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1.
J Dent Res ; : 220345241275459, 2024 Sep 21.
Artículo en Inglés | MEDLINE | ID: mdl-39305178
2.
Mult Scler Relat Disord ; 91: 105868, 2024 Sep 04.
Artículo en Inglés | MEDLINE | ID: mdl-39260224

RESUMEN

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.

3.
Emerg Med J ; 2024 Sep 11.
Artículo en Inglés | MEDLINE | ID: mdl-39266055

RESUMEN

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.

4.
Contraception ; : 110708, 2024 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-39307449

RESUMEN

Gender and sex are distinct constructs that shape family planning related experiences, outcomes, and opportunities. This commentary provides guidance to clinical and social science researchers on: 1) current definitions of gender and sex; 2) when and why capturing information about gender, sex, or both is relevant to family planning studies; 3) recommended language for each stage of the research process to accurately and affirmingly recruit participants, collect and analyze data, and disseminate findings; and 4) approaches for engaging with already collected data or published research. Failing to address gender and sex with clarity and intention in family planning research can lead to biased samples, biased instruments, and biased data, consequently limiting scholarly knowledge of family planning desires, abilities, experiences, outcomes, and preferences.

5.
Med Teach ; : 1-13, 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39312179

RESUMEN

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.

6.
J Clin Epidemiol ; : 111545, 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39322123

RESUMEN

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.

7.
J Res Nurs ; 29(4-5): 321-331, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39291220

RESUMEN

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.

8.
Stud Health Technol Inform ; 317: 115-122, 2024 Aug 30.
Artículo en Inglés | MEDLINE | ID: mdl-39234713

RESUMEN

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.


Asunto(s)
Metadatos , Alemania , Humanos , Manejo de Datos , Difusión de la Información , Programas Informáticos
9.
JMIR Res Protoc ; 13: e62765, 2024 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-39270213

RESUMEN

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.


Asunto(s)
Grupos Focales , Estudios Transversales , Humanos , Chile , Femenino , Masculino , Abastecimiento de Alimentos
10.
J Sch Psychol ; 106: 101328, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39251306

RESUMEN

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.


Asunto(s)
Psicología Educacional , Investigación Cualitativa , Humanos , Proyectos de Investigación
11.
medRxiv ; 2024 Aug 13.
Artículo en Inglés | MEDLINE | ID: mdl-39185523

RESUMEN

Objectives: We invited inexperienced clinical researchers to analyze coded health datasets and develop hypotheses. We recorded and analyzed their hypothesis generation process. All the hypotheses generated in the process were rated by the same group of seven experts by using the same metrics. This case study examines the higher quality (i.e., higher ratings) and lower quality of hypotheses and participants who generated them. We characterized the contextual factors associated with the quality of hypotheses. Methods: All participants (i.e., clinical researchers) completed a 2-hour study session to analyze data and generate scientific hypotheses using the think-aloud method. Participants' screen activity and audio were recorded and transcribed. These transcriptions were used to measure the time used to generate each hypothesis and to code cognitive events (i.e., cognitive activities used when generating hypotheses, for example, "Seeking for Connection" describes an attempt to draw connections between data points). The hypothesis ratings by the expert panel were used as the quality of the hypotheses during the analysis. We analyzed the factors associated with (1) the five highest and (2) five lowest rated hypotheses and (3) the participants who generated them, including the number of hypotheses per participant, the validity of those hypotheses, the number of cognitive events used for each hypothesis, as well as the participant's research experience and basic demographics. Results: Participants who generated the five highest-rated hypotheses used similar lengths of time (difference 3:03), whereas those who generated the five lowest-rated hypotheses used more varying lengths of time (difference 7:13). Participants who generated the five highest-rated hypotheses also utilized slightly fewer cognitive events on average compared to the five lowest-rated hypotheses (4 per hypothesis vs. 4.8 per hypothesis). When we examine the participants (who generated the five highest and five lowest hypotheses) and their total hypotheses generated during the 2-hour study sessions, the participants with the five highest-rated hypotheses again had a shorter range of time per hypothesis on average (0:03:34 vs. 0:07:17). They (with the five highest ratings) used fewer cognitive events per hypothesis (3.498 vs. 4.626). They (with the five highest ratings) also had a higher percentage of valid rate (75.51% vs. 63.63%) and generally had more experience with clinical research. Conclusion: The quality of the hypotheses was shown to be associated with the time taken to generate them, where too long or too short time to generate hypotheses appears to be negatively associated with the hypotheses' quality ratings. Also, having more experience seems to positively correlate with higher ratings of hypotheses and higher valid rates. Validity is a quality dimension used by the expert panel during rating. However, we acknowledge that our results are anecdotal. The effect may not be simply linear, and future research is necessary. These results underscore the multi-factor nature of hypothesis generation.

12.
Perspect Clin Res ; 15(3): 155-159, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39140012

RESUMEN

Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.

13.
J Pediatr Psychol ; 2024 Aug 08.
Artículo en Inglés | MEDLINE | ID: mdl-39118192

RESUMEN

OBJECTIVE: The COVID-19 pandemic required behavioral researchers to rapidly pivot to the implementation of remote study protocols to facilitate data collection. Remote implementation required robust and flexible research protocols including reliable audio/visual technology that met all the quality, security, and privacy hallmarks of lab-based equipment, while also being portable and usable by nontechnical staff and participants. The project's primary purpose was to develop a technology kit that could be deployed for data collection in homes with young children. The secondary objective was to determine the feasibility of the kit for use longitudinally across four disparate sites. METHOD: User-centered design principles were employed in the development and implementation of a technology kit deployed across urban, suburban, and rural participant locations in four states. Preliminary feasibility and usability data were gathered to determine the reliability of the kit across three timepoints. RESULTS: In study 1, a technology kit was constructed addressing all project needs including the provision of the internet to connect remotely with participants. Staff training protocols and participant-facing materials were developed to accompany deployment procedures. In study 2, data gathered in technology logs demonstrated successful capturing of video footage in 96% of opportunities with most technology challenges mitigated. Subsequent behavioral coding indicated 100% of captured assessment footage has been successfully coded to date. Moreover, participants needed less support for technology setup at their later timepoints, and staff rated the kit as highly usable. CONCLUSION: This study offers a model for future development of technology use in remote community- and home-based pediatric research.

14.
Augment Altern Commun ; : 1-12, 2024 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-39164980

RESUMEN

Smart Predict is a novel two-tablet application developed to improve conversational efficiency for people who use augmentative and alternative communication (AAC) devices. The Smart Predict system consists of two distinct applications that were built for use with two Android tablets and/or phones with Bluetooth® capability. One application is referred to as the AAC User app and the second application is called the Partner app. Smart Predict integrates vocabulary supplementation from communication partners in real-time while persons who rely on AAC generate text and maintain full control to choose words within a word prediction line. Using single-case research designs with adapted alternating treatments under two counterbalanced treatment conditions (AAC User app alone versus AAC User app + Partner app), we examined message efficiency with persons who rely on switch scanning for on-screen keyboards. User experience questionnaires were administered to determine satisfaction and workload, and to provide feedback for future development efforts. Three adults with complex communication needs and motor impairments conversed with research staff about fourteen movie trailers. Characters per minute and switch selections per character produced by the person with complex communication needs and motor impairments were measured during 15-minute interviews to represent communication speed and effort. Results indicate that message efficiency increased with the dual-tablet Smart Predict, indicating faster message generation with the vocabulary supplementation system. User satisfaction increased and perceived effort decreased under the Smart Predict conditions. Given these results within a research and development framework, the Smart Predict concept is a viable feature that could be considered within smart AAC technologies.

15.
BMJ Open ; 14(8): e087130, 2024 Aug 09.
Artículo en Inglés | MEDLINE | ID: mdl-39122395

RESUMEN

INTRODUCTION: Large-vessel occlusion (LVO) stroke is effectively treated by time-critical thrombectomy, a highly specialised procedure only available in a limited number of centres. Many patients with suspected stroke are admitted to their nearest hospital and require transfer to access treatment, with resulting delays. This study is evaluating the accuracy of a new rapid portable test for LVO stroke which could be used in the future to select patients for direct admission to a thrombectomy centre. METHODS AND ANALYSIS: Rapid Assay Diagnostic for Acute Stroke Recognition (RADAR) is a prospective observational cohort study taking place in stroke units in England. Participants are adults with a new suspected stroke with at least one face, arm or speech (FAST) symptom(s) and known onset within 6 hours or last known to be well 6-24 hours ago. The index test ('LVOne test' (Upfront Diagnostics)), consists of two portable lateral flow assays which use fingerprick capillary blood to detect d-dimer and glial fibrillary acidic protein concentrations. Reference standards comprise independently adjudicated standard CT/MRI brain±CT/MR angiography with senior clinician opinion to establish: ischaemic stroke±LVO; intracerebral haemorrhage; transient ischaemic attack; stroke mimic. Analyses will report sensitivity, specificity and negative and positive predictive values for identification of LVO stroke. Powered using a primary analysis population (≥2 FAST symptoms and known onset within 6 hours), 276 participants will detect a test specificity of 92%. The broader total study population which allows evaluation of the test for milder symptoms and unknown onset times is estimated to be 552 participants. ETHICS AND DISSEMINATION: Ethical (North East-Newcastle & North Tyneside 2 Research Ethics Committee (reference: 23/NE/0043), Health Research Authority and participating National Health Service Trust approvals are granted. Consent is required for enrolment. Dissemination of results will include presentations at conferences, publication in journals and plain English summaries. TRIAL REGISTRATION NUMBER: ISRCTN12414986.


Asunto(s)
Accidente Cerebrovascular , Humanos , Estudios Prospectivos , Accidente Cerebrovascular/diagnóstico , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Inglaterra , Trombectomía
16.
West J Nurs Res ; : 1939459241273328, 2024 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-39158006

RESUMEN

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.

17.
JMIR Hum Factors ; 11: e56669, 2024 Aug 23.
Artículo en Inglés | MEDLINE | ID: mdl-39178408

RESUMEN

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.


Asunto(s)
Investigación Cualitativa , Robótica , Interacción Social , Humanos , Anciano , Femenino , Persona de Mediana Edad , Relaciones Interpersonales
18.
BMJ Open ; 14(8): e089587, 2024 Aug 24.
Artículo en Inglés | MEDLINE | ID: mdl-39181565

RESUMEN

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.


Asunto(s)
Estudios de Equivalencia como Asunto , Proyectos de Investigación , Humanos , Abdomen/cirugía , Proyectos de Investigación/normas , Revisiones Sistemáticas como Asunto
19.
ATS Sch ; 5(2): 231-241, 2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38957495

RESUMEN

Qualitative research seeks to provide context, nuance, and depth of understanding in regard to systems, behaviors, and/or lived experiences. As such, it plays a key role in many areas of medical education. Composed of myriad methods and methodologies, each of which may be valuable for some areas of inquiry but less so for others, qualitative research can be challenging to design, conduct, and report. This challenge can be conceptualized as ensuring that the study design, conduct, and reporting are "fit for purpose," following directly from a well-formulated research question. In this Perspective, we share seven important and practical recommendations to enhance the design and conduct of high-quality qualitative research in medical education: 1) craft a strong research question, 2) link the study design to this question, 3) assemble a team with diverse expertise, 4) prioritize information power when selecting recruitment and sampling strategies, 5) collect data carefully, 6) rigorously analyze data, and 7) disseminate results that tell a complete story.

20.
Child Abuse Negl ; : 106920, 2024 Jul 02.
Artículo en Inglés | MEDLINE | ID: mdl-38960808

RESUMEN

Disclosures of sibling sexual behavior (SSB) usually affect all family members but there remains, however, a paucity in studies on therapeutical family interventions and how they can initiate changes in families. This study was designed to explore relational impacts of SSB disclosures, goals for therapy and interventions that helped a family initiate the recovery process after a SSB disclosure. A single case study design was used to analyze a family's long-term therapy process. Data on this N = 1 study comprised 18 interviews with involved therapists, five interviews with involved family members, therapy files, and notes on family sessions. Data was analyzed using a thematic approach. Relational traumas were experienced in broken relationships, relationships under pressure and damaged trust between family members. Therapy goals were to (1) recreate family's safety, (2) help the family process the SSB consequences and (3) restore trust and search for relationship healing. Appropriate interventions to target the goals included individual-centered psycho trauma treatment as well as interventions for the parents, the involved siblings, and the uninvolved siblings, followed by sessions between the involved siblings and with the whole family. Therapy outcomes were found in reduced individual trauma symptoms, a recreated sense of family safety, the start of relational trauma processing, and newfound forms of sibling/family relationships. This study provides a unique and comprehensive insight into a family's healing process after SSB disclosures from the perspectives of both professionals and family members. The effective interventions identified in this study may provide tools for therapists working with these families. This study may also offer greater insights into both the abusive and mutual types of SSB.

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