Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim...
The high prevalence of trauma exposure and subsequent negative consequences for both survivors and society as a whole emphasize the need for secondary prevention of posttraumatic stress disorder. However, clinicians and relief workers remain limited in their ability to intervene effectively in the aftermath of trauma and alleviate traumatic stress reactions that can lead to chronic PTSD. The scientific literature on early intervention for PTSD is reviewed, including early studies on psychological debriefing, pharmacological, and psychosocial interventions aimed at preventing chronic PTSD. Studies on fear extinction and memory consolidation are discussed in relation to PTSD prevention and the potential importance of immediate versus delayed intervention approaches and genetic predictors are briefly reviewed. Preliminary results from a modified prolonged exposure intervention applied within hours of trauma exposure in an emergency room setting are discussed, along with considerations related to intervention reach and overall population impact. Suggestions for future research are included. Prevention of PTSD, although currently not yet a reality, remains an exciting and hopeful possibility with current research approaches translating work from the laboratory to the clinic.
This study investigated the advantages and challenges of using Medication Electronic Monitoring System (MEMS) technology to examine adherence among pediatric kidney transplant patients. Twenty-nine patients participated in the study, with a mean age of 14.03 yr (SD = 3.34, range 8–19 yr). Patients were given a MEMS bottle and cap to be used with their primary immunosuppressant medication over a three-month period. Issues related to study eligibility, recruitment, and participant maintenance were recorded. Patients completed the Debriefing Form regarding their experiences with the MEMS. Many younger patients were on liquid medications affecting the feasibility of this technology across ages. Acceptance of this technology proved difficult, as many patients either declined upfront or dropped out because they did not want to use the MEMS. Of the final sample, 41% found transferring medication into the MEMS bottle difficult and 27.2% reported that the MEMS was a burden and/or difficult to transport. Another 22% of the patients reported that using the MEMS changed their routine, and 10.2% worried about missing their medications. Pediatric transplant centers should be cautious about solely relying on MEMS to examine adherence until more research is conducted on the feasibility...
Orthopaedic surgery requires a high degree of technical skill. Current orthopaedic surgical education is based largely on an apprenticeship model. In addition to mounting evidence of the value of simulation, recent mandated requirements will undoubtedly lead to increased emphasis on surgical skills and simulation training. The University of Iowa’s Department of Orthopaedic Surgery has created and implemented a month long surgical skills training program for PGY-1 residents. The goal of the program was to improve the basic surgical skills of six PGY-1 orthopaedic surgery residents and prepare them for future operative experiences. A modular curriculum was created by members of the orthopaedic faculty which encompassed basic skills felt to be important to the general orthopaedic surgeon. For each module multiple assessment techniques were utilized to provide constructive critique, identify errors and enhance the performance intensity of trainees. Based on feedback and debriefing surveys, the resident trainees were unanimously satisfied with the content of the surgical skills month, and felt it should remain a permanent part of our educational program. This manuscript will describe the development of the curriculum, the execution of the actual skills sessions and analysis of feedback from the residents and share valuable lessons learned and insights for future skills programs.
This study evaluated the success of sham-continuous positive airway pressure as a placebo in a 4-week clinical trial of adults with sleep apnea. Participants (n=23) were previously undiagnosed for obstructive sleep apnea, had no one in their household on sleep apnea therapy, and were willing to be randomized to either active or sham-continuous positive airway pressure. Before final debriefing, participants were asked to “guess” their group assignment. When questioned, 10 of the 23 participants (44%) were incorrect in their guess of group assignment; 2 of these participants stated that their guess was “random”. The active continuous positive airway pressure group’s average usage was significantly longer when compared to participants on the sham device (293 ± 117 minutes/day vs. 188 ± 110 minutes/day, p =.046). The results suggest that participants remained blinded to group assignment and that sham-continuous positive airway pressure is an appropriate placebo control device. Participants’ lower adherence to the sham device may be a potential problem that requires attention in the use of sham-continuous positive airway pressure as a placebo during clinical trials.
The US Preventive Services Task Force (USPSTF) now recommends screening for intimate partner violence (IPV) as part of routine preventive services for women. However, there is a lack of clarity as to the most effective methods of screening and referral. We conducted a 3-year community-based mixed-method participatory research project involving four community health centers that serve as safety net medical providers for a predominately indigent urban population. The project involved preparatory work, a multifaceted systems-level demonstration project, and a sustainability period with provider/staff debriefing. The goal was to determine if a low-tech system-level intervention would result in an increase in IPV detection and response in an urban community health center. Results highlight the challenges, but also the opportunities, for implementing the new USPSTF guidelines to screen all women of childbearing years for intimate partner violence in resource-limited primary care settings.
Current Human Subject Research training modules fail to capture ethically relevant cultural aspects of research involving American Indian and Alaska Native (AI/AN) community members. Applying a Community Engaged Research (CEnR) approach, we adapted the Collaborative IRB Training Initiative training module “assessing risk and benefits.” In a two-arm randomized controlled trial, followed by debriefing interviews, we evaluated module acceptability and understandability (test scores) among 40 reservation-based community members. Participants who took the adapted module, compared to those who took the standard module, reported higher scores on relevance of the material overall satisfaction, module quiz scores, and a trend toward higher self-efficacy. Implications of the efficacy of this approach for enhancing ethics training and community participation in research within AI/AN and other cultural populations within and outside the United States are discussed.
This paper reviews the psychological health research conducted in the United States in support of combat veterans from Iraq and Afghanistan, using the Military Psychological Health Research Continuum, which includes foundational science, epidemiology, etiology, prevention and screening, treatment, follow-up care, and services research. The review is limited to those studies involving combat veterans and military families. This review discusses perplexing issues regarding the impact of combat on the mental health of service members such as risk and resilience factors of mental health, biomarkers of posttraumatic stress syndrome (PTSD), mental health training, psychological screening, psychological debriefing, third location decompression, combat and suicide, the usefulness of psychotherapy and drug therapy for treating PTSD, role of advanced technology, telemedicine and virtual reality, methods to reduce stigma and barriers to care, and best approaches to the dissemination of evidence-based interventions. The mental health research of special populations such as women, National Guardsmen and reservists, and military families is also presented. The review concludes by identifying future areas of research.
Although several research groups within institutions in Nigeria have been involved in extensive malaria research, the link between the research community and policy formulation has not been optimal. The workshop aimed to assist post graduate students to identify knowledge gaps and to develop relevant Malaria-related research proposals in line with identified research priorities. A training needs assessment questionnaire was completed by 22 students two week prior to the workshop. Also, a one page concept letter was received from 40 residents. Thirty students were selected based the following six criteria: - answerability and ethics; efficacy and impact; deliverability, affordability; scalability, sustainability; health systems, partnership and community involvement; and equity in achieved disease burden reduction. The workshop was over a three day period. The participants at the workshop were 30 Nigeria Field Epidemiology and Laboratory Training Programme (NFELTP) residents from cohorts 4 and 5. Ten technical papers were presented by the experts from the academia, National Malaria Elimination (NMEP) Programme, NFELTP Faculty and Implementing partners including CDC/PMI. Draft proposals were developed and presented by the residents. The “strongest need” for training was on malaria prevention...
This article describes the prototyping of human–robot interactions in the University of Hertfordshire (UH) Robot House. Twelve participants took part in a long-term study in which they interacted with robots in the UH Robot House once a week for a period of 10 weeks. A prototyping method using the narrative framing technique allowed participants to engage with the robots in episodic interactions that were framed using narrative to convey the impression of a continuous long-term interaction. The goal was to examine how participants responded to the scenarios and the robots as well as specific robot behaviours, such as agent migration and expressive behaviours. Evaluation of the robots and the scenarios were elicited using several measures, including the standardised System Usability Scale, an ad hoc Scenario Acceptance Scale, as well as single-item Likert scales, open-ended questionnaire items and a debriefing interview. Results suggest that participants felt that the use of this prototyping technique allowed them insight into the use of the robot, and that they accepted the use of the robot within the scenario.
The Outline for Cultural Formulation (OCF) in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) marked an attempt to apply anthropological concepts within psychiatry. The OCF has been criticized for not providing guidelines to clinicians. The DSM-5 Cultural Issues Subgroup has since converted the OCF into the Cultural Formulation Interview (CFI) for use by any clinician with any patient in any clinical setting. This paper presents perceived barriers to CFI implementation in clinical practice reported by patients (n=32) and clinicians (n=7) at the New York site within the DSM-5 international field trial. We used an implementation fidelity paradigm to code debriefing interviews after each CFI session through deductive content analysis. The most frequent patient threats were lack of differentiation from other treatments, lack of buy-in, ambiguity of design, over-standardization of the CFI, and severity of illness. The most frequent clinician threats were lack of conceptual relevance between intervention and problem, drift from the format, repetition, severity of patient illness, and lack of clinician buy-in. The Subgroup has revised the CFI based on these barriers for final publication in DSM-5. Our findings expand knowledge on the cultural formulation by reporting the CFI’s reception among patients and clinicians.
This communication is the first of a series on South Asian fasts, festivals, and diabetes, designed to spread awareness and stimulate research on this aspect of diabetes and metabolic care. It describes the various fasts observed as part of Hindu religion and offers a classification scheme for them, labeling them as infrequent and frequent. The infrequent fasts are further sub-classified as brief and prolonged, to facilitate a scientific approach to glycemic management during these fasts. Pre-fast counseling, non-pharmacological therapy, pharmacological modification, and post-fast debriefing are discussed in detail. All available drug classes and molecules are covered in this article, which provides guidance about necessary changes in dosage and timing of administration. While in no way exhaustive, the brief review offers a basic framework which diabetes care professionals can use to counsel and manage persons in their care who wish to observe various Hindu fasts.
Many clinical outcome assessments (COAs) were originally developed for completion via pen and paper. However, in recent years there have been movements toward electronic capture of such data in an effort to reduce missing data, provide time-stamped records, minimize administrative burden, and avoid secondary data entry errors. Although established in many patient populations, the implications of using electronic COAs in schizophrenia are unknown. In accordance with International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force recommendations, in-depth cognitive debriefing and usability interviews were conducted with people with schizophrenia (n=12), their informal (unpaid) caregivers (n=12), and research support staff (n=6) to assess the suitability of administration of various electronic COA measures using an electronic tablet device. Minimal issues were encountered by participants when completing or administering the COAs in electronic format, with many finding it easier to complete instruments in this mode than by pen and paper. The majority of issues reported were specific to the device functionality rather than the electronic mode of administration. Findings support data collection via electronic tablet in people with schizophrenia and their caregivers. The appropriateness of other forms of electronic data capture (eg...
The use of simulation for teaching the knowledge, skills, and behaviors necessary for effective pediatric resuscitation has seen widespread growth and adoption across pediatric institutions. In this paper, we describe the application of simulation in pediatric resuscitation training and review the evidence for the use of simulation in neonatal resuscitation, pediatric advanced life support, procedural skills training, and crisis resource management training. We also highlight studies supporting several key instructional design elements that enhance learning, including the use of high-fidelity simulation, distributed practice, deliberate practice, feedback, and debriefing. Simulation-based training is an effective modality for teaching pediatric resuscitation concepts. Current literature has revealed some research gaps in simulation-based education, which could indicate the direction for the future of pediatric resuscitation research.
We analyzed the association between sub-scales developed with adolescents and the outcomes of precoital behaviors and vaginal sex in Lima, Peru. Adolescent participants in key informant sessions operationalized concepts identified during qualitative concept mapping into several sub-scales. Face and content validity testing and pilot application with respondent debriefing were used to refine the sub-scales. Three hundred 15–17 year olds were surveyed about the sub-scales, socio-demographics and sexual behaviors. Exploratory factor analysis confirmed six sub-scales, self-image, goals and decision-making, family education, parental rules/control, school support and peer support, which we regressed on the outcomes. Twice as many males as females reported more than three precoital behaviors and vaginal sex. Higher peer support reduced the likelihood of vaginal sex and precoital behaviors and higher family education reduced precoital behaviors. Results affirm the importance of including adolescents in the entire research process and of sex education with family- and peer-based strategies.
This review of child disaster mental health intervention studies describes the techniques used in the interventions and the outcomes addressed, and it provides a preliminary evaluation of the field. The interventions reviewed here used a variety of strategies such as cognitive behavioral approaches, exposure and narrative techniques, relaxation, coping skill development, social support, psychoeducation, eye movement desensitization and reprocessing, and debriefing. A diagnosis of posttraumatic stress disorder (PTSD) and/or posttraumatic stress reactions were the most commonly addressed outcomes although other reactions such as depression, anxiety, behavior problems, fear, and/or traumatic grief also were examined. Recommendations for future research are outlined.
Despite the important roles families play in the lives of many persons with mental illness across cultures, there is a dearth of data worldwide on how family members perceive the process of cultural assessment as well as to how to best include them. This study addresses this gap in our knowledge through analysis of data collected across six countries as part of a DSM-5 Field Trial of the Cultural Formulation Interview (CFI). At clinician discretion, individuals who accompanied patients to the clinic visit (i.e. patient companions) at the time the CFI was conducted were invited to participate in the cultural assessment and answer questions about their experience. The specific aims of this paper are (1) to describe patterns of participation of patient companions in the CFI across the six countries, and (2) to examine the comparative feasibility, acceptability, and clinical utility of the CFI from companion perspectives through analysis of both quantitative and qualitative data. Among the 321 patient interviews, only 86 (at 4 of 12 sites) included companions, all of whom were family members or other relatives. The utility, feasibility and acceptability of the CFI were rated favorably by relatives, supported by qualitative analyses of debriefing interviews. Cross-site differences in frequency of accompaniment merit further study.