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Research Protocol (research + protocol)
Selected AbstractsVariation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research ProtocolACADEMIC EMERGENCY MEDICINE, Issue 4 2007Jonathan Mansbach MD Abstract Background: Multicenter studies are becoming more common, and variability in local institutional review board (IRB) assessments can be problematic. Objective: To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. Methods: The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network http://www.emnet-usa.org Results: Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional review boards returned initial applications in a median of 19 days (IQR, 11,34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27,61 d). Seven sites did not participate in patient recruitment: two had institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. Conclusions: There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the review process and facilitate multicenter clinical research. [source] Making Risk-Benefit Assessments of Medical Research ProtocolsTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 2 2004Alex Rajczi First page of article [source] The Future of Incidental Findings: Should They be Viewed as Benefits?THE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 2 2008Lisa S. Parker This paper argues against considering incidental fndings (IFs) as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated (e.g., results of testing to determine study eligibility), those that can reasonably be characterized in terms of their nature and frequency of generation (e.g., misattributed parentage), and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit. [source] Adjuvant fractionated high-dose-rate intracavitary brachytherapy after external beam radiotherapy in Tl and T2 nasopharyngeal carcinomaHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 5 2004Jiade J. Lu MD Abstract Background. The value of high-dose-rate intracavitary brachytherapy (HDRIB) for persistent or recurrent nasopharyngeal carcinoma has been well described; however, the benefit of routine adjuvant fractionated HDRIB following external beam radiation therapy (EBRT) has not been completely determined. The objective of this analysis was to evaluate the outcome of two fractions of adjuvant HDRIB treatment in Tl and T2 nasopharyngeal carcinoma. Methods. Thirty-three consecutive and nonselected patients who had Tl and T2 non-disseminated nasopharyngeal carcinoma were treated according to an IRB approved institutional research protocol between March 1999 and July 2001. By the 1997 AJCC cancer staging classification, 22 patients (67%) had Tl disease and 11 patients (33%) had T2 disease. Seventeen of these patients who had stage I or stage II disease (i.e., NO or Nl) were treated with EBRT followed by two fractions of adjuvant HDRIB (group 1); 16 patients who had stage III or stage IV disease (i.e., N2 or N3) were treated with concurrent cisplatin, EBRT and adjuvant HDRIB and subsequent adjuvant cisplatin and fluorouracil (5-FU) chemotherapy (group 2). EBRT was delivered by daily conventional fractionation to a total dose of 66 Gy to the primary tumor. Nodal disease received 66 Gy if it was less than 3cm in maximum diameter and 70 Gy if larger or there was palpable residual disease after 66 Gy. A total of 10 Gy of HDRIB in 2 equal fractions of 5 Gy spaced 1 week apart was delivered starting 1 week after the completion of EBRT. All patients were assessed for treatment response, local control, survival, and toxicity. Results. The median follow up for all 29 surviving patients is 29 months (range: 17,38 months). One patient died 7 months and one died 18 months after radiation therapy from the effects of distant metastases; two died of unrelated causes. At the time of this analysis, one patient (3%) had persistent local disease and one patient (3%) developed pathologically confirmed local recurrence in the nasopharynx. In addition, one patient (3%) developed recurrence only in a neck node followed by distant metastasis, and two patients (6%) developed distant metastasis without locoregional relapse. The 2-year local control rate at the primary site was 93.6%, and the overall survival and disease-free survival rates were 82% and 74% respectively. All patients experienced some degree of acute and/or late toxicity related to radiation therapy. Ten patients (30%) experienced grade 3 acute and/or late toxicity and six patients (18%) developed grade 4 acute and/or late toxicity. No grade 5 toxicity occurred. No unexpected damage of structures within the HDRIB fields was detected. Conclusions. EBRT supplemented by two fractions of adjuvant HDRIB produced a 93.6% local control rate for Tl and T2 nasopharyngeal cancer at 2 years of follow up, with acceptable rates of acute and late toxicity. Brief adjuvant HDRIB appears to permit dose escalation safely, even in patients who receive chemotherapy concurrently with conventional radiation therapy. This strategy needs to be optimized and then tested in a prospective randomized phase III trial to learn if it can improve outcome. © 2004 Wiley Periodicals, Inc. Head Neck26: 389,395, 2004. [source] Effectiveness of the implementation of an evidence-based nursing model using participatory action research in oncohematology: research protocolJOURNAL OF ADVANCED NURSING, Issue 8 2010Eva Abad-Corpa abad-corpa e., meseguer-liza c., martínez-corbalán j.t., zárate-riscal l., caravaca-hernández a., paredes-sidrach de cardona a., carrillo-alcaraz a., delgado-hito p. & cabrero-garcía j. (2010) Effectiveness of the implementation of an evidence-based nursing model using participatory action research in oncohematology: research protocol. Journal of Advanced Nursing,66(8), 1845,1851. Abstract Title.,Effectiveness of the implementation of an evidence-based nursing model using participatory action research in oncohematology: research protocol. Aim., To generate changes in nursing practice introducing an evidence-based clinical practice (EBCP) model through a participatory process. To evaluate the effectiveness of the changes in terms of nurse-sensitive outcome (NSO). Background., For international nursing science, it is necessary to explore the reasons for supporting EBCP and evaluate the real repercussions and effectiveness. Methods., A mixed methods study with a sequential transformative design will be conducted in the bone marrow transplant unit of a tertiary-level Spanish hospital, in two time periods >12 months (date of approval of the protocol: 2006). To evaluate the effectiveness of the intervention, we will use a prospective quasi-experimental design with two non-equivalent and non-concurrent groups. NSO and patient health data will be collected: (a) impact of psycho-social adjustment; (b) patient satisfaction; (c) symptom control; (d) adverse effects. All patients admitted during the period of time will be included, and all staff working on the unit during a participatory action research (PAR). The PAR design will be adopted from a constructivist paradigm perspective, following Checkland's "Soft Systems" theoretical model. Qualitative techniques will be used: 2-hour group meetings with nursing professionals, to be recorded and transcribed. Field diaries (participants and researchers) will be drawn up and data analysis will be carried out by content analysis. Discussion., PAR is a rigorous research method for introducing changes into practice to improve NSO. [source] Effectiveness of planning hospital discharge and follow-up in primary care for patients with chronic obstructive pulmonary disease: research protocolJOURNAL OF ADVANCED NURSING, Issue 6 2010Eva Abad-Corpa abad-corpa e., carrillo-alcaraz a., royo-morales t., pérez-garcía m.c., rodríguez-mondejar j.j., sáez-soto a. & iniesta-sánchez j. (2010) Effectiveness of planning hospital discharge and follow-up in primary care for patients with chronic obstructive pulmonary disease: research protocol. Journal of Advanced Nursing,66(6), 1365,1370. Abstract Title.,Effectiveness of planning hospital discharge and follow-up in primary care for patients with chronic obstructive pulmonary disease: research protocol. Aim., To evaluate the effectiveness of a protocolized intervention for hospital discharge and follow-up planning for primary care patients with chronic obstructive pulmonary disease. Background., Chronic obstructive pulmonary disease is one of the main causes of morbidity and mortality internationally. These patients suffer from high rates of exacerbation and hospital readmission due to active problems at the time of hospital discharge. Methods., A quasi-experimental design will be adopted, with a control group and pseudo-randomized by services (protocol approved in 2006). Patients with pulmonary disease admitted to two tertiary-level public hospitals in Spain and their local healthcare centres will be recruited. The outcome variables will be readmission rate and patient satisfaction with nursing care provided. 48 hours after admission, both groups will be evaluated by specialist coordinating nurses, using validated scales. At the hospital, a coordinating nurse will visit each patient in the experimental group every 24 hours to identify the main caregiver, provide information about the disease, and explain treatment. In addition, the visits will be used to identify care problems and needs, and to facilitate communication between professionals. 24 hours after discharge, the coordinating nurses will inform the primary care nurses about patient discharge and nursing care planning. The two nurses will make the first home visit together. There will be follow-up phone calls at 2, 6, 12 and 24 weeks after discharge. Discussion., The characteristics of patients with this pulmonary disease make it necessary to include them in hospital discharge planning programmes using coordinating nurses. [source] Realistic Evaluation of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course for early recognition and management of deteriorating ward-based patients: research protocolJOURNAL OF ADVANCED NURSING, Issue 4 2010Jennifer McGaughey mcgaughey j., blackwood b., o'halloran p., trinder t.j. & porter s. (2010) Realistic Evaluation of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course for early recognition and management of deteriorating ward-based patients: research protocol. Journal of Advanced Nursing66(4), 923,932. Abstract Title.,Realistic Evaluation of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course for early recognition and management of deteriorating ward-based patients: research protocol. Aim., This paper is a description of a study protocol designed to evaluate the factors that enable or constrain the delivery and sustainability of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course in practice. Background., Rapid response system initiatives have been introduced to try to improve early detection and treatment of patients who deteriorate on general hospital wards. However, recent systematic reviews of the effectiveness of these initiatives show no effect on patient outcomes. Systematic reviews and professional consensus recommend that future research should focus on a broader range of process and outcome measures which consider the social, behavioural and organizational factors that had an impact on the delivery of these initiatives. Design., The design is a multiple case study on four wards in two hospitals in Northern Ireland that have implemented Early Warning Systems and Acute Life-threatening Events , Recognition and Treatment training. Data will be collected from key stakeholders using individual and focus group interviews, non-participant observation, Acute Life-threatening Events , Recognition and Treatment training records and audit of patients' observation charts and medical notes. Realistic Evaluation of the data will enable the development and refinement of theories to explain which mechanisms work in a particular context to achieve desired outcomes. Discussion., This study will produce important information that will contribute to knowledge of the organizational processes that have an impact on the delivery of initiatives to identify, respond and manage acutely ill patients in hospital. [source] Simplifying Detection of Cognitive Impairment: Comparison of the Mini-Cog and Mini-Mental State Examination in a Multiethnic SampleJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2005Soo Borson MD Objectives: To compare detection of cognitive impairment using the Mini-Cog and Mini-Mental State Examination (MMSE) and to identify sociodemographic variables that influence detection in an ethnoculturally diverse sample. Design: Cross-sectional. Setting: A registry of the University of Washington Alzheimer's Disease Research Center Satellite. Participants: A heterogeneous community sample (n=371) of predominantly ethnic minority elderly assessed using a standardized research protocol, 231 of whom met criteria for dementia or mild cognitive impairment (MCI). Measurements: Demographic data, a standardized research protocol for cognitive assessment and dementia diagnosis, MMSE, and Mini-Cog. Results: Both screens effectively detected cognitive impairment, the Mini-Cog slightly better than the MMSE (P<.01). Overall accuracy of classification was 83% for the Mini-Cog and 81% for the MMSE. The Mini-Cog was superior in recognizing patients with Alzheimer-type dementias (P=.05). Low education negatively affected detection using the MMSE (P<.001), whereas education did not affect the Mini-Cog, and low literacy minimally affected it. Conclusion: The Mini-Cog detects clinically significant cognitive impairment as well as or better than the MMSE in multiethnic elderly individuals, is easier to administer to non-English speakers, and is less biased by low education and literacy. [source] Forecasting plant migration rates: managing uncertainty for risk assessmentJOURNAL OF ECOLOGY, Issue 3 2003S. I. Higgins Summary 1Anthropogenic changes in the global climate are shifting the potential ranges of many plant species. 2Changing climates will allow some species the opportunity to expand their range, others may experience a contraction in their potential range, while the current and future ranges of some species may not overlap. Our capacity to generalize about the threat these range shifts pose to plant diversity is limited by many sources of uncertainty. 3In this paper we summarize sources of uncertainty for migration forecasts and suggest a research protocol for making forecasts in the context of uncertainty. [source] Time required to obtain endobronchial biopsies in children during fiberoptic bronchoscopyPEDIATRIC PULMONOLOGY, Issue 1 2009Nicolas Regamey MD Abstract Background Endobronchial biopsies are an important tool for the study of airway remodeling in children. We aimed to evaluate the impact of performing endobronchial biopsies as a part of fiberoptic bronchoscopy on the length of the procedure. Methods Clinically indicated fiberoptic bronchoscopy at which endobronchial biopsy was attempted as a part of a research protocol was performed in 40 children (median age 6 years, range 2 months,16 years). Time needed for airway inspection, bronchoalveolar lavage (BAL) with three aliquots of 1 ml/kg of 0.9% saline, sampling of three macroscopically adequate biopsies, teaching, and other interventions (e.g., removal of plugs) was recorded. The bronchoscopist was not aware that the procedure was being timed. Results Median (range) duration (min) was 2.5 (1.0,8.2) for airway inspection, 2.8 (1.7,9.4) for BAL, 5.3 (2.5,16.6) for biopsy sampling, 2.4 (1.5,6.6) for teaching and 4.1 (0.8,18.5) for other interventions. Three adequate biopsies were obtained in 33 (83%) children. Use of 2.0 mm biopsy forceps (via 4.0 and 4.9 mm bronchoscopes) rather than 1.0 mm (via 2.8 and 3.6 mm bronchoscopes) significantly reduced biopsy time (4.6 min vs. 8.4 min, P,<,0.001). Conclusions It takes a median of just over 5 min to obtain three endobronchial biopsies in children, which we consider an acceptable increase in the duration of fiberoptic bronchoscopy for the purpose of research. Pediatr Pulmonol. 2009; 44:76,79. © 2008 Wiley-Liss, Inc. [source] International study on antidepressant prescription pattern at 20 teaching hospitals and major psychiatric institutions in East Asia: Analysis of 1898 cases from China, Japan, Korea, Singapore and TaiwanPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 5 2007NAOKI UCHIDA md Abstract The purpose of the present study was to review the prescription patterns of antidepressants in different countries in East Asia. The survey was conducted in China, Japan, Korea, Singapore and Taiwan from October 2003 to March 2004 using the unified research protocol and questionnaire. Twenty teaching hospitals and major psychiatric hospitals participated and a total of 1898 patients receiving antidepressants were analyzed. The survey provided a number of interesting characteristics on the prescription patterns of antidepressant in East Asia. Out of 56 antidepressants listed in the Anatomical Therapeutic Chemical Classification (ATC) index by the World Health Organization (WHO) Collaborating Center for Drug Statistics Methodology (Oslo), only 26 antidepressants were prescribed in participating countries in East Asia. On average 38.4% of prescriptions of antidepressants were for patients with diagnoses other than depressive disorders. The availability and commonly prescribed antidepressants varied greatly by country. The selective serotonin re-uptake inhibitors (SSRI) and other newer antidepressants were prescribed in approximately 77.0% of all cases. At the time of the survey, only two SSRI medications were available in Japan. However, five types of SSRI were available and were often prescribed in Korea. [source] Informed Consent for Research: Current Practices in Academic Emergency MedicineACADEMIC EMERGENCY MEDICINE, Issue 6 2008Edward Monico MD Abstract Background:, The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research. Objectives:, The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs. Methods:, Between July 1, 2006, and June 30, 2007, an online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME). Results:, Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval [CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research subjects. Conclusions:, It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines. [source] Implementing Early Goal-directed Therapy in the Emergency Setting: The Challenges and Experiences of Translating Research Innovations into Clinical Reality in Academic and Community SettingsACADEMIC EMERGENCY MEDICINE, Issue 11 2007Alan E. Jones MD Research knowledge translation into clinical practice pathways is a complex process that is often time-consuming and resource-intensive. Recent evidence suggests that the use of early goal-directed therapy (EGDT) in the emergency department care of patients with severe sepsis and septic shock results in a substantial mortality benefit; however, EGDT is a time- and resource-intensive intervention. The feasibility with which institutions may translate EGDT from a research protocol into routine clinical care, among settings with varying resources, staff, and training, is largely unknown. The authors report the individual experiences of EGDT protocol development, as well as preimplementation and postimplementation experiences, at three institutions with different emergency department, intensive care unit, and hospital organization schemes. [source] Faecal calprotectin concentrations in children with functional gastrointestinal disorders diagnosed according to the Pediatric Rome III criteriaACTA PAEDIATRICA, Issue 5 2010G Flagstad Abstract Objective:, To determine if faecal calprotectin concentrations vary with different entities of functional gastrointestinal disorders (FGID) in children. Methods:, Children (4,15 years) who were consecutively referred by general practitioners to four general paediatric outpatient clinics for the evaluation of recurrent abdominal pain were assessed according to a research protocol which included clinical examination, a minimum set of blood, urine and stool tests, and clinical reassessment after 6,9 months. The diagnoses of FGID were based on the parent version of the Questionnaire on Pediatric Gastrointestinal Symptoms-Rome III. Results:, Of the 152 patients included, 142 children were diagnosed with FGID. Of these, 126 (89%) provided a stool specimen for quantification of calprotectin. The median calprotectin concentrations were at or lower than 16 mg/kg which was at the lower detection limit and there were no differences between the FGID subgroups. Nine children (7%) had slightly raised values. Conclusion:, The faecal calprotectin concentration is within normal limits in FGID and does not vary with different FGID entities suggesting that bowel inflammation is not a significant part of the pathogenesis in FGID. [source] False and Recovered Memories in the Laboratory and Clinic: A Review of Experimental and Clinical EvidenceCLINICAL PSYCHOLOGY: SCIENCE AND PRACTICE, Issue 1 2004David H. Gleaves We review the clinical and laboratory evidence for recovered and false memories. Available data suggest that, at least under certain circumstances, both false and recovered memories may occur. We suggest that the critical questions are: (a) how common is each type of memory phenomenon, (b) what factors lead to the occurrence of each (including under what conditions are each possible and/or likely to occur), and perhaps most importantly, (c) can these two types of memories be distinguished from each other? We describe laboratory analogues for both types of experiences and describe an empirical research protocol that can not only demonstrate both phenomena but also compare the two. Such comparisons can help to determine the causes of these phenomena, discover factors that influence the two, and hopefully reveal signature variables that could provide telltale signs differentiating false and recovered memories. [source] Assessing immunophenotyping performance: Proficiency-validation for adopting improved flow cytometry methodsCYTOMETRY, Issue 4 2007Lance E. Hultin Abstract Background: The continuous improvement and evolution of immune cell phenotyping requires periodic upgrading of laboratory methods and technology. Flow cytometry laboratories that are participating in research protocols sponsored by the NIAID are required to perform "switch" studies to validate performance before methods for T-cell subset analysis can be changed. Methods: Switch studies were conducted among the four flow cytometry laboratories of the Multicenter AIDS Cohort Study (MACS), comparing a 2-color, lyse-wash method and a newer, 3-color, lyse no-wash method. Two of the laboratories twice failed to satisfy the criteria for acceptable differences from the previous method. Rather than repeating more switch studies, these laboratories were allowed to adopt the 3-color, lyse no-wash method. To evaluate the impact of the switch to the new method at these two sites, their results with the new method were evaluated within the context of all laboratories participating in the NIH-NIAID-Division of AIDS Immunology Quality Assurance (IQA) proficiency-testing program. Results: Laboratory performance at these two sites substantially improved relative to the IQA standard test results. Variation across the four MACS sites and across replicate samples was also reduced. Conclusions: Although switch studies are the conventional method for assessing comparability of laboratory methods, two alternatives to the requirement of repeating failed switch studies should be considered: (1) test the new method and assess performance on the proficiency testing reference panel, and (2) prior to adoption of the new methods, use both the old and the new method on the reference panel samples and demonstrate that performance with the new method is better according to standard statistical procedures. These alternatives may help some laboratories' transition to a new and superior methodology more quickly than if they are required to attempt multiple, serial switch studies. © 2007 Clinical Cytometry Society [source] Institutional Review Boards and Multisite Studies in Health Services Research: Is There a Better Way?HEALTH SERVICES RESEARCH, Issue 1 2005Jennifer L. Gold Objective. The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. Principal Findings. (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order. Conclusions. The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general. [source] Eldercare and job productivity: An accommodation analysisJOURNAL OF LEADERSHIP STUDIES, Issue 4 2008Kenneth C. Sherman Over the next decade, the number of working adults relegated to the role of caregiver for one or more elderly family members will rapidly surge. The emotional, physical, and financial stress of caregiving has already begun to impact the productivity of the employee elder caregiver in the workplace, with estimates placing the annual costs around $30 billion. We can expect costs to grow as workers and their elderly parents continue to age. This particular study addresses the fundamental research question of what affects the job performance of employee elder caregivers. The results support the conclusion that the relationship among caregiving, personal support, organizational accommodation, and job productivity is multidimensional. Organizations attuned to the demands of elder caregiving can work with affected employees to reduce or eliminate declines in job productivity. Future researchers and practitioners can reconsider their research protocols and interventions along a wide continuum of interactions in the employee's home and workplace environments. [source] SPECIAL ARTICLE: A review of the International Brain Research Foundation novel approach to mild traumatic brain injury presented at the International Conference on Behavioral Health and Traumatic Brain InjuryJOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS, Issue 9 2010MSN (Doctoral Student), Mary Zemyan Polito CRNP Abstract "The International Conference on Behavioral Health and Traumatic Brain Injury" held at St. Joseph's Regional Medical Center in Paterson, NJ., from October 12 to 15, 2008, included a presentation on the novel assessment and treatment approach to mild traumatic brain injury (mTBI) by Philip A. DeFina, PhD, of the International Brain Research Foundation (IBRF). Because of the urgent need to treat a large number of our troops who are diagnosed with mTBI and post-traumatic stress disorder (PTSD), the conference was held to create a report for Congress titled "Recommendations to Improve the Care of Wounded Warriors NOW. March 12, 2009." This article summarizes and adds greater detail to Dr. DeFina's presentation on the current standard and novel ways to approach assessment and treatment of mTBI and PTSD. Pilot data derived from collaborative studies through the IBRF have led to the development of clinical and research protocols utilizing currently accepted, valid, and reliable neuroimaging technologies combined in novel ways to develop "neuromarkers." These neuromarkers are being evaluated in the context of an "Integrity-Deficit Matrix" model to demonstrate their ability to improve diagnostic accuracy, guide treatment programs, and possibly predict outcomes for patients suffering from traumatic brain injury. [source] Liver transplantation for incidental cholangiocarcinoma: Analysis of the Canadian experienceLIVER TRANSPLANTATION, Issue 11 2005Peter Ghali Cholangiocarcinoma is a biliary tumor, which not infrequently complicates primary sclerosing cholangitis. It carries a poor prognosis and, with the exception of carefully selected individuals in research protocols, contraindicates orthotopic liver transplantation. There has been some suggestion that cholangiocarcinomas incidentally discovered at the time of transplantation carry a better prognosis. The goal of this retrospective study was to perform a national review of outcomes after liver transplantation in Canadian recipients found to have incidental cholangiocarcinoma in their explanted native liver. Six of the seven liver transplant centers in Canada provided clinical and follow-up information on all liver transplant recipients found to have incidental cholangiocarcinoma in their explants. The diagnosis or suspicion of cholangiocarcinoma prior to transplantation were exclusion criteria for this study. Ten individuals with cholangiocarcinoma were transplanted between 1996 and 2003. The median duration of follow-up was 28 months. Eight of the 10 had PSC. All of the tumors were stage I or II. The 3-year survival for these patients was 30%. The median time to recurrence was 26 months (95% confidence interval 13uu-uu37), and the median time to death was 30 months (95% confidence interval 28uu-uu53). In conclusion, although early survival of patients transplanted for incidental cholangiocarcinoma appears good, intermediate- and long-term survival rates are not better than for individuals historically transplanted with known cholangiocarcinoma. Aggressive investigation for cholangiocarcinoma is mandated. Incidentally found tumours remain a difficult treatment problem, and prospective adjuvant chemo-, radio-, and immunotherapies should be investigated. (Liver Transpl 2005;11:1412,1416.) [source] The New Bureaucracies of Virtue or When Form Fails to Follow FunctionPOLAR: POLITICAL AND LEGAL ANTHROPOLOGY REVIEW, Issue 2 2007Charles L. Bosk As the prospective review of research protocols has expanded to include ethnography, researchers have responded with a mixture of bewilderment, irritation, and formal complaint. These responses typically center on how poorly a process modeled on the randomized clinical trial fits the realities of the more dynamic, evolving methods that are used to conduct ethnographic research. However warranted these complaints are, those voicing them have not analyzed adequately the logic in use that allowed the system of review to extend with so little resistance. This paper locates the expansion in the goal displacement that Merton identified as part of bureaucratic organization and identifies the tensions between researchers and administrators as a consequence of an inversion of the normal status hierarchy found in universities. Social scientists need to do more than complain about the regulatory process; they also need to make that apparatus an object for study. Only recently have social scientists taken up the task in earnest. This paper contributes to emerging efforts to understand how prospective review of research protocols presents challenges to ethnographers and how ethnographic proposals do the same for IRBs (Institutional Research Boards). This essay extends three themes that are already prominent in the literature discussing IRBs and ethnography: (1) the separation of bureaucratic regulations,policies,and procedures from the everyday questions of research ethics that are most likely to trouble ethnographers; (2) the goal displacement that occurs when the entire domain of research ethics is reduced to compliance with a set of federal regulations as interpreted by local committees; and (3) the difficulties of sense making when ethnographers and IRB administrators or panel members respond each to the other's concerns. [source] Ethics commentary: subjects of knowledge and control in field primatologyAMERICAN JOURNAL OF PRIMATOLOGY, Issue 9 2010N.M. Malone Abstract Our primate kin are routinely displaced from their habitats, hunted for meat, captured for trade, housed in zoos, made to perform for our entertainment, and used as subjects in biomedical testing. They are also the subjects of research inquiries by field primatologists. In this article, we place primate field studies on a continuum of human and alloprimate relationships as a heuristic device to explore the unifying ethical implications of such inter-relationships, as well as address specific ethical challenges arising from common research protocols "in the field" (e.g. risks associated with habituation, disease transmission, invasive collection of biological samples, etc.). Additionally, we question the widespread deployment of conservation- and/or local economic development-based justifications for field-based primatological pursuits. Informed by decades of combined fieldwork experience in Indonesia and the Democratic Republic of Congo, we demonstrate the process by which the adherence to a particular ethical calculus can lead to unregulated and ethically problematic research agendas. In conclusion, we offer several suggestions to consider in the establishment of a formalized code of ethics for field primatology. Am. J. Primatol. 72:779,784, 2010. © 2010 Wiley-Liss, Inc. [source] Genetic characterization of rhesus macaques (Macaca mulatta) in NepalAMERICAN JOURNAL OF PRIMATOLOGY, Issue 5 2006Randall C. Kyes Abstract Indian-origin rhesus macaques (Macaca mulatta) have long served as an animal model for the study of human disease and behavior. Given the current shortage of Indian-origin rhesus, many researchers have turned to rhesus macaques from China as a substitute. However, a number of studies have identified marked genetic differences between the Chinese and Indian animals. We investigated the genetic characteristics of a third rhesus population, the rhesus macaques of Nepal. Twenty-one rhesus macaques at the Swoyambhu Temple in Kathmandu, Nepal, were compared with more than 300 Indian- and Chinese-origin rhesus macaques. The sequence analyses of two mitochondrial DNA (mtDNA) loci, from the HVS I and 12,S rRNA regions, showed that the Nepali animals were more similar to Indian-origin than to Chinese-origin animals. The distribution of alleles at 24 short tandem repeat (STR) loci distributed across 17 chromosomes also showed greater similarity between the Nepali and Indian-origin animals. Finally, an analysis of seven major histocompatibility complex (MHC) alleles showed that the Nepali animals expressed Class I alleles that are common to Indian-origin animals, including Mamu-A*01. All of these analyses also revealed a low level of genetic diversity within this Nepali rhesus sample. We conclude that the rhesus macaques of Nepal more closely resemble rhesus macaques of Indian origin than those of Chinese origin. As such, the Nepali rhesus may offer an additional resource option for researchers who wish to maintain research protocols with animals that possess key genetic features characteristic of Indian-origin rhesus macaques. Am. J. Primatol. 68:1,11, 2006. © 2005 Wiley-Liss, Inc. [source] Ethics Review for Sale?THE MILBANK QUARTERLY, Issue 4 2000Commercial Research Review Boards, Conflict of Interest Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process. [source] Comparison of Quantitative T-Wave Alternans Profiles of Healthy Subjects and ICD PatientsANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 2 2009B.Eng., Euler De Vilhena Garcia Ph.D., M.Sc. Background: Current relevance of T-wave alternans is based on its association with electrical disorder and elevated cardiac risk. Quantitative reports would improve understanding on TWA augmentation mechanisms during mental stress or prior to tachyarrhythmias. However, little information is available about quantitative TWA values in clinical populations. This study aims to create and compare TWA profiles of healthy subjects and ICD patients, evaluated on treadmill stress protocols. Methods: Apparently healthy subjects, not in use of any medication were recruited. All eligible ICD patients were capable of performing an attenuated stress test. TWA analysis was performed during a 15-lead treadmill test. The derived comparative profile consisted of TWA amplitude and its associated heart rate, at rest (baseline) and at peak TWA value. Chi-square or Mann-Whitney tests were used with p values , 0.05. Discriminatory performance was evaluated by a binary logistic regression model. Results: 31 healthy subjects (8F, 23M) and 32 ICD patients (10F, 22M) were different on baseline TWA (1 ± 2 ,V; 8 ± 9 ,V; p < 0.001) and peak TWA values (26 ± 13 ,V; 37 ± 20 ,V; p = 0,009) as well as on baseline TWA heart rate (79 ± 10 bpm; 67 ± 15 bpm; p < 0.001) and peak TWA heart rate (118 ± 8 bpm; 90 ± 17 bpm; p < 0.001). The logistic model yielded sensitivity and specificity values of 88.9% and 92.9%, respectively. Conclusions: Healthy subjects and ICD patients have distinct TWA profiles. The new TWA profile representation (in amplitude-heart rate pairs) may help comparison among different research protocols. [source] RESEARCH PARTICIPATION AND THE RIGHT TO WITHDRAWBIOETHICS, Issue 2 2005SARAH J.L. EDWARDS ABSTRACT Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ,right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ,push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ,screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. [source] Mother,child health research (IRN-MCH): Achievements and prospects of an international networkACTA PAEDIATRICA, Issue 7 2005Guy de Thé Abstract The Inter-Academy Panel (IAP) is critical about the scarce support to mother,child health (MCH) research in developing countries. At the request of the IAP, a group of members of the French and Swedish Academies of Science have arrived at the conclusion that an efficient network between scientists in resource-poor and industrialized countries will facilitate MCH research in developing countries. The priorities for such a network have been listed as follows: The present organization for the MCH website at the Pasteur Institute in Paris should be adapted to better promote collaboration between scientists from industrialized and developing countries. To provide short-term courses for young scientists from developing countries in the design of research protocols, and in the writing of scientific reports and manuscripts. To organize workshops on various topics of relevance for MCH in developing countries in order to create new research networks for scientific collaboration between industrialized and resource-poor countries. To establish collaboration between non-governmental organizations (NGOs) that support MCH research in developing countries. Topics for such collaborative studies and the way in which they may be performed are summarized. [source] | |||||||||||||||||||