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Biomedical subjects

Teddy D Warner

Publications and source records attributed to Teddy D Warner.

At least 37 records · Page 2Linked to original sources

Nightmares, insomnia, and sleep-disordered breathing in fire evacuees seeking treatment for posttraumatic sleep disturbance.

Eight months after the Cerro Grande Fire, 78 evacuees seeking treatment for posttraumatic sleep disturbances were assessed for chronic nightmares, psychophysiological insomnia, and sleep-disordered breathing symptoms. Within this sample, 50% of participants were tested objectively for sleep-disordered breathing; 95% of those tested screened positive for sleep-disordered breathing. Multiple regression analyses demonstrated that these three sleep disorders accounted for 37% of the variance in posttraumatic stress symptoms, and each sleep disorder was significantly and independently associated with posttraumatic stress symptoms severity. The only systematic variable associated with posttraumatic stress symptoms of avoidance was sleep-disordered breathing. The findings suggest that three common sleep disorders relate to posttraumatic stress symptoms in a more complex manner than explained by the prevailing psychiatric paradigm, which conceptualizes sleep disturbances in PTSD merely as secondary symptoms of psychiatric distress.

Adult↗

Influence of ethical safeguards on research participation: comparison of perspectives of people with schizophrenia and psychiatrists.

OBJECTIVE: Several safeguards have been developed to protect research volunteers, but little is known about how the people involved in this research-the stakeholders-view these efforts to assure participant rights and well-being. The authors' goal was to examine these perspectives. METHOD: As part of a larger study, 60 people with schizophrenia and 69 psychiatrists rated the protectiveness and influence on patients' willingness to participate in research of five safeguards: informed consent, alternative decision makers, institutional review boards, data safety monitoring boards, and confidentiality measures. RESULTS: All safeguards were perceived by both the participants with schizophrenia and by the psychiatrists as protective: on a scale of 1-5 on which 1=not protective at all and 5=very much protects, the mean scores ranged from 3.54 to 4.07. Four of the five safeguards were perceived by both the people with schizophrenia and by the psychiatrists as positively influencing patients' participation decisions. On a scale of 1-5 on which 1=much less willing and 5=much more willing to participate, the mean scores for these four safeguards ranged from 3.86 to 4.30. The mean score for the safeguard of an alternative decision maker, however, was 3.09. The ratings of protectiveness made by both the people with schizophrenia and the psychiatrists were correlated with their ratings of patients' willingness to participate in studies. CONCLUSIONS: Ethical commitment to research volunteers is expressed in safeguards. These efforts appear to be viewed positively by key stakeholders and may influence research participation decision making.

Age Distribution↗

The positive role of professionalism and ethics training in medical education: a comparison of medical student and resident perspectives.

OBJECTIVE: To assess the perspectives and preferences of medical students and residents regarding professionalism and ethics education. METHODS: A new written survey with 124 items (scale: "strongly disagree" = 1, "strongly agree" = 9) was sent to all medical students (n=308) and PGY 1-3 residents (n=233) at one academic center. RESULTS: Of the 336 participants (200 students, 65% response; 136 residents 58% response), only 18% found current professionalism and ethics preparation sufficient. Respondents endorsed professionalism (means=7.48 to 8.11) and ethics topics (means=6.56 to 6.87), women more so than men (p<0.05). Respondents preferred clinically- and expert-oriented learning over formal, nontraditional, or independent approaches (p<0.0001). They preferred clinically-oriented assessment methods (p<0.0001), residents more so than medical students (p<0.0001). On several items, psychiatry residents expressed greater receptiveness to professionalism and ethics preparation. CONCLUSIONS: Medical students and residents indicate support for professionalism and ethics educational initiatives, including diverse curricular topics and clinically-attuned assessments.

Adult↗

What do we really know about conflicts of interest in biomedical research?

RATIONALE: Conflicts of interest in research have long been seen to pose serious threats to the integrity of research. Indeed, the past two decades have revealed increased attention to the possible influence of conflicts of interest as the number of research studies funded by private industry have increased. OBJECTIVES: We review empirical findings directly pertinent to issues concerning financial conflicts of interest in biomedical research, and we provide an overview of the current issues and state of understanding concerning such conflicts in research. METHODS: We searched Medline from January 1992 to January 2002 to locate current studies that have reported primary or secondary empirical data pertaining to conflicts of interest in research. RESULTS: The rate of potential conflicts of interest for researchers appears to be at least 30% in some situations although the accuracy of such a rate is untested, and the rate of disclosure of conflicts of interest is as low as 2%. Furthermore, some evidence exists to indicate that researchers with conflicting interests may indeed offer different professional opinions and judgments than those for whom such conflicts do not exist. The effectiveness of various disclosure and management methods for conflicts of interest is unknown. CONCLUSIONS: We summarize the current empirical literature, concluding that relatively little is known based on such data. We suggest a number of questions that need to be answered by future research, and we offer recommendations for policy makers to consider and evaluate in the future in identifying, revealing, and managing conflicts of interest.

Academies and Institutes↗

Schizophrenia patients' and psychiatrists' perspectives on ethical aspects of symptom re-emergence during psychopharmacological research participation.

RATIONALE: Study designs involving medication-free intervals have become the subject of controversy in the current dialogue on the ethics of serious mental-illness research. METHODS: Schizophrenia patients ( n=59; response rate 75%; 48% inpatients) and psychiatrists ( n=70; response rate 83%) responded to ten questions about a hypothetical scenario in which a schizophrenia study participant experienced the re-emergence of serious symptoms during the "wash-out" phase of a psychopharmacological trial. Patients provided their personal views, and psychiatrists gave their personal views and made predictions as to how schizophrenia patients in general would respond. RESULTS: Schizophrenia patients and psychiatrists judged the hypothetical protocol as moderately harmful. Both expressed relatively low likelihood of willingness to participate in the study, given this potential outcome. Schizophrenia patients and psychiatrists found the decision fairly easy. Psychiatrists underestimated the level of harm and overestimated the difficulty of the decision as perceived by schizophrenia patients. Schizophrenia patients acknowledged that the offer of money and request by their doctor or family would increase the likelihood of their participation, and psychiatrists accurately predicted these responses. In hypothetical decisions about the symptomatic study participant, 38% of patients and 39% of psychiatrists said they would allow him to leave the hospital. A majority of both groups (63% and 52%, respectively) indicated that medication should be given despite the study participant's objection. Psychiatrists incorrectly predicted this response, expecting instead that most schizophrenia patients would support the discharge request and few would support involuntary administration of medication. Patients and psychiatrists offered similar reasons for participation decisions but differed in their strategies for handling the situation. CONCLUSION: These findings suggest potential strengths of decisionally capable schizophrenia patients in assessing ethically important design elements of psychopharmacological trials. Implications for informed consent for research, expectations of the therapeutic obligations of clinical investigators, and the role of psychiatric advance directives in psychopharmacological research are outlined.

Adult↗

What is ethically important in clinical research? A preliminary study of attitudes of 73 psychiatric faculty and residents.

The ethical caliber of psychiatric research ultimately rests upon the shoulders of psychiatric clinicians and investigators who perform protocols and are directly responsible for the welfare of study volunteers. Little is known, however, about ethically relevant attitudes of psychiatrists toward human research. Working as part of a larger study, we surveyed all psychiatry faculty and residents at one institution in 1999 regarding the relative importance of 12 elements in the ethical conduct of human research. Responses of 73 participants were analyzed, and three factors emerged: Safeguards and Scientific Merit, Investigator Integrity and Relationship, and Patient Benefit. Safeguards and Scientific Merit, as a set, were the most salient considerations for both psychiatry faculty and residents. We found that residents placed greater importance on all factors and nearly every element than did faculty. Future research is needed to clarify the understanding of the perspectives and priorities of different stakeholders involved in human studies.

Adult↗

Measuring trauma and health status in refugees: a critical review.

CONTEXT: Refugees experience multiple traumatic events and have significant associated health problems, but data about refugee trauma and health status are often conflicting and difficult to interpret. OBJECTIVES: To assess the characteristics of the literature on refugee trauma and health, to identify and evaluate instruments used to measure refugee trauma and health status, and to recommend improvements. DATA SOURCES: MEDLINE, PsychInfo, Health and PsychoSocial Instruments, CINAHL, and Cochrane Systematic Reviews (searched through OVID from the inception of each database to October 2001), and the New Mexico Refugee Project database. STUDY SELECTION: Key terms and combination operators were applied to identify English-language publications evaluating measurement of refugee trauma and/or health status. DATA EXTRACTION: Information extracted for each article included author; year of publication; primary focus; type (empirical, review, or descriptive); and type/name and properties of instrument(s) included. Articles were excluded from further analyses if they were review or descriptive, were not primarily about refugee health status or trauma, or were only about infectious diseases. Instruments were then evaluated according to 5 criteria (purpose, construct definition, design, developmental process, reliability and validity) as described in the published literature. DATA SYNTHESIS: Of 394 publications identified, 183 were included for further analyses of their characteristics; 91 (49.7%) included quantitative data but did not evaluate measurement properties of instruments used in refugee research, 78 (42.6%) reported on statistical relationships between measures (presuming validity), and 14 (7.7%) were only about statistical properties of instruments. In these 183 publications, 125 different instruments were used; of these, 12 were developed in refugee research. None of these instruments fully met all 5 evaluation criteria, 3 met 4 criteria, and 5 met only 1 of the criteria. Another 8 standard instruments were designed and developed in nonrefugee populations but adapted for use in refugee research; of these, 2 met all 5 criteria and 6 met 4 criteria. CONCLUSIONS: The majority of articles about refugee trauma or health are either descriptive or include quantitative data from instruments that have limited or untested validity and reliability in refugees. Primary limitations to accurate measurement in refugee research are the lack of theoretical bases to instruments and inattention to using and reporting sound measurement principles.

Health Status↗

To breathe, perchance to sleep: sleep-disordered breathing and chronic insomnia among trauma survivors.

Standard psychiatric classification (DSM-IV-TR) traditionally attributes post-traumatic sleep disturbance to a secondary or symptomatic feature of a primary psychiatric disorder. The DSM-IV-TR paradigm, however, has not been validated with objective sleep assessment technology, incorporated nosological constructs from the field of sleep disorders medicine, or adequately addressed the potential for post-traumatic stress disorder (PTSD) sleep problems to manifest as primary, physical disorders, requiring independent medical assessments and therapies. This paradigm may limit understanding of sleep problems in PTSD by promulgating such terms as "insomnia related to another mental disorder," a.k.a. "psychiatric insomnia." Emerging evidence invites a broader comorbidity perspective, based on recent findings that post-traumatic sleep disturbance frequently manifests with the combination of insomnia and a higher-than-expected prevalence of sleep-disordered breathing (SDB). In this model of complex sleep disturbance, the underlying sleep pathophysiology interacts with PTSD and related psychiatric distress; and this relationship appears very important as demonstrated by improvement in insomnia, nightmares, and post-traumatic stress with successful SDB treatment, independent of psychiatric interventions. Continuous positive airway pressure treatment in PTSD patients with SDB reduced electroencephalographic arousals and sleep fragmentation, which are usually attributed to central nervous system or psychophysiological processes. Related findings and clinical experience suggest that other types of chronic insomnia may also be related to SDB. We hypothesize that an arousal-based mechanism, perhaps initiated by post-traumatic stress and/or chronic insomnia, may promote the development of SDB in a trauma survivor and perhaps other patients with chronic insomnia. We discuss potential neurohormonal pathways and neuroanatomatical sites that may be involved in this proposed interaction between insomnia and SDB.

Adult↗

A general anxiety-prone cognitive style in anxiety disorders.

OBJECTIVE: This study compared scores on the Anxious Thoughts & Tendencies (AT&T) questionnaire, a putative measure of a general anxiety-prone cognitive style, among patients with panic disorder without agoraphobia (PD, n=62), panic disorder with agoraphobia (PDA, n=29), generalized anxiety disorder (GAD, n=43), limited social phobia (LSP, n=34), generalized social phobia (GSP, n=33), and community residents (n=319). METHOD: Candidates for treatment studies completed a diagnostic interview and the AT&T. AT&T scores were compared among anxious groups using analysis of variance. Then depressed and non-depressed patients were compared. The final analysis compared anxious groups without comorbid depressive or anxiety disorders. RESULTS: AT&T scores were highest in PDA patients, followed by patients with GAD or GSP, then patients with PD or LSP, with community residents lowest. Depressed patients were higher than non-depressed patients. Patients with current or past comorbid depressive disorders did not differ. The ranking of anxious groups on AT&T scores remained unchanged after exclusion of patients with comorbid disorders. Patients with PD or LSP without comorbidity had the same AT&T levels as the community sample. CONCLUSIONS: The AT&T discriminates PDA and GAD from PD per our hypothesis. The low AT&T levels among patients with PD and LSP suggest no association with a general anxiety-prone cognitive style. LSP and GSP may be distinct disorders. The cognitive style assessed by the AT&T is also associated with depression and may be a marker for vulnerability to depression. Definitive conclusions about a pathogenic role for cognitions require their measurement before the onset of the disorder.

Adult↗

Interactive model of therapeutic response in panic disorder: moclobemide, a case in point.

It was proposed that pre-post regression slopes be used to index treatment response when the effect of baseline scores differed among treatments (interaction between treatment and baseline score). Reanalyses of two studies using imipramine and fluoxetine in panic disorder showed doserelated decreases in pre-post slopes for the frequency of unexpected panic attacks, but not for the frequency of situational panic attacks or measures of agoraphobia. This report presents similar analyses of data from a study using moclobemide. Patients (N = 452) with panic disorder were randomized to placebo or a fixed dose of moclobemide (75, 150, 300, 600, or 900 mg/day). They were treated double-blindly and evaluated at baseline and 1, 2, 3, 4, 6, and 8 weeks later. The authors analyzed the frequency of unexpected and situational panic attacks compiled from a daily diary, and fear and avoidance ratings based on the patient's main phobia using baseline (pre) and end-point (post) values for all randomized patients. Adjoining dose groups were combined. Both unexpected and situational panic attacks showed systematic doserelated suppression of pre-post treatment slopes. Neither pre-post slopes nor adjusted posttreatment means for fear and avoidance differed reliably between treatment arms. This study replicates the authors' earlier findings, except for situational panic attacks, which probably were not reliably identified. Antidepressants selectively suppress panic attacks, especially unexpected attacks, but not agoraphobia. The findings are consistent with the hypothesis that panic disorder with agoraphobia has clinically separable biologic and cognitive components that respond differentially to treatment. Antidepressants benefit primarily patients with many unexpected panic attacks. Investigators should evaluate pre-post treatment slopes before comparing adjusted posttreatment means (analysis of covariance).

Adolescent↗

Sleep-disordered breathing, psychiatric distress, and quality of life impairment in sexual assault survivors.

Using American Academy of Sleep Medicine research criteria, sleep-disordered breathing (SDB) was assessed in a pilot study of 187 sexual assault survivors with posttraumatic stress symptoms. Nightmares, sleep quality, distress, and quality of life were also assessed along with historical accounts of prior treatments for sleep complaints. Presumptive SDB diagnoses were established for 168 patients. Twenty-one of 168 underwent sleep testing, and all met objective SDB diagnostic criteria. There were no clinically meaningful differences in age, body-mass index, sleep quality, distress, or quality of life measures between 21 confirmed SDB cases and 147 suspected cases not tested. Compared with 19 women without SDB, 168 women with diagnosed or suspected SDB reported significantly worse nightmares, sleep quality, anxiety, depression, posttraumatic stress, and impaired quality of life. Despite suffering from sleep problems for an average of 20 years, which had not responded to repeated use of psychotropic medications or psychotherapy, few of these women had been referred to sleep specialists. SDB appears widespread among sexual assault survivors seeking help for nightmares. Research is needed to clarify the associations among SDB, distress, and physical and mental health impairment in trauma patients.

Adaptation, Psychological↗

Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions.

OBJECTIVE: A central ethical issue in schizophrenia research is whether participants are able to provide informed consent, particularly for protocols entailing medication washouts or placebo treatments. Few data show how patients with schizophrenia and psychiatrists assess such scientific designs regarding potential harm, willingness to participate, and the relative influence of clinicians, family members, and financial incentives upon participation decisions. METHOD: In this preliminary study, structured interviews were conducted with schizophrenia patients (N=59), and parallel surveys were completed by attending and resident psychiatrists (N=70). Four hypothetical research protocols were rated. Patients were asked about their own views; psychiatrists provided both their personal views and predictions of patient views. RESULTS: Patients and psychiatrists both perceived substantially different levels of harm across the four protocols, identifying significantly greater harm for medication washouts or placebo treatments. Participants were less willing to enroll in protocols perceived as more harmful. Schizophrenia patients found enrollment decisions relatively easy. Patients and psychiatrists indicated that doctor recommendations, monetary incentives, and, to a lesser extent, family preferences had a mild influence on participation decisions. CONCLUSIONS: Given hypothetical protocols with variable design elements, schizophrenia patients and psychiatrists made meaningful and discerning harm assessments and participation decisions. These findings suggest that schizophrenia patients may have strengths in the research consent process that may not be fully recognized. The impact of outside influences upon research enrollment decisions remains uncertain. While psychiatrists were often accurate in predicting patient responses, data suggest the importance of clarifying views of individual patients regarding specific protocols.

Adult↗

Sleep Dynamic Therapy for Cerro Grande Fire evacuees with posttraumatic stress symptoms: a preliminary report.

BACKGROUND: Sleep disturbance is common among disaster survivors with posttraumatic stress symptoms but is rarely addressed as a primary therapeutic target. Sleep Dynamic Therapy (SDT), an integrated program of primarily evidence-based, nonpharmacologic sleep medicine therapies coupled with standard clinical sleep medicine instructions, was administered to a large group of fire evacuees to treat posttraumatic insomnia and nightmares and determine effects on posttraumatic stress severity. METHOD: The trial was an uncontrolled, prospective pilot study of SDT for 66 adult men and women, 10 months after exposure to the Cerro Grande Fire. SDT was provided to the entire group in 6, weekly, 2-hour sessions. Primary and secondary outcomes included validated scales for insomnia, nightmares, posttraumatic stress, anxiety, and depression, assessed at 2 pretreatment baselines on average 8 weeks apart, weekly during treatment, posttreatment, and 12-week follow-up. RESULTS: Sixty-nine participants completed both pretreatment assessment, demonstrating small improvement in symptoms prior to starting SDT. Treatment and posttreatment assessments were completed by 66 participants, and 12-week follow-up was completed by 59 participants. From immediate pretreatment (second baseline) to posttreatment, all primary and secondary scales decreased significantly (all p values < .0001) with consistent medium-sized effects (Cohen's d = 0.29 to 1.09), and improvements were maintained at follow-up. Posttraumatic stress disorder subscales demonstrated similar changes: intrusion (d = 0.56), avoidance (d = 0.45), and arousal (d = 0.69). Fifty-three patients improved, 10 worsened, and 3 reported no change in posttraumatic stress. CONCLUSION: In an uncontrolled pilot study, chronic sleep symptoms in fire disaster evacuees were treated with SDT, which was associated with substantive and stable improvements in sleep disturbance, posttraumatic stress, anxiety, and depression 12 weeks after initiating treatment.

Clinical Protocols↗

Development of an inventory for measuring war-related events in refugees.

Knowledge about the range of war-related events experienced by refugees is lacking. This initial report of the New Mexico Refugee Project (NMRP) details the development of the Comprehensive Trauma Inventory (CTI), the first empirically developed instrument that measures war-related events in community-dwelling refugees. Both expert and participant methods using quantitative and qualitative approaches were used to broaden knowledge about the range of war-related experiences in refugees. The CTI-164, developed by expert rational methods, was administered to 36 Kurdish and 31 Vietnamese refugees along with an in-depth interview (IDI) and five other quantitative instruments measuring symptoms, impairment, and social support. Focus groups (FGs) were also conducted. Text and descriptive analyses, t tests, and correlations were used to analyze data. Refugees reported an average of 150 war-related events on the CTI-164, more than in other studies. IDIs and FGs revealed 123 war-related events and event types that were not on the CTI-164 or other measures currently used. Refugees reported multiple chronic symptoms and significant impairment in daily functioning. The CTI-164 was modestly correlated with symptoms and impairment. The definable number and type of war-related events endured by refugees is greater than in previously published research. Expert rational methods are not adequate to develop an instrument to define war-related events and measure their association with health outcomes. Participatory and qualitative methods reveal events and event types that have not been previously defined. The CTI warrants further testing after revision to incorporate items and event types determined by qualitative methods.

Adult↗

Employees' perspectives on ethically important aspects of genetic research participation: a pilot study.

PURPOSE: Insights from genetic research may greatly improve our understanding of physical and mental illnesses and assist in the prevention of disease. Early experience with genetic information suggests that it may lead to stigma, discrimination, and other psychosocial harms, however, and this may be particularly salient in some settings, such as the workplace. Despite the importance of these issues, little is known about how healthy adults, including workers, perceive and understand ethically important issues in genetic research pertaining to physical and mental illness. METHOD: We developed, pilot tested, and administered a written survey and structured interview to 63 healthy working adults in 2 settings. For this paper, we analyzed a subset of items that assessed attitudes toward ethically relevant issues related to participation in genetic research on physical and mental illness, such as its perceived importance, its acceptability for various populations, and appropriate motivations for participation. RESULTS: Our respondents strongly endorsed the importance of physical and mental illness genetic research. They viewed participation as somewhat to very acceptable for all 12 special population groups we asked about, including persons with mental illness. They perceived more positives than negatives in genetic research participation, giving neutral responses regarding potential risks. They affirmed many motivations for participation to varying degrees. Men tended to affirm genetic research participation importance, acceptability, and motivations more strongly than women. CONCLUSION: Healthy working persons may be willing partners in genetic research related to physical and mental illnesses in coming years. This project suggests the feasibility and value of evidence-based ethics inquiry, although further study is necessary. Evidence regarding stakeholders' perspectives on ethically important issues in science may help in the development of research practices and policy.

Adult↗

Medical student illness and impairment: a vignette-based survey study involving 955 students at 9 medical schools.

BACKGROUND: Physician impairment is defined by the presence of a physical, mental, or substance-related disorder that interferes with the ability to practice medicine competently and safely. The seeds of impairment may be sown early in adulthood, and medical students experience health issues that may receive insufficient attention in the context of a rigorous training period. Few empirical studies have examined the attitudes of medical students toward recognizing and acting upon signs of potentially impairing illnesses in peers. METHOD: Medical students at 9 medical schools were invited to participate in a written survey exploring personal health care issues during training. As part of this larger project, students were asked to imagine their response in 3 situations to a medical student who is discovered to have serious symptoms and potential impairment secondary to mental illness, substance abuse, or diabetes. RESULTS: Responses were gathered from 955 students (52% overall response rate). For all of the vignettes, "tell no one but encourage him/her to seek professional help" was the most prevalent reaction (45%, 53%, and 49%, respectively) as opposed to seek advice (37%, 35%, and 42%) and notify the Dean's office (18%, 12%, and 9%). Willingness to report varied by school, and women were somewhat less likely to formally report medical student illness. CONCLUSION: This study suggests that medical students attach great importance to preserving the confidentiality of fellow medical students who may experience even very severe symptoms. This pattern may have important implications for the early recognition and treatment of potentially impairing disorders. Greater attention to these issues may help assure the health of early career physicians as well as the many patients whose safety and well-being are entrusted to their care.

Disability Evaluation↗

Do psychiatrists understand research-related experiences, attitudes, and motivations of schizophrenia study participants?

Psychiatrists serve in different but important capacities with research participants. Because ethical problems may arise in research when participants misunderstand motives and responsibilities of clinical-investigators (i.e., "therapeutic misconception"), it is important that relationships between research participants and psychiatric caregivers and investigators be based on genuine mutual understanding. Considerations about attunement of psychiatrists with schizophrenia research participants have never been studied empirically. As part of a larger structured interview-survey study, we assessed the predictions of psychiatrists regarding self-reported experiences, attitudes, and motivations of individual schizophrenia research volunteers who were known to the respondent psychiatrists. Fourteen patient-psychiatrist pairs were identified for inclusion. Psychiatrists predicted schizophrenia research participants' ease of participation, privacy concerns, and willingness to participate in future research but underestimated their positive overall experience. Psychiatrists also were attuned to schizophrenia participants' attitudes and motivations regarding personal benefit but did not accurately predict their responses concerning helping others and science. Also, psychiatrists underestimated the schizophrenia participants' perceived degree of influence by researchers and caregivers during recruitment. Psychiatrists recognized the burden, primary concerns, future participation willingness, and personal benefit orientation of schizophrenia participants, but they did not appear to fully understand the overall positive quality of research experience, altruistic orientation, and relationship orientation of their schizophrenia patients who volunteer for research participation.

Adult↗