations. The primary outcome of YBCS (n = 135) engagement in oncofertility care will be collected from medical record review. We will also collect validated patient-reported outcomes. Informed by the Exploration Preparation Implementation Sustainment (EPIS) implementation science framework, we will integrate qualitative and quantitative data to explore whether and how the intervention was effective, acceptable, appropriate, and delivered with fidelity. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05414812.

Development, Usability Testing, and Implementation Assessment of Cancer Related Infertility Score Predictor, an Online Cancer Related Infertility Risk Counseling Tool.

Purpose: Oncofertility counseling of female cancer patients lacks efficient access to tailored and valid infertility risk estimates to support shared decision-making on fertility preservation treatments. The objective was to develop, conduct user-centered design, and plan clinic-based implementation of the Cancer Related Infertility Score Predictor (CRISP), a web-based tool to support infertility risk counseling. Methods: Using a mixed methods design, literature review was undertaken to abstract data on infertility, primary ovarian insufficiency, and amenorrhea risks of common cancer treatments. The CRISP website was programmed to take user input about patient ages and cancer treatments and generate a risk summary. Using user experience methodology and semistructured interviews, usability testing and implementation assessment were conducted with 12 providers recruited from 5 medical centers in Southern California. Results: The web-based CRISP tool encompasses infertility risk data for 60 treatment regimens among 10 cancer types. Usability testing demonstrated that the tool is intuitive and informed minor modifications, including adding crowd-sourced submission of additional cancer treatments. Participants rated the tool as credible, advantageous over current provider methods to ascertain infertility risks, and useful for tailoring treatment planning and counseling patients. A key barrier was lack of information on some cancer treatments. Fit within clinical workflow was feasible, particularly with electronic health record integration. Conclusions: The novel, web-based CRISP tool is a feasible, acceptable, and appropriate tool to address provider knowledge gap about cancer related infertility risks and use for patient counseling. CRISP has significant potential to support tailored oncofertility counseling in the heterogeneous young cancer patient population.

Using ethnographic approaches to document, evaluate, and facilitate virtual community-engaged implementation research.

BACKGROUND: Community Advisory Boards (CABs) have been frequently used to engage diverse partners to inform research projects. Yet, evaluating the quality of engagement has not been routine. We describe a multi-method ethnographic approach documenting and assessing partner engagement in two "virtual" CABs, for which we conducted all meetings remotely. METHODS: Two research projects for increasing equitable COVID-19 testing, vaccination, and clinical trial participation for underserved communities involved remote CAB meetings. Thirty-three partners representing 17 community groups participated in 15 sessions across the two CABs facilitated by a social change organization. We developed ethnographic documentation forms to assess multiple aspects of CAB member engagement (e.g., time spent speaking, modality used, types of interactions). Documenters were trained to observe CAB sub-groups via virtual sessions. Debriefing with the documentation team after CAB meetings supported quality assurance and process refinement. CAB members completed a brief validated survey after each meeting to assess the quality and frequency of engagement. Content and rapid thematic analysis were used to analyze documentation data. Quantitative data were summarized as frequencies and means. Qualitative and quantitative findings were triangulated. RESULTS: A total of 4,540 interactions were identified across 15 meetings. The most frequent interaction was providing information (44%), followed by responding (37-38%). The quality and frequency of stakeholder engagement were rated favorably (average 4.7 of 5). Most CAB members (96%) reported good/excellent engagement. Specific comments included appreciation for the diversity of perspectives represented by the CAB members and suggestions for improved live interpretation. Debriefing sessions led to several methodological refinements for the documentation process and forms. CONCLUSION: We highlight key strategies for documenting and assessing community engagement. Our methods allowed for rich ethnographic data collection that refined our work with community partners. We recommend ongoing trainings, including debriefing sessions and routinely reviewed assessment of data to strengthen meaningful community engagement.

A Multicomponent Telehealth Intervention to Improve Oncofertility Care Delivery Among Young Cancer Patients: A Pilot Study.

Purpose: Oncofertility care for pediatric, adolescent, and young adult cancer patients remains under-implemented across adult and pediatric oncology settings. We pilot tested an electronic health record (EHR)-enabled multicomponent oncofertility intervention (including screening, referral, and fertility consult) in an adult academic oncology program and systematically assessed intervention fit to pediatric and community oncology programs. Methods: Using surveys (n = 33), audits (n = 143), and interviews (n = 21) guided by implementation science frameworks, we pilot tested the EHR-enabled intervention for oncofertility care in young cancer patients at an adult oncology program and evaluated implementation outcomes. We interviewed health care providers from seven regional oncology and fertility programs about intervention fit to their clinical contexts. Results: We recruited 33 health care providers from an adult oncology setting and 15 health care providers from seven additional oncology and fertility settings. At the adult oncology setting, the intervention was found to be appropriate, acceptable, and feasible and improved the screening of fertility needs (from 30% pre- to 51% post-intervention); yet, some patients did not receive appropriate referrals to fertility consults. Providers across all settings suggested content and context modifications, such as adding options to the intervention or allowing the screening component to pop up at a second visit, to improve and adapt the intervention to better fit their clinical care contexts. Conclusions: We found that the EHR-enabled intervention increased the rate of goal-concordant oncofertility care delivery at an adult oncology program. We also identified facilitators, barriers, and needed adaptations to the intervention required for implementation and scaling-up across diverse oncology settings.

Mechanisms of change for a family intervention in Kenya: An Integrated Clinical and Implementation Mapping approach.

To increase cultural relevance and maximize access for historically underserved populations, there is a need to explore mechanisms underlying treatment outcomes during piloting. We developed a mixed-method approach, Integrated Clinical and Implementation Mapping (ICIM), to explore clinical and implementation mechanisms to inform improvements in content and delivery. We applied ICIM in a pilot of Tuko Pamoja, a lay counselor-delivered family intervention in Kenya (10 families with adolescents ages 12-17). ICIM is a 3-phase process to triangulate data sources to analyze how and why change occurs within individual cases and across cases. We synthesized data from session and supervision transcripts, fidelity and clinical skills ratings, surveys, and interviews. Outputs included a comprehensive narrative and visual map depicting how content and implementation factors influenced change. For Tuko Pamoja, ICIM results showed common presenting problems, including financial strain and caregivers' distress, triggering negative interactions and adolescent distress. ICIM demonstrated that active treatment ingredients included communication skills and facilitated, prescribed time together. Families improved communication, empathy, and hope, facilitated improved family functioning and mental health. Key implementation mechanisms included provider clinical competencies, alliance-building, treatment-aligned adaptations, and consistent attendance. Results guided manual and training refinements and generated hypotheses about mechanisms to test in larger trials.

The Hierarchical Taxonomy of Psychopathology (HiTOP) Is Not an Improvement Over the DSM.

In their response to our article (both in this issue), DeYoung and colleagues did not sufficiently address three fundamental flaws with the Hierarchical Taxonomy of Psychopathology (HiTOP). First, HiTOP was created using a simple-structure factor-analytic approach, which does not adequately represent the dimensional space of the symptoms of psychopathology. Consequently, HiTOP is not the empirical structure of psychopathology. Second, factor analysis and dimensional ratings do not fix the problems inherent to descriptive (folk) classification; self-reported symptoms are still the basis on which clinical judgments about people are made. Finally, HiTOP is not ready to use in real-world clinical settings. There is currently no empirical evidence demonstrating that clinicians who use HiTOP have better clinical outcomes than those who use the Diagnostic and Statistical Manual of Mental Disorders (DSM). In sum, HiTOP is a factor-analytic variation of the DSM that does not get the field closer to a more valid and useful taxonomy.

Mechanisms of action for stigma reduction among primary care providers following social contact with service users and aspirational figures in Nepal: an explanatory qualitative design.

BACKGROUND: There are increasing initiatives to reduce mental illness stigma among primary care providers (PCPs) being trained in mental health services. However, there is a gap in understanding how stigma reduction initiatives for PCPs produce changes in attitudes and clinical practices. We conducted a pilot randomized controlled trial of a stigma reduction intervention in Nepal: REducing Stigma among HealthcAre Providers (RESHAPE). In a previous analysis of this pilot, we described differences in stigmatizing attitudes and clinical behaviors between PCPs receiving a standard mental health training (mental health Gap Action Program, mhGAP) vs. those receiving an mhGAP plus RESHAPE training. The goal of this analysis is to use qualitative interview data to explain the quantitative differences in stigma outcomes identified between the trial arms. METHODS: PCPs were randomized to either standard mental health training using mhGAP led by mental health specialists or the experimental condition (RESHAPE) in which service users living with mental illness shared photographic recovery narratives and participated in facilitated social contact. Qualitative interviews were conducted with PCPs five months post-training (n = 8, standard mhGAP training; n = 20, RESHAPE). Stigmatizing attitudes and clinical practices before and after training were qualitatively explored to identify mechanisms of change. RESULTS: PCPs in both training arms described changes in knowledge, skills, and confidence in providing mental healthcare. PCPs in both arms described a positive feedback loop, in which discussing mental health with patients encouraged more patients to seek treatment and open up about their illness, which demonstrated for PCPs that mental illness can be treated and boosted their clinical confidence. Importantly, PCPs in the RESHAPE arm were more likely to describe a willingness to treat mental health patients and attributed this in part to social contact with service users during the training. CONCLUSIONS: Our qualitative research identified testable mechanisms of action for stigma reduction and improving clinical behavior: specifically, recovery stories from service users and social engagement led to greater willingness to engage with patients about mental illness, triggering a feedback loop of more positive experiences with patients who benefit from mental healthcare, which further reinforces willingness to deliver mental healthcare. Trial registration ClinicalTrials.gov identifier, NCT02793271.

Folk Classification and Factor Rotations: Whales, Sharks, and the Problems With the Hierarchical Taxonomy of Psychopathology (HiTOP).

The Hierarchical Taxonomy of Psychopathology (HiTOP) uses factor analysis to group people with similar self-reported symptoms (i.e., like-goes-with-like). It is hailed as a significant improvement over other diagnostic taxonomies. However, the purported advantages and fundamental assumptions of HiTOP have received little, if any scientific scrutiny. We critically evaluated five fundamental claims about HiTOP. We conclude that HiTOP does not demonstrate a high degree of verisimilitude and has the potential to hinder progress on understanding the etiology of psychopathology. It does not lend itself to theory-building or taxonomic evolution, and it cannot account for multifinality, equifinality, or developmental and etiological processes. In its current form, HiTOP is not ready to use in clinical settings and may result in algorithmic bias against underrepresented groups. We recommend a bifurcation strategy moving forward in which the DSM is used in clinical settings while researchers focus on developing a falsifiable theory-based classification system.

Treatment Preferences for Pharmacological versus Psychological Interventions among Primary Care Providers in Nepal: Mixed Methods Analysis of a Pilot Cluster Randomized Controlled Trial.

There is increasing evidence supporting the effectiveness of psychological interventions in low- and middle-income countries. However, primary care providers (PCPs) may prefer treating patients with medication. A secondary exploratory analysis of a pilot cluster randomized controlled trial was conducted to evaluate psychological vs. pharmacological treatment preferences among PCPs. Thirty-four health facilities, including 205 PCPs, participated in the study, with PCPs in 17 facilities assigned to a standard version of the mental health Gap Action Programme (mhGAP) training delivered by mental health specialists. PCPs in the other 17 facilities received mhGAP instruction delivered by specialists and people with lived experience of mental illness (PWLE), using a training strategy entitled Reducing Stigma among HealthcAre ProvidErs (RESHAPE). Pre- and post- intervention attitudes were measured through quantitative and qualitative tools. Qualitative interviews with 49 participants revealed that PCPs in both arms endorsed counseling's benefits and collaboration within the health system to provide counseling. In the RESHAPE arm, PCPs were more likely to increase endorsement of statements such as "depression improves without medication" (F = 9.83, p < 0.001), "not all people with depression must be treated with antidepressants" (χ2 = 17.62, p < 0.001), and "providing counseling to people who have alcohol abuse problems is effective" (χ2 = 26.20, p < 0.001). These mixed-method secondary findings from a pilot trial suggest that in-person participation of PWLE in training PCPs may not only reduce stigma but also increase PCPs' support of psychological interventions. This requires further investigation in a full-scale trial.

Applying the EPIS framework to policy-level considerations: Tobacco cessation policy implementation among California Medicaid managed care plans.

Background: In 2016, the California Department of Healthcare Services (DHCS) released an "All Plan Letter" (APL 16-014) to its Medicaid managed care plans (MCPs) providing guidance on implementing tobacco-cessation coverage among Medicaid beneficiaries. However, implementation remains poor. We apply the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to identify barriers and facilitators to fidelity to APL 16-014 across California Medicaid MCPs. Methods: We assessed fidelity through semi-structured interviews with MCP health educators (N = 24). Interviews were recorded, transcribed, and reviewed to develop initial themes regarding barriers and facilitators to implementation. Initial thematic summaries were discussed and mapped onto EPIS constructs. Results: The APL (Innovation) was described as lacking clarity and specificity in its guidelines, hindering implementation. Related to the Inner Context, MCPs described the APL as beyond the scope of their resources, pointing to their own lack of educational materials, human resources, and poor technological infrastructure as implementation barriers. In the Outer Context, MCPs identified a lack of incentives for providers and beneficiaries to offer and participate in tobacco-cessation programs, respectively. A lack of communication, educational materials, and training resources between the state and MCPs (missing Bridging Factors) were barriers to preventing MCPs from identifying smoking rates or gauging success of tobacco-cessation efforts. Facilitators included several MCPs collaborating with each other and using external resources to promote tobacco cessation. Additionally, a few MCPs used fidelity monitoring staff as Bridging Factors to facilitate provider training, track providers' identification of smokers, and follow-up with beneficiaries participating in tobacco-cessation programs. Conclusions: The release of the evidence-based APL 16-014 by California's DHCS was an important step forward in promoting tobacco-cessation services for Medicaid MCP beneficiaries. Improved communication on implementation in different environments and improved Bridging Factors such as incentives for providers and patients are needed to fully realize policy goals. Plan Language Summary: In 2016, the California Department of Healthcare Services (DHCS) in California released an "All Plan Letter" (APL 16-014) to its Medicaid managed care plans (MCPs) providing guidance on implementing tobacco-cessation coverage to address tobacco use among Medicaid beneficiaries. We conducted semi-structured interviews with health educators in California Medicaid MCPs to explore the barriers and facilitators to implementing the APL using the Exploration, Preparation, Implementation, Sustainment framework. According to MCPs, barriers included a lack of clarity in the APL guidelines; a lack of resources, including educational materials, infrastructure to identify smokers, and human resources; and a lack of incentives or penalties for providers to provide tobacco-cessation materials to beneficiaries. Facilitators included collaboration between MCPs and state and/or national public health programs. Overall, our findings can provide avenues for improving the implementation of tobacco-cessation services within Medicaid MCPs.

Syndemics theory must take local context seriously: An example of measures for poverty, mental health, and food insecurity.

Syndemics theory has provided insight into the ways that disease states and social adversity interact in marginalized populations to further disempower these groups. Yet, until recently, scholars have not identified how we might actually recognize and measure a syndemic, as opposed to a situation where there are multiple but non-interacting diseases present in a population. As researchers like those included in this special issue develop new methods for assessing syndemic interactions in diverse global populations, this short communication argues for the value of locally relevant measures. Poverty, mental health, food insecurity, and type 2 diabetes are used to illustrate the assessment of a potential syndemic from a locally grounded perspective. The discussion emphasizes the insights locally adapted measures can add and what information would be lost without their use.

Understanding mental distress in Arcahaie, Haiti: Heterogeneous uses of idioms of distress in communicating psychological suffering.

Research on mental health in specific communities requires careful attention to cultural context and language. Studies on global mental health have increasingly analyzed idioms of distress, or culturally situated ways of conceptualizing, experiencing, and expressing distress. This study examines how idioms of distress are used and understood in Arcahaie, Haiti. The goal was to enrich current understanding of mental health conceptualization and communication by exploring the heterogeneity of common idioms of distress. Interviews with community members (N = 47) explored meanings and perceived causations of 13 idioms of distress. Major themes included pervasiveness of poverty, ruminative thinking, effects of Vodou and Christian belief systems, embodied distress, and the behavior of "crazy" people (moun fou). The findings suggest some specific pathways for potential community engagement projects, including training lay-leaders in cognitive behavioral therapy using existing socioreligious infrastructure and expanding access to social engagement activities. This research contributes to a small but growing body of literature on mental illness in Haiti and to methods for studying idioms of distress.

Sample sizes for saturation in qualitative research: A systematic review of empirical tests.

OBJECTIVE: To review empirical studies that assess saturation in qualitative research in order to identify sample sizes for saturation, strategies used to assess saturation, and guidance we can draw from these studies. METHODS: We conducted a systematic review of four databases to identify studies empirically assessing sample sizes for saturation in qualitative research, supplemented by searching citing articles and reference lists. RESULTS: We identified 23 articles that used empirical data (n = 17) or statistical modeling (n = 6) to assess saturation. Studies using empirical data reached saturation within a narrow range of interviews (9-17) or focus group discussions (4-8), particularly those with relatively homogenous study populations and narrowly defined objectives. Most studies had a relatively homogenous study population and assessed code saturation; the few outliers (e.g., multi-country research, meta-themes, "code meaning" saturation) needed larger samples for saturation. CONCLUSIONS: Despite varied research topics and approaches to assessing saturation, studies converged on a relatively consistent sample size for saturation for commonly used qualitative research methods. However, these findings apply to certain types of studies (e.g., those with homogenous study populations). These results provide strong empirical guidance on effective sample sizes for qualitative research, which can be used in conjunction with the characteristics of individual studies to estimate an appropriate sample size prior to data collection. This synthesis also provides an important resource for researchers, academic journals, journal reviewers, ethical review boards, and funding agencies to facilitate greater transparency in justifying and reporting sample sizes in qualitative research. Future empirical research is needed to explore how various parameters affect sample sizes for saturation.

Challenges in simultaneous validation of mental health screening tools in multiple languages: Adolescent assessments in Hausa and Pidgin in Nigeria.

Background: With growing global recognition of the need to address mental health, a key challenge is determining who needs mental health services. Most self-report screening tools were developed in English-speaking high-income settings, and this cultural milieu influences the types and content of items, the manner in which items are asked, and the options for responding to items. Approaches have been developed for transcultural translation and validation. However, these approaches are typically applied in one language at a time, which is of limited utility in linguistically diverse settings. Methods: To address challenges in cross-cultural validation, we undertook a unique process of simultaneously validating tools in two languages in Nigeria. Through this dual-language validation, we explored how cultural and contextual differences may influence what is considered valid for a mental health tool. We validated the Depression Self Rating Scale, Child PTSD Symptom Scale (CPSS), and Disruptive Behavior Disorders Rating Scale with a community sample of 330 adolescents aged 12-17. Validity was assessed in Hausa and Pidgin, two languages commonly spoken in Nigeria. Clinical psychologists used the Kiddie-Schedule for Affective Disorders and Schizophrenia to establish caseness. Results: Most items had good discriminant validity, except on the CPSS, on which only 8 of 17 items discriminated by caseness. Findings indicate the influence of culture (e.g., linguistic differences in translatability of items) and context (e.g., items that reflect experiences of hunger or foodborne illness; different PTSD caseness by language might reflect differential trauma exposure between populations). We also identified items that operated differently between languages. Conclusion: We identified shortcomings in cross-cultural validation procedures with regard to determining whether language, context, or or other differences influence performance of items. For future validation efforts, we recommend systematically collecting information on context and stressful/traumatic exposures as a way to contextualize interpretation of the validity findings. Acronyms: Depression Self Rating Scale (DSRS), Child PTSD Symptom Scale (CPSS), Disruptive Behavior Disorders Rating Scale (DBDRS), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Area Under the Curve (AUC), Diagnostic Odds Ratio (DOR), Low- and Middle-Income Countries (LMICs), Posttraumatic Stress Disorder (PTSD).

Identification of optimal thalassemia screening strategies for migrant populations in Thailand using a qualitative approach.

BACKGROUND: Thalassemia is a common inherited hemoglobin disorder in Southeast Asia. Severe thalassemia can lead to significant morbidity for patients and economic strain for under-resourced health systems. Thailand's thalassemia prevention and control program has successfully utilized prenatal screening and diagnosis to reduce the incidence of severe thalassemia in Thai populations, but migrant populations are excluded despite having high thalassemia prevalence. We sought to identify key barriers to and facilitators of thalassemia screening and to develop tailored recommendations for providing migrants with access to thalassemia prevention and control. METHODS: We conducted 28 in-depth interviews and 4 focus group discussions (FGDs) in Chonburi, Thailand with Myanmar and Cambodian migrants, Thai healthcare providers, Thai parents of children affected by thalassemia, and migrant agents. RESULTS: Participant narratives revealed that migrants' lack of knowledge about the prevalence, manifestations, severity, and inherited nature of thalassemia led to misconceptions, fear, or indifference toward thalassemia and screening. Negative perceptions of pregnancy termination were based in religious beliefs but compounded by other sociocultural factors, presenting a key obstacle to migrant uptake of prenatal screening. Additionally, structural barriers included legal status, competing work demands, lack of health insurance, and language barriers. Participants recommended delivering public thalassemia education in migrants' native languages, implementing carrier screening, and offering thalassemia screening in convenient settings. CONCLUSIONS: An effective thalassemia prevention and control program should offer migrants targeted thalassemia education and outreach, universal coverage for thalassemia screening and prenatal care, and options for carrier screening, providing a comprehensive strategy for reducing the incidence of severe thalassemia in Thailand and establishing an inclusive model for regional thalassemia prevention and control.

Measuring mental health in humanitarian crises: a practitioner's guide to validity.

BACKGROUND: There are ongoing methodological advances in measuring mental health in humanitarian crises. This Special Section describes numerous innovations. Here we take a practitioner's view in understanding the key issues related to assessment of mental health in humanitarian contexts and how the innovations contribute to the field. MAIN BODY: In this guide for practitioners, we address the following issues: (1) clarifying the intended purpose of conducting mental health assessment in humanitarian crises: why is this information collected and for what intended purposes?; (2) determining what type of tool should be selected and the types of psychometric properties that are important for tools serving this particular purpose; (3) when a validated tool is not available, considering how qualitative and quantitative methods should be used to generate information on validity; and finally, (4) how to report on validity and its implications for interpreting information for humanitarian practitioners, governments, care providers, and other stakeholders supporting people affected by humanitarian emergencies. CONCLUSION: Ultimately, mental health assessment tools are not independent of the group with which they were designed, nor are the psychometric properties of the tools or their utility universal across purposes. Therefore, organizations and stakeholders will optimize their positive impact when choosing tools wisely, appropriately adapting and validating tools, and providing guidance on how to interpret those findings to best serve populations in need.