Development Of Research Protocols Research Articles

Protocol-in-a-Day Workshop: Expediting IRB Approval for Junior and Senior Faculty.

Delays in research protocol development may be a single factor that hinders the career progression of academic faculty. Structured educational guidance during this phase proves crucial in mitigating setbacks in Institutional Review Board (IRB) approval and expediting trial implementation. To address this, the Protocol-in-a-Day (PIAD) workshop, a comprehensive 1-day event involving members from six critical facets of RO clinical trial implementation, was established, offering significant input to individual protocols. Efficacy and satisfaction of the PIAD workshop were assessed through a 5-question survey and the average time from submission to IRB initial approval. The normality of the data was analyzed using the Shapiro-Wilk Test. Nonparametric data was analyzed using a Mann-Whitney U test for significance. A total of 18 protocols that went through the PIAD workshop were activated. The mean time to IRB approval for protocols that went through PIAD was 39.8 days compared to 58.4 days for those that did not go through the PIAD workshop. Based on survey results, 100% of PIAD participants said the PIAD workshop was useful and 94% of participants stated that the PIAD workshop improved the overall quality of their protocol. Participant surveys further highlighted substantial improvements in trial quality, language, and statistical design and revealed that all participants found the workshop helpful. Therefore, both junior and senior faculty benefitted from this educational program during protocol development, as both groups demonstrated shorter times to IRB approval than non-participants. This acceleration not only fosters efficient trial implementation but also supports academic faculty in their career development.

Partnering Research and Clinical Practice to Implement a Photon-Counting Detector CT Myocardial Perfusion Imaging Study

Implementation of research studies in clinical practice may encounter institutional, cultural, or resource barriers. Lack of nursing representation during the development of research protocols and decision-making, as well as financial constraints and competing priorities can impact translating research evidence into practice. At a large Midwestern teaching hospital, these barriers are addressed using professional nursing practice and a team-based approach to patient care and innovation, which in turn improves health outcomes for patients. The institution's commitment to nursing research in the radiology department aids in the implementation of innovative imaging technologies with the potential for improved detection and diagnosis of coronary artery disease. This article will outline radiology nursing involvement in the development of a dual-purpose research and clinical exam utilizing advanced computed tomography scanner technology. This article will also show how the institution works through common barriers to nursing research and how its efforts aid in the translation of evidence-based research into clinical practice.

Evaluation of the instrument protocol to verify the effects of the iSupport‐Brasil program for caregivers of people living with dementia

AbstractBackgroundThe World Health Organization (WHO) developed iSupport, an online, psychoeducational program for informal caregivers who assist someone who lives with dementia. The iSupport program is being adapted for use in many countries, and in Brazil, we now need to evaluate the effects of this program. However, there are no Brazilian versions of instruments needed to evaluate some of the expected outcomes (self‐efficacy, mastery, and positive aspects of caregiving) and there are no online versions of the instruments. The objective of this study was to evaluate an online protocol to evaluate the effects of the iSupport program, in Brazil.MethodAn online data‐collection form was developed for use in Brazil, based on the protocol suggested by the WHO and considering protocols being used in other countries. Caregivers who were eligible for using the program were accompanied while completing this protocol, to identify their doubts and difficulties. There were seven participants, in two subgroups, so issues identified by one group could be resolved before testing the protocol with the next. Problems were discussed in research team meetings, and solutions were developed.ResultCaregivers indicated problems that resulted in the exclusion of instruments that had similar objectives, the modification of response alternatives to better reflect the diversity of people who are informal caregivers, and wording changes to improve the clarity of instructions or items.ConclusionThis study was important for maximizing the acceptability of the protocol and the usability of the response form we developed for evaluating the Brazilian version of the iSupport program. Thus, community participation in the development of research protocols should help maximize participation rates and the validity of the information gathered, which, in this case, involves the mental health and wellbeing of informal caregivers who assist people living with dementia. Furthermore, this process enabled us to work on cultural and format adaptations of the instruments needed for evaluating the effects of the iSupport‐Brasil program, so that our protocol will be aligned with those being used in other countries to evaluate the effects of the iSupport program.

Critical Reflections on Conducting Qualitative Health Research During COVID-19: The Lived Experiences of a Cohort of Postgraduate Students in a South African University.

COVID-19 ushered in public health guidelines restricting face-to-face contact and movement, and encouraging social distancing, all of which had implications for conducting field-based research during the pandemic. For qualitative researchers, this meant adapting conventional face-to-face methods and resorting to virtual variations of the same in adherence to stipulated COVID-19 health protocols. Virtual qualitative research introduced new concerns and logistical challenges. This paper presents critical reflections on experiences of conducting qualitative research during the pandemic, from the perspectives of a cohort of postgraduate fellows. A critical reflection framework was utilised to explore fellows experiences and meanings ascribed to their experiences. The research findings illustrate three overarching processes which, in turn, shaped ways of thinking, doing and being. First, explicating tacit assumptions about their anticipated research journeys and interrogating these. Second, shifts in power differentials demonstrated by role reversal between researchers and participants, and between fellows and supervisors as they re-negotiated their positionalities in virtual research spaces. Third, context specific sense-making, in which - narrative accounts support the notion of knowledge as a social construct. Our findings have important implications for qualitative research practice. Our study documents methodological nuances and social implications of conducting qualitative research during COVID-19 and in a-South African context. In addition, our study exemplifies the use of critical reflection in qualitative research practice in the specific context of postgraduate academic research. Further, our study illustrates how the use of technology shapes qualitative research protocol development, data collection and analysis phases.

Communication of the Diagnosis of Spinal Muscular Atrophy in the Views of Patients and Family Members, a Qualitative Analysis

Communicating the diagnosis of a genetic and neurodegenerative disease, such as spinal muscular atrophy (SMA), requires a transmission centered on the patient and/or the family caregiver, ensuring autonomy to those involved and strengthening the doctor-patient relationship. Analyzing the communication of the SMA diagnosis from the perspective of patients and family members. This qualitative study was developed through semi-structured interviews, via teleconsultation. The analysis was developed by systematically condensing the answers and synthesizing them into four thematic axes (clarification of the diagnosis, communication of the prognosis, affective memory related to the event, and advice to physicians). Twenty-nine patients with SMA and 28 family caregivers of people with this condition, from all regions of Brazil, reported that individualized, clear, honest, and welcoming communication, emphasizing positive aspects, in the presence of family members and with the possibility of continuous monitoring, was important to meeting their communication needs. A lack of empathy, monitoring and guidance, and estimating life expectancy resulted in negative experiences. The communication needs of patients and family members described during the clarification of the diagnosis and prognosis of SMA predominantly involve empathic factors related to the attitude of the attending physician throughout the evolution of the disease. Future research evaluating other neurodegenerative diseases and the development of research protocols are important to improving communication between physicians, patients, and family members.

Aspects of the CPRRD Affecting Xenotransplantation Research in Human Heart-beating Brain-dead Decedents.

Aspects of the CPRRD Affecting Xenotransplantation Research in Human Heart-beating Brain-dead Decedents.

Tutoring Model 4.0 and development of research protocol

Introduction. The objective of this work was to establish the incidence of tutoring 4.0 on the development of the research protocol. 
 Method. An exploratory, cross-sectional, and correlational study was carried out with a sample of 100 students from a public university enrolled in the professional practice and social service system through a technology, device, or electronic network. 
 Results. Show that the elaboration of the antecedents of the problem was the hidden layer that explains the semantic weight of the tutoring on the elaboration of the protocol, although the research design limited the findings to the research sample, suggesting the extension of the model to others. hidden layers that the literature identifies as project financing.
 Discussion. The proposed model yields similar results to the reported literature regarding knowledge management as a determinant of knowledge production and transfer.
 Conclusion. Contrast of the model in other samples is recommended.

Characterizing Seizure-Induced Changes in the Glioma Microenvironment

Growing evidence indicates that the neurotransmitters dysregulated in psychiatric disorders are similarly dysregulated in glioblastoma (GBM) biology. Patients with psychiatric disorders are classically thought of having excessive glutamate (major depression, bipolar depression), excessive dopamine (mania, psychosis), and/or insufficient serotonin (major depression, anxiety). Analogously, GBM cells are dependent on bountiful neuronal glutamate, utilize elevated dopamine receptor expression to activate the hypoxic response and augment progression, and catabolize serotonin to drive proliferation. The clinical induction of seizure, known as electroconvulsive therapy (ECT), has been used by psychiatrists since the 1930s to treat severe cases of depression, mania, psychosis, and catatonia. ECT has been shown to decrease extracellular glutamate and glutamate receptor expression in vivo and increase blood-brain barrier (BBB) permeability. ECT, then, may have previously unexplored oncologic value. We hypothesized that seizure-induced changes in the glioma microenvironment occur with ECT, increasing permeability of the BBB, slowing tumor progression, and prolonging overall survival in glioma-bearing mice.C57BL6 mice were orthotopically injected with CT-2A-Luc mouse glioma cells. Mice were randomized to receive ECT via ear-clip electrodes or sham treatment daily up to five times per week until survival endpoints were reached. Seizure duration and rates of tonic hindlimb extension were recorded. Intracranial progression was monitored via bioluminescent signal from CT-2A-Luc xenografts. BBB permeability was assessed by subjecting mice to ECT or sham treatment immediately following tail vein injection of sodium fluorescein. Mice were saline perfused and brains were harvested for fluorescent spectroscopy.Intracranial progression was maximally reduced in ECT-treated mice relative to sham-treated mice after 17 treatments (mean sham radiance 4.7 × 109 photons/s versus mean ECT radiance 2.6 × 109 photon/s, P = 0.013). This translated into an improvement in overall survival from median 29 days in sham-treated mice to 34.5 days in ECT-treated mice (P = 0.0018). Mean seizure duration was 41.8 seconds and positively correlated with overall survival (Pearson coefficient r = 0.63, P = 0.028). Tonic hindlimb extension occurred in 68% of seizures and positively correlated with overall survival (Pearson coefficient r = 0.72, P = 0.0078). Brain parenchymal uptake of sodium fluorescein was significantly higher in ECT-treated mice, with a mean relative increase in ECS to sham radiance of 1.47 (P < 0.05).Repeated ECT slows tumor progression and prolongs overall survival in C57BL6 mice bearing CT-2A-Luc xenografts. The BBB is compromised immediately following ECT. ECT merits further oncologic investigation as a potential therapeutic in GBM.T. Sita: None. L. Hurley: None. C. Dussold: None. S. Sachdev: None. R. Stupp: Research Grant; CarThera, Paris. Consultant/ad hoc advisor for research protocol development; GT Medical Technologies, Insightec; Northwest Biotherapeutics. Scientific Advisory Board; CranioVation, TriAct, Hemispherian. IDMC of an ongoing clinical trial; Celularity. A. Stegh: None.

Evaluation of automated microvascular flow analysis software AVA 4: a validation study

BackgroundReal-time automated analysis of videos of the microvasculature is an essential step in the development of research protocols and clinical algorithms that incorporate point-of-care microvascular analysis. In response to the call for validation studies of available automated analysis software by the European Society of Intensive Care Medicine, and building on a previous validation study in sheep, we report the first human validation study of AVA 4.MethodsTwo retrospective perioperative datasets of human microcirculation videos (P1 and P2) and one prospective healthy volunteer dataset (V1) were used in this validation study. Video quality was assessed using the modified Microcirculation Image Quality Selection (MIQS) score. Videos were initially analyzed with (1) AVA software 3.2 by two experienced investigators using the gold standard semi-automated method, followed by an analysis with (2) AVA automated software 4.1. Microvascular variables measured were perfused vessel density (PVD), total vessel density (TVD), and proportion of perfused vessels (PPV). Bland–Altman analysis and intraclass correlation coefficients (ICC) were used to measure agreement between the two methods. Each method’s ability to discriminate between microcirculatory states before and after induction of general anesthesia was assessed using paired t-tests.ResultsFifty-two videos from P1, 128 videos from P2 and 26 videos from V1 met inclusion criteria for analysis. Correlational analysis and Bland–Altman analysis revealed poor agreement and no correlation between AVA 4.1 and AVA 3.2. Following the induction of general anesthesia, TVD and PVD measured using AVA 3.2 increased significantly for P1 (p < 0.05) and P2 (p < 0.05). However, these changes could not be replicated with the data generated by AVA 4.1.ConclusionsAVA 4.1 is not a suitable tool for research or clinical purposes at this time. Future validation studies of automated microvascular flow analysis software should aim to measure the new software’s agreement with the gold standard, its ability to discriminate between clinical states and the quality thresholds at which its performance becomes unacceptable.

1427. Key Clinical Research Questions Asked During Epidemic Respiratory Outbreaks: A Systematic Review of the Literature Published on Severe Acute Respiratory Syndrome and Middle East Respiratory Syndrome

BackgroundAs evidenced by the COVID-19 pandemic, rapid collection of data on clinical characterization, treatment, and diagnostics to inform rapid public health response is paramount in an outbreak of a novel infectious agent. In 2018, The World Health Organization R&D Blueprint identified a list of priority diseases for accelerated research based on their potential to cause a public health emergency. Among these diseases were Severe acute respiratory syndrome-coronavirus (SARS-CoV) and Middle East respiratory syndrome-coronavirus (MERS-CoV). To facilitate a rapid research response during an outbreak, standardized research protocols must be prepared before the outbreak occurs. The aim of this systematic review is to identify the most common clinical research questions asked during outbreaks of SARS-CoV and MERS-CoV to inform future clinical research protocol development for coronaviruses.MethodsMedline, Embase, and Global Health bibliographic databases were searched to identify clinical studies published on SARS-CoV and MERS-CoV in the outbreak setting. Studies were grouped thematically according to the clinical research question addressed.ResultsFrom the research questions and objectives, eleven themes in the literature were identified: Clinical characterisation, prognosis, diagnosis, clinical management, viral pathogenesis, epidemiological characterisation, infection prevention and control, transmission, susceptibility, psychosocial, and aetiology. Case series made up the highest proportion of study designs, while clinical trials made up the lowest. 83% of the SARS-CoV studies were published after the end of the outbreak.Themes and key clinical questions asked during outbreaks of SARS and MERS ConclusionThe thematic analysis was used to identify the key clinical research questions asked during outbreaks of SARS-CoV and MERS-CoV and study designs were recommended to answer these questions. By defining the key clinical research questions, this study provides a first step in creating standardized clinical research protocols and defining core data variables to be collected during future outbreaks of respiratory coronaviruses.Disclosures All Authors: No reported disclosures

Búsqueda de información científica para la mejora de contenidos en protocolos de investigación en asignaturas de apoyo a la titulación en la ingeniería

La formación profesional de un Ingeniero debe ser integral y cumplir con competencias que aportan en la construcción de su conocimiento, la competencia de investigación es el eje medular de este trabajo y representa el área de mejora a atender; los alumnos presentan deficiencias en la búsqueda de información científica para la generación de protocolos de investigación. Esta investigación tiene como objetivo, mejorar las estrategias de búsqueda y gestión de la información para la elaboración de protocolos de investigación mediante recursos tecnológicos y motores de búsqueda para obtener productos finales de calidad científica. Se aplican dos encuestas, de diagnóstico y de mejora, ésta última se aplica en dos momentos: antes de brindar soporte de contenido en la búsqueda de información y después de haberlo hecho, demostrando que se mejora la calidad de los productos obtenidos en las asignaturas de la línea de investigación. Se aplica durante 3 semestres escolares (tiempo1, tiempo2 y tiempo 3) a un total de muestra acumulado de 230 alumnos. La investigación es cuantitativa con diseño no experimental longitudinal de tendencia con un alcance descriptivo. Los resultados diagnósticos indican que Google es el recurso más utilizado por los alumnos para realizar sus investigaciones. Los resultados muestran una mejora en la calidad de los contenidos en protocolos de investigación al brindarles materiales exclusivos de ésta temática durante el curso. Se concluye que los alumnos necesitan una guía docente o de contenido para hacer búsquedas efectivas de información en espacios formales y reconocidos para el gremio científico.

Ovarian Cortex Transplantation

To describe a laparoscopic technique for the transplantation of a cryopreserved ovarian cortex. Educational video. University Hospital of Strasbourg, France. A 28-year-old nulliparous woman presented with anaplastic T lymphoma and was then treated with chemotherapy. Before the treatment, the ovarian cortex was collected by laparoscopy to preserve fertility. Remission was achieved, but the patient suffered from premature ovarian failure. At the age of 32 years, she wished to become pregnant. The patient was thus included in the research protocol Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function, and the transplantation site was chosen accordingly. The cortex was stored in liquid nitrogen at -196°C after slow congelation. To restore ovarian function and because of pregnancy desire, we transplanted the cryopreserved ovarian cortex in the right ovary and inside a pocket of the peritoneum of the left ovarian fossa. The first step included adhesiolysis to treat small adhesions developed after the first surgery. On the right, the ovarian cortex was opened by an antimesial incision with cold scissors. The cryopreserved ovarian cortex was placed through the cortex of the right ovary and fixed with stitches. On the left side, the peritoneum of the ovarian fossa was opened, and a subperitoneal pocket was dissected. The cortex was inserted. It was then closed with absorbable sutures or with a hemostatic pad. Six months after her surgery, the patient had natural cycles. We monitored an ovulation of both the sides. She underwent 3 in vitro fertilizations but with failures of embryo transfer. She conceived spontaneously a year after the surgery. She gave birth to a healthy child weighing 3300 g. For patients who have suffered from premature ovarian failure owing to chemotherapy, ovarian cortex transplantation can restore the ovulatory function, allow in vitro fertilization, and permit, as in our case, a spontaneous pregnancy.

Medical Acupuncture in Raynaud's Disease: Protocol Development for Conducting Systematic Review and Meta-analysis

Background: Idiopathic Raynaud’s disease is twice common in women than their counterparts, and secondary Raynaud’s disease co-occurs with a variety of medicosurgical conditions. Both diseases are managed by several medications which are invariably associated with various adverse effects.&#x0D; Objective: This study aimed to describe several standardized SPIRIT and PRISMA steps and items that help in the development of research protocol directed towards systematic review and meta-analysis conduction concerning Raynaud’s phenomenon managed by clinical acupuncture. Methods and Results: Statements, guidelines, list of items and processes related to SPIRIT and PRISMA and their extensions and updated versions are ideal methodological tools in framing Raynaud’s disease and acupuncture research protocols for scientifically conducting not only randomized controlled trials but also systematic review and meta-analysis. By extension, these methodological tools could also be applied to develop research protocols for other diseases and nontraditional treatment interventions with some modifications. A total of 53 studies were included in this study protocol.&#x0D; Discussion: In line with Traditional Chinese Medicine, the pattern of Raynaud’s disease and pros and cons of medical acupuncture should make an important component of discussion, besides the details of included randomized clinical interventions in systematic review and meta-analysis, which are but not limited to treatment effects, their strengths and limitations, quality, heterogeneity and endpoints.&#x0D; Conclusion: The development of research protocol for conducting systematic review and meta-analysis is an art and while framing the draft researchers must take into account various SPIRIT and PRISMA statements and guidelines and their latest versions applicable to various diseases including Raynaud’s phenomenon managed by traditional and modern medications across the world.

Dilemmas of Ethics in Practice in Longitudinal Health Research: Identifying Opportunities for Widening Participation of Residents.

Background: Mechanisms for widening participation of local participants in research studies can improve governance of public health research. Research conducted in longitudinal health study areas depends on there being mutual trust and respect over time between the local residents and researchers. Ethics in practice needs consideration alongside procedural ethics. By widening participation of the experimental public—local residents and resident service providers—ethics in practice and accountability are strengthened.Methods: The study was undertaken in a longitudinal health study area in rural South Africa using multiple qualitative methods. The sample included 35 individual and five group interviews with resident local leaders and service providers, 24 individual and eight group interviews with residents of the study area, and ten researchers' reflections on two critical incidents from ethnographic field notes on dilemmas of ethics in practice. The interviews were all audio-recorded (besides one where consent to record was not given) and then transcribed verbatim and translated from Shangaan into English. Thematic analysis was conducted.Results: Residents requested the reporting back of personal screening test results from research studies, and raised informed consent issues. Researchers recognized the importance of mechanisms to increase their accountability to residents throughout the research process, and the complexity of informed consent and fieldwork procedures within research studies.Conclusion: This study elicited the views of residents and researchers in a longitudinal health study area to seek guidance on how to strengthen participation in research governance. Three strategies were identified by participants to widen participation of the experimental public. Firstly, increasing study budgets so that individual screening test results could be personally delivered back to participants. Secondly, more rigorous field staff training in informed consent and study procedures with ongoing monitoring and supervision from researchers. Thirdly, increased earlier involvement of residents in research protocol development through study advisory groups. Additional strategies include deeper involvement of Community Advisory Groups and more focused dissemination of research results to specific audiences. In general, there is a need to identify strategies for increased accountability of researchers and participatory governance through involvement of the experimental public in all aspects of longitudinal public health research as part of the ethics in practice and democratization of science.

MALDI-TOF mass spectrometry technology for detecting biomarkers of antimicrobial resistance: current achievements and future perspectives.

The laboratory diagnosis of infections is based on pathogen identification and antimicrobial susceptibility determination. The gold standard of cultivation, isolation and susceptibility testing is a time-consuming procedure and in some cases this can be threatening for patients' outcome. In the current review the applications of mass spectrometry in pathogen identification and especially in detecting biomarkers of antimicrobial resistance are analyzed. MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight) mass spectrometry is a new technology that has revolutionized pathogen identification and has also proven to accelerate detection of antimicrobial resistance compared to the traditional antibiotic susceptibility tests (AST) as well as DNA amplification methodologies. The technology has incorporated up to know four different methodologies: (I) the detection of differences of mass spectra of susceptible and resistant isolates of a given microorganism using the classical strain typing methodology; (II) the analysis of bacterial induced hydrolysis of β-lactam antibiotics; (III) the detection of stable (non-radioactive) isotope-labeled amino acids; and (IV) the analysis of bacterial growth in the presence and absence of antibiotics using an internal standard. The implementation of MALDI-TOF methodologies has improved detection of resistance in aerobic, Gram-positive and Gram-negative bacteria, mycobacteria, anaerobic bacteria, fungi and viruses. The MALDI-TOF is an easy to use, rapid, reliable, economical, and environmentally friendly methodology. However, this technology needs further development of research protocols that will be validated for routine application.

The FREGAT biobank: a clinico-biological database dedicated to esophageal and gastric cancers

BackgroundWhile the incidence of esophageal and gastric cancers is increasing, the prognosis of these cancers remains bleak. Endoscopy and surgery are the standard treatments for localized tumors, but multimodal treatments, associated chemotherapy, targeted therapies, immunotherapy, radiotherapy, and surgery are needed for the vast majority of patients who present with locally advanced or metastatic disease at diagnosis. Although survival has improved, most patients still present with advanced disease at diagnosis. In addition, most patients exhibit a poor or incomplete response to treatment, experience early recurrence and have an impaired quality of life. Compared with several other cancers, the therapeutic approach is not personalized, and research is much less developed. It is, therefore, urgent to hasten the development of research protocols, and consequently, develop a large, ambitious and innovative tool through which future scientific questions may be answered. This research must be patient-related so that rapid feedback to the bedside is achieved and should aim to identify clinical-, biological- and tumor-related factors that are associated with treatment resistance. Finally, this research should also seek to explain epidemiological and social facets of disease behavior.MethodsThe prospective FREGAT database, established by the French National Cancer Institute, is focused on adult patients with carcinomas of the esophagus and stomach and on whatever might be the tumor stage or therapeutic strategy. The database includes epidemiological, clinical, and tumor characteristics data as well as follow-up, human and social sciences quality of life data, along with a tumor and serum bank.DiscussionThis innovative method of research will allow for the banking of millions of data for the development of excellent basic, translational and clinical research programs for esophageal and gastric cancer. This will ultimately improve general knowledge of these diseases, therapeutic strategies and patient survival. This database was initially developed in France on a nationwide basis, but currently, the database is available for worldwide contributions with respect to the input of patient data or the request for data for scientific projects.Trial registrationThe FREGAT database has a dedicated website (www.fregat-database.org) and is registered on the Clinicaltrials.gov site, number NCT 02526095, since August 8, 2015.

Developing Nutrition Research Capacity at the Tanzania Food and Nutrition Centre through Collaborative Training and Technical Assistance

The Tanzania Food and Nutrition Centre (TFNC) formed a partnership with Rutgers School of Health Professions (SHP), Department of Nutritional Sciences (DNS) to build nutrition research capacity in systematic review and qualitative research skills. The TFNC organizes nutrition research in Tanzania and advises the Tanzanian government on key matters related to nutrition. Due to this responsibility, they sought continuing education in nutrition research methods from Rutgers faculty for capacity building. The TFNC director and a Rutgers faculty member participated in the in-person, 10 day WHO/Cochrane/Cornell Systematic Review Summer Institute for Systematic Reviews in Global Nutrition Policy Making to meet the systematic review learning need. Post-training, a systematic review title and protocol were developed through remote communication with the author team. The qualitative research learning need was met with the provision of online education to TFNC staff. Rutgers faculty provided 3 months of education including modules on qualitative approaches, data collection, data analysis, and research protocol development. The objectives for this research education training were met: A Rutgers faculty member and the TFNC director participated in systematic review training, and a protocol with TFNC and Rutgers authors was submitted to Cochrane for review. Twenty TFNC staff participated in qualitative research online education taught by Rutgers faculty, and the TFNC staff developed a qualitative nutrition research protocol. It is feasible and productive to provide education and technical assistance through a combination of in-person and online training methods. The training resulted in sustainable research skills and in two research protocols that will be conducted collaboratively with TFNC staff and Rutgers faculty.

Supporting the role of community members employed as research staff: Perspectives of community researchers working in addiction research

Community researchers are laypersons who conduct research activities in their own communities. In addiction and HIV research, community researchers are valued for their insider status and knowledge. At the same time, their presence on the research team raises concerns about coercion and confidentiality when community researchers and participants know each other personally, and the work of navigating between the worlds of research and community leads to moral distress and burnout for some community researchers. In this paper, we draw upon the concept of ‘moral experience’ to explore the local moral worlds of community researchers in the context of addiction research. In February and March 2010, we conducted focus groups with 36 community researchers employed on community-based addiction studies in the United States to elicit perspectives on ethical and moral challenges they face in their work and insights on best practices to support their role in research. Community researchers described how their values were realized or thwarted in the context of research, and their strategies for coping with shifting identities and competing priorities. They delineated how their knowledge could be used to inform development of research protocols and help principal investigators build and maintain trust with the community researchers on their teams. Our findings contribute to current understandings of the moral experiences of community members employed in research, and inform policies and practices for the growing field of community-engaged research. Funders, research organizations, and research ethics boards should develop guidelines and standards to ensure studies have key resources in place to support community researchers and ensure quality and integrity of community-engaged work. Investigators who work with community researchers should ensure channels for frontline staff to provide input on research protocols and to create an atmosphere where challenges and concerns can be openly and safely discussed.

Dedicated researcher brings cancer care to rural communities

Dedicated researcher brings cancer care to rural communities

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey.

ObjectivePatient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed.MethodsIndividuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions.ResultsSurvey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non–patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non–patient group respondents (all p< .01).ConclusionsDespite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors.