Sex and Gender Variables in Data Set Creation and Data Cleaning for Inclusive and Accurate Reproductive Health Research and Quality Improvement.

INTRODUCTION: Existing data is often used for reproductive research and quality improvement. Electronic health records (EHRs) with a single data field for sex and gender conflate sex assigned at birth, genotype, gender identity, and the presence of anatomic tissue and organs. This is problematic for inclusion of transgender and gender-diverse populations in research. This article discusses considerations with a single-item sex and gender variable drawn from EHR records and describes an audit to determine variable validity as a criterion for inclusion or exclusion in perinatal research. METHODS: Individuals with a live birth at a large academic medical center from 2010 to 2022 were identified via electronic query, and records with male demographic information were reviewed to validate (1) the patient's date of birth and delivery date in the EHR matched the medical record number, (2) male sex and gender demographic information, and (3) male gender terms in EHR notes. RESULTS: All health records of male birthing individuals (n = 8) had EHR evidence of giving birth within the health system during the timeframe, and the date of birth matched the medical record number of the EHR. All had male gender in the EHR demographic information. Six patients did not have any male gender terms in available EHR notes, only female gender terms. Two records had recent notes using male gender terms. DISCUSSION: Current EHRs may not have reliable data on the gender and sex of gender-diverse individuals. A single sex and gender variable drawn from EHRs should not be used as inclusion or exclusion criteria for health research or quality improvement without additional record review. EHRs can be updated to collect more data on sex, gender identity, and other relevant variables to improve research and quality improvement.

Exploring the early experiences of assisted dying in Aotearoa New Zealand: a qualitative study protocol.

INTRODUCTION: Increasing numbers of jurisdictions are legalising assisted dying (AD). Developing research protocols to study the experiences and outcomes of legislation is imperative. AD is a topic that, by nature of its complexity and inherent ethical issues, lends itself to qualitative research. Using the objectives of the statutory framework, this qualitative study aims to provide a robust review of the newly formed AD service in New Zealand and the extent to which it is safe, people-centred, dignity-enhancing, accessible and available equitably to all eligible people. METHODS AND ANALYSIS: The research uses an appreciative inquiry design to focus on what is working well, what could be improved, what constitutes the 'ideal' and how to enable people to achieve that ideal. We are using online semi-structured interviews and face-to-face focus groups to explore the experiences of key stakeholders: eligible/ineligible service users; eligible/ineligible service users with impairments; families of service users; AD providers; non-providers (providers who object to AD and others who are not directly involved in providing AD but are not opposed in principle); health service leaders; and Maori community members. An estimated 110 participants will be interviewed. We will conduct thematic and regulatory analyses of data. ETHICS AND DISSEMINATION: The ethical aspects of this study have been approved by the Northern A Health and Disability Ethics Committee through the full review pathway (2023 EXP 18493). To disseminate the findings, we will draft resources to support interviewee groups, to be developed with feedback from stakeholder meetings. We will submit evidence-based recommendations to inform the government review of the End of Life Choice Act 2019. Findings will be disseminated in peer-reviewed publications, conferences, webinars, media, stakeholder feedback sessions and accessible research briefings.

Deep brain stimulation versus vagus nerve stimulation for the motor function of poststroke hemiplegia: study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Deep brain stimulation (DBS) and vagus nerve stimulation (VNS) can improve motor function in patients with poststroke hemiplegia. No comparison study exists. METHODS AND ANALYSIS: This is a randomised, double-blind, controlled clinical trial involving 64 patients who had their first stroke at least 6 months ago and are experiencing poststroke limb dysfunction. These patients must receive necessary support at home and consent to participate. The aim is to evaluate the effectiveness and safety of DBS and VNS therapies. Patients are excluded if they have implantable devices that are sensitive to electrical currents, severe abnormalities in their lower limbs or are unable to comply with the trial procedures. The study has two parallel, distinct treatment arms: the Stimulation Group and the Sham Group. Initially, the Stimulation Group will undergo immediate electrical stimulation postsurgery, while the Sham Group will receive non-stimulation 1 month later. After 3 months, these groups will swap treatments, with the Stimulation Group discontinuing stimulation and the Sham Group initiating stimulation. Six months later, both groups will resume active stimulation. Our primary outcomes will meticulously assess motor function improvements, using the Fugl-Meyer Assessment, and safety, monitored by tracking adverse reaction rates. Furthermore, we will gain a comprehensive view of patient outcomes by evaluating secondary measures, including clinical improvement (National Institutes of Health Stroke Scale), surgical complications/side effects, quality of life (36-item Short Form Questionnaire) and mental health status (Hamilton Anxiety Rating Scale/Hamilton Depression Rating Scale). To ensure a thorough understanding of the long-term effects, we will conduct follow-ups at 9 and 12 months postsurgery, with additional long-term assessments at 15 and 18 months. These follow-ups will assess the sustained performance and durability of the treatment effects. The statistical analysis will uncover the optimal treatment strategy for poststroke hemiplegia, providing valuable insights for clinicians and patients alike. ETHICS AND DISSEMINATION: This study was reviewed and approved by the Ethical Committee of Chinese PLA General Hospital (S2022-789-01). The findings will be submitted for publication in peer-reviewed journals with online accessibility, ensuring adherence to the conventional scientific publishing process while clarifying how the research outcomes will be disseminated and accessed. TRIAL REGISTRATION NUMBER: NCT06121947.

Causal Interpretations of Correlational Evidence Regarding Violence.

Inferring causation from correlation can lead to erroneous explanations of violent behavior and the development and implementation of ineffective or even harmful interventions and policies. This article explores the inferences that violence researchers draw from evidence related to violent offending. We invited authors of articles published in violence journals to complete an online survey in which they were asked to identify a factor that may be a cause of violence, cite a study that demonstrates the factor is associated with violence, and provide their inferences from that study. We read each study and coded its research design (description of a sample [n = 9], cross-sectional/retrospective non-experiment [n = 18], single-wave longitudinal non-experiment [n = 10], multi-wave longitudinal non-experiment [n = 0], or randomized experiment [n = 5]) and the appropriate inferences (inter-rater reliability was adequate; κ = 0.73-1.00). Reassuringly, participants (N = 42; 57.1% in United States; 59.5% women) rarely indicated that their identified study demonstrated that their factor was a cause of violence (0.0%-16.7%) when the study was not a randomized experiment. However, many participants failed to acknowledge any plausible alternate interpretations (e.g., reverse causality, third variable) of the results from non-experimental studies (50.0%-88.9%). Moreover, most participants incorrectly selected a causal implication as following from the results of non-experimental studies (77.8%-100%). Our results suggest that even among authors of articles published in peer-review scientific journals on violence, many appear to infer causation from correlation.

A Worked Example of Qualitative Descriptive Design: A Step-by-Step Guide for Novice and Early Career Researchers.

AIM: To provide a worked example informed by relevant literature and related studies that novice and early career researchers may use to reflect on, prepare and conduct a thoughtful and rigorous qualitative descriptive study. DESIGN: Methodological discussion of qualitative descriptive design. METHODS: Seminal work and recent related literature were reviewed to situate the discussion and identify the concepts and steps to conduct a qualitative descriptive study. RESULTS: Qualitative descriptive design is widely used in nursing and health science research. This design offers flexible use of qualitative methods, which presents a double-edged sword, posing challenges in preparing a well-developed study and achieving methodological rigour. The design often borrows methods from other qualitative traditions, which may need to be clarified for novice and early career researchers, wherein studies may be conducted using a mix and match of methods without giving justice to the heart of qualitative descriptive design. In this paper, we present a step-by-step guide, using a worked example, to demonstrate how to conduct a qualitative descriptive study. CONCLUSION: Qualitative descriptive design may be confusing due to its flexibility, which may limit the scope of research and subsequently, the quality and impact of the findings. With the appropriate application of research methods producing high-quality and relevant findings, qualitative descriptive design is a valuable qualitative method in its own right. IMPLICATIONS FOR THE PROFESSION: Novice and early career researchers may increase the impact of their findings through rigorously conducting their studies. Clarifying steps for thoughtful execution may inform novice and early career researchers, allowing for a rigorous application of the method, which, in turn, may contribute to impactful findings. IMPACT: A clear presentation of steps, supported by a worked example and related studies, may support novice and early career researchers in conducting a qualitative descriptive study with methodological rigour. REPORTING METHOD: Not applicable. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials.

BACKGROUND: It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials. METHODS: Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) 'roundtable' discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team. RESULTS: Over 40 experts contributed to the ACCESS project-patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The 'roundtable' discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials by applying one of the three INCLUDE frameworks (ethnicity, socioeconomic disadvantage, impaired capacity to consent) to one trial each, to produce the key recommendations for the guidance. Issues around implementation were explored in stakeholder interviews and key facilitators were identified: funders requesting information on inclusion, having the time and funding to implement strategies, dedicated staff, flexibility in trial protocols, and considering inclusion of under-served groups at the design stages. The STEP UP guidance is freely available at http://step-up-clinical-trials.co.uk . CONCLUSION: Researchers should consider inclusivity to shape initial trial design decisions. Trial teams and funders need to ensure that trials are given both the resources and time needed to implement the STEP UP guidance and increase the opportunities to recruit a diverse population.

Randomised clinical trials compare one or more treatments to another to see which ones work best. Trials don't always include people or groups who might benefit from the results: those excluded are sometimes called 'under- served groups'. Recent work has shone a light on this and now researchers are being asked by the public, trial funders and others to design their research so that under-served groups are more able to take part.We worked on a project to find out how to make sure everyone can be part of clinical trials. We looked at published work and held five online meetings with researchers, doctors, and patients to see what was being done already, and to think of other things that could help under-served groups take part in trials. Three groups of people, including scientists, patients, doctors and other NHS workers then  used this information to redesign three older trials using some existing inclusivity frameworks to think through the barriers for under-served groups in these trials. The three groups then talked through these trials at a 2-hour meeting, suggesting changes to the original trial plan, and discussed whether the suggestions were practical and useful. From this we came up with recommendations for how to design trials so that they have fewer barriers for under-served groups.We interviewed people to find out the best way to put these things into practice and talk through any practical issues. Using all of this information: the recommendations and what came out of the interviews, the study team created some guidance ­ 'STEP UP (Strategies for Trialists to promote Equal Participation in clinical trials for Under-served Populations)' ­ for people working in trials.

NFDI4Health Local Data Hubs Implementing a Tailored Metadata Schema for Health Data.

INTRODUCTION: NFDI4Health is a consortium funded by the German Research Foundation to make structured health data findable and accessible internationally according to the FAIR principles. Its goal is bringing data users and Data Holding Organizations (DHOs) together. It mainly considers DHOs conducting epidemiological and public health studies or clinical trials. METHODS: Local data hubs (LDH) are provided for such DHOs to connect decentralized local research data management within their organizations with the option of publishing shareable metadata via centralized NFDI4Health services such as the German central Health Study Hub. The LDH platform is based on FAIRDOM SEEK and provides a complete and flexible, locally controlled data and information management platform for health research data. A tailored NFDI4Health metadata schema for studies and their corresponding resources has been developed which is fully supported by the LDH software, e.g. for metadata transfer to other NFDI4Health services. RESULTS: The SEEK platform has been technically enhanced to support extended metadata structures tailored to the needs of the user communities in addition to the existing metadata structuring of SEEK. CONCLUSION: With the LDH and the MDS, the NFDI4Health provides all DHOs with a standardized and free and open source research data management platform for the FAIR exchange of structured health data.

Heterogenous relapse and efficacy endpoint definitions for neuromyelitis optica spectrum disorder studies: A systematic review.

BACKGROUND: Over the last years, multiple studies have been dedicated to evaluate the efficacy of different treatment options for Neuromyelitis Optica Spectrum Disorder (NMOSD). However, there is a wide variety of endpoints employed across these studies. Our goal is to conduct a systematic review describing the endpoints utilized in studies related to NMOSD. METHODS: Medline, Embase, and Cochrane were searched from inception to May 2023, to identify studies analyzing treatment options in patients with NMOSD. We collected data on baseline study characteristics and all efficacy outcomes available. RESULTS: We included 127 studies and identified approximately 40 different efficacy endpoints, categorized into 1) relapse, 2) disability, 3) visual acuity, and 4) surrogate outcomes. Most studies were retrospective (54.3 %) and aimed at attack prevention (81.4 %). The most common relapse-related outcomes were annualized relapse rate (73.2 %), followed by relapse rate (50.4 %), and relapse-free rate (36.2 %). The relapse definition also varied widely among studies, with only 73 (57.4 %) studies explicitly addressing the definition used. The most common disability outcome was the Expanded Disability Scale (97.6 %), followed by the Modified Rankin Scale (7.9 %). Visual Acuity Score was employed in 14.2 % of studies, followed by Visual Evoked Potentials (6.3 %). Imaging was the most common surrogate (20.5 %), followed by the fraction of B cells (18.1 %). CONCLUSION: Publications were heterogeneous in measuring efficacy, with different use of endpoints and relapse definitions. Standardization across studies would improve data analysis and application in clinical practice.

Common misconceptions and good practices in qualitative research in school psychology.

After a long journey in relative obscurity, qualitative research is being accepted in the field of school psychology. As more school psychology researchers and graduate students adopt it as part of their scholarly endeavors, we reflect on the qualitative research published in school psychology since 2006 in terms of what has been done so far and what can be improved going forward. This act of academic retrospection can strengthen qualitative research in school psychology by helping to identify areas of strength and weakness. We read all qualitative studies published in seven school psychology journals between 2006 and 2021 to understand their methodological character. In Section I, we discuss the methodological trends (e.g., approach to inquiry, data collection methods, data analysis strategies) we found. In Section II, we reflect upon this corpus and identify some common misconceptions about qualitative methodologies that stood out to us. We clarify these misconceptions and highlight some examples of 'good' practices in these articles that could be adopted by other researchers. Finally in Section III, we provide some general recommendations about developing school psychologists' understanding of and the ability to conduct qualitative research.

Understanding how nurses can effectively utilise social media for increasing public involvement, recruitment and impact dissemination of Clinical Research Trials.

Background: The methodologies for clinical research trials are evolving to greater usage of social media platforms, providing opportunities to incorporate smart technologies in their delivery. Research Nurses should consider how they can utilise platforms for public engagement in trials. Aim: To explore the experiences of social media platforms and clinical research trials in a healthy population group, to gain insight into how clinical researchers can utilise these platforms professionally and ethically. Methods: Using a critical realist qualitative focus group design with template analysis, we recruited 16 healthy members of the public aged 18-75 years. The data expands upon their thoughts and behaviours regarding social media platforms with their understanding of clinical research. Results: Three main themes along with their specific subthemes (1) Design: Patient and Public Involvement (Subtheme: Understanding of clinical research, Diversity of social media users), (2) Implementation: Recruitment to active studies, (Subtheme: Motivators for volunteering, Trustworthy), (3) Dissemination: Impact and Awareness of Results, (Subtheme: Information overload, Motivations for users to share information). Conclusions: This study has highlighted the need to consider the way different population groups use social media platforms and the information they share when looking to engage them in clinical research trials.

Sex and gender reporting in UK emergency medicine trials from 2010 to 2023: a systematic review.

BACKGROUND: Female participants are underrepresented in randomised control trials conducted in urgent care settings. Although sex and gender are frequently reported within demographic data, it is less common for primary outcomes to be disaggregated by sex or gender. The aim of this review is to report sex and gender of participants in the primary papers published on research listed on the National Institute of Health and Care Research (NIHR) Trauma and Emergency Care (TEC) portfolio and how these data are presented. METHODS: This is a systematic review of the published outputs of interventional trials conducted in UK EDs. Interventional trials were eligible to be included in the review if they were registered on the NIHR TEC research portfolio from January 2010, if the primary paper was published before 31 December 2023 and if the research was delivered primarily in the ED. Trials were identified through the NIHR open data platform and the primary papers were identified through specific searches using MedLine, EMBASE and PubMed. The primary objective of the review is to quantify the proportion of sex-disaggregated or gender-disaggregated primary outcomes in clinical trials within UK emergency medicine. RESULTS: The initial search revealed 169 registered research projects on the NIHR TEC portfolio during the study period, of which 24 met the inclusion criteria. Overall, 76 719 participants were included, of which 31 374 (40%) were female. Only one trial (CRYOSTAT-2) reported a sex-disaggregated analysis of the effect of the intervention on either primary or secondary outcomes, and no sex-based difference in treatment effect was detected. CONCLUSIONS: Fewer females than males were included in TEC trials from 2010 to 2023. One trial reported the primary outcome stratified by sex. There is significant scope to increase the scientific value of TEC trials to females by funders.

Essential concepts for effective mixed methods research in the health professions: AMEE Guide No. 173.

Mixed-methods research involves combining quantitative and qualitative approaches and mixing and integrating at multiple stages. It is gaining more attention and interest in health professions education research and evaluation. However, many undertake mixed-methods research for the first time without a rich understanding of the differences in practice associated with mixed-methods research. This often leads to research efforts that do not result in more complex, nuanced understandings of the phenomena being studied. Mixed-methods research requires researchers to thoughtfully and often creatively weave together their projects' various qualitative and quantitative strands. This effort ideally starts at the design stage and continues through the remainder of the research effort. We have aggregated resources and organized this guide to introduce researchers to what we see as some essential concepts, practices, and scholarship in mixed methods which will be useful to those just starting on their mixed-methods journey and those already engaging in mixed-methods research. This guide begins by discussing three vital characteristics of mixed-methods research that set it apart from mono-method research: its purposes, alternative philosophical stances, and integration, long viewed as a defining characteristic. We then discuss further important considerations, such as conducting mixed-methods literature reviews, timing and priority of qualitative and quantitative strands, and research design typologies. To complement these discussions, we have provided illustrative examples of high-quality peer-reviewed mixed-methods research from health professions education and other closely associated areas (e.g. health and clinical research). This guide also includes several activities and recommended resources, such as journals, textbooks, and professional societies, that researchers can use to deepen their practice and understanding and mixed-methods research. We hope the content, resources, article examples, and activities will be the prologue to fruitful explorations of mixed-methods research, helping researchers make informed, intentional choices about future mixed-methods efforts.

Introducing JOSPT Methods: A Journal Focused on Advancing the Research Methods Applied to the Musculoskeletal Rehabilitation Field.

SYNOPSIS: In 2025, JOSPT will continue its mission to enhance research in the field of musculoskeletal rehabilitation. JOSPT aims to support authors who are working to advance the research methods applied to answer clinical questions in the musculoskeletal rehabilitation field. Using the most robust methods helps authors ensure their studies can have immediate impact on health policies and clinical practice. With this editorial, we introduce a new gold open-access journal, JOSPT Methods, where research will be available to read for free, immediately upon publication. J Orthop Sports Phys Ther 2024;54(10):1-3. doi:10.2519/jospt.2024.12972.

Development of a Canadian Guidance for Reporting Real-world Evidence for Regulatory and Health-Technology Assessment (HTA) Decision Making.

Real-world evidence (RWE) can complement and fill knowledge gaps from randomized controlled trials to assist in health-technology assessment (HTA) for regulatory decision-making. However, the generation of RWE is an intricate process with many sequential decision points, and different methods and approaches may impact the quality and reliability of evidence. Standardization and transparency in reporting these decisions is imperative to appraise RWE and incorporate it into HTA decision-making. A partnership between Canadian health system stakeholders, namely Health Canada and Canada's Drug Agency (formerly the Canadian Agency for Drugs and Technologies in Health (CADTH)), was established to develop a guidance for standardization of reporting of RWE for regulatory and HTA decision-making in Canada. In this article, we describe the methods to develop the Guidance for Reporting Real-World Evidence document and checklist for reporting RWE for regulatory and HTA decision-making in Canada. This guidance can be adapted for other jurisdictions and will have future extensions to incorporate emerging issues with RWE and HTA decision-making.

Rethinking the Social Determination of Food in Chile Through Practices and Interactions of Actors in Food Environments: Nonexperimental, Cross-Sectional Study.

BACKGROUND: Food environments are crucial for promoting healthy and sustainable eating and preventing obesity. However, existing food environment frameworks assume an already installed causality and do not explain how associations in food environments are established or articulated, especially from an integrative and transdisciplinary approach. This research attempts to bridge these gaps through the use of Actor-Network Theory, which traces the relationship network between human (and nonhuman) actors in order to describe how these interact and what agencies (direct or remote) are involved. OBJECTIVE: This study aims to explain the practices and interactions of actors in food environments in order to approach the problem of unhealthy eating with a transdisciplinary approach. METHODS: This is a nonexperimental, cross-sectional study. Due to the complexity of the study phenomena, a mixed methods approach with 4 consecutive phases will be developed in Chile. Phase 1 involves a systematic literature review of food environment evidence since 2015, following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) protocol; phase 2 involves the application of a shortened version of the Nutrition Environment Measure Scale-Perceptions adapted to Chile (NEMS-P-Ch) in 2 neighborhoods with different socioeconomic levels; in phase 3, six focus groups in each neighborhood will be conducted to address social determinants such as gender, employment status, and migration; and in phase 4, participant observation and in-depth interviews will be used to analyze the direct and empirical exploration of the actors in their daily interaction with food environments. The triangulation and complementarity of the data will allow us to create a practical model about the practices and interactions of actors in their food environments, which reflects the complexity and transdisciplinary nature of the study. RESULTS: We have advanced in phases 1-3 of the study. In phase 1, a total of 109 manuscripts are being revised for data extraction. In phase 2, we applied the NEMS-P-Ch to 785 people, 49.4% (388/785) of whom belong to a low socioeconomic neighborhood. Participants from phase 2 are being contacted to participate in the focus groups (phase 3). By the end of July, we have conducted 6 focus groups with 5-11 participants. CONCLUSIONS: This study will provide a comprehensive understanding of how individuals interact with their food environments, offering deep insights into the factors influencing their food-related decisions. In addition, the study aims to develop a model that more accurately reflects reality by examining not only the food environments themselves but also the interactions among various stakeholders within these environments and their daily practices. The findings of this study will offer evidence-based insights to inform public policies tailored to the specific territories and communities under investigation or those with similar characteristics. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/62765.

Improving the Social Well-Being of Single Older Adults Using the LOVOT Social Robot: Qualitative Phenomenological Study.

BACKGROUND: This study examined the social well-being of single older adults through the companionship of a social robot, LOVOT (Love+Robot; Groove X). It is designed as a companion for older adults, providing love and affection through verbal and physical interaction. We investigated older adults' perceptions of the technology and how they benefitted from interacting with LOVOT, to guide the future development of social robots. OBJECTIVE: This study aimed to use a phenomenological research design to understand the participants' experiences of companionship provided by the social robot. Our research focused on (1) examining the social well-being of single older adults through the companionship of social robots and (2) understanding the perceptions of single older adults when interacting with social robots. Given the prevalence of technology use to support aging, understanding single older adults' social well-being and their perceptions of social robots is essential to guide future research on and design of social robots. METHODS: A total of 5 single women, aged 60 to 75 years, participated in the study. The participants interacted independently with the robot for a week in their own homes and then participated in a poststudy interview to share their experiences. RESULTS: In total, 4 main themes emerged from the participants' interactions with LOVOT, such as caring for a social robot, comforting presence of the social robot, meaningful connections with the social robot, and preference for LOVOT over pets. CONCLUSIONS: The results indicate that single older adults can obtain psychosocial support by interacting with LOVOT. LOVOT is easily accepted as a companion and makes single older adults feel like they have a greater sense of purpose and someone to connect with. This study suggests that social robots can provide companionship to older adults who live alone. Social robots can help alleviate loneliness by allowing single older adults to form social connections with robots as companions. These findings are particularly important given the rapid aging of the population and the increasing number of single-person households in Singapore.

Defining non-inferiority margins in randomised controlled surgical trials: a protocol for a systematic review.

BACKGROUND: The reporting of randomised controlled non-inferiority (NI) drug trials is poor with less than 50% of published trials reporting a justification of the NI margin. This is despite the introduction of the Consolidated Standards of Reporting Trials (CONSORT) extension on reporting of NI and equivalence in randomised trials. It is critical to set the appropriate NI margin as this choice dictates the conclusions of the trial. Methods to estimate the margin are heterogeneous but generally based on clinical judgement and statistical reasoning, and hence tailored to each clinical situation. Yet an appraisal of NI in clinical trials has not been undertaken. Therefore the aim of this systematic review is to assess the reporting and methodological quality of defining the NI margin. Surgical NI trials have been chosen as our prototype to assess this. METHODS: We will conduct a systematic review of published randomised controlled trials in abdominal surgery that use an NI design. Key eligibility criteria will be: surgical intervention in at least one trial arm; adult patients and a sample size of 100 or more. Ovid MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials will be searched from inception until the date of the search. Identified studies will be assessed for reporting according to the CONSORT recommendations. The outcomes are the description of the methods for defining the NI margin, and the robustness of the NI margin estimation. The latter will be based on simulations using alternative assumptions for model parameters. The results of the simulation will be compared with the trial authors' conclusions. ANTICIPATED RESULTS: The review will describe and appraise the design and reporting of surgical NI trials including shortcomings thereof and allow a comparison with pharmaceutical trials. These findings will inform researchers on the appropriate design and pitfalls when conducting surgical randomised controlled trials with an NI design and promote thorough and standardised reporting of study findings. ETHICS AND DISSEMINATION: Ethical approval is not required and any changes to the protocol will be communicated via the registration platform. The final manuscript will be submitted to a journal for publication and the findings will be disseminated through conference presentations to inform researchers and the public.

Nurturing Longitudinal Samples 2.0.

BACKGROUND: While longitudinal designs can provide significant advantages compared to single measurement/cross sectional designs, they require careful attention to study infrastructure and the risk of attrition among the sample over multiple time points. OBJECTIVE: The strategies used to design and manage an appropriate infrastructure for a longitudinal study and approaches to retain samples are explored using examples from 2 studies, a 25-year study of persons living with multiple sclerosis and a 10-year longitudinal follow-up of breast cancer survivors. RESULTS: Key strategies (developing appropriate infrastructure, minimizing costs to participants, and maximizing rewards of study participation) have helped address the serious threat of attrition in these longitudinal samples. CONCLUSION: Implementation of these strategies can help mitigate some of the disadvantages and leverage the strengths of longitudinal research to produce reliable, insightful, and impactful outcomes.